DERMAPIC 1 mg /G Gel
How to use DERMAPIC 1 mg/g GEL
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the Patient
Dermapic 1 mg/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, pharmacist, or nurse.
- 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, pharmacist, or nurse, 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 7 days.
Contents of the Package Leaflet
- What Dermapic is and what it is used for
- What you need to know before using Dermapic
- How to use Dermapic
- Possible side effects
- Storage of Dermapic
- Package Contents and Additional Information
1. What Dermapic is and what it is used for
This medication contains dimetindene maleate, an active ingredient belonging to the group of medications called antihistamines.
Dermapic is used for the relief of itching of the skin associated with skin reactions such as small skin eruptions, urticaria, insect bites and marine stings, small sunburns, and small superficial burns, in adults and children from 1 month of age.
You should consult a doctor if it 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 ingredient or any of the other components of this medication (listed in section 6).
- In newborn and premature infants.
Warnings and Precautions
Consult your doctor or pharmacist before starting to use Dermapic.
- Avoid prolonged exposure to the sun of the treated skin areas.
- Inform your doctor if you experience very intense itching or in case of extensive lesions.
- Use only on intact skin, without wounds.
Children
In children from 1 month to 2 years, do not use on extensive areas of the skin and only under medical supervision.
Other Medications and Dermapic
Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.
Pregnancy and Breastfeeding
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, Dermapic should not be applied to extensive areas of the skin. During breastfeeding, do not apply the medication to the nipples.
Driving and Using Machines
The application of this medication to the skin does not affect the ability to drive or use machines.
Dermapic contains benzalkonium chloride and propylene glycol (E-1520)
This medication contains 0.05 mg of benzalkonium chloride per gram of gel. Benzalkonium chloride may cause skin irritation. Do not apply to mucous membranes.
Do not apply this medication to the chest during breastfeeding, as it may pass to the baby.
This medication contains 150 mg of propylene glycol per gram of gel.
3. How to use Dermapic
Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.
The recommended dose is:
Adults and children from 1 month of age
Apply a small amount of the medication to the affected area. The operation can be repeated 2 to 4 times a day, if necessary.
Do not use on extensive areas of the skin.
If it worsens or does not improve after 7 days of treatment, consult your doctor.
The use of the medication in children from 1 month to 2 years of age will be done exclusively under medical advice.
Method of use
This is a topical medication. For use on intact skin, without wounds.
After applying a small amount of the medication to the area to be treated, gently massage with your hand to facilitate the penetration of the medication into the skin.
If you use more Dermapic than you should
The symptoms of overdose are:
Drowsiness (mainly in adults), excitability, difficulty 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 your doctor or go to a medical center or call the Toxicology Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.
4. Possible Side Effects
Like all medications, this medication can cause side effects, although not everyone experiences them.
During the marketing period of this medication, the following side effects have occurred, whose frequency could not be established with precision:
- Dry skin
- Burning sensation on the skin
- Rash and itching
Reporting Side Effects
If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
5. Storage of Dermapic
Keep this medication out of the sight and reach of children.
Store in the original package to protect it from light.
Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.
Use the medication within 36 months after the first opening of the tube.
Medications should not be thrown away through the sewage system or in the trash. Deposit the packages and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.
6. Package Contents and Additional Information
Composition of Dermapic
- The active ingredient 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 Product and Package Contents
Transparent, colorless, homogeneous gel without perfume.
It is presented in aluminum tubes with a polyethylene cap containing 5 g, 30 g, and 50 g of gel.
Only some package 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 Last Revision of this Package Leaflet: October 2018
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/
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- Country of registration
- Dosage formGEL, 1 mg/g
- ATC codeD04AA13
- Active substance
- Prescription requiredNo
- Manufacturer
- CompositionEDETATO DE DISODIO (0,50 mg/g mg), HIDROXIDO DE SODIO (E 524) (3,00 mg/g mg), PROPILENGLICOL (150,00 mg/g mg), BENZALCONIO, CLORURO DE (0,050 mg/g mg)
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to DERMAPIC 1 mg/g GELDosage form: GEL, 1 mg/gActive substance: dimetindeneManufacturer: Grindeks AsPrescription not requiredDosage form: GEL, 100 mg dimetindene maleateActive substance: dimetindeneManufacturer: Haleon Spain S.A.Prescription not requiredDosage form: EMULSION, 1 mgActive substance: dimetindeneManufacturer: Haleon Spain S.A.Prescription not required
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Frequently Asked Questions
Is a prescription required for DERMAPIC 1 mg/g GEL?
DERMAPIC 1 mg/g GEL does not require a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in DERMAPIC 1 mg/g GEL?
The active ingredient in DERMAPIC 1 mg/g GEL is dimetindene. This information helps identify medicines with the same composition but different brand names.
Who manufactures DERMAPIC 1 mg/g GEL?
DERMAPIC 1 mg/g GEL is manufactured by Laboratorios Normon S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of DERMAPIC 1 mg/g GEL online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether DERMAPIC 1 mg/g GEL is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
How to buy DERMAPIC 1 mg/g GEL in Spain?
Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.
You can buy DERMAPIC 1 mg/g GEL in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.
To obtain a prescription, you can use Oladoctor:
What are the alternatives to DERMAPIC 1 mg/g GEL?
Other medicines with the same active substance (dimetindene) include DIMESTIL 1mg/g GEL, FENISTIL 1 mg/g GEL, FENISTIL 1 mg/ml CUTANEOUS EMULSION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
