Clindamycin 300mg capsules

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

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Active ingredient:
Clindamycin hydrochloride
Available from:
Accord Healthcare Ltd
ATC code:
J01FF01
INN (International Name):
Clindamycin hydrochloride
Dosage:
300mg
Pharmaceutical form:
Capsule
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF:
Authorization number:
; PL 30306/0677

Read the complete document

Clindamycin 150mg and 300mg

Hard Capsules

Clindamycin hydrochloride

Package leaflet: Information for the patient

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, pharmacist or nurse.

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, pharmacist or nurse. This includes

any possible side effects not listed in this

leaflet. See section 4.

The full name of this medicine is

Clindamycin 150mg, 300mg Hard

Capsules but within the leaflet it will be

referred to as Clindamycin.

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 Capsules contain clindamycin

which is an antibiotic used in the treatment of

severe bacterial infections.

2

What you need to know before you

take Clindamycin

Do not take Clindamycin

if you are allergic to clindamycin, lincomycin

or to any of the ingredients of this medicine

(listed in section 6).

if you have diarrhoea.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before

taking Clindamycin 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

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 and monitor the amount of

Clindamycin in your blood.

you suffer from asthma, eczema or hayfever.

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.

Clindamycin 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

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 with food and drink

The capsules may be taken either before of

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 whilst breast-feeding.

Driving and using machines

No effects on the ability to drive or use

machines have been seen with Clindamycin.

Clindamycin contains lactose

If you have been told by your doctor that you

have an intolerance to some sugars, contact

your doctor before taking Clindamycin.

3

How to take Clindamycin

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 should always be swallowed

whole and washed down with a full glass of

water.

Use in adults

The usual dose of Clindamycin is between 150

and 450mg every six to eight hours, depending

on the severity of your infection.

If your doctor has prescribed Clindamycin

600mg Capsules, the usual dose is one capsule

every 8 hours.

Continued over page

AAAI6795

Continued top of next column

Clindamycin 150mg & 300mg Hard Capsules PIL - UK

item no: AAAI6795

print proof no: 4

origination date: 18.01.16

originated by: S.Anson

revision date: 19.01.16

revised by: S.Anson

dimensions: 165 x 320

pharmacode:

colours/plates:

approved for print/date

Non Printing Colours

1. Black

date sent: 18.01.16

supplier: Actavis Balkanpharma Razgrad AD

approved: 18.01.16

min pt size: 9.5

Technical Approval

Children

The usual dose in children is between 3 and

6mg per kg every six hours, depending on the

severity of the infection.

Your doctor will work out the number of

capsules that you or your child should have,

and how often they should be taken.

If your child is unable to swallow capsules, talk

to your doctor or pharmacist. Other forms of

this medicine may be more suitable.

If you take more Clindamycin than you

should

If you accidentally take too many Clindamycin

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 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,

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

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 the use of

this medicine, ask your doctor, pharmacist or

nurse.

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,

pharmacist or nurse. 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

By reporting side effects you can help provide

more information on the safety of this

medicine.

5

How to store Clindamycin

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 150mg, 300mg 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 sulfate.

Printing ink: shellac, dehydrated alcohol,

isopropyl alcohol, butyl alcohol, propylene

glycol (E1520), strong ammonia solution,

black iron oxide (E172), potassium hydroxide,

purified water.

What Clindamycin Capsules look like

and contents of the pack

Clindamycin 150mg Hard Capsules are white

hard capsules marked with ‘A714’ on the cap in

black ink.

Clindamycin 300mg Hard Capsules are white

hard capsules marked with ‘A718’ on the cap in

black ink.

Pack sizes

Blisters: 150mg: 24 hard capsules.

300mg: 30 hard capsules.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78

220 Hafnarfjörður

Iceland

Manufacturer

Balkanpharma-Razgrad AD

68, Aprilsko Vastanie Blvd

Razgrad

7200

Bulgaria

This leaflet was last revised in January 2016.

If you would like a

leaflet with larger text,

please contact

01271 385257.

Actavis, Barnstaple, EX32 8NS, UK

AAAI6795

Continued top of next column

Clindamycin 150mg & 300mg Hard Capsules PIL - UK

item no: AAAI6795

print proof no: 4

origination date: 18.01.16

originated by: S.Anson

revision date: 19.01.16

revised by: S.Anson

dimensions: 165 x 320

pharmacode:

colours/plates:

approved for print/date

Non Printing Colours

1. Black

date sent: 18.01.16

supplier: Actavis Balkanpharma Razgrad AD

approved: 18.01.16

min pt size: 9.5

Technical Approval

Read the complete document

Object 1

Clindamycin 300mg Hard Capsules

Summary of Product Characteristics Updated 04-Aug-2016 | Accord-UK Ltd

1. Name of the medicinal product

Clindamycin 300mg Hard Capsules

2. Qualitative and quantitative composition

Each capsule contains 325.78 mg clindamycin hydrochloride equivalent to 300 mg clindamycin.

Excipient with known effect:

Each capsule contains 67.82 mg anhydrous lactose (see section 4.4).

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Hard capsule

Size '0' hard gelatin capsule with opaque white cap and opaque white body imprinted with 'A718' on cap

with black ink.

4. Clinical particulars

4.1 Therapeutic indications

Clindamycin is indicated for the treatment of severe infections (see sections 4.4 and 5.1).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology and method of administration

Posology

Adults

Moderately severe infection: 150 - 300 mg every six hours

Severe infection: 1200 - 1800 mg daily in divided doses given every six to eight hours

Elderly

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.

Children: 3 - 6 mg/kg every six hours depending on the severity of the infection.

Clindamycin capsules are not suitable for children who are unable to swallow them whole. The capsules

do not provide exact mg/kg doses therefore it may be necessary to use an alternative formulation in some

cases.

Renal impairment

No dose adjustment is necessary in patients with mild to moderate impairment of renal function. In

patients with severe renal impairment or anuria, plasma concentration should be monitored. Depending on

the results, this measure can make a reduction in dosage or an increase in the dose interval of 8 or even 12

hours necessary.

Hepatic impairment

In patients with moderate to severe hepatic impairment, elimination half-life of clindamycin is prolonged.

A reduction in dosage is generally not necessary if clindamycin is administered every 8 hours. However,

the plasma concentration of clindamycin should be monitored in patients with severe hepatic impairment.

Depending on the results, this measure can make a reduction in dosage or an increase in the dose intervals

necessary.

Method of Administration

Oral.Clindamycin capsules should always be swallowed whole with a full glass of water. Absorption of

Clindamycin is not appreciably modified by the presence of food.

4.3 Contraindications

Clindamycin is contra-indicated in patients previously found to be sensitive to clindamycin, lincomycin

or to any of the excipients listed in section 6.1.

Clindamycin should not be used in patients with existing diarrhoea.

4.4 Special warnings and precautions for use

The choice of clindamycin should be based on factors such as severity of the infection, the prevalence of

resistance to other suitable agents and the risk of selecting clindamycin-resistant bacteria.

Treatment with antibacterial agents can significantly alter the normal flora of the colon leading to

overgrowth of Clostridium difficile. This has been reported with use of nearly all antibacterial agents,

including clindamycin. Clostridium difficile produces toxins A and B which contribute to the

development of Clostridium difficile associated diarrhea (CDAD) and is a primary cause of “antibiotic-

associated colitis“.

It is important to consider the diagnosis of CDAD in patients who present with diarrhea subsequent to the

administration of antibacterial agents. This may progress to colitis, including pseudomembranous colitis

(see Section 4.8), which may range from mild to fatal colitis. If antibiotic-associated diarrhoea or

antibiotic-associated colitis is suspected or confirmed, ongoing treatment with antibacterial agents,

including clindamycin, should be discontinued and adequate therapeutic measures should be initiated

immediately. Drugs inhibiting peristalsis are contraindicated in this situation.

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

Since clindamycin does not diffuse adequately into cerebrospinal fluid, the drug should not be used in the

treatment of meningitis.

Caution should be used when prescribing clindamycin to individuals with a history of gastro-intestinal

disease, especially colitis.

If therapy is prolonged, liver and kidney function tests should be performed.

The use of clindamycin may result in overgrowth of non-susceptible organisms, particularly yeasts.

Care should be observed in the use of clindamycin in atopic individuals.

Clindamycin capsules contain lactose. Patients with rare hereditary problems of galactose intolerance, the

Lapp 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.

Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible

clinical significance the two drugs should not be administered concurrently.

Vitamin K antagonists

Increased coagulation tests (PT/INR) and/or bleeding, have 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.

4.6 Fertility, pregnancy and lactation

Pregnancy

Oral and subcutaneous reproductive toxicity studies in rats and rabbits revealed no evidence of impaired

fertility or harm to the fetus due to clindamycin, except at doses that caused maternal toxicity. Animal

reproduction studies are not always predictive of human response.

Clindamycin crosses the placenta. There are inadequate data regarding the safety of clindamycin in

pregnancy. Therefore, clindamycin should only be administered to pregnant women if the potential

benefit is considered to outweigh the possible risk to the foetus. After multiple doses, amniotic fluid

concentrations were approximatley 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.

Breastfeeding

Orally and parentally administered clindamycin has been reported to appear in human breast milk in

ranges from 0.7 to 3.8 μg/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 and post-marketing

surveillance by 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);

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

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

<

1/10,00

0

Not Known

(cannot be

estimated from

available data)

Infections and

infestations

Vaginal infection

Blood and

Lymphatic

System

Disorders

Agranulocytosis

Leukopenia

Neutropenia

Thrombocytopenia

Eosinophilia

Immune System

Disorders

Anaphylactoid

reaction

Drug reaction with

eosinophilia and

systemic symptom

(DRESS)

Nervous System

Disorders

Dysgeusia

Gastrointestinal

Disorders

Abdominal pain

Diarrhoea

Pseudomembranou

s colitis (see section

4.4)

Nausea

Vomiting

Oesophageal ulcer

Oesophagitis

Hepatobiliary

Disorders

Liver function test

abnormal

Jaundice

Skin and

Subcutaneous

Tissue Disorders

Rash

maculopapular

Urticaria

Toxic epidermal

necrolysis

Stevens-Johnson

syndrome

Acute generalised

exanthematous

pustulosis (AGEP)

Erythema

multiforme

Dermatitis

exfoliative

Dermatitis bullous

Rash morbilliform

Pruritis

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows

continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are

asked to report any suspected adverse reactions via the Yellow Card Scheme Website:

www.mhra.gov.uk/yellowcard

4.9 Overdose

In cases of overdosage no specific treatment is indicated.

The serum biological half-life of clindamycin is 2.4 hours. Clindamycin cannot readily be removed from

the blood by dialysis or peritoneal dialysis.

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: Lincosamides, ATC code: J01FF01

Mode of action

Clindamycin binds to the 50S subunit of the bacterial ribosome and inhibits protein synthesis.

Clindamycin has a predominately bacteriostatic action.

Mechanism of resistance

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

) type of

resistance, which may be constitutive or inducible.

PK/PD relationship

The efficacy mainly depends on the duration of time during which the agent level is above the minimum

inhibitory concentration (MIC) of the pathogen.

Breakpoints

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

Staphylococci: sensitive ≤ 0.5 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

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

Streptococcus viridans

Anaerobes

Bacteriodes fragilis group

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

General characteristics of active substance

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.

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 the fetal circulation and has been reported

to appear in 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. The half-life is 2

to 3 hours, although this may be prolonged in pre-term neonates and patients with severe renal

impairment.

Clindamycin undergoes metabolism, presumably in the liver, to the active N-demethyl and sulfoxide

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

There is no further preclinical data of relevance to the safety assessment beyond what has already been

mentioned in this summary of product characteristics.

6. Pharmaceutical particulars

6.1 List of excipients

Capsule fill:

Anhydrous Lactose

Corn starch

Talc

Magnesium stearate

Capsule cap and body:

Titanium dioxide (E171)

Gelatin

Water

Sodium lauryl sulfate

Printing ink:

Shellac

Dehydrated alcohol

Isopropyl alcohol

Butyl alcohol

Propylene glycol (E1520)

Strong ammonia solution

Black iron oxide (E172)

Potassium hydroxide

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years

6.4 Special precautions for storage

No special storage conditions.

6.5 Nature and contents of container

Clindamycin 300 mg capsules are available in blister packs (clear PVC/Aclar film / aluminium foil)

Pack sizes: 12, 15, 16, 20, 24, 30, 32, 40, 100 and 104 hard capsules.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements for disposal.

7. Marketing authorisation holder

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78

220 Hafnarfjörður

Iceland

8. Marketing authorisation number(s)

PL 30306/0677

9. Date of first authorisation/renewal of the authorisation

12/02/2016

10. Date of revision of the text

12/02/2016

Company Contact Details

Accord-UK Ltd

Address

Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK

Telephone

+44 (0)1271 385 200

Medical Information Direct Line

+44 (0)1271 385 257

www.accord-healthcare.co.uk

+44 (0)1271 346 106

Medical Information e-mail

[email

protected]

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