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DALACIN C 150MG HARD CAPSULES

Active substance(s): CLINDAMYCIN / CLINDAMYCIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Dalacin ® C 150mg 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
‘Possible side effects’.

The name of your medicine is Dalacin C
150mg Hard Capsules. It will be referred to
as Dalacin throughout this leaflet.
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 ‘Contents of the pack and other
information’).
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.

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 breast-feeding.

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

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).
• Potential 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 StevensJohnson 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 effect 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- characterised 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 or nurse. This
includes any possible side effects not
listed in this leaflet. You can also report
side effects directly via theYellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help
provide more information on the safety of
this medicine.

5. How to store Dalacin








Keep this medicine 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 25oC.
If your capsules show signs of
deterioration or discolouration, you
should seek the advice of your
pharmacist who will tell you what to do.
Do not use this medicine if the capsules
are cracked, soft or stuck together.
Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how to throw away
medicines you no longer use. These
measures will help to protect the
environment.

6. Contents of the pack and
other information
What Dalacin contains
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.
Capsule: gelatin and titanium dioxide
(E171).
Printing ink: shellac, soya lecithin,
dimeticone (antifoam DC 1510), black iron
oxide (E172) and propylene glycol.
What Dalacin looks like and contents
of the pack
Dalacin are hard opaque gelatin capsules
with a white cap and body containing a
white powder. The capsule is imprinted
with ‘CLIN 150’ and ‘Pfizer’ in black ink.
Dalacin are available in blister packs of 24
capsules.
Manufacturer: Fareva Amboise, Zone
Industrielle, 29 route des Industries, 37530
Pocé-sur-Cisse, France.
Procured from within the EU and
repackaged by the Product Licence Holder:
Summer Healthcare Limited, 4 Petre Road,
Clayton Le Moors, Accrington, Lancashire.
BB5 5JB
POM
PL: 33948/0055
Leaflet revision date: 25th May 2017.

Blind or partially sighted?
Is this leaflet hard to read or
see? Call 01254 315040 to
obtain a leaflet in a format
suitable for you.
® Dalacin C is a registered Trade Mark of Pharmacia & Upjohn
Company LLC, Michigan, USA.

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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