Rifampicin Capsules 300mg
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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Rifampicin is and what it is used for
2. What you need to know before you take Rifampicin
3. How to take Rifampicin
4. Possible side effects
5. How to store Rifampicin
6. Contents of the pack and other information
1. What Rifampicin is and what it is used for Rifampicin belongs to a group of medicines called rifamycin antibiotics. It can be used to treat a variety of infections such as:
• Tuberculosis
• Leprosy
• Legionnaires Disease
• Brucellosis and serious staphylococcal infections
It may also be given to 'carriers', these are people who may be infected but do not have the symptoms of the infections caused by Haemophilus influenzae (which causes the flu) and Neisseria meningitidis (which causes meningitis).
2. What you need to know before you take Rifampicin Do not take Rifampicin if you:
• are allergic to rifampicin or another rifamycin antibiotic or any of the other ingredients of this medicine (listed in section 6).
• have jaundice (yellowing of the skin or whites of the eyes)
• you are taking saquinavir or ritonavir (as you may develop liver problems if you are also taking rifampicin)
Warnings and precautions
Talk to your doctor or pharmacist before taking Rifampicin if you:
• have or have ever had problems with your liver
• have kidney problems and are taking more than 600 mg of Rifampicin per day
• are diabetic; as your diabetes may become more difficult to control
• have a rare blood problem called porphyria
• are underweight, elderly, suffer from liver problems or under
2 years old and also taking isoniazid; your doctor may check your liver function
• wear contact lenses. Taking Rifampicin may permanently stain soft contact lenses.
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.
It is possible that Rifampicin may interfere with some blood tests. If you need a blood test to check bilirubin, folate or vitamin B12 levels tell your doctor you are taking Rifampicin as it may affect your results. Other medicines and Rifampicin
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, or the following:
• anticoagulants to thin the blood eg. warfarin
• anti-inflammatory medicine called corticosteroids eg. prednisolone
• medicine used after an organ transplant eg. ciclosporin, sirolimus, tacrolimus
• medicine to treat a heart condition eg. digoxin, digitoxin, quinidine, disopyramide, mexiletine, propafenone, tocainide, calcium channel blockers (diltiazem, nifedipine, verapamil, nimodipine, isradipine, nicardipine, nisoldipine)
• medicine to lower blood pressure eg. bisoprolol, propranolol, losartan, enalapril
• diuretics (water tablets) such as eplerenone
• antidiabetic medicine eg. chlorpropamide, tolbutamide, gliclazide, rosiglitazone
• antiepileptics eg. phenytoin
• strong painkillers eg. morphine, methadone
• sedatives (sleeping tablets) or medicine for anxiety eg. amobarbital, diazepam, zopiclone, zolpidem
• hormone-blocking medicine such as tamoxifen, toremifene, gestrinone
• medicine containing hormones such as oestrogen, progestogens eg. hormonal contraceptives. If you are taking an oral contraceptive to prevent pregnancy while you are taking Rifampicin, the contraceptive may not work. (see "Pregnancy and breast-feeding”).
• thyroid medicine eg. levothyroxine
• medicine for mental illness eg. haloperidol, aripiprazole
• antidepressants such as amitriptyline, nortriptyline
• antibiotics to treat infection eg. dapsone, chloramphenicol, clarithromycin, doxycycline, ciprofloxacin, telithromycin
• anti-fungal medicine eg. fluconazole, itraconazole, ketoconazole, voriconazole
• anti-viral medicine eg. saquinavir, ritonavir, indinavir, efavirenz, amprenavir, nelfinavir, atazanavir, lopinavir, nevirapine
• praziquantel, for worm infections
• medicine to lower fat levels (cholesterol, triglycerides) in the blood eg. simvastatin, clofibrate
• cancer medicine eg. irinotecan, imatinib
• quinine, often used for night cramps
• tiluzole, used in motor neurone disease (MND)
• theophylline, for asthma
• anti-sickness medicine eg. Ondansetron
• atovaquone, for malaria or pneumonia
• antacids used for indigestion. Take Rifampicin at least 1 hour before taking antacids.
• other medicines used for tuberculosis such as isoniazid or p-aminosalicylic acid (PAS). PAS and Rifampicin should be taken at least 8 hours apart.
If you are undergoing surgery please inform your doctor before the operation that you are using or have previously used Rifampicin. This is because Rifampicin and some anaesthetics (such as halothane) should not be taken together.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking this medicine. Tell your doctor if you are pregnant or planning to become pregnant. Rifampicin should not be taken during pregnancy as it can affect the growth of your unborn baby and may cause complications to the mother and baby after birth.
Rifampicin may make the contraceptive "pill” work less well. This means you should change to a different type of contraception. You must use a reliable barrier method of contraception such as condoms or the "coil” while taking Rifampicin. If you have any questions or are unsure about this talk to your doctor or pharmacist.
Do not breast-feed your baby, as small amounts of rifampicin can pass into breast milk.
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. Rifampicin contains lactose
This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicine.
Rifampicin contains azorubine (150 mg only)
The 150 mg capsule also contains a very small amount of azorubine (E122), this may cause allergic reactions.
3. How to take Rifampicin
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• You should take Rifampicin on an empty stomach, at least 30 minutes before a meal or 2 hours after a meal.
• I t is important you finish the course of treatment as directed by your doctor.
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The recommended dose for each type of infection is:
Tuberculosis (along with another medicine)
Adults
For patients weighing less than 50 kg the usual daily dose is 450 mg, for patients weighing 50 kg or more, the usual daily dose is 600 mg. Children above 3 months
The recommended daily dose is 15 (10-20) mg/kg body weight, up to a maximum of 600 mg.
Leprosy (along with another medicine)
Adults
For patients weighing less than 50 kg the usual daily dose is 450 mg, for patients weighing 50 kg or more, the usual daily dose is 600 mg. A single dose of 600 mg once a month may be given.
Children
For paucibacillary forms, Rifampicin should be administered with dapsone for a period of 6 months. For multibacillary forms, Rifampicin should be administered with dapsone and clofazimine for a period of 12 months. The recommended dose is:
Over 10 years: 450 mg once a month.
Under 10 years: 10 to 20 mg/kg bodyweight once a month. Legionnaires Disease, brucellosis, serious staphylococcal infections (along with other medicine)
The recommended daily dose is 600 mg -1200 mg in 2 to 4 divided doses throughout the day.
Prevention of meningococcal meningitis Adults
The recommended dose is 600 mg twice daily for 2 days Children
1 month and above: 10 mg/kg body weight every 12 hours for 2 days. Under 1 month: 5 mg/kg body weight every 12 hours for 2 days. The dose must not exceed 600 mg/dose.
Prevention of Haemophilus influenzae infection Adults and children 1 month and above For members of a household exposed to the infection the recommended daily dose is 20 mg/kg body weight, up to a maximum of 600 mg, once daily for 4 days.
Children under 1 month
The recommended dose is 10 mg/kg body weight once daily for 4 days. Older people
Your doctor may give you a lower dose than those stated above. Patients with liver problems
You should not be given a daily dose of more than 8 mg/kg body weight.
If you take more Rifampicin than you should
Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining capsules with you. If an overdose has been taken, you may suffer from nausea or vomiting (feeling or being sick), stomach pain, itching, headache and an increasing feeling of drowsiness. Patients with severe liver problems may pass out (become unconscious). Other signs of overdose include: swelling of the face, eyes or eyelids, fast or uneven heartbeat, dizziness, fits and heart attack.
If you forget to take Rifampicin
Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Rifampicin
Do not suddenly stop taking your medicine even if you feel better as this may cause side effects or your condition may reoccur.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following happen, stop taking Rifampicin and tell your doctor immediately or go to your nearest hospital emergency department:
• Allergic reactions such as swollen skin or swelling of the face, lips, tongue and/or throat which may cause difficulty breathing or swallowing
• Small purple spots or unusual bruising or bleeding of the skin, and/or a sudden, severe headache
• Bleeding from your nose, ear, gums, throat, skin or stomach. You may notice a feeling of tenderness and swelling in your stomach, purple spots on your skin and black or tar-like stools
• Severe diarrhoea possibly with blood in the stools
• Liver problems which may cause dark urine, pale stools, yellowing of the skin or whites of the eyes (jaundice)
• Kidney problems which may cause blood in the urine, a change in the amount of urine passed, and feeling drowsy or weak
• Severe skin reactions including blistering of the skin, mouth, eyes and genitals, and swollen blood vessels in the skin.
These side effects are serious. You may need medical attention.
Tell your doctor straight away if you notice any of the following side effects:
• Flu-like symptoms with fever, chills, headache, dizziness and bone pain
• Shortness of breath and wheezing
• Mental problems causing a change in personality, hallucinations and odd behaviour
• Signs of shock such as clammy, cold skin, a racing heartbeat and shallow breathing
• Very rare effects include blood changes causing symptoms such as fever, feeling unusually tired, chest pain, sore throat, mouth ulcers or suffering from more infections than usual. Tell your doctor straight away if you notice any of these effects.
Other side effects are:
• I tchy skin with or without a rash
• Flushing
• Loss of appetite
• Nausea or vomiting (feeling or being sick)
• Stomach pain
• Diarrhoea
• Low blood pressure
• Your tears, urine, sweat and saliva may turn a reddish colour. If you wear soft contact lenses Rifampicin may permanently stain them.
• Muscle weakness, pain or wasting
• Swelling of the legs and ankles
• I rregular periods, more likely if on long-term treatment 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 Rifampicin
Keep this medicine out of the sight and reach of children.
Do not use Rifampicin after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month. Store in a cool dry place.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the pack and other information What Rifampicin contains
The active substance is rifampicin.
The other ingredients are ascorbic acid, lactose monohydrate (see section 2 "Rifampicin contains lactose”), talc and magnesium stearate. The capsule shell includes azorubine (E122) (for 150 mg only - see section 2 "Rifampicin contains azorubine”), indigotine (E132), titanium dioxide (E171), gelatine, erythrosine (E127) and red iron oxide (E172). The capsule printing ink includes shellac, iron oxide black (E172), propylene glycol and ammonium hydroxide. What Rifampicin looks like and contents of the pack 150 mg: Your medicine comes as a hard capsule with a mauve body and a maroon cap, marked "RN 150” and "G” (the capsule contents are brick red).
300 mg: Your medicine comes as a hard capsule with a pink body and maroon cap, marked "RN 300” and "G”. (The capsule contents are brick red).
Rifampicin is available in plastic bottles (with an optional filler) of 5, 7, 8, 10, 14, 15, 16, 20, 21,25, 28, 30, 56, 60, 84, 90, 100, 250 and 500 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
This leaflet was last revised in May 2014.