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TRECLIN 1% / 0.025% W/W GEL

Active substance(s): CLINDAMYCIN PHOSPHATE / TRETINOIN

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Package leaflet: Information for the user 

Treclin 1 % / 0.025 % w/w gel

clindamycin 10 mg/g and tretinoin 0.25 mg/g
Read all of this leaflet carefully before you start using
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 Treclin is and what it is used for
2. What you need to know before you use Treclin
3. How to use Treclin
4. Possible side effects
5. How to store Treclin
6. Contents of the pack and other information
1. What Treclin is and what it is used for
Treclin contains the active substances clindamycin and
tretinoin.
Clindamycin is an antibiotic. It limits the growth of bacteria
associated with acne and the inflammation caused by these
bacteria.
Tretinoin normalizes the growth of superficial skin cells and
causes normal shedding of the cells that clog the hair
follicles in areas with acne. This prevents the build-up of
sebum and the formation of early acne lesions (blackheads
and whiteheads).
These active substances are more effective when combined
than when used separately.
Treclin is used on the skin to treat acne in patients 12 years
and older.
2. What you need to know before you use Treclin
DO NOT use Treclin:
• if you are allergic to clindamycin, tretinoin, or any of the
other ingredients of this medicine (listed in section 6).
• if you are allergic to lincomycin.
• if you have a chronic inflammatory bowel disease
(e.g. Crohn’s disease or ulcerative colitis).
• if you have a history of colitis with past antibiotic use
which is characterised by prolonged or significant
diarrhoea or abdominal cramps.
• if you or a member of your family have ever suffered
from skin cancer.
• if you are suffering from acute eczema which is
characterised by inflamed, red, dry and scaly skin.
• if you are suffering from rosacea, a skin disease which
affects the face and is characterised by redness, pimples
and peeling.
• if you are suffering from other acute inflammatory
conditions of the skin (e.g. folliculitis), especially around
the mouth (perioral dermatitis).
• if you are suffering from certain special forms of acne
vulgaris characterized by pustular and deep cystic nodular
acne lesions (acne conglobata and acne fulminans).
If any of the above applies to you, do not use this medicine
and talk to your doctor.
Warnings and precautions
• Avoid contact of this medicine with the mouth, eyes,
mucous membranes and with abraded or eczematous
skin. Be careful when applying to sensitive areas of skin.
In case of accidental contact with the eyes, rinse with
plenty of lukewarm water.

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• You should not use Treclin if you are pregnant, especially
during the first three months of the pregnancy. If you
are a woman of childbearing potential, you should not
use Treclin unless you are using contraception (see also
section “Pregnancy, breast-feeding and fertility”).
• If prolonged or significant diarrhoea or abdominal cramps
occur, stop using this medicine and talk to your doctor
immediately.
• If you have atopic eczema (chronic, itching inflammation
of the skin), please talk to your doctor before using this
medicine.
• Exposure to natural or artificial light (such as a sunlamp)
should be avoided. This is because this medicine may
make your skin more sensitive to sunburn and other
adverse effects of the sun.
An effective sunscreen with Sun Protection Factor (SPF)
of at least 30 and protective clothing (such as a hat)
should be used any time you are outside.
If nevertheless your face becomes sunburnt, stop
medication until your skin has healed.
• Talk to your doctor in case an acute inflammation of the
skin occurs when using this medicine.
• Treclin should not be applied at the same time as other
preparations used on the skin including cosmetics
(see also section “Other medicines and Treclin”).
Other medicines and Treclin
Please tell your doctor or pharmacist if you are taking or
have recently taken or might take any other medicines. This
includes medicines that you buy without a prescription or
herbal medicines. This is because Treclin can affect the way
some other medicines work. Also some other medicines can
affect the way Treclin works.
If you have used any preparations that contain sulphur,
salicylic acid, benzoyl peroxide or rescinol or any chemical
abrasives; you will need to wait until the effect of those have
subsided until you start using this medicine. Your doctor will
tell you when you can start using Treclin.
Do not use medicated soaps cleansers or scrubbing solutions
with strong drying effect during treatment with Treclin. You
should be careful when using the following that may have
a drying effect: abrasive soaps, soaps and cosmetics and
products with high concentrations of alcohol, astringents,
spices or lime.
You should ask your doctor for advice before using this
medicine together with other medicinal products containing
erythromycin or metronidazole, aminoglycosides, other
antibiotics or corticosteroids or if you are receiving neuromuscular blocking medicines e.g muscle relaxants used in
anaesthesia.
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.
Pregnancy, breast-feeding and fertility
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.
You should not use this medicine if you are pregnant,
especially during the first three months of the pregnancy,
or if you are breastfeeding. It is not known if Treclin may
harm your unborn baby or pass through your milk and
harm your baby.
If you are a woman of child-bearing age you should use
contraception while using this medicine and for one month
after discontinuation of treatment.
Driving and using machines
Treclin is unlikely to have an effect on the ability to drive or
operate machines.
Treclin contains methylparahydroxybenzoate, propylparahydroxybenzoate and butyl hydroxytoluene.
Methylparahydroxybenzoate (E 218) and propylparahydroxybenzoate (E 216) may cause allergic reactions (possibly
delayed).

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Butyl hydroxytoluene (E 321) may cause local skin reactions
(e.g. contact dermatitis), or irritation to the eyes and mucous
membranes.
3. How to use Treclin
Always use this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
A pea-sized amount of Treclin should be applied once daily
at bedtime.
Method of administration
Wash your face gently with mild soap and warm water and
pat your skin dry with a towel. Squeeze a pea-sized amount
of gel onto the fingertip. Dab the gel on your forehead, chin,
nose and both cheeks, and then gently spread it evenly over
your whole face.
Do not use more than the amount that has been suggested
by your doctor, or apply the product more frequently than
instructed. Too much medication may irritate the skin, and
will not give faster or better results.
Duration of treatment
To get the best results with Treclin, it is necessary to use it
properly and not stop using it as soon as your acne starts
to get better. Typically, it may take several weeks to have an
optimal effect. In some cases, it may take up to 12 weeks.
Please contact your doctor if symptoms persist for more than
12 weeks, as your doctor will need to re-evaluate your treatment.

• Application site symptoms such as irritation, swelling,
superficial skin damage, discolouration, itching, scaling
• Feeling hot, pain
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 (see details
below). By reporting side effects you can help provide more
­information on the safety of this medicine.
United Kingdom:
Yellow Card Scheme
Website: www.mhra.go.uk/yellowcard
Ireland:
HPRA Pharmacovigilance
Earlsfort Terrace
IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
5. How to store Treclin
Keep this medicine out of the sight and reach of children.
Do not store above 25 °C. Do not freeze.
Keep the tube tightly closed.
Do not use this medicine after the expiry date which is
stated on the carton and tube after “EXP”. The expiry date
refers to the last day of that month.

If you use more Treclin than you should
You will not get faster or better results by using more Treclin
than recommended. If you use too much a marked redness,
peeling, or discomfort may occur. In such cases, the face
should be gently washed with a mild soap and lukewarm
water. The use of this medicine should be stopped until all
these symptoms have gone away.

Once opened use within 3 months.

Overdose may also result in side effects from your stomach
and intenstine; including stomach pain, nausea, vomiting and
diarrhoea. In such cases, the use of this medicine should be
discontinued and your doctor should be contacted.

What Treclin contains
• The active substances are clindamycin and tretinoin.
1 g of gel contains 10 mg (1%) clindamycin (as clindamycin

phosphate) and 0.25 mg (0.025%) tretinoin.

Treclin is only for use on the skin. In case of accidental
ingestion, contact your doctor or go to the nearest hospital
casualty department immediately.

• The other ingredients are purified water, glycerol, carbomer, methyl parahydroxybenzoate (E 218), polysorbate 80,
disodium edetate, anhydrous citric acid, propyl para­
hydroxybenzoate (E 216), butyl hydroxytoluene (E 321),
trometamol.

If you forget to use Treclin
If you forget to use Treclin at bedtime, you should apply the
next dose at the usual time. You should not double the dose
to make up for the forgotten dose.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Uncommon: may affect up to 1 in 100 people
• Acne, dry skin, redness of the skin, increased sebum
production, photosensitivity reaction, itching, rash, scaly
rash, scaling of the skin, sunburn
• Application site reactions such as burning, inflamed skin,
dryness, redness of the skin
Rare: may affect up to 1 in 1,000 people
• Hypersensitivity
• Underactive thyroid gland (symptoms may include fatigue,
weakness, weight gain, dry hair, rough pale skin, hair loss,
increased sensitivity to cold).
• Headache
• Eye irritation
• Gastroenteritis (inflammation of any part of the gastrointestinal tract), nausea
• Inflamed skin, herpes simplex (cold sore), macular rash
(small, flat, red spots), skin bleeding, skin burning sensation, loss of skin pigmentation, skin irritation

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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 Treclin looks like and contents of the pack
This medicinal product is a translucent yellow gel.
This medicinal product is available in aluminium tubes
containing 30 g gel or 60 g gel.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishops Stortford
CM22 6PU
UK
Meda Health Sales Ireland Limited,
Unit 34/35, Block A,
Dunboyne Business Park,
Dunboyne, Co. Meath,
Ireland
Manufacturer:
Meda Pharma GmbH & Co. KG
Benzstrasse 1
61352 Bad Homburg
Germany
This leaflet was last revised in February 2016

56UKIE2066030-02

25.05.16 11:05

Studio Oberländer GmbH · Rubensstr.  33 · 60596 Frankfurt a. M. · Germany
Phone: +49 69 631520-85  ·  Fax: - 87  ·  E-Mail: info@studio-oberlaender.de

SPECIFICATION BOX: Leaflet
MANUFACTURER: Meda Pharma GmbH & Co. KG COLOURS USED:
PRODUCT:

Acnatac Treclin gel



30 g + 60 g

Black

MEDA-NO.: 56UKIE2066030-02
MFS-NO.:
LAETUS-CODE:
COUNTRY:

U.Kingdom/Ireland UKIE

LANGUAGE: English
PACK SIZE:

8 x 12,625 Zoll (203,2 x 320,675 mm) CORRECTION: 3.

FONT SIZE:

9,0 pt / 11,0 pt

DATE:

25. 05. 2016

Muster-Code

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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