Rifadin 150mg Capsules

PACKAGE LEAFLET:

INFORMATION FOR THE USER

Rifadin 150mg Capsules

rifampicin

SANOFIO

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Important things you need to know about Rifadin 150mg Capsules

• I t is very important that you take Rifadin 150mg Capsules exactly as your doctor has told you. There is a chance of you having a severe and dangerous allergic reaction if you do not take Rifadin 150mg Capsules each day as you are told

• You must keep taking Rifadin 150mg Capsules until your doctor tells you to stop.

• If you are taking any other medicines, including medicines you have bought from the pharmacy or shop, you must make sure your doctor knows

• Rifadin 150mg Capsules make all your body fluids an orange or red colour. Do not worry - this is normal and not harmful

• Take Rifadin 150mg Capsules on an empty stomach. This means at least 30 minutes before food or 2 hours after food

• If you get a temperature, are sick, begin to feel more unwell, lose your appetite or have yellowing of the skin, gums or eyes, you must talk to your doctor straight away

Read the rest 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 your pharmacist.

• This medicine has been prescribed for you. Do not pass it 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.

What is in this leaflet:

1. What Rifadin 150mg Capsules are and what they are used for

2. What you need to know before you take Rifadin 150mg Capsules

3. How to take Rifadin 150mg Capsules

4. Possible side effects

5. How to store Rifadin 150mg Capsules

6. Contents of the pack and other information

1. What Rifadin 150mg Capsules are and what they are used for

Rifadin 150mg 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. Rifadin 150mg Capsules are used to treat the following bacterial infections:

• Tuberculosis (also known as TB) alongside other medicines

• Leprosy alongside other medicines

• Brucellosis alongside other medicines

• Legionnaires Diseases alongside other medicines

• Haemophilus Influenzae

• Other serious bacterial infections

Rifadin 150mg Capsules can also be used to stop the following infections from developing;

• Meningitis

• Haemophilus Influenzae in children aged 4 years or younger

2. What you need to know before you take Rifadin 150mg Capsules

Do not take Rifadin 150mg Capsules if:

X You are allergic (hypersensitive) to

- rifampicin

- any of the other ingredients of the Rifadin 150mg Capsules (see Section 6: Further information)

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue X You have yellowing of the skin and eyes (jaundice)

X You are taking saquinavir or ritonavir for an HIV infection (see ‘Taking other medicines’ section below)

Do not take if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Rifadin 150mg Capsules.

Warnings and precautions Talk to your doctor or pharmacist before taking Rifadin 150mg capsules:

s You have liver problems

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

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

s You feel numb or weak in your arms and legs (peripheral neuropathy) s You are under weight or malnourished s You have a rare blood problem called ‘porphyria’ s You wear contact lenses. Taking Rifadin 150mg Capsules may permanently stain soft contact lenses s The person taking this medicine is a child s You are aged 65 years or older

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Rifadin 150mg 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 Rifadin 150mg capsules

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Rifadin 150mg Capsules can affect the way some other medicines work. Also some medicines can affect the way Rifadin 150mg Capsules work.

In particular, do not take this medicine, and tellyour doctor, ifyou are taking:

• Saquinavir or ritonavir used for HIV infection

The following medicines can make Rifadin 150mg Capsules work less well:

• Antacids used for indigestion. Take Rifadin 150mg Capsules at least 1 hour before taking antacids

• Other medicines used for TB such as P-aminosalicyclic acid (PAS). PAS and Rifadin 150mg 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

• Medicines for high blood pressure

• Medicines for heart problems or to control your heartbeat

• Medicines used to thin the blood such as warfarin

• Medicines used to lower cholesterol

• Water tablets (diuretics) such as eplerenone

Mental health, epilepsy and motor neurone medicines

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

• Medicines to calm or reduce anxiety (hypnotics, anxiolytics)

• Medicines to help you sleep (barbiturates)

• Medicines used for epilepsy such as phenytoin

• Some medicines used for depression such as amitriptyline and nortriptyline

• Riluzole - used for motor neurone disease Medicines for infections and the immune system

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

• Medicines used for fungal infections

• Medicines used for bacterial infections (antibiotics)

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

• Praziquantel - used for tapeworm infections

• Atovaquone - used for pneumonia 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

• Some medicines 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

• Medicines 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

• Medicines used for diabetes

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

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

• Quinine - used for malaria

• Theophylline - used for wheezing or difficulty in breathing

Taking Rifadin 150mg Capsules with food and drink

Take Rifadin 150mg Capsules on an empty stomach. This means at least 30 minutes before food or 2 hours after food.

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.

Rifadin 150mg Capsules 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 Rifadin 150mg Capsules. 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 Rifadin 150mg Capsules. This is because small amounts may pass into the mothers’ milk. If you are breastfeeding 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.

3. How to take Rifadin 150mg Capsules

Always take Rifadin 150mg Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Rifadin is also available as syrup for children.

Keep taking this medicine

• You must take the capsules each day for the whole time the doctor has told you to take them

• Do not stop and start taking the capsules. This may increase the risk of side effects and your infection will not be treated properly

How to take the capsules

• Take this medicine by mouth

• Swallow the capsules whole, with a drink of water

• Take at least 30 minutes before a meal or 2 hours after a meal.

• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

How much to take

How much you will be given will depend your age and on the type of illness Tuberculosis (TB)

• Rifadin should be given with at least one other medicine for TB

• The usual dose is:

• Patients weighing less than 50kg: A single daily dose of 450mg

• Patients weighing more than 50kg: A single daily dose of 600mg

• Children: 10mg to 20mg per kilogram of body weight each day. The maximum dose is 600mg each day

Leprosy

• Rifadin should always be given with at least one other medicine for leprosy

• Your doctor may prescribe a monthly or daily dose. The usual dose is:

• Patients weighing less than 50kg: A single daily dose of 450mg

• Patients weighing more than 50kg: A single daily dose of 600mg

Brucellosis, Legionnaires Disease or other serious bacterial infections

• Rifadin should be used together with another antibiotic

• The amount you are given will depend on how severe your infection is:

• Adults: 600mg to 1200mg each day. The dose is given in 2 to 4 divided doses

Stopping the development of Meningitis

• The usual dose is:

• Adults: 600mg twice each day for two days

• Children (1 -12 years): 10mg per kilogram of bodyweight, twice each day for two days

• Children (3 months - 1 year): 5mg per kilogram twice each day for two days

Stopping the development of Haemophilus Influenzae:

• Everybody in the same house needs to be treated under the doctors direction

• The usual dose is:

• Adults and Children: 20mg per kilogram body weight each day for four days. No more than 600mg should be given.

• Neonates (1 month): 10mg/kg each day for 4 days

Elderly patients

Your doctor may need to monitor you more closely.

People with Liver problems

You should not be given any more than 8mg per kilogram of body weight each day.

If you take more Rifadin 150mg Capsules than you should

If you take more Rifadin 150mg Capsules 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 Rifadin 150mg Capsules

If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for the forgotten capsules.

If you stop taking Rifadin 150mg Capsules

Keep taking Rifadin 150mg Capsules until your doctor tells you to stop. Do not stop taking Rifadin 150mg Capsules 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 Rifadin 150mg Capsules 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 Rifadin 150mg Capsules.

4. Possible side effects

Like all medicines, Rifadin 150mg Capsules can cause side effects, although not

everybody gets them.

Stop taking and go to a hospital straight away if you notice any of the

following serious side effects:

• You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, wheezing, swelling of your lips, face, throat or tongue

• You have a fever and yellowing of the skin or whites of the eyes, feel tired, weak or generally unwell, loss of appetite (anorexia), feeling sick (nausea), being sick (vomiting). These may be early signs of liver problems

• 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

• You bruise more easily than usual. Or you may have a painful rash of dark red spots under the skin which do not go away when you press on them (purpura). This could be because of a serious blood problem

• You have chills, tiredness, unusually pale skin colour, shortness of breath, fast heartbeat or dark coloured urine. This could be signs of a serious type of anaemia

• You have blood in your urine or an increase or decrease in amount of urine you produce. You may also get swelling, especially of the legs, ankles or feet. This may be caused by serious kidney problems

• You have a sudden severe headache. This could be a sign of bleeding in the brain

• Shortness of breath and wheezing

• You get confused, sleepy, cold clammy skin, shallow or difficult breathing, a racing heartbeat or your skin is paler than normal. These could be signs of shock

• You get more infections more easily than normal. Signs include fever, sore throat or mouth ulcers. This could be because you have a low number of white blood cells

• You have bleeding from your nose, ear, gums, throat, skin or stomach. Signs may include a feeling of tenderness and swelling in your stomach, purple spots on your skin and black or tar-like stools

Talk to your doctor straight away if you notice any of the following serious

side effects:

• Mental problems with unusual thoughts and strange visions (hallucinations)

• Severe watery diarrhoea that will not stop and you are feeling weak and have a fever. This may be something called ‘Pseudomembranous colitis’

• Flu-like symptoms including chills, fever, headache, dizziness and bone pains

Tell your doctor as soon as possible if you have any of the following side effects:

• Water retention (oedema) which may cause swollen face, stomach, arms or legs

• Muscle weakness or pain or loss of muscle reflexes

• Dizziness, feel lightheaded and faint especially when you stand or sit up quickly (due to low blood pressure)

• Swollen fingers, toes or ankles

• Being unable to concentrate, feeling nervous, irritable or depressed

• Feeling very tired and weak or difficulty sleeping (insomnia)

• Short-term memory loss, anxiety, being less alert or responsive

• Wasting of muscles or other body tissues

• Weight loss, night sweats and fever. These could be signs of a blood condition called eosinophilia

• Feeling sick or being sick

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

• Skin flushing or itching

• Irregular periods

• Diarrhoea or stomach discomfort

• Loss of appetite (anorexia)

• Headache

Other side effects you should discuss with your doctor if you are concerned about them

• You notice an orange or 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 having Rifadin 150mg Capsules.

Blood tests

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

Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet.

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 Rifadin 150mg Capsules

Keep out of sight and reach of children.

Do not use Rifadin 150mg Capsules after the expiry date which is stated on the carton and blister packs. The expiry date refers to the last day of that month.

Store below 25°C.

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

6. Contents of the pack and other information

What Rifadin 150mg Capsules contain:

• Each capsule contains 150mg of the active ingredient, rifampicin.

• The other ingredients are corn starch and magnesium stearate.

What Rifadin 150mg Capsules look like and contents of the pack

Rifadin 150mg Capsules are blue and red, hard capsules.

Rifadin 150mg Capsules are available in the following presentations:

100 capsules in amber glass bottles 100 capsules in blister packs Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK Tel: 0845 372 7101

Email: uk-medicalinformation@sanofi.com

Manufacturer

Sanofi S.P.A.

Loc. Valcanello 03012 Anagni (FR)

ITALY

This leaflet does not contain all the information required about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in April 2015