ZINDACLIN 1 % GEL

PATIENT PACKAGE INSERT IN ACCORDANCE

WITH THE PHARMACISTS’ REGULATIONS

(PREPARATIONS) - 1986

The medicine is dispensed with a doctor’s

prescription only

Zindaclin 1% Gel

Composition:

Each gram of gel contains 10 mg clindamycin (1% w/w)

equivalent to 11.88 mg clindamycin phosphate.

For a list of inactive ingredients and allergens in the

preparation - see section 6 “Further Information”.

Read the package insert carefully in its entirety

before using this medicine. This leaflet contains

concise information about the medicine. If you have

further questions, refer to the doctor or pharmacist.

This medicine has been prescribed for you. Do not

pass it on to others. It may harm them even if it seems

to you that their medical condition is similar.

The medicine is not intended for infants and children

under the age of 12.

1. WHAT IS THE MEDICINE INTENDED FOR?

The medicine is intended for the treatment of acne

vulgaris.

Therapeutic group:

Clindamycin is a lincosamide antibiotic.

2. BEFORE USING THE MEDICINE

Do not use the medicine if:

You are breastfeeding.

You are sensitive (allergic) to the active ingredient

or to any of the other ingredients contained in the

medicine.

For the list of inactive ingredients - see section 6

“Further Information”.

You are sensitive (allergic) to lincomycin - another

type of antibiotic.

Special warnings regarding use of the medicine:

Before using Zindaclin 1% Gel, tell the doctor if:

You are pregnant, think that you might be pregnant

or are trying to become pregnant.

You suffer, or have suffered in the past, from

impaired function of the digestive system (e.g.,

ulcer), inflammation of the colon.

You suffered from diarrhea while taking an

antibiotic.

You are sensitive to any food or medicine.

If you are taking, or have recently taken, other

medicines, including non-prescription medicines

and nutritional supplements, tell your doctor or

pharmacist.

Pregnancy and breastfeeding

If you are pregnant, think that you might be pregnant

or are trying to become pregnant, discuss with the

doctor before using the medicine.

Do not use the medicine when you are breastfeeding.

Clindamycin can pass into breast milk, even though

it is used only on the skin.

Important information regarding some of the

ingredients of the medicine

The preparation contains about 20% ethanol. Each

gram contains about 0.2 gram alcohol.

Do not light a cigarette or come in contact with an

open flame until the product has been completely

dried off of the skin.

3. HOW SHOULD YOU USE THE MEDICINE?

Always use according to the doctor’s instructions.

Check with the doctor or pharmacist if you are not

sure.

The dosage and treatment regimen will be determined

by the doctor only. The usual dosage in the absence of

other instructions from the doctor is generally:

Spread a thin layer of Zindaclin 1% Gel on the affected

area, once daily.

Do not exceed the recommended dose.

How to use:

Do not swallow! For external use only.

Wash, thoroughly rinse and dry the skin. Spread a

small amount of the gel in a thin layer on the whole

area where the pimples generally appear. Do not

spread locally on only the pimples themselves.

Do not spread on areas where pimples do not

generally appear.

Do not use in order to prevent the appearance of

acne.

Do not spread a thick layer of Zindaclin 1% Gel, since

this does not make the pimples disappear faster.

Do not squeeze the pimples, since this may cause

worsening of the acne and may even lead to the

development of scars.

Avoid contact with the eyes, mucous membranes

(mouth and nose). If the gel comes into contact with

these areas, wash immediately with plenty of water

It is important to replace the cap on the tube after

using Zindaclin 1% Gel.

This medicine is not intended for infants and

children under the age of 12.

Improvement will be noticed after use for 4-6 weeks.

If there is no improvement after 6 weeks or the acne

condition worsens, report to the doctor.

If you took an overdose of the medicine, wash the

skin with plenty of water. If you are worried about

this - refer to a doctor.

If a child accidentally swallowed the medicine,

immediately refer to a doctor or proceed to a hospital

emergency room and bring the package of the

medicine with you.

If you forgot to take the medicine at the required

time, do not take a double dose. Take the next dose

at the regular time and consult the doctor.

Adhere to the treatment as recommended by the

doctor.

Even if there is an improvement in your health, do not

stop treatment with the medicine without consulting

the doctor.

Do not take medicines in the dark! Check the label and

the dose each time you take medicine. Wear glasses

if you need them.

If you have further questions regarding use of the

medicine, consult the doctor or pharmacist.

4. SIDE EFFECTS

As with any medicine, use of Zindaclin 1% Gel may

cause side effects in some users. Do not be alarmed

when reading the list of side effects. You may not

suffer from any of them.

Stop use and refer to a doctor immediately if:

You suffer from diarrhea (rare).

Additional side effects

Effects appearing frequently

- dry skin

- redness of the skin

- skin burning

- irritation around the eyes

- worsening of acne

- itchy skin

Effects appearing infrequently

- sensitivity of the skin to touch

- scaly rash

You can relieve these unwanted effects by using an

oil-free moisturizing cream on the irritated area.

If one of the side effects worsens, or if you suffer

from a side effect not mentioned in the leaflet, consult

the doctor.

5. HOW SHOULD THE MEDICINE BE STORED?

Avoid poisoning! This medicine and any other

medicine must be kept in a closed place out of the

reach of children and/or infants to avoid poisoning.

Do not induce vomiting without explicit instruction

from the doctor.

Do not use the medicine after the expiry date

(exp. date) that appears on the package. The expiry

date refers to the last day of that month.

Store at a temperature below 25°C.

6. FURTHER INFORMATION

In addition to the active ingredient, the medicine

also contains:

Propylene glycol, ethanol, hydroxyethylcellulose, zinc

acetate dihydrate, sodium hydroxide, purified water.

What does the medicine look like and what are

the contents of the package - Zindaclin 1% Gel is a

white translucent gel. Zindaclin 1% Gel is packaged

in 15 gram or 30 gram sealed LDPE/HDPE tubes

with a screw cap (PP).

License holder

Taro International Ltd.,

14 Hakitor St., P.O.B. 10347, Haifa Bay 2624761.

Manufacturer

Dr. August Wolff GmbH & Co. KG Arzneimittel

Sudbrackstr. 56, 33611 Bielefeld, Germany

This leaflet was checked and approved by the Ministry

of Health in June 2013.

Registration number of the medicine in the National

Drug Registry of the Ministry of Health: 128.65.30648

The content of this leaflet has been checked and approved by the Israeli Ministry of

Health on June 2003.

Physician's Prescribing Information

Zindaclin 1% Gel

Qualitative and quantitative composition

The gel contains clindamycin phosphate equivalent to clindamycin 1% w/w.

Pharmaceutical form

A white translucent gel.

Clinical particulars

Therapeutic indications

Zindaclin 1% Gel is indicated for the treatment of mild to moderate acne vulgaris.

Dosage and method of administration

Adults and adolescents

Apply a thin film of Zindaclin 1% Gel once daily to the affected area. Patient

response should be reviewed periodically.

Children

Zindaclin 1% Gel is not indicated for use in children below the age of 12 years.

Contraindications

Zindaclin 1% Gel is contra-indicated in patients with a hypersensitivity to the active

substance clindamycin or to any of the excipients in the medicinal product. Although

cross-sensitisation to lincomycin has not been demonstrated, it is recommended that

Zindaclin 1% Gel should not be used in patients who have demonstrated lincomycin

sensitivity.

Special warnings and precautions for use

The product contains approximately 20% ethanol. Each gram contains approximately

0.2 gram alcohol.

Do not light a cigarette or come in contact with an open flame until the product has

been completely dried off.

Zindaclin 1% Gel- SPC – 01.2015

Oral and parenteral clindamycin, as well as most other antibiotics, have been

associated with severe pseudomembranous colitis. Topical clindamycin has very

rarely been associated with pseudomembranous colitis; however if diarrhea occurs the

product should be discontinued immediately.

Studies indicate a toxin(s) produced by

Clostridium difficile

is the major cause of

antibiotic-associated colitis. Colitis is usually characterized by severe persistent

diarrhea and abdominal cramps. Should antibiotic associated colitis occur, appropriate

diagnostic and therapeutics measures (Such as vancomycin treatment) should be taken

immediately. Responses may not be seen for 4-6 weeks.

Although the risk of systemic absorption following the administration of Zindaclin

1% Gel is low, the potential for the development of gastrointestinal adverse effects

should be taken into account when considering treatment in patients with previous

history of antibiotic-associated colitis, enteritis, ulcerative colitis or Crohn’s disease.

Cross resistance may occur with other antibiotics such as lincomycin and

erythromycin.

Contact with the eyes or the mucous membranes of the nose and mouth should be

avoided. In the event of accidental contact with the eyes or mucous membranes bathe

the affected area with copious amounts of cool water.

Prolonged use of clindamycin may cause resistance and/or overgrowth of non

susceptible bacteria or fungi although this is a rare occurrence.

Zindaclin 1% Gel contains propylene glycol. May cause skin irritation.

The irritation potential of Zindaclin 1% Gel may be increased if the product is used

under occlusion.

Interaction with other medicinal products and other forms of interaction

No interactions have been reported with topical clindamycin.

Pregnancy and lactation

For clindamycin applied cutaneously, no clinical data on exposed pregnancies are

available. Data on the limited number of pregnancies exposed to clindamycin

administered by other routes indicate no adverse effect on pregnancy or on the health

of the fetus/newborn child. Animal studies do not indicate direct or indirect harmful

effects with respect to pregnancy, embryonal/ fetal development, parturition or

postnatal development. Caution should be exercised when prescribing to a pregnant

woman.

Orally and parenterally administered clindamycin has been reported to appear in

breast milk. It is not known whether clindamycin is excreted in human milk following

use of Zindaclin 1% Gel. As a general rule, patients should not breast-feed while

taking a drug since many drugs are excreted in human milk. Sensitisation and

diarrhoea cannot be ruled out in nursed infants.

Zindaclin 1% Gel- SPC – 01.2015

For use during pregnancy and lactation, benefit and possible risks have to be weighed

carefully against each other.

Effects on ability to drive and use machines

None.

Undesirable effects

Approximately 10% of patients can be expected to experience an adverse reaction.

These reactions are typical of irritant dermatitis. The incidence of these is likely to

increase if an excess of gel is used. Should irritation occur, the use of moisturiser may

be of benefit.

The adverse reactions below have been reported with Zindaclin 1% Gel in clinical

trials. They are listed in decreasing order of incidence.

Organ system

Common

(>1/100, >1/10)

Uncommon

(>1/1000, <1/100)

Skin and subcutaneous

tissue disorder.

Dry skin

Erythema

Skin burning

Irritation around eyes

Acne exacerbation

Pruritis

Painful skin

Scaly rash

Whilst no case of severe diarrhoea or pseudomembranous colitis has been reported in

clinical trials with Zindaclin 1% Gel, and only a small amount of clindamycin is

absorbed percutaneously, pseudomembranous colitis has very rarely been reported

with the use of other topical clindamycin products. Therefore a theoretical risk of

pseudomembranous colitis with Zindaclin 1% Gel exists

Overdose

No cases of overdose has been reported and It is not expected that overdose would

occur in normal use.

Pharmacological properties

Pharmacotherapeutic group: Antiinfective for treatment of acne.

Pharmacodynamic properties

Zindaclin 1% Gel contains clindamycin phosphate which is hydrolyzed in the skin to

the active constituent clindamycin. Clindamycin is a lincosamide antibiotic with

primarily bacteriostataic action against Gram positive aerobes and wide range of

anaerobic bacteria.

When clindamycin phosphate is applied cutaneously, clindamycin is found in

comedone samples at sufficient levels to be active against most strains of

Zindaclin 1% Gel- SPC – 01.2015

Propionibacterium (

P. acnes

). It thus reduces the number of surface and follicular

P.

acnes,

one of the etiological factors of the disease.

As with all antibiotics, the long-term use of cutaneous clindamycin may lead to

resistance.

Pharmacokinetics properties

In Zindaclin 1% Gel, clindamycin phosphate binds with zinc to form a complex in a

formulation which result in a reduced extent of absorption. A study with Zindaclin 1%

in vitro

with human skin has shown the penetration of radiolabelled clindamycin

phosphate from the Zindaclin 1% Gel formulation to be less than 5% of the applied

dose.

When applied cutaneously at 8g/day for 5 days, ie levels well in excess of the

maximum anticipated clinical dose, a very small amount (median less than 2ng/ml) of

clindamycin was measured in the plasma.

Clindamycin phosphate is metabolised to the parent drug in the skin and clindamycin

itself is primarily metabolised in the liver via N-demethylation, sulphoxidation and

hydrolysis and predominantly excreted in the bile.

Preclinical safety data

Preclinical data for clindamycin reveal no special hazard for humans based on

conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or

toxicity to reproduction.

Pharmaceutical particulars

List of excipients

Propylene glycol, ethanol, hydroxyethylcellulose, zinc acetate dihydrate, sodium

hydroxide, purified water.

Incompatibilities

Not applicable.

Special precautions for storage

Store below 25ºC

Shelf life

24 months

Nature and content of container

Zindaclin 1% Gel- SPC – 01.2015

Zindaclin 1% Gel is packed in 15g and 30g laminate tubes with a peelable membrane

laminate seal covering the orifice. The tube is fitted with a white opaque

polypropylene cap.

Instructions for use and handling

Do not light a cigarette or come in contact with an open flame until the product has

been completely dried off.

Manufacturer

Dr August Wolff GmbH & Co.

Arzneimittel

Sudbrackstr. 56, 33611 Bielefeld, Germany

Marketing Authorisation Holder:

Taro International Ltd., 14 Hakitor St., Haifa Bay 2624761

Marketing Authorization Number:

128.65.30648

Zindaclin 1% Gel- SPC – 01.2015