L-cet®

INSTRUCTION for medical use of the medicinal product L-CEТ® (L-CET®)

Composition:

Active substance: levocetirizine dihydrochloride;

One film-coated tablet contains levocetirizine dihydrochloride 5 mg;

Excipients: microcrystalline cellulose, sodium croscarmellose, magnesium stearate, colloidal anhydrous silicon dioxide, Opadry II 85G51300 green*;

*Opadry II 85G51300 green: polyvinyl alcohol, talc, titanium dioxide (E 171), polyethylene glycol, lecithin, indigo carmine (E 132), quinoline yellow (E 104), yellow azo FCF (E 110).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: round, biconvex, film-coated tablets of green colour.

Pharmacotherapeutic group.

Antihistamines for systemic use. Piperazine derivatives. ATC code R06AE09.

Pharmacological properties.

Pharmacodynamics.

Levocetirizine is the active, stable R-enantiomer of cetirizine and belongs to the group of competitive histamine antagonists. Its pharmacological effect is due to blockade of H1-histamine receptors. The affinity of levocetirizine for H1-histamine receptors is twice as high as that of cetirizine. It affects the histamine-dependent phase of the allergic reaction, reduces eosinophil migration, vascular permeability, and limits the release of inflammatory mediators. It prevents the development and alleviates the course of allergic reactions, exerting anti-exudative, anti-pruritic, and anti-inflammatory effects, with minimal anticholinergic and anti-serotonin activity.

Pharmacokinetics.

The pharmacokinetic parameters of levocetirizine are linear, dose- and time-independent, and exhibit low variability among different patients. The pharmacokinetic profile following administration of a single enantiomer is the same as that observed with cetirizine. No chiral inversion occurs during absorption or elimination.

Absorption. After oral administration, levocetirizine is rapidly and extensively absorbed. The extent of absorption is independent of the dose and is not altered by food intake, although the maximum concentration (C_max) is reduced and reached later. Bioavailability is 100%.

In 50% of patients, the effect of levocetirizine begins within 12 minutes after a single dose, and in 95% of patients within 0.5–1 hour. In adults, peak plasma concentration (C_max) is achieved within 50 minutes after a single oral therapeutic dose. Steady-state plasma concentration is reached after 2 days of continuous dosing. C_max is 270 ng/mL after a single dose and 308 ng/mL after repeated administration of 5 mg once daily.

Distribution. There is no available information on the distribution of the drug in human tissues or on the penetration of levocetirizine across the blood-brain barrier. In animal studies, the highest concentrations were observed in the liver and kidneys, while the lowest were found in tissues of the central nervous system. Distribution of levocetirizine is limited, with a volume of distribution of 0.4 L/kg. Plasma protein binding is 90%.

Metabolism. In humans, the extent of metabolism is less than 14% of the administered dose of levocetirizine; therefore, differences due to genetic polymorphism or concomitant use of enzyme inhibitors are expected to be negligible. Metabolic processes include aromatic oxidation, N- and O-dealkylation, and conjugation with taurine. Dealkylation is primarily mediated by cytochrome CYP3A4, whereas aromatic oxidation involves multiple and/or undefined CYP isoforms. Levocetirizine did not affect the activity of cytochrome isoforms 1A2, 2C9, 2C19, 2D6, 2E1, and 3A4 at concentrations significantly exceeding the maximum levels achieved after a 5 mg oral dose. Given the low extent of metabolism and lack of inhibitory effect on metabolic enzymes, drug interactions involving levocetirizine (either as a perpetrator or victim) are unlikely.

Elimination. The drug is eliminated via two pathways: glomerular filtration and active tubular secretion. The plasma elimination half-life (T_1/2) of levocetirizine in adults is 7.9 ± 1.9 hours. The elimination half-life is shorter in younger children. The mean apparent total clearance in adults is 0.63 mL/min/kg. The majority of levocetirizine and its metabolites are excreted via the urine (approximately 85.4% of the administered dose). Only 12.9% of the administered dose is excreted in feces.

Special populations

Renal impairment.

The apparent clearance of levocetirizine correlates with creatinine clearance. Therefore, in patients with moderate to severe renal impairment, the dosing interval should be adjusted based on creatinine clearance. In anuric patients with end-stage renal disease, total clearance is reduced by approximately 80% compared to individuals without such impairment. The amount of levocetirizine removed during a standard 4-hour hemodialysis session is < 10%.

Clinical characteristics.

Indications.

For symptomatic treatment of allergic rhinitis (including perennial allergic rhinitis) and urticaria in adults and children aged 6 years and older.

Contraindications.

Hypersensitivity to levocetirizine, cetirizine, hydroxyzine, or to any other piperazine derivatives, as well as to any of the excipients of the medicinal product.

Severe form of chronic renal insufficiency (creatinine clearance < 15 mL/min) (requiring dialysis).

Interaction with other medicinal products and other forms of interaction.

Studies on levocetirizine interaction (particularly with CYP3A4 inducers) have not been conducted. Studies on cetirizine interaction (the racemate compound) have shown that concomitant administration with antipyrine, azithromycin, cimetidine, diazepam, erythromycin, glipizide, ketoconazole, or pseudoephedrine does not cause clinically significant adverse effects. In a multiple-dose study, concomitant administration with theophylline (400 mg/day) resulted in a slight reduction (by 16%) in cetirizine clearance (theophylline distribution was not altered). In a multiple-dose study with ritonavir (600 mg twice daily) and cetirizine (10 mg daily), cetirizine exposure increased by approximately 40%, while ritonavir distribution was slightly altered (–11%) with concomitant cetirizine use.

There are no data on potentiation of sedative effects when used at therapeutic doses. However, concomitant use of sedatives should be avoided during levocetirizine administration.

Food intake does not affect the extent of drug absorption, but co-ingestion of food reduces the rate of absorption.

Concomitant use of cetirizine or levocetirizine with alcohol or other central nervous system depressants in sensitive patients may result in additional impairment of attention and ability to perform tasks.

Special precautions for use.

During therapy with levocetirizine, alcohol consumption should be avoided (see section "Interaction with other medicinal products and other forms of interaction").

When prescribing the medicinal product to patients with factors predisposing to urinary retention (e.g., spinal cord injury, benign prostatic hyperplasia), it is necessary to consider that levocetirizine may increase the risk of urinary retention.

The medicinal product should be prescribed with caution to patients with epilepsy or those at risk of seizures, as levocetirizine may exacerbate seizures.

Antihistamine medicinal products suppress the response to skin allergy tests; therefore, levocetirizine should be discontinued at least 3 days prior to testing (elimination period).

Symptoms such as pruritus may occur after discontinuation of levocetirizine, even if such symptoms were not present before treatment initiation. These symptoms may resolve spontaneously. In some cases, symptom severity may be significant, requiring resumption of the medicinal product. Symptoms should resolve after resuming treatment.

Children. Levocetirizine in tablet form should not be used in children under 6 years of age, as this dosage form does not allow appropriate dose adjustment. This patient group should be prescribed levocetirizine in a dosage form suitable for pediatric use.

Excipients. The product contains the dye "Yellow Sunset FCF" (E 110), which may cause allergic reactions.

This medicinal product contains less than 1 mmol of sodium per 1 tablet, i.e., it is practically sodium-free.

Use during pregnancy or breastfeeding.

Pregnancy.

Levocetirizine is contraindicated during pregnancy.

Breastfeeding.

Cetirizine passes into breast milk; therefore, if it is necessary to use the product, breastfeeding should be discontinued.

Fertility.

There are no clinical data (including animal studies) on the effect of levocetirizine on fertility.

Ability to affect reaction speed when driving or operating machinery.

Comparative clinical trials have not shown any evidence that levocetirizine at the recommended dose impairs attention, reaction speed, or ability to drive vehicles or operate machinery.

However, some patients may experience somnolence, fatigue, or asthenia during treatment with levocetirizine. Therefore, patients intending to drive, engage in potentially hazardous activities, or operate machinery should take into account their individual response to the medicinal product.

Method of administration and dosage.

The medication should be administered to adults and children aged 6 years and older orally, regardless of food intake. The tablet should be swallowed whole with a small amount of water.

Dosage

Adults and children aged 12 years and older: The daily dose is 5 mg (1 coated tablet) once daily.

Elderly patients: Dose adjustment is recommended for elderly patients with moderate to severe renal impairment (see section "Renal impairment" below).

Renal impairment: Dosage should be individually adjusted according to renal function (eGFR [estimated glomerular filtration rate]) as specified in the table below.

Table. Dose adjustment of the medication in patients with impaired renal function.

For children with impaired renal function, the dose of the medicinal product should be individually adjusted according to the patient's renal clearance and body weight.

There are no specific data regarding the use of the drug in children with impaired renal function.

Hepatic insufficiency. Dose adjustment is not required in patients with hepatic insufficiency alone. In patients with both hepatic and renal insufficiency, dosage regimen should be adjusted according to the table above.

Children. Children aged 6 to 12 years: the recommended daily dose is 5 mg (1 coated tablet) once daily.

For children aged 2 to 6 years, dose adjustment of levocetirizine in the form of coated tablets is not feasible. It is recommended to prescribe levocetirizine in a pharmaceutical form suitable for pediatric use.

Duration of treatment.

Patients with intermittent allergic rhinitis (duration of symptoms less than 4 days per week or less than 4 weeks per year) should be treated according to the course of the disease and medical history: treatment may be discontinued if symptoms resolve and resumed again upon recurrence of symptoms. In case of persistent allergic rhinitis (duration of symptoms more than 4 days per week or more than 4 weeks per year), continuous therapy may be offered during the period of allergen exposure. There is clinical experience with levocetirizine use for at least a 6-month treatment period. For chronic conditions (chronic allergic rhinitis, chronic urticaria), the duration of treatment may extend up to 1 year [clinical trial data from cetirizine (racemate) use].

Children.

The tablet form of the drug should not be administered to children under 6 years of age, as this pharmaceutical form does not allow appropriate dose adjustment. This patient group should be prescribed levocetirizine in a pharmaceutical form suitable for pediatric use.

Overdose.

Symptoms.

Symptoms of overdose in adults may include somnolence. In children, initial symptoms may include agitation and increased irritability, followed by somnolence.

Treatment.

There is no specific antidote for levocetirizine. In case of overdose symptoms, symptomatic and supportive therapy is recommended. Gastric lavage should be considered shortly after drug intake. Hemodialysis is not effective for removing levocetirizine from the body.

Adverse Reactions.

The adverse reactions listed below have been reported from post-marketing experience with the medicinal product. The frequency of these adverse reactions cannot be determined based on the available data.

Immune system disorders: Hypersensitivity, including anaphylaxis.

Nutritional and metabolic disorders: Increased appetite.

Nervous system disorders: Somnolence, headache, increased fatigue, weakness, asthenia, convulsions, paraesthesia, dizziness, loss of consciousness, tremor, dysgeusia.

Psychiatric disorders: Sleep disorders, excitement, hallucinations, depression, aggression, insomnia, suicidal thoughts, nightmares.

Aural and vestibular disorders: Vertigo.

Eye disorders: Visual disturbances, blurred vision, nystagmus.

Cardiac disorders: Palpitations, tachycardia.

Respiratory, thoracic and mediastinal disorders: Dyspnoea.

Gastrointestinal disorders: Diarrhoea, vomiting, constipation, dry mouth, nausea, abdominal pain.

Hepatobiliary disorders: Hepatitis.

Renal and urinary disorders: Dysuria, urinary retention.

Skin and subcutaneous tissue disorders: Angioneurotic oedema, persistent drug eruptions, pruritus, rash, urticaria.

Musculoskeletal and connective tissue disorders: Myalgia, arthralgia.

General disorders and administration site conditions: Oedema.

Investigations: Increased body weight, abnormal liver function tests.

Description of selected adverse reactions

Pruritus has been reported after discontinuation of levocetirizine.

Reporting of suspected adverse reactions.

Reporting of suspected adverse reactions after medicinal product registration is highly important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua

Shelf life.

3 years.

Storage conditions.

Store at a temperature not exceeding 25 ºC.

Keep out of reach of children.

Packaging.

10 tablets in a blister; 1, 3, or 10 blisters per cardboard pack.

Prescription status.

Over-the-counter.

Manufacturer.

KUSUM HEALTHCARE PVT LTD.

Manufacturer's address and site of operations.

SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.

INSTRUCTIONS

for medical use of the medicinal product

L-CETÒ

(L-CET®)

Composition:

Active substance: levocetirizine dihydrochloride;

One film-coated tablet contains levocetirizine dihydrochloride 5 mg;

Excipients: microcrystalline cellulose, sodium croscarmellose, magnesium stearate, colloidal anhydrous silicon dioxide, Opadry II 85G51300 green*;

*Opadry II 85G51300 green: polyvinyl alcohol, talc, titanium dioxide (E 171), polyethylene glycol, lecithin, indigo carmine (E 132), quinoline yellow (E 104), yellow azo dye FCF (E 110).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: round, biconvex, film-coated tablets of green color.

Pharmacotherapeutic group.

Antihistamines for systemic use. Piperazine derivatives. ATC code: R06AE09.

Pharmacological properties

Pharmacodynamics

Levocetirizine is the active, stable R-enantiomer of cetirizine and belongs to the group of competitive histamine antagonists. Its pharmacological effect is due to blockade of H1-histamine receptors. The affinity of levocetirizine for H1-histamine receptors is twice as high as that of cetirizine. It affects the histamine-dependent stage of allergic reaction development, reduces eosinophil migration, vascular permeability, and limits the release of inflammatory mediators. It prevents the development and alleviates the course of allergic reactions, exerting anti-exudative, anti-pruritic, and anti-inflammatory effects, with minimal anticholinergic and anti-serotonin activity.

Pharmacokinetics

Pharmacokinetic parameters of levocetirizine are linear, dose- and time-independent, and show low variability among different patients. The pharmacokinetic profile after administration of the single enantiomer is the same as that observed with cetirizine. No chiral inversion occurs during absorption or elimination.

Absorption. After oral administration, levocetirizine is rapidly and extensively absorbed. The extent of absorption is independent of dose and food intake; however, maximum concentration (Cmax) is reduced and reached later when taken with food. Bioavailability is 100%.

In 50% of patients, the effect of levocetirizine begins within 12 minutes after a single dose, and in 95% of patients within 0.5–1 hour. In adults, peak plasma concentration (Cmax) is reached within 50 minutes after a single oral therapeutic dose. Steady-state plasma concentration is achieved after 2 days of daily dosing. Cmax is 270 ng/mL after a single dose and 308 ng/mL after repeated administration of 5 mg once daily.

Distribution. There is no available information on tissue distribution of the drug in humans or on the ability of levocetirizine to cross the blood-brain barrier. In animal studies, the highest concentrations were found in the liver and kidneys, and the lowest in central nervous system tissues. Distribution of levocetirizine is limited, with a volume of distribution of 0.4 L/kg. Plasma protein binding is 90%.

Metabolism. In humans, the extent of metabolism is less than 14% of the administered dose of levocetirizine; therefore, differences due to genetic polymorphism or concomitant use of enzyme inhibitors are expected to be negligible. Metabolic pathways include aromatic oxidation, N- and O-dealkylation, and conjugation with taurine. Dealkylation is primarily mediated by cytochrome CYP3A4, while aromatic oxidation involves multiple and/or undefined CYP isoforms. Levocetirizine does not inhibit the activity of cytochrome isoforms 1A2, 2C9, 2C19, 2D6, 2E1, or 3A4, even at concentrations significantly exceeding those achieved after a 5 mg oral dose. Due to its low metabolic rate and lack of inhibitory potential, drug interactions involving levocetirizine (either as perpetrator or victim) are unlikely.

Elimination. The drug is eliminated via two pathways: glomerular filtration and active tubular secretion. The plasma elimination half-life (T1/2) of levocetirizine in adults is 7.9 ± 1.9 hours. The elimination half-life is shorter in younger children. The mean apparent total clearance in adults is 0.63 mL/min/kg. The majority of levocetirizine and its metabolites are excreted in urine (on average, 85.4% of the administered dose). Only 12.9% of the administered dose is excreted in feces.

Special populations

Renal impairment

The apparent clearance of levocetirizine correlates with creatinine clearance. Therefore, in patients with moderate to severe renal impairment, the dosing interval should be adjusted based on creatinine clearance. In patients with anuria and end-stage renal disease, total clearance is reduced by approximately 80% compared to individuals with normal renal function. The amount of levocetirizine removed during a standard 4-hour hemodialysis session is less than 10%.

Clinical characteristics.

Indications.

For symptomatic treatment of allergic rhinitis (including perennial allergic rhinitis) and urticaria in adults and children aged 6 years and older.

Contraindications.

Hypersensitivity to levocetirizine, cetirizine, hydroxyzine, or to any other piperazine derivatives, as well as to any of the excipients of the medicinal product.

Severe form of chronic renal insufficiency (creatinine clearance < 15 mL/min) (dialysis required).

Interaction with other medicinal products and other forms of interaction.

Studies on levocetirizine interaction (particularly with CYP3A4 inducers) have not been conducted. Interaction studies with cetirizine (the racemate compound) have shown that concomitant administration with antipyrine, azithromycin, cimetidine, diazepam, erythromycin, glipizide, ketoconazole, or pseudoephedrine does not cause clinically significant adverse effects. In a multiple-dose study, concomitant administration with theophylline (400 mg/day) resulted in a slight decrease (by 16%) in cetirizine clearance (theophylline distribution was unchanged). In a multiple-dose study with ritonavir (600 mg twice daily) and cetirizine (10 mg daily), cetirizine exposure increased by approximately 40%, while ritonavir distribution was slightly altered (–11%) with concomitant cetirizine use.

There are no data regarding potentiation of sedative effects when used at therapeutic doses. However, concomitant use of sedatives should be avoided during levocetirizine treatment.

Food intake does not affect the extent of drug absorption, but co-administration with food reduces the rate of its absorption.

Concomitant use of cetirizine or levocetirizine with alcohol or other central nervous system depressants in sensitive patients may lead to additional reduction in attention and ability to perform tasks.

Special precautions for use

During therapy with levocetirizine, alcohol consumption should be avoided (see section "Interaction with other medicinal products and other forms of interaction").

When prescribing the medicinal product to patients with factors predisposing to urinary retention (e.g. spinal cord injury, benign prostatic hyperplasia), it should be taken into account that levocetirizine may increase the risk of urinary retention.

The medicinal product should be prescribed with caution in patients with epilepsy or at risk of seizures, as levocetirizine may exacerbate seizures.

Antihistamines suppress the response to skin allergy tests; therefore, levocetirizine should be discontinued at least 3 days before testing (elimination period).

Symptoms such as pruritus may occur after discontinuation of levocetirizine, even if such symptoms were not present prior to starting treatment. These symptoms may resolve spontaneously. In some cases, symptom severity may be significant, requiring resumption of the medicinal product. Symptoms should resolve after resuming treatment.

Children. Levocetirizine in tablet form should not be used in children under 6 years of age, as this dosage form does not allow appropriate dose adjustment. This patient group should be prescribed levocetirizine in a dosage form suitable for pediatric use.

Excipients. The product contains the colouring agent "Sunset Yellow FCF" (E 110), which may cause allergic reactions.

This medicinal product contains less than 1 mmol of sodium per tablet, i.e. it is practically sodium-free.

Use during pregnancy or breastfeeding.

Pregnancy.

Levocetirizine is contraindicated during pregnancy.

Breastfeeding.

Cetirizine passes into breast milk; therefore, breastfeeding should be discontinued if use of the medicinal product is necessary.

Fertility.

There are no clinical data (including animal studies) on the effect of levocetirizine on fertility.

Ability to affect reaction speed when driving or operating machinery.

Comparative clinical trials have not shown any evidence that levocetirizine at the recommended dose impairs attention, reaction speed, or ability to drive vehicles.

However, some patients may experience somnolence, fatigue, or asthenia during treatment with levocetirizine. Therefore, patients intending to drive, engage in potentially hazardous activities, or operate machinery should take into account their individual response to the medicinal product.

Method of Administration and Dosage

The medication should be administered to adults and children aged 6 years and older orally, regardless of food intake. The tablet should be swallowed whole with a small amount of water.

Dosage

Adults and children aged 12 years and older: The daily dose is 5 mg (1 coated tablet) once daily.

Elderly patients: Dose adjustment is recommended for elderly patients with moderate to severe renal impairment (see section "Renal Impairment" below).

Renal Impairment: Dosage should be individualized according to renal function (eGFR [estimated glomerular filtration rate]) as specified in the table below.

Table. Dose adjustment of the medication for patients with impaired renal function.

For children with impaired renal function, the dose of the medicinal product should be individually adjusted according to the patient's renal clearance and body weight.

There are no specific data regarding the use of the drug in children with impaired renal function.

Hepatic insufficiency. Patients with hepatic insufficiency alone do not require dose adjustment. Patients with both hepatic and renal insufficiency require dose adjustment according to the table above.

Children. Children aged 6 to 12 years: the recommended daily dose is 5 mg (1 coated tablet) once daily.

Dose adjustment of levocetirizine in tablet form is not feasible for children aged 2 to 6 years. It is recommended to prescribe levocetirizine in a pharmaceutical form suitable for pediatric use.

Duration of treatment.

Patients with intermittent allergic rhinitis (duration of symptoms less than 4 days per week or less than 4 weeks per year) should be treated according to the course of the disease and medical history: treatment may be discontinued if symptoms resolve and restarted upon recurrence of symptoms. In cases of persistent allergic rhinitis (duration of symptoms more than 4 days per week or more than 4 weeks per year), continuous therapy may be offered during allergen exposure periods. There is clinical experience with levocetirizine use for at least a 6-month treatment period. For chronic conditions (chronic allergic rhinitis, chronic urticaria), the treatment duration may extend up to 1 year [clinical trial data from cetirizine (racemate) use].

Children.

The tablet form of the drug should not be administered to children under 6 years of age, as this dosage form does not allow appropriate dose adjustment. This patient group should be prescribed levocetirizine in a pharmaceutical form suitable for pediatric use.

Overdose.

Symptoms.

Symptoms of overdose in adults may include somnolence. In children, initial symptoms may include excitation and increased irritability, which may subsequently be replaced by somnolence.

Treatment.

There is no specific antidote for levocetirizine. In case of overdose symptoms, symptomatic and supportive therapy is recommended. Gastric lavage should be considered shortly after drug ingestion. Hemodialysis is not effective for removing levocetirizine from the body.

Adverse Reactions

The adverse reactions listed below are based on post-marketing experience with the medicinal product. The frequency of these adverse reactions cannot be determined from the available data.

Immune system disorders: hypersensitivity, including anaphylaxis.

Nutritional and metabolic disorders: increased appetite.

Nervous system disorders: somnolence, headache, fatigue, weakness, asthenia, convulsions, paraesthesia, dizziness, loss of consciousness, tremor, dysgeusia.

Psychiatric disorders: sleep disturbances, restlessness, hallucinations, depression, aggression, insomnia, suicidal thoughts, nightmares.

Aural and vestibular disorders: vertigo.

Eye disorders: visual disturbances, blurred vision, nystagmus.

Cardiac disorders: palpitations, tachycardia.

Respiratory, thoracic and mediastinal disorders: dyspnoea.

Gastrointestinal disorders: diarrhoea, vomiting, constipation, dry mouth, nausea, abdominal pain.

Hepatobiliary disorders: hepatitis.

Renal and urinary disorders: dysuria, urinary retention.

Skin and subcutaneous tissue disorders: angioneurotic oedema, persistent drug eruptions, pruritus, rash, urticaria.

Musculoskeletal and connective tissue disorders: myalgia, arthralgia.

General disorders and administration site conditions: oedema.

Investigations: weight gain, abnormal liver function tests.

Description of selected adverse reactions

Pruritus has been reported after discontinuation of levocetirizine.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after medicinal product authorization is highly important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, as well as patients or their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua

Shelf life

3 years.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of the reach and sight of children.

Packaging

10 tablets in a blister; 1, 3, or 10 blisters in a cardboard box.

Prescription status

Over-the-counter (without prescription).

Manufacturer

KUSUM HEALTHCARE PVT LTD.

Manufacturer's address and location of operations

Plot No. M-3, Indore Special Economic Zone, Phase-II, Pithampur, Distt. Dhar, Madhya Pradesh, Pin 454774, India.