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DALACIN C 150MG CAPSULES

Active substance(s): CLINDAMYCIN / CLINDAMYCIN HYDROCHLORIDE

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Package leaflet: Information for the user

Dalacin® C 150mg 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.

If you continue to take Dalacin, you should
stop breast-feeding.
Driving and using machines
No effects on the ability to drive or use
machines have been seen with Dalacin.

The name of your medicine is Dalacin C
150mg capsules but will be referred to as
Dalacin or Dalacin capsules throughout this
leaflet.

Dalacin capsules should always be swallowed
whole with a full glass of water.

What is in this leaflet:
1. What Dalacin is and what it is used for
2. What you need to know before you take
Dalacin
3. How to take Dalacin
4. Possible side effects
5. How to store Dalacin
6. 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.

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.

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
25mg/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 in 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 store above 25°C.
Do not take the capsules after the expiry
date which is stated on the carton and
blister labels after ‘Exp’. The expiry date
refers to the last day of that month.
If the capsule become discoloured or
shows any sign of deterioration, seek the
advice of your pharmacist.
Remember if your doctor tells you to stop
taking this medicine, return any unused
medicine to your pharmacist for safe
disposal. Only keep this medicine if your
doctor tells you to.
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. Contents of the pack and other
information
What Dalacin contains
The active ingredient in Dalacin is clindamycin
hydrochloride.
Each capsule contains 150mg clindamycin as
hydrochloride.
The other ingredients are magnesium
stearate, talc, maize starch, lactose
monohydrate.
Capsule shell: titanium dioxide and gelatine.
What Dalacin looks like and contents of
the pack
Dalacin is white/white hard capsules with
markings of ‘CLIN 150’ and ‘Pfizer’.
Dalacin are available in blister pack of
12 capsules.

Manufactured by: Fareva Amboise, Zone
Industrielle - 29 route des Industries, 37530
poce-sur-Cisse, France.
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU,
UK.
Dalacin® C 150mg capsules; PL18799/2919
Leaflet date: 09.01.2018

POM

Blind or partially sighted?
Is this leaflet hard to see
or read?
Call 0208 515 3763 to
obtain the leaflet in a
format suitable for you.

Package leaflet: Information for the user

Clindamycin 150mg 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
150mg capsules but will be referred to as
Clindamycin or Clindamycin capsules
throughout this leaflet.
What is in this leaflet:
1. What Clindamycin is and what it is used
for
2. What you need to know before you take
Clindamycin
3. How to take Clindamycin
4. Possible side effects
5. How to store Clindamycin
6. 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 clindamycin 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
25mg/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 in 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 store above 25°C.
Do not take the capsules after the expiry
date which is stated on the carton and
blister labels after ‘Exp’. The expiry date
refers to the last day of that month.
If the capsule become discoloured or
shows any sign of deterioration, seek the
advice of your pharmacist.
Remember if your doctor tells you to stop
taking this medicine, return any unused
medicine to your pharmacist for safe
disposal. Only keep this medicine if your
doctor tells you to.
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. Contents of the pack and other
information
What Clindamycin contains
The active ingredient in Clindamycin is
clindamycin hydrochloride.
Each capsule contains 150mg clindamycin as
hydrochloride.
The other ingredients are magnesium
stearate, talc, maize starch, lactose
monohydrate.
Capsule shell: titanium dioxide and gelatine.
What Clindamycin looks like and contents
of the pack
Clindamycin is white/white hard capsules with
markings of ‘CLIN 150’ and ‘Pfizer’.
Clindamycin are available in blister pack of
12 capsules.
Manufactured by: Fareva Amboise, Zone
Industrielle - 29 route des Industries, 37530
poce-sur-Cisse, France.
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU,
UK.
Clindamycin 150mg capsules;
PL18799/2919
Leaflet date: 09.01.2018

POM

Blind or partially sighted?
Is this leaflet hard to see
or read?
Call 0208 515 3763 to
obtain the leaflet in a
format suitable for you.

+ 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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