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DALACIN C 150 MG HARD CAPSULES

Active substance(s): CLINDAMYCIN

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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 because it contains
important information for you.
• 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 only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
• 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. See section 4.
The name of your medicine is DALACIN® C 150 mg Hard
Capsules, but it will be referred to as Dalacin in this leaflet.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Dalacin is and what it is used for
What you need to know before you take Dalacin
How to take Dalacin
Possible side effects
How to store Dalacin
Contents of the pack and other 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. What you need to know 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 (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Dalacin if:
• 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.
• you develop any severe skin reactions or
hypersensitivity to Dalacin.
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.

Other medicines and Dalacin
Tell your doctor or pharmacist or nurse if you are taking,
have recently taken or might take any other medicines:
• erythromycin (an antibiotic).
• muscle relaxants used for operations (neuromuscular
blockers).

• oral contraceptive pills. You should use extra
contraception such as condoms whilst taking Dalacin
and for seven days after taking Dalacin.
• 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.
• CYP3A4 or CYP3A5 inducers like rifampicin may impact
effectiveness of the medicine.

Pregnancy and breast-feeding
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 breast-feeding while taking
Dalacin as clindamycin may be passed into breast milk.
Your doctor will decide if Dalacin is appropriate for you.
If you continue to take Dalacin, you should stop breastfeeding.

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

Dalacin Capsules contain lactose
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 this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist or nurse if you
are not sure.
Dalacin Capsules should always be swallowed whole with
a full glass of water.

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.

Use in children
This medicine is used for children who are able to swallow
capsules. The recommended dose in children is between
12 and 25 mg / kg /day of bodyweight, divided into six
hourly doses, depending on the severity of the infection.
Your doctor will work out the number of capsules that your
child should have. If your child is unable to swallow
capsules, talk to your doctor or pharmacist.

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

If you take more Dalacin Capsules than you
should
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 forget to take 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, this medicine 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 or pseudomembranous
colitis.
• signs of a severe allergic reaction such as sudden
wheeziness, difficulty in breathing, dizziness, swelling of
the eyelids or face or lips or throat or tongue, 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).
• Potentially life threatening skin rashes:
- a widespread rash with blistering and peeling of large
areas of skin, particularly around the mouth, nose,
eyes or genitals, known as Stevens-Johnson
syndrome, or a more severe form with extensive
peeling of the skin (more than 30% of the body
surface) known as toxic epidermal necrolysis,
- a rare skin eruption that is characterised by the rapid
appearance of areas of red skin studded with small
pustules (small blisters filled with white/yellow fluid)
(Acute Generalised Exanthematous Pustulosis
(AGEP),
- skin rash, which may blister, and looks like small
targets (central dark spots surrounded by a paler area,
with a dark ring around the edge - erythema
multiforme)
- widespread red skin rash with small pus-containing
blisters (bullous exfoliative dermatitis)
- fever, swollen lymph nodes or skin rash, these may be
symptoms of a condition known as DRESS (Drug
reaction with eosinophilia and systemic symptoms)
and can be severe and life-threatening.
Other possible side effects may include:
Common (may affect up to 1 in 10 people):
• abnormal liver function tests (poor liver function)
• pain in the stomach / abdomen, diarrhoea.
Uncommon (may affect up to 1 in 100 people)
• feeling sick or being sick
• rash-characterized by a flat red area on the skin that is
covered with small bumps, hives,
Frequency cannot be estimated from the available
data:
• infection inside and around the vagina
• inflammation of the large intestine which causes
abdominal pain, fever or diarrhoea due to infection by
Clostridium difficile.
• effects on your blood system: reduced numbers of blood
cells which may cause bruising or bleeding or weaken
the immune system
• changes in the way things taste

• inflammation of the lining of the oesophagus (gullet),
open sores or lesions in the lining of the oesophagus
(gullet)
• yellowing of the skin and whites of the eyes (jaundice)
• red or scaly skin (exfoliative dermatitis), red measles-like
rash (rash morbilliform), itching.

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed on this leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow
Card in the Google Play or Apple App Store. By
reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Dalacin
• Keep out of the sight and reach 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. Contents of the pack and other
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: Fareva Amboise, Zone Industrielle,
29 route des Industries, 37530 Poce - sur- Cisse, France.
Procured from within the EU & repackaged by PL holder:
Kosei Pharma UK Ltd., 956 Buckingham Avenue, Slough,
SL1 4NL.

Dalacin® C 150 mg Hard Capsules,
PL 39352/0097
POM
Dalacin® is a registered trademark of Pfizer Ltd.
Leaflet date: 28/12/2017

To listen to or request a
copy of this leaflet in
Braille, large print or audio
please call: 01753515054
(UK only)

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 because it contains
important information for you.
• 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 only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
• 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. See section 4.
The name of your medicine is Clindamycin 150 mg Hard
Capsules, but it will be referred to as Clindamycin in this
leaflet.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Clindamycin is and what it is used for
What you need to know before you take Clindamycin
How to take Clindamycin
Possible side effects
How to store Clindamycin
Contents of the pack and other information

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

2. What you need to know 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 (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using
Clindamycin if:
• 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.
• you develop any severe skin reactions or
hypersensitivity to Clindamycin.
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.

Other medicines and Clindamycin
Tell your doctor or pharmacist or nurse if you are taking,
have recently taken or might take any other medicines:
• erythromycin (an antibiotic).
• muscle relaxants used for operations (neuromuscular
blockers).

• oral contraceptive pills. You should use extra
contraception such as condoms whilst taking
Clindamycin and for seven days after taking
Clindamycin.
• 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.
• CYP3A4 or CYP3A5 inducers like rifampicin may impact
effectiveness of the medicine.

Pregnancy and breast-feeding
Pregnancy
If you are pregnant or think you might be pregnant you
should contact your doctor before taking Clindamycin.
Ask your doctor or pharmacist for advice before taking any
medicine.
Breast-feeding
Tell your doctor if you will be breast-feeding 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. If you continue to take
Clindamycin, you should stop breast-feeding.

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

Clindamycin Capsules contain lactose
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 this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist or nurse if you
are not sure.
Clindamycin Capsules should always be swallowed whole
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.

Use in children
This medicine is used for children who are able to swallow
capsules. The recommended dose in children is between
12 and 25 mg / kg /day of bodyweight, divided into six
hourly doses, depending on the severity of the infection.
Your doctor will work out the number of capsules that your
child should have. If your child is unable to swallow
capsules, talk to your doctor or pharmacist.

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 forget to take 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, this medicine 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 or pseudomembranous
colitis.
• signs of a severe allergic reaction such as sudden
wheeziness, difficulty in breathing, dizziness, swelling of
the eyelids or face or lips or throat or tongue, 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).
• Potentially life threatening skin rashes:
- a widespread rash with blistering and peeling of large
areas of skin, particularly around the mouth, nose,
eyes or genitals, known as Stevens-Johnson
syndrome, or a more severe form with extensive
peeling of the skin (more than 30% of the body
surface) known as toxic epidermal necrolysis,
- a rare skin eruption that is characterised by the rapid
appearance of areas of red skin studded with small
pustules (small blisters filled with white/yellow fluid)
(Acute Generalised Exanthematous Pustulosis
(AGEP),
- skin rash, which may blister, and looks like small
targets (central dark spots surrounded by a paler area,
with a dark ring around the edge - erythema
multiforme),
- widespread red skin rash with small pus-containing
blisters (bullous exfoliative dermatitis)
- fever, swollen lymph nodes or skin rash, these may be
symptoms of a condition known as DRESS (Drug
reaction with eosinophilia and systemic symptoms)
and can be severe and life-threatening.
Other possible side effects may include:

Common (may affect up to 1 in 10 people):
• abnormal liver function tests (poor liver function)
• pain in the stomach / abdomen, diarrhoea.

Uncommon (may affect up to 1 in 100 people)
• feeling sick or being sick
• rash-characterized by a flat red area on the skin that is
covered with small bumps, hives,

Frequency cannot be estimated from the
available data:
• infection inside and around the vagina
• inflammation of the large intestine which causes
abdominal pain, fever or diarrhoea due to infection by
Clostridium difficile.

• effects on your blood system: reduced numbers of blood
cells which may cause bruising or bleeding or weaken
the immune system
• changes in the way things taste
• inflammation of the lining of the oesophagus (gullet),
open sores or lesions in the lining of the oesophagus
(gullet)
• yellowing of the skin and whites of the eyes (jaundice)
• red or scaly skin (exfoliative dermatitis), red measles-like
rash (rash morbilliform), itching.

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed on this leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow
Card in the Google Play or Apple App Store. By
reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Clindamycin
• Keep out of the sight and reach 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. Contents of the pack and other
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: Fareva Amboise, Zone Industrielle,
29 route des Industries, 37530 Poce - sur- Cisse, France.
Procured from within the EU & repackaged by PL holder:
Kosei Pharma UK Ltd., 956 Buckingham Avenue, Slough,
SL1 4NL.

Clindamycin 150 mg Hard Capsules,
PL 39352/0097
Leaflet date: 28/12/2017

POM

To listen to or request a
copy of this leaflet in
Braille, large print or audio
please call: 01753515054
(UK only)

+ 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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