Algesal 10 mg/g + 100 mg/g cutaneous foam
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Algesal 10 mg/g + 100 mg/g cutaneous foam
myrtocaine lauryl sulfate/diethylamine salicylate
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or as indicated by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 7 days.
Leaflet contents:
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What Algesal is and what it is used for
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What you need to know before using Algesal
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How to use Algesal
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Possible adverse effects
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Storage of Algesal
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Contents of the container and additional information
1. What Algesal is and what it is used for
Algesal is a topical foam for application to the skin, containing myrtecaine lauryl sulfate (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 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
Do not use Algesal
- if you are allergic to myrticaïne lauryl sulfate, diethylamine salicylate (or other salicylates), or any of the other components 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.
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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 asthmatic patients 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 application site. To prevent this, gently massage the area.
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Using more than the recommended dose or applying it more frequently does not improve efficacy.
Other medicines and Algesal
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Although no interactions between Algesal 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 available 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 or operate machinery have been reported.
Algesal contains cetyl alcohol and terpene derivatives
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol.
This medicine 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 lower the epileptogenic threshold and lead to neurological events such as seizures in infants and children when used in excessive doses.
3. How to use Algesal
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. In case of 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. Shake the container for a few seconds before use. Spray while holding the container in an upright position, as close as possible to the painful area. Do not tilt the bottle during use.
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 (on the skin only). Do not apply over a large surface area of 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 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 than you should
Due to the characteristics of this topical medicine, the possibility 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
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 produce adverse effects, although not everyone experiences 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 can also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Algesal
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 refers to the last day of the month indicated.
Caution. Pressurised container. Protect from sunlight and avoid exposure to temperatures above 50°C. Do not pierce or burn, even after use. Contains 5% by mass of flammable components. Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at a SIGRE collection point. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the container and additional information
Composition of Algesal
- The active substances are myrethecaine lauryl sulfate and diethylamine salicylate. Each gram of cutaneous foam contains 10 mg of myrethecaine lauryl sulfate and 100 mg of diethylamine salicylate.
- The other components (excipients) are: disodium edetate, polysorbate 60, caprylic/capric triglyceride, light liquid paraffin, sorbitan monostearate, cetyl alcohol, lavender essence (containing linalool, coumarin, d-limonene, citronellol, amylcinnamaldehyde and terpene derivatives), purified water, and Propel-45 (propane + isobutane).
Product appearance and contents of the container
Algesal 10 mg/g + 100 mg/g cutaneous foam is an emulsion (oil/water) which, under the action of the propellant gas, forms a white, homogeneous, spongy, non-greasy, washable foam with a mild fragrance. It does not irritate the skin and produces a pleasant cooling sensation.
It is available in containers containing 60 and 100 grams of cutaneous foam.
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. Ramón y Cajal, 2
08150 Parets del Vallès (Barcelona)
Spain
Date of the most recent review of this leaflet: July 2022
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.es/