Calmatel 18 mg/g cream

Patient Information Leaflet

Introduction

Patient Information Leaflet

Calmatel 18 mg/g Cream

Picketoprofen

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

Follow exactly the instructions for use provided in this leaflet or those given 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 if you do not improve after 7 days.

Contents of the 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. 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 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 starting to use 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 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 experience 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 applied only to the affected area. It must not be used on large skin areas.

Apply the cream 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 piroprofen and for two weeks after the last application.

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

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

If skin reactions occur, treatment must be stopped immediately and you should consult your doctor.

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 using, have recently used, or might need to use any other medicines.

Pregnancy, breastfeeding and fertility

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.

The use of medicines during pregnancy can be dangerous for 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 advise you whether it is advisable to use this medicine during breastfeeding.

Driving and operating machinery

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

Calmatel contains cetostearyl alcohol, cetyl alcohol and benzyl benzoate.

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

This medicine contains 30 mg/g of benzyl benzoate.

Benzyl benzoate may cause local irritation.

3. How to use Calmatel

Follow exactly the instructions for administering the medicine 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 cream to the affected area, three times daily.

Method of administration

For topical use only.

Calmatel should be applied with gentle massage to enhance its penetration. Application following massage may produce a sensation of warmth.

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 phone number: 915 620 420 (indicating the medicine 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 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 dose, do not apply the missed dose and wait until the next scheduled application 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 cause 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.

Store below 25°C.

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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to properly 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 piketoprofen. Each gram of cream contains 18 mg of piketoprofen (as hydrochloride).
• The other components are benzyl benzoate, mixture of lauric and myristic alcohols, cetyl alcohol, polysorbate 20 (E-432), sorbitan monolaurate (E-493), polyoxyethylene cetyl stearyl alcohol, tromethamine, polyhexamethylene biguanide hydrochloride and purified water.

Appearance of the product and contents of the pack

White, unscented cream. 60 g tube.

Other presentations

Calmatel 33.28 mg/ml Cutaneous spray solution: 60 ml bottle with propellant.

Calmatel 18 mg/g Gel: 60 g tube.

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 most recent review of this leaflet: May 2023

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/