Package Insert: Information for the User

Salcamic 5 mg/g Gel

Piroxicam

Read this entire 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 or pharmacist.

• 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 or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

The piroxicam, active ingredient of this medication, belongs to the group of nonsteroidal anti-inflammatory drugs, and acts by reducing pain.

Salvacam is indicated in 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 caused by a twist.

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

No use Salvacam:

-If you are allergic to piroxicam or any of the other components of this medication (listed in section 6).

-If you have ever experienced an allergic reaction (hypersensitivity) after taking acetylsalicylic acid or any other nonsteroidal anti-inflammatory drug (NSAIDs).

-If acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs cause symptoms such as rhinitis, asthma, facial swelling, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema) or skin rash.

- If you are in the last 3 months of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Salvacam.

-Salvacam should not come into contact with the eyes or mucous membranes, or be applied to open skin wounds.

-Do not use Salvacam under occlusive dressing, the treated area must be uncovered and in contact with the air.

-If the use of Salvacam 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 (for example, circular red spots with blisters or lesions on the mucosa), the treatment with Salvacam gel should be suspended, and you should immediately see a doctor, informing them that you are taking this medication.

-With the administration of piroxicam by oral route, severe skin eruptions that may threaten the patient's life (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been described, initially appearing as red spots or circular 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 for this medication.

Additional signs that may appear are mouth sores, throat, nose, genitals, and conjunctivitis (swollen and red eyes).

These life-threatening skin eruptions often accompany flu-like symptoms. The rash may progress to the formation of generalized blisters or skin peeling.

The period of highest risk 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 piroxicam by oral route, you should not use Salvacam gel at any time.

-When the gel absorption is not complete, a light and transient skin discoloration has been observed.

-The treated areas should not be exposed to the sun (even on cloudy days) or ultraviolet lamps (UVA). If the treated area is to be exposed to the sun, photosensitivity reactions may occur.

-Do not use in children under 12 years old.

Other medications and Salvacam

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

Do not use other topical preparations on the same application site as Salvacam without consulting your doctor or pharmacist first.

Pregnancy, breastfeeding, and fertility

The oral formulations (e.g., tablets) of piroxicam may cause adverse effects on the fetus. It is unknown whether the same risk applies to Salvacam.

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 Salvacam if you are in the last 3 months of pregnancy. Do not use Salvacam during the first 6 months of pregnancy unless clearly necessary and indicated by your doctor. If treatment is needed during this period, use the lowest dose for the shortest possible time.

Driving and operating machinery

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

Salvacam contains propylene glycol

This medication contains 100 mg of propylene glycol in each gram of Salvacam gel.

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

Salvacam is a topical medication (exclusively for the skin).

Do not use occlusive dressings, the application area must be in contact with the air.

The recommended dose is:

Adults and children over 12 years old

The dose will depend on the extent of the affected area. The normal dose is 1 gram to 3 grams of gel, equivalent to 5 and 15 mg of piroxicam:

-1 gram of Salvacam is approximately equivalent to 3 cm of gel

-3 grams of Salvacam are approximately equivalent to 9 cm of gel

The application will be performed 2 to 4 times a day by extending the gel with a massage until no residue of the medication remains on the skin.

After application, wash your hands unless they are the treatment site.

Your doctor or pharmacist will indicate the duration of treatment with Salvacam.

Do not apply more than 7 consecutive days without consulting your doctor or pharmacist.

Use in children

This medication is not recommended for use in children under 12 years old, due to insufficient data available on safety and efficacy.

Use in patients over 65 years old

No dosage adjustment is required for this group of patients.

Use in patients with kidney or liver problems

No special use recommendations are available for these patient groups.

Guidelines for correct preparation and administration

Remove the original cap and make a hole in the tube mouth with the top of the same. Replace the original cap with the laminar applicator. From this moment on, the original cap can be discarded. Open the applicator, extend a layer of gel on the affected surface and gently massage until absorbed. Close the tube well after use.Wash your hands after applying the gel

If you use more Salvacam than you should

Since the application of this medication is for topical use, it is unlikely that poisoning will occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Poisoning Service. Phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Salvacam

Do not apply a double dose to compensate for the missed doses.

If you interrupt treatment with Salvacam

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

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

• Less common adverse effects (may affect between 1 and 10 of every 1,000 patients): erythema (redness), pruritus.
• Rare adverse effects (may affect between 1 and 10 of every 10,000 patients):
• phototoxic reaction.
• Adverse effects of unknown frequency (cannot be estimated from available data): dermatitis, desquamation in the application area, skin irritation and application area irritation, fixed drug exanthema (may appear as rounded or oval plaques with skin redness and swelling), blisters (urticaria), pruritus.

With oral administration of piroxicam, the following severe adverse effects have been reported with a very rare frequency (may affect fewer than 1 of every 10,000 patients): skin eruptions that may threaten the patient's life (Stevens-Johnson syndrome and toxic epidermal necrolysis). These reactions have not been related to the use of piroxicam via the skin, but the possibility of their occurrence with this medication cannot be ruled out entirely.

When the gel absorption is not complete due to insufficient friction, a light and transient skin discoloration has been observed.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus.

You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use http://www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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This product does not require special storage conditions.

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 Expiration Date. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask 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 Salvacam

The active principle is piroxicam. Each gram of gel contains 5 mg of piroxicam.

The other components (excipients) are: carbomer, isopropyl alcohol, glycerol (E-422), propylene glycol (E-1520), diisopropanolamine, and purified water.

Appearance of the product and contents of the packaging

Salvacam is a transparent yellowish gel.

It is presented in an aluminum tube with a screw cap and a laminar applicator containing 60 grams of gel.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Salvat, S.A.

C/ Gall 30 – 36 – 08950

Esplugues de Llobregat

Barcelona - Spain

Date of the last review of this leaflet:April 2024

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