Product Details

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.

▲ 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