CALMATEL 18 mg/g CREAM

1. What Calmatel is and what it is used for

Calmatel contains piketoprofen and belongs to the group of medications called non-steroidal anti-inflammatory drugs (NSAIDs).

This medication is indicated for adolescents over 12 years of age and adults for the local relief of mild and occasional pain and inflammation caused by:

• minor bruises, bumps, sprains
• torticollis or other contractures
• lower back pain
• mild sprains caused by a twist

2. What you need to know before using Calmatel

Do not use Calmatel

• If you are allergic to piketoprofen or any of the other components of this medication (listed in section 6). Discontinue treatment if signs of allergy appear.
• If acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (a type of medication used to reduce inflammation and pain) cause you rhinitis, asthma, angioedema (an allergic reaction that can cause swelling in the face, eyes, or tongue and difficulty swallowing or breathing) or hives.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Calmatel.

This medication should be used exclusively on the affected area. It should not be used on large areas.

Apply the cream to the skin with caution, avoiding contact with eyes, mucous membranes, ulcers, or open lesions or other conditions.

It is recommended to avoid sun exposure and/or UVA rays during treatment with piketoprofen and for up to two weeks after the last application.

It is recommended to wash your hands after applying the medication.

It is not recommended to use it with products containing octocrylene (an excipient used in various cosmetic and hygiene products, e.g., sunscreens, shampoos, etc.), as skin reactions may occur.

In case of skin reactions, discontinue treatment immediately and consult your doctor.

Children

The use of this medication is not recommended in children (under 12 years of age).

Using Calmatel with other medications

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

Pregnancy, breastfeeding, and fertility

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.

The use of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

It is unknown whether piketoprofen can be excreted in breast milk. Your doctor will indicate whether it is advisable to use this medication during breastfeeding.

Driving and using machines

Due to its form of administration, this medication does not affect driving ability or the use of machinery.

Calmatel contains cetearyl alcohol, cetyl alcohol, and benzyl benzoate.

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

This medication contains 30 mg/g of benzyl benzoate.

Benzyl benzoate may cause local irritation.

3. How to use Calmatel

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

Dosage

Adolescents over 12 years of age and adults:

As a general rule, apply approximately 1.5 to 2 g of cream to the affected area, 3 times a day.

Method of administration

For exclusive cutaneous administration.

Calmatel should be applied with a gentle massage to facilitate its penetration. Its application after massage may produce a sensation of heat.

If symptoms do not improve within 7 days, discontinue treatment and consult your doctor.

If you use more Calmatel than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to the nearest hospital, or contact the Toxicology Information Service, phone: 915 620 420 (indicating the medication and the amount used/ingested).

No intoxication has been reported to date.

If you forget to use Calmatel

Do not apply a double dose to make up for forgotten doses. Apply the forgotten dose when you remember and then follow your regular schedule. However, if it is almost time for your next application, do not apply the forgotten dose and wait for the next scheduled dose.

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

4. Possible side effects

Like all medications, Calmatel can cause side effects, although not everyone will experience them.

Occasionally, reactions may occur at the application site, redness, itching, burning sensation, and heat at the application site, eczema, contact dermatitis, and photosensitivity reactions (increased sensitivity to sunlight).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Calmatel

Keep this medication out of sight and reach of children.

Store below 25°C.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

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. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Calmatel composition

• The active ingredient is piketoprofen. Each gram of cream contains 18 mg of piketoprofen (as hydrochloride).
• The other components are benzyl benzoate, lauric and myristic alcohol mixture, cetyl alcohol, polysorbate 20 (E-432), sorbitan monolaurate (E-493), cetearyl alcohol polyoxyethylene, tromethamine, polyhexamethylene biguanide hydrochloride, and purified water.

Product appearance and package contents

White, non-perfumed cream. 60 g packaging.

Other presentations

Calmatel 33.28 mg/ml Cutaneous spray solution: 60 ml packaging, plus propellant.

Calmatel 18 mg/g Gel: 60 g packaging.

Marketing authorization holder and manufacturer

Marketing authorization holder

Almirall, S.A.

General Mitre, 151

08022 - Barcelona (Spain)

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca

Barcelona (Spain)

Almirall Hermal GMBH.

Scholtzstrasse 3 (Reinbek)

D-21465 - Germany

Date of the last revision of this package leaflet: May 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/