Active ingredients: Methyl nicotinate, Glycol salicylate
BALM SIFCAMINA Ointment
The package leaflets of Sifcamina Balm are available for the packs:- BALM SIFCAMINA Ointment
- BALM SIFCAMINA Gel
- BALM SIFCAMINA Spray
Why is sifcamina balm used? What is it for?
WHAT IS IT"
BALM SIFCAMINA POMATA is a drug for topical use for joint and muscle pain based on a derivative of salicylic acid.
WHY "IT IS USED
BALSAMO SIFCAMINA POMATA is used for the local treatment of painful diseases of the osteo-articular and muscular apparatus of rheumatic and traumatic origin: lumbago, intercostal pain, neuralgia, stiff neck, sprains, muscle tears.
Contraindications When sifcamina balm should not be used
BALM SIFCAMINA POMATA should not be used in the case of hypersensitivity already known to the components or other strictly correlated substances from a chemical point of view; in particular towards methyl gentisate and methyl salicylate. it is advisable to consult the doctor in case these disorders have occurred in the past.
Do not use in pediatric age.
See also chapter on PREGNANCY AND BREASTFEEDING.
Precautions for use What you need to know before taking Sifcamin Balm
WHEN IT CAN ONLY BE USED AFTER CONSULTING YOUR DOCTOR
In pregnancy and lactation BALSAMO SIFCAMINA POMATA should be used only after consulting your doctor and having evaluated with him the risk / benefit ratio in your case.
Consult your doctor if you suspect pregnancy or wish to plan a maternity leave.
It is important to know that: SIFCAMINA POMATA BALM applied locally causes a momentary redness of the skin and a pleasant sensation of local heat without any irritation even for prolonged treatments. After a short period of treatment without appreciable results, consult your doctor. prolonged, of products for topical use can give rise to sensitization phenomena and produce unwanted effects. If an allergic reaction occurs (persistent redness of the skin or swelling of mucous membranes, itching, difficulty in breathing, collapse), stop using the medicine immediately and consult your doctor. This medicine contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate which they can cause allergic reactions (possibly delayed type).
Interactions Which drugs or foods can modify the effect of Sifcamina Balm
To date, no drug interactions have been reported as a result of concomitant administration of other drugs or foods.
If you are using other medicines ask your doctor or pharmacist for advice.
Warnings It is important to know that:
WHAT TO DO DURING PREGNANCY AND BREASTFEEDING
During pregnancy and lactation the preparation should be applied only in case of real need and under the supervision of the doctor.
Dose, Method and Time of Administration How to use Sifcamina Balm: Dosage
Warning: do not exceed the indicated doses without medical advice.
Apply on the skin a quantity of SIFCAMINA POMATA BALM proportionate to the surface to be treated and, with the fingertips, rub gently until the BALM is completely penetrated through the skin; a few minutes are enough to ensure total absorption.
It is advisable to cover the rubbed area with cotton wool or a woolen cloth to prolong vasodilation and local heat as much as possible. The application must be repeated every day or even twice a day, in the morning and in the evening, if the pain is particularly troublesome.
Warning: use only for short periods of treatment.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Overdose What to do if you have taken too much Sifcamin Balm
No clinical manifestations of overdose have been reported.
In case of accidental ingestion / intake of an excessive dose of SIFCAMINA POMATA BALM, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Sifcamin Balm
The use, especially if prolonged, of products for local use can give rise to sensitization phenomena (very persistent redness of the skin or swelling of the skin or mucous membranes, itching). If this occurs, stop the treatment and consult your doctor to establish suitable therapy.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
These effects are generally transient.
However, when they occur, it is advisable to consult your doctor or pharmacist.
It is important to inform your doctor or pharmacist of any undesirable effects not described in the package leaflet.
Request and fill in the undesirable effects card available at the pharmacy (Model B).
Expiry and Retention
Warning: do not use the medicine after the expiry date indicated on the package.
Keep this medicine out of the reach of children.
It is important to have the information on the medicine available at all times, so keep both the box and the package leaflet.
Other information
COMPOSITION
100 g of ointment contain:
- Active ingredients: Methyl nicotinate 1 g - Salicylate glycol 10 g.
- Excipients: White wax, Lavender essence, Methyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Polyoxyethylene stearate, Sorbitan monostearate, Sodium edetate, Sorbitol 70% crystallizable, Stearic acid, Purified water.
HOW IT LOOKS
BALM SIFCAMINA POMATA comes in the form of a tube containing an ointment for external use. The contents of the package are 50 grams of ointment.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
BALM SIFCAMINA®
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Balm sifcamina gel: 100 g of gel contain:
active principles : glycol salicylate g 10.00; methyl nicotinate g 0.10
excipients : propylene glycol 25.00 g; 20.00 g isopropyl alcohol; 1.20 g carboxypolymethylene; triethanolamine 0.25 g; methyl p-hydroxybenzoate 0.10 g; lavender essence 0.40 g; purified water g 42.95
Sifcamina spray conditioner: 100 g of solution contain:
active principles : salicylated glycol g 25,000; methyl nicotinate 3.750 g;
excipients : isopropyl alcohol 70.496 g; perfume 0.754 g.
Balm sifcamina gel: 100 g of ointment contain:
active principles : methyl nicotinate 1 g; salicylated glycol 10 g.
excipients : white wax, lavender essence, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, polyoxyethylene stearate, sorbitan monostearate, sodium edetate, crystallizable sorbitol 70%, stearic acid, purified water.
03.0 PHARMACEUTICAL FORM
Topical gel, spray, ointment.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Local treatment of painful affections of the osteo-articular and muscular apparatus of rheumatic and traumatic origin: lower back, intercostal pain, neuralgia, stiff neck, sprains, muscle tears.
04.2 Posology and method of administration
Gel:
apply a quantity of sifcamina gel balm proportionate to the surface to be treated and, with the fingertips, gently massage until the gel is completely penetrated through the skin; a few minutes are enough to ensure total absorption. the application must be repeated every day or even twice a day, in the morning and in the evening, if the pain is particularly troublesome.
Spray:
in painful affections or small traumas, press the dispenser button and spray 3-4 times, directing the jet on the affected part. to favor the beneficial effect of the active ingredients and prolong the pleasant sensation of local heat, it is advisable to cover the part with wool or heat-insulating clothing. keep the can at a distance of 10 cm from the application area.
Ointment:
apply a quantity of sifcamina balm proportionate to the surface to be treated and, with the fingertips, rub gently until the balm is completely penetrated through the skin; a few minutes are enough to ensure total absorption. It is advisable to cover the rubbed area with cotton wool or a woolen cloth to prolong the vasodilation and local heat as much as possible. The application must be repeated every day or even twice a day, in the morning and in the evening, if the pain is particularly troublesome. Do not exceed the recommended dose.
04.3 Contraindications
Hypersensitivity already known to the components. do not use in pediatric age.
04.4 Special warnings and appropriate precautions for use
Avoid prolonged applications for a long time; after a short period of treatment without appreciable results, consult your doctor. Do not exceed the recommended dose. Keep out of reach of children.
04.5 Interactions with other medicinal products and other forms of interaction
To date, no drug interactions have been reported as a result of concomitant administration of other drugs.
04.6 Pregnancy and breastfeeding
During pregnancy and lactation the preparation should be applied only in case of real need and under the supervision of the doctor.
04.7 Effects on ability to drive and use machines
The preparation does not act on the center of vigilance and does not affect the ability to react so it does not interfere with the ability to drive vehicles or use machines.
04.8 Undesirable effects
The use, especially if prolonged of products for topical use, can give rise to sensitization phenomena. If this occurs, stop the treatment and institute a suitable therapy.
04.9 Overdose
No clinical manifestations of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Sifcamina balm is a medicament for skin application with an analgesic, revulsive, decontracting action.
Methyl nicotinate: thanks to its decontracting action, it favors the resolution of contracture and muscle stiffness also resulting from sports activities: moreover, thanks to its peripheral vasodilating action, it facilitates, through the increase of local vascularization, the transcutaneous penetration of salicylated glycol.
Salicylate glycol: anti-inflammatory for external use, practically odorless, penetrates through the skin and carries out a pain-relieving and anti-inflammatory action on the affected muscles and joints.
05.2 Pharmacokinetic properties
As for the pharmacokinetic aspect, the presence of methyl nicotinate causes cutaneous absorption of salicylate glycol faster than that observed following administration of this salicylic derivative alone topically: its bioavailability is however significantly lower than that that would occur following oral administration, the possible risks of systemic absorption are therefore very low.
05.3 Preclinical safety data
No specific toxic-pharmacological studies have been carried out on the gel pharmaceutical form, as these are active ingredients already known. the studies specifically conducted on sifcamina ointment balm and sifcamina spray balm have shown that the combination does not cause systemic effects even after repeated applications on intact or scarified skin of experimental animals.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Balm sifcamina gel: 100 g of gel contain:
propylene glycol 25.00 g; 20.00 g isopropyl alcohol; 1.20 g carboxypolymethylene; triethanolamine 0.25 g; methyl p-hydroxybenzoate 0.10 g; lavender essence 0.40 g; purified water g 42.95.
Sifcamina spray conditioner: 100 g of solution contain:
70.496 g isopropyl alcohol; perfume 0.754 g.
Balm sifcamina gel: 100 g of ointment contain:
white wax, lavender essence, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, polyoxyethylene stearate, sorbitan monostearate, sodium edetate, 70% crystallizable sorbitol, stearic acid, purified water.
06.2 Incompatibility
Unavailable.
06.3 Period of validity
Balm Sifcamina Gel, Spray, Ointment: 3 years, as the product is properly stored and in intact packaging conditions. Do not use the medicine after the expiry date stated on the package.
06.4 Special precautions for storage
Spray: the preparation is flammable; do not spray on a flame or on an incandescent body, do not burn not even after use - Protect from sunlight and do not expose to heat sources. Store at a temperature not exceeding 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
Balm Sifcamina Gel: aluminum tube with plastic cap containing 40g of gel,
Sifcamina spray conditioner: aluminum cylinder, internally lacquered with epoxy-phenolic resin, hermetically closed by a valve for continuous delivery, equipped with a dispenser button containing 34.5g of solution,
Balm sifcamina ointment: aluminum tube with plastic cap containing 50g of ointment.
06.6 Instructions for use and handling
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07.0 MARKETING AUTHORIZATION HOLDER
TEOFARMA S.r.l. via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)
08.0 MARKETING AUTHORIZATION NUMBER
Sifcamina Gel Conditioner: 001063080
Sifcamina Spray Conditioner: 001063078
Balm Sifcamina Ointment: 001063066
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
January 1948 - June 2005
10.0 DATE OF REVISION OF THE TEXT
01/08/2007
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