Clindamycin Phosphate 1% Topical Solution
S824 LEAFLET Dalacin T 20140808
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DALACIN-T TOPICAL SOLUTION (clindamycin phosphate)
The name of your medicine is Dalacin -T Topical Solution but will be referred to as Dalacin T throughout the following leaflet.
This product is also available as a topical lotion.
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.
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 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 diarrhea or usually get diarrhoea when you take antibiotics.
If 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 lotion or 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 breast-feeding 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.
Dalacin T Lotion contains cetostearyl alcohol and methyl parahydroxybenzoate
Cetostearyl alcohol may cause local skin reactions such as dermatitis (an inflammation of the skin). Methyl parahydroxybenzoate may cause allergic reactions that can be delayed.
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.
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 or lotion.
The Dalacin T Solution bottle has an automatic pad dispenser. Gently apply a thin film onto your skin using the pad on the applicator.
The Dalacin T Lotion bottle has a dispensing cap. Wash your hands before and after use and dry them, apply a thin film of the lotion by gently rubbing it into your skin, you may use a cotton pad for this or you can use your fingers. Always replace the cap after use.
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 Lotion and Dalacin T Topical Solution are:
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
6. CONTENTS OF THE PACK AND OTHER INFORMATION
• 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
• Dalacin T Topical lotion may cause gastrointestinal disturbances (with symptoms such as diarrhoea and nausea)
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 DALACIN T
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C. Replace cap tightly after use.
• Do not use after the expiry date printed on the carton or bottle label.
• If your doctor tells you to stop using the solution, please take it back to the pharmacist for safe disposal. Only keep the solution if your doctor tells you to.
• If the solution becomes discoloured or you notice any other signs of deterioration, you should ask your doctor or pharmacist before using it.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
What Dalacin T contains
• Dalacin T contains the active ingredient, clindamycin phosphate. Each ml of clear aqueous solution contains clindamycin phosphate equivalent to 10mg clindamycin.
• It also contains the following inactive ingredients: isopropyl alcohol, propylene glycol and purified water.
What Dalacin T looks like and contents of the pack
Dalacin T is available as bottles of 30ml, with an enclosed cap applicator.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Pfizer Manufacturing Belgium NV, Rijksweg 12, B-2870 Puurs, Belgium.
And
Pharmacia and Upjohn Company, Kalamazoo, Michigan, USA.
|POM | PL No: 19488/0824
Leaflet revision date: 08 August 2014
Dalacin-T is a registered trade mark of Pharmacia & Upjohn Company LLC, USA.
S824 LEAFLET Dalacin T 20140808
S824 LEAFLET Clindamycin 20140808
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CLINDAMYCIN PHOSPHATE 1% TOPICAL SOLUTION
The name of your medicine is Clindamycin Phosphate 1% Topical Solution but will be referred to as Clindamycin throughout the following leaflet.
This product is also available as a topical lotion.
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.
What is in this leaflet
1. What Clindamycin is and what it is used for
2. What you need to know before you use Clindamycin
3. How to use Clindamycin
4. Possible side effects
5. How to store Clindamycin
6. Contents of the pack and other information
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 breast-feeding while using Clindamycin as the active substance in this medicine may be passed into breast milk. Your doctor will decide if Clindamycin 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.
Clindamycin Solution contains propylene glycol
This may cause skin irritation.
Clindamycin Lotion contains cetostearyl alcohol and methyl parahydroxybenzoate
Cetostearyl alcohol may cause local skin reactions such as dermatitis (an inflammation of the skin). Methyl parahydroxybenzoate may cause allergic reactions that can be delayed.
3. HOW TO USE CLINDAMYCIN
1. WHAT CLINDAMYCIN IS AND WHAT IT IS USED FOR
Clindamycin contains an antibiotic called clindamycin phosphate and comes as either a solution or lotion. The solution and the lotion are used on the skin to treat acne.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CLINDAMYCIN
Do not use Clindamycin:
• 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 if you have diarrhea or usually get diarrhoea when you take antibiotics.
If you develop severe or prolonged or bloody diarrhoea during or after using Clindamycinell 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 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 lotion or the topical solution around your mouth as they each have an unpleasant taste.
Clindamycin Topical Solution is flammable. Do not use the solution near flames or while you are smoking.
Other medicines and Clindamycin
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.
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.
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 or lotion.
The Clindamycin Solution bottle has an automatic pad dispenser. Gently apply a thin film onto your skin using the pad on the applicator.
The Clindamycin Lotion bottle has a dispensing cap. Wash your hands before and after use and dry them, apply a thin film of the lotion by gently rubbing it into your skin, you may use a cotton pad for this or you can use your fingers. Always replace the cap after use.
If you forget to apply Clindamycin
Do not worry if you miss one or two applications; just carry on as soon as you remember.
If you stop using Clindamycin
Do not stop using Clindamycin 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 Topical Solution may make your skin dry (very common side effect).
Other side effects that have been seen with Clindamycin Topical Lotion and Clindamycin Topical Solution are:
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
6. CONTENTS OF THE PACK AND OTHER INFORMATION
• 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
• Clindamycin Topical lotion may cause gastrointestinal disturbances (with symptoms such as diarrhoea and nausea)
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
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C. Replace cap tightly after use.
• Do not use after the expiry date printed on the carton or bottle label.
• If your doctor tells you to stop using the solution, please take it back to the pharmacist for safe disposal. Only keep the solution if your doctor tells you to.
• If the solution becomes discoloured or you notice any other signs of deterioration, you should ask your doctor or pharmacist before using it.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
What Clindamycin contains
• Clindamycin contains the active ingredient, clindamycin phosphate. Each ml of clear aqueous solution contains clindamycin phosphate equivalent to 10mg clindamycin.
• It also contains the following inactive ingredients: isopropyl alcohol, propylene glycol and purified water.
What Clindamycin looks like and contents of the pack
Clindamycin is available as bottles of 30ml, with an enclosed cap applicator.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Pfizer Manufacturing Belgium NV, Rijksweg 12, B-2870 Puurs, Belgium.
And
Pharmacia and Upjohn Company, Kalamazoo, Michigan, USA.
pQMl PL No: 19488/0824
Leaflet revision date: 08 August 2014
S824 LEAFLET Clindamycin 20140808