Patient Information Leaflet

Sasulen 5 mg/g Gel

piroxicam

Read this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Sasulen gel contains piroxicam, which belongs to a group of medicines called topical nonsteroidal anti-inflammatory drugs that acts by reducing inflammation and pain.

Sasulen gel is indicated for adults and children over 12 years old for local relief of mild and occasional pain and inflammation caused by: small bruises, blows, and strains, torticollis or other contractures, back pain (lumbalgias) or mild sprains resulting from a twist.

Do not use Sasulen gel

• if you are allergic to piroxicam or any of the other ingredients of this medication (listed in section 6).
• if you have had reactions of hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs: symptoms of asthma, allergic rhinitis,swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema)or urticaria (skin rash)
• if you have ever had any heart, liver, or kidney problems.
• if you are in the last 3 months of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Sasulen gel

• Sasulen should not come into contact with the eyes or mucous membranes, or be applied to open skin wounds.
• Do not use Sasulen under occlusive dressing, the treated area must be uncovered and in contact with the air.
• If the use of Sasulen causes irritation in the application area, consult your doctor.
• If you present a skin rash or symptoms on the skin, stop using piroxicam immediately, seek urgent medical advice and inform your doctor that you are using this medication.
• If you present symptoms or signs of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis (for example, circular red patches with blisters or lesions on the mucosa) the treatment with Sasulen gel must be suspended, and you must go immediately to a doctor, informing them that you are taking this medication.
• With the administration of piroxicam by oral route, skin rashes that may threaten the patient's life (Stevens-Johnson syndrome and Toxic Epidermal Necrolysis) have been described, initially appearing as points or circular red patches, often with a central blister. These reactions have not been related to the use of piroxicam by topical route, but cannot be completely ruled out.
• Other additional signs that may appear are mouth sores, throat, nose, genitals, and conjunctivitis (swollen and red eyes).
• These skin rashes that may threaten the patient's life often accompany flu-like symptoms. The rash may progress to the formation of generalized blisters or skin peeling.
• The period of highest risk of appearance of severe skin reactions is during the first weeks of treatment.
• If you have developed Stevens-Johnson syndrome or Toxic Epidermal Necrolysis with the use of Sasulen gel, you should not use Sasulen gel at any time.
• If you present any heart, liver, or kidney problems
• The treated areas should not be exposed to the sun (even on cloudy days) or ultraviolet lamps (UVA) during treatment and for two weeks after stopping treatment. If the treated area with this medication is to be exposed to the sun, photosensitivity reactions may occur.
• Do not use in children under 12 years.

If symptoms worsen or persist after seven days of treatment, the patient's clinical situation should be evaluated.

Children and adolescents

Sasulen gel should not be administered to children under 12 years old, as the safety and efficacy of piroxicam have not been established in children under this age.

Other medications and Sasulen gel

It is unlikely that there will be an interaction between Sasulen gel and other medications due to its topical administration route.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

Pregnancy

Sasulen gel is not recommended during pregnancy, as its safety has not been established in pregnant women.

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

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

Do not use Sasulen gel if you are in the last 3 months of pregnancy. Do not use Sasulen gel during the first 6 months of pregnancy unless it is clearly necessary and your doctor indicates it. If you need treatment during this period, use the lowest dose for the shortest possible time.

Breastfeeding

This medication is not recommended during breastfeeding, as its clinical safety has not been established in breastfeeding women.

Fertility

This medication is not recommended in women of childbearing age who are trying to become pregnant. In women with difficulty becoming pregnant or women undergoing fertility treatment, the treatment with this medication should be considered.

Driving and operating machinery

The influence of Sasulen gel on the ability to drive and operate machinery is negligible or insignificant.

Sasulen gel contains alcohol bencílico, aceite de ricino polioxietilenado, propilenglicol, and butilhidroxitolueno (E-321)

This medication contains 10 mg of alcohol bencílico per gram of medication. Alcohol bencílico may cause allergic reactions andmoderate local irritation.

This medication may cause skin reactions because it contains ricin oil polioxietilenado (cremophor).

This medication contains 200 mg of propilenglicol per gram of medication. Propilenglicol may cause skin irritation.

This medication may produce local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butilhidroxitolueno (from the cream perfume)

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

Your doctor will establish the most suitable dose and treatment duration for you, according to your condition and response to treatment.

The recommended dose of this medication is:

Adults and children over 12 years old

Apply to the affected area and depending on the extent of the same, a dose of one gram (1.5 cm of gel) to three grams (4.5 cm of gel), equivalent to 5 mg and 15 mg of piroxicam, repeating the application of two to four times a day.

Geriatric patients (over 65 years old)

No special precautions are required for use in this population group.

Pediatric population

Do not administer in children under 12 years old due to the absence of data on their safety and efficacy in this population.

Patients with kidney or liver problems

No special use recommendations are available for these patient groups.

Instructions for correct administration of the gel

Sasulen gel is intended for use exclusively on the skin. After application, it is not recommended to use tight clothing or occlusive bandages.

1. Remove the cap and make a hole in the tube mouth with the top of the same.
2. Apply to the affected area, between 1 gram (1.5 cm) and 3 grams (4.5 cm) of gel, as needed, repeating the application between 2 and 4 times a day, performing a small massage to facilitate the absorption of the product, until no residue of the medication remains on the skin.
3. After application, hands should be washed unless they are the treatment site, in order to avoid accidental contact with eyes and mucous membranes.

The duration of continuous treatment should be limited to a maximum of 7 days.

Use in children and adolescents

This medication should not be administered to children under 12 years old due to the lack of studies on its safety and efficacy.

If you use more Sasulen gel than you should

Since Sasulen gel is an exclusive external product, it is unlikely that poisoning cases will occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, visit your health center or call the Toxicological Information Service. Telephone (91) 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Sasulen gel

Do not apply a double dose to compensate for the missed doses. Apply it as soon as you remember and continue with the usual schedule.

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

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

Rarely:may affect up to 1 in 100 people

• Mild to moderate local irritation
• Redness (erythema)
• Itching on the skin
• Dermatitis

Prolonged or extensive topical administration may cause typical systemic adverse reactions of NSAIDs.

Rare:may affect up to 1 in 1,000 people

• Nausea
• Upper abdominal discomfort (dyspepsia)
• Phototoxic reactions
• Blisters filled with fluid
• Itchy skin eruptions

Very rare:may affect up to 1 in 10,000 people

• Spasms in the bronchi that prevent air from reaching the lungs, difficulty breathing
• Abdominal pain, gastritis
• Angioedema (skin irritation and swelling)
• Severe allergic reaction affecting the entire body (anaphylactic reactions)
• Stevens-Johnson syndrome and Toxic Epidermal Necrolysis characterized by skin peeling, fever, pain, skin eruptions, and blisters and ulcers on mucous membranes, which can be life-threatening.

Adverse effects of unknown frequency:

• Fixed drug eruption (may appear as rounded or oval plaques with skin redness and swelling)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 on the safety of this medication.

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

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.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sasulen gel

• The active ingredient is piroxicam. Each gram of gel contains 5 mg of piroxicam.
• The other components (excipients) are: ethanol, propylene glycol, diisopropanolamine, benzyl alcohol, polyoxyl 40 hydrogenated castor oil, carbomer, hydroxyethylcellulose, herbal aroma, cream fragrance (contains butylhydroxytoluene E-321), quinoline yellow (E-104), patent blue V (E-131), sodium chloride, and purified water.

Appearance of the product and contents of the packaging

Sasulen gel is presented in a 60 g aluminum tube containing a transparent, pale green gel with a light herbal odor.

Holder of the marketing authorization

Laboratorios Veris, S.A.

Parque empresarial CRISTALIA

Vía de los Poblados, 3 - Edif. 2 – 2º izda.

28033 Madrid

Manufacturer and batch liberator

Faes Farma Portugal, S.A.

Rua Elias Garcia, 28

Amadora, Lisboa

2700-327 Portugal

Last review date of this leaflet:April 2024

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