SASULEN 5 mg/g GEL

2. What you need to know before starting to use Sasulen Gel

Do not use Sasulen Gel

• if you are allergic to piroxicam or any of the other components of this medication (listed in section 6).
• if you have suffered hypersensitivity reactions to acetylsalicylic acid or other non-steroidal anti-inflammatory medications: 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 cardiac, hepatic, or renal disorders.
• 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, nor should it be applied to open skin lesions.
• 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 experience a skin rash or skin symptoms, stop using piroxicam immediately, seek urgent medical advice, and inform your doctor that you are using this medication.
• If you experience symptoms or signs of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis (e.g., circular red patches with blisters or lesions on the mucous membranes), treatment with Sasulen Gel should be discontinued, and you should immediately consult a doctor, informing them that you are taking this medication.
• With the oral administration of piroxicam, life-threatening skin rashes (Stevens-Johnson syndrome and Toxic Epidermal Necrolysis) have been described, initially appearing as red patches or spots, often with a central blister. These reactions have not been associated with the topical use of piroxicam, but it cannot be entirely ruled out that they may occur with this medication.
• Other additional signs that may appear are sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes).
• These life-threatening skin rashes are often accompanied by flu-like symptoms. The rash can progress to the formation of generalized blisters or skin peeling.
• The period of highest risk for the appearance of severe skin reactions is during the first few 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 have any cardiac, hepatic, or renal disorders
• The treated areas should not be exposed to the sun (even if cloudy) or to ultraviolet lamps (UVA) during the treatment period and up to two weeks after discontinuation, as photosensitivity reactions may occur.
• Do not use in children under 12 years of age.

If the symptoms worsen or persist after 7 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 of age, 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 route of administration.

Inform your doctor or pharmacist if you are using, have recently used, 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 if the same risk applies to Sasulen Gel.

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.

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 clearly necessary and as indicated by your doctor. If treatment is needed during this period, the lowest dose should be used for the shortest possible time.

Breastfeeding

The use of this medication is not recommended during breastfeeding, as its clinical safety has not been established in breastfeeding women.

Fertility

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

Driving and Using Machines

The influence of Sasulen Gel on the ability to drive and use machines is negligible or non-existent.

Sasulen Gel contains benzyl alcohol, polyoxyethylene castor oil, propylene glycol, and butylhydroxytoluene (E-321)

This medication contains 10 mg of benzyl alcohol per gram of medication. Benzyl alcohol may cause allergic reactions and moderate local irritation.

This medication may cause skin reactions because it contains polyoxyethylene castor oil (Cremophor).

This medication contains 200 mg of propylene glycol per gram of medication. Propylene glycol may cause skin irritation.

This medication may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation because it contains butylhydroxytoluene (from cream perfume)

3. How to use Sasulen Gel

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The recommended dose of this medication is:

Adults and children over 12 years of age

Apply to the affected area, depending on the extent of the area, a dose of 1 gram (1.5 cm of gel) to 3 grams (4.5 cm of gel), equivalent to 5 mg and 15 mg of piroxicam, repeating the application 2 to 4 times a day.

Elderly patients (over 65 years of age)

No special precautions are required for this population.

Pediatric population

Do not administer to children under 12 years of age due to the lack of data on its safety and efficacy in this population.

Patients with kidney or liver problems

No special recommendations are required for these patient groups.

Instructions for the correct administration of the gel

Sasulen Gel is intended for exclusive use on the skin. After application, it is not recommended to use tight clothing or occlusive dressings.

1. Remove the cap and make an opening in the tube mouth with the top part of the tube.
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 2 to 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, wash your hands unless they are the treatment area, to avoid unintentional 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 of age due to the lack of studies on its safety and efficacy.

If you use more Sasulen Gel than you should

Since Sasulen Gel is a product for exclusive external use, it is unlikely that overdose situations will occur.

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

If you forget to use Sasulen Gel

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Uncommon: may affect up to 1 in 100 people

• Mild or moderate local irritation
• Redness (erythema)
• Itching of the skin
• Dermatitis.

Prolonged or extensive topical administration may cause the appearance of systemic adverse reactions typical of non-steroidal anti-inflammatory medications.

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

• Nausea
• Discomfort in the upper abdomen (dyspepsia)
• Photosensitivity reactions
• Blisters filled with fluid
• Itchy skin rashes

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

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

Frequency not known:

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaRAM.es/. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Sasulen Gel

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated 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 wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Sasulen Gel

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

Appearance of the Product and Package Contents

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

Marketing Authorization Holder

Laboratorios Veris, S.A.

Parque Empresarial CRISTALIA

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

28033 Madrid

Manufacturer and Batch Release

Faes Farma Portugal, S.A.

Rua Elias Garcia, 28

Amadora, Lisboa

2700-327 Portugal

Date of the last revision of this package leaflet:April 2024

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.