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com

APPROVED
Order of the Chairman
RSU "Committee for Medical and
Pharmaceutical Control of the
Ministry of Health of the
Republic of Kazakhstan"
dated "___" ___________ 2020
No. ____________

Instructions for medical use of the

medicinal product (Insert leaflet)

Trade name
Klenzit-S MS

International non-proprietary name No

Dosage form, dosage Gel for

external use, 30 g

Pharmacotherapeutic group
Dermatology. Anti-acne drugs. Anti-acne drugs for topical use. Anti-
infective drugs for the treatment of acne (acne). Clindamycin
combinations.
ATX code D10AF51

Indications for use

- acne

List of information required before application

Contraindications
- hypersensitivity to the active substances or to any of the excipients

- hypersensitivity to lincomycin
- regional enteritis or ulcerative colitis
- antibiotic-associated colitis
- children's age up to 12 years
- During pregnancy and breastfeeding Necessary
precautions for use The product is for local use only.

Avoid contact with eyes, lips, corners of the nose, skin near the eyes and mucous
membranes. If the gel accidentally gets on these areas, rinse them thoroughly
with warm water.
Do not apply the gel to cuts, abrasions, eczematous, sun-tanned skin or
other skin lesions.
During treatment, avoid excessive exposure to sunlight and ultraviolet
light, including lamps, due to increased skin sensitivity and increased
risk of solar erythema. Extreme weather events such as wind or cold
can cause skin irritation in patients.

Should not be used in patients with severe acne, dermatitis, seborrhea;

for the treatment of burns.
The drug contains methyl parahydroxybenzoate, which can cause
delayed-type allergic reactions. The excipient propylene glycol
monostearate may cause skin irritation. Interactions with other drugs
Since adapalene can cause local skin irritation in some patients, in order
to avoid a cumulative effect, it is not recommended to use it
simultaneously with other products that have a drying or irritating
effect (medicinal or abrasive soaps and detergents; soaps and
cosmetics that have a drying effect; perfumes containing ethanol funds,
etc.).

Incompatible with solutions containing vitamin B complex,

aminoglycosides, ampicillin, calcium gluconate and magnesium sulfate.
Shows antagonism with erythromycin.
Since the product may cause local irritation in some patients,
concomitant use of other potentially irritating topical products
increases the risk of adverse skin effects. Caution should be exercised
when using preparations containing sulfur, resorcinol or salicylic acid in
combination with the drug.

If it is necessary to use the drug with other drugs, Klenzit-S MS, gel
should be used once a day at night and other drugs should be used in
the morning.
Clindamycin may block neuromuscular transmission and should
therefore be used with caution in patients receiving other
neuromuscular agents due to possible increased effects.

Special Warnings
Clindamycin is absorbed when applied topically to the skin and in some
cases in sensitive patients can cause diarrhea, colitis (including
pseudomembranous colitis). If any of these phenomena occur, you
should immediately stop using the drug. Symptoms may also occur
within a few weeks after discontinuation of therapy.

Colitis usually presents with severe diarrhea and abdominal cramps.

Endoscopy may reveal pseudomembranous
colitis. For diagnostic purposes, a stool test for C. difficile toxins should be
performed, an analysis for C. difficile should be done.
Vancomycin may be effective in treating severe antibiotic-associated
colitis. The usual dose is 125-500 mg orally every 6 hours for 7-10 days.

Topical clindamycin should be used with caution in patients with atopic

disease.
Application in pediatrics
The safety and efficacy of adapalene and clindamycin, alone or in combination,
have not been studied in children under 12 years of age.
During pregnancy or breastfeeding
Adapalene
Animal studies with oral adapalene have shown reproductive toxicity
with high systemic exposure. Clinical experience with topical use of
adapalene during pregnancy is limited, but the few available data do
not indicate adverse effects on pregnancy or fetal health detected in
early pregnancy. Due to the limited data available, adapalene should
not be used during pregnancy. In the event of an unexpected
pregnancy, treatment should be discontinued.

Studies of the penetration of adapalene into animal or human breast

milk after skin application have not been conducted. The effect of
adapalene on the nursing child is not expected, since the systemic
effect of adapalene on a nursing woman is negligible. Adapalene can be
used during breastfeeding. To avoid contact exposure to the child, the
use of adapalene in the breast area should be avoided during
breastfeeding.
Clindamycin
Limited data on pregnancies exposed to clindamycin in the first
trimester do not indicate an adverse effect of clindamycin on pregnancy
or fetal/newborn health. Clindamycin was not teratogenic in rat and
mouse reproduction studies using subcutaneous and oral doses of
clindamycin.

It is not known whether clindamycin is excreted in breast milk after topical

application. Oral and parenteral administration of clindamycin has been
reported to result in the appearance of clindamycin in breast milk.
Because of the possible occurrence of serious adverse reactions in nursing
infants, a decision should be made as to whether to stop breastfeeding or
stop taking the drug, taking into account the importance of the drug to
the mother.
Features of the influence of the drug on ability manage
vehicle or potentially dangerous machinery Klenzit-C MS, gel does not
affect the ability of patients to drive vehicles or engage in other
potentially
hazardous activities that require increased concentration of attention
and speed of psychomotor reactions.

Recommendations for use

Dosing regimen
Klenzit-S MS should be used in adults and children over 12 years of age.
Apply a thin layer of gel to clean, dry skin, on the affected area once a
day at night.
In the first weeks of therapy, an exacerbation of acne may occur. This is due to
the action of the active substance on previously invisible lesions. Do not stop
therapy. The duration of treatment is determined by the doctor. A second course
of treatment is possible after consultation with a doctor.
Method and route of
administration For outdoor use
Measures to be taken in case of overdose Over-applying the gel will
not result in a faster or better result.

Symptoms:severe skin reactions - redness, peeling, and also burning,

diarrhea, bloody stools and colitis (including pseudomembranous).

Treatment:symptomatic, local removal of the gel.

Recommendations for seeking advice from a healthcare
professional about how to use the drug

It is necessary to seek the advice of a doctor or pharmacist to explain

how to use the drug.

Description of adverse reactions that occur with the standard use

of drugs and measures to be taken in this case

Adapalene
Often
- dryness, irritation, burning sensation of the skin, erythema
Infrequently
- contact dermatitis, skin discomfort, sunburn, itching, skin exfoliation,
increased acne
Unknown*
- skin pain, swelling of the skin; eyelid irritation, eyelid erythema, eyelid itching, eyelid edema
Clindamycin
Approximately 10% of patients are expected to experience adverse
reactions. These reactions are typical of contact dermatitis. Their
frequency may increase if an excess amount of gel is used. If irritation
occurs, use moisturizers.
Often
- dry skin, erythema, burning skin, irritation around the eyes,
exacerbation of acne, itching
Infrequently
- soreness of the skin, peeling of the skin skin
* Post-marketing surveillance data
Although no cases of severe diarrhea or pseudomembranous colitis
have been reported in clinical studies with clindamycin and only small
amounts of clindamycin are absorbed percutaneously,
pseudomembranous colitis has been very rarely reported with other
topical clindamycin products. Therefore, there is a theoretical risk of
developing pseudomembranous colitis with clindamycin.

At occurrence unwanted medicinal reactions

address to medical employee pharmaceutical
to an employee or directly to the information database on adverse
reactions (actions) to drugs, including reports of drug failure RSE on
REM "National Center for Expertise of Medicines and Medical Devices"
Committee for Medical and Pharmaceutical Control of the Ministry of
Health of the Republic of Kazakhstan http://www.ndda.kz

additional information The

composition of the medicinal product
1 g of gel contains
active substances: adapalene microspherical, 1.00 mg,
clindamycin phosphate equivalent to clindamycin, 10.00 mg
Excipients:disodium edetate, carbomer 940
(Carborol 940), propylene glycol monostearate, methyl
parahydroxybenzoate, phenoxyethanol,
poloxamer 407, sodium hydroxide, purified
water.
Description of appearance, smell, taste
Homogeneous yellowish-white gel.

Release form and packaging

30 g of the drug is placed in a tube of laminated aluminum. Each tube,
together with instructions for medical use in Kazakh and Russian, is
placed in a cardboard box.

Shelf life
2 years
Do not use after the expiration date!
Storage conditions
Store at a temperature not exceeding 25-
C. Do not freeze!
Keep out of the reach of children!

Terms of dispensing from pharmacies

Over the counter

Manufacturer information
Glenmark Pharmaceuticals Ltd
Production site address: PLOT No. E 37.39, MIDS Area, Satpur, Nasik -
422007, Maharashtra, India.
Phone: +91-1795-393200,
Fax: +91-1795-393210.
Email address:webmaster@glenmark.com

Marketing Authorization Holder Glenmark

Pharmaceuticals Ltd
Address: Glenmark House, HDO-Corporate Building, Wing-A, B.D. Savant
Marg, Chakala, Off Western Express Highway, Andheri (I), Mumbai - 400
099, India
Tel: + 0091-22-4018 9999.
Fax: + 0091-22-4018 9986.

Name, address and contact details (telephone, fax, e-mail) of the

organization on the territory of the Republic of Kazakhstan that
accepts claims (proposals) on the quality of medicines from
consumersand responsible for post-registration surveillance of
drug safety

Representation Companies GLENMARK PHARMACEUTICALS

LIMITED (GLENMARK PHARMACEUTICALS LIMITED)"
Address: Republic of Kazakhstan, 050005, Almaty, Al-Farabi Avenue, 7,
business center "Nurly Tau", block 4 A, office 12.
Tel.: + 7(727) 311 04 41,
Email address: Safety.KZ&UZ@glenmarkpharma.com