Consumer medicine information

Salofalk foam

Mesalazine

BRAND INFORMATION

Brand name

Salofalk Foam

Active ingredient

Mesalazine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Salofalk foam.

SUMMARY CMI

SALOFALK® foam

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using SALOFALK foam?

SALOFALK foam contains the active ingredient mesalazine (5-aminosalicylic acid). SALOFALK foam is used to treat, and prevent relapses of mild to moderate attacks of ulcerative colitis (inflammation of the large bowel).

For more information, see Section 1. Why am I using SALOFALK foam? in the full CMI.

2. What should I know before I use SALOFALK foam?

Do not use if you have ever had an allergic reaction to SALOFALK foam or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use SALOFALK foam? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with SALOFALK foam and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use SALOFALK foam?

  • The usual dose is of SALOFALK foam is two applications once daily at bedtime, although your doctor or pharmacist will tell you exactly how much to use and where to find this information.
  • This medicine may only be used rectally, so it has to be inserted through the anus. Do NOT take it by mouth.

More instructions can be found in Section 4. How do I use SALOFALK foam? in the full CMI.

5. What should I know while using SALOFALK foam?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using SALOFALK foam.
  • Remind them if any new medicines are about to be started.
Things you should not do
  • Do not use SALOFALK foam to treat any complaint other than that directed by your doctor. It may not be safe to use SALOFALK foam for another complaint.
  • Do not give SALOFALK foam to someone else even if their symptoms are the same. It may not be safe for another person to use SALOFALK foam.
Driving or using machines
  • This medicine is not expected to affect your ability to drive a car or operate machinery.
  • However, you should still be careful before you drive or use any machines or tools until you know how SALOFALK foam affects you. SALOFALK foam may cause dizziness in some people.
Looking after your medicine
  • Keep SALOFALK foam in a cool dry place, protected from light, where the temperature stays below 25°C.
  • Do not refrigerate or freeze.
  • Keep away from flames or sparks including cigarettes, SALOFALK foam contains flammable gas. Heat and dampness can destroy some medicines including SALOFALK foam.
  • Keep it where children cannot reach it.
  • A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

For more information, see Section 5. What should I know while using SALOFALK foam? In the full CMI.

6. Are there any side effects?

All medicines can have side effects. If they do occur, they are usually mild and temporary. The most common side effects using SALOFALK foam are: headache, mild stomach pains, excessive gas in the stomach or bowel, increased number of bowel motions, diarrhoea, nausea and vomiting, rash or itchy skin. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? In the full CMI.



FULL CMI

SALOFALK® foam

Active ingredient: mesalazine

Consumer Medicine Information (CMI)

This leaflet provides important information about using SALOFALK foam. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using SALOFALK foam.

Where to find information in this leaflet:

1. Why am I using SALOFALK foam?
2. What should I know before I use SALOFALK foam?
3. What if I am taking other medicines?
4. How do I use SALOFALK foam?
5. What should I know while using SALOFALK foam?
6. Are there any side effects?
7. Product details

1. Why am I using SALOFALK foam?

SALOFALK foam contains the active ingredient mesalazine (5-aminosalicylic acid). Mesalazine is an anti-inflammatory agent used to treat inflammatory bowel disease.

SALOFALK foam is used to treat, and prevent relapses of mild to moderate attacks of ulcerative colitis (inflammation of the bowel).

Ask your doctor if you have any questions about why SALOFALK foam has been prescribed for you.

Your doctor may have prescribed SALOFALK foam for another reason.

Do not give SALOFALK foam to a child below 12 years of age. The safety and effectiveness of SALOFALK foam in this group have not been established.

2. What should I know before I use SALOFALK foam?

Warnings

SALOFALK foam is not addictive.

Do not use SALOFALK foam if:

  • you are allergic to mesalazine, to salicylates such as acetylsalicylic acid (e.g. Aspirin®) or any of the ingredients listed at the end of this leaflet. Signs of allergic reactions may include itchy skin rash, shortness of breath and swelling of the face or tongue.
  • you suffer from a severe kidney or liver problem.
  • the expiry date (EXP) printed on the pack has passed. If you use this medicine after the expiry date has passed, it may not work as well.
  • the product package is torn or shows signs of tampering.
  • Always check the ingredients to make sure you can use this medicine. If unsure, speak to your doctor or pharmacist.

Check with your doctor if you:

  • have any allergies to any other medicines, foods, preservatives or dyes.
  • have or have had any other medical conditions, especially lung or breathing problems such as asthma. SALOFALK foam contains sulfite which may cause an allergic reaction
  • have kidney problems. Kidney stones may develop with use of mesalazine, the active ingredient in SALOFALK foam. Symptoms may include pain in the side of abdomen and blood in urine. Take care to drink sufficient amounts of liquid during treatment with SALOFALK foam.
  • have liver problems.
  • have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after using mesalazine.

If you have not told your doctor about any of the above, tell them before you start to use SALOFALK foam.

Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) have been reported in association with mesalazine treatment. Stop using SALOFALK foam and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in Side effects section below.

SALOFALK foam contains propylene glycol which may cause skin irritation in some people. In addition, propylene glycol may cause drowsiness and confusion in people with kidney problems.

SALOFALK foam also contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

People who take medicines containing mesalazine, such as SALOFALK foam, may notice red-brown discolouration in the toilet bowl. This is due to mesalazine in urine of these people coming in contact with sodium hypochlorite bleach used to clean the toilet. This is the result of a chemical reaction between mesalazine and bleach and is harmless.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed. SALOFALK foam should not be used during breastfeeding as there is no experience using it in breastfeeding women.

Your doctor will discuss the risks and benefits of using SALOFALK foam if you are pregnant or breastfeeding.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

SALOFALK foam may interfere with the action of the following types of medicines:

  • anticoagulants which are medicines used to stop blood clots, e.g. warfarin.

Some medicines may interfere with SALOFALK and affect how it works.

  • glucocorticoids which are medicines used to treat inflammation or swelling, e.g. prednisolone
  • sulphonylureas which are medicines used to lower blood sugar
  • methotrexate which is a medicine used to treat some types of cancer and arthritis.
  • probenecid/sulphinpyrazone which are medicines used to treat gout
  • spironolactone/frusemide which are medicines which lower blood pressure or increase volume of urine
  • rifampicin which is a medicine used to treat tuberculosis
  • azathioprine which is a medicine used to suppress the immune system
  • mercaptopurine or thioguanine which are medicines used to treat leukaemia.

You may need to use different amounts of the above medicines, or you may need to take different medicines when you are using SALOFALK foam. Your doctor or pharmacist will advise you.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect SALOFALK foam.

4. How do I use SALOFALK foam?

How much to use

Follow all directions given to you by your doctor or your pharmacist carefully.

They may differ from the information contained in this leaflet.

  • The usual dose of SALOFALK foam is two applications once daily at bedtime, although the doctor or pharmacist will tell you exactly how much to use and where to find this information.
  • Each SALOFALK foam can contains 80 g of foam which delivers a total of 14 applications, with each application delivering 1g of mesalazine. If your doctor prescribed a dose of 1g/day, you will need to administer one (1) application each day. Alternatively, if your doctor prescribed a dose of 2g/day, you will need to administer two (2) applications each day.

When to use SALOFALK foam

  • SALOFALK foam should be used each evening at bedtime.

How to use SALOFALK foam

If possible, go to the toilet and empty your bowels before using SALOFALK foam.

Store and use SALOFALK foam at room temperature, 20 - 25°C (see also section on storage).

  1. Wash your hands thoroughly with soap and water.
  2. Push the applicator firmly onto the spout of the aerosol can.

  1. Shake the can for 15 seconds each time before use.
  2. Each time you use a new can, remove the safety tab from under the pump dome at the top of the aerosol can.

  1. Each time you use a new can, twist the pump dome in a clockwise direction until the semi-circular gap underneath it is in line with the nozzle. It is now ready to use.

  1. Place your forefinger on top of the pump dome. Turn the aerosol can upside down and keep it upright with the pump dome pointing down for it to work properly.

  1. Stand with one foot on the floor and raise the other foot onto a chair or stool.

  1. Insert the applicator into the rectum as far as is comfortable. To administer SALOFALK foam, push the pump dome in fully once with your index finger and hold for 5 seconds, to prime the aerosol can and then very slowly lift your finger off the pump dome. The foam containing 1 g of mesalazine is now being delivered and you must wait 15 seconds for the dosing to be completed. If you doctor has prescribed 2 g of mesalazine/day, keep the applicator in place and repeat the above process.
  2. Wait a further 15 seconds before slowly withdrawing the applicator from the rectum to allow any residual foam to be released. This is important to reduce the risk of local irritation around your anus.
  3. Remove the applicator from the spout of the aerosol can and dispose of it in the plastic bag provided as domestic waste.

  1. Wash your hands thoroughly and try not to empty your bowels again until the next morning.

You may experience a little discomfort and a feeling of urgency to empty your bowels immediately after the foam insertion. This is normal and expected due to the inflammation present within the bowel. Try to resist this urge to empty your bowels for as long as possible. This feeling will subside as treatment continues and the inflammation decreases.

How long to use SALOFALK foam

Continue using your SALOFALK foam for as long as your doctor tells you.

This medicine helps control your condition but does not cure it. It is important to keep using your SALFALK foam for as long as your doctor tells you, even if you feel well.

If you forget to use SALOFALK foam

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed. If you are not sure what to do, ask your doctor or pharmacist.

If you use too much SALOFALK foam

If you think that you have used too much SALOFALK foam, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26) for advice, or
  • contact your doctor, or
  • go to the Accident & Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

Possible symptoms of overdose may include feeling sick, vomiting and diarrhoea.

5. What should I know while using SALOFALK foam?

Things you should do

Make sure that all of your doctors and pharmacists who are treating you know you are using SALOFALK foam. Remind them if any new medicines are about to be started.

Tell your doctor immediately if you become pregnant or if you wish to breastfeed while using SALOFALK foam.

Things you should not do

  • Do not use SALOFALK foam to treat any complaint other than that directed by your doctor. It may not be safe to use SALOFALK foam for another complaint.
  • Do not give SALOFALK foam to someone else even if their symptoms are the same. It may not be safe for another person to use SALOFALK foam.
  • Do not change the dosage without checking with your doctor.

Driving or using machines

This medicine is not expected to affect your ability to drive a car or operate machinery. However, you should be careful before you drive or use any machines or tools until you know how SALOFALK foam affects you.

SALOFALK foam may cause dizziness in some people.

Looking after your medicine

  • Keep SALOFALK foam in a cool dry place, protected from light, where the temperature stays below 25°C.
  • Do not refrigerate or freeze.
  • Keep away from flames or sparks including cigarettes, SALOFALK foam contains flammable gas. Heat and dampness can destroy some medicines including SALOFALK foam.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

When to discard your medicine

Use SALOFALK foam within 12 weeks of first opening.

Getting rid of any unwanted medicine

Do not pierce or burn the SALOFALK foam can even when empty.

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
  • headache
  • mild stomach pain
  • excessive gas in the stomach or bowel
  • abdominal discomfort
  • diarrhoea
  • anal discomfort
  • anal irritation
  • painful feeling of incomplete emptying of the bowel
  • increased number of bowel motions
  • nausea (feeling sick)
  • rash or itchy skin
  • dizziness
  • common cold
  • fever, muscle aches and pains, painful joints and chest pain (sometimes spreading to the neck and shoulders, and sometimes fever)
  • mild skin rash, itching or hives
  • numbness, tingling or weakness of the arms and legs
  • pain in the upper belly (may be due to inflammation of the pancreas)
  • worsening of ulcerative colitis.
Speak to your doctor if you have any of these mild effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • general allergic reaction such as skin rash, fever, joint pain and/or breathing difficulties or a general inflammation of your large bowel (causing severe diarrhoea and abdominal pain)
  • marked reduction of general health, especially if accompanied by fever and/or sore throat or mouth. Very rarely this can be due to a low white blood cell count (agranulocytosis), which may increase the risk of developing a serious infection. Other blood cells may also be affected (e.g. platelets or red cells causing aplastic anemia or thrombocytopenia) with symptoms which may include unexplained bleeding, purple spots or patches under your skin especially on lips and nails, anemia (feeling tired, weak and looking pale,). A blood test can confirm whether your symptoms are due to this medicine. These reactions are very rare.
  • Serious skin rashes with reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes, widespread rash, fever and enlarged lymph nodes. These can be preceded by fever and flu-like symptoms. These reactions occur in an unknown number of patients (frequency not known).
  • Shortness of breath, chest pain or irregular heartbeat, or swollen limbs which may be indicative of cardiac hypersensitivity reactions. These reactions are rare.
  • Problems with your kidney function (can occur very rarely), e.g. a change in the color or amount of urine produced and swollen limbs or a sudden flank pain (caused by a kidney stone) (occur in an unknown number of patients (frequency not known)). As a precaution, your doctor may have your blood, liver and kidney tested regularly during treatment with this medicine.
Other rare events, which have been reported with mesalazine include:
  • changes in liver function tests
  • liver disease with nausea, vomiting, loss of appetite, feeling generally unwell, abdominal pain, fever, itching, yellowing of the skin and eyes, and dark colored urine
  • allergic, inflammatory or other lung conditions
  • shortness of breath, difficulty breathing, cough, wheezing, chest pain that worsens when breathing, lung shadow on x-ray due to allergic and/or inflammatory lung conditions.
  • increased sensitivity of the skin to sun and ultraviolet light (photosensitivity)
  • reversible decrease in semen production (oligospermia)
  • hair loss and the development of baldness (alopecia)
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

As a precaution, your doctor may have your blood, liver and kidney tested regularly during treatment with SALOFALK foam.

Tell your doctor or pharmacist if you notice anything which is unusual, including anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking/using any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What SALOFALK foam contains

Active ingredient
(main ingredient)		1 g mesalazine in each application
Other ingredients
(inactive ingredients)
  • Sodium metabisulfite
  • polysorbate 60
  • cetostearyl alcohol
  • disodium edetate
  • propylene glycol
  • propane
  • butane
  • isobutane.

Do not take this medicine if you are allergic to any of these ingredients.

What SALOFALK foam looks like

SALOFALK foam is a greyish white to slightly reddish violet, creamy firm foam.

SALOFALK foam carton includes one (1) aerosol can, containing 80 g of foam, 14 applicators for the administration of the foam and 14 plastic bags to dispose of each applicator.

This provides flexibility based on your doctor's prescription. If the prescribed dose is 1g/day, you will use all 14 applicators (a new one each day) over 2 weeks. If the prescribed dose is 2g/day, you will need to administer two (2) doses with one applicator each day. Therefore, you would only need 7 applicators and you can discard the 7 unused applicators with the used can.

Who distributes SALOFALK foam

Dr Falk Pharma Australia Pty Ltd,
815 Pacific Highway,
Chatswood, NSW 2067,
Australia

Australian Registration Number: AUST R 95960

SALOFALK® is a registered trademark of Dr. Falk Pharma GmbH, Germany.

This leaflet was prepared in June 2023.

Published by MIMS October 2023

BRAND INFORMATION

Brand name

Salofalk Foam

Active ingredient

Mesalazine

Schedule

S4

 

1 Name of Medicine

Salofalk Foam mesalazine 1 g/application.

Mesalazine.

2 Qualitative and Quantitative Composition

Salofalk Foam contains 1 g/application mesalazine as the active ingredient.

Excipients with known effect.

Propylene glycol, cetostearyl alcohol, sodium metabisulfite.
See Section 4.4 Special Warnings and Precautions for Use.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Salofalk Foam is a white-greyish to slightly reddish violet, creamy firm foam.

4 Clinical Particulars

4.1 Therapeutic Indications

Salofalk Foam is indicated in the treatment of acute ulcerative colitis of mild to moderate severity and for the maintenance treatment of ulcerative colitis.

4.2 Dose and Method of Administration

Unless otherwise advised a dose of 2 g or 4 g mesalazine as Salofalk Foam once a day is used for the treatment of acute ulcerative colitis or maintenance of remission.
A dose of 2 g Salofalk Foam is equivalent to 2 applications.
Salofalk Foam should be administered at room temperature, 20 - 25°C (please also see Section 6.4 Special Precautions for Storage). For each new canister, a safety tab must first be removed under the pump dome at the top of the canister and then the pump dome must be twisted in a clockwise direction until a semi-circular gap underneath is in line with the nozzle. A new applicator is then fitted on the nozzle and is ready to use. Prior to each administration, the cannister should be shaken for about 15 seconds. The patient should then place one foot on a chair and the other on the floor and turn the canister upside down while keeping it vertical and then gently insert the applicator into the rectum as far as comfortable. To administer a dose of Salofalk Foam, the patient should place their index finger on the pump dome and then fully push it down one time, holding their finger in place for 5 seconds, to prime the canister, prior to slowly lifting their finger off the pump dome. The foam is being released at this time. Note the canister will only work properly when held with the pump dome pointing down. The applicator should be kept in situ for 15 seconds to allow any residual foam to actuate. The above procedure should be repeated for the second dose. Following the second actuation, the applicator should be held in position for a further 15 seconds before being withdrawn from the rectum. This is important to reduce the potential for the anus being exposed to foam and the possibility of local irritation, which might occur if the applicator is withdrawn too quickly. The best results are achieved if the bowels are evacuated prior to instillation of Salofalk Foam. A step-by-step procedure for administration is also included in the Salofalk Foam CMI. The dosage should be adjusted to suit the progress of the condition. Discontinuation of treatment should be under supervision of the physician.
Due to the considerable variation in the severity of the ulcerative colitis and the extent of the affected area it is not possible to recommend a uniform dose of mesalazine which will provide optimal effects. In clinical trials, rectal doses of 2-4 g mesalazine/day as foam have been used in the therapy of both acute ulcerative colitis and maintenance of remission.

Use in children.

Salofalk Foam should not be used in children 12 years old and under, as there is little experience with this age group.

4.3 Contraindications

Salofalk Foam is contraindicated in patients with the following:
Hypersensitivity to salicylic acid, salicylic acid derivatives, e.g. mesalazine/ 5-ASA and sulfites or to any of the other ingredients in the Salofalk Foam.
Severe impairment of hepatic and renal function.
Salofalk Foam should be used with caution in patients with bronchial asthma. It contains sulfite which may cause hypersensitivity reactions.

4.4 Special Warnings and Precautions for Use

Salofalk Foam should be given/used under medical supervision.

Use in pulmonary function impairment.

Mesalazine should be used/given with caution in patients with pulmonary function impairment, particularly asthma and in patients with known hypersensitivity to sulfasalazine containing preparations. Treatment in the latter patients should be instituted with careful medical supervision. Treatment should be discontinued immediately if symptoms of acute intolerance, e.g. cramps, acute abdominal pain, fever, severe headache and skin rash, occur.

Use in hepatic impairment.

Caution is recommended in patients with impaired hepatic function. Salofalk Foam is contraindicated in patients with severe hepatic impairment (see Section 4.3 Contraindications).
As mesalazine might cause hepatic impairment due to hypersensitivity reactions, blood parameters, like blood counts and liver function and cholestasis parameters (e.g. ALT, AST, alkaline phosphatase, γGT) may be monitored like the renal parameters.

Blood dyscrasia.

Serious blood dyscrasias have been reported very rarely with mesalazine. Haematological investigations should be performed if patients suffer from unexplained haemorrhages, bruises, purpura, anaemia, fever or pharyngolaryngeal pain. Salofalk should be discontinued in case of suspected or confirmed blood dyscrasia.

Epigastric pain.

Epigastric pain, also commonly associated with inflammatory bowel disease and prednisone or sulfasalazine therapy, should be investigated in order to exclude pericarditis, hepatitis and pancreatitis either as adverse drug reactions to 5-ASA or secondary manifestations of inflammatory bowel disease. Cardiac hypersensitivity reactions (myocarditis, and pericarditis) induced by mesalazine have been rarely reported. Salofalk should then be discontinued immediately if these reactions occur.

Use in renal impairment.

Mesalazine is not recommended in patients with impaired renal function. The blood and renal status should be determined prior to and during treatment, at the discretion of the treating physician. As a guideline, checks are recommended 14 days after commencement of treatment, then a further 2 to 3 times at 4-weekly intervals. If the findings are normal, follow-up tests should be conducted every three months or immediately if additional signs of the disorder occur. To check renal function, it is recommended that levels of serum urea (BUN) and creatinine be determined as well as performing a urine sediment test. Mesalazine-induced renal toxicity should be considered if renal function deteriorates during treatment. If this is the case, Salofalk should be discontinued immediately.

Nephrolithiasis.

Cases of nephrolithiasis have been reported with the use of mesalazine, including stones with mesalazine content. Ensure adequate fluid intake during treatment.

Severe cutaneous adverse reactions.

Severe cutaneous adverse reactions (SCARs), including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment. Salofalk Foam should be discontinued, at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity.

Urine discoloration.

Mesalazine may produce red-brown urine discoloration after contact with sodium hypochlorite bleach (e.g. in toilets cleaned with sodium hypochlorite contained in certain bleaches).

Use in the elderly.

Specific clinical data in only elderly patients for mesalazine are not available, but mesalazine has been used in patients up to 75 years of age in clinical trials.

Paediatric use.

Salofalk Foam should not be used in children 12 years old and under, as there is little experience with this age group.

Effects on laboratory tests.

Not known to interfere with laboratory tests or physical diagnostic agents.

Excipients with known effect.

This medicine contains 3.44 g propylene glycol in each actuation of Salofalk Foam. Propylene glycol may cause skin irritation, lactic acidosis, hyperosmolality, haemolysis and CNS depression. Care should be taken when administering Salofalk Foam to patients with diminished renal function.
This medicine contains cetostearyl alcohol that may cause local skin reactions (e.g. contact dermatitis).
Salofalk Foam also contains sodium metabisulfite. In isolated cases hypersensitivity reactions principally in the form of respiratory problems may be experienced also by non-asthmatics due to the content of sulphite.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Studies to evaluate the potential interaction between Salofalk Foam and other drugs have not been performed. In common with other salicylates, interactions may occur during concomitant administration of mesalazine and the following drugs.

Coumarin-type anticoagulants.

Possible potentiation of the anticoagulant effect action (increasing the risk of gastrointestinal haemorrhage).

Glucocorticoids.

Possible increase in undesirable gastric effects.

Sulphonylureas.

Possible increase in the blood glucose-lowering effects.

Methotrexate.

Possible increase in toxic potential of methotrexate.

Probenecid/ sulphinpyrazone.

Possible attenuation of the uricosuric effects.

Spironolactone/ frusemide.

Possible attenuation of the diuretic effects.

Rifampicin.

Possible attenuation of the tuberculostatic effects.
There is weak evidence that mesalazine might decrease the anticoagulant effect of warfarin.
In patients who are concomitantly treated with azathioprine, 6-mercaptopurine or thioguanine, possible enhanced myelosuppressive effects of azathioprine, 6-mercaptopurine or thioguanine should be taken into account.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Fertility and reproductive performance were not impaired in rats treated orally with mesalazine prior to and during mating (both sexes) and throughout gestation and lactation (females) at doses up to 320 mg/kg/day, which is less than the maximal recommended clinical dose of Salofalk Foam on a body surface area basis.
(Category C)
There was no evidence of embryotoxicity or teratogenicity in rats and rabbits treated orally with mesalazine during the period of organogenesis at respective doses of up to 320 and 495 mg/kg/day, representing less than, and about twice, the maximal recommended clinical dose of Salofalk Foam on a body surface area basis. Oral mesalazine does not show direct or indirect harmful effects with respect to parturition or postnatal development in animals.
No animal studies with Salofalk Foam have been performed.
Human data on use during pregnancy are limited. No adverse effect of mesalazine on pregnancy or on the health of the foetus/ newborn child was shown. To date no other relevant epidemiologic data are available. In one single case after oral use of 2-4 g mesalazine per day during the 3rd and 5th months of pregnancy, renal failure in the neonate was reported.
Salofalk Foam should only be used during pregnancy if the potential benefit outweighs the possible risk.
 In rats, there were no adverse effects on dams or offspring from oral administration of mesalazine during late gestation and throughout lactation at doses up to 320 mg/kg/day, which is less than the maximal recommended clinical dose of Salofalk Foam on a body surface area basis.
There has been a report of a patient receiving mesalazine suppositories during the lactation period. Twelve hours after the initial dose, the infant developed watery diarrhoea that disappeared on discontinuation of the mesalazine therapy but reappeared on rechallenge. There have been reports of mesalazine and of its metabolite N-acetyl-5-ASA found in breast milk. But, there is no experience with Salofalk Foam in lactating women. Salofalk Foam should not be used during lactation unless the likely benefit of treatment outweighs the potential hazard. If the infant develops diarrhoea, the treatment should be temporarily discontinued and further medical advice sought.

4.7 Effects on Ability to Drive and Use Machines

Mesalazine is generally not expected to affect the ability of patients to drive or operate machinery. However, as Salofalk Foam may cause dizziness, patients should be cautioned about their ability to drive a car and operate machinery.

4.8 Adverse Effects (Undesirable Effects)

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems.
The most common adverse events seen in clinical study are headache, hair loss, abdominal pain, diarrhoea and rash.
In a placebo controlled clinical trial involving 111 patients, the rate of patients reporting at least 1 adverse event is 29.6% and 42.1% in the mesalazine and placebo foam groups, respectively. The absolute and relative frequencies of patients with adverse events by body system are shown in Table 1.
The following adverse events presented by body system have been reported in international post marketing surveillance of all Salofalk preparations including Salofalk Foam. In many cases, the relationship to Salofalk treatment has not been established.
The common (≥ 1 to < 10%) adverse events were as follows:

Body as a whole - general disorders and administration site conditions.

Headache, abdominal distension.

Gastrointestinal system disorders.

Abdominal pain, diarrhoea, nausea and vomiting, flatulence, exacerbation of ulcerative colitis.

Skin and appendages disorder.

Rash including pruritus, urticaria.
The following additional adverse reactions were uncommon and reported by < 1% of patients:

Body as a whole - general disorders and administration site conditions.

Fever, allergic reaction, anal discomfort, application site irritation, painful rectal tenesmus.

Central and peripheral nervous system disorders.

Dizziness, paraesthesia, peripheral neuropathy.

Collagen disorders.

Lupus erythematosus syndrome (as observed for preparations with a similar chemical structure).

Gastrointestinal system disorders.

Acute pancreatitis, pancolitis, neonate diarrhoea.

Liver and biliary system disorders.

Hepatitis, increased liver enzyme values (transaminase activity), intrahepatic cholestasis, increased bilirubin, changes in pancreatic enzymes (lipase and amylase increased), eosinophil count increased.

Musculo-skeletal system disorders.

Arthralgia, myalgia, myositis.

Myo-, endo-, pericardial and valve disorders.

Pericarditis, myocarditis, pericardial effusion.

Platelet, bleeding and clotting disorders.

Thrombocytopenia.

Red blood cell disorders.

Aplastic anaemia, haemolytic anaemia.

Reproductive system disorders.

Oligospermia (reversible).

Respiratory, thoracic and mediastinal disorders.

Allergic and fibrotic lung reactions, dyspnoea, cough, bronchospasm, pleural effusion, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis (in isolated cases hypersensitivity reactions, principally in the form of respiratory problems, may be experienced by non-asthmatics due to the content of sodium metabisulfite).

Skin and appendages disorders.

Alopecia, allergic exanthema, increased sweating.

Urinary system disorders.

Acute or chronic interstitial nephritis, renal insufficiency, renal failure, nephrotoxicity.

White cell and RES disorders.

Agranulocytosis, leukopenia, neutropenia, pancytopenia.
The following additional adverse events were rare and reported by < 0.1% of patients:

Skin and appendages disorders.

Photosensitivity.
(More severe reactions are reported in patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema).
The following additional adverse events were very rare and reported by < 0.01% of patients:

Liver and biliary system disorders.

Cholestatic hepatitis.
The frequency of the following adverse events is not known:

Urinary system disorders.

Nephrolithiasis (see Section 4.4 Special Warnings and Precautions for Use).

Skin and subcutaneous tissue disorders SOC.

Drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN).
Severe cutaneous adverse reactions (SCARs), including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment (see Section 4.4).

4.9 Overdose

There are rare data on overdosage (e.g. intended suicide with high oral doses of mesalazine), which do not indicate renal or hepatic toxicity.
Possible symptoms may include nausea, vomiting and diarrhoea and symptoms similar to salicylate overdose.
There is no specific antidote. General supportive and symptomatic measures are recommended.
For information on the management of overdosage, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Mesalazine has been identified as the active component of sulfasalazine in inflammatory bowel disease and is thought to have a topical action. The mechanism of action by which mesalazine protects the mucosa in chronic inflammatory bowel disease is not yet fully known.
Mesalazine seems to act in multiple ways against several inflammatory mediators and principles. The results of in vitro investigations indicate that inhibition of lipoxygenase may play a role. Effects on prostaglandin concentrations in the intestinal mucosa have also been demonstrated, as has an influence on leukotriene production. Mesalazine may also function as a radical scavenger of reactive oxygen compounds.

Clinical trials.

The criteria used to evaluate the efficacy of the substance in the therapy of ulcerative colitis are frequency of bowel movements, rectal haemorrhage, abdominal pain, general well being, temperature, extra intestinal manifestations, ESR and haemoglobin. These criteria have been summarised in the clinical activity index (CAI) to evaluate the efficacy of treatment for ulcerative colitis.
In a multi-centre, randomised, double blind, placebo-controlled study (SAF-4/UCA) involving 111 patients, the efficacy of Salofalk 2 g/60 mL foam in the therapy of ulcerative colitis was significantly better than that of placebo at six weeks. The response rate was 64.8% vs. 40.4% placebo (p = 0.0082). The study showed an endoscopic improvement of 70.4 vs. 45.6% in the placebo group.
Results of the studies and post marketing reports show that Salofalk Foam is well tolerated in patients with ulcerative colitis.

5.2 Pharmacokinetic Properties

General considerations.

The efficacy of mesalazine (5-ASA) appears to be determined not by the systemic but the local availability of the substance at the target site.

Absorption.

The systemic absorption of mesalazine decreases in the intestinal tract from the proximal to distal segments. Because of low systemic absorption rates from oral delayed release preparations or rectal applications forms of mesalazine, the main elimination route is via faeces.

Distribution.

The plasma protein binding of mesalazine and acetylated mesalazine is 43% and 78%, respectively.

Metabolism.

Metabolism of mesalazine occurs mainly in the intestinal mucosa and, to a lesser extent, in the liver. The main metabolite is N-acetyl-5-aminosalicylic acid, which, similar to mesalazine, is predominantly eliminated by the renal and faecal routes. It appears to have no therapeutic activity or specific toxic effects. The acetylation step appears irreversible. As metabolism occurs mainly in the intestinal mucosa, it has not been possible to differentiate between a rapid and slow acetylation form as in the case of sulfasalazine/sulfapyridine.

Excretion.

Systemically absorbed mesalazine and N-acetyl-5-ASA are eliminated mainly via kidneys. Biliary excretion is a minor route of elimination.

Salofalk Foam.

In an open, randomised, cross-over study, healthy volunteers were given a daily total of 7 doses of Salofalk Foam, with dose consisting of 2 actuations equivalent to 2 g mesalazine per day. The Cmax values after the first and last dose (steady state, 7 doses) are 985.1 nanogram/mL at tmax of 2.3 h and 774.9 nanogram/mL at tmax of 2.4 h, respectively. A summary of the pharmacokinetic data is presented in Table 2:
In an open, non-randomised, single dose study, patients with active ulcerative proctitis or proctosigmoiditis were administered a single dose of foam consisting of 2 actuations, equivalent to 2 g mesalazine. Results showed a Cmax value of 1661.3 nanogram/mL for mesalazine at tmax of 1.3 hour, and for N-acetyl-5-ASA a median Cmax of 1579.3 nanogram/mL at a tmax of 2.4 hours. The urinary recovery of 5-ASA + N-acetyl-5-ASA within 48 hours after single dose application of 2 g mesalazine was 5.5%. Pharmacokinetic data for Salofalk Foam in patients with active ulcerative proctitis or protosigmoiditis are summarised in Table 3:
There is little pharmacokinetic data available for rectal administered mesalazine in children. There is no pharmacokinetic data in the elderly using Salofalk Foam.
Scintigraphic evaluation of samarium (153Sm) labelled Salofalk Foam versus Salofalk enema showed that there is no significant difference in the rectal spread and intestinal distribution between the two dosage forms. Tables 4 and 5 show the rectal and intestinal distribution of Salofalk Foam versus Salofalk enema in patients with left-sided ulcerative colitis and healthy subjects.
The rectal and intestinal distribution of a single dose of Salofalk Foam (2 g) and a single dose of Salofalk enema (2 g/60 mL) in healthy subjects:
The rectal and intestinal distribution of a single dose of Salofalk Foam (2 g) and a single dose of Salofalk enema (2 g/60 mL) in patients with left-sided ulcerative colitis:

5.3 Preclinical Safety Data

Genotoxicity.

There was no evidence of genotoxic potential with mesalazine in bacterial gene mutation assays, of chromosomal damage in mouse haematopoietic cells following a single oral dose, or of increases in sister chromatid exchange frequencies in Chinese hamster bone marrow following a single intraperitoneal dose.

Carcinogenicity.

There was no evidence of carcinogenicity in rats treated with mesalazine in the diet for 127 weeks at doses up to 320 mg/kg/day, associated with plasma concentrations of mesalazine and N-acetyl-5-ASA of 1- and 6-fold the respective clinical plasma concentrations associated with a 1500 mg dose of the granules and the 4 g/60 mL enema.

6 Pharmaceutical Particulars

6.1 List of Excipients

Salofalk Foam contains sodium metabisulfite, polysorbate 60, cetostearyl alcohol, disodium edetate, propylene glycol, propane, butane and isobutane.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Do not refrigerate or freeze.
This is a pressurised container, containing 3.75% by mass of flammable propellant. It should be kept away from any flames or sparks, including cigarettes. It should be protected from direct sunlight and must not be pierced or burnt even when empty. Do not refrigerate or freeze. Actuated containers should be used up within 12 weeks.

6.5 Nature and Contents of Container

Salofalk Foam is available in an aluminium pressurised container with a metering valve containing 80 g of foam and 14 disposable PVC applicators for the administration of the foam. The disposable unit consists of an applicator tip protected by a polyethylene tray and lubricated with white soft paraffin and liquid paraffin. The unit has a one-way valve to prevent back flow of the dispensed product. Each can contains sufficient foam for 14 applications (equivalent to 7 doses of 2 g mesalazine).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Mesalazine is a white to greyish, voluminous powder, slightly pink in colour. It is practically insoluble in ethanol (90%), methanol (70%), water, ether and chloroform, soluble in HCl (warmed 10% solution); soluble in NaOH (10% solution, with salt formation).
Proper name: 5-Aminosalicylic Acid, chemical name: 2-hydroxy-5-aminobenzoic acid, also referred to as 5-amino salicylic acid or 5-ASA. C7H7NO3 = 153.1.

Chemical structure.


CAS number.

89-57-6.

7 Medicine Schedule (Poisons Standard)

Schedule 4.

Summary Table of Changes