Algesal Activado 10 mg/g + 100 mg/g ointment
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package Leaflet: Information for the Patient
AlgesalActivado 10 mg/g + 100 mg/g ointment
mepivacaine / diethylamine salicylate
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve after 7 days.
Leaflet Contents
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What Algesal Activado is and what it is used for
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What you need to know before using Algesal Activado
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How to use Algesal Activado
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Possible side effects
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How to store Algesal Activado
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Contents of the pack and other information
1. What Algesal Activado is and what it is used for
Algesal Activado is a topical ointment for application on the skin, containing mirtheocaine (a local anesthetic) and diethylamine salicylate (an anti-inflammatory and analgesic). This medicine belongs to the group of topical medications for muscular and joint pain.
Algesal Activado is indicated for the local symptomatic relief of muscular, joint, and rheumatic pain, such as sprains, torticollis, lumbago, and other conditions 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 Activado
Do not use Algesal Activado
- if you are allergic to myrticaïne, diethylamine salicylate (or other salicylates), or any of the other ingredients of this medicine (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 Activado.
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You must stop treatment and see a doctor if you experience any of the adverse effects described in section 4 “Possible side effects” of this leaflet.
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Do not use this medicine if you have asthma, as asthmatics are at risk of allergy to salicylates.
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Do not apply on fragile skin, mucous membranes, eyes, or sensitive areas (e.g., wounds).
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Do not apply on open wounds, suppurative dermatitis, eczema, or skin infections.
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Do not use with occlusive dressings.
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This medicine may cause moderate keratosis at the site of application. To prevent this, gently massage the area.
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Using more than the recommended dose or applying the product more frequently does not improve effectiveness.
Other medicines and Algesal Activado
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Although no interactions between Algesal Activado and other medicines have been reported 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
There is limited data on the use of this medicine during pregnancy and breastfeeding. Therefore, its use is not recommended.
Driving and using machines
No effects on the ability to drive vehicles or operate machinery have been reported.
Algesal Activado contains cetyl alcohol, glyceryl ricinoleate, and terpene derivatives
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol.
This medicine may cause skin reactions because it contains glyceryl ricinoleate.
This medicine contains lavender essence with linalool, coumarin, d-limonene, citronellol, and amyl cinnamaldehyde. Linalool, coumarin, d-limonene, citronellol, and amyl cinnamaldehyde may cause allergic reactions. The terpene derivatives in this excipient may lower the epileptogenic threshold and lead to neurological events such as seizures in infants and children if used in excessive doses.
3. How to use Algesal Activado
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults and children over 7 years of age
Apply 2 or 3 times a day to the painful/affected area, gently massaging until completely absorbed.
Wash hands after each application to avoid accidental contact with eyes and mucous membranes.
Do not bandage the application site.
This medicine is for cutaneous use (exclusively on intact skin). Do not apply over a large surface area of the skin. Use only 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. Use with caution in this patient group.
Patients with hepatic impairment
There are no specific studies in patients with hepatic impairment. Use with caution in this patient group.
If you use more Algesal Activado than you should
Due to the characteristics of this medicine for cutaneous use, the likelihood of intoxication is rare.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Algesal Activado
Do not use a double dose to make up for missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Frequency not known (cannot be estimated from available data):
- Moderate keratolysis.
- Local allergic-type reactions (erythematous reactions or pruritus).
- Cross-allergy to salicylates, which may lead to the occurrence of Samter and Beers syndrome (nasal polyposis, edema).
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Algesal Activado
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Algesal Activado:
- The active substances are myrticaine and diethylamine salicylate. Each gram of ointment contains 10 mg of myrticaine and 100 mg of diethylamine salicylate.
- The other components (excipients) are: sodium sulfite, hydrochloric acid, light paraffin, ethylene glycol palmitostearate, glycerol palmitostearate, cetostearyl alcohol, polyethylene glycol 300 palmitostearate, saturated pregelatinized glycerides, glycerol ricinoleate, lavender essence (containing linalool, coumarin, d-limonene, citronellol, amyl cinnamaldehyde and terpene derivatives), and purified water.
Appearance of the product and contents of the pack
Algesal Activado 10 mg/g + 100 mg/g ointment is a non-greasy, washable cream-like ointment, slightly perfumed, white in color and homogeneous in appearance.
It is available in 60-gram packs of ointment in aluminum tubes.
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 the most recent revision of this leaflet: July 2022
Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/