MISTICK ANTIHISTAMINE

Patient Information Leaflet: Information for the User

Mistick Antihistamine 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 you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 3–4 days.

Contents of this leaflet:

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

1. What Mistick Antihistamine is and what it is used for

This medicine contains the active substance promethazine, which belongs to a group of medicines called antihistamines. Mistick Antihistamine 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 need to know before using Mistick antihistamine

Do not use Mistick antihistamine

• 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 disease characterized by inflammation (eczema);
• if you have open wounds excreting fluid (exudative lesions); if the patient is a child under 2 years of age

Warnings and precautions
Talk to your doctor or pharmacist before using Mistick antihistamine.
If you use the product for prolonged periods or for a purpose different from that indicated in this 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 on healing wounds for more than 3–4 days. If you are using Mistick antihistamine 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 rash), irritation, or burning.

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

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

Pregnancy and breastfeeding
If you are pregnant, think 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
Mistick antihistamine does not affect or only slightly affects the ability to drive vehicles or operate machinery. However, if you use high doses of this medicine or apply it over large areas of skin, absorption of the medicine may cause drowsiness. If this occurs, avoid driving and operating machinery.

MISTICK ANTISTAMINIC contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
This medicine contains parahydroxybenzoates which may cause allergic reactions (including delayed reactions).

3. How to use Mistick antihistamine

Use this medicine 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 times daily.
Avoid applying the cream to large areas or for prolonged periods, and do not exceed the recommended doses.
If you use more Mistick antihistamine than you should
Cases of overdose are not known.
If you ingest/absorb an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to use Mistick antihistamine
Do not use a double dose to make up for the missed dose.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• allergic reactions;
• increased sensitivity of the skin to light (photosensitivity);
• drowsiness, if high doses of this medicine are applied to large areas of skin. Following the instructions provided in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Mistick antihistamine

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 tightly closed original packaging, protected from light.
Do not dispose of any medicine 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 Mistick antihistamine contains

• The active substance is promethazine hydrochloride. 100 g of cream contain 2.0 g of promethazine.
• The other components are: white beeswax, liquid paraffin, stearic acid, glycerol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, triethanolamine, purified water.

Description of the appearance of Mistick antihistamine and contents of the pack
Pack containing one 30 g tube of cream.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Marco Viti Farmaceutici S.p.A. - Via Mentana, 38 - 36100 Vicenza
Manufacturer
Zeta Farmaceutici S.p.A. - Via Galvani, 10 - 36066 Sandrigo (VI)