Detramax 2.5 mg/g + 15 mg/g ointment
SpainTable of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Detramax 2.5 mg/g + 15 mg/g ointment
Hydrocortisone / Pramocaine hydrochloride
Read the entire leaflet carefully before you start using this medicine, as 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.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your doctor or pharmacist.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve after 5–7 days.
Contents of the leaflet
- What Detramax is and what it is used for
- What you need to know before using Detramax
- How to use Detramax
- Possible side effects
- How to store Detramax
- Contents of the pack and other information
1. What Detramax is and what it is used for
It contains as active ingredients for topical use, hydrocortisone (a corticosteroid) with anti-inflammatory action, and procaine hydrochloride, with local anesthetic effect.
Detramax is indicated for the temporary symptomatic relief of itching and pain of the skin due to minor skin irritations that respond to corticosteroids, such as allergic reactions to soaps, detergents, metals, insect bites, jellyfish, and nettles.
2. What you need to know before using Detramax
Do not use Detramax:
- If you are allergic to hydrocortisone, propanocaine, or any of the other ingredients of this medicine (listed in section 6).
- On skin infected by bacteria, fungi, or viruses (e.g. herpes or chickenpox).
- On wounds or mucous membranes (e.g. eyes, mouth, as well as anal or genital areas).
- For acne, or for treating athlete's foot.
- For the treatment of ulcers.
- For irritation or chafing caused by diapers.
- In cases of tuberculosis or syphilis affecting the skin.
- On areas of redness or reaction around a vaccine site.
- On areas affected by facial skin inflammation with redness (rosacea) or inflammation around the mouth (perioral dermatitis).
Warnings and precautions
Consult your doctor or pharmacist before starting to use Detramax.
- Detramax is intended only for external skin treatment. Do not apply any type of dressing or bandage to the treated area unless directed by your doctor.
- Corticosteroids (one of the active substances in this medicine) should not be used over large areas of the body or for prolonged periods, as this significantly increases the risk of adverse effects.
- Avoid contact with eyes and mucous membranes, and wash your hands after use.
- If you develop an allergic reaction to the medicine, stop treatment immediately.
- If you develop an infection during use of this medicine, consult your doctor regarding appropriate treatment.
- Contact your doctor if you experience blurred vision or other visual disturbances.
Children
Do not use in children under 12 years of age unless prescribed by a doctor. In such cases, note that diapers cause occlusion, which increases absorption of the medicine.
Use of Detramax with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
No interactions are known.
Pregnancy, breastfeeding and fertility
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.
As a general rule, this ointment should not be applied during the first trimester of pregnancy.
It is recommended not to use this medicine during pregnancy unless your doctor considers it necessary, having weighed the benefits against the potential risks.
Pregnant or breastfeeding women should not use Detramax over extensive skin areas, for prolonged periods, or with occlusive dressings.
Do not apply Detramax to the breasts during breastfeeding.
Driving and using machines
Treatment with this medicine does not affect the ability to drive or operate machinery.
Detramax ointment contains cetostearyl alcohol, methyl parahydroxybenzoate (E-218), and propylene glycol
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetostearyl alcohol.
It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E218).
It may also cause skin irritation because it contains propylene glycol.
3. How to use Detramax
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Cutaneous use
Apply a small amount of ointment to the affected area 1 to 3 times daily with gentle massage.
Wash hands after each application.
If symptoms persist for more than 5–7 days, depending on the indication, or if symptoms worsen, discontinue treatment and consult your doctor.
Use in children
Do not use in children under 12 years of age unless otherwise directed by a physician.
If you use more Detramax than you should
Using larger amounts than recommended of corticosteroids increases the risk of adverse effects.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to your doctor, or call the Toxicology Information Service at Telephone: 91 562 04 20, indicating the medication and the amount applied/ingested.
If you forget to use Detramax
Do not use a double dose to make up for missed doses.
If you forget to apply the ointment at the scheduled time, apply it as soon as possible and continue with the usual dosing schedule.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The adverse effects that may occur are mainly due to excessive use of the medicine or use under occlusive dressing.
An allergic reaction such as contact dermatitis may occur.
The use of corticosteroids on the skin may lead to cutaneous atrophy (thinning of the skin), telangiectasia (small visible veins on the skin), striae (stretch marks), particularly during prolonged treatment, redness, hypertrichosis (excessive hair growth), bruising, acne, delayed wound healing, rosacea (inflammation with redness of the facial skin), perioral dermatitis (inflammation around the mouth), or secondary infections such as fungal infections of the skin or mucous membranes.
Prolonged use or application over large areas may result in absorption through the skin and produce systemic effects (occurring in areas of the body other than the site of application), such as glaucoma (increased eye pressure), blurred vision – with unknown frequency (cannot be estimated from available data), or a disorder characterized by swelling of the face, neck, and obesity.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Detramax
No special storage conditions are required.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Detramax ointment
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The active substances are hydrocortisone and propoxycaine hydrochloride. Each gram contains 2.5 mg of hydrocortisone (0.25%) and 15 mg of propoxycaine hydrochloride (1.5%).
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The other components are: glycerol (E422), propylene glycol, cetostearyl alcohol, methylparaben (nipagin) (E218), ethanol and purified water.
Appearance of the medicine and contents of the pack
Detramax is a bright white, soft-textured ointment supplied in aluminium tubes.
Each tube contains 30 g.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Anotaciones Farmacéuticas S.L.
Calle D’Amposta, nº 14-18, planta 2 puerta 2B,
08174 - Sant Cugat del Vallès, Barcelona (Spain).
Manufacturer
Laboratorios Bohm, S.A.
Calle Molinaseca, 23. Polígono Industrial Cobo Calleja, Fuenlabrada,
28947 Madrid (Spain).
Date of the most recent revision of this leaflet: April 2022
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/