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DALACIN CREAM 2% W/W

Active substance(s): CLINDAMYCIN / CLINDAMYCIN / CLINDAMYCIN

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PATIENT INFORMATION LEAFLET

2957
18.10.16[2]

Dalacin® Cream 2% w/w
(clindamycin phosphate)
This medicine is available using the above name but will be referred to as
Dalacin Cream throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
 If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Dalacin Cream is and what it is used for
2. Before you use Dalacin Cream
3. How to use Dalacin Cream
4. Possible side effects
5. How to store Dalacin Cream
6. Further information
1. What Dalacin Cream is and what it is used for
Dalacin Cream is a vaginal cream. It contains clindamycin phosphate
which is an antibiotic. It is used in the treatment of bacterial vaginosis (a
bacterial infection of the vagina).
2. Before you use Dalacin Cream
Do not use Dalacin Cream
If you are allergic (hypersensitive) to clindamycin, lincomycin or to any of
the other ingredients in this cream.
Do not use if you suffer with a history of inflammatory bowel disease or
antibiotic-associated colitis.

Taking other medicines
Dalacin Cream may affect other medicines taken at the same time.

Insertion:
Remove the cap from the tube.

Please tell your doctor if you are taking erythromycin (an antibiotic) or
have recently taken any other medicines including medicines obtained
without a prescription.

Screw one of the disposable plastic
applicators supplied on to the tube
where the cap has been removed.

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.

Holding the tube from the bottom,
squeeze gently and force the cream
into the applicator

Pregnancy
The use of Dalacin Cream in the first three months of pregnancy is not
recommended as there is insufficient evidence of safety.
Tell your doctor before using this medicine if you are pregnant or think
you may be pregnant. If you are pregnant the cream should only be used
after careful discussion with your doctor who will decide if this treatment is
appropriate for you.
Breast – feeding
Tell your doctor if you will be breast-feeding while using Dalacin Cream
as the active substance in this medicine may be passed into breast milk.
Your doctor will decide if Dalacin Cream 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 Cream.
Important information about some of the ingredients of Dalacin
Cream
Dalacin Cream contains propylene glycol and cetostearyl alcohol which
may cause local skin irritation and inflammation.

Take special care with Dalacin Cream
Before taking this medicine make sure that your doctor knows 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 Cream 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.

3. How to use Dalacin Cream
Always use Dalacin Cream exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure how to
use this cream.

Dalacin cream is not recommended for use in children.

Your doctor may recommend a shorter, three-day course of treatment
depending on your symptoms.

As with all vaginal infections, sexual intercourse during treatment with
Dalacin Cream is not recommended. Dalacin Cream may weaken
condoms and diaphragms. Do not rely on condoms or contraceptive
diaphragms when using this medicine for 72 hours following treatment.
The use of other vaginal products such as tampons or douches (vaginal
washes) during treatment with the cream is not recommended.

The usual dose is one applicator full (approx 5 grams), which should
be placed into the vagina each night at bedtime for seven consecutive
nights.

Always wash your hands before using the cream.

When the plunger stops moving, the applicator is full.
Unscrew the applicator and replace
the cap on the tube.
Lie on your back, firmly grasp the
applicator barrel, and insert gently
into the vagina as far as possible
without causing discomfort. Still
holding the barrel, slowly push the
plunger until it stops and all the
cream has been expelled.
Carefully withdraw the applicator and dispose of it. It is preferable to wrap
it in paper before disposal in a waste container. Do not try to flush it down
the toilet.
Wash your hands well after applying the cream.
If you use more Dalacin Cream than you should
Tell your doctor. Do not use any more cream until your doctor tells you to.
If you swallow Dalacin Cream
If you or somebody else swallows some Dalacin Cream contact your
doctor. The cream is not likely to cause any harm but your doctor will be
able to give you advice on what to do.
If you miss a dose of Dalacin Cream
If the forgotten dose is just a few hours late, use it straight away.
If it is nearly time for your next application, miss out the forgotten one.
Do the next application at the normal time. Do not use double the amount
but carry on using your Cream at the usual times.
If you stop taking Dalacin Cream
Sometimes you may feel better after only a few days treatment.
Even if you do feel better, do not stop using the cream until you have
completed the full course of treatment.
If you have any further questions on how to take this product, ask your
doctor or pharmacist.

4. Possible side effects
Like all medicines, Dalacin Cream 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.
 experience an allergic reaction or skin reaction such as hives or a
measles-like rash. These are very rare side effects.
Very common side effects (likely to occur in more than 1 in 10 patients):
 Effects on your genital area: irritation of the vagina or cervix
Uncommon side effects (likely to occur in less than 1 in 100 patients):
 Effects on your nervous system: dizziness, vertigo, headaches.
 Effects on your stomach and intestines: heartburn, nausea (feeling
sick), vomiting, diarrhoea, stomach pain and constipation.
If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
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 Cream
 Keep out of the sight and reach of children.
 Do not use Dalacin Cream after the expiry date which is stated on the
tube and carton. The expiry date refers to the last day of that month.
 Do not store above 25ºC. Do not freeze.
 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 your medicines show any signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what to do.

6. Further Information
What Dalacin Cream contains
 The active substance is clindamycin phosphate.
 Each gram of cream contains 20mg clindamycin (as phosphate).
The other ingredients are: benzyl alcohol, sorbitan stearate, polysorbate
60, propylene glycol, stearic acid, cetostearyl alcohol, cetyl palmitate,
liquid paraffin and water.
What Dalacin Cream looks like and contents of the pack
Dalacin Cream is a white, semi solid cream. It is supplied in a laminated
tube.
Each tube contains 40g of cream, packed in a cardboard carton together
with the leaflet and 7 applicators.
Manufacturer and Product Licence Holder
Manufactured by
Pfizer Service Company, Zaventem, Belgium.
Pfizer Manufacturing Belgium NV, Puurs, Belgium.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2957

Leaflet revision and issue date (Ref) 18.10.16[2]
Dalacin is a trademark of Pfizer Enterprises Sarl.

PATIENT INFORMATION LEAFLET

2957
18.10.16[2]

Clindamycin 2% w/w Cream
(clindamycin phosphate)
This medicine is available using any of the above names but will be
referred to as Clindamycin Cream throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
 If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Clindamycin Cream is and what it is used for
2. Before you use Clindamycin Cream
3. How to use Clindamycin Cream
4. Possible side effects
5. How to store Clindamycin Cream
6. Further information
1. What Clindamycin Cream is and what it is used for
Clindamycin Cream is a vaginal cream. It contains clindamycin phosphate
which is an antibiotic. It is used in the treatment of bacterial vaginosis (a
bacterial infection of the vagina).

Taking other medicines
Clindamycin Cream may affect other medicines taken at the same time.

Insertion:
Remove the cap from the tube.

Please tell your doctor if you are taking erythromycin (an antibiotic) or
have recently taken any other medicines including medicines obtained
without a prescription.

Screw one of the disposable plastic
applicators supplied on to the tube
where the cap has been removed.

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.

Holding the tube from the bottom,
squeeze gently and force the cream
into the applicator

Pregnancy
The use of Clindamycin Cream in the first three months of pregnancy is
not recommended as there is insufficient evidence of safety.
Tell your doctor before using this medicine if you are pregnant or think
you may be pregnant. If you are pregnant the cream should only be used
after careful discussion with your doctor who will decide if this treatment is
appropriate for you.
Breast – feeding
Tell your doctor if you will be breast-feeding while using Clindamycin
Cream as the active substance in this medicine may be passed into
breast milk. Your doctor will decide if Clindamycin Cream 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.

When the plunger stops moving, the applicator is full.
Unscrew the applicator and replace
the cap on the tube.
Lie on your back, firmly grasp the
applicator barrel, and insert gently
into the vagina as far as possible
without causing discomfort. Still
holding the barrel, slowly push the
plunger until it stops and all the
cream has been expelled.
Carefully withdraw the applicator and dispose of it. It is preferable to wrap
it in paper before disposal in a waste container. Do not try to flush it down
the toilet.
Wash your hands well after applying the cream.

2. Before you use Clindamycin Cream
Do not use Clindamycin Cream
If you are allergic (hypersensitive) to clindamycin, lincomycin or to any of
the other ingredients in this cream.

Driving and using machines
No effects on the ability to drive or use machines have been seen with
Clindamycin Cream.

If you use more Clindamycin Cream than you should
Tell your doctor. Do not use any more cream until your doctor tells you to.

Do not use if you suffer with a history of inflammatory bowel disease or
antibiotic-associated colitis.

Important information about some of the ingredients of Clindamycin
Cream
Clindamycin Cream contains propylene glycol and cetostearyl alcohol
which may cause local skin irritation and inflammation.

If you swallow Clindamycin Cream
If you or somebody else swallows some Clindamycin Cream contact your
doctor. The cream is not likely to cause any harm but your doctor will be
able to give you advice on what to do.

3. How to use Clindamycin Cream
Always use Clindamycin Cream exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure how to
use this cream.

If you miss a dose of Clindamycin Cream
If the forgotten dose is just a few hours late, use it straight away.
If it is nearly time for your next application, miss out the forgotten one.
Do the next application at the normal time. Do not use double the amount
but carry on using your Cream at the usual times.

Take special care with Clindamycin Cream
Before taking this medicine make sure that your doctor knows 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
Clindamycin Cream 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.

The usual dose is one applicator full (approx 5 grams), which should
be placed into the vagina each night at bedtime for seven consecutive
nights.

Clindamycin Cream is not recommended for use in children.
As with all vaginal infections, sexual intercourse during treatment with
Clindamycin Cream is not recommended. Clindamycin Cream may
weaken condoms and diaphragms. Do not rely on condoms or
contraceptive diaphragms when using this medicine for 72 hours following
treatment.
The use of other vaginal products such as tampons or douches (vaginal
washes) during treatment with the cream is not recommended.

Your doctor may recommend a shorter, three day course of treatment
depending on your symptoms.
Always wash your hands before using the cream.

If you stop taking Clindamycin Cream
Sometimes you may feel better after only a few days treatment.
Even if you do feel better, do not stop using the cream until you have
completed the full course of treatment.
If you have any further questions on how to take this product, ask your
doctor or pharmacist.

4. Possible side effects
Like all medicines, Clindamycin Cream 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.
 experience an allergic reaction or skin reaction such as hives or a
measles-like rash. These are very rare side effects.
Very common side effects (likely to occur in more than 1 in 10 patients):
 Effects on your genital area: irritation of the vagina or cervix
Uncommon side effects (likely to occur in less than 1 in 100 patients):
 Effects on your nervous system: dizziness, vertigo, headaches.
 Effects on your stomach and intestines: heartburn, nausea (feeling
sick), vomiting, diarrhoea, stomach pain and constipation.
If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
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 Clindamycin Cream
 Keep out of the sight and reach of children.
 Do not use Clindamycin Cream after the expiry date which is stated on
the tube and carton. The expiry date refers to the last day of that month.
 Do not store above 25ºC. Do not freeze.
 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 your medicines show any signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what to do.

6. Further Information
What Clindamycin Cream contains
 The active substance is clindamycin phosphate.
 Each gram of cream contains 20mg clindamycin (as phosphate).
The other ingredients are: benzyl alcohol, sorbitan stearate, polysorbate
60, propylene glycol, stearic acid, cetostearyl alcohol, cetyl palmitate,
liquid paraffin and water.
What Clindamycin Cream looks like and contents of the pack
Clindamycin Cream is a white, semi solid cream. It is supplied in a
laminated tube.
Each tube contains 40g of cream, packed in a cardboard carton together
with the leaflet and 7 applicators.
Manufacturer and Product Licence Holder
Manufactured by
Pfizer Service Company, Zaventem, Belgium.
Pfizer Manufacturing Belgium NV, Puurs, Belgium.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd. 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2957

Leaflet revision and issue date (Ref) 18.10.16[2]

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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