Alontan antihistamine
Italy
Table of Contents
Package leaflet: Information for the user
ALONTAN ANTISTAMINICO 2% cream
Promethazine hydrochloride
Please read this leaflet carefully before using this medicine because 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 to do.
- Keep this leaflet. You may need to read it again.
- If you want more information or advice, consult your pharmacist.
- If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice improvement or if you notice worsening of symptoms.
Contents of this leaflet:
- What ALONTAN ANTISTAMINICO is and what it is used for
- What you need to know before using ALONTAN ANTISTAMINICO
- How to use ALONTAN ANTISTAMINICO
- Possible side effects
- How to store ALONTAN ANTISTAMINICO
- Contents of the pack and other information
1. What ALONTAN ANTISTAMINICO is and what it is used for
ALONTAN ANTISTAMINICO contains the active substance Promethazine hydrochloride and belongs to the group of antihistamine medicines for topical (local) use.
ALONTAN ANTISTAMINICO is used for the local symptomatic treatment of insect bites and other localized skin irritations such as redness, burning, itching, and sun erythema.
Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms.
2. What you need to know before using ALONTAN ANTISTAMINIC
Do not use ALONTAN ANTISTAMINIC
- if you are allergic to promethazine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
- if you have a skin inflammation characterized by itching, redness, and swelling (eczema).
- if you have exuding lesions, i.e. lesions producing serum or pus.
- in children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using ALONTAN ANTISTAMINIC.
Prolonged and inappropriate use of the medicine may lead to allergic sensitization, resulting in worsening of symptoms. If this occurs, discontinue treatment and consult your doctor to establish an appropriate therapy.
Since the application of ALONTAN ANTISTAMINIC 2% cream may delay the healing process, do not use this medicine for more than 3–4 consecutive days on lesions undergoing such a process.
In case of sunburn, apply the medicine and avoid further sun exposure to the irritated skin.
If skin eruptions (appearance of red spots on the skin), irritation, or burning occur, discontinue treatment.
Children
Do not use the medicine in children under 2 years of age.
Other medicines and ALONTAN ANTISTAMINIC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other topical medications are known.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy, use this medicine only if clearly needed and under medical supervision.
Driving and using machines
If you are particularly sensitive, extensive application of the medicine over large areas of skin may cause drowsiness. Therefore, under these circumstances, the medicine may impair your ability to drive or operate machinery.
ALONTAN ANTISTAMINIC contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate, which may cause allergic reactions (including delayed-type reactions).
3. How to use ALONTAN ANTISTAMINICO
Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply the cream 2–3 times a day to the affected area.
Avoid applying it to large areas exceeding 10% of the body surface area.
Do not exceed the recommended doses.
Use the medicine only for short-term treatment.
If you use more ALONTAN ANTISTAMINICO than you should
Cases of overdose have not been reported.
In case of accidental ingestion/overdose of ALONTAN ANTISTAMINICO 2% cream, inform your doctor immediately or go to the nearest hospital.
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 everyone will experience them.
ALONTAN ANTISTAMINICO 2% cream may cause allergic reactions.
The use of promethazine has been associated with photosensitivity reactions (increased sensitivity to light).
Applying the medicine abundantly on very large areas of skin may cause drowsiness.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist.
You may also report side effects directly via the website: http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store ALONTAN ANTISTAMINICO
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 product in its original, undamaged packaging, properly stored.
Store in the original packaging to protect the medicine from light and heat.
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.
It is important to always keep the medicine information available; therefore, retain both the carton and the leaflet.
6. Package contents and other information
What ALONTAN ANTISTAMINIC contains
- The active substance is promethazine hydrochloride. 100 g of cream contain 2.25 g of promethazine hydrochloride, equivalent to 2.0 g of promethazine base.
- The other components are: liquid paraffin, stearic acid, glycerol, xalifin 15, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, white wax, purified water, thiourea.
Description of the appearance of ALONTAN ANTISTAMINIC and package contents
White, homogeneous cream in an aluminium tube with painted surface, complete with screw cap mounted on the mouth, with a sealed orifice to be pierced at the time of use.
Marketing Authorization Holder
PIETRASANTA PHARMA S.p.A. - Via S. Francesco, 67 – 55049 Viareggio (LU)
Manufacturer
Industria Farmaceutica NOVA ARGENTIA S.p.A. - Via G. Pascoli, 1 - Gorgonzola - Milano