Tretinoin Same

Package leaflet: Information for the patient

tretinoina same 0.05% cream

tretinoina
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 using Tretinoina Same
3. How to use Tretinoina Same
4. Possible side effects
5. How to store Tretinoina Same
6. Package contents and other information

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

Tretinoina Same is a topical cream containing the active substance tretinoin, which belongs to the class of retinoids. Tretinoina Same is indicated for the local treatment of acne (acne vulgaris).

2. What you need to know before using Tretinoin Same

Do not use Tretinoin Same

• if you are allergic to tretinoin or to 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
Talk to your doctor or pharmacist before using Tretinoin Same.

• Avoid exposure to direct sunlight and ultraviolet lamps, as they may cause skin irritation. If you cannot avoid such exposure, keep the areas where you apply the medicine covered or use products containing high-protection sunscreens.
• If you have skin irritation due to sun exposure (sunburn), you must wait until it has completely resolved before starting or continuing treatment with this medicine. Keep this recommendation in mind if, due to your occupation, you are particularly exposed to sunlight or if, due to hereditary predisposition, you are highly sensitive to sunlight and tend to develop skin damage.
• X-ray irradiation and environmental factors such as wind and cold may increase skin irritation and redness in people treated with Tretinoin Same.
• If you suffer from a skin inflammatory condition called eczema, you may experience severe irritation (see section 4 “Possible side effects”).
• Do not overuse this medicine, as this would cause excessive skin irritation without improving the therapeutic response.
• During treatment with Tretinoin Same, you may use cosmetics, provided the affected skin areas are thoroughly cleaned before applying the medicine.
• Avoid contact of hair products such as permanent wave solutions or medicated shampoos with skin areas treated with this medicine, as they may cause irritation.
• Avoid depilation immediately before applying the medicine.
• Avoid contact of Tretinoin Same with eyes, mouth, nostrils, and mucous membranes, as it may be irritating. If this occurs, rinse thoroughly with water.
• Prolonged or excessive use of topical skin products may lead to sensitization reactions (allergy to one or more components) (see section 4 “Possible side effects”).

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Children
Use in children under 12 years of age is not recommended, as the efficacy and safety of the medicine in this age group have not been established.
Other medicines and Tretinoin Same
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• If you are simultaneously using other products that promote skin desquamation, such as resorcinol and salicylic acid, exercise particular caution, as serious irritative reactions may occur. If you have used such products, consult your doctor or pharmacist, as it is advisable to wait an appropriate interval before starting treatment with Tretinoin Same.
• Exercise the same caution if you use medicated or abrasive soaps (scrubs), cosmetics with strong drying effects, products with high alcohol content, astringents, etc.
• Unless otherwise directed by your doctor, concomitant prolonged therapy with corticosteroids (medicines used for inflammation) is not recommended, as it may promote the development of comedones (blackheads).
• Avoid concomitant use of photosensitizing medicines (which increase sensitivity to light), such as thiazides (medicines used to lower blood pressure), tetracyclines, fluoroquinolones, sulfonamides (medicines used to treat bacterial infections), and phenothiazines (medicines used to treat psychosis and depression).

Pregnancy, breastfeeding, and fertility
Pregnancy
DO NOT USE Tretinoin Same IF YOU ARE PREGNANT OR PLANNING A PREGNANCY. Your doctor can provide further information.
Breastfeeding
If you are breastfeeding, use Tretinoin Same only if clearly needed and under strict medical supervision.
Driving and using machines
Tretinoin Same does not affect the ability to drive or operate machinery.
Tretinoin Same contains cetyl alcohol, sorbic acid, and butylated hydroxytoluene (BHT)
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 Tretinoin Same

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply this medicine once daily, preferably in the evening, to dry skin, after cleansing the affected areas. Gently spread a thin layer of the cream onto the lesions using a cotton swab or your fingers. After each application, wash your hands thoroughly.
Therapeutic effects become noticeable after 2-3 weeks of treatment, but it may take up to 6 weeks to achieve significant results.
During the first weeks of treatment, you may experience redness at the application sites and an apparent worsening of inflammation. This is due to the action of the medicine on deep-seated skin lesions that were previously not visible.
If skin irritation becomes too severe, you should increase the interval between applications. However, mild irritation is necessary to achieve significant results within a reasonable timeframe.
After several weeks of treatment, improvement will be achieved, and this can be maintained by applying Tretinoin Same less frequently (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 Tretinoin Same than you should
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Using excessive amounts of the product does not improve therapeutic outcomes but causes unpleasant skin irritation (with redness, desquamation, etc.); this irritation resolves upon discontinuation of treatment.
Accidental ingestion of Tretinoin Same causes effects similar to those observed with high oral doses of vitamin A (pruritus, dry skin, joint pain, loss of appetite, etc.).
In case of accidental ingestion or swallowing of Tretinoin Same, contact your doctor immediately or go to the nearest hospital.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur after using this medicine:

• Irritation, sometimes severe, at the application site (erythema). If this occurs, even when following the recommended application methods and dosage, you should temporarily stop treatment, consult your doctor, and subsequently use a lower concentration than previously used. Severe irritation may also occur when applied to skin affected by eczema (skin inflammatory reaction). If you have eczema in the area of application, you must use this medicine with great caution (see section "Warnings and precautions").
• Skin lightening (reduction in skin pigmentation)
• Allergic skin reaction, very rare. Following the instructions provided in this leaflet reduces the risk of adverse reactions.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor or pharmacist.
You may also report adverse reactions directly via the national reporting system at the following website: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Tretinoina Same

This medicinal product does not require any special storage conditions.
Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
The expiry date refers to the product in its original, undamaged packaging, correctly stored.
Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tretinoina Same contains
The active substance is tretinoin. 100 g of cream contain 0.05 g of tretinoin.
The other components are: cetyl alcohol, stearic acid, isopropyl myristate, polysorbate 60, sorbitan stearate,
70% non-crystallizable sorbitol, sorbic acid (E200), sodium edetate, butylated hydroxytoluene (E321), purified water.
Description of the appearance of Tretinoina Same and contents of the pack
Tretinoina Same is a cream contained in a 20-gram tube.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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)