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CLINDAMYCIN STADA 600 MG HARD CAPSULES

Active substance(s): CLINDAMYCIN HYDROCHLORIDE / CLINDAMYCIN HYDROCHLORIDE / CLINDAMYCIN HYDROCHLORIDE

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Package leaflet: Information for the patient
Clindamycin STADA 600 mg hard capsules
clindamycin

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. This includes any possible
side effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Clindamycin capsules is and what it is used for
2. What you need to know before you take Clindamycin capsules
3. How to take Clindamycin capsules
4. Possible side effects
5. How to store Clindamycin capsules
6. Contents of the pack and other information

1. What Clindamycin capsules is and what it is used for
This medicine contains clindamycin, which is an antibiotic. It is used to treat infections.
Clindamycin is usually reserved for the treatment of serious infections, especially when other
antibiotics have been unable to clear the infection and when the infection is caused by
bacteria that are sensitive to clindamycin.
Clindamycin is indicated for the treatment of:
 Intra-abdominal infections
 Skin and soft tissue infections
 Respiratory tract infections
 Pelvic inflammatory disease
2. What you need to know before you take Clindamycin capsules
DO NOT take Clindamycin capsules:
 if you are allergic to clindamycin, lincomycin or to any of the ingredients of this medicine
(listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Clindamycin capsules
Tell your doctor if:
 you 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 capsules 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. If you have serious liver or kidney
problems, your doctor may reduce your dose of Clindamycin capsules and monitor

Clindamycin capsules in your blood.
 you suffer from asthma, eczema or hayfever.
 if you have diarrhoea.
If you have to take Clindamycin capsules 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 capsules treatment.
Clindamycin capsules does not get into the brain and is therefore not suitable for treating
serious infections in and around the brain (e.g. meningitis). Your doctor may need to give you
another antibiotic if you have these infections.
Other medicines and Clindamycin capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any 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 used to treat infections.
 muscle relaxants used for operations.
 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.
Clindamycin capsules with food
The capsules may be taken either before or after a meal.
Pregnancy and breast-feeding
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your
doctor for advice before taking this medicine.
Breast-feeding
The active substance in this medicine may pass into breast milk. You should not take
Clindamycin capsules whilst breast-feeding.
Driving and using machines
No effects on the ability to drive or use machines have been seen with Clindamycin capsules
contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking Clindamycin capsules.

3. How to take Clindamycin capsules
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Clindamycin capsules should always be swallowed whole and washed down with a full glass
of water.
Use in adults and adolescents over 12 years of age
The recommended dose of Clindamycin capsules is between 600 and 1,800 mg daily,
depending on the severity of your infection, every 6 to 8 hours.

For dosages that cannot be achieved with Clindamycin STADA 600 mg hard capsules, other
pharmaceutical forms with lower dosages are available.
Use in children
For this age group other clindamycin containing medicinal products with lower doses are
available.
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 capsules
If the forgotten dose is just a few hours late, take it straight away. If it is nearly time for your
next dose then miss out the forgotten one. Do not take a double dose to make up for a
missed dose.
If you stop taking Clindamycin capsules
If you stop taking the medicine too soon your infection may come back again or get worse.
Do not stop taking Clindamycin capsules unless your doctor tells you to.
If you have any further questions on the use of this medicine, 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 a 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: vaginal infection
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 Yellow 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 Clindamycin capsules
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton and blister after
EXP.
The expiry date refers to the last day of that month.
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 protect the
environment.

6. Contents of the pack and other information
What Clindamycin capsules contain
 The active substance is clindamycin.
Each capsule contains clindamycin hydrochloride equivalent to 600 mg of the active
substance.
 The other ingredients are:
Capsule contents: anhydrous lactose, corn starch, talc, magnesium stearate
Capsule shell:
titanium dioxide (E171), gelatin, water, sodium lauryl sulphate
Printing ink:
shellac, black iron oxide (E172), potassium salts of potassium
hydroxides,
What Clindamycin capsules looks like and contents of the pack
600 mg capsules are white hard capsules marked with ‘A724’ on the cap in
black ink.
Pack sizes
Blisters: 8, 12, 15, 16, 18, 25, 30, 32, 36, 100 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastr. 2-18
61118 Bad Vilbel
Germany
Manufacturer
STADA Arzneimittel AG
Stadastr.2-18
61118 Bad Vilbel
Germany
LAMP SAN PROSPERO S.p.A.
Via della Pace, 25/A
41030 San Prospero (Modena)
Italy
Hemofarm A.D Vršac, Sabac plant
Hajduk Velijkova bb

YU – 15000 Sabac
Serbia
Sanico N.V.
Veedijk 59
2300 Turnhout
Belgium
TTCproduction GmbH
Klagenfurter Straße 311
9462 Sankt Leonhard
Austria
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Wien
Austria
BALKANPHARMA-RAZGRAD AD
68, Aprilsko Vastanie Blvd.,
7200 Razgrad
Bulgaria

This medicinal product is authorised in the Member States of the EEA under the following
names:
UK
BE
LU
DE
AT
NL

Clindamycin STADA 600 mg hard capsules
Clindamycine EG 600 mg harde capsules
Clindamycine EG 600 mg gélules
Clindamycin AL 600 mg Hartkapseln
Clindamycin STADA 600 mg Hartkapseln
Clindamycine CF 600 mg, harde capsules

This leaflet was last revised in October 2016.

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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