Capsolin - Package Leaflet

Indications Contraindications Precautions for use Warnings Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage Other Information

Active ingredients: Capsicum oleoresin, Camphor, Eucalyptus oil

CAPSOLIN ointment 40 g

Indications Why is Capsolin used? What is it for?

PHARMACOTHERAPEUTIC CATEGORY:

topical pain reliever

THERAPEUTIC INDICATIONS:

Capsolin is an effective revulsive indicated for relieving neuralgic and joint pains; it is therefore indicated in lumbago, in the painful after-effects of bruises and sprains, and in all those conditions in which the revulsive

Contraindications When Capsolin should not be used

Hypersensitivity to the active substances or to any of the excipients. The product is contraindicated in pediatric age.

Children with a history of epilepsy or febrile seizures.

Precautions for use What you need to know before taking Capsolin

Capsolin must not be brought into contact with eyes and mucous surfaces or applied to injured or inflamed skin. It should not be used immediately after a hot bath. It is advisable to wash your hands thoroughly after using Capsolin. Not to be used in skin areas near the eyes with which any contact must be avoided, as well as mucous membranes.

Warnings It is important to know that:

The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena or eruptions. In this case it is necessary to suspend the treatment and consult your doctor.

This product contains terpene derivatives which, in excessive doses, can cause neurological disorders such as convulsions in infants and children.

The treatment should not be prolonged for more than 3 days due to the risks associated with the accumulation of terpene derivatives, such as camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needles, eucalyptus and turpentine (due to their lipophilic properties the rate of metabolism and disposal is not known) in tissues and brain, in particular neuropsychological disorders.

A higher dose than recommended should not be used to avoid an increased risk of adverse drug reactions and disorders associated with overdose. (see section Overdose)

The product is flammable, it must not be approached to flames.

If after a few days of treatment there are no appreciable results, consult your doctor.

Capsolin should not be used concomitantly with other products (medicinal or cosmetic) containing terpene derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal or inhalation).

Pregnancy: There are no or limited amount of data on the use of camphor, turpentine oil and eucalyptus oil in pregnant women.

Capsolin is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures.

Lactation: There is insufficient information on the excretion of camphor, turpentine oil and eucalyptus oil in breast milk.

Capsolin should not be used while breastfeeding.

Dosage and method of use How to use Capsolin: Dosage

Apply a small amount of Capsolin on the skin surface of the affected area and rub lightly with your fingers or with a piece of cloth or linen. It should not be rubbed for a long time as blisters could form, especially in the case of delicate skin. Since the effect of Capsolin is greater on moist skin than on dry skin, a more energetic action can be obtained by applying, immediately after using Capsolin, a cloth moistened with water. The treated surface should not be covered with bandages or forced with too tight clothing.Capsolin, when used for patients with delicate skin, should be diluted with one to three parts of vaseline or olive oil.

The duration of treatment should not exceed 3 days.

Overdose What to do if you have taken too much Capsolin

In case of accidental oral intake or incorrect administration in infants and children there may be a risk of neurological disorders. In case of accidental ingestion of Capsolin by children, it is important to immediately consult a doctor who institutes the appropriate therapy. Don't try to induce vomiting. If necessary, administer appropriate symptomatic treatment in specialized treatment centers

Side Effects What are the side effects of Capsolin

Capsolin is usually well tolerated. Due to the presence of camphor, eucalyptus oil and turpentine oil and in case of non-observance of the recommended doses there may be a risk of seizures in children and infants.

Report any undesirable effect not described in this leaflet to your doctor or pharmacist.

Expiry and Retention

Do not use the product after the expiry date indicated on the package.

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

Deadline "> Other information

COMPOSITION:

100 g contain

Active ingredients: 2.5 g capsicum oleoresin, 5.25 g camphor, 9.75 g turpentine oil, 2.5 g eucalyptus oil.

Excipients: wax, paraffin.

PHARMACEUTICAL FORM:

ointment 40 g

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.

Further information on Capsolin can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT - 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION - 03.0 PHARMACEUTICAL FORM - 04.0 CLINICAL PARTICULARS - 04.1 Therapeutic indications - 04.2 Posology and method of administration - 04.3 Contraindications - 04.4 Special warnings and appropriate precautions for use - 04.5 Interactions with other medicinal products and other forms of interaction - 04.6 Pregnancy and lactation - 04.7 Effects on the ability to drive and use machines - 04.8 Undesirable effects - 04.9 Overdose - 05.0 PHARMACOLOGICAL PROPERTIES - 05.1 "Pharmacodynamic properties - 05.2 Pharmacokinetic properties" - 05.3 Preclinical safety data - 06.0 PHARMACEUTICAL PARTICULARS - 06.1 Excipients - 06.2 Incompatibility "- 06.3 Shelf life" - 06.4 Special precautions for storage - 06.5 Nature of the primary packaging and contents of the package - 06.6 Instructions for use and handling - 07.0 AUTHORIZATION HOLDER ALL "PLACING ON THE MARKET - 08.0 MARKETING AUTHORIZATION NUMBER - 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION - 10.0 DATE OF REVISION OF THE TEXT - 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY - 12.0 INSTRUCTIONS FOR RADIOPHONES ON EXTEMPORARY PREPARATION AND QUALITY CONTROL -

01.0 NAME OF THE MEDICINAL PRODUCT -

CAPSOLIN.

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

100 g contain: capsicum oleoresin 2.5 g, camphor 5.25 g, turpentine oil 9.75 g, eucalyptus oil 2.5 g.

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM -

Ointment.

04.0 CLINICAL INFORMATION -

04.1 Therapeutic indications -

Capsolin is an effective revulsive indicated for relieving neuralgic and joint pains; it is therefore indicated in lumbago, in the painful after-effects of bruises and sprains, and in all those conditions in which the revulsives are applied.

04.2 Posology and method of administration -

Apply a small amount of Capsolin on the skin surface of the affected area and rub lightly with your fingers or with a piece of cloth or linen.

It should not be rubbed for a long time as blisters may form, especially in the case of delicate skin.

So long as; the effect of Capsolin is greater on moist skin than on dry skin, a more energetic action can be obtained by applying, immediately after using Capsolin, a cloth moistened with water. The treated surface should not be covered with bandages or forced with clothing that is too tight.

Capsolin, when used for patients with delicate skin, should be diluted with one to three parts of petroleum jelly or olive oil.

The duration of the treatment should not exceed 3 days.

04.3 Contraindications -

Hypersensitivity to the active substances or to any of the excipients.

The product is contraindicated in pediatric age.

Children with a history of epilepsy or febrile seizures.

04.4 Special warnings and appropriate precautions for use -

The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena or eruptions. In this case it is necessary to suspend the treatment and consult your doctor.

This product contains terpene derivatives which, in excessive doses, can cause neurological disorders such as convulsions in infants and children.

The treatment should not be prolonged for more than 3 days due to the risks associated with the accumulation of terpene derivatives, such as camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needles, eucalyptus and turpentine (due to their lipophilic properties the rate of metabolism and disposal is not known) in tissues and brain, in particular neuropsychological disorders.

A higher than recommended dose should not be used to avoid an increased risk of adverse drug reactions and disorders associated with overdose (see section 4.9).

The product is flammable, it must not be approached to flames.

Capsolin must not be brought into contact with eyes and mucous surfaces nor applied to injured or inflamed skin. It should not be used immediately after a hot bath. It is recommended to wash your hands thoroughly after using Capsolin.

Not to be used in skin areas near the eyes with which any contact must be avoided, as well as mucous membranes.

04.5 Interactions with other medicinal products and other forms of interaction -

Capsolin should not be used concomitantly with other products (medicinal or cosmetic) containing terpene derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal or inhalation).

04.6 Pregnancy and breastfeeding -

Pregnancy

There are no or limited data on the use of camphor, turpentine oil and eucalyptus oil in pregnant women.

Capsolin is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures.

Feeding time

There is insufficient information on the excretion of camphor, turpentine oil and eucalyptus oil in breast milk.

Capsolin should not be used while breastfeeding.

04.7 Effects on ability to drive and use machines -

There are no known negative effects on driving ability and use of machines.

04.8 Undesirable effects -

Due to the presence of camphor, turpentine oil and eucalyptus oil and in case of non-observance of the recommended doses there may be a risk of seizures in children and infants.

04.9 Overdose -

Overdose can cause skin irritation.

Improper use:

In case of accidental oral intake or incorrect administration in infants and children there may be a risk of neurological disorders.

If necessary, administer appropriate symptomatic treatment in specialized treatment centers.

Ingestion of the ointment could cause gastrointestinal symptoms such as vomiting and diarrhea. Treatment should be symptomatic.

Acute intoxication has been observed following accidental intake of a large dose with symptoms such as nausea, vomiting, abdominal pain, headache, dizziness, sensation of heat / flushing, convulsions, respiratory depression and coma.

Patients with severe gastrointestinal or neurological symptoms of intoxication should be observed and treated symptomatically.

Do not induce vomiting.

05.0 PHARMACOLOGICAL PROPERTIES -

05.1 "Pharmacodynamic properties -

The active ingredients contained in Capsolin give the product revulsive and local vasodilating properties that can be usefully exploited for the topical therapy of painful conditions.

The capsaicin contained in the capsicum oleoresin interferes with the synthesis and with the release of Substance P from the peripheral nociceptive endings and this gives Capsolin a rapid and strong analgesic activity.

Terpene derivatives can lower the epileptogenic threshold.

05.2 "Pharmacokinetic properties -

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05.3 Preclinical safety data -

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06.0 PHARMACEUTICAL INFORMATION -

06.1 Excipients -

100 g contain: wax, paraffin.

06.2 Incompatibility "-

None.

06.3 Period of validity "-

5 years.

06.4 Special precautions for storage -

None.

06.5 Nature of the immediate packaging and contents of the package -

40 g aluminum tube.

06.6 Instructions for use and handling -

See section "Posology and method of administration".

07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -

Pharmaceutical Laboratory S.I.T. Hygienic Therapeutic Specialties S.r.l. - Via Cavour 70 - Mede (PV).

08.0 MARKETING AUTHORIZATION NUMBER -

AIC n. 006903025.

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -

June 1, 2010.

10.0 DATE OF REVISION OF THE TEXT -

July 2012.

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY -

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL -

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