CLINDAMYCIN PHOSPHATE 1% TOPICAL SOLUTION

Active substance: CLINDAMYCIN PHOSPHATE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT

Dalacin® T Topical Solution /
Clindamycin Phosphate 1%
Topical Solution
(clindamycin phosphate)
This medicine is known by the above names but will
be referred to as Dalacin T throughout 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 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
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 after the date shown as ‘EXP’ which is
printed on the carton label and bottle.
Do not store above 25°C.
Keep the container tightly closed.
If your solution becomes discoloured or shows visible
signs of deterioration, talk to your doctor or 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 in Dalacin T Topical Solution
is clindamycin phosphate. This is a type of
antibiotic. Each millilitre of solution contains 10 mg
of clindamycin (as the phosphate).
The solution also contains isopropyl alcohol, propylene
glycol and water. These are inactive ingredients.
What Dalacin T looks like and contents of the pack
Dalacin T is a white plastic bottle with a separate
Dab-O-Matic applicator and a white screw lid
containing a clear liquid.
The bottle contains 30 ml of solution.
Dalacin T is manufactured Pfizer Italia SRL, Ascoli,
Piceno, Italy and is procured from within the EU by
the Product Licence holder: Caseview (PL) Limited,
20 Alliance Court, Alliance Road, London W3 0RB
and repackaged by OPD Laboratories Ltd., Unit 6
Colonial Way, Watford, Herts WD24 4PR.
PL 13826/1586

POM

Dalacin T Topical Solution /
Clindamycin Phosphate 1% Topical Solution
Leaflet revision date (ref) 06/08/2014
Dalacin is registered Trade Mark of Pharmacia &
Upjohn Company, U.S.A.
To request a copy of this leaflet in Braille, large
print or audio please call 01923 332 796.

Expand view ⇕

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.

Hide
(web4)