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CLINDAMYCIN PHOSPHATE TOPICAL LOTION

Active substance(s): CLINDAMYCIN / CLINDAMYCIN PHOSPHATE

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

DALACIN T® TOPICAL LOTION
CLINDAMYCIN PHOSPHATE TOPICAL LOTION
(clindamycin phosphate)
Patient Information leaflet

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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.

WARNING!

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.

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.
DATE:

Take care when using the lotion around your mouth as it has an unpleasant taste.
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.

DATE:
19/08/14

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.

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PRODUCT:

CUSTOMER:

UK PIL DATED JUNE 2014
REPORTING OF SIDE EFFECTS
MULTIPLE MANUFACTURERS

DT

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.

Dalacin topical Lotion

ARTWORKER:

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.

DATE OF PROOF:

Q.A.
APPROVED:
PRE-PRESS NO.:

05-0440

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).

Dalacin T contains cetosteryl achohol and methyl parahydroxybenzoate.
Cetostearyl alcohol may cause local skin reactions such as dermatitis (an inflammation of the skin). Methyl
parahydroxybenzoate (methyl paraben) 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 lotion.
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.

Colour
Swatch

Black

WARNING!

CUSTOMER
APPROVED:

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
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
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

This medicine is known as the above names but will be referred to as Dalacin T throughout the 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 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.

PROOF HISTORY:
v.1 - 19/08/14

Leaflet Flat Size = 148 x 317

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

Other side effects that have been seen with Dalacin T Topical Lotion 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
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)






DATE:

CUSTOMER
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WARNING!

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
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 T Topical Lotion/ Clindamycin Phosphate Topical Lotion should not be stored above 25°C.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN
If your doctor tells you to stop using Dalacin T Topical Lotion/ Clindamycin Phosphate Topical
Lotion, please take any remaining medicine back to the pharmacist for safe disposal.
Only keep the bottle if your doctor tells you to.
If your medicine becomes discoloured or show signs of deterioration you should consult your
pharmacist who will advise you what to do.
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.

Dalacin T Topical Lotion/ Clindamycin Phosphate Topical Lotion also contains the following inactive
ingredients: glycerol, sodium lauryl sarcosinate, stearic acid, Lexemul T, cetostearyl alcohol, isostearyl
alcohol, methyl paraben and water.
Dalacin T Topical Lotion/ Clindamycin Phosphate Topical Lotion is available in bottles of 30ml.

DATE:

Q.A.
APPROVED:

6. Contents of the pack and other information
Your lotion is called Dalacin T Topical Lotion/ Clindamycin Phosphate Topical Lotion.
Each millilitre of white to off-white emulsion, in an aqueous base, contains 10mg of the active ingredient
clindamycin (as the phosphate).

19/08/14
DATE OF PROOF:

Leaflet revision and issue date (Ref.) 28.05.2015
DALACIN T is a registered trademark of Pharmacia & Upjohn Company.

CODE:

UK PIL DATED JUNE 2014
REPORTING OF SIDE EFFECTS
MULTIPLE MANUFACTURERS

DT
ARTWORKER:
PRODUCT:

PL No: 18799/2653

This product is manufactured by Pfizer Manufacturing Belgium NV/SA., Rijksweg 12, B-2870 Puurs,
Belgium and/or Pfizer Service Company BVBA, 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.

Dalacin topical Lotion

05-0440
PRE-PRESS NO.:
CUSTOMER:

POM

Colour
Swatch

Black

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
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
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR

Notes:

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.

PROOF HISTORY:
v.1 - 19/08/14

Leaflet Flat Size = 148 x 317

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

WARNING!

27mm

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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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