Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Chloramphenicol is and what it is used for

• 2. What you need to know before you take Chloramphenicol

• 3. How to take Chloramphenicol

• 4. Possible side effects

• 5. How to store Chloramphenicol

• 6. Contents of the pack and other information

1. what chloramphenicol is and what it is used for

Chloramphenicol belongs to a group of medicines known as antibiotics which are used for the treatment of infections.

Chloramphenicol is used for the treatment of severe infections and typhoid fever, when other antibiotics would not be effective or suitable.

If you are not sure why you are being prescribed Chloramphenicol, then please ask you doctor.

2. what you need to know before you take chloramphenicol- are allergic to chloramphenicol or any of the other ingredients of this medicine (listed in section 6)

• – have recently had or are going to have a vaccination

• – have problems with your blood

• – have porphyria, an inherited iron disorder

• – are taking any other medicines which may cause bone marrow depression

• – are pregnant, or breast feeding

Warnings and precautions

Talk to your doctor or pharmacist before taking Chloramphenicol if you:

• have liver or kidney problems
• are elderly
• are taking any of the medicines listed in the next section ‘Other medicines and Chloramphenicol’

Other medicines and Chloramphenicol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• paracetamol for pain and fever
• penicillins and rifampicin, antibiotics used to treat bacterial infections
• coumarin anticoagulants, medicines used to thin the blood and prevent clotsting, such as warfarin
• sulphonylureas, medicines used to treat diabetes, such as tolbutamide and gliclazide
• anticonvulsants, medicines to treat epilepsy and seizures, such as carbamazepine, phenytoin or phenobarbital
• ciclosporin and tacrolimus, used to suppress the immune system and prevent the rejection of organs after transplant
• oestrogens used for contraception or hormone replacement therapy (HRT)
• hydroxocobalamin, a form of vitamin B12 used to treat conditions caused by vitamin B12 deficiency
• any medicines that may supress bone marrow function, including:

o sulfonamide antibiotics

o phenylbutazone for pain and inflammation

o medicines used to treat cancer

o some antipsychotics (such as clozapine, flupentixol, fluphenazine, haloperidol, zuclopenthixol)

o procainamide to treat irregular or uneven heart beat

o some antiretrovirals (such as zidovudine, lamivudine, abacavir)

o propylthiouracil for treating an over-active thyroid

Pregnancy and breast-feeding

Do not use this medicine during pregnancy or while breast feeding, as it may harm your baby.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Chloramphenicol does not to effect your ability to drive or use machinery.

3. how to take chloramphenicol

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended doses are:

Adults and elderly : Your doctor will decide on the amount of Chloramphenicol to take based on your bodyweight and the severity of your infection, the usual dose is 500 mg (2 capsules) every 6 hours to be taken by mouth.

Children : Not recommended.

If you take more Chloramphenicol than you should

If you take more capsules then you should contact your doctor or go to the nearest hospital casualty department immediately. Take this leaflet and the medicine pack with you, so the doctor knows what has been taken.

If you forget to take Chloramphenicol

If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose and take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Chloramphenicol

Keep taking this medicine until the course is finished, even if you feel better. If you stop taking this medicine too soon, the infection may come back.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

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

If you get any of the following side effects, stop taking Chloramphenicol and see your doctor or go to the nearest hospital emergency department immediately:

• an allergic reaction to chloramphenicol, the signs of which can include red raised lumps (hives), rashes, itching, swelling of the hands, feet, face, lips, tongue or throat which may cause difficulty in swallowing or breathing
• suddenly developing failure of the circulatory system symptoms include fatigue, blackouts, fainting, chest pain, shortness of breath, weakness, dizziness, vomiting and palpitations
• Grey Syndrome – usually in new-born or premature infants, where the skin appears grey, and the infant is listless and weak.

If you get any of the following side effects, tell your doctor straight away:

• changes to your blood due to depression of the bone marrow, such as altered numbers of white blood cells, red blood cells or blood platelets. This may cause symptoms including unexplained bleeding, bruising, increased risk of infections, sore throat, fever, weakness, breathlessness, pale skin or general illness.

Because of the various blood conditions that may be caused by Chloramphenicol, it is essential that periodic blood counts be undertaken during treatment.

• inflammation of the nerves of the eye causing blurred vision
• ear problems such as hearing loss, ringing in the ears, or a feeling of dizziness or “spinning” (vertigo)

Tell your doctor or pharmacist if you get any of the following side effects:

• nausea, vomiting, inflammation of the mouth and tongue, diarrhoea, inflammation of the small intestine and the colon

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store chloramphenicol

Keep this medicine out of the sight and reach of children.

Store your medicine below 25°C, in a dry place. Keep the container closed.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

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 protect the environment.

6. contents of the pack and other informationthe active ingredient is chloramphenicol. each capsule contains 250 mg of chloramphenicol.

The other ingredients are pregelatinised maize starch, sodium starch glycollate, magnesium stearate, gelatin and titanium dioxide.

What Chloramphenicol Capsules look like and contents of the pack

Chloramphenicol Capsules are white opaque capsules. They are available in pots of 100 and 500.

Marketing Authorisation Holder

Chelonia Healthcare Limited, 11 Boumpoulinas Street, 3rd Floor, 1060 Nicosia, Cy­prus

Manufacturer

DDSA Pharmaceuticals Ltd., Chatfield Road, off York Road, London SW11 3SE.

For any information about this medicine, please contact the Marketing Authorisation Hol­der

This leaflet was last revised in 08/2016.

B. PACKAGE LEAFLET

Package Leaflet: Information For The Patient

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Cafcol is and what it is used for

• 2. What you need to know before you take Cafcol

• 3. How to take Cafcol

• 4. Possible side effects

• 5. How to store Cafcol

• 6. Contents of the pack and other information

1. what cafcol is and what it is used for

Cafcol conatins the active ingredient chloramphenicol that belongs to a group of medicines known as antibiotics which are used for the treatment of infections.

Cafcol is used for the treatment of severe infections and typhoid fever, when other antibiotics would not be effective or suitable.

If you are not sure why you are being prescribed Cafcol, then please ask you doctor.

2. what you need to know before you take cafcol- are allergic to chloramphenicol or any of the other ingredients of this medicine (listed in section 6)

• – have recently had or are going to have a vaccination

• – have problems with your blood

• – have porphyria, an inherited iron disorder

• – are taking any other medicines which may cause bone marrow depression

• – are pregnant, or breast feeding

Warnings and precautions

Talk to your doctor or pharmacist before taking Cafcol if you:

• have liver or kidney problems
• are elderly
• are taking any of the medicines listed in the next section ‘Other medicines and Cafcol’

Other medicines and Cafcol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• paracetamol for pain and fever
• penicillins and rifampicin, antibiotics used to treat bacterial infections
• coumarin anticoagulants, medicines used to thin the blood and prevent clotsting, such as warfarin
• sulphonylureas, medicines used to treat diabetes, such as tolbutamide and gliclazide
• anticonvulsants, medicines to treat epilepsy and seizures, such as carbamazepine, phenytoin or phenobarbital
• ciclosporin and tacrolimus, used to suppress the immune system and prevent the rejection of organs after transplant
• oestrogens used for contraception or hormone replacement therapy (HRT)
• hydroxocobalamin, a form of vitamin B12 used to treat conditions caused by vitamin B12 deficiency
• any medicines that may supress bone marrow function, including:

o sulfonamide antibiotics

o phenylbutazone for pain and inflammation

o medicines used to treat cancer

o some antipsychotics (such as clozapine, flupentixol, fluphenazine, haloperidol, zuclopenthixol)

o procainamide to treat irregular or uneven heart beat

o some antiretrovirals (such as zidovudine, lamivudine, abacavir)

o propylthiouracil for treating an over-active thyroid

Pregnancy and breast-feeding

Do not use this medicine during pregnancy or while breast feeding, as it may harm your baby.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Cafcol does not to effect your ability to drive or use machinery.

3. how to take cafcol

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended doses are:

Adults and elderly : Your doctor will decide on the amount of Cafcol to take based on your bodyweight and the severity of your infection, the usual dose is 500 mg (2 capsules) every 6 hours to be taken by mouth.

Children : Not recommended.

If you take more Cafcol than you should

If you take more capsules then you should contact your doctor or go to the nearest hospital casualty department immediately. Take this leaflet and the medicine pack with you, so the doctor knows what has been taken.

If you forget to take Cafcol

If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose and take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Cafcol

Keep taking this medicine until the course is finished, even if you feel better. If you stop taking this medicine too soon, the infection may come back.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

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

If you get any of the following side effects, stop taking Cafcol and see your doctor or go to the nearest hospital emergency department immediately:

• an allergic reaction to chloramphenicol, the signs of which can include red raised lumps (hives), rashes, itching, swelling of the hands, feet, face, lips, tongue or throat which may cause difficulty in swallowing or breathing
• suddenly developing failure of the circulatory system symptoms include fatigue, blackouts, fainting, chest pain, shortness of breath, weakness, dizziness, vomiting and palpitations
• Grey Syndrome – usually in new-born or premature infants, where the skin appears grey, and the infant is listless and weak.

If you get any of the following side effects, tell your doctor straight away:

• changes to your blood due to depression of the bone marrow, such as altered numbers of white blood cells, red blood cells or blood platelets. This may cause symptoms including unexplained bleeding, bruising, increased risk of infections, sore throat, fever, weakness, breathlessness, pale skin or general illness.

Because of the various blood conditions that may be caused by Cafcol, it is essential that periodic blood counts be undertaken during treatment.

• inflammation of the nerves of the eye causing blurred vision
• ear problems such as hearing loss, ringing in the ears, or a feeling of dizziness or “spinning” (vertigo)

Tell your doctor or pharmacist if you get any of the following side effects:

• nausea, vomiting, inflammation of the mouth and tongue, diarrhoea, inflammation of the small intestine and the colon

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store cafcol

Keep this medicine out of the sight and reach of children.

Store your medicine below 25°C, in a dry place. Keep the container closed.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

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 protect the environment.

6. contents of the pack and other informationthe active ingredient is chloramphenicol. each capsule contains 250 mg of chloramphenicol.

The other ingredients are pregelatinised maize starch, sodium starch glycollate, magnesium stearate, gelatin and titanium dioxide.

What Cafcol Capsules look like and contents of the pack

Cafcol Capsules are white opaque capsules. They are available in pots of 100 and 500.

Marketing Authorisation Holder

Chelonia Healthcare Limited, 11 Boumpoulinas Street, 3rd Floor, 1060 Nicosia, Cy­prus

Manufacturer

DDSA Pharmaceuticals Ltd., Chatfield Road, off York Road, London SW11 3SE.

For any information about this medicine, please contact the Marketing Authorisation Hol­der

This leaflet was last revised in 08/2016.

B. PACKAGE LEAFLET

Package Leaflet: Information For The Patient

CAFCOL

Chloramphenicol 250 mg Capsules

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Cafcol is and what it is used for

• 2. What you need to know before you take Cafcol

• 3. How to take Cafcol

• 4. Possible side effects

• 5. How to store Cafcol

• 6. Contents of the pack and other information

1. what cafcol is and what it is used for

Cafcol conatins the active ingredient chloramphenicol that belongs to a group of medicines known as antibiotics which are used for the treatment of infections.

Cafcol is used for the treatment of severe infections and typhoid fever, when other antibiotics would not be effective or suitable.

If you are not sure why you are being prescribed Cafcol, then please ask you doctor.

2. what you need to know before you take cafcol- are allergic to chloramphenicol or any of the other ingredients of this medicine (listed in section 6)

• – have recently had or are going to have a vaccination

• – have problems with your blood

• – have porphyria, an inherited iron disorder

• – are taking any other medicines which may cause bone marrow depression

• – are pregnant, or breast feeding

Warnings and precautions

Talk to your doctor or pharmacist before taking Cafcol if you:

• have liver or kidney problems
• are elderly
• are taking any of the medicines listed in the next section ‘Other medicines and Cafcol’

Other medicines and Cafcol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• paracetamol for pain and fever
• penicillins and rifampicin, antibiotics used to treat bacterial infections
• coumarin anticoagulants, medicines used to thin the blood and prevent clotsting, such as warfarin
• sulphonylureas, medicines used to treat diabetes, such as tolbutamide and gliclazide
• anticonvulsants, medicines to treat epilepsy and seizures, such as carbamazepine, phenytoin or phenobarbital
• ciclosporin and tacrolimus, used to suppress the immune system and prevent the rejection of organs after transplant
• oestrogens used for contraception or hormone replacement therapy (HRT)
• hydroxocobalamin, a form of vitamin B12 used to treat conditions caused by vitamin B12 deficiency
• any medicines that may supress bone marrow function, including:

o sulfonamide antibiotics

o phenylbutazone for pain and inflammation

o medicines used to treat cancer

o some antipsychotics (such as clozapine, flupentixol, fluphenazine, haloperidol, zuclopenthixol)

o procainamide to treat irregular or uneven heart beat

o some antiretrovirals (such as zidovudine, lamivudine, abacavir)

o propylthiouracil for treating an over-active thyroid

Pregnancy and breast-feeding

Do not use this medicine during pregnancy or while breast feeding, as it may harm your baby.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Cafcol does not to effect your ability to drive or use machinery.

3. how to take cafcol

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended doses are:

Adults and elderly : Your doctor will decide on the amount of Cafcol to take based on your bodyweight and the severity of your infection, the usual dose is 500 mg (2 capsules) every 6 hours to be taken by mouth.

Children : Not recommended.

If you take more Cafcol than you should

If you take more capsules then you should contact your doctor or go to the nearest hospital casualty department immediately. Take this leaflet and the medicine pack with you, so the doctor knows what has been taken.

If you forget to take Cafcol

If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose and take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Cafcol

Keep taking this medicine until the course is finished, even if you feel better. If you stop taking this medicine too soon, the infection may come back.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

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

If you get any of the following side effects, stop taking Cafcol and see your doctor or go to the nearest hospital emergency department immediately:

• an allergic reaction to chloramphenicol, the signs of which can include red raised lumps (hives), rashes, itching, swelling of the hands, feet, face, lips, tongue or throat which may cause difficulty in swallowing or breathing
• suddenly developing failure of the circulatory system symptoms include fatigue, blackouts, fainting, chest pain, shortness of breath, weakness, dizziness, vomiting and palpitations
• Grey Syndrome – usually in new-born or premature infants, where the skin appears grey, and the infant is listless and weak.
• changes to your blood due to depression of the bone marrow, such as altered numbers of white blood cells, red blood cells or blood platelets. This may cause symptoms including unexplained bleeding, bruising, increased risk of infections, sore throat, fever, weakness, breathlessness, pale skin or general illness.

Because of the various blood conditions that may be caused by Cafcol, it is essential that periodic blood counts be undertaken during treatment.

• inflammation of the nerves of the eye causing blurred vision
• ear problems such as hearing loss, ringing in the ears, or a feeling of dizziness or “spinning” (vertigo)
• nausea, vomiting, inflammation of the mouth and tongue, diarrhoea, inflammation of the small intestine and the colon