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DALACIN T 1% W/V TOPICAL SOLUTION

Active substance(s): CLINDAMYCIN PHOSPHATE

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Add/Amend (05) To change the generic product name from (Clindamycin Phosphate 1% w/v Topical Solution) to (Clindamycin 1% w/v Topical Solution)
PATIENT INFORMATION LEAFLET

2340
By BasherH at 4:48 pm, Aug 27, 2014
27.08.14[8]

Dalacin T® 1% w/v Topical Solution
Clindamycin 1 % w/v Topical Solution
(clindamycin phosphate)
Your medicine is available using any one of above names but will be
referred to as Dalacin T throughout this leaflet.
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 onto
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

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 blood- stained 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.

1. What Dalacin T is and what it is used for
Dalacin T contains an antibiotic called clindamycin phosphate and comes
as a solution. The solution is used on the skin to treat acne.

Dalacin T contains propylene glycol
This may cause skin irritation.

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.

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.
The Dalacin T Solution bottle has an automatic pad dispenser. Gently
apply a thin film onto your skin using the pad on the applicator.

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 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 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 solution around your mouth as it
has an unpleasant taste.
Dalacin T is flammable. Do not use the solution near flames or while you
are smoking.

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 how to use 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).

Assessed against UK PIL dated June 2014

Other side effects that have been seen with Dalacin T Topical Lotion
and 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.
 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.
The expiry date refers to the last day of that month.
 Do not store above 25°C.
 If your solution becomes discoloured or shows any sign of deterioration,
return to your pharmacist.
 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. Contents of the pack and other information
What Dalacin T contains
The active ingredient is Dalacin T is clindamycin phosphate.
Each ml of solution contains 10mg of clindamycin (as phosphate).
Also contains isopropyl alcohol, propylene glycol and purified water.
What Dalacin T looks like and contents of the pack
Dalacin T is a clear colourless aqueous solution with an alcoholic odour
and comes in a 30ml plastic bottle with an automatic pad dispenser and
screw cap.
Manufacturer and Product Licence Holder
Manufactured by Pfizer Service Company, Hoge Wei, 10, 1930,
Zaventem, Belgium and is procured from the EU by Product Licence
holder Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL No: 20636/2340

Leaflet revision and issue date (Ref) 27.08.14[8]
Dalacin T is a trademark Pharmacia & Upjohn Company LLC.

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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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