TRETINOINA 0.05% Krem

Treść ulotki

1. tretinoina same 0.05% cream
   1. What is Tretinoina Same and what is it used for
   2. What you need to know before using Tretinoina Same
   3. How to use Tretinoina Same
   4. Possible side effects
   5. How to store Tretinoina Same
   6. Contents of the pack and other information

___________________________________________________________________________________________

tretinoina same 0.05% cream

tretinoina

Read this leaflet carefully before you start using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Tretinoina Same is and what it is used for
• 2. What you need to know before you use Tretinoina Same
• 3. How to use Tretinoina Same
• 4. Possible side effects
• 5. How to store Tretinoina Same
• 6. Contents of the pack and other information

1. What is Tretinoina Same and what is it used for

Tretinoina Same is a cream for application to the skin containing the active ingredient tretinoin, which belongs to the
category of retinoids. Tretinoina Same is indicated for the local treatment of acne (acne vulgaris).

2. What you need to know before using Tretinoina Same

Do not use Tretinoina Same

• if you are allergic to tretinoin or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant (see section “Pregnancy and breastfeeding”).
• if you are planning a pregnancy.

Warnings and precautions
Consult your doctor or pharmacist before using Tretinoina Same.

• Absolutely avoid exposure to direct sunlight and ultraviolet lamps as they cause skin irritation. If you cannot avoid such exposure, keep the areas where you apply the medicine covered or use preparations containing high protection sunscreens.
• If you have skin irritation following sun exposure (sunburn), you should wait for it to disappear before starting or continuing treatment with this medicine. Keep this recommendation in mind if, due to your work, you are particularly exposed to the sun or if, due to hereditary predisposition, you are very sensitive to light and tend to develop skin damage as a result.
• Irradiation with X-rays, weather agents such as wind and cold, can cause an increase in irritation and redness of the skin in people treated with Tretinoina Same.
• If you suffer from an inflammatory skin reaction called eczema, you may experience severe irritation (see section 4 “Possible side effects”).
• Do not overuse this medicine, as this would determine excessive skin irritation without improving the therapeutic response to treatment.
• During treatment with Tretinoina Same, you can use cosmetics as long as the areas of skin involved are thoroughly cleaned before applying the medicine.
• Avoid contact of hair products, such as perming solutions or medicated shampoos, with the skin areas treated with this medicine, as they may cause irritation.
• Avoid waxing immediately before applying the medicine.
• Avoid contact of Tretinoina Same with the eyes, mouth, nostrils and mucous membranes as it may be irritating. If this happens, wash thoroughly with water.
• The use, especially if prolonged, of products to be applied to the skin can give rise to sensitization phenomena (allergy to one or more components) (see section 4 “Possible side effects”).

pag. 1

___________________________________________________________________________________________

Children
Use in children under 12 years of age is not recommended, as the efficacy and safety of use of the
medicine in this age group have not been established.

Other medicines and Tretinoina Same
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• If you are simultaneously using other preparations that promote skin exfoliation, such as resorcinol and salicylic acid, take particular care as serious irritant phenomena may occur. If you have used these preparations, ask your doctor or pharmacist for advice, as it is advisable to wait an appropriate interval of time before starting treatment with Tretinoina Same.
• You must exercise the same caution if you use medicated or abrasive soaps (scrubs), cosmetics with a strong dehydrating effect, products with a high alcohol content, astringents, etc.
• Unless otherwise indicated by your doctor, prolonged concomitant therapy with corticosteroids (medicines used for inflammation) is not recommended as it may promote the appearance of comedones (blackheads).
• Avoid concomitant use of photosensitizing drugs (which increase sensitivity to light) such as thiazides (medicines used to lower blood pressure), tetracyclines, fluoroquinolones, sulfonamides (medicines used for the treatment of bacterial infections) and phenothiazines (medicines used for the treatment of psychosis and depression).

Pregnancy, breastfeeding and fertility

Pregnancy

DO NOT USETretinoina Same if you are pregnant or planning a pregnancy. Your doctor can give you
more information.

Breastfeeding
If you are breastfeeding, use Tretinoina Same only if absolutely necessary and under strict medical supervision.

Driving and using machines
Tretinoina Same does not impair the ability to drive or operate machinery.

Tretinoina Samecontains cetyl alcohol, sorbic acid and butylated hydroxytoluene
Cetyl alcohol and sorbic acid (E200) may cause localized skin reactions (e.g. contact dermatitis).
Butylated hydroxytoluene (E321) may cause localized skin reactions (e.g. contact dermatitis) or irritation to the
eyes and mucous membranes.

3. How to use Tretinoina Same

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your
doctor or pharmacist.
Apply this medicine once a day, preferably in the evening, to dry skin, after having cleaned the affected areas.
Spread the cream lightly on the lesions with a cotton ball or with your fingers. After each
application, wash your hands thoroughly.
The therapeutic effect is noticeable after 2-3 weeks of treatment, but up to 6
weeks may be necessary to obtain significant results.
During the first weeks of treatment, you may experience redness at the application sites and an apparent
intensification of inflammation, due to the action of this medicine on skin lesions located
deeply and previously invisible.
If skin irritation is too intense, you should increase the time interval between applications.
However, mild irritation is necessary if you want to achieve significant results within a reasonable time.
After a few weeks of treatment, you will obtain improvements that remain by applying Tretinoina Same at
longer intervals (every 2-3 days).
For a satisfactory response, it is important to apply the medicine regularly.
Do not ingest this medicine.
Do not exceed the recommended doses.

If you use more Tretinoina Same than you should
page 2

___________________________________________________________________________________________
The use of excessive doses of the product does not improve therapeutic results but causes unpleasant skin irritation
(with redness, scaling, etc.); this irritation disappears by stopping the applications.
Accidental ingestion of Tretinoina Same causes effects similar to those observed with high oral doses of
vitamin A (itching, dry skin, joint pain, loss of appetite, etc.).
In case of accidental ingestion/intake of Tretinoina Same, immediately inform your doctor or go to the nearest
hospital.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Following the use of this medicine, the following side effects may occur:

• Irritation, even severe, of the application area (erythema). If this occurs, even after following the recommended methods of use and dosages, you should temporarily interrupt the treatment, consult your doctor and subsequently use a concentration lower than the one previously used. Irritation, even severe, may also occur if applied to skin affected by eczema (skin inflammatory reaction). If you suffer from eczema in the application area, you should use this medicine with great caution (see section “Warnings and precautions”).
• Skin lightening (decrease in skin pigmentation)
• Allergic skin reaction, very rarely

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or
pharmacist. You can also report side effects directly through the national reporting system
at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Tretinoina Same

This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the packaging after Scad. The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tretinoina Same contains
The active ingredient is tretinoin. 100 g of cream contain 0.05 g of tretinoin.
The other ingredients are: cetyl alcohol, stearic acid, isopropyl myristate, polysorbate 60, sorbitan stearate,
sorbitol 70% non-crystallizing, sorbic acid (E200), sodium edetate, butylhydroxytoluene (E321), purified water.

Description of the appearance of Tretinoina Same and contents of the pack
Tretinoina Same is a cream contained in a tube of 20 grams.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Savoma Medicinali S.p.A. - Via Baganza, 2/A - 43125 Parma

Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)
page 3