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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Granules for oral solution for children 25 mg/1.3 g: sachets 10 or 30 pcs.
Marketing Authorization Holder
Vifitech, CJSC (Russia)
Dosage Form
| 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.
Tablets 50 mg: 50 or 100 pcs.
Marketing Authorization Holder
Vifitech, CJSC (Russia)
Dosage Form
| 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.
