iMedi.co.uk

Tambocor Xl 200mg Capsules

Patient Information Leaflet

Tambocor XL 200 mg Capsules

Flecainide acetate

Read all of this leaflet carefully before you start taking

this medicine because it contains important information for you.

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

•    I f you have any further questions, ask your doctor or nurse.

•    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.

What is in this leaflet:

1.    What Tambocor XL is and what it is used for

2.    what you need to know before you take Tambocor XL capsules

3.    How to take Tambocor XL capsules

4.    Possible side effects

5.    How to store Tambocor XL capsules

6.    Contents of the pack and other information.

1. What Tambocor XL is and what it is used for

Tambocor XL capsules belong to a group of medicines called anti-arrhythmics. Anti-arrhythmics work by controlling the rate and rhythm of the heart.

Tambocor XL capsules are used to treat:

•    I rregular heart beat (arrhythmias)

•    Heart beat too fast (tachycardia)

•    Rapid contractions of muscles in the heart (atrial fibrillation).

Tambocor XL capsules are not used for initial therapy. They are only used as maintenance therapy after your condition is under control.

2. What you need to know before you take Tambocor XL capsules

Do not take Tambocor XL capsules and tell your doctor or nurse if:

•    You are allergic to active substance flecainide acetate or any of the other ingredients of Tambocor XL capsules (See section 6)

•    You have heart failure

•    You have cardiogenic shock (your heart is unable to pump as much blood as your body needs)

•    You have had a heart attack (myocardial infarction)

•    Your heart misses beats (have heart block)

•    You have long-standing rapid contractions of muscles in the heart (atrial fibrillation)

•    You have or have ever had any heart problems including problems with the valves in your heart or conduction problems

•    You have a specific condition where your heart beats abnormally (sinus node dysfunction)

•    You are pregnant or breast-feeding.

•    You have Brugada Syndrome, a genetic disease that causes severe disturbances of the rhythm of the heart and may lead to sudden death in apparently healthy individuals.

Tambocor XL capsules are not recommended for use in children under l2 years of age, however, dairy products such as milk, infant formula and possibly yoghurt, may reduce how much Tambocor XL is absorbed in children and infants.

If any of the above applies to you tell your doctor or nurse.

Before you take Tambocor XL capsules your doctor or nurse may check:

•    Your fluid levels are correct

•    Your liver and kidney functions.

This is to check that Tambocor XL capsules are right for you and to help the doctor calculate the dose you need.

Check with your doctor or nurse before taking Tambocor XL capsules if:

•    You have high blood pressure

•    You have chest pains (angina)

•    You have heart disease

•    You have kidney disease or kidney problems

•    You have liver disease or liver problems

•    You wear a pacemaker.

Tell your doctor or nurse if you are taking any of the following medicines:

•    Any other medicine used to treat irregular heart beat (heart arrhythmias) or heart problems. Examples of such medicines include cardiac glycosides, beta-blockers, verapamil, propranol or amiodarone

•    Medicines to treat high blood pressure

•    Medicines used to treat depression (antidepressants), such as tricyclic antidepressants, Prozac, fluoxetine, paroxetine or reboxetine

•    Medicines used to prevent epileptic fits (anticonvulsants) such as phenytoin, phenobarbital or carbamazepine

•    Medicines to treat mental illness (antipsychotics) such as clozapine

•    Medicines to treat allergic reactions (antihistamines) such as mizolastine or terfenadine

•    Medicine to treat malaria (quinine)

•    Medicine to treat HIV such as ritonavir, lopinavir or indinavir

•    Water tablets (diuretics)

•    Medicine to treat stomach ulcers (cimetidine)

•    Medicine to help stop you smoking (bupropion)

•    Any other medicine, including medicines obtained without a prescription.

These medicines may interfere with your treatment.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nurse or doctor for advice.

Driving and using machines:

Driving ability, operation of machinery and work without a secure fit may be affected by adverse reactions such as dizziness and visual disturbances (if present).

3. How to take Tambocor XL capsules

Always take Tambocor XL capsules exactly as your doctor has told you.

Important:

Your doctor will choose the dose that is right for your condition. Usually your treatment with Tambocor XL capsules will be started under hospital supervision.

Remember: Tambocor XL capsules are not used for initial therapy. They are only used as maintenance therapy after your condition is under control.

Tambocor XL capsules should be swallowed whole with some water. They should not be broken open or chewed. If you have switched from a different formulation (e.g. from an injection of Tambocor) your doctor should do so with caution and monitor you closely.

Adults

•    The usual dose is one 200 mg capsule per day.

•    Occasionally your doctor may decide you need a higher or lower dose than this. If this is the case your doctor may prescribe Tambocor tablets.

The elderly and patients with kidney or heart problems

•    For elderly patients, and patients with kidney or heart problems, the doctor may tell you to take a lower dose.

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While you are taking this medicine, your doctor may ask you to have check-ups. These are to make sure that your medicine is working properly and that the dose you are taking is right for you.

Children

• Tambocor XL capsules are not recommended for children under 12 years of age, however, dairy products such as milk, infant formula and possibly yoghurt, may reduce how much Tambocor XL is absorbed in children and infants.

If you take more Tambocor XL capsules than you should

If you accidentally take too much, immediately go to the nearest hospital casualty department.

If you forget to take Tambocor XL capsules

Do not take a double dose to make up for a missed dose. Simply take the next dose as planned.

If you stop taking Tambocor XL capsules

Do not stop taking Tambocor XL capsules without first talking to your doctor.

If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines Tambocor XL capsules can cause side effects, although not everybody gets them.

Some side effects could be serious. If you have any of the side effects listed below, seek immediate medical help:

Common (affects 1 in 100 people):

•    Your heartbeat changes; it starts to pound, or it gets faster or slower

•    You have chest pain

•    You become breathless or have other breathing or lung problems

•    You have a fever, become flushed or sweat.

•    You faint or you feel faint Rare (affects 1 in 10,000 people):

•    You have ringing in your ears

•    Your skin and eyes begin to go yellow (jaundice)

•    You have fits (convulsions)

Other side effects (how often they happen is unknown):

   heart attack

   cardiac failure/arrest (loss of breathing, and consciousness and loss of heart function)

Other side effects include the following, if they get serious, please tell your doctor:

Very common (affects more than 1 in 10 people):

•    Dizziness

•    Double or blurred vision Common (affects 1 in 100 people):

•    Feeling week or tired

•    Lack of energy and strength

•    Swelling (fluid retention)

Uncommon (affects 1 in 1,000 people):

•    Blood disorders (reduced red and white blood cell count and reduced platelet count)

•    Feeling or being sick

•    Constipation

•    Stomach pain or indigestion

•    Loss of appetite

•    Diarrhoea

•    Wind

•    Feeling bloated

•    Red, itchy or swollen skin rash

•    Hair loss

Rare (affects 1 in 10,000 people):

•    Vertigo (feeling like the room is spinning)

•    Confusion and hallucinations

•    Depression

•    Feeling anxious (worried)

•    Forgetfulness

•    Difficulty sleeping

•    Numbness, tingling, tickling, prickling or burning sensation of the skin

•    Unsteady walking, uncontrolled movements or poor coordination, difficulty speaking

•    Reduced sense of touch

•    Excessive sweating and flushed skin

•    Shaking (tremors)

•    A strong desire to sleep or sleep for long periods

•    Headache

Very rare (affects less than 1 in 10,000 people):

•    Small cloudy spots on the eyeball

•    Sensitivity of the skin to sunlight

Other side effects (how often they happen is unknown):

•    I ung disease and scarring of the lungs

•    I iver disease 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: www.mhra.gov.uk/yellowcard

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

5.    How to store Tambocor XL capsules

Keep out of the reach and sight of children.

Do not store above 25 °C.

Keep the container in the outer carton to protect the capsules from light and moisture.

Do not use Tambocor XL capsules after the expiry date 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. Return any medicine you no longer need to your pharmacist.

6.    Contents of the pack and other information

What Tambocor XL capsules contain

•    The active substance in Tambocor XL capsules is flecainide acetate. Each 200 mg capsule contains 200 mg flecainide acetate.

•    The other ingredients are microcrystalline cellulose (E 460i), methacrylic acid - methyl methacrylate copolymer, macrogol 400, talc (E 553b), gelatin, titanium dioxide (E 171), iron oxide black (E 172), and erythrosine (E 127), shellac (E 904) and propylene glycol (E 152).

•    Ingredients for printing ink, n-butyl alcohol, purified water, shellac glaze, iron oxide black (E 172), propylene glycol, dehydrated ethanol, isopropylene glycol, dehydrated ethanol, isopropyl alcohol, ammonium hydroxide 28 % or shellac, dehydrated lcohol, isopropyl alcohol, propylene glycol, strong ammonia solution, black iron oxide (E172), potassium hydroxide, purified water.

What Tambocor XL capsules look like

Tambocor XL 200 mg capsules are light grey and pink with ‘3M 200’ printed in black ink.

Tambocor XL 200mg capsules come in packs containing 15, 30 or 60 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Meda Pharmaceuticals Ltd, Skyway House, Parsonage Road, Takeley, Bishop’s Stortford, CM22 6PU, UK.

Manufacturer:

3M Health Care Limited, 1 Morley Street, Loughborough, Leicester, LE11 1EP, UK.

This leaflet was last revised 12/2014.

If this leaflet is difficult to see or read and you would like it in a different format, please contact Meda Pharmaceutical Ltd, Skyway House, Parsonage Road, Takeley, Bishop’s Stortford, CM22 6PU, UK.

6204 2365 3 56UK1833410-02 Tambocor is a trademark of MEDA AB. The Triangle Logo on the packaging is a trademark of 3M and is used under license.

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