Chloramphenicol Capsules Bp 250mg
position of pharmacode
Chloramphenicol ess*™, gen™*
Capsules BP 250 mg
Chloramphenicol ismw
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What this medicine is and what it is used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information
1. What this medicine is and what it is used for
Chloramphenicol capsules contain chloramphenicol which is an antibiotic for specific uses.
They are used for for the treatment of typhoid fever and other dangerous infections where other antibiotics are not effective.
2. Before you take
Do NOT take Chloramphenicol capsules if you:
• are allergic to chloramphenicol or any of the other ingredients (see Section 6)
• have recently been vaccinated
• have porphyria (a metabolism disorder which causes abdominal pains and mental disorder)
• have a minor infection
• are taking medicines that may suppress your bone marrow
• are pregnant or breast-feeding.
If any of the above apply to you, speak to your doctor or pharmacist.
Take special care with Chloramphenicol capsules
Before taking the capsules, tell your doctor if you:
• have liver or kidney problems
• are elderly
• are taking any of the medicines listed in the next section 'Taking other medicines'.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, and herbal preparations.
Some medicines may be affected by Chloramphenicol or they may affect how well Chloramphenicol will work.
Tell your doctor or pharmacist if you are taking:
• paracetamol
• medicines that thin the blood (e.g. warfarin)
• antidiabetics (sulphonylureas such as gliclazide)
• medicines that may suppress the bone marrow (e.g. carbamazepine, penicillamine, sulphonamides, phenylbutazone)
• medicines to treat cancer
• antipsychotic drugs (e.g. clozapine, flupenthixol, fluphenazine, procainamide)
• sulphonamide antibiotics (e.g. co-trimoxazole)
• anticonvulsants for epilepsy or related conditions (e.g. phenytoin)
• barbiturates (e.g. phenobarbitone)
• immunosuppressants (e.g. ciclosporin or tacrolimus)
• penicillin or rifampicin type antibiotics
• vitamin B12 (hydroxocobalamin)
• oral contraceptives containing oestroqen (the pill)
• medicines that treat over-active thyroid disease (e.g. carbimazole, propylthiouracil)
• anti-retroviral medicines that treat HIV infection (e.g. zidovudine).
Pregnancy and breast-feeding DO NOT take Chloramphenicol capsules if you are pregnant, planning to become pregnant or breast-feeding as they may harm the baby.
Chloramphenicol may cause a condition called Grey Baby Syndrome, where the baby's skin appears grey and the baby is listless and weak. This may be fatal and requires immediate medical attention.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Chloramphenicol capsules are unlikely to affect your ability to operate machinery or to drive.
3. How to take
Always take Chloramphenicol capsules exactly as your doctor has told you and always read the label. Your doctor will decide on the appropriate dose to suit your condition. Ask your doctor or pharmacist if you are not sure.
• Swallow the capsules whole with a drink of water.
Doses
Adults and the elderly: the usual dose is 500 mg (2 capsules) every 6 hours or 50 mg per kg body weight daily in divided doses.
Blood tests may be carried out to check the level of chloramphenicol in your body and to make sure your blood is functioning properly, as chloramphenicol can damage blood cells.
Children: this medicine is NOT suitable for children.
If you take more than you should
It is likely that you will be taking these capsules in hospital and, therefore, it is unlikely that you will overdose.
However, if you do take more capsules than you should:
Continued over page
FRONT
1. Tell your doctor, pharmacist or nearest hospital casualty department immediately.
2. Take the container and any remaining capsules with you so that people can see what you have taken.
3. Do this even if you feel well.
If you forget to take
If you forget to take a dose take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as usual.
Do not take a double dose to make up for a missed dose.
Tell the doctor if you miss a dose.
If you stop taking
Do not stop just because you feel better. If you stop too soon, the infection may come back. Keep taking your capsules until the prescribed course is finished.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
By reporting side effects you can help provide more information on the safety of this medicine.
• Keep out of the reach and sight of children.
• Do not take after the expiry date which is stated on the label and on the carton. The expiry date refers to the last day of that month.
• Store in a cool dry place in the original package.
• Do not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.
Like all medicines, Chloramphenicol Capsules can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them.
STOP taking the capsules and seek medical
help immediately if you have any of the following allergic reactions:
• difficulty breathing or swallowing, swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised lumps
• blistering of the mouth, eyes, or genital region, patchy areas of rash, peeling skin.
Seek immediate medical attention if you have any of the following symptoms:
• drowsiness, feeling faint, sudden loss of consciousness, shortness of breath, nausea, vomiting
• unusual or increased bleeding or bruising
• fever, sore throat, mouth ulcers, repeated infections or infections that will not go away
• feeling tired, breathless, and looking pale
• sudden loss or blurring of vision, loss of colour vision, eye pain which worsens with eye movement
• ringing in the ears or temporary hearing loss, head-spins (vertigo), dizziness.
Tell your doctor if you get any of the following side effects:
• inflamed, sore and swollen tongue, sore mouth, difficulty chewing and eating
• fever, nausea, vomiting, diarrhoea, abdominal pain and/or bloating, blood in stool, fatigue, dehydration, swelling.
Use of chloramphenicol in pregnancy and in newborn babies can result in Grey Baby Syndrome, where the baby's skin appears grey and the baby is listless and weak. This may be fatal and requires immediate medical attention.
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
What Chloramphenicol Capsules contain
• The active ingredient is chloramphenicol (250 mg).
• The other ingredients are:
starch, talc, magnesium stearate and sodium laurilsulfate.
The capsule shell is gelatin and titanium dioxide (E171).
What Chloramphenicol Capsules look like and contents of the pack
Chloramphenicol Capsules are off-white hard gelatin capsules.
They are available in packs of 30, 50, 60, 100, or 1000. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chemidex Pharma Ltd., trading as Essential Generics, 7 Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB.
Manufacturer
Famar L’Aigle, Zone Industrielle No1, Route de Crulai, L’AIGLE, 61300, France.
This leaflet was last revised in
December 2014
75/L/f/4
ESSENTIAL GENERICS
REVERSE