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Microsoft word - ft_retirides_en_dll 12nov09.doc

1. Name of the medicinal product:
RETIRIDES 0.025% cream 30 g. RETIRIDES
0.05% cream 30 g. RETIRIDES 0.1% cream 30 g. 2. Qualitative and quantitative
One gram of RETIRIDES 0.025% cream contains 0.25 mg tretinoin
and excipient QS 1 g. One gram of RETIRIDES 0.05% cream contains 0.5 mg
tretinoin and excipient QS 1 g (0.5%). One gram of RETIRIDES 0.1% cream
contains 1 mg tretinoin and excipients QS 1 g (0.1%). 3. Pharmaceutical form:
Emollient cream. 4. Clinical Particulars: 4.1 Therapeutic indications: Acne:
Topical treatment for acne (also called acne vulgaris), particularly with comedones
(blackheads and whiteheads), pustules and papules. Photoageing: RETIRIDES
0.05% CREAM topical adjuvant treatment for the reduction of fine lines, mottled
hyperpigmentation and roughness of facial skin caused by secondary photoageing
of the skin from chronic sun exposure in patients who are unable to reduce these
effects through careful skin care and protecting their skin from the sun only.
RETIRIDES 0.05% CREAM is not a cosmetic and should only be used on
prescription and as part of an intensive skin care programme including teaching
patients to avoid the sun and the use of sun protection and moisturising products.
RETIRIDES has not been proven to have a therapeutic effect on the most severe
signs of solar exposure such as deep wrinkles, yellowish tint, lentigines (dark
spots), talangiectasias (dilated blood vessels), loss of skin elasticity, keratinocytic
and melanocytic atypia or dermal elastosis. 4.2 Posology and method of
Acne treatment: Depending on skin type and severity of the
condition, the cream with the appropriate concentration (RETIRIDES comes in
concentrations of 0.025%, 0.05% and 0.1%) is prescribed together with the number
of daily applications. It is recommended that treatment should begin with a lower
concentration cream applied once a day. Depending on the patient’s response to
treatment, the concentration and/or number of applications may be increased.
Correct application of the product as an acne treatment: Individuals undergoing
treatment should avoid washing their face too often, not more than twice or three
times a day, and should use a neutral soap and dry without rubbing. The cream
should not be applied until half an hour after the face is washed. Photoageing:
RETIRIDES 0.05% CREAM should be applied sparingly only once a night, lightly
covering the affected areas (face or arms). RETIRIDES 0.05% CREAM may
produce temporary itching and a sensation of heat. When RETIRIDES 0.05%
CREAM is applied, there is normally a slight temporary redness similar to light
sunburn. Applying RETIRIDES 0.05% CREAM more often or in larger amounts will
not lead to faster or improved treatment. It may cause your skin to become very
irritated, with effects such as redness, itching and peeling, among others, (see
Special warnings and precautions for use). All areas to be treated with RETIRIDES
0.05% CREAM must be clean. Use of a mild, non-medicinal soap is recommended.
Skin should be dried by patting and without rubbing. The skin should be left to dry
for at least 20-30 minutes before RETIRIDES 0.05% CREAM is applied. Washing
the treated area twice a day is enough. Length of treatment: RETIRIDES 0.05%
CREAM does not bring immediate improvement to signs of photoageing. This
occurs gradually during the course of treatment. Clinical tests show that the
appearance of visible improvements may vary. However, definite beneficial effects
are generally observed within 3-4 months of starting the treatment. The safety and
effectiveness of daily tretinoin 0.5% use have not been established for a period
exceeding 48 weeks. Once the maximum beneficial effects of using RETIRIDES
0.05% CREAM have been achieved, they can be maintained by applying the
cream between once and three times a week. If there is no maintenance of the
therapy, the beneficial effects achieved will diminish over time. RETIRIDES 0.05%
CREAM can be used with cosmetics and moisturisers during treatment. Skin
should be completely clean before RETIRIDES 0.05% CREAM is applied (see
Special warnings and precautions for use). Patients should be informed of the
importance of protecting their skin from the sun with sun screens, moisturising
products and suitable clothes. In the specific case of treatment for photoageing, the
safety and effectiveness of the daily use of RETIRIDES 0.05% CREAM for more
than 48 weeks have not been established either for prevention or treatment of
actinic keratosis or cutaneous neoplasms. Use with children: The safety and
effectiveness of using RETIRIDES 0.05% CREAM with children have not been
established. Use by persons aged 50+: The safety and effectiveness of using
RETIRIDES 0.05% CREAM with persons aged 50 years and over have not been
established. 4.3 Contraindications: Background of sensitivity/hypersensitivity
reactions to any of the ingredients. Pregnancy, family or personal history of
cutaneous epithelioma. 4.4 Special warnings and precautions for use: Local
irritation Acne: Where acne treatment is concerned, this irritation is directly linked
to the effectiveness of the product and disappears when the applications are more
spread out. During the first weeks of treatment an apparent exacerbation of the
condition is observed. This is a normal reaction. It is caused by the rapid
elimination of microcysts being formed in the deeper layers of the skin.
Photoageing: It is recommended that the treatment with RETIRIDES 0.05%
CREAM should not be started or resumed while there is skin irritation (for example
redness, flaking, itching and sunburn). If the degree of local irritation persists,
patients should be advised to apply the cream less frequently or to stop the
treatment temporarily. The use of RETIRIDES 0.05% CREAM by some individuals
(for example patients with eczema, sunburn, etc.) could cause severe local
redness, swelling, itching, feeling of burning, stinging, blisters, scabs and/or flaking
in the area where the cream is applied. Tretinoin has been reported to cause
serious irritation in skin suffering from eczema and should be used with the
greatest precaution by patients with this condition. Patients suffering from
persistent or severe irritation should discontinue treatment with RETIRIDES 0.05%
CREAM and see their doctor if necessary (see Posology and method of
administration). For both acne and photoageing treatments, care should be taken
with the use of other local irritant treatments, particularly those with an abrasive,
drying or peeling effect (see Interaction with other medicinal products and other
forms of interaction). Extreme climatic conditions such as cold wind and low
humidity may also irritate skin treated with RETIRIDES 0.05% CREAM and may
increase dryness (see Exposure to sunlight). Exposure to sunlight: Exposure to
sunlight, including ultraviolet sunlamps (UVB) should be avoided or reduced during
tretinoin use. Patients with sunburn should be advised not to use the product until
they are fully recovered owing to the potentially severe irritation that could be
produced on sensitive skin. Patients experiencing considerable occupational sun
exposure and/or persons inherently sensitive to sunlight should take special
precautions. When exposure to sun cannot be avoided, the use of products with
sun screens and protective clothing is recommended for the treated areas. General
precautions for use: RETIRIDES 0.05% CREAM must be used under medical
supervision, as part of a comprehensive skin care programme, including teaching
patients about the benefits of avoiding sun exposure and general skin care by
using sun screens, moisturisers and protective clothing. Care should be taken to
avoid contact with eyes, eyelids, corners of the nose, mouth, mucus membranes
and other areas where this treatment is not indicated in order to minimise further
skin irritation. Care should be taken not to allow build ups of cream to occur in skin
folds. In areas of more sensitive skin, such as the neck and forearm, there is a
greater risk of irritation. It is therefore recommended that the frequency of
application should be reduced. The effectiveness of RETIRIDES 0.05% CREAM
has not been established in persons over 50 years of age or in persons with
moderately or heavily pigmented skin. In the specific case of treatment for
photoageing, the safety and effectiveness of the daily use of RETIRIDES 0.05%
CREAM for more than 48 weeks has not been established either for prevention or
treatment of actinic keratosis or cutaneous neoplasms. All areas to be treated with
RETIRIDES 0.05% CREAM must be clean. Use of a mild, non-medicinal soap is
recommended. Skin should be dried by patting and without rubbing. The skin
should be left to dry for at least 20-30 minutes before RETIRIDES 0.05% CREAM
is applied. It is more than enough to wash the treated area twice a day. 4.5
Interaction with other medicaments and other forms of interaction:
RETIRIDES 0.05% CREAM should be used with care in the presence of:
concomitant topical medicinal products; personal hygiene products with an
abrasive, drying or peeling effect, including soaps, shampoos, cosmetics and
astringents (particularly those containing alcohol, whitening agents or perfumes),
medicinal soaps and shampoos, perm fluid, electrolysis, hair removal creams and
waxes and preparations and products that can dry the skin, unless treatment is
made under medical supervision. RETIRIDES 0.05% CREAM should not be
applied when drugs producing light sensitivity are being taken (such as Thiazides,
Tetracyclines, Fluoroquinolones, Phenothiazides and Sulphonamides) owing to the
risk of increased toxicity. 4.6 Pregnancy and lactation: In clinical trials with 0.05%
tretinoin in emollient cream, the human topical dose based on an adult weighing 50
kg applying a maximum volume of 500 mg of 0.05% cream was 0.005 mg/kg. In
studies on reproduction in animals, oral tretinoin is known to be teratogenic and
has shown to be foetotoxic in rats when administered in doses 500 times higher
than the human topical dose. In studies on reproduction in rats and rabbits, topical
tretinoin used at doses 1000 times higher than the human topical dose caused
minor skeletal deformities, for example irregularly curved bones and partially
ossified cranial bones. “Tretinoin 0.05% should not be used by pregnant women,
women wishing to become pregnant and women with high risk of becoming
pregnant.” Although it has not been demonstrated that tretinoin for topical use has
teratogenic effects, use is not recommended for pregnant women, particularly
during the first three months. It is not known if tretinoin is excreted in human breast
milk. Therefore, it should only be administered to breastfeeding women where the
therapeutic benefits justify possible risks. 4.7 Effects on ability to drive and use
RETIRIDES 0.05% CREAM is administered via the skin. Its effect on
the ability to drive or use machines is unknown. 4.8 Undesirable effects: The
most commonly reported local reactions during therapy are: skin dryness and
flaking, stinging, itching, burning sensation, severe local redness, oedema, blisters,
eschars, pruritus, and temporary hypo and hyperpigmentation. These cutaneous
reactions were generally slight to moderate and generally well-tolerated. They
normally occurred at the start of therapy, except for skin dryness and flaking, which
persisted throughout the treatment, and generally diminished during treatment (see
Local irritation). Clinical studies with tretinoin 0.05% did not show incidences of
genuine allergic sensitivity to contact. Increased sensitivity to sunlight and other
sources of UVB light has been observed. 4.9. Overdose: Excess application of
RETIRIDES 0.05% CREAM does not improve the results of treatment and may
cause marked irritation, for example redness, flaking and pruritus. RETIRIDES
0.05% CREAM taken orally may lead to similar effects to those associated with
excessive vitamin A intake (for example pruritus, skin dryness, arthralgia, anorexia,
and vomiting). 5. Pharmacological properties: (See complete technical
specifications). 6. Pharmaceutical particulars: 6.1 List of excipients: De-ionised
water, lactic acid, cetyl alcohol, decyl oleate, isopropyl myristate, non-self-
emulsifying glycerol monostearate, sodium chloride 20% concentration, acetylated
lanolin alcohol, perfume vertalina 72, ceteareth-30, proline, PEG-400
monostearate, urea, collagen, sodium citrate, methylparaben, propylparaben,
vitamin E. 6.2 Incompatibilities: None stated. 6.3 Shelf life: 3 years. 6.4 Special
precautions for storage:
No special storage conditions are required. Close the
container well after use. 6.5 Nature and contents of container: Aluminium tubes
covered in a latex band and enamelled with modified polyester resins. The caps
are made from polypropylene. The container holds 30 g of product. 6.6
Instructions for use/handling:
None stated. 6.7 Administrative data:
LABORATORIOS OTC IBÉRICA S.A. C/Monturiol, 2 Pol. Ind. Sur - 08754 EL


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