TANTUM VERDE

TANTUM VERDE 3 mg lozenges with mint flavor

Important notes (mandatory information)

Tantum Verde with mint flavour 3 mg lozenges. Active ingredient: Benzydamine hydrochloride. Areas of application: for the symptomatic local treatment of pain and irritation in the mouth and throat.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Tantum Verde with mint flavour 3 mg lozenges
Active ingredient: Benzydamine hydrochloride

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

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

What this package leaflet contains

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

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

Tantum Verde contains the active ingredient benzydamine, an anti-inflammatory agent that is used in adults and children over 6 years of age for the symptomatic local treatment of pain and irritation in the mouth and throat. If you do not feel better or if you feel worse after 3 days, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE USING TANTUM VERDE?

Tantum Verde must not be used if you are allergic to benzydamine hydrochloride, levomenthol 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:

• if you have phenylketonuria.
• if you have or have had asthma.
• if you are hypersensitive to acetylsalicylic acid or other pain-relieving or anti-inflammatory medicines called non-steroidal anti-inflammatory drugs.
• if your doctor has told you that you have an intolerance to certain sugars, do not use this medicine until you have consulted your doctor.
• 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, you should see your doctor or dentist.

Use of Tantum Verde with other medicines

Please tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines.

Use of Tantum Verde with food and drink

Food and drink have no influence.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Tantum Verde should not be used during pregnancy and breast-feeding.

Driving and using machines

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

Tantum Verde contains isomalt

This medicine contains isomalt (E953). Do not take Tantum Verde until you have consulted your doctor if you know that you have an intolerance to certain sugars.

Tantum Verde contains aspartame

This medicine contains aspartame (E951) as a source of phenylalanine and may be harmful if you have phenylketonuria.

3. HOW TO USE TANTUM VERDE?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Adults and children over 6 years: one lozenge 3 times a day. Do not use more than 3 lozenges per day.

Use in children

Children between 6 and 11 years: This medicine should be used under the supervision of an adult. The dosage form "lozenge" is not suitable for children under 6 years of age. Do not use Tantum Verde for more than 7 days. If the pain persists or worsens, consult your doctor or pharmacist.

For use in the mouth and throat. Allow one lozenge to dissolve slowly in your mouth. Do not swallow. Do not chew.

If you have used more Tantum Verde than you should

In case of accidental use of too many lozenges, you should immediately notify your doctor or pharmacist or go to the nearest hospital. Take the pack with you, regardless of whether it still contains lozenges or not. In very rare cases, children have experienced agitation, convulsions, sweating, ataxia, tremors and vomiting after oral administration of benzydamine in doses approximately 100 times higher than those of the lozenges.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

Uncommon (may affect 1 to 10 in 1,000 people):

• Redness or sunburn due to skin sensitivity to sunlight.

Rare (may affect 1 to 10 in 10,000 people):

• Burning and dry mouth. If this occurs, 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 (may affect less than 1 in 10,000 people):

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

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

• Severe allergic reactions (anaphylactic reactions).
• Local loss of sensitivity of the oral mucosa (oral hypoaesthesia).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of 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 reach of children. Do not use this medicine after the expiry date which is stated on the pack after "Use by". The expiry date refers to the last day of the month indicated. Do not store above 25°C. Store in the original package to protect the contents from moisture. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Tantum Verde contains

The active ingredient is benzydamine hydrochloride. One lozenge contains 3 mg benzydamine hydrochloride (equivalent to 2.68 mg benzydamine). The other ingredients are: isomalt (E953), aspartame (E951), levomenthol, citric acid monohydrate, lemon flavour, mint flavour, quinoline yellow (E104), indigo carmine (E132).

What Tantum Verde looks like and contents of the pack

Green, square lozenges with a central indentation, wrapped in paper. Packs of 20 (2 x 10) and 30 (3 x 10) lozenges. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

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
Brigittenauer Lände 50-54
1200 Vienna Austria
Telephone: 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 package leaflet was last revised in January 2017.

Source: Package leaflet information
Status: 02/2018
Active ingredient: Benzydamine hydrochloride. Areas of application: for the symptomatic local treatment of pain and irritation in the mouth and throat.