Clindamycin 150mg capsules

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

Buy It Now

Active ingredient:
Clindamycin hydrochloride
Available from:
Somex Pharma
ATC code:
J01FF01
INN (International Name):
Clindamycin hydrochloride
Dosage:
150mg
Pharmaceutical form:
Capsule
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 05010600; GTIN: 15060089611179 15060089611186

Read the complete document

Package leaflet: Information for the patient

Clindamycin 75 mg Capsules, hard

Clindamycin 150 mg Capsules, hard

Clindamycin 300 mg Capsules, hard

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

What Clindamycin is and what it is used for

What you need to know before you take Clindamycin

How to take Clindamycin Capsules

Possible side effects

How to store Clindamycin Capsules

Contents of the pack and other information

1. What Clindamycin is and what it is used for

Clindamycin Capsules contain clindamycin 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 Capsules:

if you are allergic to clindamycin, lincomycin or any of the other ingredients of this

medicine listed in section 6.

Warnings and precautions

Talk to your doctor or pharmacist before taking Clindamycin Capsules 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 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.

you suffer from asthma, eczema or hayfever.

you develop any severe skin reactions or hypersensitivity to Clindamycin Capsules.

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 Capsules

Tell your doctor or pharmacist 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 breast-feeding, think you may be pregnant or are planning to

have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 Capsules as

clindamycin may be passed into breast milk. Your doctor will decide if Clindamycin

Capsules are appropriate for you. If you continue to take Clindamycin Capsules, you should

stop breast-feeding.

Driving and using machines

No effects on the ability to drive or use machines have been seen with Clindamycin

Capsules.

Clindamycin Capsules contains lactose

This medicine contains lactose (a kind of sugar). If you have been told by your doctor that

you have an intolerance to some sugars, contact your doctor before taking this medicinal

product.

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 with a full glass of water.

Adults and Elderly Patients

The recommended dose is between 150 and 450 mg (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 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 Clindamycin Capsules

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 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 Capsules

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

forgotten 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 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 Website: 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 Capsules

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton

after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 75 mg, 150 mg or 300 mg of clindamycin.

The other ingredients are lactose monohydrate, maize starch and talc.

The 75 mg capsule shell contains Gelatin, Sodium Laurilsulfate, Brilliant Blue (E133),

Erythrosine (E127) and Titanium dioxide (E171).

The 150 mg capsule shell contains Gelatin, Sodium Laurilsulfate, Iron Oxide Black (E172),

Iron Oxide Red (E172), Erythrosine (E127) and Titanium dioxide (E171).

The 300 mg capsule shell contains Gelatin, Sodium Laurilsulfate, Brilliant Blue (E133),

Erythrosine (E127 and Titanium Dioxide (E171).

The Printing Ink contains Shellac, Black Iron Oxide (E172), Potassium Hydroxide (E525)

and Titanium Dioxide (E171)

What Clindamycin Capsules look like and contents of the pack

Clindamycin 75 mg is hard gelatin capsule (dimension 14 mm), red-violet cap printed

‘RENATA’ in white and off-white to light cream body printed ‘Q 75’ in black containing

white crystalline powder.

Clindamycin 150 mg is hard gelatin capsule (dimension 18 mm), raspberry coloured cap

printed ‘RENATA’ in white and off-white to light cream body printed ‘Q 150’ in black

containing white crystalline powder.

Clindamycin 300 mg is hard gelatin capsule (dimension 21 mm), red-violet cap printed

‘RENATA’ in white and off-white to light cream body printed ‘Q 300’ in black containing

white crystalline powder.

Clindamycin Capsules are available in the following pack sizes:

75 mg: 24 capsules

150 mg: 20, 24, 30, 40 and 100 capsules

300 mg: 16, 24, 30 and 32 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Renata (UK) Limited

Greenway Business Centre

Harlow Business Park,

Harlow,

CM19 5QE

United Kingdom

Distributed by:

Lucis Pharma Ltd

14 Aston Magna

Moreton in Marsh

Gloucestershire,

GL56 9QQ

United Kingdom

Manufacturer:

Elara Pharmaservices Limited.

Iron Farm,

7 Grimes Gate,

Diseworth,

DE74 2QD,

United Kingdom

This medicinal product is authorised in the Member States of the EEA under the

following names:

Ireland

Clindamycin 75/150/300 mg Capsules, hard

United Kingdom

Clindamycin 75/150/300 mg Capsules, hard

This leaflet was revised in September 2019

LUCIS Clindamycin 75/150/300 MG Capsules, Hard PIL

Version 1 Created 04.06.19

Font: Times New Roman Light & Bold 9.5pt (leading auto and as shown)

Now Version 6 - created 19.09.19

Profile size shown is 225 x 290 (profile advised 08.05.19)

VICTOR DESIGN

Package leaflet: Information for the patient

Clindamycin 75 mg Capsules, hard

Clindamycin 150 mg Capsules, hard

Clindamycin 300 mg Capsules, hard

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 is and what it is used for

2. What you need to know before you take Clindamycin

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 is and what it is used for

Clindamycin Capsules contain clindamycin 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 Capsules:

if you are

allergic

to clindamycin, lincomycin or any of the other ingredients of this

medicine listed in section 6.

Warnings and precautions

Talk to your doctor or pharmacist before taking Clindamycin Capsules 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 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.

you suffer from asthma, eczema or hayfever.

you develop any severe skin reactions or hypersensitivity to Clindamycin Capsules.

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 Capsules

Tell your doctor or pharmacist 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 breast-feeding, think you may be pregnant or are planning to

have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 Capsules as

clindamycin may be passed into breast milk. Your doctor will decide if Clindamycin

Capsules are appropriate for you. If you continue to take Clindamycin Capsules, you should

stop breast-feeding.

Driving and using machines

No effects on the ability to drive or use machines have been seen with Clindamycin

Capsules.

Clindamycin Capsules contains lactose

This medicine contains lactose (a kind of sugar). If you have been told by your doctor that

you have an intolerance to some sugars, contact your doctor before taking this medicinal

product.

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 with a full glass of water.

Adults and Elderly Patients

The recommended dose is between 150 and 450 mg (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 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 Clindamycin Capsules

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 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 Capsules

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

forgotten 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 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 Website: 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 Capsules

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton

after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 75 mg, 150 mg or 300 mg of clindamycin.

The other ingredients are lactose monohydrate, maize starch and talc.

The 75 mg capsule shell contains Gelatin, Sodium Laurilsulfate, Brilliant Blue (E133),

Erythrosine (E127) and Titanium dioxide (E171).

The 150 mg capsule shell contains Gelatin, Sodium Laurilsulfate, Iron Oxide Black (E172),

Iron Oxide Red (E172), Erythrosine (E127) and Titanium dioxide (E171).

The 300 mg capsule shell contains Gelatin, Sodium Laurilsulfate, Brilliant Blue (E133),

Erythrosine (E127) and Titanium Dioxide (E171).

The Printing Ink contains Shellac, Black Iron Oxide (E172), Potassium Hydroxide (E525)

and Titanium Dioxide (E171)

What Clindamycin Capsules look like and contents of the pack

Clindamycin 75 mg is hard gelatin capsule (dimension 14 mm), red-violet cap printed

‘RENATA’ in white and off-white to light cream body printed ‘Q 75’ in black containing

white crystalline powder.

Clindamycin 150 mg is hard gelatin capsule (dimension 18 mm), raspberry coloured cap

printed ‘RENATA’ in white and off-white to light cream body printed ‘Q 150’ in black

containing white crystalline powder.

Clindamycin 300 mg is hard gelatin capsule (dimension 21 mm), red-violet cap printed

‘RENATA’ in white and off-white to light cream body printed ‘Q 300’ in black containing

white crystalline powder.

Clindamycin Capsules are available in the following pack sizes:

75 mg: 24 capsules

150 mg: 20, 24, 30, 40 and 100 capsules

300 mg: 16, 24, 30 and 32 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Renata (UK) Limited

Greenway Business Centre

Harlow Business Park,

Harlow,

CM19 5QE

United Kingdom

Distributed by:

Lucis Pharma Limited

14 Aston Magna

Moreton in Marsh

Gloucestershire,

GL56 9QQ

United Kingdom

Manufacturer:

Elara Pharmaservices Limited

Iron Farm,

7 Grimes Gate,

Diseworth,

DE74 2QD,

United Kingdom

This medicinal product is authorised in the Member States of the EEA under the

following names:

Ireland

Clindamycin 75/150/300 mg Capsules, hard

United Kingdom

Clindamycin 75/150/300 mg Capsules, hard

This leaflet was revised in September 2019

Read the complete document

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Clindamycin 150mg Capsules, hard

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Clindamycin 150mg Capsules, hard

Each capsule contains clindamycin hydrochloride equivalent to 150 mg clindamycin.

Excipient with known effect

Each capsule contains 114.65 mg lactose monohydrate equivalent to 108.92 mg of

lactose (see section 4.4).

For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

Capsule, hard.

Clindamycin 150mg Capsules, hard

Size ‘1’ hard gelatin white capsules with marking ‘I 62’ on cap.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Antibacterial. Serious infections caused by susceptible Gram-positive organisms,

staphylococci (both penicillinase- and non-penicillinase-producing), streptococci

(except Streptococcus faecalis) and pneumococci. It is also indicated in serious

infections caused by susceptible anaerobic pathogens.

Clindamycin does not penetrate the blood/brain barrier in therapeutically effective

quantities.

4.2

Posology and method of administration

Posology

Adults: Moderately severe infection, 150 - 300 mg every six hours; severe infection,

300 - 450 mg every six hours.

Elderly patients: The half-life, volume of distribution and clearance, and extent of

absorption after administration of clindamycin hydrochloride are not altered by

increased age. Analysis of data from clinical studies has not revealed any age-related

increase in toxicity. Dosage requirements in elderly patients, therefore, should not be

influenced by age alone.

Paediatric population: 3 - 6 mg/kg every six hours depending on the severity of the

infection.

Dosage in Renal/Hepatic Impairment: Clindamycin dosage modification is not

necessary in patients with renal or hepatic insufficiency.

Note: In cases of beta-haemolytic streptococcal infection, treatment with Clindamycin

Capsules should continue for at least 10 days to diminish the likelihood of subsequent

rheumatic fever or glomerulonephritis.

Method of administration

Oral. Clindamycin Capsules should always be taken with a full glass of water.

Absorption of Clindamycin Capsules is not appreciably modified by the presence of

food.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section

6.1 or lincomycin.

4.4

Special warnings and precautions for use

Warnings:

Severe

hypersensitivity

reactions,

including

severe

skin

reactions

such

drug

reaction

with

eosinophilia

systemic

symptoms

(DRESS),

Stevens-Johnson

syndrome

(SJS),

toxic

epidermal

necrolysis

(TEN),

acute

generalised

exanthematous

pustulosis

(AGEP)

have

been

reported

patients

receiving

clindamycin therapy. If a hypersensitivity or severe skin reaction occurs, clindamycin

should be discontinued and appropriate therapy should be initiated (see sections 4.3

and 4.8).

Clindamycin Capsules should only be used in the treatment of serious infections. In

considering the use of the product, the practitioner should bear in mind the type of

infection and the potential hazard of the diarrhoea which may develop, since cases of

colitis

have

been

reported

during,

even

three

weeks

following,

administration of clindamycin.

Studies indicate a toxin(s) produced by clostridia (especially Clostridium difficile) is

the principal direct cause of antibiotic-associated colitis. These studies also indicate

that this toxigenic clostridium is usually sensitive in vitro to vancomycin. When 125

mg to 500 mg of vancomycin are administered orally four times a day for 7 - 10 days,

there is a rapid observed disappearance of the toxin from faecal samples and a

coincident clinical recovery from the diarrhoea. (Where the patient is receiving

cholestyramine

addition

vancomycin,

consideration

should

given

separating the times of administration).

Colitis is a disease which has a clinical spectrum from mild, watery diarrhoea to

severe, persistent diarrhoea, leucocytosis, fever, severe abdominal cramps, which may

be associated with the passage of blood and mucus. If allowed to progress, it may

produce peritonitis, shock and toxic megacolon. This may be fatal.

The appearance of marked diarrhoea should be regarded as an indication that the

product should be discontinued immediately. The disease is likely to follow a more

severe course in older patients or patients who are debilitated. Diagnosis is usually

made by the recognition of the clinical symptoms, but can be substantiated by

endoscopic demonstration of pseudomembranous colitis. The presence of the disease

may be further confirmed by culture of the stool for Clostridium difficile on selective

media and assay of the stool specimen for the toxin(s) of C. difficile.

Clostridium difficile associated diarrhoea (CDAD) has been reported with use of

nearly all antibacterial agents, including clindamycin, and may range in severity from

mild diarrhoea to fatal colitis. Treatment with antibacterial agents alters the normal

flora of the colon leading to overgrowth of C difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD.

Hypertoxin producing strains of C. difficile cause increased morbidity and mortality,

as these infections can

refractory to

antimicrobial therapy

require

colectomy. CDAD must be considered in all patients who present with diarrhoea

following antibiotic use. Careful medical history is necessary since CDAD has been

reported to occur over two months after the administration of antibacterial agents.

Precautions: Caution should be used when prescribing Clindamycin Capsules to

individuals with a history of gastro-intestinal disease, especially colitis.

Periodic liver and kidney function tests should be carried out during prolonged

therapy. Such monitoring is also recommended in neonates and infants.

Prolonged administration of Clindamycin Capsules, as with any anti-infective, may

result in super-infection due to organisms resistant to clindamycin.

Care should be observed in the use of Clindamycin Capsules in atopic individuals.

This medicinal product contains lactose. Patients with rare hereditary problems of

galactose intolerance, total lactase deficiency or glucose-galactose malabsorption

should not take this medicine.

4.5

Interaction with other medicinal products and other forms of interaction

Clindamycin has been shown to have neuromuscular blocking properties that may

enhance the action of other neuromuscular blocking agents. It should be used with

caution, therefore, in patients receiving such agents.

Vitamin K antagonists

Increased coagulation tests (PT/INR) and/or bleeding, has been reported in patients

treated with clindamycin in combination with a vitamin K antagonist (e.g. warfarin,

acenocoumarol and fluindione). Coagulation tests, therefore, should be frequently

monitored in patients treated with vitamin K antagonists.

Co-administration

clindamycin

with

inhibitors

CYP3A4

CYP3A5

Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by

CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-

desmethylclindamycin. Therefore, inhibitors of CYP3A4 and CYP3A5 may reduce

clindamycin clearance and inducers of these isoenzymes may increase clindamycin

clearance.

In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of

effectiveness.

vitro

studies

indicate

that

clindamycin

does

inhibit

CYP1A2,

CYP2C9,

CYP2C19, CYP2E1 or CYP2D6 and only moderately inhibits CYP3A4. Therefore,

clinically important interactions between clindamycin and co-administered drugs

metabolized by these CYP enzymes are unlikely.

4.6

Fertility, pregnancy and lactation

Pregnancy

There was evidence of maternal toxicity and embryofetal toxicity in animal studies

(see section 5.3).

Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid

concentrations were approximately 30% of maternal blood concentrations.

In clinical trials with pregnant women, the systemic administration of clindamycin

during the second and third trimesters has not been associated with an increased

frequency of congenital abnormalities. There are no adequate and well-controlled

studies in pregnant women during the first trimester of pregnancy.

Clindamycin should be used in pregnancy only if clearly needed.

Breast-feeding

Orally and parenterally administered clindamycin has been reported to appear in

human breast milk in ranges from 0.7 to 3.8µg/ml. Because of the potential for

serious adverse reactions in nursing infants clindamycin should not be taken by

nursing mothers.

Fertility

Fertility studies in rats treated orally with clindamycin revealed no effects on fertility

or mating ability.

4.7

Effects on ability to drive and use machines

Clindamycin has no or negligible influence on the ability to drive and use machines.

4.8

Undesirable effects

The table below lists the adverse reactions identified through clinical trial experience

post-marketing

surveillance

system

organ class and frequency.

Adverse

reactions identified from post-marketing experience are included in italics.

The frequency grouping is defined using the following convention:

Very common (

1/10); Common (

1/100 to <1/10); Uncommon (

1/1,000 to

<1/100); Rare (

1/10,000 to <1/1,000); Very Rare (< 1/10,000); and Not known

(cannot be estimated from the available data). Within each frequency grouping,

undesirable effects are presented in order of decreasing seriousness.

System Organ Class

Common

1/100 to < 1/10

Uncommon

1/1000 to

<1/100

Rare

1/10000 to

<1/1000

Not Known

(cannot be estimated

from available data)

Infections and

infestations

pseudomembranous

colitis*#

Clostridium

difficile colitis*,

Vaginal infection*

Blood and

Lymphatic System

Disorders

Agranulocytosis*,

Leucopenia*,

Neutropenia*,

Thrombocytopenia*,

Eosinophilia

Immune System

Disorders

Anaphylactic shock*

Anaphylactoid

reaction*,

Anaphylactic reaction*,

Hypersensitivity*

Nervous System

Disorders

Dysgeusia

Gastrointestinal

Disorders

Abdominal pain,

Diarrhoea

Nausea,

Vomiting

Oesophageal ulcer*‡,

Oesophagitis*‡

Hepatobiliary

Disorders

Jaundice*

Skin and

Subcutaneous

Tissue Disorders

Rash

maculopapular,

Urticaria

Toxic epidermal

necrolysis (TEN)*,

Stevens-Johnson

syndrome (SJS)*,

Drug reaction with

eosinophilia and

systemic symptoms

(DRESS)*

Acute generalised

exanthematous

pustulosis (AGEP)*,

Angioedema*,

Erythema multiforme,

Dermatitis exfoliative*,

Dermatitis bullous*,

Rash morbilliform*,

Pruritus

Investigations

Liver function test

abnormal

* ADR identified post-marketing.

‡ ADRs apply only to oral formulations.

# See section 4.4.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is

important.

allows

continued

monitoring

benefit

risk

balance

medicinal product. Healthcare professionals are asked to report any suspected adverse

reactions 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.

4.9

Overdose

In cases of overdosage no specific treatment is indicated.

The serum biological half-life of clindamycin is 2.4 hours. Haemodialysis and

peritoneal dialysis are not effective in removing clindamycin from the serum..

If an allergic adverse reaction occurs, therapy should be with the usual emergency

treatments, including corticosteroids, adrenaline and antihistamines.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: lincosamide antibiotics.

ATC Code: D10AF01.

Mode of action

Clindamycin is a lincosamide antibiotic with a primarily bacteriostatic action against

Gram-positive aerobes and a wide range of anaerobic bacteria. Lincosamides such as

clindamycin bind to the 50S subunit of the bacterial ribosome similarly to macrolides

such as erythromycin and inhibit protein synthesis. The action of clindamycin is

predominantly bacteriostatic although high concentrations may be slowly bactericidal

against sensitive strains. Although clindamycin phosphate is inactive in vitro, rapid in

vivo hydrolysis converts this compound to the antibacterially active clindamycin.

Resistance

Resistance to clindamycin usually occurs via macrolide-lincosamide-streptogramin B

(MLSB) type of resistance, which may be constitutive or inducible.

Breakpoints

The minimum inhibitory concentrations (MIC) breakpoints are as follows:

EUCAST

Staphylococci: sensitive

0.25 resistant > 0.5

Streptococci ABCG and pneumoniae: sensitive

0.5 resistant > 0.5

Gram positive anaerobes: sensitive

4 resistant > 4

Gram negative anaerobes:

4 resistant > 4

PK/PD relationship

Efficacy is related to the ratio of the area of the concentration-time curve of unbound

antibiotic to the MIC for the pathogen (fAUC/MIC).

Susceptibility

The prevalence of acquired resistance may vary geographically and with time for

selected species and local information on resistance is desirable, particularly when

treating severe infections. As necessary, expert advice should be sought when local

prevalence of resistance is such that the utility of the agent in at least some types of

infections is questionable.

Species

Susceptible

Gram-positive aerobes

Staphylococcus aureus*

Staphylococcus epidermidis

Streptococcus pneumonia

Streptococcus pyogenes

Viridans streptococci

Anaerobes

Bacteriodes fragilis group

Prevotella formerly known as Bacteroides melaninogenicus

Bifidobacterium spp.

Clostridium perfringens

Eubacterium spp.

Fusobacterium spp.

Peptococcus spp.

Peptostreptococcus spp.

Propionibacterium spp.

Veillonella spp.

Resistant

Clostridia spp.

Enterococci

Enterobacteriaceae

*Up to 50% of methicillin-susceptible S. aureus have been reported to be resistant to

clindamycin in some areas. More than 90% of methicillin-resistant S.aureus (MRSA)

are resistant to clindamycin and it should not be used while awaiting susceptibility

test results if there is any suspicion of MRSA.

5.2

Pharmacokinetic properties

Absorption

About 90% of a dose of clindamycin hydrochloride is absorbed from the gastro-

intestinal tract; concentrations of 2 to 3 micrograms per ml occur within one hour

after a 150 mg dose of clindamycin, with average concentrations of about 0.7

micrograms per ml after 6 hours. After doses of 300 and 600 mg peak plasma

concentrations of 4 and 8 micrograms per ml, respectively, have been reported.

Absorption is not significantly diminished by food in the stomach but the rate of

absorption may be reduced.

Distribution

Clindamycin is widely distributed in body fluids and tissues including bone, but it

does not reach the csf in significant concentrations. It diffuses across the placenta into

fetal

circulation

been

reported

appear

breast

milk.

High

concentrations occur in bile. It accumulates in leucocytes and macrophages. Over

90% of clindamycin in the circulation is bound to plasma proteins. In vitro studies in

human liver and intestinal microsomes indicated that clindamycin is predominantly

oxidized by CYP3A4, with minor contribution from CYP3A5, to form clindamycin

sulfoxide and a minor metabolite, N-desmethylclindamycin. The half-life is 2 to 3

hours, although this may be prolonged in pre-term neonates and patients with severe

renal impairment.

Elimination

Clindamycin

undergoes

metabolism,

presumably

liver,

active

demethyl and sulphoxide metabolites, and also some inactive metabolites. About 10%

of a dose is excreted in the urine as active drug or metabolites and about 4% in the

faeces; the remainder is excreted as inactive metabolites. Excretion is slow, and takes

place over several days. It is not effectively removed from the blood by dialysis.

Characteristics in patients

No special characteristics. See section 4.4 "Special warnings and special precautions

for use" for further information.

5.3

Preclinical safety data

None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Lactose monohydrate,

Maize starch,

Talc,

Magnesium stearate.

The 150 mg capsule shells contain:

Gelatin,

Titanium dioxide (E171).

Printing ink:

Shellac,

Black iron oxide (E172),

Propylene glycol (E1520)

6.2

Incompatibilities

Not applicable

6.3

Shelf life

27 months

6.4

Special precautions for storage

Do not store above 30

6.5

Nature and contents of container

Blister pack composed of clear, transparent 250 micron PVC foil and 25 micron

aluminium lidding foil.

Packs of 7, 10, 14, 15, 20, 24, 28, 30, 56, 60, 84, 90, 100, 112 and 120 capsules are

available.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance

with local requirements.

7

MARKETING AUTHORISATION HOLDER

Morningside Healthcare Ltd.

Unit C, Harcourt Way

Leicester, LE19 1WP, UK

8

MARKETING AUTHORISATION NUMBER(S)

PL 20117/0282

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

03/11/2017

10

DATE OF REVISION OF THE TEXT

07/05/2020

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