Clindamycin 1% W/V Topical Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
Dalacin® T Topical Solution
(clindamycin phosphate)
Read all of this leaflet carefully before you start using 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 your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness 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.
This product is known as Dalacin® T Topical Solution, but will be referred to as Dalacin T throughout this l eaflet. This product is also available as a lotion.
What is in this leaflet:
1. What Dalacin T is and what it is used for
2. What you need to know before you use Dalacin T
3. How to use Dalacin T
4. Possible side effects
5. How to store Dalacin T
6. Contents of the pack and other information
1. What Dalacin T is and what it is used for
Dalacin T contains an antibiotic called clindamycin phosphate and comes as either a solution or a lotion. The solution and the lotion are used on the skin to treat acne.
2. What you need to know before you use Dalacin T
Do not use Dalacin T:
• if you are hypersensitive (allergic) to clindamycin, lincomycin or to any of the other ingredients of this medicine (listed in section 6).
• If you have a history of inflammatory bowel disease or antibiotic-associated colitis.
Warnings and precautions
Talk to your doctor or pharmacist before using Dalacin T if you have diarrhoea or usually get diarrhoea when you take antibiotics.
I f you develop severe or prolonged or bloody diarrhoea during or after using Dalacin tell your doctor immediately since it may be necessary to interrupt the treatment. This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics.
Dalacin T Topical Solution contains alcohol, which can cause burning or irritation of your eyes. Keep it away from your eyes, mouth, and cuts or grazes on your skin. If you get any of these sensitive areas, wash it away with plenty of cool water. Take care when using the topical solution around your mouth as they each have an unpleasant taste.
Dalacin T Topical Solution is flammable. Do not use the solution near flames or while you are smoking.
Other medicines and Dalacin T
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Tell your doctor if you are using any skin treatments that contain benzoyl peroxide. These medicines should not be used at the same time as Dalacin T.
If you are going to hospital for a surgical procedure, tell your doctor and/or anaesthetist if you are taking drugs that cause paralysis of muscle (neuromuscular blocking agents).
Warfarin or similar medicines -used to thin the blood. You may be more likely to have a bleed.
Your doctor may need to take regular blood tests to check how well your blood can clot.
Pregnancy and breast-feeding Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Breast-feeding
Tell your doctor if you will be breastfeeding while using Dalacin T as the active substance in this medicine may be passed into breast milk.
Your doctor will decide if Dalacin T is suitable for you. Although it is not likely that a nursing infant will take in very much of the active substance from the milk it drinks, if your baby gets bloodstained diarrhoea or shows any signs of illness, tell your doctor at once. You should stop breast-feeding if this happens.
Driving and using machines No effects on the ability to drive or use machines have been seen with Dalacin T.
Dalacin T Solution contains propylene glycol
This may cause skin irritation.
3. How to use Dalacin T
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
POM
Usually, you should use this medicine twice a day, shake the bottle well before use. Wash the affected area and put on a thin film of solution.
The Dalacin T Solution bottle has an automatic pad dispenser.
Gently apply a thin film onto your skin using the pad on the applicator.
If you forget to apply Dalacin T
Do not worry if you miss one or two applications; just carry on as soon as you remember.
If you stop using Dalacin T
Do not stop using Dalacin T as soon as your acne starts to get better. Ask your doctor when you should stop the treatment.
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.
Tell your doctor immediately
if you develop severe, persistent or bloody diarrhoea (which may be associated with stomach pain or fever). This is an uncommon side effect which may occur after treatment with antibiotics and can be a sign of serious bowel inflammation.
Dalacin T Topical Solution may make your skin dry (very common side effect).
Other side effects that have been seen with Dalacin T Topical Solution
Very common: may affect more than 1 in 10 people
• Skin irritation (may cause symptoms such as burning, itching, peeling), hives.
Common: may affect up to 1 in
10 people
• Oily skin
Uncommon: may affect up to 1 in
100 people (only seen with
Dalacin T Topical solution)
• Gastrointestinal disturbances (may cause symptoms such as diarrhoea, and nausea).
Frequency not known, but may also occur
• Severe acne (also known as gram-negative folliculitis), stinging of the eye, stomach pain, inflammation of the skin caused by contact with irritants or allergens.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or n urse. 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 Dalacin T
• Keep out of the sight and reach of children.
• Do not use Dalacin T after the expiry date which is stated on the bottle and carton. The expiry date refers to the last day of that month.
• Replace the cap tightly after use.
• Do not store above 25°C.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Dalacin T contains
The active substance is clindamycin phosphate. Each ml contains clindamycin phosphate BP equivalent to 10 mg of clindamycin.
The other ingredients are:
• Solution: isopropyl alcohol, propylene glycol, hydrochloric acid, sodium hydroxide and water.
What Dalacin T looks like and contents of the pack
Dalacin T Solution is a clear colourless solution in a white plastic bottle with an applicator and plastic cap.
Bottles contain 30 ml of Dalacin T Solution.
Manufactured by: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium.
Procured from within the EU & repackaged by Product Licence holder: Kosei Pharma UK Ltd., 956 Buckingham Avenue, Slough Trading Estate, Slough, SL1 4NL, UK.
Dalacin T Topical Solution PL 39352/0110
Dalacin® is a registered trademark of Pfizer Ltd.
Leaflet Date: 06.08.2014
Clindamycin 1% w/v Topical Solution
(clindamycin phosphate)
Read all of this leaflet carefully before you start using 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 your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness 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.
This product is known as Clindamycin 1% w/v Topical Solution but will be referred to as Clindamycin solution throughout this leaflet. This product is also available as a lotion.
What is in this leaflet:
1. What Clindamycin solution is and what it is used for
2. What you need to know before you use Clindamycin solution
3. How to use Clindamycin solution
4. Possible side effects
5. How to store Clindamycin solution
6. Contents of the pack and other information
1. What clindamycin solution is and what it is used for
Clindamycin solution contains an antibiotic called clindamycin phosphate and comes as either a solution or a lotion. The solution and the lotion are used on the skin to treat acne.
2. What you need to know before you use Clindamycin solution
Do not use Clindamycin solution:
• if you are hypersensitive (allergic) to clindamycin, lincomycin or to any of the other ingredients of this medicine (listed in section 6).
• If you have a history of inflammatory bowel disease or antibiotic-associated colitis.
Warnings and precautions
Talk to your doctor or pharmacist before using Clindamycin solution if you have diarrhoea or usually get diarrhoea when you take antibiotics. If you develop severe or prolonged or bloody diarrhoea during or after using Clindamycin solution tell your doctor immediately since it may be necessary to interrupt the treatment. This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics.
Clindamycin solution contains alcohol, which can cause burning or irritation of your eyes. Keep it away from your eyes, mouth, and cuts or grazes on your skin. If you get any of these sensitive areas, wash it away with plenty of cool water. Take care when using the topical solution around your mouth as they each have an unpleasant taste.
Clindamycin solution is flammable. Do not use the solution near flames or while you are smoking.
Other medicines and Clindamycin solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Tell your doctor if you are using any skin treatments that contain benzoyl peroxide. These medicines should not be used at the same time as Clindamycin solution.
If you are going to hospital for a surgical procedure, tell your doctor and/or anaesthetist if you are taking drugs that cause paralysis of muscle (neuromuscular blocking agents).
Warfarin or similar medicines -used to thin the blood. You may be more likely to have a bleed.
Your doctor may need to take regular blood tests to check how well your blood can clot.
Pregnancy and breast-feeding Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Breast-feeding
Tell your doctor if you will be breastfeeding while using Clindamycin solution as the active substance in this medicine may be passed into breast milk. Your doctor will decide if Clindamycin solution is suitable for you. Although it is not likely that a nursing infant will take in very much of the active substance from the milk it drinks, if your baby gets bloodstained diarrhoea or shows any signs of illness, tell your doctor at once. You should stop breast-feeding if this happens.
Driving and using machines
No effects on the ability to drive or use machines have been seen with Clindamycin solution.
Clindamycin solution contains propylene glycol
This may cause skin irritation.
3. How to use Clindamycin solution
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Usually, you should use this medicine twice a day, shake the bottle well before use. Wash the affected area and put on a thin film of solution.
The Clindamycin solution bottle has an automatic pad dispenser.
Gently apply a thin film onto your skin using the pad on the applicator.
If you forget to apply Clindamycin solution
Do not worry if you miss one or two applications; just carry on as soon as you remember.
If you stop using Clindamycin solution
Do not stop using Clindamycin solution as soon as your acne starts to get better. Ask your doctor when you should stop the treatment.
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.
Tell your doctor immediately
if you develop severe, persistent or bloody diarrhoea (which may be associated with stomach pain or fever). This is an uncommon side effect which may occur after treatment with antibiotics and can be a sign of serious bowel inflammation.
Clindamycin solution may make your skin dry (very common side effect).
Other side effects that have been seen with Clindamycin solution.
Very common: may affect more than 1 in 10 people
• Skin irritation (may cause symptoms such as burning, itching, peeling), hives.
Common: may affect up to 1 in 10 people
• Oily skin
Uncommon: may affect up to 1 in 100 people (only seen with Clindamycin solution)
• Gastrointestinal disturbances (may cause symptoms such as diarrhoea, and nausea).
Frequency not known, but may also occur
• Severe acne (also known as gram-negative folliculitis), stinging of the eye, stomach pain, inflammation of the skin caused by contact with irritants or allergens.
Reporting of side effects
If you get any side effects, talk to your doctor or 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 Clindamycin solution
• Keep out of the sight and reach of children.
• Do not use Clindamycin solution after the expiry date which is stated on the bottle and carton. The expiry date refers to the last day of that month.
• Replace cap tightly after use.
• Do not store above 25°C.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Clindamycin solution contains
The active substance is clindamycin phosphate. Each ml contains clindamycin phosphate BP equivalent to 10 mg of clindamycin. The other ingredient are:
• Solution: isopropyl alcohol, propylene glycol, hydrochloric acid, sodium hydroxide and water.
What Clindamycin solution looks like and contents of the pack
Clindamycin solution is a clear colourless solution in a white plastic bottle with an applicator and plastic cap.
Bottles contain 30 ml of Clindamycin solution.
Manufactured by: Pfizer Manufacturing Belgium NV,
Rijksweg 12, 2870 Puurs, Belgium.
Procured from within the EU & repackaged by Product Licence holder: Kosei Pharma UK Ltd.,
956 Buckingham Avenue, Slough Trading Estate, Slough, SL1 4NL, UK.
Clindamycin 1% w/v Topical Solution
PL 39352/0110
Leaflet Date: 06.08.2014
POM