Tantum Verde 3 mg - Mint-flavored lozenges

The active ingredient benzydamine hydrochloride has anti-inflammatory and pain-relieving properties.

Application

What is Tantum Verde and what is it used for?

The active ingredient benzydamine hydrochloride has anti-inflammatory and pain-relieving properties. After rapid absorption and local accumulation in the inflamed tissue, symptoms quickly subside. Tantum Verde® is well tolerated locally and provides targeted therapy for inflammatory symptoms and difficulty swallowing.

Areas of application
Symptomatic treatment of painful inflammations of the mouth and
throat, such as gingivitis, tonsillitis, pharyngitis, and laryngitis. Tantum Verde® is therefore suitable for relieving symptoms, especially during common colds.

If you do not feel better or even worse after 3 days, contact your doctor.

How is it used?

What is Tantum Verde and what is it used for?

The active ingredient benzydamine hydrochloride has anti-inflammatory and pain-relieving properties. After rapid absorption and local accumulation in the inflamed tissue, symptoms quickly subside. Tantum Verde is well tolerated locally and provides targeted therapy for inflammatory symptoms and difficulty swallowing.

Areas of application
Symptomatic treatment of painful inflammations of the mouth and throat, such as gingivitis, tonsillitis, pharyngitis, and laryngitis. Tantum Verde is therefore suitable for relieving symptoms, especially during common colds.

If you do not feel better or even worse after 3 days, contact your doctor.

What should you consider before taking it?

What should you consider before using Tantum Verde?

Tantum Verde must not be taken,

- if you are allergic to benzydamine hydrochloride or any of the other ingredients of Tantum Verde listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before using Tantum Verde – lozenges.
The use of this medicine, especially long-term use, can lead to sensitization. In this case, or if any of the listed side effects occur, the preparation should be temporarily discontinued and the treating physician contacted.

If nausea or vomiting occurs, the preparation should be temporarily discontinued.

Tantum Verde lozenges should be used with caution if you have a history of bronchial asthma, as bronchospasms may occur.

If the pain in the mouth and throat increases or if there is no improvement within 3 days, you must contact your treating doctor or dentist. Initial signs of side effects must also be reported to the doctor. This also applies if accidentally high doses of benzydamine hydrochloride are taken (e.g., by children).

If you are hypersensitive to salicylic acid or other anti-inflammatory pain relievers, so-called NSAIDs, the use of benzydamine hydrochloride is not recommended.

Long-term use of the medication could affect the bacterial flora of the oral cavity.

Use of Tantum Verde with other medicines

Tell your doctor or pharmacist if you are taking / using other medicines, have recently taken / used other medicines or intend to take / use other medicines.
No interactions are known.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
When used as intended, use during pregnancy and breastfeeding is possible.

Driving and operating machinery

Tantum Verde has no or negligible influence on the ability to drive and operate machinery.

This medicine contains 3.5 mg aspartame (E 951) per lozenge, corresponding to 3.5 mg/3202 mg.

Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare inherited disorder in which phenylalanine accumulates because the body cannot break it down sufficiently.

Tantum Verde lozenges contain isomalt

Please only take Tantum Verde 3 mg lozenges with honey and orange flavor after consulting your doctor if you know that you suffer from sugar intolerance.

Tantum Verde lozenges contain a fragrance (lemon flavor, peppermint flavor) 

This medicine contains a fragrance with benzyl alcohol, citral, citronellol, D-limonene, eugenol, geraniol and linalool, which can cause allergic reactions.

Tantum Verde lozenges contain butylhydroxyanisole (E 320)

Butylhydroxyanisole (E 320) can cause localized skin irritation (e.g., contact dermatitis), irritation of the eyes and mucous membranes.

How to take the medicine?

How to use Tantum Verde?

Always use this medicine exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure.

The recommended dose is:
Adults, adolescents and children from 6 years:
Take one lozenge 3 - 4 times a day.
For sucking. Let the lozenge slowly dissolve in your mouth.
Treatment should not last longer than 7 days.

Children between 6-11 years:
The medicine should only be used under adult supervision.

Children under 6 years:
Due to the dosage form, the medicine should only be used by children over 6 years of age. Tantum Verde Spray is available for children under 6 years of age.

Elderly patients:
There are no specific recommendations for dosage in elderly patients. Unless otherwise prescribed by the doctor, the dosage specified for adults applies.

Patients with impaired kidney or liver function:
The same dosage and method of administration as for adults are recommended.

If you have forgotten to use Tantum Verde 3 mg lozenges

Do not take a double dose if you have forgotten the previous dose.

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

What side effects are possible?

What side effects are possible?

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

Some side effects occur occasionally.

(may affect 1 to 10 out of 1,000 treated persons)

• Photosensitivity

Some side effects occur rarely.

(may affect 1 to 10 out of 10,000 treated persons)

• Hypersensitivity reactions
• Burning mouth and dry mouth
• Numbness in the mouth and throat (This effect is part of the medicine's action and disappears after a short time.)

Some side effects occur very rarely.

(may affect less than 1 out of 10,000 people treated)

• Spasm of the glottis of the larynx (laryngospasm)
• Painful subcutaneous swelling of the mucous membrane (angioedema)
• Nausea
• Vomiting

Frequency of side effects is not known.

(Frequency cannot be estimated from the available data)
Severe allergic reactions (hypersensitivity)

Signs of a severe allergic reaction (anaphylactic shock) may include
dyspnoea (difficulty breathing), chest pain, chest tightness, dizziness,
feeling weak, severe skin itching, palpable lumps on the skin, swelling of the
face, lips, tongue and/or throat and can be potentially life-threatening.

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 Office for Safety in Health Care. By reporting side effects, you can help provide more information on the safety of this medicine.

Federal Office for Safety in Health Care.
Traisengasse 5
1200 VIENNA
AUSTRIA
Fax: + 43 (0) 50 555 36207
Website: http://www.basg.gv.at

Special storage instructions

How to store Tantum Verde?

Do not store above 30 C.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the foil strip and the outer carton after "EXP". The expiry date refers to the last day of that month.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of medicines when you no longer use them. You are helping to protect the environment.

Special notes on content

Contents of the pack and other information

What Tantum Verde contains

- The active substance is: benzydamine hydrochloride. Each lozenge contains 3 mg of benzydamine hydrochloride.
- The other ingredients are: aspartame (E 951), isomalt, menthol, citric acid monohydrate, peppermint flavor (contains benzyl alcohol, citronellol, D-limonene, eugenol, geraniol and linalool), lemon flavor (contains benzyl alcohol, citral, citronellol, D-limonene, geraniol, linalool and butylhydroxyanisole [E 320]), quinoline yellow (E 104) and indigotine (E 132).

What Tantum Verde looks like and contents of the pack

Green lozenges with a characteristic mint-lemon flavor. The lozenges can be packed in PVC/PE/PVDC – ALU blisters or wrapped in paraffin paper.

Pack size: 20 lozenges.

Not all pack sizes may be marketed.