DIMESTIL 1mg/g GEL

Introduction

Package Leaflet: Information for the User

Dimestil 1mg/g gel

dimetindene maleate

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after three days.

Contents of the Package Leaflet

1. What Dimestil 1 mg/g gel is and what it is used for
2. What you need to know before using Dimestil 1 mg/g gel
3. How to use Dimestil 1 mg/g gel
4. Possible side effects
5. Storage of Dimestil 1 mg/g gel
6. Package Contents and Additional Information

1. What Dimestil 1 mg/g gel is and what it is used for

Dimestil contains an active ingredient that belongs to a group of medications called antihistamines, which are used to relieve skin allergies and pruritus (itching) due to various causes.

Dimestil reduces itching by stopping the action of histamine in the body. Histamine is a substance released by the body during allergic reactions. When this medication penetrates the skin, it relieves itching and irritation within a few minutes. Dimestil also has local anesthetic properties.

Dimestil is used for short-term relief of itching associated with skin reactions, such as skin rashes, urticaria, insect bites, sunburn, and superficial first-degree burns (red skin) in adults, adolescents, and children from one month of age.

Dimestil should be used under medical supervision in children between one month and two years of age.

You should consult a doctor if it worsens or does not improve after three days.

2. What you need to know before using Dimestil 1 mg/g gel

Do not use Dimestil 1mg/g gel

• If you are allergic to dimetindene maleate or any of the other components of this medication (listed in section 6). In case of doubt, consult your doctor or pharmacist.

• If you have second- or third-degree burns on the skin.
• In children under one month, especially premature babies.
• Application to large areas of skin.
• Application to damaged skin.

Warnings and Precautions

• Avoid prolonged sun exposure to areas of skin treated intensively with Dimestil 1 mg/g gel.
• Consult your doctor if you experience very intense itching or lesions in large areas of skin.
• Do not use on large areas of skin or mucous membranes.

If you have any doubts, consult your doctor or pharmacist before using this medication.

Children

In infants and young children, avoid using it on large areas of skin, especially if it is damaged or inflamed.

Do not use Dimestil in children under one month, especially in premature babies (see "Do not use Dimestil 1 mg/g gel").

Other Medications and Dimestil 1mg/g gel

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

During pregnancy and breastfeeding, Dimestil should not be applied to large areas of skin, especially if it is inflamed or damaged.

During breastfeeding, do not apply the gel to the nipples.

Driving and Using Machines

The influence of Dimestil on the ability to drive and use machines is nil or insignificant.

Dimestil 1mg/g gel contains benzalkonium chloride and propylene glycol

This medication contains 0.05 mg of benzalkonium chloride per gram of gel. Benzalkonium chloride may irritate the skin. This medication should not be applied to the breasts during breastfeeding because the baby may ingest it with breast milk. Do not apply to mucous membranes.

This medication contains 150 mg of propylene glycol per gram of gel. Propylene glycol may cause skin irritation.

Do not use this medication in babies under four weeks of age with open wounds or large areas of eroded or damaged skin (such as burns) without consulting your doctor or pharmacist first.

3. How to use Dimestil 1 mg/g gel

Follow the instructions for using the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The recommended dose is:

Apply a thin layer of Dimestil to the affected skin area with itching in adults, adolescents, and children up to three times a day.

You should consult a doctor if it worsens or does not improve after three days.

The maximum treatment duration without medical supervision is seven days.

Use in Children

In infants and young children, avoid using it on large areas of skin, especially if it is damaged or inflamed.

Do not use Dimestil in children under one month, especially in premature babies (see "Do not use Dimestil 1 mg/g gel").

Dimestil should be used under medical supervision in children between one month and two years.

How to use Dimestil 1mg/g gel

Dimestil is a topical medication. It is used on intact skin, without wounds.

Do not cover it with occlusive dressings.

Do not use it on large areas of skin, damaged skin, or mucous membranes.

Apply a small amount to the area to be treated. Then, gently massage with your hand to facilitate the penetration of the medication into the skin.

If you use more Dimestil 1mg/g than you should

Consult your doctor immediately if you or your child has used a significant amount of this medication on large areas of skin or if Dimestil has been ingested accidentally.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Dimestil 1mg/g gel

If you forget to use Dimestil, use it as soon as you remember and then continue with the usual dosage. Do not apply a double dose to make up for forgotten doses.

If you have any other doubts about using this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Uncommon (may affect less than 1 in 100 patients):

• dry skin,
• burning sensation.

Very rare (may affect less than 1 in 10,000 patients):

• allergic skin inflammation (allergic dermatitis).

Reporting Side Effects

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Dimestil 1 mg/g gel

Do not store above 25°C. Do not freeze.

Validity period after first opening: three months.

Keep out of sight and reach of children.

Do not use this medication after the expiration date shown on the box and tube, after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dimestil 1mg/g gel

• The active ingredient is dimetindene maleate. 1 g of gel contains 1 mg of dimetindene maleate.

• The other ingredients are propylene glycol, carbomers type 974P, sodium hydroxide, disodium edetate, benzalkonium chloride, and purified water.

Appearance of the Product and Package Contents

Dimestil is a colorless, transparent to slightly opalescent gel, and practically odorless.

Primary Packaging

Aluminum tube (30 g or 50 g) with a sealed aluminum protective membrane and a white HDPE (high-density polyethylene) or PP (polypropylene) screw cap with a conical tip for puncturing the membrane. The aluminum tubes have one of two possible types of interior epoxyphenolic lacquer coating (J 3092 or TU25/N 48567) that differ.

Secondary Packaging

Cardboard box with aluminum tube and package leaflet.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

AS GRINDEKS.

Krustpils iela 53, Riga, LV-1057, Latvia

Phone: +371 67083205

Fax: +371 67083505

Email: grindeks@grindeks.lv

You can request more information about this medication by contacting the local representative of the marketing authorization holder

Grindeks Kalceks España, S.L.

C/ José Abascal, 58 – 2º Dcha.

Madrid, 28003, Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Portugal Dimestil

Latvia Dimestil 1 mg/g gel

Lithuania Frest 1 mg/g gelis

Estonia Dimestil

Czech Republic Frest

Slovakia Frest 1 mg/g gel

Hungary Dimestil 1 mg/g gel

Poland Frest

Romania Frest 1 mg/g gel

Slovenia Frest 1 mg/g gel

Austria Dimestil 1 mg/g gel

Germany Dimestil 1 mg/g Gel

Bulgaria Dimestil 1 mg/g ???

Croatia Dimetindenmaleat Grindeks 1 mg/g gel

Greece Dimestil 1 mg/g gel

Italy Frest

Spain Dimestil 1 mg/g gel

Date of the last revision of this package leaflet 03/2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.