Tantum Verde with Orange-Honey Flavor 3 mg lozenges.

Active ingredient: benzydamine hydrochloride.
Areas of application: For the symptomatic local pain and irritation treatment in the mouth and throat.

Read the leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or exactly as prescribed by your doctor or the pharmacist.
- Keep this leaflet. You might want 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 also applies to side effects not listed in this leaflet. See section 4.
- If you do not feel better after 3 days, contact your doctor.

This leaflet contains:
1. What is Tantum Verde and what is it used for?
2. What do you need to know before using Tantum Verde?
3. How to use Tantum Verde?
4. What are the possible side effects?
5. How to store Tantum Verde?
6. Further information
1. What is Tantum Verde and what is it used for?

Tantum Verde contains benzydamine, which is used in adults and children over 6 years of age for the symptomatic local pain and irritation treatment in the mouth and throat.

2. What do you need to know before using Tantum Verde?

Tantum Verde must not be used:
- if you are hypersensitive (allergic) to benzydamine hydrochloride or any of the other ingredients.

Take special care when using Tantum Verde:
- in patients who have or have suffered from asthma.
- if you are hypersensitive to aspirin or other pain or anti - inflammatory medicines called non - steroidal anti - inflammatory drugs (NSAs).
- if your doctor has told you that you have a sugar intolerance. Do not take this medicine until you have spoken to your doctor.
- if within 3 days the pain in the mouth or throat worsens or does not improve, fever or other symptoms occur. You should contact your doctor or dentist.

When using Tantum Verde with other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Tantum Verde with food and drink:
Food and drinks have no influence.

Pregnancy and breastfeeding:
If you are pregnant, planning to become pregnant, or if you are breastfeeding you should tell your doctor. He will then decide whether you should take Tantum Verde.

Driving and using machines:
Tantum Verde does not affect your ability to drive or use machines.

Important information about certain of the ingredients of Tantum Verde:
This medicine contains isomalt (E 953). If your doctor has told you that you have an intolerance to sugar, do not take this medicine until you have spoken to your doctor. This medicinal product contains sunset yellow (E 110), which can cause allergic reactions.

3. How to use Tantum Verde?

Always use Tantum Verde exactly as prescribed by your doctor. Please consult with your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the usual dose is:
Adults and children over 6 years: one lozenge 3 times a day. Do not take more than 3 lozenges a day.
Children 6-11 years of age: This medicine should be used under adult supervision.
The "lozenge" dosage form is not suitable for children under 6 years of age.
Do not use Tantum Verde for more than 7 days. For use in the mouth and throat. Let a lozenge slowly dissolve in your mouth. Don't swallow it. Don't chew.

If you use more Tantum Verde than you should:
If you accidentally have taken too many lozenges, you should contact your doctor or pharmacist immediately or go to the nearest hospital. Take the pack with you, regardless of whether it still contains lozenges or not. In very rare cases, after oral administration of benzydamine in doses approximately 100 times higher than a single dose of the lozenge, children have experienced agitation, convulsions, sweating, ataxia, tremors and vomiting.

If you have any further questions about how to use the medicinal product, ask your doctor or pharmacist.

4. What are the possible side effects?

Like all medicines, Tantum Verde can cause side effects, although not everybody gets them.

When evaluating side effects, the following frequencies are used as a basis:
Very common: affects more than 1 in 10 people
Common: affects 1 to 10 patients in 100
Uncommon: affects 1 to 10 patients in 1,000
Rare: affects 1 to 10 patients in 10,000
Very rare: less than 1 patients in 10,000
Not known: frequency cannot be estimated from the available data

Uncommon side effects (affecting 1 to 10 in 1,000 people):
- Redness or sunburn of the skin, which is sensitive to sunlight.

Rare side effects (affecting 1 to 10 in 10,000 patients):
- Burning mouth and dry mouth. If this happens to you, take sips of water to lessen the effect.
- Hypersensitivity reactions, redness or itching, especially if the whole body is affected (allergic reactions).

Very rare side effects (affects less than 1 in 10,000 people):
- Sudden swelling in the mouth and throat or the mucous membranes (angioedema).
- Difficult breathing (laryngeal spasm).

Frequency not known (cannot be estimated from the available data):
- Severe allergic reactions (anaphylactic reactions).
- Local loss of sensitivity of the oral mucosa (oral hypoesthesia).

Tell your doctor or pharmacist if you get any of the listed side effects, or if you notice any side effects not listed in this leaflet.

5. How to store Tantum Verde?

Keep out of reach of children. Do not use Tantum Verde after the expiry date which is printed on the label after "EXP". The expiry date refers to the last day of the month. Do not store above 30 ° C. Store in the original packaging in order to protect from moisture.

6. Further information

- The active ingredient is benzydamine hydrochloride. One lozenge contains 3 mg benzydamine hydrochloride (equivalent to 2.68 mg benzydamine).
- The other ingredients are: isomalt (E 953), acesulfame potassium, citric acid monohydrate, orange flavor, honey flavor, levomenthol, quinoline yellow (E 104), yellow orange S (El 10).

What Tantum Verde looks like and contents of the pack:
Orange-yellow, square lozenges with a central indentation, which are wrapped in paper, each as a bag with 10 lozenges. Packs of 20 and 30 lozenges. Not all pack sizes may be marketed.
Pharmaceutical licence holder:
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A. Viale Amelia 70 00181, Rome, Italy
Co-Distributor
CSC Pharmaceuticals Handels GmbH
Gewerbestr. 18-20
2102 Bisamberg
Austria
Manufacturer:
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A. Via Vecchia del Pinocchio, 22 60131 Ancona Italy