RIFADIN 600 MG INFUSION, RIFAMPICIN 600 MG INFUSION - patient leaflet, side effects, dosage

Patient leaflet - RIFADIN 600 MG INFUSION, RIFAMPICIN 600 MG INFUSION

1. what rifadin is and what it is used for

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

Rifadin is used to treat the following bacterial infections when medicines can not be given by mouth:

– Tuberculosis (also known as TB) alongside other medicines
– Leprosy alongside other medicines
– Brucellosis alongside other medicines
– Legionnaires Diseases alongside other medicines
– Other serious bacterial infections

2. what you need to know before you take rifadin

Do not have Rifadin if:

– You are allergic (hypersensitive) to

– rifampicin
– any of the other ingredients of the Rifadin (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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rifadin if:

– You have liver problems
– You have any kidney problems and if you are having more than 600 mg 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 (Please see section 4 Possible side effects).
– You wear contact lenses. Having Rifadin 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.

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

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.

– 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 and contact your doctor or seek medical attention immediately.

Other medicines and Rifadin

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 can affect the way some other medicines work. Also some medicines can affect the way Rifadin 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 work less well:

– Antacids used for indigestion. Have Rifadin at least 1 hour before taking antacids
– Other medicines used for TB such as P-aminosalicyclic acid (PAS).

PAS and Rifadin 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 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. 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. 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 Rifadin contains:

Rifadin contains:

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

Rifadin ® 600 mg Infusion

(rifampicin)

The following information is intended for healthcare professionals only. Practical information on preparation and administration of Rifadin 600 mg Infusion (see also Section 3).

Posology and method of administration

Treatment with Rifadin for Infusion should include concomitant use of other appropriate antibacterials to prevent the emergence of resistant strains of causative organism.

Tuberculosis:

Adults: A single daily administration of 600 mg given by intravenous infusion over 2 to 3 hours has been found to be effective and well tolerated for adult patients. Serum concentrations following this dosage regimen are similar to those obtained after 600 mg by mouth.

Children: The usual paediatric regimen is a single daily dose of up to 20 mg/ kg bodyweight; the total daily dose should not normally exceed 600 mg.

Leprosy: The recommended daily dose is 10 mg/kg.

Usual daily dose:

Patients weighing less than 50 kg – 450 mg.

Patients weighing 50 kg or more – 600 mg.

Alternatively, 600 mg doses of rifampicin may be given once per month.

In the treatment of leprosy, rifampicin should always be used in conjunction with at least one other antileprosy drug.

Brucellosis, Legionnaires Disease or serious staphylococcal infections:

Adults: The recommended daily dose is 600 – 1200 mg given in 2 to 4 divided doses, together with another antibacterial agent with similar properties to prevent the emergence of resistant strains.

Impaired liver function: A daily dose of 8 mg/kg should not be exceeded in patients with impaired liver function.

Use in the elderly: In elderly patients, the renal excretion of rifampicin is decreased proportionally with physiological decrease of renal function; due to compensatory increase of liver excretion, the serum terminal half-life is similar to that of younger patients. However, as increased blood levels have been noted in one study of rifampicin in elderly patients, caution should be exercised in using rifampicin in such patients, especially if there is evidence of liver function impairment. When patients are able to accept oral medication, they should be transferred to Rifadin Capsules or Syrup (for further information on these products see their summaries of product characteristics).

3. HOW RIFADIN IS GIVEN

Rifadin is given by a doctor or nurse. This is because it needs to be given as a slow drip into a vein (infusion).

How much is given

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

Tuberculosis (TB)

– The usual dose is:

– Adults: A single daily dose of 600 mg given over 2 – 3 hours
– Children: Up to 20 mg per kilogram of body weight each day.

The maximum dose is 600 mg each day

Leprosy

– Your doctor may prescribe a monthly or daily dose

– Patients weighing less than 50kg: A single daily dose of 450 mg
– Patients weighing more than 50kg: A single daily dose of 600 mg Brucellosis, Legionnaires Disease or other serious bacterial infections – The amount you are given will depend on how severe your infection is
– Adults: 600 mg to 1200 mg 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 8 mg per kilogram of body weight each day

If you are given more Rifadin than you should

Your doctor will carefully calculate how much Rifadin 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, 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

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 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.

4. possible side effects

Like all medicines, Rifadin can cause side effects, although not everybody gets them.

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 generalised 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 reactions: 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
– 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.

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 Website: 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

– Keep out of the sight and reach of children.
– Do not use Rifadin after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month.
– Do not store above 25°C.
– If the powder becomes discoloured or show any signs of deterioration, consult your pharmacist who will tell you what to do.
– Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. contents of the pack and other information

What Rifadin contains:

The active ingredient is rifampicin.

Once the solvent and powder have been mixed, each 10ml solution contains 600 mg of the active substance, rifampicin.

The other ingredients are sodium sulfoxylate formaldehyde, sodium hydroxide.

Each solvent ampoule contains 10 ml water for injections.

Before use, the powder is dissolved with the dissolution agent, and diluted in an infusion liquid.

What Rifadin look like and contents of the pack

Rifadin is presented as a 20 ml clear glass vial sealed with rubber stopper and aluminium/plastic flip-off cap (colour coded blue) containing a red to brick-red coloured powder and a 10 ml clear glass ampoule containing a colourless solvent.

Pack size – 20 ml vial containing 600 mg rifampicin + 10 ml ampoule containing solvent.

Manufacturer and product licence holder

Manufactured by

Sanofi S.p.A., Localita Valcanello, I-03012 Anagni, ltaly.

Procured from within the EU by product licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.

POM PL 20636/2922

Leaflet revision and issue date (Ref): 19.02.22[12]

Rifadin is a trademark of Gruppo Lepetit S.r.l.

Blind or partially sighted?

Is this leaflet hard to see or read? Call 020 8423 2111 to obtain the leaflet in a format suitable for you.

Overdose

Human Experience

Signs and Symptoms :

Nausea, vomiting, abdominal pain, pruritus, headache and increasing lethargy will probably occur within a short time after acute ingestion; unconsciousness may occur when there is severe hepatic disease. Transient increases in liver enzymes and/or bilirubin may occur. Brownish-red or orange colouration of the skin, urine, sweat, saliva, tears and faeces will occur, and its intensity is proportional to the amount ingested. Facial or periorbital oedema has also been reported in paediatric patients. Hypotension, sinus tachycardia, ventricular arrhythmias, seizures and cardiac arrest were reported in some fatal cases.

The minimum acute lethal or toxic dose is not well established. However, nonfatal acute overdoses in adults have been reported with doses ranging from 9 to 12 g rifampicin. Fatal acute overdoses in adults have been reported with doses ranging from 14–60 g. Alcohol or a history of alcohol abuse was involved in some of the fatal and nonfatal reports. Nonfatal overdoses in paediatric patients ages 1 to 4 years old of 100 mg/kg for one to two doses have been reported.

Management :

Intensive supportive measures should be instituted and individual symptoms treated as they arise. Since nausea and vomiting are likely to be present, gastric lavage is probably preferable to induction of emesis. Following evacuation of the gastric contents, the instillation of activated charcoal slurry into the stomach may help absorb any remaining drug from the gastrointestinal tract. Antiemetic medication may be required to control severe nausea and vomiting. Active diuresis (with measured intake and output) will help promote excretion of the drug. Haemodialysis may be of value in some patients.

Incompatibilities

Compatibilities: Rifadin for Infusion is compatible with the following infusion solutions: up to 6 hours with Saline Solution and up to 8 hours with Glucose 5%.

Incompatibilities: Rifadin for Infusion is incompatible with the following: Perfudex, Sodium Bicarbonate 5%, Sodium Lactate 0.167M, Ringer Acetate with Glucose.

Shelf life

Unopened vial of lyophilisate: 36 months

Unopened ampoule of solvent: 60 months

Shelf life after dilution or reconstitution:

Up to 30 hours with Water for injections (10 ml WFI)

Up to 8 hours with Water for injections (10 ml WFI) and then diluted in glucose 5% solution for infusion

Up to 6 hours with Water for injections (10 ml WFI) and then diluted in sodium chloride 0.9% solution for infusion

Special precautions for storage

Do not store above 25°C.

Product licence holder

Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.

Rifampicin 600 mg Infusion

2922

19.02.22[12]

PATIENT INFORMATION LEAFLET

Important things you need to know about Rifampicin

– 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
– Rifampicin 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.

Your medicine is available using the above name but will be referred to as Rifampicin throughout this leaflet.

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 Rifampicin is given
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 contains a medicine called rifampicin. It belongs to a group of medicines called anti-infectives. It works by killing the bacteria that cause infections.

Rifampicin is used to treat the following bacterial infections when medicines can not be given by mouth:

– Tuberculosis (also known as TB) alongside other medicines
– Leprosy alongside other medicines
– Brucellosis alongside other medicines
– Legionnaires Diseases alongside other medicines
– Other serious bacterial infections

2. what you need to know before you take rifampicin

Do not have Rifampicin if:

– You are allergic (hypersensitive) to

– rifampicin
– any of the other ingredients of the Rifampicin (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 Rifampicin.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rifampicin if:

– You have liver problems
– You have any kidney problems and if you are having more than 600 mg 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 (Please see

Section 4 Possible side effects).

– You wear contact lenses. Having Rifampicin 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 Rifampicin.

Blood Tests

Take special care with Rifampicin

– 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 Rifampicin and contact your doctor or seek medical attention immediately.

Other medicines and Rifampicin

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 Rifampicin can affect the way some other medicines work. Also some medicines can affect the way Rifampicin 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 Rifampicin work less well:

– Antacids used for indigestion. Have Rifampicin at least 1 hour before taking antacids
– Other medicines used for TB such as P-aminosalicyclic acid (PAS).

PAS and Rifampicin 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. Rifampicin 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 Rifampicin. 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 Rifampicin. 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

Important information about some of the ingredients of Rifampicin Rifampicin contains:

Rifampicin contains:

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

Rifampicin 600 mg Infusion

The following information is intended for healthcare professionals only. Practical information on preparation and administration of Rifampicin 600 mg Infusion (see also Section 3).

Posology and method of administration

Treatment with Rifampicin for Infusion should include concomitant use of other appropriate antibacterials to prevent the emergence of resistant strains of causative organism.

Tuberculosis:

Children: The usual paediatric regimen is a single daily dose of up to 20 mg/ kg bodyweight; the total daily dose should not normally exceed 600 mg.

Leprosy: The recommended daily dose is 10 mg/kg.

Usual daily dose:

Patients weighing less than 50 kg – 450 mg.

Patients weighing 50 kg or more – 600 mg.

Alternatively, 600 mg doses of rifampicin may be given once per month.

In the treatment of leprosy, rifampicin should always be used in conjunction with at least one other antileprosy drug.

Brucellosis, Legionnaires Disease or serious staphylococcal infections:

Adults: The recommended daily dose is 600 – 1200 mg given in 2 to 4 divided doses, together with another antibacterial agent with similar properties to prevent the emergence of resistant strains.

Impaired liver function: A daily dose of 8 mg/kg should not be exceeded in patients with impaired liver function.

Use in the elderly: In elderly patients, the renal excretion of rifampicin is decreased proportionally with physiological decrease of renal function; due to compensatory increase of liver excretion, the serum terminal half-life is similar to that of younger patients. However, as increased blood levels have been noted in one study of rifampicin in elderly patients, caution should be exercised in using rifampicin in such patients, especially if there is evidence of liver function impairment. When patients are able to accept oral medication, they should be transferred to Rifampicin Capsules or Syrup (for further information on these products see their summaries of product characteristics).

3. HOW RIFAMPICIN IS GIVEN

Rifampicin is given by a doctor or nurse. This is because it needs to be given as a slow drip into a vein (infusion).

How much is given

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

Tuberculosis (TB)

– The usual dose is:

– Adults: A single daily dose of 600 mg given over 2 – 3 hours
– Children: Up to 20 mg per kilogram of body weight each day.

The maximum dose is 600 mg each day

Leprosy

– Your doctor may prescribe a monthly or daily dose

– Patients weighing less than 50kg: A single daily dose of 450 mg
– Patients weighing more than 50kg: A single daily dose of 600 mg Brucellosis, Legionnaires Disease or other serious bacterial infections – The amount you are given will depend on how severe your infection is
– Adults: 600 mg to 1200 mg 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 8 mg per kilogram of body weight each day

If you are given more Rifampicin than you should

Your doctor will carefully calculate how much Rifampicin 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 Rifampicin, tell your doctor or nurse.

If you miss a dose of Rifampicin

Tests

Having Rifampicin 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 Rifampicin.

4. possible side effects

Like all medicines, Rifampicin can cause side effects, although not everybody gets them.

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 generalised 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 reactions: Symptoms of tuberculosis can return, or new symptoms can occur after initial improvement during treatment.

– 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
– 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 Rifampicin.

Blood tests

– A blood test may show changes in the way the liver is working

Reporting of side effects

5. how to store rifampicin

– Keep out of the sight and reach of children.
– Do not use Rifampicin after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month.
– Do not store above 25°C.
– If the powder becomes discoloured or show any signs of deterioration, consult your pharmacist who will tell you what to do.
– Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. contents of the pack and other information

What Rifampicin contains:

The active ingredient is rifampicin.

Once the solvent and powder have been mixed, each 10ml solution contains 600 mg of the active substance, rifampicin.

The other ingredients are sodium sulfoxylate formaldehyde, sodium hydroxide.

Each solvent ampoule contains 10ml water for injections.

Before use, the powder is dissolved with the dissolution agent, and diluted in an infusion liquid.

What Rifampicin look like and contents of the pack

Rifampicin is presented as a 20 ml clear glass vial sealed with rubber stopper and aluminium/plastic flip-off cap (colour coded blue) containing a red to brick-red coloured powder and a 10 ml clear glass ampoule containing a colourless solvent.

Pack size – 20 ml vial containing 600 mg rifampicin + 10 ml ampoule containing solvent.

Manufacturer and product licence holder

Manufactured by

Sanofi S.p.A., Localita Valcanello, I-03012 Anagni, ltaly.

Procured from within the EU by product licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.

POM PL 20636/2922

Leaflet revision and issue date (Ref): 19.02.22[12]

Blind or partially sighted?

Is this leaflet hard to see or read? Call 020 8423 2111 to obtain the leaflet in a format suitable for you.

Overdose

Human Experience

Signs and Symptoms :

Management :

Incompatibilities

Compatibilities: Rifampicin for Infusion is compatible with the following infusion solutions: up to 6 hours with Saline Solution and up to 8 hours with Glucose 5%.

Incompatibilities: Rifampicin for Infusion is incompatible with the following: Perfudex, Sodium Bicarbonate 5%, Sodium Lactate 0.167M, Ringer Acetate with Glucose.

Shelf life

Unopened vial of lyophilisate: 36 months

Unopened ampoule of solvent: 60 months

Shelf life after dilution or reconstitution:

Up to 30 hours with Water for injections (10 ml WFI)

Up to 8 hours with Water for injections (10 ml WFI) and then diluted in glucose 5% solution for infusion

Up to 6 hours with Water for injections (10 ml WFI) and then diluted in sodium chloride 0.9% solution for infusion

Special precautions for storage

Do not store above 25°C.

Product licence holder

Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.

RIFADIN 600 MG INFUSION, RIFAMPICIN 600 MG INFUSION - patient leaflet, side effects, dosage

Table of contents

Patient leaflet - RIFADIN 600 MG INFUSION, RIFAMPICIN 600 MG INFUSION

1. what rifadin is and what it is used for

2. what you need to know before you take rifadin

Rifadin ® 600 mg Infusion

4. possible side effects

5. how to store rifadin

6. contents of the pack and other information

1. what rifampicin is and what it is used for

2. what you need to know before you take rifampicin

Rifampicin 600 mg Infusion

4. possible side effects

5. how to store rifampicin

6. contents of the pack and other information