Viamal Trauma

PACKAGE LEAFLET: INFORMATION FOR THE USER

VIAMAL Trauma gel

Diethylammonium salicylate 100 mg - Sodium heparin 0.368 mg - Menthol 2 mg
Please read this leaflet carefully before using/giving this medicine to the child, because
it contains important information for you/the child.
Use/give this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if symptoms worsen after 3 days.

Contents of this leaflet:

1. What Viamal Trauma is and what it is used for
2. What you need to know before using/giving Viamal Trauma to the child
3. How to use/give Viamal Trauma to the child
4. Possible side effects
5. How to store Viamal Trauma
6. Contents of the pack and other information

1. What Viamal Trauma is and what it is used for

Viamal Trauma is a topical medicinal product containing three active substances: diethylammonium salicylate, sodium heparin and menthol.
Diethylammonium salicylate has anti-inflammatory and analgesic properties. Furthermore, by softening the skin, it facilitates the absorption of the other two active ingredients.
Heparin prevents blood coagulation, rapidly reducing bleeding and fluid accumulation in the superficial layers of the skin. Thus, heparin reduces swelling and the sensation of tension, and pain is relieved.
Menthol enhances the effect of heparin and has a mild local anesthetic action, as well as a pleasant cooling effect.
Viamal Trauma is formulated as a gel and is rapidly absorbed through the skin, penetrating deeply into the tissues.
Viamal Trauma is used in adults and in children over 6 years of age for joint and muscle pain, as supportive treatment for local trauma such as: bruises, sprains, haematomas (blood accumulation in tissues), and muscle tears.
Consult a doctor if you/your child do not feel better or feel worse after 3 days.

2. What you need to know before using/giving Viamal Trauma to a child

Do not use/give Viamal Trauma to the child

• if you and/or the child are allergic to diethylammonium salicylate, sodium heparin, and menthol or to any of the other ingredients of this medicine (listed in section 6)
• if you and/or the child have kidney damage due to previous illnesses and the body surface area to be treated is large
• if you and/or the child are also using other topical preparations containing salicylates (anti-inflammatory agents), unless otherwise directed by a doctor
• if you and/or the child have influenza or chickenpox
• if you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding") Do not give Viamal Trauma:
• to infants and children under 6 years of age
• to children who have previously suffered from epilepsy or febrile convulsions.

Warnings and precautions
Talk to your doctor or pharmacist before using/giving Viamal Trauma to the child.
Do not exceed 3 days of treatment, as you/the child may experience undesirable effects on the brain due to accumulation of terpene substances, such as menthol and pine oil, contained in this medicine.
Do not use a dose higher than recommended to avoid an increased risk of adverse reactions to the medicine and symptoms associated with overdose.
Do not use on damaged skin (wounds, burns, irritated skin).
Avoid exposing the treated area to sunlight.

Do not use occlusive dressings (gauze bandages or other materials) or apply heat, as this may increase absorption through the skin.
Avoid contact with eyes and mucous membranes.
This medicine is flammable; therefore, do not bring it near flames.

Children and adolescents
Do not give Viamal Trauma to infants, children under 6 years of age, or children who have previously suffered from epilepsy or febrile convulsions (see section "Do not use/give Viamal Trauma to the child"), as neurological disorders may occur.

Misuse
In case of accidental oral ingestion, incorrect administration in newborns or children under six years of age, or in children with a history of epilepsy or febrile convulsions, neurological disorders may occur. In case of misuse, contact your doctor immediately or go to the nearest hospital.

Other medicines and Viamal Trauma
Inform your doctor or pharmacist if you/the child are taking, have recently taken, or might take any other medicines.
Do not use/give Viamal Trauma to the child if you and/or the child are also using other topical preparations containing salicylates (anti-inflammatory agents), unless otherwise directed by a doctor (see section "Do not use/give Viamal Trauma to the child").
Do not use/give Viamal Trauma to the child if you and/or the child are using/taking other products (medicines or cosmetics) containing terpene substances such as camphor, cineole, niaouli, wild thyme, terpineol, terpin, citral, eucalyptus, and turpentine, regardless of the route of administration (oral, rectal, cutaneous, nasal, or inhaled).
If you are taking blood-thinning medicines (coumarins, e.g., warfarin), your doctor will monitor you carefully due to a possible increase in anticoagulant activity.

Pregnancy and breastfeeding
If you are pregnant, suspect you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
The use of Viamal Trauma is not recommended if you are pregnant or if you are a woman of childbearing potential who is not using contraceptive measures.

Breastfeeding
The use of Viamal Trauma is not recommended if you are breastfeeding.

Driving and using machinery
Viamal Trauma does not affect the ability to drive vehicles or operate machinery.

Viamal Trauma contains Pine Oil
This medicine contains Pine Oil fragrance, which in turn contains Limonene.
Limonene may cause allergic reactions.

3. How to use Viamal Trauma

Use this medicine exactly as described in this leaflet or as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults and children over 6 years of age
Dosage
Unless otherwise directed by a physician, apply the gel 2–3 times daily to the affected areas of the body.
Do not exceed the recommended doses, as this may increase the risk of experiencing adverse effects (see section 4) and problems associated with overdosage (see section “If you use/ give the child more Viamal Trauma than you should”).
Method of application
Spread the gel evenly with gentle pressure over the affected areas of the body.
In cases of bruises (blood accumulation under the skin) or painful injuries, apply the gel and allow it to absorb on its own.
Use Viamal Trauma only on limited skin areas and only if the skin to be treated is intact and free of open wounds.
If necessary, Viamal Trauma can be removed by washing the area where the gel was applied; it is non-greasy, has a pleasant odor, and provides a pleasant cooling sensation.
Avoid contact of the gel with eyes, nose, and mouth.
The product is flammable; keep away from flames.
Duration of treatment
Do not exceed 3 days of treatment (see section “Warnings and precautions”).
If after a short period of treatment (3 days) no appreciable improvement occurs, consult your doctor.
If you use more Viamal Trauma than you should
If an excessive dose of Viamal Trauma is used, skin irritation may occur.
In case of excessive dosing, there may be a risk of brain-related disturbances. If an overdose has occurred, inform your doctor immediately or go to the nearest hospital.
If you forget to use Viamal Trauma
Do not use/double the dose to make up for a missed application.
If you stop using Viamal Trauma
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you experience any of the following side effects, STOP treatment and consult your doctor immediately:

• allergic reactions
• prolonged vomiting
• profound drowsiness

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• application site burns

Additional side effects in children
Effects on the nervous system

• seizures. This effect may occur in children when the dose and duration of treatment recommended by the doctor are not respected.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Viamal Trauma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Viamal Trauma contains

• The active substances are: diethylammonium salicylate; sodium heparin and menthol (1 g of gel contains 100 mg of diethylammonium salicylate, 0.368 mg of sodium heparin and 2 mg of menthol)
• The other components are: polyacrylic acid, sorbitan polyethylene glycol oleate, polyethylene glycol ricinoleate, isopropanol, pine oil, contains limonene (see section 2 Viamal Trauma contains pine oil), sodium hydroxide, purified water.

Description of the appearance of Viamal Trauma and pack sizes
Viamal Trauma is a gel for local application, for external use. The gel is contained in a 50 g aluminium tube with a closure cap.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Polifarma Benessere S.r.l.
Via Laurentina, 289
00142 Rome
Manufacturer
Industria Farmaceutica Nova Argentia S.p.A.
Via G. Pascoli, 1
20064 Gorgonzola (MI)