Tegens 160 mg 20 sachets granules for oral solution

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Symptoms attributable to venous insufficiency; states of capillary fragility.

ACTIVE INGREDIENTS

TEGENS 160 mg hard capsules: Each capsule contains: Active ingredient: blueberry anthocyanoside complex with 36% anthocyanosides (Myrtocyan) 160 mg. TEGENS 160 mg granules for oral solution: Each sachet contains: Active ingredient: blueberry anthocyanoside complex with 36% anthocyanosides (Myrtocyan) 160 mg. Excipient(s) with known effects: one capsule contains 20 mg of lactose. One sachet contains 15 mg of lactose. For the full list of excipients, see section 6.1.

EXCIPIENTS

Hard capsules: mannitol, lactose, methylcellulose, citric acid, precipitated silica, magnesium stearate, gelatin (shell excipient). Granules for oral solution: mannitol, lactose monohydrate, methylcellulose, anhydrous citric acid, blueberry aroma, ammonium glycyrrhizate.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1.

DOSAGE

Dosage ADULTS: capsules or sachets of granules: 1-2 per day. It is advisable to take this medicine in the morning and in the evening, with intervals of 12-24 hours. Do not exceed the recommended doses. Pediatric population The use of the product is reserved for adults. Method of administration The granules, to be taken as such or dissolved in a little water, are recommended in subjects with swallowing difficulties and in conditions of irritability of the gastric mucosa due to gastric-ulcerative processes.

CONSERVATION

Hard capsules: Store at a temperature not exceeding 30°C. Granules for oral solution: no special precautions for storage.

WARNINGS

As with all symptomatic treatments, it is necessary to contact your doctor if the symptoms do not improve after a short period of treatment. Clinical use has not highlighted the need for particular precautions when using the drug. This medicine contains lactose: patients suffering from rare hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medicine. Pediatric population The use of the product is reserved for adults.

INTERACTIONS

Phenomena attributable to interactions with other substances have never been reported.

SIDE EFFECTS

TEGENS has excellent tolerability. Rare cases of gastrointestinal disorders have been reported, such as heartburn, nausea and a sense of gastric heaviness, and skin rashes.Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: http://www.agenziafarmaco.gov.it/it/responsabili.

OVERDOSE

No cases of overdose have been reported.

PREGNANCY AND BREASTFEEDING

Pregnancy The safety of the drug in pregnancy has not been determined, therefore it is advisable not to administer the product during pregnancy. Breastfeeding During breastfeeding, the product should be used in cases of actual necessity under the direct supervision of the doctor.

EFFECTS ON DRIVING ABILITY

There are no known negative effects on the ability to drive and use machines.