ALGESAL ACTIVATED 10 mg/g + 100 mg/g OINTMENT

Introduction

Patient Information: Summary of Product Characteristics

AlgesalActivated 10 mg/g + 100 mg/g Ointment

myrtecaine / diethylamine salicylate

Read the entire summary of product characteristics carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication exactly as stated in this summary or as indicated by your doctor or pharmacist.

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

Summary of Product Characteristics

1. What Algesal Activated is and what it is used for
2. What you need to know before using Algesal Activated
3. How to use Algesal Activated
4. Possible side effects
5. Storage of Algesal Activated

1. Contents of the pack and further information

1. What Algesal Activated is and what it is used for

Algesal Activated is an ointment for application to the skin that contains myrtecaine (local anesthetic) and diethylamine salicylate (anti-inflammatory and analgesic). This medication belongs to the group of topical medications for muscle and joint pain.

Algesal Activated is indicated for the local symptomatic relief of muscle, joint, and rheumatic pain, such as sprains, torticollis, lumbago, and others of similar nature, in adults and children over 7 years of age.

You should consult a doctor if your condition worsens or does not improve after 7 days.

2. What you need to know before using Algesal Activated

Do not use Algesal Activated

• if you are allergic to myrtecaine, diethylamine 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 of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Algesal Activated.

• You must discontinue treatment and consult a doctor if you experience any of the side effects described in section 4 "Possible side effects" of this summary.
• Do not use this medication if you have asthma, as it constitutes a risk population for 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 Activated

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

Although no interactions between Algesal Activated and other medications have 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 this medication during pregnancy and breastfeeding. Therefore, its use is not recommended.

Driving and using machines

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

Algesal Activated contains cetyl alcohol, glyceryl ricinoleate, and terpene derivatives

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

This medication may cause skin reactions because it contains glyceryl ricinoleate.

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 in 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 Activated

Follow the administration instructions for the medication exactly as stated in this summary 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.

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 intact 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 dosage recommendations for elderly patients.

Patients with renal impairment

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

Patients with hepatic impairment

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

If you use more Algesal Activated than you should

Due to the characteristics of this topical 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 Activated

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 cause side effects, although not everyone will 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 polyps, 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 summary. 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 Activated

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated 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 wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Algesal Activated:

• The active ingredients are myrtecaine and diethylamine salicylate. Each gram of ointment contains 10 mg of myrtecaine and 100 mg of diethylamine salicylate.
• The other components (excipients) are: sodium sulfite, hydrochloric acid, light paraffin, ethylene glycol palmitostearate, glycerol palmitostearate, cetyl alcohol, polyethylene glycol 300 palmitostearate, saturated preglicolized glycerides, glyceryl ricinoleate, lavender essence (contains linalool, coumarin, d-limonene, citronellol, amylcinnamaldehyde, and terpene derivatives), and purified water.

Appearance of the product and contents of the pack

Algesal Activated 10 mg/g + 100 mg/g ointment is a non-greasy, washable ointment, lightly perfumed, white in color, and homogeneous in appearance.

It is available in 60-gram tubes of aluminum.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio 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 last revision of this summary: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/