Tantum Verde forte 3 mg/ml spray, 15 ml - oral cavity diseases

Tantum Verde forte 3 mg/ml spray, 15 ml - oral cavity diseases

TANTUM VERDE forte 3 mg/ml oral mucosal spray (solution)

Benzydamine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

Do not throw this leaflet away as you may need to read it again.
If you want to know more or consult, ask your pharmacist.
If you experience side effects (even if they are not listed in this leaflet), contact your doctor or pharmacist. See Chapter 4.
If your condition has not improved or even worsened within 7 days, consult a doctor.
What is this leaflet about?

What TANTUM VERDE forte is and what it is used for
What you need to know before taking TANTUM VERDE forte
How to use TANTUM VERDE forte
Possible side effects
How to keep TANTUM VERDE in the fort
Package contents and other information

What TANTUM VERDE forte is and what it is used for
TANTUM VERDE forte is a pain-relieving non-steroidal anti-inflammatory drug. When used locally, the oral mucosal spray disinfects and causes local anesthesia. Its active ingredient, benzydamine, strongly suppresses inflammation and reduces pain. Because benzydamine is quickly absorbed and accumulates in the inflamed tissues, the disorder quickly resolves.

TANTUM VERDE forte is used for local symptomatic treatment of painful inflammation and swelling of the mouth, pharynx and gums.

If your condition has not improved or even worsened within 7 days, consult a doctor.

What you need to know before taking TANTUM VERDE forte
TANTUM VERDE forte should not be used:

- if you are allergic to benzydamine hydrochloride or any of the excipients of this medicine (listed in section 6).

- if you are allergic to salicylic acid and/or any non-steroidal anti-inflammatory drug.

Warnings and precautions

Talk to your doctor or pharmacist before taking TANTUM VERDE forte.

If a large amount of TANTUM VERDE forte is accidentally swallowed (e.g. by a child), it is necessary to inform the doctor immediately. The first aid measure may be to induce vomiting.

If short-term treatment with benzydamine does not produce the desired effect, it is necessary to consult a doctor.

Care should be taken not to get the medicinal product into the eyes.

For children

The safety and efficacy of TANTUM VERDE forte in children under 3 years of age have not been established.

Other medicines and TANTUM VERDE forte

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, or if you are not sure.

No interactions between TANTUM VERDE forte oral mucosa spray and other drugs have been observed.

Taking TANTUM VERDE forte with food and drink

Interaction with food and drinks does not occur.

Pregnancy, lactation and fertility

If you are pregnant, breast-feeding, think you may be pregnant, or are planning to become pregnant, talk to your doctor or pharmacist before taking this medicine.

Pregnancy

Animal reproduction toxicity studies are insufficient and there are no or insufficient data on the use of benzydamine during pregnancy, therefore TANTUM VERDE forte should not be used during pregnancy.

Breastfeeding

There is insufficient information on the excretion of benzydamine in animal milk, therefore TANTUM VERDE forte should not be used during breastfeeding.

Fertility

TANTUM VERDE forte has no effect on fertility.

Driving and machine control

TANTUM VERDE forte does not affect the ability to drive and use machines.

TANTUM VERDE forte contains methyl parahydroxybenzoate (E218).

May cause allergic reactions, which may be delayed, and in exceptional cases, bronchospasm.

TANTUM VERDE forte contains macrogolglycerol hydroxystearate.

May cause stomach upset and diarrhea.

How to use TANTUM VERDE forte
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If in doubt, ask your doctor or pharmacist.

TANTUM VERDE forte should be sprayed 2-6 times a day. Do not exceed the recommended dose.

For adult patients

It is necessary to spray 2 - 4 sprays 2 - 6 times a day.

For elderly patients

It is not necessary to change the dosage specifically for elderly patients.

For patients with impaired kidney or liver function

No special dosage adjustment is necessary for patients with impaired renal or hepatic function.

Use in children and adolescents

For teenagers over 12 years old

It is necessary to spray 2-4 sprays 2-6 times a day.

For children aged 6-12

It is necessary to spray 2 sprays 2-6 times a day.

For children aged 3-5 years

It is necessary to spray 1 spray per 8 kg of body weight (maximum 2 sprays) 2-6 times a day.

Duration of treatment

If after 7 days of treatment the symptoms of inflammation persist or worsen, consult a doctor. Radiomucositis is usually treated for 3-5 weeks.

Spray instructions

Lift the spray pump tube.
Insert the tube into your mouth and, pressing firmly with your finger on the marked area, spray the medicine directly on the inflamed area of the mouth or into the pharynx, if you are treating a lesion.
What to do if you take too much TANTUM VERDE forte?

There have been no cases of overdose with topical benzydamine.

Accidental ingestion of a small amount of TANTUM VERDE forte is not harmful.

If you have taken or accidentally swallowed large doses of the medicine, seek advice from your doctor or pharmacist immediately.

If you forget to take TANTUM VERDE forte

Do not take a double dose to make up for a missed dose.

When you stop taking TANTUM VERDE forte

If you stop using the drug earlier than recommended, the expected effect may not occur.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

An oropharyngeal solution may be felt immediately after using the oral mucosal spray. This effect depends on the way the drug works and disappears quickly.

The following side effects have been observed with an unknown frequency (cannot be estimated from the available data):

burning sensation in the mouth, dry mouth;
vomiting or nausea;
allergic reactions (hypersensitivity);
severe allergic reaction (anaphylactic shock) which may include difficulty breathing, chest pain or pressure in the chest and/or feeling dizzy/fainting, severe itching or raised bumps on the skin, swelling of the face, lips, tongue and/or throat, potentially life-threatening.
If any of the above-mentioned side effects occur, stop taking the medicine and consult a doctor.