Rifadin For Infusion 600mg

Important things you need to know about Rifadin Infusion

• You must keep taking it until your doctor tells you to stop.
• If you are having any other medicines, including medicines you have bought from the pharmacy or shop, you must make sure your doctor knows
• Rifadin Infusion makes all your body fluids an orange or red colour. Do not worry - this is normal and not harmful
• 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 having 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 Infusion is and what it is used for
2. What you need to know before you take Rifadin Infusion
3. How Rifadin Infusion is given
4. Possible side effects
5. How to store Rifadin Infusion
6. Contents of the pack and other information

Do not have Rifadin Infusion if:

• You are allergic (hypersensitive) to
  • rifampicin
  • any of the other ingredients of the Rifadin Infusion (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

• You have yellowing of the skin and eyes (jaundice)
• You are taking saquinavir or ritonavir for an HIV infection (see ‘Taking other medicines’ section below)

Do not have if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before having Rifadin Infusion.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rifadin Infusion 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. Having Rifadin Infusion may permanently stain soft contact lenses
• The person having 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 having Rifadin Infusion.

Blood Tests

Your doctor will need to check your blood before you are given this medicine. This will help your doctor know if any changes happen to your blood after having this medicine. You may also need to have regular blood tests to check how your liver is working.

Take special care with Rifadin Infusion

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 Infusion

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 Infusion can affect the way some other medicines work. Also some medicines can affect the way Rifadin Infusion work.

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

• Saquinavir or ritonavir used for HIV infection

The following medicines can make Rifadin Infusion work less well:

• Antacids used for indigestion. Have Rifadin Infusion at least 1 hour before taking antacids
• Other medicines used for TB such as P-aminosalicyclic acid (PAS). PAS and Rifadin Infusion should be taken at least 8 hours apart

Tell your doctor if you are having 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

Pregnancy and breast-feeding

Talk to your doctor before having this medicine if you are pregnant, plan to get pregnant or think you are pregnant. Rifadin Infusion 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 having Rifadin Infusion. If you have any questions or are unsure about this talk to your doctor or pharmacist.

You should not breast-feed if you are having Rifadin Infusion. 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 having this medicine. If this happens, do not drive or use any tools or machines.

Important information about some of the ingredients of Rifadin Infusion

Rifadin Infusion contains:

• Sodium: The infusion contains less than 1 mmol sodium (23 mg) per daily dose and is essentially ‘sodium-free’.

How much is given

If you are not sure why you are being given Rifadin Infusion or have any questions about how much Rifadin Infusion is being given to you, speak to your doctor or nurse.

Tuberculosis (TB)

• The usual dose is:
  • Adults: A single daily dose of 600mg given over 2 - 3 hours
  • Children: Up to 20mg per kilogram of body weight each day. The maximum dose is 600mg each day

Leprosy

• Your doctor may prescribe a monthly or daily dose
  • 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

• 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.

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 are given more Rifadin Infusion than you should

Your doctor will carefully calculate how much Rifadin Infusion you should get. Therefore it is unlikely your doctor or nurse will give you too much of this medicine. But, if you think that you have been given too much or too little Rifadin Infusion, tell your doctor or nurse.

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 having 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 miss a dose of Rifadin Infusion

Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However, if you think you may have missed a dose, then talk to your doctor or nurse.

Tests

Having Rifadin Infusion 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 having Rifadin Infusion.

Tell a nurse or doctor 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 tarlike stools
• 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
• Pain, redness or swelling at the site of injection

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 Infusion.

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.

What Rifadin Infusion contains:

• Once the solvent and powder have been mixed, each 10ml solution contains 600mg of the active substance, rifampicin.
• The other ingredients are sodium sulfoxyformaldehyde, sodium hydroxide, water for injections

What Rifadin Infusion look like and contents of the pack

Rifadin Infusion is presented as a 20ml clear glass vial containing 600mg rifampicin and a 10ml clear glass ampoule containing the solvent.

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