SUMMARY CMI

CURAM^® DUO 400/57

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 is my child using Curam Duo 400/57?

Curam Duo 400/57 contains the active ingredients amoxicillin and clavulanic acid. Curam Duo 400/57 is used for the short term treatment of a wide range of infections caused by bacteria. These infections may affect the chest (e.g. bronchitis or pneumonia), bladder (e.g. cystitis), sinuses (e.g. sinusitis), the ears (e.g. otitis media) or the skin.

For more information, see Section 1. Why is my child using Curam Duo 400/57? in the full CMI.

2. What should I know before giving my child Curam Duo 400/57?

Do not use if you have ever had an allergic reaction to amoxicillin, clavulanic acid, other penicillin based antibiotics or similar antibiotics (such as cephalosporins) 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 giving my child Curam Duo 400/57? in the full CMI.

3. What if my child is taking other medicines?

Some medicines may interfere with Curam Duo 400/57 and affect how it works.

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

4. How do I give Curam Duo 400/57?

• Always use this medicine exactly as the doctor or pharmacist has told you to.
• The usual dose of this medicine is one dose taken twice a day. The dose may vary depending on your child's weight.

More instructions can be found in Section 4. How do I give Curam Duo 400/57? in the full CMI.

5. What should I know while giving Curam Duo 400/57?

For more information, see Section 5. What should I know while giving Curam Duo 400/57? in the full CMI.

6. Are there any side effects?

Side effects include diarrhoea, thrust, nausea, vomiting, dizziness, headache, indigestion, skin rash, and itching. Serious side effects include severe allergic reactions, skin reactions, yellowing of skin/eyes (liver problems), and severe diarrhoea.

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

CURAM^® DUO 400/57

Active ingredient(s): amoxicillin trihydrate & potassium clavulanate

Consumer Medicine Information (CMI)

This leaflet provides important information about using Curam Duo 400/57. 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 Curam Duo 400/57.

Where to find information in this leaflet:

1. Why is my child using Curam Duo 400/57?
2. What should I know before giving my child Curam Duo 400/57?
3. What if my child is taking other medicines?
4. How do I give Curam Duo 400/57?
5. What should I know while giving Curam Duo 400/57?
6. Are there any side effects?
7. Product details

1. Why is my child using Curam Duo 400/57?

Curam Duo 400/57 contains two active ingredients. One of these is a penicillin called amoxicillin and the other is clavulanic acid. Curam Duo 400/57 belongs to the penicillin group of antibiotics.

Curam Duo 400/57 is used for the short term treatment of a wide range of infections caused by bacteria. These infections may affect the chest (e.g. bronchitis or pneumonia), bladder (e.g. cystitis), sinuses (e.g. sinusitis), the ears (e.g. otitis media) or the skin.

Curam Duo 400/57 works by killing the bacteria that cause these infections.

Curam Duo 400/57 is used for the treatment of the infections listed. However, the doctor may prescribe these medicines for another use. If you want more information, ask the doctor.

There is no evidence that Curam Duo 400/57 is addictive.

2. What should I know before giving my child Curam Duo 400/57?

Warnings

Do not give Curam Duo 400/57 if:

• your child is allergic to amoxicillin, clavulanic acid, other penicillin based antibiotics or similar antibiotics (such as cephalosporins) or any of the ingredients listed at the end of this leaflet. If your child has ever had an allergic reaction (such as a rash) when taking an antibiotic you should tell the doctor before any Curam Duo 400/57 is given.
  Always check the ingredients to make sure you can use this medicine.
• your child has previously experienced liver problems or jaundice when taking an antibiotic or any other medicines.
• the expiry date (EXP) printed on the pack has passed.
• the packaging is torn or shows signs of tampering.

This medicine is for the person named by the doctor. Do not give this medicine to anyone else.

Check with your doctor if your child:

• has ever had an allergic reaction (such as a rash) to any antibiotics or medicines in the past
• is allergic to foods, dyes, preservatives or any other medicines.
• has glandular fever (mononucleosis) or a blood disorder.
• has liver or kidney problems. The dosage of Curam Duo 400/57 may need to be changed or your child may need to be given an alternative medicine.
• Is not urinating regularly or not able to drink very much.
• has phenylketonuria. Curam Duo 400/57 contains aspartame.
• is required to have urine glucose (sugar) test.
  This medicine may affect the results of these tests.

Curam Duo 400/57 can make some existing conditions worse, or cause serious side effects, such as severe allergic reactions, serious skin reactions, chest pain, repetitive vomiting within 1 to 4 hours of Curam Duo 400/57 administration, serious liver problems or severe diarrhoea or inflammation of the large intestines (pseudomembranous colitis). You must look out for certain symptoms while giving this medicine to your child to help reduce the risk of any problems.

During treatment, your child 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

If your child is pregnant or intend to become pregnant, do not take this medicine without checking with your doctor.

Before taking this medicine, talk to your doctor if your child is breastfeeding or intend to breastfeed.

Your doctor will consider the risks and benefits of this treatment.

3. What if my child is taking other medicines?

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

In particular, tell the doctor if your child is taking any of the following:

• warfarin or other anticoagulants used to prevent blood clots
• mycophenolate
• medicines used to treat gout (e.g. probenecid or allopurinol)
• other antibiotics
• methotrexate (a medicine used to treat cancer or rheumatic diseases
• contraceptive pill. As with other antibiotics, your child may need to use extra birth control methods (e.g. condoms) while taking Curam Duo 400/57.

These may affect how Curam Duo 400/57 works or make it more likely that your child will have side effects.

Some medicines may interfere with Curam Duo 400/57 and affect how it works.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements your child is taking and if these affect Curam Duo 400/57.

4. How do I give Curam Duo 400/57?

Always follow the directions given to you by the doctor or pharmacist. Their directions may differ from the information contained in this leaflet.

Please read the direction label carefully. If you have any concerns about how to give this medicine, talk to the doctor or pharmacist.

How much to give

• Give this medicine as directed by the doctor or pharmacist
• The usual dose of this medicine is one dose taken twice a day. The dose may vary depending on your child's weight.
• Ask your doctor or pharmacist if you are unsure of the correct dose for your child.
• They will tell you exactly how much to give.
• Follow the instructions they give you.
• If you give the wrong dose, Curam Duo 400/57 may not work as well and your child's problem may not improve.

How to give Curam Duo 400/57

• The suspension will be prepared by your pharmacist who checks the seal prior to reconstitution. Shake the bottle well and accurately measure the dose with a measuring spoon. Your pharmacist will explain how many millilitres of suspension will be needed to receive the correct dose.
• Do not use the reconstituted suspension if the colour is not off-white.
• Shaking the bottle and using a measuring spoon will make sure that you get the correct dose. A measuring spoon is included with the product. Make sure the whole dose is swallowed each time.

When to give Curam Duo 400/57

• Give this medicine at about the same time each day.
• Giving this medicine at about the same time each day will have the best effect. It will also help you remember when to give it.
• Curam Duo 400/57 should be given immediately before or with the first mouthful of food. Curam Duo 400/57 works best when given this way. It may also help to prevent stomach upsets. However, this medicine will still work if given without food.

How long to give Curam Duo 400/57

• Continue giving this medicine until the course is finished or for as long as your doctor advises. Do not stop giving this medicine just because your child feels better as the infection can return.
• Do not stop giving Curam Duo 400/57, or change the dose without first checking with your doctor.

If you forget to give Curam Duo 400/57

Give the missed dose as soon as you remember, and continue to give it as you would normally.

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

Do not take a double dose to make up for the dose you missed.

This may increase the chance of your child getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to give the medicine, ask your pharmacist for some hints.

If your child takes too much Curam Duo 400/57

If you think that your child has used too much Curam Duo 400/57, your child may need urgent medical attention.

You should immediately:

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

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

5. What should I know while giving Curam Duo 400/57?

Things you should do

Tell your doctor if, for any reason, your child has not taken this medicine exactly as directed. Otherwise, your doctor may think that it was not effective and change your child's treatment unnecessarily.

If your child is about to be started on any new medicines, tell the doctor or pharmacist that your child is taking Curam Duo 400/57.

Call your doctor straight away if your child:

• develops itching, swelling or a skin rash while taking Curam Duo 400/57, do not give any more this medicine.
• develops severe diarrhoea either while taking this medicine or within several weeks after treatment. Do not give any medication to stop the diarrhoea (e.g. Lomotil^® or Imodium^®).

Remind any doctor, dentist or pharmacist your child visits that your child is using Curam Duo 400/57.

Things you should not do

• Do not give this medicine to anyone else, even if their symptoms seem similar to your child's.
• Do not use this medicine to treat any other complaints unless your child's doctor says to.

Driving or using machines

Be careful before your child drives or uses any machines or tools until you know how Curam Duo 400/57 affects your child.

Looking after your medicine

• Do not keep the bottle of Curam Duo 400/57 longer than 7 days after it has been made up and store in the fridge between 2°C and 8°C. Do not freeze.

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 out of the sight and reach of children.

Getting rid of any unwanted medicine

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

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

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

Reporting side effects

After you have received medical advice for any side effects your child experiences, 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 giving any of your child's medicines.

7. Product details

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

What Curam Duo 400/57 contains

Curam Duo 400/57 does not contain sucrose, gluten, tartrazine or any other azo dyes.

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

What Curam Duo 400/57 looks like

Curam Duo 400/57 powder for suspension – available as an off-white powder, and when reconstituted with water it becomes an off-white suspension.

Available in 120 mL bottles containing 60 mL suspension, with a measuring spoon included. (Aust R 147109).

Who distributes Curam Duo 400/57

Sandoz Pty Ltd
100 Pacific Highway
North Sydney, NSW 2060
Australia

Tel 1800 726 369

This leaflet was prepared in June 2024.

® Registered Trade Mark. The trade marks mentioned in this material are the property of their respective owners.

Published by MIMS September 2024

1 Name of Medicine

Amoxicillin trihydrate and potassium clavulanate.

2 Qualitative and Quantitative Composition

Curam Duo 400/57 contains 400 mg/5 mL amoxicillin (as trihydrate) and 57 mg/5 mL clavulanic acid (as potassium clavulanate).

Excipients with known effect.

3 Pharmaceutical Form

Powder for suspension: off-white powder and off-white suspension.

4 Clinical Particulars

4.1 Therapeutic Indications

Curam Duo 400/57 (amoxicillin and clavulanic acid) is indicated for the short-term treatment of the following bacterial infections when caused by sensitive organisms (see Section 5.1 Pharmacodynamic Properties, Microbiology):
skin and skin structure infections;
urinary tract infections (complicated and uncomplicated);
upper respiratory tract infections including sinusitis and otitis media;
lower respiratory tract infections including acute exacerbations of chronic bronchitis and community acquired pneumonia.
Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to Curam Duo 400/57 (amoxicillin and clavulanic acid). However, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in Microbiology, therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies. Once these results are known, therapy should be adjusted if appropriate.
The treatment of mixed infections caused by amoxicillin susceptible organisms and beta-lactamase producing organisms susceptible to Curam Duo 400/57 (amoxicillin and clavulanic acid) should not require the addition of another antibiotic due to the amoxicillin content of Curam Duo 400/57.

4.2 Dose and Method of Administration

Dosage.

Children aged 2 months up to 12 years.

Method of administration.

Directions for reconstituting the oral suspension.

Dosage adjustment.

Renal impairment.

Hepatic impairment.

4.3 Contraindications

Curam Duo 400/57 (amoxicillin and clavulanic acid) is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.
Curam Duo 400/57 (amoxicillin and clavulanic acid) is contraindicated in patients with a history of allergic reaction to beta-lactams, e.g. penicillins, cephalosporins, carbapenems or monobactams.
Curam Duo 400/57 (amoxicillin and clavulanic acid) is also contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanic acid.

4.4 Special Warnings and Precautions for Use

Use with caution in the following circumstances:
Curam Duo 400/57 (amoxicillin and clavulanic acid) contains aspartame, and should be used with caution in patients with phenylketonuria.
Before initiating therapy with amoxicillin/clavulanic acid, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens.
Serious and occasionally fatal hypersensitivity (including anaphylactoid and severe cutaneous adverse reactions) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with any penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction. Presenting symptoms of such reactions can include chest pain occurring in association with an allergic reaction to amoxicillin/clavulanic acid (see Section 4.8 Adverse Effects (Undesirable Effects)). If an allergic reaction occurs, Curam Duo 400/57 (amoxicillin and clavulanic acid) should be discontinued and the appropriate therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management, including intubation, should also be administered as indicated.
Drug-induced enterocolitis syndrome (DIES) has been reported mainly in children receiving amoxicillin/clavulanate (see Section 4.8 Adverse Effects (Undesirable Effects)). DIES is an allergic reaction with the leading symptom of protracted vomiting (1-4 hours after administration of amoxicillin/clavulanate) in the absence of allergic skin or respiratory symptoms. Further symptoms could comprise abdominal pain, diarrhoea, hypotension or leucocytosis with neutrophilia. There have been severe cases including progression to shock.
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including amoxicillin. A toxin produced by Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). Mild cases usually respond to drug discontinuation alone. However, in moderate to severe cases appropriate therapy with a suitable oral antibiotic agent effective against Clostridium difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated. Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil) may prolong and/or worsen the condition and should not be used.
As with any potent drug, periodic assessment of organ system functions, including renal, hepatic and haemopoietic function is advisable during prolonged therapy.
Since Curam Duo 400/57 (amoxicillin and clavulanic acid) contains amoxicillin, an aminopenicillin, it is not the treatment of choice in patients presenting with sore throat or pharyngitis because of the possibility that the underlying cause is infectious mononucleosis, in the presence of which there is a high incidence of rash if amoxicillin is used.
Curam Duo 400/57 (amoxicillin and clavulanic acid) should be given with caution to patients with lymphatic leukaemia since they are especially susceptible to amoxicillin induced skin rashes.
Amoxicillin/clavulanic acid should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.
Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.
Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin/clavulanic acid and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur (usually involving Aerobacter, Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted.
Cholestatic hepatitis, which may be severe but is usually reversible, has been reported. Signs and symptoms may not become apparent until several weeks after treatment has ceased. In most cases resolution has occurred with time. However, in extremely rare circumstances, deaths have been reported. These have almost always been cases associated with serious underlying disease or concomitant medications. Hepatic events subsequent to amoxicillin and clavulanic acid have occurred predominantly in males and elderly patients and may be associated with prolonged treatment. These events have been very rarely reported in children.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin but does not notably affect clavulanic acid excretion. Concurrent use with Curam Duo 400/57 (amoxicillin and clavulanic acid) may result in increased and prolonged blood levels of amoxicillin but not of clavulanic acid.
The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricaemia present in these patients. There are no data with Curam Duo 400/57 (amoxicillin and clavulanic acid) and allopurinol administered concurrently.
In common with other antibiotics, Curam Duo 400/57 (amoxicillin and clavulanic acid) may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of oral contraceptives. Patients should be warned accordingly.
In the literature, there are rare cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin.
Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.
In patients receiving mycophenolate mofetil, reduction in pre-dose concentration of the active metabolite mycophenolic acid (MPA) has been reported following commencement of oral amoxicillin plus clavulanic acid. The change in pre-dose level may not accurately represent changes in overall MPA exposure. However, close clinical monitoring should be performed during the combination and shortly after antibiotic treatment.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Adverse effects on the ability to drive or operate machinery have not been observed. However, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ability to drive and use machines.

4.8 Adverse Effects (Undesirable Effects)

Amoxicillin and clavulanic acid is generally well tolerated. The majority of events were of a mild and transient nature.

Clinical trials.

Post-marketing.

Infections and infestations.

Cardiac disorders.

Gastrointestinal disorders.

Hepatobiliary.

Nervous system disorders.

Haemopoietic and lymphatic systems.

Hypersensitivity and skin.

Renal and urinary disorders.

Miscellaneous.

Reporting suspected adverse effects.

4.9 Overdose

Problems of overdosage with Curam Duo 400/57 (amoxicillin and clavulanic acid) are unlikely to occur. If encountered, gastrointestinal symptoms and disturbance of the fluid and electrolyte balance may be evident. They may be treated symptomatically, with attention to the water/ electrolyte balance.
Amoxicillin crystalluria, in some cases leading to renal failure, has been observed. (See Section 4.4 Special Warnings and Precautions for Use).
Amoxicillin may be removed from the circulation by haemodialysis.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: combinations of penicillins, incl. beta-lactamase inhibitors; ATC code: J01CR02.

Mechanism of action.

In vitro studies.

Susceptible (S).

Intermediate (I).

Resistant (R).

Note.

Resistance in Streptococcus pneumoniae.

Resistance in Haemophilus influenzae.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Lemon flavouring 15.12.0598 (ARTG PI: 10094), peach-apricot flavour 26F22 (ARTG PI: 10089), citric acid, sodium citrate, aspartame, purified talc, orange 55301 AP0551 (ARTG PI: 12686), guar gum and silicon dioxide. Contains sulfites.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
For information on interactions with other medicines and other forms of interactions, see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

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 dry powder below 25°C. Under these conditions, the shelf life is 3 years.
Store reconstituted suspension at 2°C to 8°C in a refrigerator. Under these conditions, the shelf life is 7 days.

6.5 Nature and Contents of Container

Packaged in 60 mL, 120 mL or 150 mL amber glass bottle with screw closure.
Also contains a 5 mL measuring spoon.
Not all presentations may be marketed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Amoxicillin trihydrate.

Chemical structure.

Potassium clavulanate.

Chemical structure.

CAS number.

Amoxicillin trihydrate.

Potassium clavulanate.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes