Rifadin For Infusion 600mg

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Rifadin® 600mg Infusion

Rifampicin

Technical Leaflet - Rifadin® 600mg Infusion

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 for Infusion 600mg

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.

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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.

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 half-life is similar to that of younger patients. However, as increased blood levels have been noted in one study

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rifadin 600mg Infusion

rifampicin

SANOFI^

Other medicines and Rifadin Infusion

Is this leaflet hard to see or read? Phone 0845 372 7101 for help

Important things you need to know about Rifadin Infusion

You must keep taking it until your doctor tells you to stop. If you are having any other medicines, including medicines you have bought from the pharmacy or shop, you must make sure your doctor knows Rifadin Infusion makes all your body fluids an orange or red colour. Do not worry - this is normal and not harmful

If you get a temperature, are sick, begin to feel more unwell, lose your appetite or have yellowing of the skin, gums or eyes, you must talk to your doctor straight away

Read the rest of this leaflet carefully before you start having this medicine.

Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your pharmacist. This medicine has been prescribed for you. Do not pass it to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

What is in this leaflet

1. What Rifadin Infusion is and what it is used for

2. What you need to know before you take Rifadin Infusion

3. How Rifadin Infusion is given

4. Possible side effects

5. How to store Rifadin Infusion

6. Contents of the pack and other information

1. What Rifadin Infusion is and what it is used for

Rifadin Infusion 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 Infusion 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 Infusion

Do not have Rifadin Infusion if:

X You are allergic (hypersensitive) to

- rifampicin

- any of the other ingredients of the Rifadin Infusion (see Section 6: Further information)

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

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

Warnings and precautions Talk to your doctor or pharmacist before taking Rifadin Infusion

▲ 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 Infusion may permanently stain soft contact lenses

▲ The person having this medicine is a child

▲ You are aged 65 years or older

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

Blood Tests

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

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Rifadin Infusion can affect the way some other medicines work. Also some medicines can affect the way Rifadin Infusion work.

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

• Saquinavir or ritonavir used for HIV infection

The following medicines can make Rifadin Infusion work less well:

• Antacids used for indigestion. Have Rifadin Infusion at least 1 hour before taking antacids

• Other medicines used for TB such as P-aminosalicyclic acid (PAS). PAS and Rifadin Infusion should be taken at least 8 hours apart

Tell your doctor if you are having any of the following medicines:

Heart and blood medicines

• Medicines for high blood pressure

• Medicines for heart problems or to control your _

heartbeat

• Medicines used to thin the blood such as warfarin

• 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 Infusion may make the contraceptive “pill” work less well. This means you should change to a different type of contraception. Instead, you must use a reliable barrier method of contraception such as condoms or the “coil” while having Rifadin Infusion. If you have any questions or are unsure about this talk to your doctor or pharmacist. You should not breast-feed if you are having Rifadin Infusion. This is because small amounts may pass into the mothers' milk. If you are breast- feeding or planning to breast feed, talk to your doctor or pharmacist before taking any medicine.

Driving and using machines

You may feel dizzy or faint, have problems with vision or have other side effects that could affect your ability to drive while having this medicine. If this happens, do not drive or use any tools or machines.

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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).

6. PHARMACEUTICAL PARTICULARS 6.1. List of excipients

Sodium sulfoxylate formaldehyde

Sodium hydroxide

Solvent

Water for Injections.

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.

6.3. Shelf life

Unopened vial of lyophilisate: 4 years

Unopened ampoule of solvent: 5 years

Reconstituted Solution: 6 hours

6.4. Special precautions for storage

Store below 25°C.

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6.5. Nature and contents of container

20ml clear neutral glass vial sealed with butyl rubber stopper and aluminium/plastic “flip-off” cap (colour coded blue) containing 600mg Rifampicin and 10ml clear glass ampoule containing solvent.

Pack size: combination of 1 vial of lyophilisate and 1 ampoule of solvent.

6.6. Special precautions for disposal

Not applicable.

7. MARKETING AUTHORISATION HOLDER

Aventis Pharma Ltd

trading as Marion Merrell or Aventis Pharma

One Onslow Street

Guildford

Surrey

GU1 4YS

8. MARKETING AUTHORISATION NUMBER

PL 04425/0051

9. DATE OF FIRST AUTHORISATION/RENEWAL OF

AUTHORISATION

7^th December 1982 / 28^th January 1994

10. DATE OF REVISION OF THE TEXT

11/2013

89028957

Important information about some of the ingredients of Rifadin Infusion

Rifadin Infusion contains:

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

3. How Rifadin Infusion is given

Rifadin Infusion 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 Infusion or have any questions about how much Rifadin Infusion is being given to you, speak to your doctor or nurse.

Tuberculosis (TB)

• The usual dose is:

• Adults: A single daily dose of 600mg given over 2 -3 hours

• Children: Up to 20mg per kilogram of body weight each day. The maximum dose is 600mg each day

Leprosy

• Your doctor may prescribe a monthly or daily dose

• Patients weighing less than 50kg: A single daily dose of 450mg

• Patients weighing more than 50kg: A single daily dose of 600mg

Brucellosis, Legionnaires Disease or other serious bacterial infections

• The amount you are given will depend on how severe your infection is

• Adults: 600mg to 1200mg each day. The dose is given in 2 to 4 divided doses.

Elderly patients

Your doctor may need to monitor you more closely People with Liver problems

You should not be given any more than 8mg per kilogram of body weight each day

If you are given more Rifadin Infusion than you should

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

You may feel sick (nausea), be sick (vomiting), have stomach pain, itching or a headache. You may also feel tired, sleepy, dizzy or light-headed. Other signs of having too much includes swelling of the face, eyes or eyelids, slurring of speech, difficulty breathing, fast heartbeat, uneven heartbeats, fits and heart attack.

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

Tests

Having Rifadin Infusion may affect the results of some blood tests. In particular, tests for folate, vitamin B12 and liver function. If you are going to have a blood test, it is important to tell your doctor that you are having Rifadin Infusion.

4. Possible side effects

Like all medicines, Rifadin Infusion 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

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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

• 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 Infusion.

Blood tests

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

United Kingdom

You can also report side effects directly via the Yellow Card

Scheme at: www.mhra.gov.uk/yellowcard

Malta

You can also report side effects directly via ADR Reporting www.medicinesauthority.gov.mt/adrportal By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Rifadin Infusion

Keep this medicine in a safe place where children cannot see or reach it.

Do not use Rifadin Infusion after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month.

Store below 25°C

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 Infusion contains:

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

• The other ingredients are sodium sulfoxyformaldehyde, sodium hydroxide, water for injections

What Rifadin Infusion look like and contents of the pack

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

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 April 2015