Package Insert: Information for the User

Fastum 25 mg/g Gel

ketoprofen

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

-Keep this package insert, as you may need to refer to it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Fastum contains ketoprofen, which is a medication belonging to the group of nonsteroidal anti-inflammatory drugs.

Fastum is indicated for the treatment of painful, inflammatory, or bruising alterations in the joints, tendons, ligaments, and muscles(arthritis, periarthritis, synovitis, tendinitis, tenosynovitis, bursitis, bruises, sprains, dislocations, meniscal injuries of the knee, torticollis, lower back pain).

Do not use Fastum

• If you have a history of skin allergy to ketoprofen, dexketoprofen, tiaprofenic acid, fenofibrate, UV blockers, perfumes, or any other components of this medication (listed in section 6).
• If you have had an allergic reaction to acetylsalicylic acid or any other nonsteroidal anti-inflammatory drug (NSAID), characterized by difficulty breathing, nasal mucosa inflammation, or rashes.
• On open wounds, skin infections, eczema, acne, mucous membranes, genital area, eyes, or around the eyes.
• If you are in the last 3 months of pregnancy.
• Stop using Fastum immediately if you experience any skin reaction, including skin reactions after applying products containing octocrylene (octocrylene is an excipient in various cosmetic and hygiene products such as shampoo, aftershave lotion, bath and shower gel, skin creams, lip balms, anti-aging creams, makeup removers, hair dyes, and hair colorants that are used to delay photodegradation).
• Do not expose treated areas to the sun, even on cloudy days, or to ultraviolet lamps (solariums, sunlamps) during treatment and for 2 weeks after stopping treatment.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Fastum.

• If you have heart, liver, or kidney problems, as isolated cases of systemic adverse reactions affecting the kidneys have been observed when using topical medications in the same group as Fastum.
• Do not use tight clothing or occlusive bandages after applying the gel.
• Stop treatment immediately if any skin reaction appears after applying Fastum.
• The gel should not come into contact with mucous membranes and eyes.
• Exposure to the sun (even on cloudy days) or ultraviolet lamps (UVA) on areas that have been in contact with Fastum may cause severe skin reactions (phototoxicity). Therefore, it is necessary:

• To cover treated areas with clothing to protect them during treatment and for 2 weeks after stopping treatment to avoid any risk of phototoxicity.
• To wash your hands thoroughly after each application of Fastum.

• Prolonged or excessive use of the product may cause systemic effects such as hypersensitivity and asthma.
• Treatment should be interrupted in case of an eruption.
• Do not exceed the recommended treatment duration, as the risk of developing contact dermatitis and phototoxicity increases with time.
• Patients with asthma combined with chronic rhinitis, sinusitis, and/or nasal polyps have a higher risk of developing an allergy to acetylsalicylic acid and/or other NSAIDs than the general population.

Children and adolescents

The safety and efficacy of ketoprofen in children have not been established.

Other medications and Fastum

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

Inform your doctor if you are taking oral anticoagulants (blood thinners).

It is unlikely to interact with other medications due to its direct application to the skin.

Do not apply other topical preparations to the same area of the skin where you are using this medication.

Pregnancy, breastfeeding, and fertility

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

Do not use ketoprofen if you are in the last 3 months of pregnancy. Do not use ketoprofen during the first 6 months of pregnancy unless it is clearly necessary and as directed by your doctor. If you need treatment during this period, you should use the minimum dose for the shortest possible time.

Oral formulations (e.g., tablets) may cause adverse effects in the fetus. It is unknown whether the same risk applies to topical ketoprofen.

There is insufficient data on the elimination of ketoprofen through breast milk, so it is not recommended to use it during breastfeeding.

Driving and operating machinery

No effects on the ability to drive and operate machinery have been described.

Fastum contains parahydroxybenzoic acid methyl ester, parahydroxybenzoic acid propyl ester, ethanol, and lavender essence.

This medication may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoic acid methyl ester and parahydroxybenzoic acid propyl ester.

This medication contains 400 mg of ethanol in each gram of gel. It may cause a burning sensation on injured skin.

This medication contains lavender essence with benzyl benzoate, amyl cinnamaldehyde, citral, eugenol, hydroxycitronellal, coumarin, geraniol, farnesol, linalool, benzyl benzoate, citronellol, and d-limonene, which may cause allergic reactions.

Cutaneous use.

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Fastum is used topically. Apply the gel one or more times a day (3-5 cm or more according to the extent of the affected area), giving a gentle massage to facilitate absorption.

The total daily dose must not exceed 15 g per day, which is equivalent to 28 cm of skin.

Close the Fastum tube after each use. Wash your hands after each application.

Your doctor will indicate the duration of your treatment with Fastum.

The duration of continuous treatment with topical ketoprofen must be limited to a maximum of 7 days.

If you estimate that the action of Fastum is too strong or too weak, inform your doctor or pharmacist.

If you use more Fastum than you should

Since the medication administration is topical, overdose is very unlikely.

In case of accidental ingestion of Fastum, contact your doctor or the emergency department of the nearest hospital immediately.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Fastum

If you forgot to apply a dose, apply the usual dose as soon as possible, but do not apply a double dose to compensate for the missed one.

Like all medications, this medication may have adverse effects, although not all people may experience them.

The most frequent adverse effects are localized skin reactions, which may extend around the application site and are rarely severe and/or generalized.

Adverse effects may occur with the following frequency:

Rare (may affect up to 1 in 100 patients):

- Skin allergic reactions such as redness (erythema), itching (pruritus), or skin inflammation (eczema), burning sensation.

Very rare (may affect up to 1 in 1,000 patients):

• Skin reaction upon exposing the application site to the sun (photosensitivity), redness, or skin prominence. Appearance of white or reddish papules on the skin with itching (urticaria). More severe reactions, such as blister-like lesions similar to burns (eczema bullosum or flictenular) that may spread or generalize.

Very rare (may affect up to 1 in 10,000 patients):

• Ulceration of the stomach wall or beginning of the intestine (ulcer), gastrointestinal bleeding, diarrhea.
• Contact dermatitis (allergic skin reaction).
• Impaired kidney function or worsening of existing impaired kidney function (renal insufficiency).

Frequency unknown (cannot be estimated from available data):

- Generalized urticaria accompanied by inflammation of feet, hands, throat, lips, and respiratory tracts (angioedema), severe allergic reaction (anaphylactic reaction including anaphylactic shock, hypersensitivity reactions) and bullous dermatitis.

Older patients are more susceptible to the adverse effects of nonsteroidal anti-inflammatory drugs, a group to which ketoprofen, the active principle of Fastum, belongs.

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 Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on 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 shown on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Fastum

• The active principle is ketoprofen. Each gram of gel contains 25 mg of ketoprofen.
• The other components are methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), carbomer, ethanol at 96%, trometamol, lavender essence(which contains: benzyl alcohol, amylcinamaldehyde, citral, eugenol, hydroxycitronellal, coumarin, geraniol, farnesol, linalol, benzyl benzoate, citronellol, and d-limonene)and purified water.

Appearance of the product and content of the packaging

Fastum is a transparent gel. Each package contains60 gramsof gel.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Menarini, S.A.

Alfons XII, 587

08918 Badalona (Barcelona)

Spain

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization

Guidotti Farma, S.L.

Alfons XII, 587

08918 Badalona (Barcelona)

Spain

Last review date of this prospectus:January 2023.

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)