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DALACIN 2%W/W CREAM

Active substance(s): CLINDAMYCIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER.

Dalacin® 2%w/w Cream
(clindamycin phosphate)
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 your
pharmacist.
 This medicine has been prescribed for you. Do not pass it
onto others. It may harm them, even if their symptoms are
the same as yours.
 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 your
pharmacist.
The name of your medicine is Dalacin 2%w/w Cream, but it will
be referred to as Dalacin Cream in this leaflet.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Dalacin Cream is and what it is used for
Before you use Dalacin Cream
How to use Dalacin Cream
Possible side effects
How to store Dalacin Cream
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.

Take special care with Dalacin Cream

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 breastfeeding 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.

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

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.
Dalacin cream is not recommended for use in children.
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.

Always wash your hands before using the cream.

The use of other vaginal products such as tampons or douches
(vaginal washes) during treatment with the cream is not
recommended.

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.

Taking other medicines
Dalacin Cream may affect other medicines taken at the same
time.
Please tell your doctor if you are taking erythromycin (an
antibiotic) or have recently taken any other medicines including
medicines obtained without a prescription.
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.

Insertion:
Remove the cap from the tube.
Screw one of the disposable plastic
applicators supplied on to the tube where
the cap has been removed.
Holding the tube from the bottom,
squeeze gently and force the cream into
the applicator.
When the plunger stops moving, the applicator is full.
Unscrew the applicator and replace the cap on the tube.

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.

6. Further information
What Dalacin Cream contains


If you swallow Dalacin Cream

The active substance is clindamycin phosphate.
Each 1 gram of cream contains 20mg of clindamycin.
The other ingredients are: sorbitan stearate, polysorbate 60,
propylene glycol, stearic acid, cetostearyl alcohol, cetyl
palmitate, liquid paraffin, benzyl alcohol and water.

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

What Dalacin Cream looks like and contents of the
pack

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.
If your medicine shows any signs of deterioration, seek the
advice of 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.

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.
Manufactured by: Pharmacia & Upjohn Company, Kalamazoo,
Michigan, USA. Or
Pfizer Service Company BVBA, Zaventem, Belgium.
Procured from within the EU & repackaged by Product
Licence holder: Kosei Pharma UK Limited,
956 Buckingham Avenue, Slough Trading Estate, Slough,
SL1 4NL, UK.

Dalacin® 2%w/w Cream,
PL: 39352/0008
Dalacin® is a registered trademark of Pfizer Ltd.
Leaflet date: 05/07/2016

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER.

Clindamycin 2%w/w Cream
(clindamycin phosphate)
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 your
pharmacist.
This medicine has been prescribed for you. Do not pass it
onto others. It may harm them, even if their symptoms are
the same as yours.
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 your
pharmacist.

The name of your medicine is Clindamycin 2%w/w Cream, but it
will be referred to as Clindamycin Cream in this leaflet.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Clindamycin Cream is and what it is used for
Before you use Clindamycin Cream
How to use Clindamycin Cream
Possible side effects
How to store Clindamycin Cream
Further Information

1. What Clindamycin Cream is and
what it is used for

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 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 Clindamycin Cream.

Important information about some of the ingredients
of Clindamycin Cream

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).

Clindamycin Cream contains propylene glycol and cetostearyl
alcohol which may cause local skin irritation and inflammation.

2. Before you 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.

Do not use Clindamycin 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.

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.
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.

Taking other medicines
Clindamycin Cream may affect other medicines taken at the
same time.
Please tell your doctor if you are taking erythromycin (an
antibiotic) or have recently taken any other medicines including
medicines obtained without a prescription.
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.

3. How to use Clindamycin Cream

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.
Your doctor may recommend a shorter, three day course of
treatment depending on your symptoms.
Always wash your hands before using the cream.
Insertion:
Remove the cap from the tube.
Screw one of the disposable plastic
applicators supplied on to the tube where
the cap has been removed.
Holding the tube from the bottom,
squeeze gently and force the cream into
the applicator.
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 Clindamycin Cream than you should
Tell your doctor. Do not use any more cream until your doctor
tells you to.

If you swallow Clindamycin Cream

6. Further information
What Clindamycin Cream contains


The active substance is clindamycin phosphate.
Each 1 gram of cream contains 20mg of clindamycin.
The other ingredients are: sorbitan stearate, polysorbate 60,
propylene glycol, stearic acid, cetostearyl alcohol, cetyl
palmitate, liquid paraffin, benzyl alcohol and water.

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.



If you miss a dose of Clindamycin Cream

What Clindamycin Cream looks like and contents of
the pack

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 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.
If your medicine shows any signs of deterioration, seek the
advice of 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.

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.
Manufactured by: Pharmacia & Upjohn Company, Kalamazoo,
Michigan, USA. Or
Pfizer Service Company BVBA, Zaventem, Belgium.
Procured from within the EU & repackaged by Product
Licence holder: Kosei Pharma UK Limited,
956 Buckingham Avenue, Slough Trading Estate, Slough,
SL1 4NL, UK.

Clindamycin 2%w/w Cream,
PL: 39352/0008
Leaflet date: 05/07/2016

POM

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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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