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RIFAMPICIN 600MG INFUSION

Active substance(s): RIFAMPICIN

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Rifadin® 600mg Infusion

2920
10.08.17[4]

(rifampicin)
PATIENT INFORMATION LEAFLET
Important things you need to know about Rifadin
- 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 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.
This medicine is available using the above name but will be referred to as
Rifadin throughout the leaflet.
What is in this leaflet
1. What Rifadin is and what it is used for
2. What you need to know before you take Rifadin
3. How Rifadin is given
4. Possible side effects
5. How to store Rifadin
6. Contents of the pack and other information
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
- 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 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.

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

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.

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.

In particular, do not have this medicine, and tell your doctor, if you are
taking:
- Saquinavir or ritonavir used for HIV infection

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

Rifadin® 600mg Infusion
(rifampicin)
Technical Leaflet
The following information is extracted from the SPC.
Technical information for the preparation and administration of Rifadin
600mg infusion.
1. NAME OF THE MEDICINAL PRODUCT
Rifadin 600mg Infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Rifampicin 600mg
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lyophilisate (for reconstitution prior to use) and accompanying
ampoule of solvent.
4.2. 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 600mg 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 600mg by mouth.
Children: The usual paediatric regimen is a single daily dose of up to 20mg/kg
bodyweight; the total daily dose should not normally exceed 600mg.
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 - 1200mg given in 2 to 4 divided
doses, together with another antibacterial agent with similar properties to
prevent the emergence of resistant strains.

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 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
- You get blistering, peeling, bleeding, scaling or fluid filled patches on any
part of your skin. This includes your lips, eyes, mouth, nose, genitals,
hands or feet. You may have a serious skin problem
- 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 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
If you experience any of the following side effects contact your doctor
as soon as possible:
- Severe extensive skin damage (separation of the epidermis and superficial
mucous membranes) (toxic epidermal necrolysis, TEN)
- A drug reaction that causes rash, fever inflammation of internal organs,
hematologic abnormalities and systemic illness (DRESS syndrome)
- Skin blistering, red/purple rash, fever headache, cough and joint pain
(Stevens-Johnson syndrome, SJS).
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

Impaired liver function: A daily dose of 8mg/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 halflife 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).

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 an orange or reddish colour in your urine, sweat, phlegm
(sputum), saliva or tears. This is quite common and you need not worry.
However, the red colour may permanently stain soft contact lenses. The
red 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 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 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 other 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.
- Each vial contains 600mg of 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 Rifadin look like and contents of the pack
Rifadin is presented as a 20ml clear glass vial sealed with rubber stopper
and aluminium/plastic flip-off cap (colour coded blue) containing
faint-orange to red-brown colour lyophilisate and a 10ml clear glass
ampoule containing the solvent.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by
Sanofi-Aventis 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 20636/2920

Leaflet revision and issue date (Ref): 10.08.17[4]
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.

6.3. Shelf life
Unopened vial of lyophilisate:
Unopened ampoule of solvent:
Reconstituted Solution:

4 years
5 years
6 hours

6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
Rifadin is presented as a 20ml clear glass vial sealed with rubber
stopper and aluminium/plastic flip-off cap (colour coded blue) containing
faint-orange to red-brown colour lyophilisate and a 10ml clear glass
ampoule containing the solvent.

6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Sodium sulfoxylate formaldehyde
Sodium hydroxide
Solvent
Water for Injections.

6.6. Special precautions for disposal
Not applicable.

6.2 Incompatibilities
Compatibilities: Rifadin for Infusion is compatible with the following
infusion solutions for up to 6 hours: Glucose 5%, Saline Solution.
Incompatibilities: Rifadin for Infusion is incompatible with the following:
Perfudex, Sodium Bicarbonate 5%, Sodium Lactate 0.167M, Ringer
Acetate with Glucose.

Leaflet revision and issue date (Ref): 10.08.17[4]

6.7. Product licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex
HA1 1XD.

Rifampicin 600mg Infusion

2920
10.08.17[4]

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.
This medicine is available using the above name but will be referred to as
Rifampicin throughout the 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
cannot 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
- 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 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
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.
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

Rifampicin 600mg Infusion
Technical Leaflet
The following information is extracted from the SPC.
Technical information for the preparation and administration of Rifampicin
600mg Infusion.
1. NAME OF THE MEDICINAL PRODUCT
Rifampicin 600mg Infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Rifampicin 600mg
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lyophilisate (for reconstitution prior to use) and accompanying
ampoule of solvent.
4.2. 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.

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
- 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 and neviparine
- 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
- 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
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 Rifampicin
Rifampicin contains:
- Sodium: The infusion contains less than 1 mmol sodium (23 mg) per daily
dose and is essentially ‘sodium-free’.
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 600mg given over 2 - 3 hours
Tuberculosis:
Adults: A single daily administration of 600mg 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 600mg by mouth.
Children: The usual paediatric regimen is a single daily dose of up to
20mg/kg bodyweight; the total daily dose should not normally exceed 600mg.
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 - 1200mg given in 2 to 4 divided
doses, together with another antibacterial agent with similar properties to
prevent the emergence of resistant strains.

- 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 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.
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 Rifampicin
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 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
- You get blistering, peeling, bleeding, scaling or fluid filled patches on any
part of your skin. This includes your lips, eyes, mouth, nose, genitals,
hands or feet. You may have a serious skin problem
- 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 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
If you experience any of the following side effects contact your doctor
as soon as possible:
- Severe extensive skin damage (separation of the epidermis and superficial
mucous membranes) (toxic epidermal necrolysis, TEN)
- A drug reaction that causes rash, fever inflammation of internal organs,
hematologic abnormalities and systemic illness (DRESS syndrome)
- Skin blistering, red/purple rash, fever headache, cough and joint pain
(Stevens-Johnson syndrome, SJS).
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
Impaired liver function: A daily dose of 8mg/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 halflife 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).

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 an orange or reddish colour in your urine, sweat, phlegm
(sputum), saliva or tears. This is quite common and you need not worry.
However, the red colour may permanently stain soft contact lenses. The
red 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
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 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 other 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.
- Each vial contains 600mg of 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 20ml clear glass vial sealed with rubber stopper
and aluminium/plastic flip-off cap (colour coded blue) containing faint-orange
to red-brown colour lyophilisate and a 10ml clear glass ampoule containing
the solvent.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by
Sanofi-Aventis S.p.A., Localita Valcanello, 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 20636/2920

Leaflet revision and issue date (Ref): 10.08.17[4]

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.

6.3. Shelf life
Unopened vial of lyophilisate:
Unopened ampoule of solvent:
Reconstituted Solution:

4 years
5 years
6 hours

6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
Rifampicin is presented as a 20ml clear glass vial sealed with rubber
stopper and aluminium/plastic “flip-off’ cap (colour coded blue)
containing faint-orange to red-brown 600mg rifampicin and a 10ml clear
glass ampoule containing the solvent.

6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Sodium sulfoxylate formaldehyde
Sodium hydroxide
Solvent
Water for Injections

6.6. Special precautions for disposal
Not applicable.

6.2 Incompatibilities
Compatibilities: Rifampicin for Infusion is compatible with the following
infusion solutions for up to 6 hours: Glucose 5%, Saline Solution.
Incompatibilities: Rifampicin for Infusion is incompatible with the
following:
Perfudex, Sodium Bicarbonate 5%, Sodium Lactate 0.167M, Ringer
Acetate with Glucose.

Leaflet revision and issue date (Ref): 10.08.17[4]

6.7. Product licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex
HA1 1XD.

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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