Mucaltin® forte with vitamin c

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MUCALTIN® FORTE WITH VITAMIN C (MUCALTIN FORTE WITH VITAMIN C)

Composition:

Active substances: 1 tablet contains mukaltin 100 mg, ascorbic acid 100 mg;

Excipients: sucrose (saccharose), microcrystalline cellulose, sorbitol (E 420), aspartame (E 951), calcium stearate, flavoring agent (orange).

Pharmaceutical form. Chewable tablets.

Main physicochemical properties: greyish-brown tablets with specks, round-shaped with biconvex surface; non-uniformity of tablet surface coloration is permissible.

Pharmacotherapeutic group. Expectorant agents. ATC code R05C A05.

Pharmacological properties.

Mucaltin® Forte with vitamin C is an expectorant agent whose action is due to its secretolytic and broncholytic properties. The drug exerts a moderate antitussive effect, reduces the number of coughing episodes and their intensity, increases the volume of sputum production, and decreases its viscosity. It has soothing, anti-inflammatory, and demulcent actions. Normalizes altered bronchopulmonary secretion and improves sputum expulsion.

Ascorbic acid (vitamin C) participates in redox reactions, carbohydrate and tyrosine metabolism, iron metabolism, conversion of folic acid into folinic acid, blood coagulation, synthesis of steroid hormones, collagen and procollagen, tissue regeneration, regulation of capillary permeability, lipid and protein synthesis, and cellular respiration processes.

Vitamin C enhances the body's resistance to infections and adverse environmental influences.

Clinical characteristics.

Indications.

Cough associated with acute and chronic respiratory tract diseases accompanied by the production of thick and viscous bronchial secretions and/or impaired expectoration: bronchitis, pneumonia, bronchiectasis, bronchial asthma.

Contraindications.

Hypersensitivity to the components of the drug. Thrombosis, thrombophlebitis, diabetes mellitus, severe kidney diseases. Phenylketonuria, congenital fructose intolerance, glucose-galactose malabsorption syndrome.

Interaction with other medicinal products and other types of interactions.

Do not administer simultaneously with drugs that suppress cough (e.g., codeine).

Due to the presence of ascorbic acid in the formulation, the drug reduces the toxicity of sulfonamide agents, decreases the effect of heparin and indirect anticoagulants, promotes iron absorption, enhances the absorption of penicillin and tetracycline, and intensifies the side effects of salicylates (increased risk of crystalluria).

The use of oral contraceptives, consumption of fruit juices, and alkaline beverages reduces the level of vitamin C in the body.

Vitamin C in combination with deferoxamine increases tissue iron toxicity, particularly in the myocardium, which may lead to circulatory decompensation. Therefore, Mucaltin® Forte with vitamin C should be taken only 2 hours after deferoxamine injection.

Vitamin C increases the total clearance of ethanol.

When the recommended doses of Mucaltin® Forte with vitamin C are significantly exceeded, the drug may reduce the effectiveness of tricyclic antidepressants, neuroleptics—phenothiazine derivatives, tubular reabsorption of amphetamine, impair renal excretion of mexiletine, and inhibit the disulfiram-alcohol reaction in patients treated with disulfiram.

Special precautions.

The drug may alter the results of various laboratory tests (blood glucose, bilirubin levels, transaminase and lactate dehydrogenase activities). Absorption of vitamin C may be impaired in intestinal dyskinesia, enteritis, and achylia.

High doses of the drug significantly exceeding the recommended amounts, due to the presence of vitamin C in the formulation, should not be used in patients with increased blood coagulability, a history of kidney disease, hemochromatosis, thalassemia, polycythemia, or urolithiasis.

If dyspnea, fever, or purulent sputum occur during treatment, immediate medical consultation is required.

In some patients with chronic inflammatory lung diseases, at the beginning of treatment with Mucaltin® Forte with vitamin C, sputum viscosity may increase due to the release of accumulated sputum in the bronchial tree containing large amounts of debris, proteins, and inflammatory cells. Therefore, in cases of diffuse bronchial involvement, significant changes in the physicochemical properties of sputum, and impaired mucociliary transport, therapy with Mucaltin® Forte with vitamin C should be combined with the administration of mucolytic agents.

Due to the presence of sucrose in the formulation, the drug may have a harmful effect on teeth.

Use during pregnancy or breastfeeding.
Experience of use is lacking.

Ability to affect reaction rate while driving or operating machinery.
No effect.

Dosage and Administration

For adults and children aged 12 years and older: 1 tablet 4 times daily before meals. The tablets should be chewed until completely dissolved. The dose for children aged 3 to 12 years is 1 tablet 3 times daily.

The usual duration of treatment is 5–7 days. If symptoms persist after this treatment period, consult a physician regarding the possibility of extending the treatment.

Children. The drug is contraindicated in children under 3 years of age.

Overdose.

Overdose is unlikely when the recommended therapeutic doses are used.

In case of overdose, the following may occur: nausea, vomiting, heartburn, diarrhea, dizziness, increased excitability, sleep disturbances, headache, vitamin C hypervitaminosis, kidney glomerular apparatus damage, crystalluria, formation of urate and oxalate stones; possible suppression of pancreatic islet function, impaired glycogen synthesis up to the development of diabetes mellitus, arterial hypertension, myocardial dystrophy, thrombocytosis, hyperprothrombinemia, erythrocytopenia, neutrophilic leukocytosis, and disturbances in zinc and copper metabolism.

Treatment: gastric lavage should be performed and medical advice sought. Therapy is symptomatic.

Side effects.

In some cases, allergic reactions are possible, including rash, urticaria, skin itching, angioedema (Quincke's edema), anaphylactic shock.

Nervous system side effects: headache.

Gastrointestinal side effects: dyspeptic disorders, including heartburn, diarrhea, nausea, vomiting.

Blood and lymphatic system side effects: in patients with glucose-6-phosphate dehydrogenase deficiency of red blood cells, hemolysis of erythrocytes may occur.

Other side effects: sensation of warmth.

If adverse reactions occur, the drug should be discontinued.

Shelf life. 2 years.

Storage conditions.

In the original packaging, at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

10 tablets per blister, 2 or 10 blisters per carton.

Availability. Over-the-counter (without prescription).

Manufacturer.

JSC "Kyivmedpreparat".

JSC "Halychpharm".

Manufacturer's address and place of business.

139 Saksaganskoho Street, Kyiv, 01032, Ukraine.

6/8 Opryshkivska Street, Lviv, 79024, Ukraine.

Marketing Authorization Holder.

JSC "Halychpharm".

Address of the Marketing Authorization Holder.

6/8 Opryshkivska Street, Lviv, 79024, Ukraine.