TRECLIN

Posology Adults and adolescents (≥ 12 years) Once daily at bedtime the entire face should be washed with mild soap and dried. A pea-sized amount of medication should be squeezed onto one fingertip, dot onto the chin; cheeks, nose, and forehead, then gently rub over the entire face.

Treatment with Treclin should not exceed 12 weeks of continuous use without careful evaluation. It should be noted that therapeutic improvement may not be observed for several weeks after starting treatment. In case of a missed dose of Treclin, the patient should wait for the next dose at the usual time.

Patients should not double the dose to make up for the forgotten dose. Use in Children below 12 years of age Treclin is not recommended for use in children below 12 years of age, since safety and efficacy of Treclin in children have not been established.

Use in the Elderly (>65 years of age) Safety and efficacy of Treclin in patients above the age of 65 years have not been established. Renal and hepatic impairment In view of the low systemic exposure to clindamycin and tretinoin following topical administration of Treclin, moderate renal or hepatic impairment is not expected to result in systemic exposure of clinical concern.

However, clindamycin and tretinoin serum concentrations have not been studied in patients with renal or hepatic disease following topical administration. Individual decisions are advisable in severe cases. Method of administration Treclin is indicated for external (dermatological) use only.

The application of Treclin should avoid eyes, eyelids, lips and nostrils. After the application the patient should wash hands.

Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Reported frequencies in clinical trials are as following: Immune system disorders: Rare: Hypersensitivity Endocrine disorders: Rare: Hypothyroidism Nervous system disorders: Rare: Headache Eye disorders: Rare: Eye irritation Gastrointestinal disorders: Rare: Gastroenteritis, nausea Skin and subcutaneous tissue disorders: Uncommon: Acne, dry skin, erythema, seborrhoea, photosensitivity reaction, pruritus, rash, exfoliative rash, skin exfoliation, sunburn Rare: Dermatitis, herpes simplex, macular rash, skin bleeding, skin burning sensation, skin depigmentation, skin irritation.

General disorders and administration site conditions:

Uncommon: Application site reaction, application site burning, application site dermatitis, application site dryness, application site erythema, Rare: Application site irritation, application site swelling, application site erosion, application site discolouration, application site pruritus, application site desquamation, feeling hot, pain Paediatric population The proportion of paediatric patients (12-17 years) reporting a specific drug- related adverse reaction was consistent with that which was reported in the overall population.

The incidence of dry skin in adolescent population (12-17 years) was slightly higher in clinical trials than in the overall population. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Treclin is not for oral, ophthalmic, intranasal or intravaginal use. Treclin is not recommended in treatment of mild acne vulgaris. Contact with the mouth, eyes and mucous membranes and with abraded or eczematous skin should be avoided.

Application to sensitive areas of skin should be made with caution. In the event of accidental contact with the eyes, bathe with large amounts of water. Antibiotic-associated colitis (also known as Clostridium difficile-associated colitis or CDAD) has been reported with the use of some other topical clindamycin products.

This is unlikely to occur with Treclin, as plasma levels have been determined and the percutaneous absorption of clindamycin is clinically negligible. If prolonged or significant diarrhoea occurs or the patient suffers from abdominal cramps, treatment with Treclin should be discontinued immediately, as the symptoms may indicate antibiotic-associated colitis.

Suitable diagnostic methods, such as the determination of Clostridium difficile and toxin and, if necessary, colonoscopy should be employed and treatment options for colitis considered. Use of more than the recommended amount or too frequent application may cause redness, stinging and discomfort.

If severe irritation occurs, especially in the early stage of therapy, patient should be advised to discontinue temporarily or reduce the frequency of application. Treclin should be prescribed with caution in atopic subjects. Treclin should not be applied at the same time as other topical preparations (including cosmetics) because of possible incompatibility and interaction with tretinoin.

Particular caution should be exercised in the use of keratolytic agents such as sulphur, salicylic acid, benzoyl peroxide or resorcinol and chemical abrasives. If the patient has been treated with such preparations, the effect of the peeling agents must subside before any commencement of Treclin therapy.

Some medicated cleansers and scrubbing solutions have a strong drying effect. They should not be used in patients receiving tretinoin topical therapy. Abrasive soaps, soaps and cosmetics as well as spices or lime should be used with caution.

Because of increased susceptibility to UV radiation, photosensitivity may occur during treatment with Treclin Gel. g. a hat), should be used. Use of sun lamps or sun beds should be avoided during treatment and patients with sunburn should not use this product until recovered Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution.

If sunburn occurs, discontinue therapy with Treclin until the severe erythema and peeling subside. Occasional gram-negative folliculitis has been reported during treatment with clindamycin 1% topical products. If this should occur, therapy with Treclin should be discontinued and alternative therapy should be initiated.

Long-term use of clindamycin may cause resistance and/or overgrowth of non- susceptible dermal bacteria or fungi although this is a rare occurrence. 5) Simultaneous use of oral and topical antibiotics should be avoided, particularly if chemically different.

The excipients methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly delayed). g. contact dermatitis), or irritation to the eyes and mucous membranes. The excipient polysorbate 80 (E433) can cause allergic reactions.

1)  In patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis  In patients who have a personal or familial history of skin cancer  In patients who have a history of acute eczemas, rosacea and perioral dermatitis  In patients with pustular and deep cystic nodular acne varieties (acne conglobate and acne fulminans).