ALGESAL 10 mg/g + 100 mg/g CUTANEOUS FOAM

2. What you need to know before starting to use Algesal

Do not use Algesal

• if you are allergic to myrtecaine laurilsulfate, diethylamine salicylate (or other salicylates) or to any of the other components of this medication (listed in section 6).
• if you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding").
• in children under 7 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Algesal.

• You must interrupt treatment and consult a doctor if you experience any of the side effects described in section 4 "Possible side effects" of this package leaflet.
• Do not use this medication if you are asthmatic, as it constitutes a risk population regarding salicylate allergy.

• Do not apply to fragile skin, mucous membranes, eyes, or sensitive areas (e.g., wounds).
• Do not apply to open wounds, suppurative dermatitis, eczema, or skin infections.
• Do not apply with occlusive dressings.
• This medication may produce moderate keratosis at the application site. To avoid this, a gentle massage should be performed.
• Use exceeding the recommended dose or application with greater frequency does not improve the result.

Other medications and Algesal

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

Although no interaction between Algesal and other medications has been described to date, it is not recommended to apply other topical preparations to the same area without consulting your doctor.

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.

There is limited data on the use of the medication during pregnancy and breastfeeding. Therefore, its use is not recommended.

Driving and using machines

No effect on the ability to drive vehicles or use machines has been described.

Algesal contains cetyl alcohol and terpene derivatives

This medication may produce local skin reactions (such as contact dermatitis) because it contains cetyl alcohol.

This medication contains lavender essence with linalool, coumarin, d-limonene, citronellol, and amylcinnamaldehyde. Linalool, coumarin, d-limonene, citronellol, and amylcinnamaldehyde may cause allergic reactions. The terpene derivatives of this excipient may decrease the epileptogenic threshold and lead to neurological accidents such as convulsions in infants and children in excessive doses.

3. How to use Algesal

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.

Adults and children over 7 years of age

Apply 2 or 3 times a day to the painful/affected area, performing a gentle massage, until completely absorbed. The container should be shaken for a few seconds before use. Spray while keeping the container in a vertical position as close as possible to the painful area. Do not tilt the bottle during use.

Wash your hands after each application to avoid unintentional contact with eyes and mucous membranes. Do not bandage the application area

This medication is for cutaneous use (exclusively on the skin). Do not administer on an extensive skin surface. Use exclusively on the affected area.

Use in children

Do not use in children under 7 years of age.

Elderly patients

There are no specific recommendations for elderly patients.

Patients with renal insufficiency

There are no specific studies in patients with renal insufficiency. Its use is recommended with caution in this group of patients.

Patients with hepatic insufficiency

There are no specific studies in patients with hepatic insufficiency. Its use is recommended with caution in this group of patients.

If you use more Algesal than you should

Due to the characteristics of this cutaneous medication, the possibility of intoxication is rare.

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

If you forget to use Algesal

Do not use a double dose to make up for forgotten doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can produce side effects, although not all people experience them.

Frequency not known (cannot be estimated from available data):

• Moderate keratolysis.
• Local allergic reactions (erythematous or pruritic reactions).
• Cross-allergy to salicylates that can produce the appearance of Samter and Beers syndrome (nasal polyposis, edema).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 Algesal

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

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

Warning. Pressurized container. Protect from sunlight and avoid exposing to temperatures above 50°C. Do not puncture or burn, even after use. Contains 5% by mass of flammable components. Medications should not be thrown down the drain or into the trash. Deposit the containers and medications you no longer need in the SIGRE Point. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Contents of the packaging and additional information

Composition of Algesal

• The active ingredients are myrtecaine laurilsulfate and diethylamine salicylate. Each gram of cutaneous foam contains 10 mg of myrtecaine laurilsulfate and 100 mg of diethylamine salicylate.
• The other components (excipients) are: disodium edetate, polysorbate 60, capric/capric triglyceride, light liquid paraffin, sorbitan monooleate, cetyl alcohol, lavender essence (containing linalool, coumarin, d-limonene, citronellol, amylcinnamaldehyde, and terpene derivatives), purified water, and Propel-45 (propane + isobutane).

Appearance of the product and contents of the packaging

Algesal 10 mg/g + 100 mg/g cutaneous foam is an emulsion (oil/water) that, due to the action of the propellant gas, gives rise to the formation of a white, homogeneous, spongy, non-greasy, and washable foam, slightly perfumed, which does not irritate the skin and produces a pleasant feeling of coolness.

It is available in containers with 60 and 100 grams of cutaneous foam.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Manufacturer

Meribel Pharma Parets, S.L.U.

C/ Ramón y Cajal, 2

08150 Parets del Vallès (Barcelona)

Spain

Date of the last revision of this package leaflet:July 2022

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