Package Insert: Information for the User

Calmatel18 mg/gGel

Piketoprofeno

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

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

• Keep this package insert, as you may need to refer to 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 not listed in this package insert. See section 4.
• You shouldconsult a doctor if it worsens or does not improve after 7 days

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

This medicine is indicated for 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 gel with caution on 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 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 it 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.

In case of skin reactions, you should immediately stop treatment and consult your doctor.

Frequent applications may cause skin irritation and dryness.

Due to its ethanol content, do not bring the gel tube close to open flames or direct fire, in case of a possible accident.

Children

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

Use of 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 may be hazardous to the embryo or fetus and should be monitored by your doctor.

The safety of piketoprofeno in breastfeeding women is unknown. Your doctor will advise you on whether it is safe 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 containspropylene glycol.This medication contains 170 mg/g of propylene glycol.

Propylene glycol may cause skin 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, it will be applied to the affected area, approximately 1.5 to 2 g of gel, 3 times a day.

Administration form

For exclusive cutaneous administration.

Calmatel will be applied accompanied by a gentle massage to facilitate its penetration.You may feel a sensation of cold after the massage.

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 everyone 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).

Reporting 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 for Pharmacovigilance of Medicinal Products for Human Use: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.

No special storage conditions are required.

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.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Calmatel

• The active principle is piketoprofeno. Each g of gel contains 18 mg of piketoprofeno.
• The other components arehydroxypropylcellulose(E-463), propylene glycol (E-1520), lavender essence and ethanol.

Appearance of the product and content of the container

Transparent, colorless or slightly yellowish gel with lavender odor, conditioned in a tin-coated aluminum tube; lacquered and printed on the outside; with a polyethylene screw cap.

Container of60 g.

Other presentations

Calmatel 18 mg/g Cream: Container of60 g.

Calmatel33.28 mg/mlSolution for cutaneous pulverization: Container of 60 ml, with propellant.

Holder of the marketing authorization and responsible for the manufacturing

Holderof the marketing authorization

Almirall, S.A.

General Mitre, 151

08022‑Barcelona (Spain)

Responsible for the manufacturing

Industrias Farmacéuticas Almirall, S.A.

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

or

Almirall Hermal GmbH

Scholtzstraße 3

21465 Reinbek

Germany

Last review date of this prospectus: November 2013

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/