CALMATEL 33.28 mg/ml Topical Solution

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, blows, sprains
• torcicollis or other contractures
• lower back pain
• mild sprains resulting from a twist

2. What you need to know before starting to use 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 urticaria.

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 cutaneous spray solution with caution to the skin, 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 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.

Cautious use is recommended. Do not use near incandescent sources or spray near fire. Keep the container protected from excessive heat sources as well as away from any flame or spark source. Do not smoke during use.

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 benzyl alcohol

This medication contains 19.97 mg of benzyl alcohol in 1.2 ml (1 propulsion).

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol may cause moderate 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

Adolescentsover 12 years of ageand adults:

As a general rule, apply to the affected area, 1-2 propulsions for a few seconds, 3 times a day.

Method of administration

For cutaneous use only.

Its application does not require massage and may produce a sensation of cold.

If symptoms do not improve within 7 days, discontinue treatment and consult a 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 the usual schedule. However, if it is almost time for the next application, do not apply the forgotten dose and wait for the next scheduled dose.

If you have any other doubts about the use of 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 Medication Surveillance System for Human Use: 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 the sight and reach of children.

No special storage conditions are required.

Pressurized container. Protect from sunlight and avoid exposure to temperatures above 50°C. Do not puncture or burn, even after use. Extremely flammable. Keep away from any flame or spark source.

Do not use this medication after the expiration date stated on the container 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 containers and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Calmatel Composition

• The active ingredient is piketoprofen. Each 50g bottle contains 2g of piketoprofen.
• The other components are: Excipients (camphor, benzyl alcohol (E-1519), methyl salicylate, isopropyl myristate, lavender essence, isopropanol); Propellant (carbon dioxide (E-290)).

Product Appearance and Package Contents

Yellow cutaneous spray solution with a characteristic odor. Aluminum spray can, varnished, lacquered, and serigraphed on the outside; with a valve and polyethylene propeller. Container with 60 ml, plus propellant.

Other Presentations

Calmatel 18 mg/g Cream: 60g container.

Calmatel 18 mg/g Gel: 60g container.

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)

or

Laboratoires Chemineau

93, route de Monnaie

37210 Vouvray

France

Date of the last revision of this package leaflet: November 2013

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/