read all of this leaflet carefully before you - Angelini.it

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
This is a SELF-TREATMENT medicinal product which you can use in case of mild and
transitory ailments easy to be identified with no need of medical help.
This medicine is available without prescription. However it is to be correctly used in order to
ensure efficacy and reduce side effects.
If you have any further questions, ask your pharmacist.
If the problem should persist after a short period of treatment, consult your physician.
TANTUM VERDE P 3 mg lemon flavoured tablets
benzydamine hydrochloride
Composition
Each tablet contains:
Active ingredient: benzydamine hydrochloride 3 mg (equivalent to benzydamine 2.68 mg);
Excipients: Isomalt (E 953), Aspartame (E 951), Citric acid monohydrate, Lemon flavour, Mint
flavour, Quinoline yellow (E104), Indigotin (E132).
How it presents
Tantum Verde P is marketed in the form of tablets; tablets are translucent, light-green, squareshaped
with a central cavity and a typical lemon flavour.
Each packaging of lemon flavoured tablet contains 20 or 30 tablets.
What it is
Tantm verde P is a medicinal product for oral use, effective in the symptomatic treatment of
irritations of mouth and throat.
Tantum verde P also produce a local anesthetic action of medium intensity.
Marketing Authorization Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A., viale Amelia 70, 00181 Rome
Manufacturer
Disch AG (Gruppo Ricola) - Othmarsingen (Svizzera)
Final inspector
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona -
Why it is used for
Tantum Verde P is used as symptomatic treatment for pain and irritations (which manifest burning,
reddening, swelling sensation, difficulty in swallowing) of mouth and throat.
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When it should not be used
Hypersensitivity to active ingredient or other strictly correlated chemical substances.
Given the type of pharmaceutical form, the administration of Tantum Verde P tablets must be
limited to children over 6 years.
When it should only be used on medical advice
Pregnancy and breastfeeding (see “how to behave in pregnancy and breastfeeding).
How to behave in pregnancy and breastfeeding
In pregnant and breastfeeding women, Tantum Verde P tablets should only be used after consulting
the doctor and assessing with him the individual risk/benefit ratio.
Consult your physician if you suspect a possible pregnancy or are planning a pregnancy.
Medications and food able to alter the effect of the drug
Where using other medicinal products, ask for your physician or pharmacist’s advice.
It is important to know that
In a limited number of patients, oro-pharyngeal ulcers may be a sign of more serious pathologies. If
symptoms should persist for more than 3 days, therefore, the patient must consult his physician or
dentist if necessary.
The use of benzydamine is inadvisable in cases of hypersensitivity to salicylic acid or other FANS
Caution should be used in patients with history of bronchial asthma, as bronchospasm events may
develop in these group of subjects.
The control of an adult person is advisable when used for children between 6 and 11 years of age.
The aspartame sweetener contains a phenylalanine derivative and must not therefore be used by
patients suffering from phenylketonuria.
The product contains isomalt: in cases of established intolerance to sugars, the attending physician
should be consulted before using the medication.
Tantum Verde P tablets are sugar free (therefore may also be used by patients suffering from
hyperglycemia or on low-calorie diets who must avoid sugar intake) and contain aspartame as
sweetening.
Use of this product at the advised dosage does not alter driving capacity or use of other machinery.
Notes of Health Education
Some environmental conditions, such as temperature decrease or changes, increased humidity rate
etc., may cause the inflammation in the upper respiratory tract, as these favour attack of pathogenic
germs.
Typical symptomatology includes, amongst others, burning sensation, throat pain, swallowing
distress.
In order to prevent exacerbation of those symptoms, it may be helpful to avoid some further
irritating factors such as smoke, dry air, smog, crowded places, etc.
How to use this medicinal product
How much
One tablet three times a day.
Warning: do not exceed the prescribed dose unless recommended by your physician.
When and how long
Take the drug when necessary, at any time during the day.
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Do not use for more than 7 days.
Consult your doctor if the problem is repeated or has been recently showing changes in characters.
Which way
In order to obtain maximum benefit, it is advisable to slowly dissolve tablet in mouth.
What to do in case of overdose:
No case of overdose has been reported for the tablets.
In case of overdose only a symptomatic treatment is possible; empty the stomach provoking vomit
or by gastric lavage keeping the patient under observation with support treatment and keeping an
adequate hydration.
If you have accidentally swallowed/taken an excess dose of Tantum Verde P tablets, inform the
doctor at once or refer to the closest hospital. Take this explanatory leaflet with you.
Side effects
Gastrointestinal disorders
Rare (> 1/10.000, < 1/1000):
Burning sensation in the mouth
Dryness of the mouth
Immune system disorders
Rare (> 1/10.000, < 1/1000)
Hypersensitivity reactions
Respiratory, chest and mediastinum disorders
Very rare (< 1/10.000)
Laryngospasm
Skin and subcutaneous tissue disorders
Photosensitivity
Very rare (< 1/10.000)
Angioedema
Observance of directions contained in the explanatory leaflet reduces the risk of side effects.
Though they are usually short-lived, when side effects develop, it is advisable for you to contact
your doctor or the pharmacist. It is important that side effects not listed in this explanatory leaflet
are reported in to your doctor or pharmacist.
Ask for and fill in the side effects report from available at the pharmacy (B form).
Shelf life and storage
See the expiry date reported on the packaging. This date refers to the properly stored unopened
package.
Warning: do not use the product after the expiry date shown on the package.
Store below 25 °C in the original packaging.
Keep the product out of the reach and the sight of children.
Keep box and explanatory leaflet, so that information concerning the drug is available all the time.
Explanatory leaflet revised by the Italian Medicines Agency: February 2006
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