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.

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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 used 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. Your doctor will want to know if you are prone to allergies, especially if you get skin reactions with redness, itching or rash.

Do not take this medicine if you have now or have ever had:

  • an ulcer (stomach or intestinal)
  • bleeding from the stomach or bowel (symptoms of which may include blood in your stools or black stools)
  • severe kidney or liver problems
  • severe heart failure

Do not take this medicine during the last three months of pregnancy. Use of this medicine during the last three months of pregnancy may affect your baby and may delay labour and birth.

Do not breastfeed if you are taking this medicine. The active ingredient in Imflac Tablets passes into breast milk and there is a possibility that your baby may be affected.

Imflac tablets should not be taken by children

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

  • liver or kidney function problems
  • currently suffering from any infection
  • past history of ulcers (stomach or intestinal)
  • gastrointestinal problems such as stomach ulcer, bleeding or black stools, or have experienced stomach discomfort or heartburn after taking anti-inflammatory medicines in the past
  • severe attacks of indigestion, or any other stomach or bowel disorder in the past (e.g. Crohn’s disease, ulcerative colitis)
  • a rare liver condition called porphyria
  • asthma or any other lung disease that causes difficulty in breathing
  • seasonal allergies (e.g. hay fever)
  • repeated chest infection
  • polyps in the nose
  • diabetes
  • recent major surgery
  • a tendency to bleed or other blood problems such as anaemia
  • history of haemorrhoids (piles) or irritation of the rectum (back passage)
  • any other problems with your heart or blood vessels, including disease of the heart with shortness of breath, and swelling of the feet or lips due to fluid build-up; high blood pressure or significant risk of high level of fat in your blood, diabetes or if you smoke, as treatment with Imflac Tablets is not recommended, and if your doctor decides to prescribe Imflac Tablets you must not increase the dose above 100 mg per day if you are treated for more than 4 weeks
  • dehydration (e.g. due to sickness, diarrhoea, before or after recent major surgery)
  • swollen feet.

It is generally important to take the lowest dose that relieves your pain and/or swelling and for the shortest time possible in order to keep your risk for heart problems or high blood pressure as small as possible.

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 doctor or pharmacist if you are pregnant or plan on becoming pregnant or are breastfeeding. There is not enough information to recommend the use of this medicine during the first 6 months of pregnancy and it must not be used during the last 3 months. This medicine may also reduce fertility and affect your chances of becoming pregnant. Your doctor or pharmacist can discuss with you the risks and benefits involved.

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 or selective serotonin-reuptake inhibitors (SSRIs), a medicine used to treat some types of depression
  • Diuretics, also called fluid or water tablets
  • Warfarin or other “blood thinners” ( medicines used to prevent blood clotting)
  • Antidiabetic agents, for diabetes
  • Methotrexate, a medicine used for treatment of rheumatoid arthritis, as well as some types of cancers
  • Cyclosporin, tacrolimus ( medicines used after organ transplants, as well as in the treatment of rheumatoid arthritis)
  • Certain antibiotics called quinolones
  • Glucocorticoids, a group of anti-inflammatory medications
  • ACE inhibitors or beta-blockers, medicines used to treat high blood pressure, heart conditions, glaucoma and migraine
  • Corticosteroids, medicines such as prednisone and cortisone, which reduce the activity of your immune system
  • Antacids used for indigestion. You can still take these medicines while you are taking IMFLAC. However, you must take IMFLAC at least 1 hour before or 2 hours after taking any antacid to make sure there is no problem with adsorption.
  • Voriconazole, a medicine used to treat fungal infections
  • Sulfinpyrazone, a medicine used to treat gout
  • Phenytoin, a medicine used in treatment of epilepsy
  • Trimethoprim ( a medicine used to treat urinary tract infections)

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

Adults
The usual dosage is one or two tablets two to three times a day when necessary.

Not recommended for use in children.

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 tablets may be taken. After that dose, you must wait at least 4 hours before taking any more 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 persist.

How to take IMFLAC

The tablets should be swallowed whole with a full glass of water. Do not chew them. The tablets have a special coating to stop them from dissolving until they have gone through the stomach into the bowel. If you chew them, the coating is destroyed.

When to take Imflac Tablets

Take your medicine with or immediately after a meal. If you take it on an empty stomach, it may cause stomach upset.

How long to take Imflac Tablets

Imflac Tablets are for short term use only.

If pain persists for more than 3 days, please see your doctor.

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 sign of discomfort or poisoning.

Symptoms of an overdose may include: nausea, vomiting, gastrointestinal haemorrhage, diarrhoea, abdominal pain, drowsiness, tinnitus (ringing in the ears) or convulsions, headache, dizziness and blurred vision

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While you are using IMFLAC

Things you must do

If you become pregnant while taking IMFLAC, tell your pharmacist 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 at any time while taking IMFLAC, you experience any signs or symptoms of problems with your heart or blood vessels such as chest pain, shortness of breath weakness or slurring of speech, contact your doctor immediately.

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 and affect kidney function.

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 (also called ASA or acetylsalicylic acid)
  • Other salicylates
  • Other forms of diclofenac
  • ibuprofen
  • Any other NSAID medicine

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

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • stomach or abdominal pain, abdominal cramps, wind, indigestion, loss of appetite
  • heartburn or pain behind or below the breastbone (possible symptoms of an ulcer in the tube that carries food from the throat to the stomach)
  • nausea (feeling sick), vomiting
  • constipation, diarrhoea
  • sore mouth or tongue
  • altered taste sensation
  • anorexia
  • rashes
  • dizziness, spinning sensation (vertigo)
  • drowsiness, disorientation, forgetfulness
  • feeling depressed, anxious or irritable
  • strange or disturbing thoughts or moods
  • shakiness, sleeplessness, nightmares
  • tingling or numbness of the hands or feet
  • feeling of fast or irregular heart beat
  • unusual weight gain or swelling of arms, hands, feet, ankles or legs due to fluid build up
  • symptoms of sunburn (such as redness, itching, swelling, blistering of the lips, eyes, mouth, and/or skin) that happen more quickly than normal
  • skin inflammation with flaking or peeling
  • blurred or double vision
  • buzzing or ringing in the ears, difficulty hearing
  • hypertension (high blood pressure)
  • hair loss or thinning
  • headache.

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

  • signs of possible blood vessel inflammation such as red or purple skin
  • signs of possible stomach problems such as severe pain or tenderness in the stomach, vomiting blood or material that looks like coffee grounds, bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea
  • signs of allergy such as: rash, skin rash with blisters, itching or hives on the skin; swelling of the face, lips, mouth, tongue, throat or other part of the body which may cause difficulty to swallow; low blood pressure (hypotension), shortness of breath, wheezing, troubled breathing, or feelings of tightness in the chest
  • peptic ulceration and gastrointestinal bleeding may occur in some patients. If you feel unusually weak and tired, or notice blood in your faeces, together with severe stomach pain, stop taking the tablets and see your doctor immediately.
  • signs of liver problem such as persistent nausea, loss of appetite, unusual tiredness, vomiting, pain in the upper abdomen, yellowing of skin and/or eyes, dark urine or pale bowel motions
  • signs of a possible blood problem such as constant “flu-like” symptoms (chills, fever, sore throat, aching joints, swollen glands, tiredness or lack of energy), bleeding or bruising more easily than normal signs of serious skin reaction such as painful red areas, large blisters, peeling of layers of skin, bleeding in the lips, eyes, mouth, nose or genitals. These signs may be accompanied by fever and chills, aching muscles and feeling generally unwell.
  • signs of a possible effect on brain, such as sudden and severe headache, stiff neck, severe nausea, dizziness, numbness, difficulty in speaking, paralysis, convulsions (fits)
  • signs of possible kidney disorders such as a change in the colour or amount of urine passed, frequent need to urinate, burning feeling when passing urine, blood in the urine or excess protein in the urine
  • fainting or seizures (fits)
  • signs of cardiac failure such as breathlessness, difficulty breathing when lying down, swelling of the feet or legs
  • chest pain, which may be a sign of a heart attack.

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. 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 and 30 tablets.

(not all pack sizes are marketed)

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.

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Supplier

Amneal Pharma Australia Pty Ltd
12 River St,
South Yarra
VIC 3141

IMFLAC tablets blister AUST R 90103

This leaflet was prepared in March 2016

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CMI provided by MIMS Australia, February 2017  

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