Rifadin 100 mg / 5 ml oral suspension – patient leaflet, side effects, dosage

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 medicines
• 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

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.

Warnings and precautions Talk to your doctor or pharmacist before taking Rifadin Oral Suspension if:

▲ You have liver problems

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

PACKAGE LEAFLET:

INFORMATION FOR THE USER Rifadin^® 100mg/5ml Oral Suspension

rifampicin

Is this leaflet hard to see or read? Phone 0800 035 2525 for help

▲ 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’

▲You have a problem with bleeding or a tendency to bruise easily

▲Your symptoms of tuberculosis return or get worse (see section 4 Possible side effects)

▲ You wear contact lenses. Taking Rifadin Oral Suspension 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 Rifadin Oral Suspension. 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.

Take special care with Rifadin Oral Suspension

Serious skin reactions including

Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported with the use of Rifadin Oral Suspension.

• SJS/TEN can appear initially as reddish target spots or circular patches often with

  central blisters on the trunk. Also ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread peeling of the skin and life-threatening complications or be fatal.

  • DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high body

    temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

  • AGEP appears at the initiation of treatment as a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The most common location: mainly localized on the skin folds, trunk, and upper extremities

The highest risk for occurrence of serious skin reactions is within 2 days to 2 months after treatment initiation depending on the condition. If you develop a serious rash or another of these skin symptoms, stop taking Rifadin Oral Suspension and contact your doctor or seek medical attention immediately.

Other medicines and 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.

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 Rifadin Oral Suspension work less well:

• Antacids used for indigestion. Take

  Rifadin Oral Suspension at least 1 hour before taking antacids

• Other medicines used for TB such as

  P-aminosalicyclic acid (PAS). PAS and Rifadin Oral Suspension 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 and clopidogrel
• 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, neviparine, daclatasvir, simeprevir, sofosbuvir and telaprevir

• 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

  • Other antibiotic medicines such as cefazolin
  • 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.

You should not breast-feed if you are taking Rifadin Oral Suspension. 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.

Important information about some of the ingredients of Rifadin Oral Suspension Rifadin Oral Suspension contains:

• Sucrose: The Oral Suspension contains 2 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 intolerance to some sugars, contact your 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 metabisulfite: 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. How to 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

  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 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 product, 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

  • Serious skin rashes including

    Steven-Johnson syndrome, toxic epidermal necrolysis. These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. See also section 2.

  • Widespread rash, high body temperature, liver enzyme elevations, blood

    abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug

    hypersensitivity syndrome). See also section 2.

  • A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalized exanthematous pustulosis). See also section 2.
  • 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 severe bleeding (haemorrhage)

  • Paradoxical drug reaction: Symptoms of tuberculosis can return, or new symptoms can occur after initial improvement during treatment. Paradoxical reactions have been reported as early as 2 weeks and as late as 18 months after beginning anti-tuberculosis treatment. Paradoxical reactions are typically associated with fever, swollen lymph nodes (lymphadenitis),

    breathlessness, and cough. Patients with paradoxical drug reaction can also experience headaches, loss of appetite, and weight loss.

    • 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
• Loss of appetite (anorexia)
• Headache
• Diarrhoea or stomach discomfort Other side effects you should discuss with your doctor if you are concerned about them

• You notice a discolouration (yellow, brown, orange or red colour) in your teeth, urine, sweat, phlegm (sputum), saliva or tears. This is quite common and you need not worry. However, the colour may permanently stain soft contact lenses. The 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 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to 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 1ml of Oral Suspension contains 20mg of the active ingredient, rifampicin.

  • The other ingredients agar, sucrose, methyl-p-hydroxybenzoate, propyl-p-hydroxybenzoate, potassium sorbate, sodium metabisulphite, tween 80, 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, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Tel: 0800 035 2525

Email: uk-medicalinformation@sanofi.com Manufacturer

Sanofi S.r.l., Via Valcanello, 4 - 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 August 2021

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