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1. Tolfenamic Acid 200mg Tablets
2. Tolfenamic Acid 200mg Tablets

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Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Clotam Rapid is and what it is used for

2.    Before you take Clotam Rapid

3.    How to take Clotam Rapid

4.    Possible side effects

5.    How to store Clotam Rapid

6.    Further information

1.    WHAT CLOTAM RAPID IS AND WHAT IT IS USED FOR

Tolfenamic acid is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain. Clotam Rapid is effective in treating the pain associated with an acute attack of migraine in adults.

2.    BEFORE YOU TAKE CLOTAM RAPID Do not take Clotam Rapid if you

•    are allergic (hypersensitive) to tolfenamic acid or any of the other ingredients of Clotam Rapid (See section 6 for a full listing)

•    have previously experienced allergic reactions (e.g. asthma, nasal discharge, nettle rash or swelling of the face, lips, tongue or throat) when taking ibuprofen, aspirin or other NSAIDs

•    have severe liver, kidney or heart failure

•    are pregnant in the last three months of your pregnancy

•    have or have ever had a peptic ulcer or peptic bleeding (ulcer or bleeding in your stomach or duodenum)

•    have ever had bleeding in your digestive tract due to NSAID treatment

The use of this medicine in children is not recommended.

Take special care with Clotam Rapid if you

•    are taking other NSAIDs including NSAIDs known as COX-2 inhibitors

•    are elderly

•    have or have had asthma

•    have decreased heart, liver or kidney function

•    have had high blood pressure

•    have had a gastrointestinal disease (Crohn's disease or inflammation of the colon and rectum)

•    have a connective tissue disease such as systemic lupus erythematosus (SLE)

If any of the above applies, you should inform your doctor before taking Clotam Rapid.

Warnings

Medicines such as Clotam Rapid may be associated with a small increased risk of heart attack f myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is particularly important of the following as they may affect, or be affected by, Clotam Rapid:

•    Any other NSAIDs (including aspirin), as Clotam Rapid may increase the risk of undesirable effects

•    Cardiac glycosides (heart medicines), as Clotam Rapid may increase the risk of undesirable effects and aggrevate heart failure

•    Corticosteroids (used to treat various inflammatory conditions), as Clotam Rapid may increase the risk of gastrointestinal undesirable effects

•    Quinolones (antibiotics), as Clotam Rapid may increase the risk of developing convulsions

•    Tacrolimus, ciclosporin (medicines used to suppress the immune system), as Clotam Rapid may increase the risk of kidney problems

•    Water tablets (diuretic medicine), as Clotam Rapid may increase the risk of kidney problems

•    Medicines used to treat anxiety and depression known as selective serotonin re-uptake inhibitors (SSRIs)

•    Medicines used to treat high blood pressure

•    Mifepristone (abortion pill)

•    Lithium (used to treat certain mental conditions)

•    Methotrexate (used to treat e.g. cancer, psoriasis and rheumatism)

•    Blood thinners such as warfarin or aspirin

•    Zidovudine (used in cases of HIV infection)

Taking Clotam Rapid with food and drink

Clotam Rapid should be taken with or after food. Drink a glass of water with your medicine.

Pregnancy

Do not use Clotam Rapid if you are pregnant. Ask your doctor for advice before taking any medicine.

•    If you become pregnant during treatment with Clotam Rapid, you should stop taking the medicine and consult your doctor.

•    Clotam Rapid may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Breast-feeding

Do not use Clotam Rapid if you are breast-feeding. Ask your doctor for advice before taking any medicine.

Driving and using machines

Clotam Rapid may cause dizziness, drowsiness, exhaustion and visual disturbances. If you are affected by these, do not drive or use machines.

3. HOW TO TAKE CLOTAM RAPID Dosage

Always take Clotam Rapid exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will prescribe a dose suitable for you. Depending on your response the dose may be repeated once after 1 -2 hours. The tablets should be taken orally (by mouth).

The tablets should be swallowed whole. Drink a glass of water with your medicine.

The usual dose is:

Adults: Migraine - acute attacks: 200mg when the first symptoms of migraine appear. The treatment can be repeated once after 1 -2 hours if a satisfactory effect is not obtained.

Children: Use in children is not recommended.

Elderly: Your doctor will prescribe a suitable dose for you.

If you take more Clotam Rapid than you should

If you have taken more Clotam Rapid than you should, contact your doctor or your local hospital immediately.

If you forget to take Clotam Rapid

Do not take a double dose to make up for a forgotten dose.

If you stop taking Clotam Rapid

It is very important that you take your medicine as your doctor nas told you to. You should not suddenly stop taking Clotam Rapid, before you have spoken to your doctor about it. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Clotam Rapid can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

If you suffer from any of the following side effects at any time during your treatment STOP TAKING the medicine and seek immediate medical help:

•    Pass blood in your faeces (stools/motions)

•    Pass black tarry stools

•    Vomit any blood or dark particles that look like coffee grounds

STOP TAKING the medicine and tell your doctor if you experience:

•    Indigestion or heartburn

•    Stomach pain or other abnormal stomach symptoms

If any of the following serious side effects occur, STOP TAKING this medicine and contact your doctor immediately or go straight to the casualty ward at your nearest hospital.

•    Peptic ulcer (belching, discomfort in the stomach, vomiting)

•    Gastrointestinal bleeding

•    An allergic shock reaction (shortness of breath, rash or wheezing)

•    Swelling of the face, lips, tongue or throat

•    Serious skin reactions such as toxic epidermal necrolysis (the top layer of the skin peels off in sheets)

•    Lack of a type of white blood cells (flu-like symptoms, cold, high fever, sore throat)

•    Decrease in the number of all blood cells (flu-like symptoms, fatigue, dizziness, spontaneous bleedings)

•    Meningitis (stiff neck, headache, fever or disorientation)

•    Reddish or purplish spots on the skin

•    Hallucinations

•    Inflammation of the liver (yellowing of the skin or whites of the eyes)

•    Inflammation of the kidney and kidney failure (urination disturbances)

•    Bloody stool

•    Vomiting of blood

•    Allergic reactions such as asthma, aggravated asthma, wheezing, difficulty of breathing

Other side effects include the following and you should inform your doctor as soon as you notice any of these:

•    Swelling

•    Nausea

•    Vomiting

•    Diarrhoea

•    Flatulence (wind)

•    Constipation

•    Indigestion

•    Stomach pain

•    Inflammation of the mouth or stomach

•    Worsening of gastrointestinal diseases (Crohn's disease or inflammation of the colon and rectum)

•    Rash

•    Itching

•    Nettle rash

•    Visual disturbances

•    Headache

•    Sensation of pins and needles on the skin

•    Depression

•    Confusion

•    Tinnitus

•    Trembling or shaking

•    Feeling of elation

•    Dizziness

•    Vague feeling of weakness

•    Exhaustion

•    Drowsiness

•    Slight pain when passing urine

•    Discolouration of urine (little more lemon coloured)

•    Decreased liver or kidney function

•    Sensitivity to light

Medicines such as Clotam may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

5.    HOWTO STORE CLOTAM RAPID

Keep out of the reach and sight of children. Do not store above 25°C. Do not use Clotam Rapid after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION What Clotam Rapid contains

•    The active substance is tolfenamic acid.

•    The other ingredients are: Maize starch, sodium starch glycollate, macrogol, alginic acid, microcrystalline cellulose, croscarmellose sodium, silica colloidal anhydrous and sodium stearyl fumarate.

What Clotam Rapid looks like and contents of the pack

Clotam Rapid 200mg is a white, oval, convex, scored tablet, with the markings FM7 and GEA on one side.

Clotam Rapid is packed in blisters with 10 tablets.

Marketing Authorisation Holder

A/S GEA Farmaceutisk Fabrik, Edvard Thomsens Vej 14,

2300 Copenhagen S, Denmark.

Manufacturer

FAMAR S.A.,7 Anthoussas Av., 153 44 Anthoussa Attiki, Greece or

SandozA/S, Edvard Thomsens Vej 14,2300 Copenhagen S, Denmark

Distributed by: Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA, UK.

Latest revision: October 2012