MEDACfN T Gel contains an antibiotic called clindamycin phosphate and comes as either a
solution or a gel. The solution and the gel are used on the skin to treat acne.

Always use MEDACfN T exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
- Before use , clean & dry the skin area, to be treated.
- Spread gel evenly on affected area.

- In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous
membranes), bathe with copious amounts of cool tap water.
- Use twice daily

Before using MEDACIN T, make sure that your doctor knows if you have diarrhoea or usually
get diarrhoea when you take antibiotics.
If you develop severe or prolonged or bloody diarrhoea during or after using MEDACIN T 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.

Please tell your doctor or pharmacist if you are using or have recently used any other
medicines. This includes medicines that can be bought without a prescription.
Tell your doctor if you are using any skin treatments that contain benzoyl peroxide. These
medicines should not be used at the same time as MEDACIN T.
If you are going to hospital for a surgical procedure, tell your doctor and/or anaesthetist if you
are taking drugs that cause paralysis of muscle (neuromuscular blocking agents).

If you are pregnant or think you might be pregnant you should contact your doctor before using
MEDACINT.
Tell your doctor if you will be breast-feeding while using MEDACIN T as the active substance
in this medicine may be passed into breast milk. Your doctor will decide if MEDACIN T is
suitable for you. Although it is not likely that a nursing infant will take in very much of the
active substance from the milk it drinks, if your baby gets bloodstained diarrhoea or shows any
signs of illness, tell your doctor at once. You should stop breast-feeding if this happens.

No effects on the ability to drive or use machines have been seen with MEDACIN T.

Like all medicines, MEDACIN T 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 an uncommon side effect which may occur
after treatment with antibiotics and can be a sign of serious bowel inflammation.
Other side effects that have been seen with MEDACIN T
Very common: may affect more than 1 in 10 people
• Skin irritation (may cause symptoms such as burning, itching, peeling), hives.
Common: may affect up to 1 in 10 people
• Oily skin
Uncommon: may affect up to 1 in 100 people
• Gastrointestinal disturbances (may cause symptoms such as diarrhoea, and nausea).

Frequency not known, but may also occur
p age 5 0 f 14
Medpharma, U .A.E
Regional Administrative
Information
Product Information
• Severe acne (also known as gram-negative folliculitis), stinging of the eye, stomach pain,
inflammation of the skin caused by contact with irritants or allergens.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

If you use too much MEDACIN T contact a doctor or your nearest Accident and Emergency
Department taking this leaflet and pack with you.

Pharmacotherapeutic group: Anti-infectives for treatment of acne, ATC Code: DAlOAFOl.
Microbiology
Clindamycin is a lincosamide antibiotic that inhibits bacterial protein synthesis. It binds to the
50S ribosomal subunit and affects both ribosome assembly and the translation process.
Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this
compound to the antibacterially active clindamycin.
Clindamycin has been shown to have in vitro activity against isolates of the following
organisms:
Anaerobic gram positive nonsporeforming bacilli, including:
• Propionibacterium acnes.
EUCAST has established susceptibility interpretive criteria for gram-negative and grampositive
anaerobes (with the exception of C.
mg/L.

In a U.S. surveillance study, clindamycin MICs were :::;4 mg/L for 97% of P. acnes isolates
tested.
In some bacterial species, cross resistance has been demonstrated in vitro among lincosamides,
macrolides, and streptogramins B.

Clinical efficacy and safety
P. acnes produces an extracellular lipase that hydrolyses sebum triglycerides to glycerol, used
by the organism as a growth substrate, and free fatty acids, which have pro-inflammatory and
comedogenic properties. A double-blind study had been conducted to examine the effect of
topical 1% clindamycin hydrochloride hydrate in a hydroalcoholic vehicle as compared to the
effect of the vehicle alone. Fourteen patients applied clindamycin or vehicle alone twice daily
for eight weeks. Free fatty acid surface lipid percentages, quantitative bacterial counts, and
clinical response were assessed every two weeks. A significant reduction (88%) in the
percentage of free fatty acids in the surface lipids was seen in the clindamycin-treated group
and not in the vehicle-treated group. Free fatty acids on the skin surface have been decreased
from approximately 14% to 2% following application of clindamycin solution in a
hydroalcoholic base to 9 patients (average age 22.3 years) with acne vulgaris. There was no
significant change in the surface micro flora. Despite the short duration of treatment, objective
clinical improvement was seen in three of nine treated patients, while none was observed in the
placebo-treated patients.

Following multiple topical applications of clindamycin phosphate at a concentration equivalent
to 1 0 mg clindamycin per mL in an isopropylA!~mfRrmf~~~;t>:I:J~Q!.l
clindamycin are present in the serum (0-3 n se is recovered
in urine as clindamycin.

Clindamycin concentrations has been demonstrated in comedones from acne patients. The
mean (±SD) concentration of clindamycin in extracted comedones after application of
clindamycin topical solution for 4 weeks was 0.60±0. 11 meg.
Older people
Clinical studies for topical clindamycin did not include sufficient numbers of subjects aged 65
and over to determine whether they respond differently from younger subjects.

Embryo fetal development studies using oral doses in rats and subcutaneous doses in rats and
rabbits, revealed no evidence of developmental toxicity except at doses that produced maternal
toxicity. In reproductive studies in rats there was no evidence of impaired fertility.
Clindamycin was not genotoxic when evaluated in the in vivo rat micronucleus test and the
Ames test.
Long-term studies in animals to evaluate carcinogenic potential have not been performed with
clindamycin.

Carbo mer
Propylene glycol
Glycerin
Disodium EDT A
Methyl paraben
Triethanolamine
Fragrance
Purified water.

None Known

Store below 25°C. Do not refregirate

MEDACIN T Gel is a off- white, smooth, translucent gel, with characteristic odour of fresh
apple available in 30 gm aluminum tube packed inside a box along with leaflet.

Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.