LENIL 2 % Cream

Зміст інструкції

1. LENIL ANTIPRURITO 2% cream
   1. What is LENIL ANTIPRURITO and what is it used for
   2. What you need to know before using LENIL ANTIPRURITO
   3. How to use LENIL ANTIPRURITO
   4. Possible side effects

LENIL ANTIPRURITO 2% cream

Prometazina

Read this leaflet carefully before using this medicine as it contains important information for you.
Always 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 worsen after 3 - 4 days.

Contents of this leaflet:

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

1. What is LENIL ANTIPRURITO and what is it used for

This medicine contains the active ingredient promethazine, belonging to the group of medicines called
antihistamines. LENIL ANTIPRURITO works by relieving the symptoms of skin irritation (itching, redness,
burning), and is used to treat irritations caused by insect bites or excessive exposure to the sun
(sunburn).
See a doctor if you do not feel better or if you feel worse after 3 - 4 days.

2. What you need to know before using LENIL ANTIPRURITO

Do not useLENIL ANTIPRURITO

• if you are allergic to promethazine, to other substances chemically similar to promethazine or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a skin condition that manifests with inflammation (eczema);
• if you have open and weeping wounds (secreting lesions);
• if the patient is a child under 2 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using LENIL ANTIPRURITO.
If you use the product for prolonged periods or for a use other than that reported on the leaflet, you may experience
skin irritation (allergic sensitization phenomena) which worsen your condition. If this should
occur, stop treatment with this medicine and inform your doctor who will indicate an alternative
therapy.
Do not apply this medicine to healing lesions for more than 3-4 days. If you are using LENIL
ANTIPRURITO to treat sunburn (solar erythema), avoid exposing the irritated area to the sun.
Stop treatment with this medicine if you notice the appearance of small pimples (skin rashes),
irritation and burning.

Children
This medicine should not be used in children under 2 years of age.

Other medicines and LENIL ANTIPRURITO
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No interactions with other topical drugs are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be 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 this medicine only if strictly necessary and under the direct control of the doctor.

Driving and operating machinery
Lenil antiprurito does not alter or slightly alters the ability to drive vehicles or operate machinery. If you use high
doses of this medicine or apply it to large areas of the skin, absorption of the medicine may cause
drowsiness. If this should occur, avoid driving and operating machinery.

LENIL ANTIPRURITO contains para-hydroxybenzoates, propylene glycol, cetostearyl alcohol, bromophenol,
butylated hydroxyanisole and butylated hydroxytoluene:

• para-hydroxybenzoates which may cause allergic reactions (including delayed reactions);
• propylene glycol which may cause skin irritation;
• cetostearyl alcohol and bromophenol. May cause local skin reactions (e.g. contact dermatitis);
• butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) which may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use LENIL ANTIPRURITO

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.
The recommended dose is 2 - 3 applications per day.
Avoid applying the cream to very large areas or for prolonged periods, do not exceed the recommended doses.

If you use more LENIL ANTIPRURITO than you should
Cases of overdose are not known.
If you ingest/accidentally take an excessive dose of this medicine, immediately
inform your doctor or go to the nearest hospital.

If you forget to use LENIL ANTIPRURITO
Do not use a double dose to make up for a missed dose
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• allergic-type reactions;
• increased skin sensitivity to light (photosensitivity);
• drowsiness, if high doses of this medicine are applied to very large areas of skin.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects helps to provide more information on the safety of this medicine.

5How to store LENIL ANTIPRURITO
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging.
The expiry date refers to the last day of that month.
Keep this medicine in its packaging, tightly closed, protected from light.
Do not throw away any medicine in the water or in the household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.

6Contents of the pack and other information
What LENIL ANTIPRURITO contains

• The active ingredient is promethazine hydrochloride. 100 g of cream contains 2.0 g of promethazine.
• The other ingredients are: white soft paraffin, cetostearyl alcohol, ethoxylated cetostearyl alcohol, hydrogenated fatty acids, sodium lauryl sulfate, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, phenoxyethanol, propylene glycol, dimethicone, sodium dehydroacetate, isopropyl myristate, bronopol, disodium edetate, PEG-20 monostearate, BHA, BHT, hexylene glycol, citric acid monohydrate, glyceryl oleate, ascorbyl palmitate, fragrance, purified water.

Description of the appearance of LENIL ANTIPRURITO and contents of the pack
Pack containing a tube of 30 g of cream.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Zeta Farmaceutici S.p.A. - Via Mentana, 38 - 36100 Vicenza

Manufacturer
Zeta Farmaceutici S.p.A. - Via Galvani, 10 - 36066 Sandrigo (VI)