Imflac Tablets

Imflac Tablets is a brand of medicine containing the active ingredients diclofenac sodium (anti-inflammatory medicines (NSAIDs)).

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

IMFLAC

IMFLAC (diclofenac sodium) 25 mg enteric coated tablets


Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the common questions about IMFLAC. It does not contain all the available information. It does not take the place of talking to your pharmacist or doctor.

All medicines have risks and benefits. Your pharmacist or doctor will be able to advise you about the risks and benefits of taking IMFLAC.

If you have any concerns about taking this medicine, ask your pharmacist or doctor. Keep this leaflet with the medicine. You may want to read it again.

What IMFLAC is used for

IMFLAC contains the active ingredient diclofenac sodium.

IMFLAC is used for the temporary relief of pain associated with inflammation, (including sprains, strains, and minor back and joint pain) migraine headaches, period pain, dental pain and tendonitis e.g. tennis elbow.

IMFLAC belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

IMFLAC acts by reducing pain and swelling. It will not cure your condition.

There is no evidence that IMFLAC is addictive.

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Before you take IMFLAC

When you must not take IMFLAC

Do not take IMFLAC if you are allergic to:

  • diclofenac (active ingredient) or any of the inactive ingredients listed at the end of this leaflet under Product Description.
  • Aspirin
  • Any other NSAID medicine

Many medicines that are use to treat headache, period pain and other aches and pains contain aspirin or other NSAID medicines. If you are not sure if you are taking any of these medicines, ask your pharmacist. Symptoms of an allergic reaction to these medicines may include:

  • Asthma, wheezing or shortness of breath
  • Swelling of the face, lips or tongue which may cause difficulty in breathing
  • Hives, itching or skin rash
  • Fainting

If you are allergic to aspirin or other NSAID medicines and take IMFLAC, these symptoms may be severe.

Do not take IMFLAC if at the present time you have an ulcer (gastric or duodenal) or are bleeding from the stomach or bowel. If you take IMFLAC your stomach problem may become worse.

Do not take IMFLAC if it has passed the expiry date shown on the packaging or if the packaging appears to have been tampered with.

Do not give IMFLAC to a child under 14 years of age. IMFLAC is not recommended for use in children under 14 years of age, as there is not enough information on its use in children under that age.

If you are not sure whether you should be taking IMFLAC, talk to your pharmacist or doctor.

Before you start to take IMFLAC

Tell your pharmacist or doctor if you are allergic to other medicines, foods, dyes or preservatives.

Tell your pharmacist or doctor if you have now or ever had:

  • Ulcers (gastric or duodenal)
  • Severe attacks of indigestion or other stomach trouble
  • Disease of the bowel (e.g. Crohn's disease, ulcerative colitis)
  • Bleeding from your rectum (back passage)

Tell your pharmacist or doctor if you have any of these health problems / medical conditions at the present time:

  • Heart disease
  • Kidney disease
  • Liver disease
  • High blood pressure
  • A tendency to bleed or other blood problems such as anaemia
  • Asthma

Your pharmacist or doctor may want to take special precautions if you have any of these conditions.

Tell your pharmacist or doctor if you have an infection at the present time. If you take IMFLAC while you have an infection, some of the signs may be hidden (pain, fever, swelling, redness). You may think mistakenly, that you are better or that the infection is not serious.

Tell your pharmacist or doctor if you are pregnant or are planning to become pregnant or are breast feeding while you will be using IMFLAC. Like most NSAID medicines, IMFLAC is not recommended to be used during pregnancy or while breast feeding. Your pharmacist or doctor can discus with you the benefits and risks of taking IMFLAC.

If you have not told your pharmacist or doctor about any of these things, tell him/her before you take IMFLAC.

Taking other medicines

Tell your pharmacist or doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop. In particular, tell your pharmacist or doctor if you take any of the following:

  • Aspirin, salicylates or other NSAID medicines
  • Warfarin, a medicine used to stop blood clots
  • Digoxin, a heart tablet
  • Lithium, a medicine used to treat some types of depression
  • Diuretics, also called fluid or water tablets
  • Antidiabetic agents, for diabetes
  • Methotrexate, a medicine used for treatment of rheumatoid arthritis, as well as some types of cancers
  • Cyclosporin, a medicine used after organ transplants, as well as in the treatment of rheumatoid arthritis,
  • Certain antibiotics called quinolones
  • Glucocorticoids, a group of anti-inflammatory medications

These medicines may be affected by IMFLAC, or may affect how well IMFLAC works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your pharmacist or doctor will advise you.

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How to take IMFLAC

Follow directions given to you by your pharmacist or doctor carefully. These instructions may differ from the information contained in this leaflet. If you do not understand any of the instructions, ask your pharmacist or doctor for advice.

How much to take

For most painful conditions the usual dose is 2 tablets initially, followed by either 1 or 2 tablets at 8 hourly intervals as required.

In milder cases, as well as in children over the age of 14 years old, 1 to 2 tablets initially, followed if necessary by 1 tablet at 8 hourly intervals, is usually enough.

For menstrual pain (period pain) the usual dose is 2 to 4 tablets at first sign of symptoms. You may need to take 2 tablets up to three times daily for the next few days as required.

For migraine headache the usual dose is 2 tablets at the first sign of a migraine attack. If the pain is not relieved within 2 hours, a further 2 tablet may be taken. After that dose, you must wait at least 4 hours before taking anymore IMFLAC.

Do not take more than 8 tablets in 24 hours, for relief of any of the above conditions.

For migraine attacks do not take more than 8 tablets in 24 hours even if you have had more than one migraine attack within that 24 hour period. See your pharmacist or doctor if symptoms persists.

How to take IMFLAC

IMFLAC tablets should be swallowed whole with a full glass of liquid. You may take it with or immediately after food in order to reduce the chance of stomach upset.

Do not lie down for about 15 to 30 min after taking the tablets. This helps them to reach your stomach quickly and prevents throat irritation, which could lead to problems with swallowing.

How long to take it

Do not take IMFLAC for longer than your pharmacist or doctor advises. It is usually taken for a short time only (up to 1 week). For menstrual cramps (period pain), the tablets are usually taken during each period as soon as cramps begin and continued for a few days until the pain goes away.

If you forget to take your dose

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

Otherwise, take your dose as soon as you remember, and continue to take it as you would normally.

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

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

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) or go to accident and emergency at your nearest hospital, if you think that you or anyone else has taken too much IMFLAC. Do this even if there is no signs of discomfort or poisoning.

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While you are using IMFLAC

Things you must do

If you become pregnant while taking IMFLAC, tell your pharmacists or doctor immediately. He / she can discuss with you the risk of using it while you are pregnant.

If you are to be started on any new medicine, remind your pharmacist and doctor that you are taking IMFLAC.

Take IMFLAC as directed by your pharmacist or doctor. If you do not follow these instructions your condition may not improve or you may have unwanted side effects. If, for any reason you have not taken your medicine exactly as directed or as described in this leaflet, tell your pharmacist or doctor. Otherwise he/she may think that it was not effective and change your treatment unnecessarily.

If you feel the medicine is not helping, tell your pharmacist or doctor.

If you are going to have surgery, make sure the surgeon and the anaesthetist know that you are taking IMFLAC. NSAID medicines can slow down blood clotting.

If you get an infection while taking IMFLAC tell your pharmacist or doctor. This medicine can hide some signs of an infection (pain, fever, swelling, redness). You may think mistakenly, that you are better or that the infection is not serious.

Tell any doctor, dentist or pharmacist that treats you that you are on IMFLAC.

Things you must not do

Do not take any of the medicines listed below while you are taking IMFLAC without first consulting your pharmacist or doctor.

  • Aspirin (alao called ASA or acetylsalicylic acid)
  • Other salicylates
  • Other forms of diclofenac.
  • Any other NSAID medicines

If you take these medicines together with IMFLAC, they may cause unwanted side effects. If you need to take something for a headache or fever, it is usually okay to take paracetamol. If you are not sure ask your pharmacists or doctor.

Do not give this medicine to anyone else even if their condition seems similar to yours.

Do not take Imflac to treat any other complaint unless your doctor or pharmacist advises you to do so.

Things to be careful of

Make sure you know how you react to Imflac before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy. IMFLAC may cause dizziness or light-headedness in some people.

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Side effects

All medicines can have unwanted effects. Sometimes they are serious, most of the time they are not

If you are over the age of 65 years old, you should be especially careful while taking this medicine. Report any side effects promptly to your pharmacist or doctor. As people get older they are more likely to get side effects from this medicine.

Do not be alarmed by this list of possible side effects. You may not experience any of them. If you have any problems ask your pharmacist or doctor to answer any questions that you might have.

The most common side effects seen in patients taking diclofenac preparations are:

  • stomach upset including nausea, vomiting, heartburn, indgestion, cramps
  • loss of appetite
  • constipation, diarrhoea. Pain in the stomach, wind
  • dizziness, light headeness
  • drowsiness, sleepiness, disorentation
  • buzzing or ringing in the ears
  • change in mood, i.e. feeling depressed, anxious or irritable
  • trembling, sleeplessness, nightmares
  • headache
  • sore mouth or tongue
  • hair loss or thinning
  • altered taste sensation
  • rashes

These are the more common side effects of IMFLAC. Mostly, these are mild and short-lived.

If any of the following happen tell your doctor immediately:

  • severe pain or tenderness in the stomach
  • signs of frequent or worrying infections such as fever, sever chills, sore throat or moth ulcers
  • bleeding or bruising more easily than normal; reddish or purplish blotches under the skin
  • signs of anaemia such as tiredness, being short of breath, looking pale
  • a change in the colour of urine passed, blood in the urine
  • a change in the amount or frequency of urine passed, burning feeling when passing urine
  • signs of a liver problem such as tiredness, lack of energy, itching of the of the skin, yellowing of the skin and eyes, pain in the abdomen
  • unusual weight gain, swelling of the ankles or legs
  • symptoms of sunburn (such as redness, itching, swelling, blistering) which may occur more quickly than normal
  • eye problems such as blurred or double vision
  • severe dizziness, spinning sensations
  • severe or persistent headache
  • tingling or numbness of the hands or feet
  • fast or irregular heart beat, also called palpitations
  • difficulty hearing

These are serious side effects. You may need urgent medical attention or hospitalisation. All of these side effects are rare.

If any of the following happen , STOP taking IMFLAC and tell your doctor immediately or go to the Accident and emergency at your nearest hospital

  • vomiting blood or material that looks like coffee grounds
  • bleeding from the back passage, black sticky stools or bloody diarrhoea
  • swelling of the face, lips or tongue which may cause difficulty swallowing or breathing
  • asthma, wheezing, shortness of breath
  • sudden or severe itching, skin rash or hives
  • fainting or seizures (fits)
  • pain or tightness in the chest

These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

Other side effects not listed above may also occur in some people. Tell your doctor if you notice any other effects.

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After using IMFLAC

Storage

Keep IMFLAC in the original packaging until you need to take it.

Store below 25°C in a dry place. Do not leave or store IMFLAC in the bathroom, near a sink or stove, on a windowsill or in a car. Heat and dampness can destroy some medicines.

Keep IMFLAC 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.

Disposal

Return any unused or out of date medicine to your pharmacist.

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Product Description

What IMFLAC looks like

IMFLAC tablets are round, brown-yellow film coated tablets. IMFLAC tablets are available in blister packs of 3 , 5, 10, 15, 20, 25, 30 tablets.

Ingredients

Active Ingredient

Diclofenac sodium

Other ingredients (excipients)

Lactose, calcium hydrogen phosphate, microcrystalline cellulose, maize starch, sodium starch glycollate, magnesium stearate, colloidal silicon dioxide, methacrylic acid copolymer, triethyl citrate, talc, titanium dioxide and yellow ferric oxide.

Supplier

Douglas Pharmaceuticals Australia Ltd
3/10 Inglewood Place
Norwest Business Park
Baulkham Hills
NSW 2153

IMFLAC tablets blister AUST RXXXX

Date of most resent amendment 6 May 2002

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CMI provided by MIMS Australia, September 2016  

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