CLOTAM RAPID, TOLFENAMIC ACID 200 MG TABLETS - patient leaflet, side effects, dosage

In this leaflet:

• 1. What Tolfenamic Acid 200mg Tablets are and what they are used for

• 2. Before you take Tolfenamic Acid 200mg Tablets

• 3. How to take Tolfenamic Acid 200mg Tablets

• 4. Possible side effects

• 5. How to store Tolfenamic Acid 200mg Tablets

• 6. Further information

1. WHAT TOLFENAMIC ACID 200MG TABLETS ARE AND

Tolfenamic acid is one of a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain. Tolfenamic Acid 200mg Tablets are effective in treating the pain associated with an acute attack of migraine in adults.

• 2. BEFORE YOU TAKE TOLFENAMIC ACID 200MG

TABLETS

Do not take Tolfenamic Acid 200mg Tablets if you

• are allergic (hypersensitive) to tolfenamic acid or any of the other ingredients of Tolfenamic Acid 200mg Tablets (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 in your last three months of 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 Tolfenamic Acid 200mg Tablets 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 Tolfenamic Acid 200mg Tablets.

Warnings

Medicines such as Tolfenamic Acid 200mg Tablets may be associated with a small increased risk of heart attack (“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, Tolfenamic Acid 200mg Tablets:

• Any other NSAIDs (including aspirin), as Tolfenamic Acid 200mg Tablets may increase the risk of undesirable effects
• Cardiac glycosides (heart medicines), as Tolfenamic Acid 200mg Tablets may increase the risk of undesirable effects and aggrevate heart failure
• Corticosteroids (used to treat various inflammatory conditions), as Tolfenamic Acid 200mg Tablets may increase the risk of gastrointestinal undesirable effects
• Quinolones (antibiotics), as Tolfenamic Acid 200mg Tablets may increase the risk of developing convulsions
• Tacrolimus, ciclosporin (medicines used to suppress the immune system), as Tolfenamic Acid 200mg Tablets may increase the risk of kidney problems
• Water tablets (diuretic medicine), as Tolfenamic Acid 200mg Tablets 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 Tolfenamic Acid 200mg Tablets with food and drink Tolfenamic Acid 200mg Tablets should be taken with or after food. Drink a glass of water with your medicine.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask you doctor or pharmacist for advice before taking this medicine.

Abnormalities have been reported in babies whose mothers have taken NSAIDs during pregnancy. You should not take tolfenamic acid during the last three months of pregnancy as it may affect the baby’s kidney function and circulation, blood clotting in both the mother and baby, and labour.

Tolfenamic Acid should be avoided if you are breast-feeding, as small amounts of the medicine may pass into the breast milk.

Tolfenamic Acid 200mg Tablets 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.

Driving and using machines

Tolfenamic Acid 200mg Tablets may cause dizziness, drowsiness, exhaustion and visual disturbances. If you are affected by these, do not drive or use machines.

3. how to take tolfenamic acid 200mg tablets

Dosage

Always take Tolfenamic Acid 200mg Tablets 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 Tolfenamic Acid 200mg Tablets than you should

If you have taken more Tolfenamic Acid 200mg Tablets than you should, contact your doctor or your local hospital immediately.

If you forget to take Tolfenamic Acid 200mg Tablets Do not take a double dose to make up for a forgotten dose.

If you stop taking Tolfenamic Acid 200mg Tablets

It is very important that you take your medicine as your doctor has told you to. You should not suddenly stop taking Tolfenamic Acid 200mg Tablets, 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, Tolfenamic Acid 200mg Tablets can cause side effects, although not everybody gets them.

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 Tolfenamic Acid 200mg Tablets may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store tolfenamic acid 200mg tablets

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use Tolfenamic Acid 200mg Tablets 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 Tolfenamic Acid 200mg Tablets contain

• 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 Tolfenamic Acid 200mg Tablets look like and contents of the pack

In this leaflet:

1. What Tolfenamic Acid 200mg Tablets are and what they are used for

_ 2. Before you take Tolfenamic Acid 200mg Tablets

• 3. How to take Tolfenamic Acid 200mg Tablets

• 4. Possible side effects

• 5. How to store Tolfenamic Acid 200mg Tablets

• 6. Further information

1. WHAT TOLFENAMIC ACID 200MG TABLETS ARE AND

Tolfenamic acid is one of a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain. Tolfenamic Acid 200mg Tablets are effective in treating the pain associated with an acute attack of migraine in adults.

• 2. BEFORE YOU TAKE TOLFENAMIC ACID 200MG TABLETS

Do not take Tolfenamic Acid 200mg Tablets if you

• are allergic (hypersensitive) to tolfenamic acid or any of the other ingredients of Tolfenamic Acid 200mg Tablets (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 in your last three months of 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 Tolfenamic Acid 200mg Tablets 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 Tolfenamic Acid 200mg Tablets.

Warnings

Medicines such as Tolfenamic Acid 200mg Tablets may be associated with a small increased risk of heart attack (“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, Tolfenamic Acid 200mg Tablets:

• Any other NSAIDs (including aspirin), as Tolfenamic Acid 200mg Tablets may increase the risk of undesirable effects
• Cardiac glycosides (heart medicines), as Tolfenamic Acid 200mg Tablets may increase the risk of undesirable effects and aggrevate heart failure
• Corticosteroids (used to treat various inflammatory conditions), as Tolfenamic Acid 200mg Tablets may increase the risk of gastrointestinal undesirable effects
• Quinolones (antibiotics), as Tolfenamic Acid 200mg Tablets may increase the risk of developing convulsions
• Tacrolimus, ciclosporin (medicines used to suppress the immune system), as Tolfenamic Acid 200mg Tablets may increase the risk of kidney problems
• Water tablets (diuretic medicine), as Tolfenamic Acid 200mg Tablets 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 Tolfenamic Acid 200mg Tablets with food and drink

Tolfenamic Acid 200mg Tablets should be taken with or after food. Drink a glass of water with your medicine.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask you doctor or pharmacist for advice before taking this medicine.

Abnormalities have been reported in babies whose mothers have taken NSAIDs during pregnancy. You should not take tolfenamic acid during the last three months of pregnancy as it may affect the baby’s kidney function and circulation, blood clotting in both the mother and baby, and labour.

Tolfenamic Acid should be avoided if you are breast-feeding, as small amounts of the medicine may pass into the breast milk.

Tolfenamic Acid 200mg Tablets 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.

Driving and using machines

Tolfenamic Acid 200mg Tablets may cause dizziness, drowsiness, exhaustion and visual disturbances. If you are affected by these, do not drive or use machines.

3. how to take tolfenamic acid 200mg tablets

Dosage

Always take Tolfenamic Acid 200mg Tablets 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 Tolfenamic Acid 200mg Tablets than you should

If you have taken more Tolfenamic Acid 200mg Tablets than you should, contact your doctor or your local hospital immediately.

If you forget to take Tolfenamic Acid 200mg Tablets Do not take a double dose to make up for a forgotten dose.

If you stop taking Tolfenamic Acid 200mg Tablets

It is very important that you take your medicine as your doctor has told you to. You should not suddenly stop taking Tolfenamic Acid 200mg Tablets, 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.

-----

Like all medicines, Tolfenamic Acid 200mg Tablets can cause “ side effects, although not everybody gets them.

J 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 Tolfenamic Acid 200mg Tablets may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store tolfenamic acid 200mg tablets

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use Tolfenamic Acid 200mg Tablets 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 Tolfenamic Acid 200mg Tablets contain

• 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 Tolfenamic Acid 200mg Tablets look like and contents of the pack

Tolfenamic Acid 200mg Tablets are white, oval, convex, scored tablets, with the markings FM7 and GEA on one side.

Tolfenamic Acid 200mg Tablets are 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

Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

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

This leaflet was last revised in 03/2015

31031439

1 1/03/2015