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CLINDAMYCIN PHOSPHATE 1% TOPICAL SOLUTION

Active substance(s): CLINDAMYCIN / CLINDAMYCIN PHOSPHATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

DALACIN® T TOPICAL SOLUTION
CLINDAMYCIN PHOSPHATE 1% TOPICAL SOLUTION
(clindamycin phosphate)
This product is available as any of the above names but will be referred to as
Dalacin T throughout the remainder of this leaflet. Please note that the leaflet also
contains information about Dalacin® T Topical Lotion 10mg/ml.
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 diarrhoea or
usually get diarrhoea when you take antibiotics.
If you develop severe or prolonged or bloody diarrhoea during or after using
Dalacin T 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 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.
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 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 Lotion 10mg/ml
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
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.
• 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, 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 use Dalacin T after the expiry date which is stated on the bottle and the
carton.
• 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.
• If solution becomes discoloured or show any signs of deterioration, you should
consult your pharmacist who will advise you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Dalacin T contains
Each ml of solution contains 10 mg of clindamycin (as the phosphate).
The other ingredients are: propylene glycol, isopropyl alcohol, sodium hydroxide,
hydrochloric acid and purified water.
What Dalacin T looks like and contents of the pack
Dalacin T is a white HDPE bottle with a separate Dab-O-Matic applicator and a
white screw lid containing a clear liquid.
Bottle contains 30ml of Dalacin T solution.
PL No: 15814/1083

POM

Dalacin T is manufactured by Pfizer Service Company BVBA, Zaventem, Belgium
OR Pfizer Manufacturing Belgium NV, Belgium.
Procured from within the EU and repackaged by the Product Licence holder:
O.P.D. Laboratories Ltd., Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 07.08.2014.
Dalacin T is a trademark of Pharmacia & Upjohn Company.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332
796.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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