Calmatel 33.28 mg/ml solution for cutaneous spray

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Calmatel 33.28 mg/ml Cutaneous spray solution

Picketoprofen

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

Follow exactly the instructions for use of the medicine contained in this leaflet or those provided by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse 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:

1. What Calmatel is and what it is used for
2. What you need to know before using Calmatel
3. How to use Calmatel
4. Possible adverse effects
5. Storage of Calmatel
6. Package contents and additional information

1. What Calmatel is and what it is used for

Calmatel contains piroxicam and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine 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, strains
• torticollis or other muscle spasms
• lumbago
• mild sprains resulting from twisting injuries

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

Do not use Calmatel

• If you are allergic to piroxicam or any of the other components of this medicine (listed in section 6). Discontinue treatment immediately if signs of allergy occur.
• If acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (a type of medication used to reduce inflammation and pain) cause you to develop rhinitis, asthma, angioedema (an allergic reaction that may cause swelling of 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 medicine should be used exclusively on the affected area. It should not be used on large skin areas.

Apply the topical spray solution carefully, avoiding contact with eyes, mucous membranes, ulcers, open wounds, or other skin conditions.

Exposure to sunlight and/or UVA rays should be avoided during treatment with piroctone olamine and for two weeks after the last application.

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

Do not use together with products containing octocrylene (an excipient found in various cosmetic and hygiene products, e.g. sunscreens, shampoos, etc.), as skin reactions may occur.

If skin reactions occur, discontinue treatment immediately and consult your doctor.

Use with caution. Do not use near incandescent heat sources or spray near fire. Keep the container protected from excessive heat and away from any flame or source of sparks. Do not smoke while using this product.

Children

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

Use of Calmatel with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

It is unknown whether piroctone olamine is excreted in breast milk. Your doctor will advise you whether it is appropriate to use this medicine during breastfeeding.

Driving and use of machines

Due to its route of administration, this medicine does not affect the ability to drive or operate machinery.

Calmatel contains benzyl alcohol

This medicine contains 19.97 mg of benzyl alcohol in 1.2 ml (1 spray).

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol may cause moderate local irritation.

3. How to use Calmatel

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

Dosage

Adolescents over 12 years of age and adults:

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

Method of administration

For cutaneous use only.

No massage is required after application, and a cooling sensation may be felt.

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 at telephone number: 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 missed doses. Apply the missed dose as soon as you remember, then continue with your regular schedule. However, if it is almost time for the next application, do not apply the missed dose and wait to apply the next dose at the scheduled time.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Calmatel may produce adverse effects, although not everyone will experience them.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Calmatel

Keep this medicine 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 pierce or burn, even after use. Extremely flammable. Keep away from all flames and sources of sparks.

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.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to 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 Calmatel

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

Appearance of the medicine and contents of the pack

Yellow-coloured solution for cutaneous spray with a characteristic odour. Aluminium spray container, internally lacquered and externally varnished and screen-printed, with valve and polyethylene actuator. Pack containing 60 ml, plus propellant.

Other presentations

Calmatel 18 mg/g Cream: 60 g tube.

Calmatel 18 mg/g Gel: 60 g tube.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of this package leaflet: November 2013

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/