Prospect: information for the patient

AlgesalActivated 10 mg/g + 100 mg/g ointment

mirtecaína / salicilato de dietilamina

Read this prospect thoroughly before starting to use this medication, because it contains important information for you.

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

• Keep this prospect, 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 prospect. 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 Activado is a topical cream to be applied to the skin that contains menthol (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 Activado is indicated for the local symptomatic relief of muscle, joint, and rheumatic pains such as sprains, torticollis, lumbago, and others of similar nature, in adults and children over 7 years old.

Consult a doctor if it worsens or does not improve after 7 days.

No use Algesal Activado

-If you are allergic to menthol, diethylamino salicylate (or other salicylates) or any of the other ingredients in 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 Activado.

• 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 high-risk population for salicylate allergy.

-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 will not improve the result.

Other medications and Algesal Activado

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 Activado 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 plan 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 machinery

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

Algesal Activado contains cetomacrogol, ricinoleate of glycerol and terpenic derivatives

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

This medication may cause skin reactions because it contains ricinoleate of glycerol.

This medication contains lavender oil with linalol, coumarin, d-limonene, citronellol and amylcinnamaldehyde. Linalol, coumarin, d-limonene, citronellol and amylcinnamaldehyde 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 medication administration instructions 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 to the affected area, practicing a gentle massage until complete absorption.

Wash your hands after each application to avoid accidental contact with eyes and mucous membranes.

Do not cover the application area.

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

Use in children

Do not use in children under 7 years old.

Geriatric patients

No specific dosage 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.

Patients with hepatic insufficiency

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

If you use more Algesal Activado 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Algesal Activado

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

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.

No special storage conditions are required.

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

Composition of Algesal Activated:

- The active principles are mirtcaína and diethylamino salicylate. Each gram of ointment contains 10 mg of mirtcaína and 100 mg of diethylamino salicylate.

- The other components (excipients) are: sodium sulfite, hydrochloric acid, light paraffin, ethylene glycol palmitoestearate, glycerol palmitoestearate, cetyl alcohol, polyethylene glycol 300 palmitoestearate, preglycerolized saturated triglycerides, glyceryl ricinoleate, lavender essence (contains linalol, coumarin, d-limonene, citronellol, amylcinnamaldehyde, and terpene derivatives) and purified water.

Appearance of the product and content of the container

Algesal Activated 10 mg/g + 100 mg/g ointment is a non-greasy, washable, and slightly perfumed, white, and homogeneous paste.

It is available in 60-gram ointment containers in aluminum tubes.

Holder of the marketing authorization and responsible for manufacturing

H older of the marketing authorization

Laboratorio STADA, 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

Last review date 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/