Calmatel 18 mg/g gel

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Calmatel 18 mg/g Gel

Picketoprofen

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

Always follow exactly the instructions for taking the medicine as described in this leaflet or as directed 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 any 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.

Contents of the package leaflet:

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. Contents of the pack and other information

1. What Calmatel is and what it is used for

Calmatel contains piroprofen 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, sprains
• torticollis or other muscle spasms
• lumbago
• mild sprains resulting from twisting injuries

2. What you need to know before using Calmatel

Do not use Calmatel

• If you are allergic to piroprofen or to 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, tongue, or 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 only on the affected area. It must not be used on large skin areas.

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

It is recommended to avoid exposure to sunlight and/or UVA rays during treatment with piroprofen 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.

Frequent applications may cause skin irritation and dryness.

Due to its ethanol (alcohol) content, the gel tube must not be exposed to flames or direct fire, to prevent possible accidents.

Children

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 taking, have recently taken, or might need to take any other medicines.

Pregnancy, breastfeeding, and fertility

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

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

It is unknown whether piroprofen 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 propylene glycol. This medicine contains 170 mg/g of propylene glycol.

Propylene glycol may cause skin 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 approximately 1.5 to 2 g of gel to the affected area, three times daily.

Method of administration

For topical use only.

Calmatel should be applied with a gentle massage to enhance its penetration. A sensation of cold may be felt after application and massage.

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, immediately consult your doctor or pharmacist, 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 cases of intoxication have been reported to date.

If you forget to use Calmatel

Do not apply a double dose to make up for a missed dose. Apply the missed dose as soon as you remember, then continue with your regular schedule. However, if it is almost time for your next dose, 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 warm 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.

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.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers 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 piroketoprofen. Each g of gel contains 18 mg of piroketoprofen.
• The other components are hypromellose (E-463), propylene glycol (E-1520), lavender fragrance and ethanol.

Appearance of the product and contents of the pack

Colorless or slightly yellowish transparent gel with a lavender odour, packed in a lacquered aluminium tube; exterior screen-printed; with a polyethylene screw cap.

Pack size: 60 g.

Other presentations

Calmatel 18 mg/g Cream: 60 g pack.

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

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

Almirall Hermal GmbH

Scholtzstraße 3

21465 Reinbek

Germany

Date of the most recent revision of this leaflet: November 2013

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