Label: information for the patient

Algesal10 mg/g + 100 mg/g topical foam

mirtecaína laurilsulfato/salicilato de dietilamina

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

Follow exactly the administration instructions of the medication contained in this label or those indicated by your doctor or pharmacist.

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

6.Contents of the package and additional information

Algesal is a topical skin foam that contains mepivacaine lauryl sulfate (local anesthetic) and diethylamino salicylate (anti-inflammatory and analgesic). This medication belongs to the group of topical pain relievers for muscle and joint pain.

Algesal is indicated for the local symptomatic relief of muscle, joint, and rheumatic pain such as strains, torticollis, lumbago, and other similar conditions, in adults and children over 7 years old.

Consult a doctor if symptoms worsen or do not improve after 7 days.

No use Algesal

-If you are allergic to methyl salicylate, laurilsulfate, diethylamino salicylate (or other salicylates) or 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 old.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Algesal.

• You must interrupt treatment and see a doctor if you experience any of the adverse effects described in section 4 “Possible adverse effects” of this leaflet.
• Do not use this medication if you are asthmatic as it constitutes a risk population regarding allergy to salicylates.

-Do not apply on fragile skin, mucous membranes, eyes or sensitive areas (e.g. wounds).

-Do not apply on open wounds, suppurative dermatitis, eczemas or skin infections.

-Do not apply with occlusive dressings.

-This medication may cause moderate keratosis at the application site. To prevent this, you must perform a gentle massage.

-Using a dose higher than the recommended dose or applying it more frequently does not improve the result.

Other medications and Algesal

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

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

Pregnancy and breastfeeding

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

There are few data available on the use of this medication during pregnancy and breastfeeding. Therefore, its use is not recommended.

Driving and operating machines

No effects on the ability to drive vehicles and use machines have been described.

Algesal contains cetomacrogol and terpenic derivatives

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

This medication contains lavender oil with linalol, coumarin, d-limonene, citronellol and amyl cinnamaldehyde. Linalol, coumarin, d-limonene, citronellol and amyl cinnamaldehyde may cause allergic reactions. The terpenic derivatives of this excipient may decrease the epileptogenic threshold and lead to neurological accidents such as convulsions in infants and children in excessive doses.

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

Adults and children over 7 years old

Apply 2 or 3 times a day on the affected painful area, practicing a gentle massage, until complete absorption. The container should be shaken for a few seconds before use. Sprinkle 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 accidental contact with eyes and mucous membranes. Do not bandage the application area

This medication is for topical use (exclusively on the skin). Do not administer on a large skin surface. Use exclusively on the affected area.

Use in children

Do not use in children under 7 years old.

Geriatric patients

No specific recommendations are available for geriatric patients.

Patients with renal insufficiency

No specific studies are available for patients with renal insufficiency. Use with caution in this patient group is recommended.

Patients with hepatic insufficiency

No specific studies are available for patients with hepatic insufficiency. Use with caution in this patient group is recommended.

If you use more Algesal than you should

Due to the characteristics of this topical medication, the possibility of overdose is rare.

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

If you forgot to use Algesal

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

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

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

Unknown frequency (cannot be estimated with available data):

• Moderate keratolysis.
• Local allergic reactions (erythematous or pruritic reactions).
• Cross-reactivity to salicylates that may cause the appearance of the Samter and Beers syndrome (nasal polyp, edema).

Reporting 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 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 about the safety of this medication.

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.

Attention. Pressurized container. Protect from sunlight and avoid exposing it to temperatures above 50°C. Do not pierce or burn, even after use. Contains 5% by mass of flammable components. Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE Collection Point. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Algesal

-The active principles are mirtcaína laurilsulfate and salicylate of diethylamine. Each gram of skin foam contains 10 mg of mirtcaína laurilsulfate and 100 mg of salicylate of diethylamine.

-The other components (excipients) are: sodium edetate, polisorbate 60, caprylic/capric triglyceride, light liquid paraffin, monostearate of sorbitan, cetilic alcohol, lavender essence (which contains linalol, coumarin, d-limonene, citronellol, amylcinnamaldehyde and terpene derivatives), purified water and Propel-45 (propane + isobutane).

Appearance of the product and content of the packaging

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

It is available in packaging with 60 and100 gramsof skin foam.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Responsible for manufacturing

Recipharm Parets, S.L.

Santiago Ramón y Cajal, 2

08150 Parets del Vallès (Barcelona)

Spain

Date of the last review of this leaflet:July 2022

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