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Package leaflet: Information for the user

Dalacin® C

75 mg Capsules

clindamycin hydrochloride

Read all of this leaflet carefully before
you start taking this medicine because
it contains important information for
• Keep this leaflet. You may need to read it
• 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.

What is in this leaflet:
1. What Dalacin is and what it is used for
2. What you need to know before you take
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
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
• 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
• 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 and breast-feeding
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.
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 breast-feeding.
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 (2 to 6 capsules) every 6 hours,
depending on the severity of your infection.
Use in children
The recommended dose in children is between
3 and 6mg per kg of bodyweight 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 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.
Continued overleaf...

bruising or bleeding or weaken the immune
If you forget to take Dalacin
If the forgotten dose is just a few hours late, use it
• changes in the way things taste
straight away. If it is nearly time for your next dose
miss out the forgotten one. Do not take a double
• inflammation of the lining of the
dose to make up for a missed dose.
oesophagus (gullet), open sores or lesions in
the lining of the oesophagus (gullet)
If you stop taking Dalacin

of the skin and whites of the eyes
If you stop taking the medicine too soon your
infection may come back again or get worse.
• red or scaly skin (exfoliative dermatitis), red
Do not stop taking Dalacin unless your doctor tells
measles-like rash (rash morbilliform), itching.
you to.
If you have any further questions on how to take this Reporting of side effects
product, ask your doctor or pharmacist.
If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible side
4. Possible side effects
effects not listed in this leaflet. You can also report
Like all medicines, this medicine can cause side ef- side effects directly via the Yellow Card Scheme at: By reporting side
fects, although not everybody gets them.
effects you can help provide more information on
Tell your doctor immediately if you develop:
the safety of this medicine.
• severe, persistent or bloody diarrhoea (which may
be associated with stomach pain or fever). This is 5. How to store Dalacin
an uncommon side effect which may occur during
or after completing treatment with antibiotics and • Keep this medicine out of the sight and reach of
can be a sign of serious bowel inflammation or
• Do not use Dalacin C Capsules after the expiry
pseudomembranous colitis.
date which is stated on the carton and blister
• signs of a severe allergic reaction such as sudden
labels. The expiry date refers to the last day of that
wheeziness, difficulty in breathing, dizziness
swelling of the eyelids orface or lips or throat or
• Store below 25°C.
tongue, rash or itching (especially affecting the
whole body).
• Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
• blistering and peeling of large areas of skin, fever,
throw away medicines you no longer use. These
cough, feeling unwell and swelling of the gums,
measures will help to protect the environment.
tongue or lips.
• yellowing of the skin and whites of the eyes
6. Contents of the pack and other
• Potentially life threatening skin rashes:
-- a widespread rash with blistering and peeling
What Dalacin C Capsules contain
of large areas of skin, particularly around
the mouth, nose, eyes or genitals, known
The active substance is clindamycin
as Stevens-Johnson syndrome, or a more
hydrochloride. Each capsule contains clindamycin
severe form with extensive peeling of the skin hydrochloride equivalent to 75mg of clindamycin.
(more than 30% of the body surface) known The other ingredients are lactose, maize starch,
as toxic epidermal necrolysis,
talc, magnesium stearate.
Capsule: gelatin, indigo carmine (E132), quinoline
-- a rare skin eruption that is characterised
yellow (E104) and titanium dioxide (E171).
by the rapid appearance of areas of red
Printing ink: shellac, soya lecithin, dimeticone
skin studded with small pustules (small
(Antifoam DC 1510).
blisters filled with white/yellow fluid) (Acute
Generalised Exanthematous Pustulosis
What Dalacin C Capsules look like and
contents of the pack
-- skin rash, which may blister, and looks like
Dalacin C Capsules are hard capsules coloured
small targets (central dark spots surrounded
green/white and with markings of ‘CLIN 75’ and
by a paler area, with a dark ring around the
edge - erythema multiforme)
Dalacin C Capsules 75 mg are available in blister
-- widespread red skin rash with small puspacks of 24 and 100 capsules.
containing blisters (bullous exfoliative
Marketing Authorisation Holder
Pfizer Limited,
-- fever, swollen lymph nodes or skin rash,
Ramsgate Road, Sandwich, Kent, CT13 9NJ,
these may be symptoms of a condition
known as DRESS (Drug reaction with
eosinophilia and systemic symptoms) and
can be severe and life-threatening.
Fareva Amboise,
Other possible side effects may include:
Zone Industrielle, 29 route des Industries, 37530
Common (may affect up to 1 in 10 people):
• abnormal liver function tests (poor liver function) France
• pain in the stomach / abdomen, diarrhoea.
Company Contact address:
If you have any comments on the way this leaflet
Uncommon (may affect up to 1 in 100
is written, please contact Medical Information at
Pfizer Limited in Walton Oaks, Tadworth, Surrey.
• feeling sick or being sick
Tel: 01304 616161.
• rash- characterized by a flat red area on the
This leaflet was last revised in 02/2017.
skin that is covered with small bumps, hives,
Ref: DA 10_3 Caps 75mg UK
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

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.