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DALACIN C 150 MG HARD CAPSULES

Active substance: CLINDAMYCIN

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MOCK UP PIL
PACKAGE LEAFLET: INFORMATION FOR THE USER

DALACIN® C 150 mg Hard Capsules
(clindamycin hydrochloride)
Read all of this leaflet carefully before you
start taking this medicine




Keep this leaflet. You may need to read it again.
If you have any further questions, ask your
doctor or pharmacist.
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.
®

The name of your medicine is DALACIN C 150 mg
Hard Capsules, but it will be referred to as Dalacin
in this leaflet.

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

What Dalacin is and what it is used for
Before you take Dalacin
How to take Dalacin
Possible side effects
How to store Dalacin
Further information

1. What Dalacin is and what it is used
for
Dalacin contains clindamycin hydrochloride which is
an antibiotic used in the treatment of serious
bacterial infections.

2. Before you take Dalacin
Do not take Dalacin
If you are allergic (hypersensitive) to clindamycin,
lincomycin or to any of the other ingredients in this
medicine.

Take special care with Dalacin
Tell your doctor if you have any of the following
conditions to help him or her decide if Dalacin is
suitable for you:
• you have diarrhoea or usually get diarrhoea
when you take antibiotics or have ever suffered
from problems with your stomach or intestines. 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.
• you suffer from problems with your kidneys or
liver.
• you suffer from asthma, eczema or hayfever.
Dalacin does not get into the brain and is therefore
not suitable for treating serious infections in and
around the brain. Your doctor may need to give you
another antibiotic if you have these infections.

Taking other medicines
Some medicines can affect the way this medicine
works, or the medicine itself can reduce the
effectiveness of other medicines taken at the same
time. These include:
• erythromycin (an antibiotic).
• muscle relaxants used for operations.
• oral contraceptive pills. You should use extra
contraception such as condoms whilst taking
Dalacin and for seven days after taking Dalacin.
Please tell your doctor if you are taking or have
recently taken any other medicines including
medicines obtained without a prescription.

Taking Dalacin with food and drink
The capsules may be taken either before or after a
meal.

Pregnancy
If you are pregnant or think you might be pregnant
you should contact your doctor before taking
Dalacin.
Ask your doctor or pharmacist for advice before
taking any medicine.

Breast-feeding
Tell your doctor if you will be breastfeeding while
taking Dalacin as the active substance in this
medicine may be passed into breast milk. Your
doctor will decide if Dalacin is appropriate 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 Dalacin.

Important information about some of the
ingredients of Dalacin Capsules
Dalacin Capsules contains lactose a type of sugar.
If you have been told that you have an intolerance
to some sugars, contact your doctor before taking
this medicinal product.

3. How to take Dalacin
Always take Dalacin exactly as your doctor has told
you. You should check with your doctor or
pharmacist if you are not sure how to take this
medicine.
Dalacin Capsules should always be swallowed
whole and washed down with a full glass of water.

If you have to take Dalacin for a long time, your
doctor may arrange regular liver, kidney and blood
tests. Do not miss these check-ups with your doctor.

Other possible side effects may include:
• Effects on your nervous system: impaired
sense of taste
• Effects on your skin: reddening of the skin,
skin rash, itching (hives)
• Effects on your stomach and intestines:
throat ulcers, sore throat, feeling sick, being sick,
stomach pain and diarrhoea
• Effects on your blood system: reduced
numbers of blood cells which may cause
bruising or bleeding or weaken the immune
system
• Effects on your liver: poor liver function
• Effects on your genital area: inflammation of
the vagina.

Long term use can also make you more likely to get
other infections that do not respond to Dalacin
treatment.

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.

If you take more Dalacin Capsules than you
should

5. How to store Dalacin

Adults and Elderly Patients
The recommended dose of Dalacin is between 150
and 450mg (1 to 3 capsules) every 6 hours,
depending on the severity of your infection.

Children
The recommended dose in children is between 3
and 6mg per kg every six hours, depending on the
severity of the infection. Your doctor will work out
the number of capsules that your child should have.

Long term use of Dalacin

If you accidentally take too many Dalacin Capsules
contact your doctor at once or go to the nearest
hospital casualty department. Always take the
labelled medicine package with you, whether there
are any Dalacin Capsules left or not. Do not take
any more capsules until your doctor tells you to.

If you miss a dose of Dalacin
If the forgotten dose is just a few hours late, use it
straight away. If it is nearly time for your next dose
miss out the forgotten one. Do not take a double
dose to make up for a missed dose.

If you stop taking Dalacin
If you stop taking the medicine too soon your
infection may come back again or get worse.
Do not stop taking Dalacin unless your doctor tells
you to.
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 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 during or after completing treatment with
antibiotics and can be a sign of serious bowel
inflammation.
• signs of a severe allergic reaction such as
sudden wheeziness, difficulty in breathing,
swelling of eyelids, face or lips, rash or itching
(especially affecting the whole body).
• blistering and peeling of large areas of skin,
fever, cough, feeling unwell and swelling of the
gums, tongue or lips.
• yellowing of the skin and whites of the eyes
(jaundice).







Keep out of the reach and sight of children.
Do not use Dalacin Capsules after the expiry
date which is stated on the carton and blister
labels. The expiry date refers to the last day of
that month.
Do not store above 25°C.
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 medicine gets discoloured or shows any
signs of deterioration, seek the advice of your
pharmacist.

6. Further information
What Dalacin Capsules contain
The active substance is clindamycin hydrochloride.
Each capsule contains clindamycin hydrochloride
equivalent to 150mg of clindamycin.
The other ingredients are lactose monohydrate,
maize starch, talc, magnesium stearate, titanium
dioxide E171, gelatin, black iron oxide E172.

What Dalacin Capsules look like and
contents of the pack
Dalacin Capsules are white hard capsules marked
with ‘Pfizer’ logo on the cap & ‘CLIN 150’ on the
body in black ink and contains a white powder.
Dalacin Capsules 150 mg are available in blister
packs of 16 or 24 capsules.
Manufactured by: Pfizer PGM, Zone Industrielle, 29
route des Industries, 37530 Poce sur Cisse, France.
Procured from within the EU & repackaged by PL
holder: Kosei Pharma UK Ltd., 897 Plymouth Road,
Slough Trading Estate, Slough, SL1 4LP.
®

Dalacin C 150 mg Hard Capsules,
PL 39352/0097
®

POM

Dalacin is a registered trademark of Pfizer Ltd.
Leaflet date: 21.05.2012

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clindamycin 150 mg Hard Capsules
(clindamycin hydrochloride)
Read all of this leaflet carefully before you
start taking this medicine




Keep this leaflet. You may need to read it again.
If you have any further questions, ask your
doctor or pharmacist.
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.

The name of your medicine is Clindamycin 150 mg
Hard Capsules, but it will be referred to as
Clindamycin in this leaflet.

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

What Clindamycin is and what it is used for
Before you take Clindamycin
How to take Clindamycin
Possible side effects
How to store Clindamycin
Further information

Taking other medicines
Some medicines can affect the way this medicine
works, or the medicine itself can reduce the
effectiveness of other medicines taken at the same
time. These include:
• erythromycin (an antibiotic).
• muscle relaxants used for operations.
• oral contraceptive pills. You should use extra
contraception such as condoms whilst taking
Clindamycin and for seven days after taking
Clindamycin.
Please tell your doctor if you are taking or have
recently taken any other medicines including
medicines obtained without a prescription.

Taking Clindamycin with food and drink
The capsules may be taken either before or after a
meal.

Pregnancy

1. What Clindamycin is and what it is
used for

If you are pregnant or think you might be pregnant
you should contact your doctor before taking
Clindamycin.

Clindamycin contains clindamycin hydrochloride
which is an antibiotic used in the treatment of
serious bacterial infections.

Ask your doctor or pharmacist for advice before
taking any medicine.

Breast-feeding

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

Take special care with Clindamycin
Tell your doctor if you have any of the following
conditions to help him or her decide if Clindamycin
is suitable for you:
• you have diarrhoea or usually get diarrhoea
when you take antibiotics or have ever suffered
from problems with your stomach or intestines. If
you develop severe or prolonged or bloody
diarrhoea during or after using Clindamycin 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.
• you suffer from problems with your kidneys or
liver.
• you suffer from asthma, eczema or hayfever.
Clindamycin does not get into the brain and is
therefore not suitable for treating serious infections
in and around the brain. Your doctor may need to
give you another antibiotic if you have these
infections.

Tell your doctor if you will be breastfeeding while
taking Clindamycin as the active substance in this
medicine may be passed into breast milk. Your
doctor will decide if Clindamycin is appropriate 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.

Important information about some of the
ingredients of Clindamycin Capsules
Clindamycin Capsules contains lactose a type of
sugar. If you have been told that you have an
intolerance to some sugars, contact your doctor
before taking this medicinal product.

3. How to take Clindamycin
Always take Clindamycin exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure how to take this
medicine.
Clindamycin Capsules should always be swallowed
whole and washed down with a full glass of water.

Adults and Elderly Patients
The recommended dose of Clindamycin is between
150 and 450mg (1 to 3 capsules) every 6 hours,
depending on the severity of your infection.

Children
The recommended dose in children is between 3
and 6mg per kg every six hours, depending on the
severity of the infection. Your doctor will work out
the number of capsules that your child should have.

Long term use of Clindamycin
If you have to take Clindamycin for a long time, your
doctor may arrange regular liver, kidney and blood
tests. Do not miss these check-ups with your doctor.
Long term use can also make you more likely to get
other infections that do not respond to Clindamycin
treatment.

If you take more Clindamycin Capsules
than you should
If you accidentally take too many Clindamycin
Capsules contact your doctor at once or go to the
nearest hospital casualty department. Always take
the labelled medicine package with you, whether
there are any Clindamycin Capsules left or not. Do
not take any more capsules until your doctor tells
you to.

If you miss a dose of Clindamycin
If the forgotten dose is just a few hours late, use it
straight away. If it is nearly time for your next dose
miss out the forgotten one. Do not take a double
dose to make up for a missed dose.

If you stop taking Clindamycin
If you stop taking the medicine too soon your
infection may come back again or get worse.
Do not stop taking Clindamycin unless your doctor
tells you to.
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 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 during or after completing treatment with
antibiotics and can be a sign of serious bowel
inflammation.
• signs of a severe allergic reaction such as
sudden wheeziness, difficulty in breathing,
swelling of eyelids, face or lips, rash or itching
(especially affecting the whole body).
• blistering and peeling of large areas of skin,
fever, cough, feeling unwell and swelling of the
gums, tongue or lips.
• yellowing of the skin and whites of the eyes
(jaundice).

Other possible side effects may include:
• Effects on your nervous system: impaired
sense of taste
• Effects on your skin: reddening of the skin,
skin rash, itching (hives)
• Effects on your stomach and intestines:
throat ulcers, sore throat, feeling sick, being sick,
stomach pain and diarrhoea
• Effects on your blood system: reduced
numbers of blood cells which may cause
bruising or bleeding or weaken the immune
system
• Effects on your liver: poor liver function
• Effects on your genital area: inflammation of
the vagina.
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.

5. How to store Clindamycin






Keep out of the reach and sight of children.
Do not use Clindamycin Capsules after the
expiry date which is stated on the carton and
blister labels. The expiry date refers to the last
day of that month.
Do not store above 25°C.
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 medicine gets discoloured or shows any
signs of deterioration, seek the advice of your
pharmacist.

6. Further information
What Clindamycin Capsules contain
The active substance is clindamycin hydrochloride.
Each capsule contains clindamycin hydrochloride
equivalent to 150mg of clindamycin.
The other ingredients are lactose monohydrate,
maize starch, talc, magnesium stearate, titanium
dioxide E171, gelatin & black iron oxide E172.

What Clindamycin Capsules look like and
contents of the pack
Clindamycin Capsules are white hard capsules
marked with ‘Pfizer’ logo on the cap & ‘CLIN 150’ on
the body in black ink and contains a white powder.
Clindamycin Capsules 150 mg are available in
blister packs of 16 or 24 capsules.
Manufactured by: Pfizer PGM, Zone Industrielle, 29
route des Industries, 37530 Poce sur Cisse, France.
Procured from within the EU & repackaged by PL
holder: Kosei Pharma UK Ltd., 897 Plymouth Road,
Slough Trading Estate, Slough, SL1 4LP.

Clindamycin 150 mg Hard Capsules,
PL 39352/0097
Leaflet date: 21.05.2012

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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