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RIFADIN 100MG/5ML ORAL SUSPENSION

Active substance(s): RIFAMPICIN

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Rifadin® 100mg/5ml Oral Suspension
rifampicin
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2. What you need to know before you take Rifadin Oral Suspension

Important things you need to know about Rifadin Oral Suspension
• It is very important that you take Rifadin Oral Suspension exactly as your doctor has told
you. There is a chance of you having a severe and dangerous allergic reaction if you do
not take your Oral Suspension each day as you are told
• You must keep taking it until your doctor tells you to stop
• If you are taking any other medicines, including medicines you have bought from the
pharmacy or shop, you must make sure your doctor knows
• Rifadin Oral Suspension makes all your body fluids an orange or red colour. Do not worry,
this is normal and not harmful
• Take Rifadin Oral Suspension on an empty stomach. This means at least 30 minutes
before food or 2 hours after food
• 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 taking 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 Oral Suspension is and what it is used for
2. What you need to know before you take Rifadin Oral Suspensionl Suspension
3. How to take Rifadin Oral Suspension Oral Suspension
4. Possible side effects
5. How to store Rifadin Oral Suspension Oral Suspension
6. Contents of the pack and other information
1. What Rifadin Oral Suspension is and what it is used for

Rifadin Oral Suspension is used to treat the following bacterial infections:
• Tuberculosis (also known as TB) alongside other medicines
• Leprosy alongside other medicines
• Brucellosis alongside other medicines
• Legionnaires Diseases alongside other medicines
• Haemophilus Influenzae
• Other serious bacterial infections
Rifadin Oral Suspension can also be used to stop the following infections from developing:
• Meningitis
• Haemophilus Influenzae in children aged 4 years or younger

i

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

Do not take Rifadin Oral Suspension if:
You are allergic (hypersensitive) to
- rifampicin
- any of the other ingredients of the Rifadin Oral Suspension (see Section 6: Further information)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling
of your lips, face, throat or tongue
X You have yellowing of the skin and eyes (jaundice)
X You are taking saquinavir or ritonavir for an HIV infection (see ‘Taking other medicines’
section below)
Do not take if any of the above apply to you. If you are not sure, talk to your doctor or
pharmacist before taking Rifadin Oral Suspension.
X

Warnings and precautions
Talk to your doctor or pharmacist before taking Rifadin Oral Suspension
V You have liver problems
V You have any kidney problems and if you are having more than 600mg rifampicin per day
V You have diabetes. Your diabetes may become more difficult to control while taking this
medicine
V You feel numb or weak in your arms and legs (peripheral neuropathy)
V You are under weight or malnourished
V You have a rare blood problem called ‘porphyria’
V You wear contact lenses. Taking Rifadin Oral Suspension may permanently stain soft
contact lenses
V The person taking this medicine is a child
V You are aged 65 years or older
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before
taking Rifadin Oral Suspension.
Blood Tests
Your doctor will need to check your blood before you take this medicine. This will help your
doctor know if any changes happen to your blood after taking this medicine. You may also
need to have regular blood tests to check how your liver is working.

Other medicines and Rifadin Oral Suspension
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines. This includes medicines you buy without a prescription, including herbal
medicines. This is because Rifadin Oral Suspension can affect the way some other medicines
work. Also some medicines can affect the way Rifadin Oral Suspension works.
In particular, do not take this medicine, and tell your doctor, if you are taking:
• Saquinavir or ritonavir used for HIV infection
The following medicines can make Rifadin Oral Suspension work less well:
• Antacids used for indigestion. Take Rifadin Oral Suspension at least 1 hour before taking
antacids
• Other medicines used for TB such as P-aminosalicyclic acid (PAS). PAS and Rifadin Oral
Suspension should be taken at least 8 hours apart
Tell your doctor if you are taking any of the following medicines:
Heart and blood medicines
• Medicines for high blood pressure
• Medicines for heart problems or to control your heartbeat
• Medicines used to thin the blood such as warfarin
• 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
Taking Rifadin Oral Suspension with food and drink
Take Rifadin Oral Suspension on an empty stomach. This means at least 30 minutes before
food or 2 hours after food.
Pregnancy, breast-feeding and fertility
Talk to your doctor before taking this medicine if you are pregnant, plan to get pregnant or
think you are pregnant.
Rifadin Oral Suspension may make the contraceptive “pill” work less well. This means you
should change to a different type of contraception. Instead, you must use a reliable barrier
method of contraception such as condoms or the “coil” while taking Rifadin Oral Suspension.
If you have any questions or are unsure about this talk to your doctor or pharmacist.
You should not breast-feed if you are taking Rifadin Oral Suspension. This is because small
amounts may pass into the mothers’ milk. If you are breast-feeding or planning to breast
feed, talk to your doctor or pharmacist before taking any medicine.
Driving and using machines
You may feel dizzy or faint, have problems with vision or have other side effects that could
affect your ability to drive while taking this medicine. If this happens, do not drive or use any
tools or machines.
Important information about some of the ingredients of Rifadin Oral Suspension Oral
Rifadin Oral Suspension contains:
• Sucrose: The Oral Suspension contains 2 g of sucrose per 5 ml dose. This should be taken
into account in patients with diabetes mellitus. May also be harmful to teeth. If you have
been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
• Sodium: The Oral Suspension contains 7.2 mg of sodium per 600mg daily dose and is
essentially ‘sodium-free’.
• Sodium metabisulfite: These may rarely cause severe allergic reactions (hypersensitivity)
and difficulty in breathing (bronchospasm). This is more likely to happen if you have a
history of asthma or allergies. Tell a doctor or nurse straight away if you get a rash,
swallowing or breathing problems and swelling of your lips, face, throat or tongue.
• Methyl-p-hydroxybenzoate and propyl-p-hydroxybenzoate: these may
cause an allergic reaction (this might not happen straight away). Signs of an
allergic reaction include: a rash, swallowing or breathing problems, swelling
of your lips, face, throat or tongue.

• Ethanol: This medicinal product contains small amounts of ethanol (alcohol), less than
100mg per dose.
• Potassium: this medicine contains 10.4 mg potassium per 30 ml dose. This is to be taken
into consideration by patients with reduced kidney function or patients on a controlled
potassium diet.
3. How to take Rifadin Oral Suspension
Always take Rifadin Oral Suspension exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
Keep taking this medicine
• You must take this medicine each day for the whole time the doctor has told you to take it
• Do not stop and start taking the Oral Suspension. This may increase the risk of side effects
and your infection will not be treated properly
How to take the Oral Suspension Oral Suspension
• Shake well before use;
• Take this medicine by mouth;
• Take at least 30 minutes before a meal or 2 hours after a meal;
• Only use the measuring cup supplied in the Rifadin Oral Suspension pack to measure your
dose. Do not use the cup to measure other medicinal products;
• You will be able to measure the dose in the measuring cup supplied with the Oral Suspension;
• The measurement graduations of the cup show you how to measure between 2.5ml
(50mg) and 7.5ml (150mg);
• You may need to measure out more than one 7.5ml (150mg) cup to make up your dose.
Talk to your doctor or pharmacist if you are unsure how much to measure;
• If the dose is less than 2.5ml (50mg), talk to your doctor or pharmacist about how to
measure the dose;
• If you feel the effect of your medicine is too weak or too strong, do not change the dose
yourself, but ask your doctor.
How much to take
How much you will be given will depend your age and on the type of illness
Tuberculosis (TB)
• Rifadin should be given with at least one other medicine for TB
• The usual dose is:
• Patients weighing less than 50kg: A single daily dose of 450mg
• Patients weighing more than 50kg: A single daily dose of 600mg
• Children: 10mg to 20mg per kilogram of body weight each day. The maximum dose is
600mg each day
Leprosy
• Rifadin should always be given with at least one other medicine for leprosy
• Your doctor may prescribe a monthly or daily dose. The usual dose is:
• 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
• Rifadin should be used together with another antibiotic
• 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

Stopping the development of Meningitis
• The usual dose is:
• Adults: 600mg twice each day for two days
• Children (1 -12 years): 10mg per kilogram of bodyweight, twice each day for two days
• Children (3 months - 1 year): 5mg per kilogram twice each day for two days
Stopping the development of Haemophilus Influenzae:
• Everybody in the same house needs to be treated under the doctors direction
• The usual dose is:
• Adults and Children: 20mg per kilogram body weight each day for four days. No more
than 600mg should be given.
• Neonates (1 month): 10mg/kg each day for 4 days
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 take more Rifadin Oral Suspension than you should
If you take more Rifadin Oral Suspension than you should, tell a doctor or go to a hospital
casualty department straight away. Take the medicine pack with you. This is so the doctor
knows what you have taken.
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 taking 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 forget to take Rifadin Oral Suspension Oral Suspension
If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next
dose, skip the missed dose. Do not take a double dose to make up for the forgotten dose.
If you stop taking Rifadin Oral Suspension Oral Suspension
Keep taking Rifadin Oral Suspension until your doctor tells you to stop. Do not stop taking
Rifadin Oral Suspension just because you feel better. If you stop, your infection may get worse.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Tests
Taking Rifadin Oral Suspension 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 taking Rifadin Oral Suspension.
4. Possible side effects
Like all medicines, Rifadin Oral Suspension can cause side effects, although not everybody gets them.
Stop taking and go to a hospital 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
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
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

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 Oral Suspension.
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 Oral Suspension
Keep this medicine in a safe place where children cannot see or reach it.
Do not use Rifadin Oral Suspension after the expiry date which is stated on the carton and
blister packs. The expiry date refers to the last day of that month.
Do not store above 25°C.
Store the bottle and measuring cup in the original outer carton.
Medicines should not be disposed of via waterwaste or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.
6. Contents of the pack and other information
What Rifadin Oral Suspension contains:
• Each 1ml of Oral Suspension contains 20mg of the active ingredient, rifampicin.
• The other ingredients agar, sucrose, methyl-p-hydroxybenzoate, propyl-p-hydroxybenzoate,
potassium sorbate, sodium metabisulphite, tween 80, raspberry essence (contains small
amount of ethanol), saccharin, diethanolamine, purified water
What Rifadin Oral Suspension look like and contents of the pack
Rifadin Oral Suspension is a raspberry flavoured and coloured suspension. It is supplied in a
120ml amber bottle, accompanied by a 7.5ml (150mg) measuring cup.
Marketing Authorisation Holder
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Tel: 0845 372 7101
Email: uk-medicalinformation@sanofi.com
Manufacturer
Sanofi S.P.A., Loc. Valcanello - 03012 Anagni (FR), ITALY
This leaflet does not contain all the information required about your medicine.
If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in December 2015
89027064
© Sanofi 1982 - 2015

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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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