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PACKAGE LEAFLET: INFORMATION FOR THE USER

Rifater 50, 120, 300mg Tablets isoniazid, rifampicin, pyrazinamide

SANOFI^

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Important things you need to know about Rifater Tablets

1. What Rifater Tablets are and what they are used for

2. What you need to know before you take Rifater Tablets

Do not take Rifater Tablets if:

X You are allergic (hypersensitive) to

-    isoniazid

-    rifampicin

-    pyrazinamide

-    any of the other ingredients of the Rifater Tablets (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 Rifater Tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rifater Tablets

▲    You have liver problems

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

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

▲    You have or have ever had gout (pain or swelling in the joints)

▲    You are coughing up blood

▲    You have epilepsy

▲    You have or have ever had mental health problems (such as depression or schizophrenia)

▲    You feel numb or weak in your arms and legs (peripheral neuropathy)

You have an HIV infection You are under weight or malnourished You drink alcohol every day or you are an alcoholic You inject yourself with drugs You are a black or Hispanic woman You have a rare blood problem called 'porphyria'

You doctor has told you that your body takes a long time to get rid of some drugs (you have a slow acetylator status)

▲    You wear contact lenses. Taking Rifater Tablets may permanently stain soft contact lenses

▲    The person taking this medicine is a child

▲    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 Rifater Tablets.

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. If you are aged 35 years or older, you will also need to have monthly blood tests to check how your liver is working.

Other medicines and Rifater Tablets

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 Rifater Tablets can affect the way some other medicines work. Also some medicines can affect the way Rifater Tablets work.

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

X Saquinavir or ritonavir used for HIV infection

The following medicines can make Rifater Tablets work less well:

•    Antacids used for indigestion. Take Rifater Tablets at least 1 hour before taking antacids

•    Other medicines used for TB such as P-aminosalicyclic acid (PAS) and cycloserine. PAS and Rifater Tablets 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 and carbamazepine

•    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 an HIV infection such as stavudine and zalcitabine

•    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

•    Sulfinpyrazone - used for gout Other medicines

•    Medicines used for diabetes

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

•    Medicines used for erection problems such as tadalafil

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

•    Probenecid (used with a medicine called cidofovir to stop kidney damage)

•    Quinine - used for malaria

•    Theophylline - used for wheezing or difficulty in breathing

Taking Rifater Tablets with food and drink

If Rifater Tablets are taken with the food and drink listed below you may experience headache, sweating, flushing, fast, uneven or forceful heartbeat (palpitations), dizziness, feel lightheaded or faint (due to low blood pressure).

While taking Rifater Tablets do not have:

•    Cheese

•    Skipjack tuna or other tropical fish

•    Red wine

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. Rifater Tablets 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 Rifater Tablets. 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 Rifater Tablets. 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

Important information about some of the ingredients

of Rifater Tablets

Rifater Tablets contain:

•    Sucrose: If you have been told by your doctor that you can not tolerate some sugars, talk to your doctor before taking Rifater Tablets

•    Sodium: These tablets contains less than 1 mmol sodium (23 mg) per daily dose and are essentially 'sodium-free'.

3. How to take Rifater Tablets

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

Keep taking this medicine

•    You must take the tablets every day for the whole time the doctor has told you to take them

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

How to take the tablets

•    Take this medicine by mouth

•    Swallow the tablets whole, with a drink of water

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

•    Take all your tablets together each day, as a single dose

•    Do not give this medicine to children

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

Your doctor may ask you to take Vitamin B₆ during treatment with Rifater Tablets, especially if you are malnourished, elderly or a diabetic.

How much to take

The usual dose is:

Adults and the Elderly

•    Between 3 and 6 tablets each day. The amount depends on your body weight

•    If you are elderly, your doctor may monitor your treatment more closely

Children

This medicine is not recommended for use in children.

If you take more Rifater Tablets than you should

If you take more Rifater Tablets 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, light-headed, have blurred or strange visions (hallucinations) and faint or feel faint. 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 Rifater Tablets

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 tablets.

Tests

Taking Rifater Tablets 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 tes¹t², it is important to tell your doctor that you are taking Rifater Tablets.

4. Possible side effects

Like all medicines, this medicine 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 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

If you experience any of the following side effects

contact your doctor as soon as possible:

•    Inflammation of the pancreas, which causes severe pain in the abdomen and back (pancreatitis, frequency not known).

•    Severe extensive skin damage (separation of the epidermis and superficial mucous membranes) (toxic epidermal necrolysis, TEN, may affect up to 1 in 1,000 people).

•    a drug reaction that causes rash, fever, inflammation of internal organs, hematologic abnormalities and systemic illness (DRESS syndrome, may affect up to 1 in 1,000 people).

•    Yellowing of the skin or whites of the eyes, or urine getting darker and stools paler, fatigue, weakness, malaise, loss of appetite, nausea or vomiting caused by liver problems (hepatitis, may affect up to 1 in 100 people).

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)

•    Your stomach ulcer gets worse

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

•    Your fits get worse or you start to have fits

•    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

•    Balance problems with dizziness (vertigo)

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

•    Unusual skin sensations such as feeling numb, tingling, pricking, burning or creeping on the skin (paraesthesia)

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

•    Blurred or distorted eyesight

•    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:

•    Acne

•    Loss of appetite (anorexia)

•    Headache

•    Skin flushing or itching

•    Painful, red, swollen joints

•    Pain or discomfort when passing urine

•    Irregular periods

•    Constipation, diarrhoea, stomach discomfort or dry mouth

•    Breast enlargement in men

•    Increased thirst, going to the toilet more often and feeling tired. Your blood sugar may be high

•    Inflammation of the blood vessels.

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 Rifater Tablets.

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 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 Rifater Tablets

Keep this medicine in a safe place where children cannot see or reach it.

Do not use Rifater Tablets 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. Store in the original container. 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 Rifater Tablets contain:

•    Each tablet contains 50mg of isoniazid, 120mg of rifampicin and 300mg of pyrazinamide. These are the active ingredients

•    The other ingredients are polyvinylpyrrolidone, sodium carboxymethylcellulose, sodium lauryl sulphate, calcium stearate, sucrose, acacia gum, talc, light magnesium carbonate, kaolin, colloidal silicon-dioxide, aluminium hydroxide gel and colours titanium dioxide (E171) and iron oxide (E172)

What Rifater Tablets look like and contents of the pack

The tablets are light pink, smooth, shiny, round and sugar coated. Each pack contains 100 tablets.

Marketing Authorisation Holder

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 February 2016

© Sanofi 1984 - 2016    89029191

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