Dermapic 1 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Dermapic 1 mg/g gel
Dimetindene maleate
Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for administration provided in this leaflet or as directed by your doctor, pharmacist, or nurse.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 7 days.
Contents of the leaflet
- What Dermapic is and what it is used for
- What you need to know before using Dermapic
- How to use Dermapic
- Possible adverse effects
- How to store Dermapic
- Contents of the pack and other information
1. What Dermapic is and what it is used for
This medicine contains dimetindene maleate, an active substance belonging to a group of medicines called antihistamines.
Dermapic is used to relieve itching of the skin associated with skin reactions such as minor rashes, urticaria, insect and marine animal bites, mild sunburn, and minor superficial burns in adults and children from 1 month of age.
You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.
2. What you need to know before using Dermapic
Do not use Dermapic
- If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
- In newborn and premature infants.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Dermapic.
- Avoid prolonged sun exposure of the treated skin areas.
- Inform your doctor if you experience severe itching or in case of extensive skin lesions.
- Use only on intact, undamaged skin, not on wounds.
Children
In children from 1 month to 2 years of age, do not use on large areas of skin and only under medical supervision.
Other medicines and Dermapic
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, Dermapic should not be applied to large areas of skin. During breastfeeding, do not apply the medicine on the nipples.
Driving and using machines
The application of this medicine to the skin does not affect the ability to drive or operate machinery.
Dermapic contains benzalkonium chloride and propylene glycol (E-1520)
This medicine contains 0.05 mg of benzalkonium chloride per gram of gel. Benzalkonium chloride may cause skin irritation. Do not apply on mucous membranes.
Do not apply this medicine to the chest during breastfeeding, as it may pass to the baby.
This medicine contains 150 mg of propylene glycol per gram of gel.
3. How to use Dermapic
Follow exactly the instructions for administering the medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Adults and children from 1 month of age
Apply a small amount of the medicine to the affected area. This procedure may be repeated 2 to 4 times a day, if necessary.
Do not use on large areas of skin.
If symptoms worsen or do not improve after 7 days of treatment, consult your doctor.
The use of this medicine in children from 1 month up to 2 years of age must be done exclusively under medical advice.
Method of administration
This is a topical medicine. For use on intact, unbroken skin.
After applying a small amount of the medicine to the affected area, gently massage with your hand to facilitate penetration of the medicine into the skin.
If you use more Dermapic than you should
Symptoms of overdose include:
Somnolence (mainly in adults), excitability, difficulty in coordinating movements (ataxia), hallucinations, involuntary muscle contractions (tonic-clonic spasms), pupil dilation (mydriasis), dry mouth, facial flushing, urinary retention, and fever (especially in children).
In case of overdose or accidental ingestion, consult a doctor immediately or go to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The following adverse effects have been reported during the marketing period of this medicine, although their frequency cannot be precisely determined:
- Dry skin
- Skin burning sensation
- Rash and itching
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Dermapic
Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Use the medicine within 36 months after first opening the tube.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the package and other information
Composition of Dermapic
- The active substance is dimetindene maleate. Each gram of gel contains 1 mg of dimetindene maleate.
- The other components (excipients) are: benzalkonium chloride, disodium edetate (E-385), carbomer, sodium hydroxide (E-524), propylene glycol (E-1520), and purified water.
Appearance of the medicinal product and contents of the pack
A transparent, colorless, homogeneous, and fragrance-free gel.
It is available in aluminum tubes with a polyethylene cap containing 5 g, 30 g, and 50 g of gel.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)
Manufacturer
Pharmaceutical Works POLPHARMA S.A.
Medana Branch in Sieradz
10 W. Lokietka St, 98-200 Sieradz,
(Poland)
Date of the most recent revision of this leaflet: October 2018
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/