Prospect: information for the user

Calmatel18 mg/gCream

Piketoprofeno

Read this prospect carefully before starting to use this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this prospect or those indicated by your doctor, pharmacist, or nurse.

• Keep this prospect, 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 not listed in this prospect. See section 4.

• You should consult a doctor if it worsens or does not improve after 7 days.

1. What is Calmatel and for what it is used

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

3. How to use Calmatel

4. Possible adverse effects

5. Storage of Calmatel

6. Contents of the package and additional information.

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

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

• small bruises, blows, strains
• stiff neck or other contractures
• lower back pain
• mild sprains resulting from a twist

Do not use Calmatel

• If you are allergic to piketoprofeno or any of the other components of this medication (listed in section 6).Stop treatment if signs of allergy appear.
• If acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (a type of medication used to reduce inflammation and pain) cause you to have 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 cream with caution to the skin, avoiding contact with eyes, mucous membranes, open ulcers or wounds, or other skin conditions.

It is recommended to avoid exposure to the sun and/or UVA rays during treatment with piketoprofeno and for 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 that contain octocrylene (an excipient used in various cosmetic and hygiene products, e.g. sunscreens, shampoos, etc.), as they may cause skin reactions.

If skin reactions appear, you should immediately stop treatment and consult your doctor.

Children

This medication is not recommended for use in children (under 12 years old).

Using Calmatel with other medications

Inform your doctor or pharmacist that you are using, have used recently, 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.

The excretion of piketoprofeno through breast milk is unknown. Your doctor will advise you on whether it is advisable to use this medication during breastfeeding.

Driving and operating machinery

Due to its administration form, this medication does not affect driving or operating machinery.

Calmatel contains alcohol cetoestearílico, alcohol cetílico, and benzoate of benzyl.

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

This medication contains 30 mg/g of benzoate of benzyl.

Benzoate of benzyl may cause local irritation.

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

Dosage

Adolescents over 12 years and adults:

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

Administration form

For exclusive topical administration.

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

If symptoms do not improve in 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 Toxicological Information Service, phone: 915 620 420 (indicating the medication and the amount used/ingested).

No cases of intoxication have been reported to date.

If you forgot to use Calmatel

Do not apply a double dose to compensate for the missed doses. Apply the missed dose when you remember and then continue with your regular schedule. However, if a few hours are left before the next application, do not apply the missed dose and wait for the next dose at the scheduled time.

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

Like all medications, Calmatel may produce adverse effects, although not all people will experience them.

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

Communication 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance for Human Use Medications:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Store below 25°C.

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

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE collection pointof the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will helpprotect the environment.

Composition of Calmatel

• The active principle is piketoprofeno. Each gram of cream contains 18 mg of piketoprofeno (as chlorhydrate).
• The other components arebenzoate of benzyl, mixture of lauric and myristic alcohols, cetilic alcohol, polisorbate 20 (E-432), monolaurate of sorbitan (E-493), polioxyethylenated cetostearic alcohol, trometamol, polihexametilenbiguanido chlorhydrate and purified water.

Appearance of the product and contents of the packaging

White, non-perfumed cream. Packaging of60 g.

Other presentations

Calmatel 33.28 mg/ml Skin spray solution: Packaging of 60 ml, with propellant.

Calmatel 18 mg/g Gel: Packaging of60 g.

Holder of the marketing authorization and responsible for manufacturing

Holderof the marketing authorization

Almirall, S.A.

General Mitre, 151

08022‑Barcelona (Spain)

Responsible for manufacturing

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-6108740 Sant Andreu de la Barca Barcelona (Spain)

Almirall Hermal GMBH.

Scholtzstrasse 3 (Reinbek)

D-21465 – Germany

Last review date of this leaflet: May 2023

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicaments and Sanitary Products (AEMPS)http://www.aemps.gob.es/