PACKAGE LEAFLET: INFORMATION FOR THE USER

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Rimactane® 300 mg Capsules

rifampicin

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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any of the side-effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Rimactane is and what it is used for

2.    What you need to know before you take Rimactane

3.    How to take Rimactane

4.    Possible side effects

5.    How to store Rimactane

6.    Contents of the pack and other information

A SANDOZ

What Rimactane is and what it is used for

Rimactane Capsules contain a medicine called rifampicin. It belongs to a group of medicines called anti-bacterials. It works by killing the bacteria that cause infections.

Rimactane Capsules are used to treat the following bacterial infections:

•    In combination with other drugs for the treatment and prevention of tuberculosis (also known as TB), an infectious disease mainly affecting the lungs and some other infections

•    Prevention of meningococcal meningitis.

What you need to know before you take Rimactane

Do not take Rimactane if you:

•    are allergic to active substance or to any of the other ingredients of this medicine (listed in section 6).

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

•    have jaundice - yellowing of the skin or whites of the eyes caused by liver or blood problems.

•    are taking saquinavir or ritonavir for an HIV infection (see ‘Other medicines and Rimactane’ section below).

Do not take if any of the above applies to you. If you

are not sure, talk to your doctor or pharmacist

before taking Rimactane Capsules.

Warnings and precautions

Talk to your doctor or pharmacist before taking

Rimactane if you:

•    have a rare blood disorder called ‘porphyria’.

•    have or previously had any liver problem.

•    have any kidney problems and if you are having more than 600 mg rifampicin per day.

•    have a history of alcohol dependence.

•    have taken a course of rifampicin in the past.

•    have diabetes. Your diabetes may become more difficult to control while taking this medicine.

•    feel numb or weak in your arms and legs (peripheral neuropathy).

•    are under weight or malnourished.

•    wear contact lenses. Taking Rimactane Capsules may permanently stain soft contact lenses. Do not wear soft contact lenses whilst you are taking this medicine and for one week after stopping treatment.

•    the person taking this medicine is a child.

•    are aged 65 years or older.

Mental health, epilepsy and motor neurone

medicines

•    for thought disorders known as ‘antipsychotics’ such as haloperidol

•    to calm or reduce anxiety (hypnotics, anxiolytics)

•    to help you sleep (barbiturates)

•    used for epilepsy such as phenytoin

•    used for depression such as amitriptyline and nortriptyline

•    riluzole - used for motor neurone disease.

Medicines for infections and the immune

system

•    used for viral infections such as indinavir, efavirenz, amprenavir, nelfinavir, atazanavir, lopinavir and neviparine

•    used for fungal infections

•    used for bacterial infections (antibiotics)

•    used for lowering your immune system such as ciclosporin, sirolimus and tacrolimus

•    praziquantel - used for tapeworm infections

•    atovaquone - used for pneumonia

•    fexofenadine- used for allergies.

Hormone and cancer medicines

•    some hormone medicines (estrogen, systemic hormones, progestogens) used for contraception or some types of cancer such as ethinyloestradiol, levonorgestrel or dydrogesterone

•    some hormone medicines (anti-estrogens) used for breast cancer or endometriosis such as tamoxifen, toremifene and gestrinone

•    used for cancer (cytotoxics) such as imatinib

•    levothyroxine (thyroid hormone) used for thyroid problems

•    irinotecan - used for cancer.

Pain, inflammation and gout medicines

•    non-steroidal anti-inflammatory drugs (NSAIDS) such as etoricoxib, aspirin and indometacin

•    used for pain such as codeine, morphine, fentanyl or pethidine

•    corticosteroids used for inflammation such as hydrocortisone, betamethasone and prednisolone

•    methadone - used for heroin withdrawal.

Other medicines

•    used for diabetes

•    used to relax muscles before surgery (anaesthetics) such as halothane

•    used for feeling sick or being sick such as ondansetron and aprepitant

•    quinine - used for malaria

•    theophylline - used for wheezing or difficulty in breathing

•    fesoterodine - used for overactive bladder

•    tadalafil - used for impotence

•    cimetidine - used for ulcer-healing drugs.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Rimactane Capsules.

Blood Tests

Your doctor will need to check your blood before you take this medicine. This will help your doctor know if any changes happen to your blood after taking this medicine. You may also need to have regular blood tests to check how your liver is working.

Other medicines and Rimactane

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Rimactane Capsules can affect the way some other medicines work. Also some medicines can affect the way Rimactane Capsules work.

In particular, do not take this medicine, and tell your doctor, if you are taking:

•    Saquinavir or ritonavir used for HIV infection.

The following medicines can make Rimactane Capsules work less well:

•    Antacids used for indigestion. Take Rimactane Capsules at least 1 hour before taking antacids

•    Other medicines used for TB such as P-aminosalicyclic acid (PAS). PAS and Rimactane Capsules should be taken at least 8 hours apart.

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

Heart and blood medicines

•    for high blood pressure, heart disorders or to control your heartbeat such as

-    digoxin

-    antiarrhythmics (e.g. quinidine, lorcainide, disopyramide)

-    beta blockers (e.g. propanolol, atenolol)

-    calcium channel blockers (e.g. nifedipine, verapamil)

-    ACE inhibitors (e.g. enalapril, imidapril)

-    vasodilators (e.g. bosentan)

-    water tablets (diuretics) such as eplerenone

•    used to thin the blood such as warfarin

•    used to lower cholesterol

•    used to reduce blood lipid level such as simvastatin, fluvastatin.

Taking Rimactane with food and drink

Take Rimactane on an empty stomach. This means at least 30 minutes before food or 2 hours after food. Do not drink any alcohol while you are taking Rimactane.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, plan to get pregnant or think you are pregnant.

Rimactane may make the contraceptive “pill” work less well. This means you should change to a different type of contraception. Instead, you must use a reliable barrier method of contraception such as condoms or the “coil” while taking Rimactane. If you have any questions or are unsure about this talk to your doctor or pharmacist.

You should not breast-feed if you are taking Rimactane. This is because small amounts may pass into the mothers’ milk. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine.

Driving and using machines

You may feel dizzy or faint, have problems with vision or have other side effects that could affect your ability to drive while taking this medicine. If this happens, do not drive or use any tools or machines.

Rimactane contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3 How to take Rimactane

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Take your medicine on an empty stomach. The best time to take it is half an hour before a meal with water.

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For the treatment of tuberculosis:

Adults: 450 mg or 600 mg Rimactane daily, depending on your weight, for 6-9 months.

Children: 10 mg to 20 mg per kg of body weight daily for 6-9 months. The maximum dose is 600 mg each day.

Occasionally the Rimactane dose is given 2-3 times a week instead of daily.

Rimactane must always be taken with at least one and preferably two other anti-tuberculosis drugs.

For the prevention of meningococcal meningitis:

Adults: 600 mg twice a day for 2 days.

Children over 1 month: 10 mg per kg every 12 hours for 2 days.

Children under 1 month: 5 mg per kg every 12 hours for 2 days.

The maximum dose is 600 mg.

If you are not sure how many capsules to take, ask your doctor or pharmacist.

Second time (or subsequent) treatment

If you have been treated with Rimactane before, your doctor will probably start with a smaller dose.

If you take more Rimactane than you should

If you take more Rimactane than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you.

This is so the doctor knows what you have taken. You may feel sick (nausea), be sick (vomiting), have stomach pain, itching or a headache. You may also feel tired, sleepy, dizzy or light-headed. Other signs of taking too much includes swelling of the face, eyes or eyelids, slurring of speech, difficulty breathing, fast heartbeat, uneven heartbeats, fits and heart attack.

If you forget to take Rimactane

If you forget to take a tablet you should take it as soon as you remember. However, if this is within 2 hours of your next dose you should skip the missed capsule and carry on taking the rest of your capsules as usual.

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

If you stop taking Rimactane

Keep taking Rimactane until your doctor tells you to stop. Do not stop taking Rimactane just because you feel better. If you stop, your infection may get worse. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Tests

Taking Rimactane may affect the results of some blood tests. In particular, tests for folate, vitamin B12 and liver function. If you are going to have a blood test, it is important to tell your doctor that you are taking Rimactane.

•    a painful rash of dark red spots under the skin which do not go away when you press on them (purpura)

•    brain haemorrhage (bleeding)

•    disturbances in the menstrual cycle (in extreme cases absence of a menstrual period)

•    worsening of Addison disease (failure of adrenal glands)

•    worsening of porphyria (a type of blood disorder).

Very rare side effects - affects less than 1 out of 10,000 people

•    blood disorders (low white blood cells).

You may notice a reddish colour in your urine, sweat, phlegm (sputum), saliva or tears. This is quite common and you need not worry. However, the red colour may permanently stain soft contact lenses. The red colour in tears may last for some time after you have stopped taking the capsules. Do not wear lenses until you are sure your tears are colourless.

Blood tests

•    A blood test may show changes in the way the liver is working.

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 (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 Rimactane

Keep this medicine out of the sight and reach of children.

Do not take this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

Rimactane should be kept in the original package, in a safe, dry place at room temperature (below 30°C).

Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines no longer use. These measures will help protect the environment.

Contents of the pack and other information

4 Possible side effects

Like all medicines, this medicine can cause side-effects although not everybody gets them.

Serious side effects:

If you have any of the following symptoms of a serious side effect stop taking this medicine and tell your doctor immediately or go to the casualty department at your nearest hospital:

•    You get blistering, peeling, bleeding, scaling or fluid filled patches on any part of your skin. This includes your lips, eyes, mouth, nose, genitals, hands or feet. You may have a serious skin problem.

•    Allergic reactions causing rashes, fever, difficulty breathing, swallowing problem, wheezing, swelling of the face, lips, tongue, throat, hands or feet.

•    Serious liver problems such as hepatitis or jaundice (yellowing of the whites of the eyes and skin).

•    Flu-like symptoms including chills, fever, headache, dizziness and bone pains may be followed by bleeding into the skin, breathing difficulties, asthma-like attacks, anaemia, shock and kidney failure.

Other side effects:

Common side effects - affects less than 1 out of 10 people

•    flushing, itching with or without skin rash or eye irritation and redness

•    loss of appetite (anorexia)

•    stomach pains, feeling sick (nausea)

•    gaseous distension and upset stomach

•    headache, dizziness, unusual tiredness, weakness, drowsiness, light-headedness

•    hair loss

•    Asymptomatic increase in liver enzymes.

Uncommon side effects - affects less than 1 out of 100 people

•    urticarial (hives) and more serious hypersensitivity cutaneous reactions.

Rare side effects - affects less than 1 out of 1,000 people

•    difficulty controlling movements, confusion

•    kidney problems (sometimes with lower back pain, fever and rash)

•    severe skin reactions, such as Stevens-Johnson syndrome, vasculitis, exudative conjunctivitis and generalised hypersensitivity reactions, e.g. exfoliative dermatitis, Lyell's syndrome and pemphigoid reactions

•    blurred or loss of vision

•    being sick (vomiting) or diarrhoea

•    diarrhoea that is serious, lasts a long time or has blood in it with stomach pain or fever (Pseudomembranous colitis)

•    inflammation of the colon

•    muscular weakness

•    myopathy

•    problems with the coordination of voluntary muscles (ataxia)

•    psychoses

•    mental confusion

•    visual disturbances

•    blood disorders (reduced platelet count)

•    weight loss, night sweats and fever (eosinophilia)

What Rimactane contains

The active substance in Rimactane is rifampicin. Each Rimactane 300 mg capsule contains 300 mg rifampicin.

The other ingredients are: calcium stearate, lactose, titanium dioxide (E171), iron oxide red (E172), iron oxide black (E172), gelatine, shellac glaze, propylene glycol (E1520) and ammonium hydroxide (E527) and iron oxide yellow (E172).

What Rimactane looks like and the contents of the pack

Rimactane 300 mg capsules are opaque, two-piece, hard gelatine capsules, reddish-brown in colour, marked with ‘NG 300’.

The capsules come in secure containers of 100 and blister packs of 60. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Sandoz GmbH,

Biochemiestr. 10, 6250 Kundl,

Austria

This leaflet was last revised in 12/2014.

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