Salvacam 5 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Salvacam 5 mg/g Gel
Piroxicam
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
- Keep this leaflet, as you may need to read 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 effects not listed in this leaflet. See section 4.
- You should consult a doctor if you get worse or do not improve<after 7 days.
Contents of the leaflet
- What Salvacam is and what it is used for
- What you need to know before using Salvacam
- How to use Salvacam
- Possible adverse effects
- Storage of Salvacam
- Contents of the pack and other information
1. What Salvacam is and what it is used for
Piroxicam, the active ingredient in this medicine, belongs to the group of non-steroidal anti-inflammatory drugs, and works by reducing pain.
Salvacam is indicated in adults and children over 12 years of age for the local relief of mild and occasional pain and inflammation caused by: minor bruises, knocks and sprains, torticollis or other muscle spasms, back pain (lumbago), or mild sprains resulting from twisting injuries.
You should consult a doctor if your condition worsens or does not improve after 7 days.
2. What you need to know before using Salvacam
Do not use Salvacam:
- if you are allergic to piroxicam or to any of the other ingredients of this medicine (listed in section 6).
- if you have ever had an allergic reaction (hypersensitivity) after taking acetylsalicylic acid or any other non-steroidal anti-inflammatory drug (NSAIDs).
- if acetylsalicylic acid or other non-steroidal anti-inflammatory medicines cause you symptoms such as rhinitis, asthma, swelling of the face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing (angioedema), or skin rash.
- if you are in the last 3 months of pregnancy.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Salvacam.
- Salvacam must not come into contact with the eyes or mucous membranes, nor should it be applied to open skin lesions.
- Do not use Salvacam under occlusive dressings; the treated area must remain uncovered and in contact with air.
- If use of Salvacam causes irritation at the application site, consult your doctor.
- If you develop a skin rash or skin symptoms, stop using piroxicam immediately, seek urgent medical advice, and inform your doctor that you are using this medicine.
- If you experience symptoms or signs of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis (for example, red circular spots with blisters or lesions in the mucosa), treatment with Salvacam gel must be stopped immediately, and you must seek immediate medical attention, informing the doctor that you are using this medicine.
- With oral administration of piroxicam, skin rashes that may be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported. These initially appear as spots or red circular patches, often with a central blister. These reactions have not been linked to the use of piroxicam applied cutaneously, but the possibility that they may occur with this medicine cannot be completely ruled out.
Additional symptoms that may occur include sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes).
These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or skin peeling.
The period of highest risk for the occurrence of severe skin reactions is during the first weeks of treatment.
- If you have previously developed Stevens-Johnson syndrome or Toxic Epidermal Necrolysis while taking piroxicam orally, you must never use Salvacam gel.
- When absorption of the gel is incomplete, slight and transient skin discoloration has been observed.
- Treated areas must not be exposed to sunlight (even when cloudy) or to ultraviolet (UVA) lamps. Exposure to sunlight of areas treated with this medicine may cause photosensitivity reactions.
- Do not use in children under 12 years of age.
Other medicines and Salvacam
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Do not use other topical preparations at the same application site as Salvacam without first consulting your doctor or pharmacist.
Pregnancy, breast-feeding and fertility
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 breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Do not use Salvacam if you are in the last 3 months of pregnancy. You should not use Salvacam during the first 6 months of pregnancy unless clearly necessary and specifically advised by your doctor. If treatment is needed during this period, the lowest effective dose for the shortest possible duration should be used.
Driving and using machines
The influence of Salvacam on the ability to drive and operate machinery is negligible or none.
Salvacam contains propylene glycol
This medicine contains 100 mg of propylene glycol in each gram of Salvacam gel.
3. How to use Salvacam
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Salvacam is a topical medicine (for external use on the skin only).
Do not use occlusive dressings; the application area must remain in contact with the air.
The recommended dose is:
Adults and children over 12 years of age
The dose will depend on the extent of the affected area. The usual 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
Apply 2 to 4 times daily, spreading the gel with a gentle massage until no residue of the medicine remains on the skin.
After application, wash your hands unless the hands are the treated area.
Your doctor or pharmacist will determine the duration of treatment with Salvacam.
Do not use for more than 7 consecutive days without consulting your doctor or pharmacist.
Use in children
This medicine is not recommended for use in children under 12 years of age due to insufficient data on safety and efficacy.
Use in patients over 65 years of age
No dose adjustment is required for this patient group.
Use in patients with kidney or liver problems
There are no special usage recommendations for these patient groups.
Instructions for correct preparation and administration
Unscrew the original cap and pierce the seal at the mouth of the tube using the top part of the cap. Replace the original cap with the laminar applicator. From this point on, the original cap may be discarded. Remove the cap from the applicator, apply a thin layer of gel over the affected area, and gently massage until fully absorbed. Close the tube tightly after use. Wash your hands after applying the gel.
If you use more Salvacam than you should
Because this medicine is intended for topical use, intoxication is unlikely.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Salvacam
Do not apply a double dose to make up for missed doses.
If you stop using Salvacam
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Salvacam may cause adverse effects, although not everyone experiences them.
- Uncommon adverse effects (may affect between 1 and 10 out of 1,000 patients): erythema (redness), itching.
- Rare adverse effects (may affect between 1 and 10 out of 10,000 patients):
- photosensitivity reaction.
- Adverse effects of unknown frequency (cannot be estimated from available data): dermatitis, peeling at the application site, skin irritation, irritation at the application site, fixed drug eruption (may appear as round or oval patches with redness and swelling of the skin), blisters (urticaria), itching.
With oral administration of piroxicam, the following serious adverse effects have been reported very rarely (may affect less than 1 in 10,000 patients): skin eruptions that may be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis). These reactions have not been associated with the use of piroxicam via cutaneous route, but the possibility that they may occur with this medicine cannot be entirely ruled out.
When absorption of the gel is incomplete due to insufficient rubbing, slight and transient skin discoloration has been observed.
Reporting of 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 leaflet.
You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaRAM.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Salvacam
No special storage conditions are required.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Salvacam
The active substance 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 container
Salvacam is a yellowish transparent gel.
It is supplied in an aluminium tube with a screw cap and a lamellar applicator, containing 60 grams of gel.
Marketing Authorisation Holder and Manufacturer
Laboratorios Salvat, S.A.
C/ Gall 30 – 36 – 08950
Esplugues de Llobregat
Barcelona - Spain
Date of the most recent review of this leaflet: April 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob/.es