ALLEFIN 20 mg + 10 Mg Gel

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Allefin, (20 mg + 10 mg)/g, gel
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Allefin and what is it used for
   1. Indications
4. Important information before using Allefin
   1. When not to use Allefin:
   2. Warnings and precautions
   3. Children and adolescents
   4. Allefin and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Allefin contains propylene glycol
5. How to use Allefin
   1. Use in children
   2. Using more than the recommended dose of Allefin
   3. Missing a dose of Allefin
6. Possible side effects
   1. Reporting side effects
7. How to store Allefin
8. Contents of the packaging and other information
   1. What Allefin contains
   2. What Allefin looks like and what the packaging contains
   3. Marketing authorization holder and manufacturer
   4. Medicine information
   5. Date of last update of the leaflet:

Leaflet attached to the packaging: patient information

Allefin, (20 mg + 10 mg)/g, gel

Diphenhydramine hydrochloride + Lidocaine hydrochloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Allefin and what is it used for
• 2. Important information before using Allefin
• 3. How to use Allefin
• 4. Possible side effects
• 5. How to store Allefin
• 6. Contents of the packaging and other information

1. What is Allefin and what is it used for

Allefin contains two active substances: diphenhydramine hydrochloride and lidocaine hydrochloride. Diphenhydramine inhibits the action of histamine (responsible for allergic reactions) and has an antipruritic effect. Lidocaine has a local anesthetic effect. The medicine reduces redness, swelling, and skin exudate.

Indications

Allefin is indicated for use in adults, adolescents, and children over 2 years of age, for the symptomatic treatment of contact allergic and inflammatory skin changes with accompanying itching, responding to treatment with antihistamines and resulting from external factors, such as: insect bites and stings, contact with certain plants (e.g., nettle, ivy), jellyfish stings.

2. Important information before using Allefin

When not to use Allefin:

Warnings and precautions

Before starting to use Allefin, discuss it with your doctor, pharmacist, or nurse.
The medicine should be used with caution after neurological disorders and in heart muscle failure.
The skin treated with Allefin should not be exposed to sunlight.

Children and adolescents

Do not use in children under 2 years of age.

Allefin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Particularly, inform your doctor or pharmacist if you are taking:

• medicines metabolized by the CYP2D6 enzyme, e.g., metoprolol and venlafaxine (diphenhydramine inhibits the activity of the CYP2D6 enzyme, which may affect the metabolism of these medicines);
• antibacterial medicines from the sulfonamide group (lidocaine weakens their effect);
• antiarrhythmic medicines of class IB or other local anesthetics (there is a risk of summing up the adverse effects of these medicines);
• MAO inhibitor medicines (used to treat depression or Parkinson's disease);
• tricyclic antidepressant medicines;
• antipsychotic medicines from the phenothiazine derivative group;
• anticoagulant medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
Lidocaine crosses the placenta, but animal studies have not shown any harmful effects on the fetus. Due to the lack of studies confirming the safety of using the medicine during pregnancy, Allefin should be avoided during pregnancy.
Breastfeeding
Lidocaine passes into breast milk, but in very small amounts, which usually does not pose a risk to the child. However, due to the lack of studies confirming the safety of using the medicine during breastfeeding, Allefin should be avoided during breastfeeding.

Driving and using machines

Allefin has no influence or negligible influence on the ability to drive and use machines.

Allefin contains propylene glycol

The medicine contains 60 mg of propylene glycol in 1 g of gel.

3. How to use Allefin

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
Allefin is intended for topical use on the skin.
Dosage
Apply a small amount of gel to the affected area of the skin and gently spread. Use as needed, 2 or 3 times a day.

Use in children

Do not use in children under 2 years of age.

Using more than the recommended dose of Allefin

In case of use inconsistent with the recommendations, reactions related to lidocaine overdose may occur. Lidocaine may disrupt the function of the central nervous system and the cardiovascular system. Symptoms of its overdose may include dizziness and numbness around the mouth, difficulty focusing, and ringing in the ears, nausea, vomiting, decreased blood pressure.
If such symptoms occur, stop using the medicine and contact your doctor.

Missing a dose of Allefin

Do not use a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Allefin can cause side effects, although not everybody gets them.
To date, no severe side effects have been reported after topical administration of diphenhydramine and lidocaine.
Frequency not known (cannot be estimated from the available data):

• redness, allergic reaction.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181 C, 02-222 Warsaw,
tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Allefin

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Do not store in the refrigerator or freeze.
Shelf life after first opening the tube: 3 years, but no longer than the expiry date stated on the packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Allefin contains

• The active substances of Allefin are diphenhydramine hydrochloride and lidocaine hydrochloride. 1 g of gel contains 20 mg of diphenhydramine hydrochloride and 10 mg of lidocaine hydrochloride.
• The other ingredients (excipients) are: propylene glycol (E 1520), hydroxyethyl cellulose, citronella essential oil, disodium edetate, purified water.

What Allefin looks like and what the packaging contains

The medicine is a clear to cloudy gel, colorless to white, with a characteristic citronella smell.
Pack sizes: 20 g, 30 g
The packaging consists of an aluminum tube with a membrane, coated internally with an epoxy-phenolic lacquer, closed with an HDPE cap with a piercer, in a cardboard box.
Pack size: 5 g,
The packaging consists of an aluminum tube, coated internally with an epoxy-phenolic lacquer, closed with an HDPE cap, in a cardboard box.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
ul. Żmigrodzka 242 E, 51-131 Wrocław

Medicine information

tel.: 22 742 00 22
e-mail: [email protected]

Date of last update of the leaflet: