TANTUM VERDE 1.5 mg/ml solution for oral use

Important Information (Mandatory Information)

Tantum Verde 1.5 mg/ml solution. Active substance: Benzydamine hydrochloride. Areas of application: used undiluted for rinsing or gargling in the mouth and throat area. Warning: Contains 10% alcohol by volume!

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Tantum Verde 1.5 mg/ml solution for use in the oral cavity
Active substance: Benzydamine hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information. Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse after 3 days, contact your doctor.

What is in this leaflet

1. WHAT TANTUM VERDE IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE TANTUM VERDE
3. HOW TO USE TANTUM VERDE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE TANTUM VERDE
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT TANTUM VERDE IS AND WHAT IT IS USED FOR

Tantum Verde is an anti-inflammatory agent (antiphlogistic) for the mouth and throat. Tantum Verde contains benzydamine, which is used for the symptomatic treatment of pain and irritation in the mouth and throat area.
Tantum Verde is a ready-to-use solution and is used undiluted for rinsing or gargling in the mouth and throat area. In the vast majority of cases, only a few days are required to treat acute signs of inflammation with Tantum Verde. If you do not feel better or if you feel worse after 3 days, contact your doctor.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE TANTUM VERDE

Do not use Tantum Verde if you are allergic to benzydamine, methyl 4-hydroxybenzoate or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before using Tantum Verde or if these symptoms occur:

• if you suffer or have suffered from asthma;
• if you are hypersensitive to acetylsalicylic acid or other pain-relieving or anti-inflammatory medicines called non-steroidal anti-inflammatory drugs (NSAIDs);
• if the pain in your mouth or throat gets worse or does not improve within 3 days, or if you develop a fever or other symptoms.

Children and adolescents

This medicine can also be used by children and adolescents.

Other medicines and Tantum Verde

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Tantum Verde with food and drink

Food and drink do not affect the effectiveness of this medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. They will then decide whether you should use Tantum Verde.

Driving and using machines

Tantum Verde does not affect your ability to drive or use machines.

This medicine contains 10% alcohol by volume.

3. HOW TO USE TANTUM VERDE

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is 15 ml (1 tablespoon) twice a day (morning and evening after meals). For inflammation in the oral cavity, rinse for 20 - 30 seconds, and for inflammation in the throat area, gargle. More frequent use (up to 5 times a day) in case of severe pain is harmless.

Use in children and adolescents

Use in children and adolescents is harmless, provided they are already able to rinse or gargle with the solution.

If you use more Tantum Verde

than you should

Overdosing is not expected when used as intended; poisoning is only possible if larger quantities of Tantum Verde are swallowed. In very rare cases, however, excitement, sweating, shaking and vomiting, restlessness, convulsions and coordination disorders (ataxia) have occurred in children after taking very large amounts of the active substance benzydamine (corresponding to 200 ml of Tantum Verde). In the event of an acute overdose, please contact the nearest available doctor. They will decide on further action.

If you forget to use Tantum Verde

If you have used too little Tantum Verde, the time until the effect starts may be prolonged. In this case, the treatment may also fail completely. If you forget to use Tantum Verde, please continue treatment as recommended without increasing the frequency of use or the dose.

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

4. POSSIBLE SIDE EFFECTS

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

Uncommon side effects (may affect up to 1 in 100 people):

• Redness or sunburn due to increased sensitivity of the skin to sunlight.

Rare side effects (may affect up to 1 in 1,000 people):

• Burning mouth and dry mouth. If this happens to you, drink a glass of water in sips to reduce the effect.
• Hypersensitivity reactions, redness or itching, especially if the whole body is affected (allergic reactions).

Very rare side effects (may affect up to 1 in 10,000 people):

• Sudden swelling in the mouth and throat area or of the mucous membranes (angioedema).
• Difficulty breathing (laryngospasm).

Not known (frequency cannot be estimated from the available data):

• Acute, severe hypersensitivity reactions (anaphylactic reactions).

Methyl 4-hydroxybenzoate can cause hypersensitivity reactions, including delayed reactions.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, Website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE TANTUM VERDE

Keep this medicine out of the sight and reach of children. Store in the original package in order to protect the contents from light. Do not use this medicine after the expiry date which is stated on the label and carton after "EXP". The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Tantum Verde contains

The active substance is: Benzydamine hydrochloride. 1 ml of solution contains 1.5 mg of benzydamine hydrochloride, corresponding to 1.34 mg of benzydamine. The other ingredients are: Methyl 4-hydroxybenzoate (Ph.Eur.), ethanol 96% (v/v), glycerol, sodium hydrogen carbonate, polysorbate 20, saccharin, purified water, mint flavor, quinoline yellow 70% (E 104), patent blue V 85% (E 131).

What Tantum Verde looks like and contents of the pack

Tantum Verde is a clear, green solution in a colorless glass bottle with a screw cap. Packs of 120 ml and 240 ml. Not all pack sizes may be marketed.

Marketing Authorization Holder

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
Viale Amelia 70
00181 Rome
Italy

Co-distributor

Angelini Pharma Österreich GmbH
Gewerbestr. 18-20
2102 Bisamberg
Austria
Tel.: 00800 42762727

Manufacturer

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
Via Vecchia del Pinocchio 22
60131 Ancona
Italy

This leaflet was last revised in April 2015.

Source: Information from the package leaflet
Status: 10/2017
Active substance: Benzydamine hydrochloride. Areas of application: used undiluted for rinsing or gargling in the mouth and throat area. Warning: Contains 10% alcohol by volume!