Package Insert: Information for the User

Detramax 2.5 mg/g + 15 mg/g Cream

Hydrocortisone / Propanocaine Hydrochloride

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

Follow exactly the administration instructions contained in this package insert or those indicated by your doctor or pharmacist..

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5-7 days.

Contains as active ingredients for topical use, hydrocortisone (a corticosteroid), with anti-inflammatory action and propanocaine hydrochloride, with local anesthetic effect.

Detramax is indicated for the temporary relief of symptomatic itching and skin pain due to small skin irritations that respond to corticosteroids, such as contact dermatitis caused by soaps, detergents, metals, insect bites, jellyfish, and nettle stings.

Do not use Detramax:

• If you are allergic to hydrocortisone, propanocaine, or any of the other components of this medication (listed in section 6).
• On infected skin, caused by bacteria, fungi, or viruses (e.g. herpes or chickenpox).
• On wounds and mucous membranes (e.g. in eyes, mouth, or in the anal or genital area).
• For acne, or for the treatment of athlete's foot.
• For the treatment of ulcers.
• For irritation or redness caused by diapers.
• In case of tuberculosis or syphilis that affects the skin.
• On an area of redness or reaction around a vaccine.
• In areas affected by inflammation with redness of the skin on the face (rosacea) or around the mouth (perioral dermatitis).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Detramax.

• Detramax should only be used for external treatment of the skin. Do not apply any type of dressing to the treated area, unless your doctor advises it.
• Corticosteroids (one of the active principles of this medication), should not be used on 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 experience an allergic reaction to the medication, discontinue treatment.
• If you develop an infection during use of this medication, consult your doctor about treatment.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children

Do not use in children under 12 years old, unless prescribed by a doctor; in this case, be aware that diapers can cause occlusion, increasing the absorption of the medication.

Use of Detramax with other medications

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

No interactions are known.

Pregnancy, breastfeeding, and fertility

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

As a general rule, do not apply the ointment during the first trimester of pregnancy.

It is recommended not to use this medication during pregnancy unless your doctor considers it necessary, weighing the benefits against the potential risk.

Pregnant or breastfeeding women should not use Detramax on extensive areas of skin or for prolonged periods, or use occlusive dressings.

Do not apply Detramax to the breasts during breastfeeding.

Driving and operating machinery

The treatment with this medication does not affect the ability to drive or operate machinery.

Detramax ointment contains cetearyl alcohol, methyl parahydroxybenzoate (E-218), and propylene glycol

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetearyl 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.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Cutaneous Use

Apply a small amount of ointment to the affected area 1 to 3 times a day with a gentle massage.

Wash your hands after each application.

If symptoms persist for more than 5-7 days, as indicated, or worsen, discontinue treatment and consult your doctor.

Use in Children

Do not use in children under 12 years old unless your doctor indicates otherwise.

If You Use More Detramax Than You Should

The use of quantities greater than those recommended of corticosteroids increases the risk of adverse effects.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, visit your doctor, or call the Toxicological Information Service Telephone: 91 562 04 20, indicating the medication and the amount applied/taken.

If You Forget to Use Detramax

Do not use a double dose to compensate for the missed doses.

If you forget to apply the ointment at the scheduled time, apply it as soon as possible and continue with the usual regimen.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The adverse effects that may occur are primarily due to excessive use of the medication or use with occlusive dressing.

An allergic reaction such as contact dermatitis may occur.

The use of corticosteroids on the skin may lead to skin atrophy (skin thinning), telangiectasia (small veins visible on the skin), striae, especially during prolonged treatments, redness, hirsutism (excessive hair growth), bruises, acne, delayed healing, rosacea (inflammation with redness of the skin on the face), perioral dermatitis (inflammation around the mouth), secondary infection such as fungal infection, on the skin or mucous membranes.

Prolonged use or use on extensive areas may cause absorption through the skin and result in a systemic effect (in areas of the body other than the application site), such as glaucoma (increased eye pressure), blurred vision – with an unknown frequency (cannot be estimated from available data) or may cause a condition characterized by facial swelling, neck swelling, and obesity.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This product does not require special storage conditions.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medication that you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medication that you no longer need. By doing so, you will help protect the environment.

Composition of Detramax ointment

• The active principles are hydrocortisone and propanocaine hydrochloride. Each gram contains 2.5 mg of hydrocortisone (0.25%) and 15 mg of propanocaine hydrochloride (1.5%).

• The other components are: glycerol (E422), propylene glycol, cetoestearic alcohol, methyl parahydroxybenzoate (nipagin) (E218), ethanol, and purified water.

Appearance of the product and contents of the packaging

Detramax is a bright white ointment with a smooth texture, presented in aluminum tubes.

Each tube contains 30 g.

Holder of the marketing authorization and responsible manufacturer

Holder

Anotaciones Farmacéuticas S.L.

Ctra. de Rubí to Sant Cugat, Km 1, nº 40-50,

08174 - Sant Cugat del Vallés. Barcelona (Spain).

Responsible manufacturer

Laboratorios Bohm, S.A.

C/ Molinaseca, 23. Industrial Estate Cobo Calleja, Fuenlabrada,

28947 Madrid (Spain).

Last review date of this leaflet: April 2022.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/