Tantum verde forte
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Tantum Verde Forte
3 mg/ml, oral and throat spray
Benzydamini hydrochloridum
Please read the leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used according to the instructions in this patient leaflet or as directed by a doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
- If there is no improvement after 7 days, or if you feel worse, consult your doctor.
Contents of the leaflet:
- What Tantum Verde Forte is and what it is used for
- Important information before using Tantum Verde Forte
- How to use Tantum Verde Forte
- Possible side effects
- How to store Tantum Verde Forte
- Contents of the pack and other information
1. What Tantum Verde Forte is and what it is used for
Tantum Verde Forte contains the active substance benzydamine, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Benzydamine has strong anti-inflammatory and analgesic properties and acts locally as a local anesthetic and antiseptic. Due to its excellent local absorption and high concentration in inflamed tissues, symptoms quickly subside. The medicine is well tolerated and suitable for local treatment of inflammatory symptoms.
Tantum Verde Forte is used to treat symptoms (pain, redness, swelling) associated with inflammation of the mouth and throat, such as bacterial and viral infections, laryngitis, mucosal inflammation following radiotherapy, postoperative conditions in otorhinolaryngology and dentistry, and after intubation.
2. Important information before using Tantum Verde Forte
When not to use Tantum Verde Forte
If the patient is allergic to the active substance or to any of the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
Before starting treatment with Tantum Verde Forte, discuss it with your doctor or
pharmacist.
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The use, especially long-term, of locally acting medicines may cause allergic reactions. In such a case, discontinue the medicine and consult a doctor, who will recommend appropriate management.
Tantum Verde Forte and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to use.
No interactions between Tantum Verde Forte and other medicines are known.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The doctor will decide on the suitability of using this medicine during pregnancy and breastfeeding.
Driving and operating machinery
This medicine has no influence on the ability to drive or operate machinery.
Tantum Verde Forte contains methyl parahydroxybenzoate (E 218) and hydrogenated castor oil.
The medicine may cause allergic reactions (including delayed-type reactions).
The medicine may cause skin reactions.
3. How to use Tantum Verde Forte
This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is intended for use in adults, particularly in individuals who cannot gargle.
Use the medicine 2 to 6 times daily, administering 2–4 doses each time.
Each dose contains 0.17 ml of solution.
Do not exceed the recommended dose.
This medicine is intended for short-term use only. Continuous treatment should not exceed 7 days. If symptoms recur or worsen, consult a doctor.
Instructions for use:
- Raise the cannula.
- Place the cannula in the mouth and direct its outlet towards the inflamed area in the oral cavity or throat.
- Press firmly with a finger on the knurled surface of the pump until a dose of the medicine is released. Repeat this action the required number of times.
Note: When using the medicine for the first time, press the pump several times to prime it and ensure proper spray function.
If the effect of the medicine feels too strong or too weak, consult your doctor.
Use of more than the recommended dose of Tantum Verde Forte
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If more than the recommended dose is used or if a large amount of the medicine is accidentally swallowed, contact a doctor or pharmacist immediately. Bring this leaflet with you.
Missed dose of Tantum Verde Forte
Do not use a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Uncommon
(less than 1 in 100 people, but more than 1 in 1000 people):
skin damage due to photosensitivity (phototoxic reactions).
Rare
(less than 1 in 1000 people, but more than 1 in 10,000 people):
burning sensation or dryness in the mouth.
Very rare
(less than 1 in 10,000 people):
laryngospasm, angioedema.
Frequency not known
(cannot be estimated from the available data):
- allergic reaction (hypersensitivity),
- severe allergic reaction (anaphylactic shock), the symptoms of which may include difficulty breathing, pain or tightness in the chest, and (or) dizziness/fainting, severe itching of the skin or raised skin rashes, swelling of the face, lips, tongue, and (or) throat, which may potentially be life-threatening.
- nausea, vomiting, oral mucositis, dizziness, headache.
Local symptoms are related to the pharmacodynamic action of benzydamine, which, among other effects, has a local anaesthetic action.
Local adverse effects are usually transient, resolve spontaneously, and rarely require additional treatment.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting adverse effects, additional information on the safety of the medicine can be collected.
5. How to store Tantum Verde Forte
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Keep this medicine out of sight and reach of children.
No special storage instructions apply.
After opening, use within 6 months.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the pack and other information
What Tantum Verde Forte contains
- The active substance is benzydamine hydrochloride. 100 ml of solution contains 0.3 g of benzydamine hydrochloride.
- Other ingredients are: glycerol, ethanol 96%, sodium saccharin, methyl parahydroxybenzoate (E 218), peppermint flavouring composition, hydrogenated castor oil, purified water.
What Tantum Verde Forte looks like and contents of the pack
Tantum Verde Forte is a mint-flavoured solution for spraying into the oral cavity and throat.
The packaging consists of an HDPE bottle containing 15 ml of solution, equipped with a dosing pump.
The bottle is placed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Lithuania, country of export:
Angelini Pharma Österreich GmbH
Brigittenauer Lände 50-54
1200 Vienna
Austria
Manufacturer
A.C.R.A.F. S.p.A
Via Vecchia del Pinocchio 22
60131 Ancona
Italy
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in Lithuania, country of export: LT/1/01/0257/006
Parallel import authorisation number: 77/18
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