PACKAGE LEAFLET: INFORMATION FOR THE USER

Rifadin® 100mg/5ml Oral Suspension

rifampicin

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Important things you need to know about Rifadin Oral Suspension

•    It is very important that you take Rifadin Oral Suspension 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 your Oral Suspension each day as you are told

•    You must keep taking it 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 Oral Suspension makes all your body fluids an orange or red colour. Do not worry, this is normal and not harmful

•    Take Rifadin Oral Suspension 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 Oral Suspension is and what it is used for

2.    What you need to know before you take Rifadin Oral Suspension

3.    How to take Rifadin Oral Suspension

4.    Possible side effects

5.    How to store Rifadin Oral Suspension

6.    Contents of the pack and other information

1. What Rifadin Oral Suspension is and what it is used for

Rifadin Oral Suspension contains a medicine called rifampicin. It belongs to a group of medicines called anti bacterials. It works by killing the bacteria that cause infections.

Rifadin Oral Suspension is used to treat the following bacterial infections:

•    Tuberculosis (also known as TB) alongside other medicines

•    Leprosy alongside other med ici nes

•    Brucellosis alongside other medicines

•    Legionnaires Diseases alongside other medicines

•    Haemophilus Influenzae

•    Other serious bacterial infections

Rifadin Oral Suspension 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 Oral Suspension

LAJ Do not take Rifadin Oral Suspension if:

X You are allergic (hypersensitive) to

-    rifampicin

-    any of the other ingredients of the Rifadin Oral Suspension (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 Oral Suspension.

▲    You have liver problems

▲    You have any kid ney 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 feel numb or weak in your arms and legs (peripheral neuropathy)

▲    You are under weight or malnourished

▲    You have a rare blood problem called 'porphyria'

A You wear contact lenses. Taking Rifadin Oral Suspension may permanently stain soft contact lenses

A The person taking this medicine is a child A You a re 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 Oral Suspension.

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 Oral Suspension can affect the way some other medicines work. Also some medicines can affect the way Rifadin Oral Suspension works.

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 e pie re none

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 Oral Suspension with food and drink

Take Rifadin Oral Suspension on an empty stomach. This means at least 30 minutes before food or 2 hours after food.

Pregnancy, breast-feeding and fertility

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

Rifadin Oral Suspension 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 Oral Suspension. If you have any questions or are unsure about this talk to your doctor or pharmacist.

Important information about some of the ingredients of Rifadin Oral Suspension

Rifadin Oral Suspension contains:

« Sucrose: The Oral Suspension contains2 g of sucrose per 5 ml dose. This should be taken into account in patients with diabetes mellitus. May also be harmful to teeth. If you have been told by your doctor that you have an i ntolerance to some sugars, contact you r doctor before taking this medicinal product.

•    Sodium: The Oral Suspension contains 7.2 mg of sodium per 600mg daily dose and is essentially'sodium-free'.

•    Sodium meta bisulfite: These may rarely cause severe allergic reactions (hypersensitivity) and difficulty in breathing (bronchospasm). This is more likely to happen if you have a history of asthma or allergies. Tell a doctor or nurse straight away if you get a rash, swallowing or breathing problems and swelling of your lips, face, throat or tongue.

•    Methyl-p-hydroxybenzoate and propyl-p-hydroxybenzoate: these may cause an allergic reaction (this might not happen straight away). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

« Ethanol: This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per dose.

• Potassium: this medicine contains 10.4 mg potassium per 30 ml dose. This is to be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

3. Howto take Rifadin Oral Suspension

Always take Rifadin Oral Suspension 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 this medicine each day for the whole time the doctor has told you to take it

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

How to take the Oral Suspension

•    Shake well before use;

•    Take this medicine by mouth;

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

•    Only use the measuring cup supplied in the Rifadin Oral Suspension pack to measure your dose. Do not use the cup to measure other medicinal products;

•    You will be able to measure the dose in the measuring cup supplied with the Oral Suspension;

•    The measurement graduations of the cup show you how to measure between 2.5ml (50mg) and 7.5ml (150mg);

•    You may need to measure out more than one 7.5ml (150mg) cup to make up your dose. Talk to your doctor or pharmacist if you are unsure how much to measure;

•    If the dose is less than 2.5ml (50mg), talk to your doctor or pharmacist about how to measure the dose;

•    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 Tu berculosis (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:

•    Ad ults: 600mg to 1200mg each day. The dose is given in 2 to 4 d ivided doses

Stopping the development of Meningitis

•    The usual dose is:

•    Adults: 600mg twice each day for two days

•    Children (1 -12years): lOmg 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 Child ren: 20mg per kilogram body weight each day for four days. No more than 600mgshould be given.

•    Neonates (1 month): lOmg/kgeach 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 Smg per kilogram of body weight each day.

If you take more Rifadin Oral Suspension than you should

If you take more Rifadin Oral Suspension 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 Oral Suspension

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 dose.

If you stop taking Rifadin Oral Suspension

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

Taking Rifadin Oral Suspension 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 Oral Suspension.

4. Possible side effects

Like all medicines, Rifadin Oral Suspension 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. Oryou 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 urineyou 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-1 ike 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 wil I not stop and you are feeling weak and havea 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 eosinophi lia

•    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

•    Loss of appetite (a norexia)

•    Headache

•    Dia rrhoea or stomach d iscomfort

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 Oral Suspension.

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 nu rse. 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. Howto store Rifadin Oral Suspension

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

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

Do not store above 25°C

Store the bottle and measuring cup in the original outer carton.

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 Oral Suspension contains:

•    Each 1 ml of Oral Suspension contains 20mg of the active ingredient, rifampicin.

•    The other ingredients agar, sucrose, methy l-p-hydroxy benzoate, propyl-p-hydroxy benzoate, potassium sorbate, sodium metabisulphite, tween SO, raspberry essence (contains small amount of ethanol), saccharin, diethanolamine, purified water

What Rifadin Oral Suspension look like and contents of the pack

Rifadin Oral Suspension is a raspberry flavoured and coloured suspension. It is supplied in a

120ml amber bottle, accompanied by a 7.5ml (150mg) measuring cup.

Marketing Authorisation Holder

Marketing Authorisation Holder

Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Tel: 084 5 372 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 December 2015

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