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Reglisam (Tablets, Granules) Instructions for Use

ATC Code

R07AX (Other drugs for the treatment of respiratory diseases)

Active Substance

Ammonium glycyrrhizate (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

Herbal preparation with expectorant and anti-inflammatory effects

Pharmacotherapeutic Group

Anti-inflammatory agent

Pharmacological Action

It has anti-inflammatory properties, stimulates the function of the adrenal cortex, and has a moderate expectorant effect.

Indications

As an expectorant for respiratory tract diseases with difficult-to-discharge sputum (including bronchial asthma); eczema, allergic dermatitis; asthenic conditions; arterial hypotension; Addison’s disease (diencephalic-pituitary forms, as monotherapy and in combination with ACTH); adrenal insufficiency (against the background of long-term corticosteroid therapy), including the prevention of withdrawal syndrome during the cessation of corticosteroid treatment or reduction of their dose (as part of complex therapy).

ICD codes

ICD-10 code Indication
E27.1 Primary adrenocortical insufficiency
E27.3 Drug-induced adrenocortical insufficiency
F48.0 Neurasthenia
I95 Hypotension
J20 Acute bronchitis
J42 Unspecified chronic bronchitis
J45 Asthma
K59.0 Constipation
L20.8 Other atopic dermatitis (neurodermatitis, eczema)
L23 Allergic contact dermatitis
L24 Irritant contact dermatitis
L28.0 Lichen simplex chronicus (circumscribed neurodermatitis)
L30.0 Nummular eczema
ICD-11 code Indication
5A74.0 Acquired insufficiency of the adrenal cortex
6A8Z Affective disorders, unspecified
9A06.70 Atopic eczema of the eyelids
BA2Z Hypotension, unspecified
CA20.1Z Chronic bronchitis, unspecified
CA23 Asthma
CA42.Z Acute bronchitis, unspecified
DB32.1 Slow-transit constipation
DD91.1 Functional constipation
DE2Z Diseases of the digestive system, unspecified
EA80.0 Infantile atopic eczema
EA80.1 Childhood atopic eczema
EA80.2 Adult atopic eczema
EA80.Z Atopic eczema, unspecified
EA82 Nummular dermatitis
EA83.00 Lichen simplex of vulva
EA83.01 Lichen simplex of male genital organs
EA83.02 Lichen simplex of perianal area
EA83.0Z Lichen simplex of unspecified location
EA85.20 Atopic hand eczema
EK00.Z Allergic contact dermatitis, unspecified
EK02.Z Irritant contact dermatitis, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally. The dose must be individualized based on the patient’s age, clinical indication, and the specific dosage form (tablets or granules) prescribed.

For respiratory conditions with difficult sputum expectoration, including bronchial asthma, take as an expectorant.

For dermatological conditions such as eczema and allergic dermatitis, use for its anti-inflammatory properties.

In cases of arterial hypotension, asthenic conditions, and Addison’s disease, administer to stimulate adrenal cortex function.

For adrenal insufficiency related to long-term corticosteroid therapy, use to prevent withdrawal syndrome during dose reduction or cessation as part of complex therapy.

Adhere strictly to the prescribed dosing schedule. Do not exceed the recommended duration of use.

Monitor for potential adverse effects, including fluid retention and allergic reactions.

In pediatric patients over 5 months, use only age-appropriate dosage forms. This product is contraindicated in children under 5 months of age.

Consult the full prescribing information for specific dosing instructions related to the chosen formulation.

Adverse Reactions

Possible retention of water in the body; allergic reactions.

Contraindications

Hypersensitivity to ammonium glycyrrhizinate, severe organic heart lesions; hepatic and/or renal failure, pregnancy, breastfeeding period, children under 5 months of age; in children over 5 months, there are contraindications for certain dosage forms.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and breastfeeding.

Use in Hepatic Impairment

Use is contraindicated in hepatic insufficiency.

Use in Renal Impairment

Use is contraindicated in renal insufficiency.

Pediatric Use

Use is contraindicated in children under 5 months of age. In children over 5 months, it should be used in dosage forms intended for the corresponding age category.

Special Precautions

In children over 5 months, it should be used in dosage forms intended for the corresponding age category.

Drug Interactions

It is possible to enhance the effect of drugs that stimulate the function of the adrenal cortex.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Vifitech, CJSC (Russia)

Dosage Form

Bottle OTC Icon Reglisam Granules for oral solution for children 25 mg/1.3 g: sachets 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Granules for the preparation of an oral solution for children from white to white with a yellowish tint.

1 sachet
Ammonium glycyrrhizate 25 mg

Excipients: sodium citrate dihydrate (sodium hydrogen citrate) – 0.05 g, potato starch – 0.01 g, milk sugar (lactose monohydrate) – 1.215 g.

1.3 g – sachets made of packaging paper with polyethylene coating or laminated paper (10) – cardboard packs.
1.3 g – sachets made of packaging paper with polyethylene coating or laminated paper (30) – cardboard packs.

Marketing Authorization Holder

Vifitech, CJSC (Russia)

Dosage Form

Bottle OTC Icon Reglisam Tablets 50 mg: 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets round, flat-cylindrical in shape with a bevel, from white with a yellowish tint to yellow with a brownish tint with inclusions of a darker color.

1 tab.
Ammonium glycyrrhizate 50 mg

Excipients: sodium chloride – 0.1 g, potato starch – 0.008 g, talc – 0.001 g.

10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.

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