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CLINDAMYCIN 1% TOPICAL SOLUTION

Active substance(s): CLINDAMYCIN

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S1292 LEAFLET Dalacin T 20140808

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

DALACIN-T 1% TOPICAL SOLUTION
(clindamycin phosphate)
The name of your medicine is Dalacin-T 1% Topical Solution but
will be referred to as Dalacin T throughout the following leaflet.
This product is also available as a topical lotion.
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

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.

5. How to store Dalacin T
6. Contents of the pack and other information

3. HOW TO USE DALACIN T

1. WHAT DALACIN T IS AND WHAT IT IS USED FOR

Always use this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

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.

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.

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.

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

Warnings and precautions

Do not worry if you miss one or two applications; just carry on as
soon as you remember.

Talk to your doctor or pharmacist before using Dalacin T if you have
diarrhea or usually get diarrhoea when you take antibiotics.

If you stop using Dalacin T

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.

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 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Dalacin T contains


Dalacin T contains the active ingredient, clindamycin
phosphate. Each ml of clear aqueous solution contains
clindamycin phosphate equivalent to 10mg clindamycin.



It also contains the following inactive ingredients: isopropyl
alcohol, propylene glycol and purified water.

What Dalacin T looks like and contents of the pack
Dalacin T is a clear colourless solution in a plastic bottle with an
automatic pad dispenser and cap. Dalacin T is available as bottles
of 30ml.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, HA0 1DX.

5. HOW TO STORE DALACIN T
Manufacturer



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C. Replace cap tightly after use.



This product is manufactured by Pfizer Manufacturing Belgium NV,
Rijksweg 12, B-2870 Puurs, Belgium.

Do not use after the expiry date printed on the carton or bottle
label.

And



If your doctor tells you to stop using the solution, please take it
back to the pharmacist for safe disposal. Only keep the solution
if your doctor tells you to.



If the solution becomes discoloured or you notice any other
signs of deterioration, you should ask your doctor or pharmacist
before using it.

Leaflet revision date: 08 August 2014



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines that are no longer required. These measures will
help to protect the environment.

Dalacin-T is a registered trade mark of Pharmacia & Upjohn
Company LLC, USA.

Pfizer Service Company BVPA, Hoge Wei, 1930 Zaventem,
Belgium.
POM

PL No: 19488/1292

S1292 LEAFLET Dalacin T 20140808

S1292 LEAFLET Clindamycin 20140808

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

CLINDAMYCIN 1% TOPICAL SOLUTION
The name of your medicine is Clindamycin 1% Topical Solution but
will be referred to as Clindamycin throughout the following leaflet.
This product is also available as a topical lotion.
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.

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
Clindamycin as the active substance in this medicine may be
passed into breast milk. Your doctor will decide if Clindamycin 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 Clindamycin.
Clindamycin Solution contains propylene glycol

What is in this leaflet

This may cause skin irritation.

1. What Clindamycin is and what it is used for
2. What you need to know before you use Clindamycin
3. How to use Clindamycin

Clindamycin Lotion contains cetostearyl alcohol and methyl
parahydroxybenzoate

6. Contents of the pack and other information

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.

1. WHAT CLINDAMYCIN IS AND WHAT IT IS USED FOR

3. HOW TO USE CLINDAMYCIN

Clindamycin 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.

Always use this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

4. Possible side effects
5. How to store Clindamycin

2. WHAT YOU NEED TO KNOW BEFORE YOU USE
CLINDAMYCIN
Do not use Clindamycin:


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.

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

Warnings and precautions
Talk to your doctor or pharmacist before using Clindamycin if you
have diarrhea or usually get diarrhoea when you take antibiotics.
If you develop severe or prolonged or bloody diarrhoea during or
after using Clindamycinell 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.
Clindamycin 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.
Clindamycin Topical Solution is flammable. Do not use the solution
near flames or while you are smoking.
Other medicines and Clindamycin
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 Clindamycin.
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.

If you forget to apply Clindamycin
Do not worry if you miss one or two applications; just carry on as
soon as you remember.
If you stop using Clindamycin
Do not stop using Clindamycin 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. Clindamycin Topical Solution may make your skin dry
(very common side effect).
Other side effects that have been seen with Clindamycin
Topical Lotion and Clindamycin 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
Clindamycin 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



Clindamycin 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 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Clindamycin contains


Clindamycin contains the active ingredient, clindamycin
phosphate. Each ml of clear aqueous solution contains
clindamycin phosphate equivalent to 10mg clindamycin.



It also contains the following inactive ingredients: isopropyl
alcohol, propylene glycol and purified water.

What Clindamycin looks like and contents of the pack
Clindamycin is a clear colourless solution in a plastic bottle with an
automatic pad dispenser and cap. Clindamycin is available as
bottles of 30ml.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, HA0 1DX.

5. HOW TO STORE CLINDAMYCIN
Manufacturer



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C. Replace cap tightly after use.



This product is manufactured by Pfizer Manufacturing Belgium NV,
Rijksweg 12, B-2870 Puurs, Belgium.

Do not use after the expiry date printed on the carton or bottle
label.

And



If your doctor tells you to stop using the solution, please take it
back to the pharmacist for safe disposal. Only keep the solution
if your doctor tells you to.



If the solution becomes discoloured or you notice any other
signs of deterioration, you should ask your doctor or pharmacist
before using it.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines that are no longer required. These measures will
help to protect the environment.

Pfizer Service Company BVPA, Hoge Wei, 1930 Zaventem,
Belgium.
POM

PL No: 19488/1292

Leaflet revision date: 08 August 2014
S1292 LEAFLET Clindamycin 20140808

+ Expand Transcript

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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