LENIRIT 0.5% Cream

Зміст інструкції

1. Lenirit 0,5% Crema
   1. What is Lenirit and what is it used for
   2. What you need to know before using Lenirit
   3. How to use Lenirit
   4. Possible side effects
   5. How to store Lenirit
   6. Package Contents and Other Information

Lenirit 0,5% Crema

Idrocortisone acetato

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

• Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse after 7 days.

Contents of this leaflet:

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

1. What is Lenirit and what is it used for

Lenirit contains the active ingredient hydrocortisone acetate, a corticosteroid with anti-
inflammatory, anti-allergic and anti-pruritic activity.
Lenirit is used in the treatment of insect bites, itching, erythema or localised burns and eczema (inflammatory skin reactions with itching).
See your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before using Lenirit

Do not use Lenirit

• if you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6);
• if you have a skin infection or disease caused by viruses, bacteria or fungi;
• on skin ulcers, wounds or skin tumours;
• on the skin of the face, in the anogenital area or on large lesions;
• to treat infectious diseases (such as syphilis), viral infectious diseases (such as herpes and chickenpox), localised skin rashes around the mouth and nose, acne, rosacea, skin reactions after vaccination, pustular psoriasis;
• in newborns and children under 2 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using Lenirit if you:

• are an elderly person (especially if you suffer from osteoporosis, high blood pressure, low levels of potassium in the blood, diabetes mellitus);
• suffer from subcutaneous atrophy (thinning of the subcutaneous tissues);
• suffer from liver or kidney failure.

The use, especially if prolonged, of topical medicines can cause irritation or allergic reactions. In such
cases stop treatment and consult your doctor.
Contact your doctor if you experience blurred vision or other visual disturbances.
Avoid contact of the cream with areas adjacent to the eyes as penetration of the medicine into the
eyes can cause glaucoma (increased internal eye pressure) and cataracts. If this happens,
rinse the affected area thoroughly with water.
Avoid prolonged use as it may cause dilation of blood vessels and thinning of the skin.
Avoid prolonged use of the cream, especially on a large area of skin, or its application on non-
intact skin as the medicine can be absorbed into the blood and cause systemic effects (which can
affect different parts of the body).
Do not cover the treated area with occlusive (non-breathable) dressings as this may also
promote absorption of the medicine into the blood, causing the appearance of undesirable effects that
occur with systemic administration (e.g. orally or intravenously) of corticosteroids. For
the same reason, avoid applying the cream to children in the nappy area.

Children
Do not use Lenirit in newborns and children under two years of age.
Particular caution is recommended when using the medicine in children due to the greater risk,
compared to adults, of systemic effects induced by corticosteroids (e.g. Cushing's syndrome).
Prolonged use of corticosteroids in children can cause growth and developmental disorders.

Other medicines and Lenirit
No interactions with other medicines are known.
However, inform your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine. Use Lenirit only on
medical advice and under medical supervision.

Lenirit contains parabens
Parabensmay cause allergic reactions (including delayed reactions).

3. How to use Lenirit

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply a thin layer of cream to the area to be treated, twice a day, rubbing gently. Do not
exceed the recommended doses.

Use in children
Do not use Lenirit in newborns and children under two years of age.
Use Lenirit with caution in children over 2 years of age and limit the duration of treatment to the shortest
possible.

If you use more Lenirit than you should
Cases of overdose with topical use of hydrocortisone at the concentration contained in
Lenirit are not known.
If you accidentally use an excessive dose of cream, wash the treated area thoroughly with running water.

If you stop using Lenirit
Do not interrupt therapy abruptly. Discontinue treatment gradually, for example by continuing
intermittently before stopping it.
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.
Below are reported the side effects reported; their frequency is not known.
During the application of the cream, you may experience acne, lesions similar to bruises due to the rupture of
capillaries under the skin surface, thinning of the skin, dry skin, increased
hair growth, skin discoloration, striae (stretch marks), dilation of capillaries that appear on the
skin as fine red or bluish streaks, dermatitis affecting the areas around the mouth and nose,
infection involving the upper part of the hair follicle (folliculitis), itching, blurred vision.
Actions that promote the absorption of the cream (e.g. an occlusive bandage) can cause
systemic-type side effects such as swelling (edema), increased blood pressure and
compromised immune system.
Prolonged use, especially on large areas, of creams containing corticosteroids can cause the development of
hypercortisolism (excessive increase of certain hormones).
Prolonged use of corticosteroids in children can cause growth and development disorders.
Application of the cream to the eyelid area has occasionally caused increased
intraocular pressure (glaucoma) or cataracts.

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 system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lenirit

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after Exp. The expiry date
refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water 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 Lenirit contains

• The active ingredient is hydrocortisone acetate. 100 g of cream contains 0.5 g of hydrocortisone acetate.
• The other ingredients are polyglycolic ester of fatty acids C-C, self-emulsifying glyceryl monostearate, squalane, cetyl palmitate, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, fragrance, purified water.

Description of the appearance of Lenirit and package contents
Lenirit is a dermatological cream of white color, available in aluminum tubes of 20 g.

Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan

Manufacturer
DOPPEL Farmaceutici S.r.l., Via Martiri delle Foibe, 1 - 29016 – Cortemaggiore (Pc)
Lachifarma S.r.l. Laboratorio Chimico Salentino, S.S. 16 Zona Industriale - 73010 Zollino (LE)