Dalacin Topical Solution
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This medicine is known as the above name. A lotion is also available.
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 Topical Solution is and what it is used for
2. What you need to know before you use Dalacin Topical Solution
3. How to use Dalacin Topical Solution
4. Possible side effects
5. How to store Dalacin Topical Solution
6. Contents of the pack and other information
1. What Dalacin Topical Solution is and what it is used for
Dalacin Topical Solution 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 Topical Solution Do not use Dalacin Topical 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 Dalacin Topical 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 Dalacin Topical 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.
Dalacin 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 it has an unpleasant taste.
Dalacin Topical Solution is flammable. Do not use the solution near flames or while you are smoking.
Other medicines and Dalacin Topical 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 Dalacin Topical 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 breast feeding while using Dalacin Topical Solution as the active substance in this medicine may be passed into breast milk. Your doctor will decide if Dalacin Topical 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 Dalacin Topical Solution.
Dalacin Topical Solution contains propylene glycol
This may cause skin irritation.
3. How to use Dalacin Topical 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 Dalacin Topical Solution bottle has an automatic pad dispenser. Gently apply a thin film onto your skin using the pad on the applicator.
Always replace the cap after use.
WARNING! WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY WARNING! THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
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If you forget to apply Dalacin Topical Solution
Do not worry if you miss one or two applications; just carry on as soon as you remember.
If you stop using Dalacin Topical Solution
Do not stop using Dalacin Topical 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.
Dalacin Topical Solution may make your skin dry (very common side effect).
Other side effects that have been seen with Dalacin 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
Uncommon: may affect up to 1 in 100 people (only seen with Dalacin 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 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 Topical Solution
• Do not use after the expiry date printed on the carton or bottle label after EXP. The expiry date refers to the last day of that month.
• Dalacin Topical Solution should be stored below 25°C and away from any naked flames or heat source since the solution is inflammable.
• KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN
• If your doctor tells you to stop using the solution, please take any remaining solution back to the pharmacist for safe disposal. Only keep the solution if your doctor tells you to.
• If your solution becomes cloudy or discoloured you should consult your pharmacist who will advise you what to do.
6. Contents of the pack and other information
Your solution is called Dalacin Topical Solution. Each millilitre of clear colourless solution contains 10mg of the active ingredient clindamycin (as the phosphate).
Dalacin Topical Solution also contains the following inactive ingredients: isopropyl alcohol, propylene glycol and water.
Dalacin Topical Solution is available in bottles of 30ml.
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PL No: 18799/2654
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This product is manufactured by Pfizer Manufacturing Belgium NV/SA., Rijksweg 12, 2870 Puurs, Belgium and/or Pfizer Service Company, Hoge Wei, 10 1930, Zaventem, Belgium and procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Leaflet revision and issue date (Ref.) 28.05.2015
DALACIN is a registered trademark of Pfizer Enterprises Sarl.
w
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o
LU
■f LL
< z
Q I-
-I £
WARNING! WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY WARNING! THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
