Skip to Content

CLINDAMYCIN 2% W/W CREAM

Active substance(s): CLINDAMYCIN / CLINDAMYCIN PHOSPHATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Dalacin® Cream 2%

Ref: 1173/270814/1/F

(clindamycin phosphate)
Patient Information 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 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.
Your medicine is called Dalacin Cream 2% but will
be referred to as Dalacin Cream throughout the
leaflet.

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).

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.
Pregnancy
The use of Dalacin Cream in the first three months
of pregnancy is not recommended as there is in
sufficient 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.

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.

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

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.
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.

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.
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.

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.

CERVIX
VAGINA

5 How to store Dalacin

RECTUM

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.






Keep out of the sight and reach of children.
Do not use this medicine after the expiry date
which is stated on the packaging. The expiry date
refers to the last day of that month.
Do not store above 25°C. 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.

6 Further Information
What Dalacin contains
• The active substance is clindamycin phosphate.
Each gram of cream contains 20 mg of
clindamycin.
• The other ingredients are: benzyl alcohol, sorbitan
stearate, polysorbate 60, propylene glycol, stearic
acid, cetostearyl alcohol, cetyl palmitate, paraffin
liquid and purified water.
What Dalacin looks like and content of the pack
Dalacin is a white, semi solid cream with seven
applicators.
Dalacin is available as a tube containing 40 g of
cream and a white plastic tub containing seven
applicators packed in a cardboard carton together
with the leaflet.
Manufacturer and Licence Holder
This medicine is manufactured by Pharmacia &
Upjohn Company, Kalamazoo, Michigan, USA and
is procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1173

Dalacin is a registered trademark of Pfizer
Enterprises Sarl.
Leaflet revision date: 27/08/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref: 1173/270814/1/B

Clindamycin 2% w/w Cream

Ref: 1173/270814/2/F

(clindamycin phosphate)
Patient Information 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 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.
Your medicine is called Clindamycin 2% w/w Cream
but will be referred to as Clindamycin Cream
throughout the leaflet.

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.
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.
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.
Driving and using machines
No effects on the ability to drive or use machines
have been seen with Clindamycin 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. 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 nor 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.

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.

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.
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.

CERVIX
VAGINA

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.

RECTUM

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
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
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

5 How to store Clindamycin Cream






Keep out of the sight and reach of children.
Do not use this medicine after the expiry date
which is stated on the packaging. The expiry date
refers to the last day of that month.
Do not store above 25°C. 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.

6 Further Information
What Clindamycin cream contains
• The active substance is clindamycin phosphate.
Each gram of cream contains 20 mg of
clindamycin.
• The other ingredients are: benzyl alcohol, sorbitan
stearate, polysorbate 60, propylene glycol, stearic
acid, cetostearyl alcohol, cetyl palmitate, paraffin
liquid and purified water.
What Clindamycin cream looks like and content
of the pack
Clindamycin is a white, semi solid cream with seven
applicators.
Clindamycin is available as a tube containing 40g of
cream and a white plastic tub containing seven
applicators packed in a cardboard carton together
with the leaflet.
Manufacturer and Licence Holder
This medicine is manufactured by Pharmacia &
Upjohn Company, Kalamazoo, Michigan, USA and
is procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1173

Leaflet revision date: 27/08/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
Ref: 1173/270814/2/B

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