Zerinol Throat Mint 18 Tablets 20 mg

WARNINGS
The medicine should not be used in children younger 'less than 12 years. 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. Furthermore, in the initial phase of Stevens-Johnson syndrome or toxic epidermal necrolysis (NET), the patient may initially experience non-specific symptoms similar to those of influenza, such as fever, muscle aches, rhinitis, cough and sore throat. Because of 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 can occur in the context of latent disease (eg pharyngeal / laryngeal edema). Local allergic reactions can also cause dyspnea. The local anesthetic properties of ambroxol can alter the sensory perception at the level of the pharyngeal space. The drug is not suitable for the treatment of oral ulcers. In case of impaired renal function or severe liver disease, the medicine can 'be used only after medical consultation. 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 lozenge contains less than 1 mg of lactose. However, patients with rare hereditary problems of galactose intolerance, LAPP lactase deficiency or with glucose / galactose malabsorption problems should use the drug with caution.
PHARMACOTHERAPEUTIC CATEGORY
Prepare for the pharyngeal cavity.
STORAGE
Do not store above 30 degrees C.
CONTRAINDICATIONS / SECONDARY EFFECT
Known hypersensitivity to ambroxol or to any of the excipients. Patients with fructose intolerance should not take the product, as these contain significant amounts of sorbitol.
NAME
ZERINOL THROAT MINT 20 MG PADS
EXCIPIENTS
Mint flavor (gum arabic, Chinese mint oil, maltodextrin, lactose-monohydrate), sorbitol, sodium saccharin, macrogol 6000, talc.
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 conducted with the drug, but only identified as reported cases during post-marketing observation. Immune system disorders, skin and subcutaneous tissue disorders. 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 may increase if the patient takes the same active ingredient again. Nervous system disorders. Common: 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; not known: vomiting, dry throat.
PREGNANCY AND BREASTFEEDING
Animal studies do not indicate direct or indirect harmful effects on fertility. 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. Nevertheless', normal precautions should be taken when taking medication during pregnancy. Especially during the first trimester, the use of the drug is not recommended. Ambroxol hydrochloride is excreted in breast milk. Although undesirable effects on infants are not expected, the use of the drug is not recommended during breastfeeding.
INDICATIONS
Symptomatic treatment of pain in acute inflammations of the throat.
INTERACTIONS
No clinically relevant interactions with other drugs have been observed.
DOSAGE
Adults and children over 12 years: up to 6 tablets per day, to be dissolved in the mouth. The pharmacp should not be used for more '3 days. If symptoms or high fever persist. The medicine should not be used in children younger 'less than 12 years.
ACTIVE PRINCIPLES
Ambroxol hydrochloride.