Reasons for adding or updating:

• Change to section 4.2 - Posology and method of administration
• Change to section 4.6 - Fertility, pregnancy and lactation
• Change to section 5.1 - Pharmacodynamic properties
• Change to section 5.2 - Pharmacokinetic properties
• Change to section 6.2 - Incompatibilities
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 20-May-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2:
Elderly changed to older.

Section 4.6:
Sub section lactation changed to breast-feeding.

Section 5.1
addition of pharmacotherapeutic group.

Section 5.2
Text formatted.
Addition of the following text;
Characteristics in patients
No special characteristics.  See section 4.4 "Special warnings and special precautions for use" for further information


Section 6.2
None know changed to not applicable.

Section 10.
Date replaced with approval date.

Reasons for adding or updating:

• Change to section 2 - Qualitative and quantitative composition
• Change to section 4.2 - Posology and method of administration
• Change to section 4.3 - Contraindications
• Change to section 4.4 - Special warnings and precautions for use
• Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
• Change to section 4.6 - Fertility, pregnancy and lactation
• Change to section 4.7 - Effects on ability to drive and use machines
• Change to section 4.8 - Undesirable effects
• Change to section 4.9 - Overdose
• Change to section 6.5 - Nature and contents of container
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 09-Apr-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 2:

Updated with 'exipient with know effect'

Section 4.2:

Posology added as sub section.
Older patients replaced with Elderly people.
Children replaced with Paediatric population


Section 4.3:

Text updated as below;
Clindamycin is contraindicated in patients previously found to be sensitive to Clindamycin, lincomycin, or to any excipient listed in Section 6.1 (List of excipients).Clindamycin should not be used in patients with existing diarrhoea.


Section 4.4:

Addition of following text recarding CDAD;
It is important to consider the diagnosis of CDAD in patients who present with diarrhoea 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.

Since clindamycin does not diffuse adequately into cerebrospinal fluid, the drug should not be used in the treatment of meningitis.
The use of clindamycin may result in overgrowth of non-susceptible organisms, particularly yeasts.

Section 4.5;

Addition of the following text;
Due to possible clinical significance, the two drugs should not be administered concurrently and therefore clindamycin should not be given in combination with macrolides or streptogramin antibacterial agents.


Section 4.6:

Addition of the following text;
Pregnancy
Oral and subcutaneous reproductive toxicity studies in rats and rabbits revealed no evidence of impaired fertility or harm to the foetus due to clindamycin, except at doses that caused maternal toxicity. Animal reproduction studies are not always predictive of human response. 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.

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.

Section 4.7:

Text updated as below;
Clindamycin has no or negligible influence on the ability to drive and use machines.


Section 4.8:

Side effected updated inline with the system orga class table to make it more specific aganist each organ class.

Addition of reporting of suspected adverse reactions.


Section 4.9:

Addition of the following text;
Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.

Section 6.5:

Addition of text as not all pack sizes may be marketed.

Section 10:

Date replaced with 09/04/2015

Reasons for adding or updating:

• Change to section 6.1 - List of excipients

Date of revision of text on the SPC: 12-Mar-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Printing ink excipients are changed in section 6.1.

Reasons for adding or updating:

• Change to section 2 - Qualitative and quantitative composition
• Change to section 4.4 - Special warnings and precautions for use

Date of revision of text on the SPC: 24-Sep-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



In section 2 – Lactose warning added

 In section 4.4- Additional text on lactose
Clindamycin 150mg Capsules contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.

Reasons for adding or updating:

• Change to section 3 - Pharmaceutical form
• Change to section 4.1 - Therapeutic indications
• Change to section 4.2 - Posology and method of administration
• Change to section 4.4 - Special warnings and precautions for Use
• Change to section 4.7 - Effects on Ability to Drive and Use Machines
• Change to section 5.1 - Pharmacodynamic Properties

Date of revision of text on the SPC: 10-Feb-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



As agreed and confirmed with the eMC on 26-July-2012, the summary of changes includes amendments made to the following sections within the SPC for this update only:

3 pharmaceutical form;
4.1 therapeutic indications;
4.2 posology and method of administration;
4.4 special warnings and precautions for use;
4.7 effects on ability to drive and use machines;
5.1 pharmacodynamic properties

Reasons for adding or updating:

• Change to section 4.3 - Contraindications
• Change to section 4.4 - Special warnings and precautions for Use
• Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
• Change to section 4.6 - Pregnancy and Lactation
• Change to section 4.7 - Effects on Ability to Drive and Use Machines
• Change to section 4.8 - Undesirable Effects
• Change to section 4.9 - Overdose

Date of revision of text on the SPC: 01-Dec-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update of safety sections

Reasons for adding or updating:

• New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Legal Category:POM

Black Triangle (CHM): NO