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CLINDAMYCIN CREAM 2%

Active substance(s): CLINDAMYCIN

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Pregnancy

Dalacin® Cream 2% / Clindamycin Cream 2%
(clindamycin phosphate)

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.

PATIENT INFORMATION LEAFLET
Your medicine is available using the name Dalacin Cream 2% or Clindamycin Cream 2%, but it will be
referred to as Dalacin Cream throughout this leaflet.

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.

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.

In
1.
2.
3.
4.
5.
6.
1.

Driving and using machines

No effects on the ability to drive or use machines have been seen with Dalacin Cream.

this leaflet:
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

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.

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.

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.

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

BEFORE YOU USE DALACIN CREAM

Do not use Dalacin Cream

Insertion:

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.

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

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.

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.

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

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.

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.

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.

Page 1 of 2

6.

If you use more Dalacin Cream than you should

Tell your doctor. Do not use any more cream until your doctor tells you to.

FURTHER INFORMATION

What Dalacin Cream contains

It contains the active ingredient clindamycin phosphate (equivalent to 2% clindamycin).

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.

It also contains benzyl alcohol, sorbitan monostearate, polysorbate 60, propylene glycol, stearic acid,
cetostearyl alcohol, cetyl palmitate, liquid paraffin, and purified water.

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.

Each tube contains 40g of cream, which is enough for 3 or 7 doses.

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 Dalacin Cream at the usual times.

Manufacturer

If you stop taking Dalacin Cream

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.

Manufactured by: Pharmacia & Upjohn Company, Kalamazoo, Michigan, USA.

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.

Product Licence holder: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

If you have any further questions on how to take this product, ask your doctor or pharmacist.

4.

PL No: 04423/0386

POSSIBLE SIDE EFFECTS

POM

Like all medicines, Dalacin Cream can cause side effects, although not everybody gets them.

Leaflet revision and issue date (Ref): 12.08.14

Tell your doctor immediately if you:

Dalacin




®

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

Do not store above 30°C. Do not freeze.
Keep out of the sight and reach of children.
If your doctor decides to stop treatment, return the tube to the pharmacist for safe disposal.
If your medicine appears to be discoloured or shows any other signs of deterioration, please return to
your pharmacist who will advise you further.
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.
Check the expiry date printed on the package. If it is out of date, or becomes out of date during use,
do not use the cream and tell your pharmacist.
Page 2 of 2

is a registered trademark of Pharmacia & Upjohn Company.

Pregnancy

Dalacin® Cream 2% / Clindamycin Cream 2%
(clindamycin phosphate)

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.

PATIENT INFORMATION LEAFLET
Your medicine is available using the name Dalacin Cream 2% or Clindamycin Cream 2%, but it will be
referred to as Dalacin Cream throughout this leaflet.

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.

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.

In
1.
2.
3.
4.
5.
6.
1.

Driving and using machines

No effects on the ability to drive or use machines have been seen with Dalacin Cream.

this leaflet:
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

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.

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.

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.

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

BEFORE YOU USE DALACIN CREAM

Do not use Dalacin Cream

Insertion:

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.

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

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.

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.

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

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.

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.

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.

Page 1 of 2

6.

If you use more Dalacin Cream than you should

Tell your doctor. Do not use any more cream until your doctor tells you to.

FURTHER INFORMATION

What Dalacin Cream contains

It contains the active ingredient clindamycin phosphate (equivalent to 2% clindamycin).

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.

It also contains benzyl alcohol, sorbitan monostearate, polysorbate 60, propylene glycol, stearic acid,
cetostearyl alcohol, cetyl palmitate, liquid paraffin, and purified water.

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.

Each tube contains 40g of cream, which is enough for 3 or 7 doses.

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 Dalacin Cream at the usual times.

Manufacturer

If you stop taking Dalacin Cream

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.

Manufactured by: Pharmacia & Upjohn Company, Kalamazoo, Michigan, USA.

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.

Product Licence holder: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

If you have any further questions on how to take this product, ask your doctor or pharmacist.

4.

PL No: 04423/0386

POSSIBLE SIDE EFFECTS

POM

Like all medicines, Dalacin Cream can cause side effects, although not everybody gets them.

Leaflet revision and issue date (Ref): 12.08.14

Tell your doctor immediately if you:

Dalacin




®

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

Do not store above 30°C. Do not freeze.
Keep out of the sight and reach of children.
If your doctor decides to stop treatment, return the tube to the pharmacist for safe disposal.
If your medicine appears to be discoloured or shows any other signs of deterioration, please return to
your pharmacist who will advise you further.
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.
Check the expiry date printed on the package. If it is out of date, or becomes out of date during use,
do not use the cream and tell your pharmacist.
Page 2 of 2

is a registered trademark of Pharmacia & Upjohn Company.

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.

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