Zerinol Throat Lemon 20mg Ambroxol Hydrochloride 18 Tablets

Lemon flavored tablets based on ambroxol hydrochloride.

Therapeutic indications

Zerinol Gola is used in the symptomatic treatment of acute pain in sore 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 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 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. The symptoms observed in cases of accidental overdose and / or in cases of 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 trials with Zerinol Gola 20 mg, but only identified as cases reported during post observation. -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 seen with allergies, the severity of allergic reactions can increase if the patient takes the same substance again

- Nervous system disorders:

• Common frequency: dysgeusia (altered perception of flavors).

- Gastrointestinal, respiratory, thoracic and mediastinal disorders

• Common: hypoesthesia of the oral cavity and pharynx, nausea.
• Uncommon: diarrhea, pain in the upper abdominal quadrants, dyspepsia, dry mouth.
• Rare: dry throat.
• Not known: vomiting

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 Gola 20 mg tablets is not recommended.

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

Special warnings

Zerinol Throat 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 dyspnea can occur in the context of latent disease such as a swollen throat. Local allergic reactions (see section 4.8: angioneurotic edema) can also cause dyspnoea.

The local anesthetic properties of ambroxol can alter sensory perception at the level of the pharyngeal space. Zerinol Throat 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 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 per tablet) and 37.8 mg of sucrose per maximum recommended daily dose (6.3 mg per tablet). Patients with a rare hereditary condition of fructose intolerance should not take this medicine.

The local anesthetic properties of ambroxol can alter sensory perception at the level of the pharyngeal space. Zerinol Throat 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 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 per tablet) and 37.8 mg of sucrose per maximum recommended daily dose (6.3 mg per tablet). Patients with a rare hereditary condition of fructose intolerance should not take this medicine.

Expiry 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 Zerinol Gola tablet contains:

Active principle

20 mg of ambroxol hydrochloride

Excipients

Lemon flavor (containing sucrose), Frescofort flavor, Sorbitol (E420), Sucralose, Macrogol 6000, Talc