Flucold®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FLUCOLD® (FLUCOLD®)

Composition:

Active substances: 1 tablet contains paracetamol 500 mg, anhydrous caffeine 30 mg, phenylpropanolamine hydrochloride 25 mg, chlorpheniramine maleate 2 mg;

Excipients: maize starch, talc, sodium starch glycolate (type A), magnesium stearate, gelatin, povidone K-30, Ponceau 4R (E 124) dye, methylparaben (E 218), propylparaben (E 216).

Pharmaceutical form. Tablets.

Main physicochemical properties: pink tablets with specks of dark pink and white, round-shaped, biconvex, film-coated, with a score line and the inscription «MSSK» on one side and «FLUCOLD» on the other.

Pharmacotherapeutic group.

Analgesics and antipyretics. Paracetamol combinations without psychotropic agents.

ATC code N02BE51.

Pharmacological Properties

Pharmacodynamics

The pharmacological activity of the medicinal product is due to the properties of paracetamol, caffeine, phenylpropanolamine hydrochloride, and chlorpheniramine maleate contained in its composition. Paracetamol has antipyretic, analgesic, and anti-inflammatory effects. The mechanism of action is associated with inhibition of prostaglandin synthesis.

Caffeine exerts a stimulating effect on the central nervous system, primarily on the cerebral cortex, respiratory center, and vasomotor center. It increases mental and physical performance, reduces drowsiness, fatigue, and counteracts the effects of agents that depress the central nervous system.

Phenylpropanolamine hydrochloride produces vasoconstrictive action, reducing swelling of the nasal mucosa and paranasal sinuses.

Chlorpheniramine maleate has antihistaminic and anticholinergic effects. By blocking H1-receptors, it exerts an anti-allergic effect, reduces vascular permeability of the mucous membranes of the upper respiratory tract, and decreases lacrimation, as well as itching in the eyes and nose.

Pharmacokinetics

The pharmacokinetic properties of the medicinal product are determined by the pharmacokinetics of each ingredient. Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Maximum plasma concentration is reached within 2 hours after administration. It is metabolized in the liver and primarily excreted in urine as glucuronide and sulfate conjugates. Less than 5% is excreted unchanged. The elimination half-life ranges from 1 to 4 hours. The drug is evenly distributed throughout all body fluids, with approximately 25% bound to plasma proteins.

Chlorpheniramine maleate is rapidly absorbed from the gastrointestinal tract and distributed throughout all body tissues. Approximately 25% binds to plasma proteins. Phenylpropanolamine is readily absorbed after oral administration, with peak plasma concentrations achieved within 1–2 hours; the average elimination half-life is 2–3 hours. Phenylpropanolamine undergoes extensive metabolism in the body and is primarily excreted in urine. Caffeine is rapidly absorbed and distributed throughout all tissues and body fluids, including the central nervous system, embryonic tissues, and breast milk. It is rapidly metabolized and excreted in urine. The plasma half-life is approximately 3 hours. About 70% of the dose is excreted in urine.

Clinical characteristics.

Indications.

Symptomatic treatment of acute respiratory viral infections (ARVI) and influenza accompanied by elevated body temperature, chills, headache, nasal discharge and nasal congestion, sneezing, malaise, and body aches.

Contraindications.

Hypersensitivity to the components of the drug, to other xanthine derivatives (theophylline, theobromine), opioids, antihistamines, or sympathomimetic amines. Chronic obstructive pulmonary diseases. Emphysema. Severe cardiovascular diseases, including conduction disorders, tendency to vascular spasm, pronounced atherosclerosis, severe form of ischemic heart disease. Acute myocardial infarction, unstable angina. Peripheral arterial thrombosis, thrombophlebitis. Decompensated heart failure. Ventricular tachycardia. Hyperthyroidism. Severe impairment of liver and/or kidney function. Acute pancreatitis, hepatitis. Stenosing ulcers of the stomach and duodenum. Congenital hyperbilirubinemia. Gilbert's syndrome. Severe arterial hypertension. Paroxysmal tachycardia. Benign prostatic hyperplasia with difficult urination. Bladder neck obstruction. Blood disorders (severe anemia, leukopenia), hyperthyroidism. Pyloroduodenal obstruction. Pheochromocytoma. Diabetes mellitus. Bronchial asthma. Risk of respiratory failure. Closed-angle glaucoma. Increased intraocular pressure. Glucose-6-phosphate dehydrogenase deficiency. Alcoholism. Increased excitability. Sleep disorders. Epilepsy. Concomitant use with monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuation of their use.

Concomitant use with tricyclic antidepressants, β-blockers, or other antihypertensive drugs and sympathomimetics. Advanced patient age (over 60 years). Pregnancy or breastfeeding period. Children under 12 years of age. Not recommended for use in patients with increased blood coagulability or predisposition to thrombosis. Do not use concurrently with drugs that suppress or enhance appetite, or amphetamine-like psychostimulants.

Special precautions.

Do not exceed the recommended dose.

Interaction with other medicinal products and other types of interactions.

The absorption rate of paracetamol may increase when used concomitantly with metoclopramide and domperidone, and decrease with cholestyramine. Prolonged concomitant use enhances the anticoagulant effect of coumarins (e.g., warfarin and other coumarins), increasing the risk of bleeding due to prolonged regular use of paracetamol. Single doses do not show significant effects. Tetracycline increases the risk of anemia and methemoglobinemia induced by paracetamol; antacids and food reduce paracetamol absorption. Probenecid affects the plasma concentration and excretion of paracetamol. Concurrent use of paracetamol with azidothymidine may cause neutropenia. Barbiturates reduce the antipyretic effect of paracetamol. Anticonvulsant drugs (phenytoin, barbiturates, carbamazepine), which stimulate hepatic microsomal enzyme activity, may enhance the hepatotoxic effect of paracetamol due to increased conversion of the drug into hepatotoxic metabolites. Concurrent use of paracetamol with hepatotoxic agents increases the hepatotoxic effects of the drugs. Concurrent use of barbiturates, tricyclic antidepressants, or alcohol consumption may prolong the half-life of paracetamol. Concurrent use of high doses of paracetamol with isoniazid increases the risk of hepatotoxic syndrome. Concomitant use of paracetamol with nonsteroidal anti-inflammatory drugs increases the risk of renal complications. Paracetamol reduces the effectiveness of diuretics. The effect of paracetamol is enhanced when combined with codeine, ascorbic acid, scopolamine, chlorpheniramine, propyphenazone, and caffeine.

Paracetamol should be used cautiously with flucloxacillin, as concomitant use has been associated with metabolic acidosis with a high anion gap (HAGMA) due to pyroglutamic acidosis, especially in patients with risk factors (see section "Special considerations").

Do not use concurrently with alcohol.

Interaction of phenylpropanolamine hydrochloride with MAO inhibitors causes a hypertensive effect; with tricyclic antidepressants (amitriptyline) – increases the risk of cardiovascular adverse effects; with digoxin and cardiac glycosides – leads to arrhythmias and myocardial infarction. Phenylpropanolamine, when used with other sympathomimetics, increases the risk of cardiovascular adverse reactions and may reduce the effectiveness of β-blockers and other antihypertensive drugs (reserpine, methyldopa), increasing the risk of arterial hypertension and cardiovascular adverse effects.

Maprotiline (tetracyclic antidepressant) and other anticholinergic drugs: the anticholinergic effect of these drugs or antihistamines such as chlorpheniramine may be intensified. Concurrent use of chlorpheniramine with MAO inhibitors or furazolidone may lead to hypertensive crisis, nervous excitation, and hyperpyrexia. Antidepressants, antiparkinsonian, and antipsychotic drugs, phenothiazine derivatives, increase the risk of urinary retention, dry mouth, and constipation. Concurrent use with ergot alkaloids (ergotamine, methysergide) increases the risk of ergotism; with halothane – increases the risk of ventricular arrhythmia.

The sedative effect of chlorpheniramine maleate may be significantly enhanced by concomitant use with hypnotics, barbiturates, sedatives, neuroleptics, tranquilizers, anesthetics, narcotic analgesics, and alcohol. Chlorpheniramine maleate enhances the anticholinergic effect of atropine, spasmolytics, tricyclic antidepressants, and antiparkinsonian drugs.

Incompatibility of chlorpheniramine maleate with calcium chloride, kanamycin sulfate, norepinephrine, and phenobarbital has been reported.

Caffeine enhances the effect (improves bioavailability) of analgesic-antipyretic drugs, potentiates the effects of xanthine derivatives, α- and β-adrenomimetics, and psychostimulants. Caffeine increases the likelihood of liver damage caused by hepatotoxic drugs.

Cimetidine, hormonal contraceptives, and isoniazid enhance the action of caffeine.

Caffeine reduces the effect of opioid analgesics, anxiolytics, hypnotics, and sedatives; it acts as an antagonist of anesthetic agents and other drugs that depress the central nervous system, and as a competitive antagonist of adenosine and adenosine-5'-triphosphate (ATP). Concurrent use of caffeine with ergotamine improves ergotamine absorption in the gastrointestinal tract; with thyrotropic agents – increases thyroid effect. Caffeine reduces lithium concentration in blood. Concurrent use of caffeine with MAO inhibitors may cause dangerous elevation of blood pressure.

Ototoxic and photosensitizing drugs may enhance adverse effects when used concomitantly. Tricyclic antidepressants enhance sympathomimetic action. Glucocorticoids increase the risk of glaucoma development.

Special precautions for use.

Avoid concomitant use with other medications intended for symptomatic treatment of cold and flu, and medicinal products containing paracetamol. This medicinal product is not recommended for concomitant use with sedatives, hypnotics, or alcoholic beverages. The risk of overdose is increased in patients with alcoholic liver disease.

Use with caution in individuals predisposed to increased blood pressure.

Before prescribing this medicinal product, ensure that the underlying cause of cough has been identified and that suppression of cough will not increase the risk of clinical or physiological complications. Use with caution in patients with compensated heart failure, in patients at risk of seizures, in patients with chronic obstructive respiratory diseases, persistent or chronic cough due to smoking or pulmonary emphysema, especially when cough is associated with excessive mucus secretion, and in patients with congenital long QT syndrome or in cases of prolonged use of medicinal products that may prolong the QT interval.

Use of this drug may result in a positive analytical finding in doping controls. The drug should be discontinued several days before undergoing such tests.

Chlorpheniramine may mask hypersensitivity symptoms and may affect the results of skin tests.

The drug should be prescribed by a physician only after assessing the benefit-risk ratio in the following conditions: arterial hypertension, cardiac arrhythmias, and urinary retention disorders. If the drug is used long-term as recommended by a physician, monitoring of liver function and peripheral blood count is necessary.

Avoid concomitant use with other medications intended for symptomatic treatment of cold and flu, medicinal products containing paracetamol, sympathomimetics (phenylephrine, pseudoephedrine), barbiturates, and tranquilizers, as their simultaneous use with paracetamol may lead to impaired liver function.

When using this drug, avoid excessive consumption of coffee, strong tea, other stimulant beverages, and medicinal products containing caffeine. This may cause sleep disturbances, tremor, tension, irritability, palpitations, dizziness, and arrhythmias.

If high fever persists for 3 days or more, or recurs, or if pain continues for more than 5 days, the treatment strategy should be re-evaluated.

Consult a physician before using the drug if the patient is taking warfarin or similar anticoagulant agents, or if the patient has difficulty urinating or suffers from Raynaud's disease (which may manifest as pain in fingers and toes in response to cold or stress).

Consult a physician regarding the possibility of using the drug in patients with impaired kidney or liver function.

It should be noted that in patients with alcoholic liver damage, the risk of hepatotoxic effects of paracetamol is increased. The drug may affect laboratory test results for blood glucose and uric acid levels.

In patients with severe infections such as sepsis, associated with reduced glutathione levels, the use of paracetamol increases the risk of metabolic acidosis. Symptoms of metabolic acidosis include deep, rapid, or labored breathing, nausea, vomiting, and loss of appetite. Immediate medical attention should be sought if these symptoms occur.

Cases of high anion gap metabolic acidosis (HAGMA) due to 5-oxoprolinuria have been reported in patients with severe conditions such as severe renal failure and sepsis, or in patients with malnutrition or other causes of glutathione deficiency (e.g., chronic alcoholism), who received long-term therapeutic doses of paracetamol or a combination of paracetamol and flucloxacillin. If HAGMA due to 5-oxoprolinuria is suspected, immediate discontinuation of paracetamol and close monitoring of the patient are recommended. Measurement of 5-oxoproline levels in urine may be helpful in confirming 5-oxoprolinuria as the underlying cause of HAGMA in patients with multiple risk factors.

Patients who take analgesics daily for mild forms of arthritis should consult a physician.

If symptoms persist, consult a physician.

If headache becomes persistent, consult a physician.

Very rare cases of severe skin reactions have been reported. If skin redness, rash, blisters, or skin peeling occur, discontinue paracetamol and seek immediate medical attention.

Use during pregnancy or breastfeeding.

Contraindicated.

Ability to affect reaction speed when driving or operating machinery.

During treatment, avoid driving, operating machinery, and engaging in other potentially hazardous activities.

Dosage and Administration

The medicinal product is intended for oral administration.

For adults and children aged 12 years and older, the recommended dose is 1 tablet every 6 hours, but not more than 4 tablets per day. The duration of treatment is determined by a physician. The treatment duration should not exceed 5 days. The maximum duration of use without prior medical consultation is 3 days.

Do not take together with medicinal products containing paracetamol.

Do not exceed the recommended dose.

Children.

This product is indicated for treatment of children aged 12 years and older.

Overdose.

In case of paracetamol overdose, symptoms within the first 24 hours may include pallor, nausea, vomiting, anorexia, abdominal pain, diarrhea, and epigastric discomfort (0–24 hours); gastrointestinal bleeding; increased activity of liver transaminases, lactate dehydrogenase, elevated bilirubin levels, and decreased prothrombin levels (24–48 hours); hepatotoxic effect characterized by general symptoms (abdominal pain, weakness, asthenia, increased sweating) and specific symptoms (hepatomegaly, jaundice, elevated liver enzymes). After ingestion of large doses, disorientation, excitement, dizziness, sleep disturbances, cardiac arrhythmias, and pancreatitis may occur. In isolated cases, acute renal failure with tubular necrosis has been reported, manifesting as lumbar pain, hematuria, and proteinuria; nephrotoxicity (renal colic, interstitial nephritis). In severe poisoning, liver failure may progress to encephalopathy, hemorrhages, hypoglycemia, coma, and may be fatal.

Ingestion of 10 g or more of paracetamol by adults, especially when combined with alcohol, or ingestion of more than 0.15 g/kg body weight by children may lead to hepatocellular necrosis, resulting in encephalopathy, hepatic coma, and potentially death. In patients with risk factors (long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John’s wort, or other drugs inducing liver enzymes; chronic excessive alcohol consumption; glutathione deficiency (digestive disorders, cystic fibrosis, HIV infection, fasting, cachexia)), ingestion of 5 g or more of paracetamol may cause liver damage. It is believed that the additional amount of toxic metabolites formed during overdose irreversibly binds to liver tissue.

The first clinical signs of hepatonecrosis may appear 12–48 hours after overdose. Hepatotoxic effects may lead to hepatonecrosis and may be complicated by hepatic encephalopathy (impaired thinking, depression of higher nervous activity, excitement, and stupor), DIC syndrome, hypoglycemia, metabolic acidosis, arrhythmias, seizures, respiratory depression, coma, cerebral edema, hypocoagulation, and collapse. Glucose metabolism disturbances and metabolic acidosis may occur. Cardiac arrhythmias and pancreatitis have also been reported. Rarely, liver dysfunction may develop rapidly and may be complicated by renal failure. With prolonged use of the drug in high doses, hematopoietic system disorders may include aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia, and myocardial dystrophy.

In case of overdose, symptoms may include excessive sweating, dizziness, psychomotor agitation or CNS depression, drowsiness, impaired consciousness, cardiac arrhythmias, tachycardia, extrasystoles, tremor, hyperreflexia, seizures, pancreatitis, and sleep disturbances. After ingestion of large doses, disorientation, excitement, dizziness, bacterial infection, fungal infection, sepsis, coagulopathy, hypophosphatemia, lactic acidosis, cardiomyopathy, hypotension, respiratory failure, and glucose metabolism disturbances may occur.

When the drug is taken in large doses, adverse reactions may affect the central nervous system (CNS) – dizziness, psychomotor agitation, disorientation; and the urinary system – nephrotoxicity (renal colic, interstitial nephritis, capillary necrosis).

In case of overdose, immediate medical assistance is required. The patient should be taken to a hospital immediately, even if early symptoms of overdose are absent. Symptoms may be limited to nausea and vomiting and may not reflect the severity of overdose or risk of organ damage. Treatment with activated charcoal should be considered if the excessive dose of paracetamol was ingested within the past hour. Plasma paracetamol concentration should be measured 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be administered within 24 hours after paracetamol ingestion, but the maximum protective effect is achieved when administered within 8 hours after ingestion. The efficacy of the antidote decreases significantly after this time. If necessary, intravenous administration of N-acetylcysteine should be performed according to the established dosing regimen. In the absence of vomiting, oral methionine may be used as an alternative in remote areas outside the hospital setting.

In case of phenylpropanolamine hydrochloride overdose, symptoms include hyperhidrosis, psychomotor agitation or CNS depression, insomnia, behavioral changes, headache, dizziness, drowsiness, impaired consciousness, tachycardia, arrhythmias, extrasystoles, tremor, hyperreflexia, seizures, nausea, vomiting, irritability, restlessness, and arterial hypertension.

In case of chlorpheniramine maleate overdose, the clinical picture may vary from depression to excitation (restlessness and seizures). Anticholinergic-like symptoms may occur: mydriasis, photophobia, dry skin and mucous membranes, elevated body temperature, intestinal atony, decreased level of consciousness, fever, urinary retention, tachycardia, nausea, vomiting, agitated state, hallucinations, psychiatric disorders, seizures, or arrhythmias. CNS depression may be accompanied by respiratory depression and cardiovascular disturbances (decreased pulse rate, decreased arterial pressure up to circulatory failure). Rhabdomyolysis and renal failure may rarely develop in patients with prolonged agitation, seizures, or in comatose patients.

Large doses of caffeine may cause epigastric pain, vomiting, diuresis, rapid breathing, extrasystoles, tachycardia, or cardiac arrhythmia, and effects on the central nervous system (dizziness, insomnia, nervous excitement, irritability, affective state, anxiety, tremor, convulsions, agitation, anxiety, delirium, increased tactile or pain sensitivity), headache, loss of appetite, weakness, hot flashes, hallucinations, hypokalemia, hyponatremia, increased blood glucose, metabolic acidosis, acute skeletal muscle necrosis. Clinically significant symptoms of caffeine overdose may also be associated with liver damage caused by paracetamol.

Treatment. In case of paracetamol overdose, immediate medical assistance is required. The patient should be taken to a hospital immediately, even if early symptoms of overdose are absent. Symptoms may be limited to nausea and vomiting and may not reflect the severity of overdose or risk of organ damage. Treatment with activated charcoal should be considered if the excessive dose of paracetamol was ingested within the past hour. Gastric lavage should be performed within the first hours after suspected overdose.

There is no specific antidote for caffeine, but supportive measures such as administration of β-adrenergic antagonists may help alleviate cardiotoxic effects. Gastric lavage is necessary; oxygen therapy is recommended; diazepam should be administered in case of seizures. Symptomatic therapy is indicated.

Gastric lavage should be performed within the first 6 hours after suspected overdose, followed by hospitalization.

Within the first 8 hours after overdose – oral administration of methionine or intravenous administration of cysteamine or N-acetylcysteine; symptomatic therapy; in case of severe hypertension – administration of α-, β-adrenergic blockers; monitoring of respiratory and circulatory systems (adrenaline must not be used).

Side effects.

Skin and subcutaneous tissue disorders: skin and mucous membrane rashes (usually erythematous), pruritus, urticaria, purpura, allergic and angioneurotic edema, acute generalized exanthematous pustulosis, local drug dermatitis, erythroderma, erythema multiforme, exudative erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), hemorrhages, photosensitization, including fatal outcomes.

Metabolism and nutrition disorders: metabolic acidosis with high anion gap (frequency unknown).

Immune system disorders: anaphylaxis; hypersensitivity reactions, including skin pruritus, skin and mucous membrane rashes (usually generalized and erythematous rash, urticaria); exudative erythema multiforme (including Stevens-Johnson syndrome), anaphylactic shock, angioneurotic edema, toxic epidermal necrolysis (Lyell's syndrome), hypersensitivity necrotizing vasculitis, facial swelling, eyelid swelling, tongue swelling, swelling of hands.

Nervous system disorders: headache, dizziness, psychomotor agitation and disorientation, restlessness, nervous excitability, fear sensations, irritability, sleep disturbances, insomnia, somnolence, confusion, hallucinations, night terrors, depressive states, euphoria, dyspnea, tremor, paresthesia and heaviness in extremities, discomfort sensation, tinnitus, epileptic seizures, anxiety, in individual cases – coma, convulsions, dyskinesia, behavioral changes, general weakness.

Respiratory system disorders: bronchospasm in patients sensitive to acetylsalicylic (aspirin) acid and other nonsteroidal anti-inflammatory agents, nasal dryness, cyanosis, dyspnea.

Eye disorders: visual disturbances and accommodation disorders, mydriasis, increased intraocular pressure, dry eyes.

Aural and vestibular disorders: tinnitus, vertigo.

Gastrointestinal disorders: nausea, vomiting, heartburn, dry mouth, sore throat, hoarseness, epigastric discomfort and pain, diarrhea, hemorrhages, constipation, flatulence, hypersalivation, decreased appetite, exacerbation of peptic ulcer.

Hepatobiliary disorders: liver function abnormalities, increased liver enzyme activity, usually without development of jaundice; hepatotoxic effects, hepatic necrosis (with high-dose use).

Endocrine disorders: hypoglycemia, up to hyperglycemic coma.

Blood and lymphatic system disorders: hemolytic anemia (especially in patients with glucose-6-phosphate dehydrogenase deficiency), bruises or bleeding, sulfhemoglobinemia and methemoglobinemia (cyanosis, dyspnea, chest pain). With prolonged use in high doses – aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia.

Renal and urinary system disorders: nephrotoxicity, interstitial nephritis, papillary necrosis, urinary disorders, dysuria, increased excretion of sodium and calcium, urinary retention and difficulty in urination, aseptic pyuria, renal colic, nephrotoxic effect, oliguria.

Cardiovascular disorders: arterial hypertension, tachycardia or reflex bradycardia, arrhythmia, dyspnea, chest pain, palpitations, edema, myocardial dystrophy (dose-dependent effect with prolonged use).

Other: general weakness, increased sweating, fever, hypoglycemia, glucosuria, disturbances in zinc and copper metabolism, increased creatinine clearance, increased excretion of sodium and calcium, nasal congestion; possible false elevation of blood uric acid levels when measured by the Bittner method; slight increase in 5-hydroxyindoleacetic acid, vanillylmandelic acid, and catecholamines in urine.

With prolonged use in high doses: glomerular apparatus damage, kidney damage, crystalluria, formation of urate, cystine and/or oxalate stones in kidneys and urinary tract, renal failure, damage to islet apparatus and pancreas (hyperglycemia, glucosuria), and impaired glycogen synthesis up to development of diabetes mellitus. Concurrent use of the drug at recommended doses with caffeine-containing products may enhance caffeine-related side effects such as dizziness, increased excitability, insomnia, restlessness, anxiety, irritability, headache, gastrointestinal disturbances, and tachycardia.

The medicinal product may have a slight laxative effect.

Excipients such as povidone K-30 and the dye "Ponceau 4R" (E 124) may cause allergic reactions.

Methylparaben (E 218) and propylparaben (E 216) may cause allergic reactions (possibly delayed-type).

Description of specific adverse reactions

Metabolic acidosis with high anion gap

Cases of metabolic acidosis with high anion gap, caused by pyroglutamic acidosis, have been observed in patients with risk factors who used paracetamol (see section "Special precautions for use"). Pyroglutamic acidosis may occur due to low glutathione levels in such patients.

Shelf life.

4 years.

Storage conditions.

Store in original packaging, out of reach of children, at a temperature not exceeding 25 °C.

Packaging.

No. 4 – 4 tablets per strip in a paper envelope;

No. 12 – 4 tablets per strip, 3 such strips in a cardboard box;

No. 200 – 4 tablets per strip in a paper envelope, 50 such envelopes in a cardboard box.

Prescription category.

Prescription only.

Manufacturer.

Nabros Pharma Pvt. Ltd.

Manufacturer's address and location of business activity.

Survey No. 110/A/2 Amit Farm, Jayn Upasraya, near Coca Cola Factory, NH No. 8, Kajipura – 387411, Kheda, India.