Package leaflet: Information for the user

LENIL ANTIPRURITIC 2% cream

Promethazine
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If any of the side effects occur, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if you notice worsening of symptoms after 3–4 days.

Contents of this leaflet:

What LENIL ANTIPRURITIC is and what it is used for
What you need to know before using LENIL ANTIPRURITIC
How to use LENIL ANTIPRURITIC
Possible side effects
How to store LENIL ANTIPRURITIC
Contents of the pack and other information

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

This medicinal product contains the active substance promethazine, which belongs to a group of medicines called antihistamines. LENIL ANTIPRURITIC works by relieving symptoms of skin irritation (itching, redness, burning), and is used to treat irritations caused by insect bites or excessive exposure to the sun (sunburn).
Consult your doctor if you do not feel better or if you feel worse after 3–4 days.

2. What you should know before using LENIL ANTIPRURITIC

Do not use LENIL ANTIPRURITIC

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 characterized by inflammation (eczema);
if you have open, oozing wounds (exuding lesions);
if the patient is a child under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using LENIL ANTIPRURITIC.
If you use the product for prolonged periods or for a purpose different from that indicated in the leaflet, you may experience skin irritation (allergic sensitization phenomena) which could worsen your condition. If this occurs, stop treatment with this medicine and inform your doctor, who will recommend an alternative therapy.
Do not apply this medicine to healing lesions for longer than 3–4 days. If you are using LENIL ANTIPRURITIC to treat sunburn (solar erythema), avoid exposing the affected area to sunlight.
Stop treatment with this medicine if you notice the appearance of small pimples (skin eruptions), irritation, or burning.

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

Other medicines and LENIL ANTIPRURITIC
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions with other topical medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Use this medicine only if strictly necessary and under direct medical supervision.

Driving and using machines
LENIL ANTIPRURITIC does not affect or only slightly affects the ability to drive or operate machinery. However, if you use high doses of this medicine or apply it to large areas of skin, systemic absorption may cause drowsiness. If this occurs, avoid driving and operating machinery.

LENIL ANTIPRURITIC contains parahydroxybenzoates, propylene glycol, cetostearyl alcohol, bronopol,
butylated hydroxyanisole (BHA), and butylated hydroxytoluene (BHT):

parahydroxybenzoates, which may cause allergic reactions (including delayed reactions);
propylene glycol, which may cause skin irritation;
cetostearyl alcohol and bronopol, which 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 eyes and mucous membranes.

3. How to use LENIL ANTIPRURITIC

Use this medicinal product exactly as stated in this leaflet or as directed 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 large areas of skin or for prolonged periods, and do not exceed the recommended doses.
If you use more LENIL ANTIPRURITIC than you should
Cases of overdose are not known.
In case of accidental ingestion/overdose of this medicinal product, contact your doctor immediately or go to the nearest hospital.
If you forget to use LENIL ANTIPRURITIC
Do not use a double dose to make up for the missed dose.
If you have any doubts about the use of this medicinal product, 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:

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

Following the instructions contained 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. Adverse reactions may also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting adverse reactions helps provide more information on the safety of this medicine.
5 How to store LENIL ANTIPRURITIC
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of that month.
Store this medicine in its original tightly closed packaging, protected from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6 Contents of the pack and other information
What LENIL ANTIPRURITIC contains

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

Description of the appearance of LENIL ANTIPRURITIC and pack contents
Pack containing one 30 g tube 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)