Zerinol Throat Mint 20mg Ambroxol Hydrochloride 18 Tablets

Mint flavored tablets based on ambroxol hydrochloride.

Therapeutic indications

Zerinol Gola Menta is used in the symptomatic treatment of pain in acute inflammations of the throat.

Dosage and Posology

The drug should be taken according to the following doses and methods in adults and children over 12 years: up to 6 tablets per day, to be dissolved in the mouth.

Zerinol Throat mint 20 mg lozenges should not be used for more than 3 days. If symptoms or a high fever persist, the patient should consult a doctor. Zerinol Throat mint 20 mg lozenges should not be used in children under 12 years of age.

Overdose

No specific symptoms of overdose in humans have been reported to date. Symptoms observed in cases of accidental overdose and / or medication errors are consistent with the expected side effects of Zerinol Throat 20 mg tablets at recommended doses, and may require symptomatic treatment.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients
• Fructose intolerance as these contain significant amounts of sorbitol.

Side effects

Frequency estimated based on available clinical data: very common: ≥ 10%, common: ≥ 1% and <10%, uncommon: ≥ 0.1% and <1%, rare: ≥ 0.01% and <0.1%, very rare: <0.01% not known: frequency cannot be estimated from the available data, as adverse reactions were not observed in clinical studies with Zerinol Gola 20 mg, but only identified as observed cases post-marketing.

- Immune system disorders, skin and subcutaneous tissue disorders:

• Frequency not known: anaphylactic reactions including anaphylactic shock, angioedema, rash, urticaria, pruritus and other hypersensitivity reactions. As is generally observed for allergies, the severity of allergic reactions can increase if the patient takes the same active ingredient again

- Nervous system disorders:

• Common frequency: dysgeusia (altered perception of flavors). Gastrointestinal, respiratory, thoracic and mediastinal disorders
• Common frequency: hypoesthesia of the oral cavity and pharynx, nausea.
• Frequency uncommon: diarrhea, pain in the upper abdominal quadrants, dyspepsia, dry mouth.
• Frequency not known: vomiting, dry throat

Pregnancy and breastfeeding

Ambroxol hydrochloride crosses the placental barrier. Animal studies have not shown any direct or indirect harmful effects on pregnancy, embryonal / fetal development, parturition or postnatal growth. Extensive clinical experience after the 28th week of pregnancy has not shown the appearance of harmful effects on the fetus. Nonetheless, normal precautions should be taken when taking medication during pregnancy. Especially during the first trimester, the use of Zerinol Throat mint 20 mg lozenges is not recommended.

Ambroxol hydrochloride is excreted in breast milk. Although no adverse effects on infants are expected, the use of Zerinol Throat mint 20 mg lozenges is not recommended during breastfeeding.

Special warnings

Zerinol Throat mint 20 mg lozenges should not be used in children under 12 years of age. In very few cases, severe skin lesions such as Stevens-Johnson Syndrome and toxic epidermal necrolysis (NET) have been observed simultaneously with the administration of expectorants such as ambroxol hydrochloride. Most of these injuries could be explained by the severity of the patient's underlying disease and / or other concomitant medications. Also, in the early stage of Stevens-Johnson syndrome or toxic epidermal necrolysis (NET), the patient may initially experience nonspecific, flu-like symptoms, such as fever, body aches, rhinitis, cough, and sore. of throat. Due to these misleading symptoms it is possible that symptomatic treatment with cough and cold medications may be undertaken. Therefore, if new skin or mucosal lesions occur, consult your doctor immediately and stop treatment with ambroxol hydrochloride as a precaution.

Episodes of dyspnoea may occur in the context of latent disease (eg pharyngeal / laryngeal edema). Local allergic reactions (see section 4.8: angioneurotic edema) can also cause dyspnoea. The local anesthetic properties of ambroxol can alter sensory perception in the pharyngeal space (see section 4.8: oral and pharyngeal hypoesthesia). Zerinol Throat mint 20 mg lozenges are not suitable for the treatment of oral ulcers. In such cases, contact your doctor. In case of impaired kidney function or severe liver disease, Zerinol Gola mint 20 mg tablets can only be used after consulting your doctor. As with any medicinal product, with hepatic metabolism followed by renal elimination, accumulation of metabolites of ambroxol in the liver may occur in severe renal insufficiency.

This medicinal product contains 8.2 g of sorbitol per maximum recommended daily dose (1.37 g / tablet). Patients with a rare hereditary condition of fructose intolerance should not take this medicine. One Zerinol Throat Mint 20 mg lozenge lozenge contains less than 1 mg of lactose. This dose does not normally cause disturbances in lactose intolerant subjects. However, patients with rare hereditary problems of galactose intolerance, the LAPP lactase deficiency or with problems of glucose / galactose malabsorption should use Zerinol Gola Mint 20 mg lozenges with caution.

Expiration and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Do not store above 30 ° C.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

One tablet of Zerinol Gola Menta contains:

Active principle

20 mg of ambroxol hydrochloride

Excipients

Mint flavor (gum arabic, Chinese mint oil, maltodextrin, lactose monohydrate), sorbitol, sodium saccharin, macrogol 6000, talc.