GRIPGO Paracetamol / Caffeine Anhydrous / Phenylephrine Hydrochloride / Chlorphenamine Maleate Tablet 1's
NONRXDRUG-DR-XY45852-1pc
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Features
Brand
Gripgo
Full Details
Dosage Strength
500mg / 30mg / 10mg / 2mg
Drug Ingredients
- Caffeine
- Chlorphenamine Maleate
- Paracetamol
- Phenylephrine
Drug Packaging
Tablet 1's
Generic Name
Paracetamol / Caffeine Anhydrous / Phenylephrine Hydrochloride / Chlorphenamine Maleate
Dosage Form
Tablet
Registration Number
DR-XY45852
Drug Classification
Over-The-Counter (OTC)
Description
Indications/Uses
Paracetamol/Caffeine Anhydrous/Phenylephrine HCl/Chlorpheniramine Maleate (Gripgo) is indicated for symptomatic relief from symptoms of myalgia and fever associated with common cold such as running nose, sneezing, nasal congestion, blocked nose, rhinitis, sinusitis, headache, sore throat, eye pain, muscle pain and cough.
Dosage/Direction for Use
Adults, children aged 12 years and over and the elderly: 1 tablet 3-4 times a day, not exceeding 4 tablets in a day.
These doses should not be repeated more frequently than every four hours.
Do not take continuously for more than 7 days without medical advice.
Mode of administration: Oral.
These doses should not be repeated more frequently than every four hours.
Do not take continuously for more than 7 days without medical advice.
Mode of administration: Oral.
Overdosage
Paracetamol: Liver damage is possible in adults who have taken 10g or more of Paracetamol. Ingestion of 5 g or more of Paracetamol may lead to liver damage if the patient has risk factors.
Risk factors: If the patient: is on long term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's Wort or other drugs that induce liver enzymes; regularly consumes ethanol in excess of recommended amounts; is likely to be glutathione depleted e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms: Symptoms of Paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycemia, cerebral edema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management: Immediate treatment is essential in the management of Paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma Paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of Paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 h from ingestion should be discussed with the National Poisons Information Service (NPIS) or a liver unit.
Caffeine anhydrous: Symptoms and signs: Overdose of Caffeine anhydrous may result in epigastric pain, vomiting, diuresis, tachycardia or cardiac arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions).
It must be noted that for clinically significant symptoms of Caffeine anhydrous overdose to occur with this product, the amount ingested would be associated with serious.
Paracetamol-related liver toxicity.
Treatment: No specific antidote is available, but supportive measures may be used.
Phenylephrine HCl: Symptoms and signs: Phenylephrine HCl overdosage is likely to result in effects similar to those listed under adverse reactions. Additional symptoms may include hypertension and possibly reflex bradycardia. In severe cases confusion, hallucinations, seizures and arrhythmias may occur. However the amount required to produce serious Phenylephrine HCl toxicity would be greater than that required to cause Paracetamol-related liver toxicity.
Treatment: Treatment should be as clinically appropriate. Severe hypertension may need to be treated with alpha blocking drugs such as phentolamine.
Chlorphenamine Maleate: Symptoms and signs: The estimated lethal dose of Chlorphenamine Maleate is 25 to 50 mg/kg body weight. Symptoms and signs include sedation, paradoxical excitation of the CNS, toxicpsychosis, convulsions, apnoea, anticholinergic effects, dystonic reactions and cardiovascular collapse including arrhythmias.
Treatment: Symptomatic and supportive measures should be provided with special attention to cardiac, respiratory, renal and hepatic functions and fluid and electrolyte balance. If overdosage is by the oral route, treatment with activated charcoal should be considered provided there are no contraindications for use and the overdose has been taken recently (treatment is most effective if given within an hour of ingestion). Treat hypotension and arrhythmias vigorously. CNS convulsions may be treated with i.v. diazepam.
Haemoperfusion may be used in severe cases.
Risk factors: If the patient: is on long term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's Wort or other drugs that induce liver enzymes; regularly consumes ethanol in excess of recommended amounts; is likely to be glutathione depleted e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms: Symptoms of Paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycemia, cerebral edema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management: Immediate treatment is essential in the management of Paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma Paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of Paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 h from ingestion should be discussed with the National Poisons Information Service (NPIS) or a liver unit.
Caffeine anhydrous: Symptoms and signs: Overdose of Caffeine anhydrous may result in epigastric pain, vomiting, diuresis, tachycardia or cardiac arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions).
It must be noted that for clinically significant symptoms of Caffeine anhydrous overdose to occur with this product, the amount ingested would be associated with serious.
Paracetamol-related liver toxicity.
Treatment: No specific antidote is available, but supportive measures may be used.
Phenylephrine HCl: Symptoms and signs: Phenylephrine HCl overdosage is likely to result in effects similar to those listed under adverse reactions. Additional symptoms may include hypertension and possibly reflex bradycardia. In severe cases confusion, hallucinations, seizures and arrhythmias may occur. However the amount required to produce serious Phenylephrine HCl toxicity would be greater than that required to cause Paracetamol-related liver toxicity.
Treatment: Treatment should be as clinically appropriate. Severe hypertension may need to be treated with alpha blocking drugs such as phentolamine.
Chlorphenamine Maleate: Symptoms and signs: The estimated lethal dose of Chlorphenamine Maleate is 25 to 50 mg/kg body weight. Symptoms and signs include sedation, paradoxical excitation of the CNS, toxicpsychosis, convulsions, apnoea, anticholinergic effects, dystonic reactions and cardiovascular collapse including arrhythmias.
Treatment: Symptomatic and supportive measures should be provided with special attention to cardiac, respiratory, renal and hepatic functions and fluid and electrolyte balance. If overdosage is by the oral route, treatment with activated charcoal should be considered provided there are no contraindications for use and the overdose has been taken recently (treatment is most effective if given within an hour of ingestion). Treat hypotension and arrhythmias vigorously. CNS convulsions may be treated with i.v. diazepam.
Haemoperfusion may be used in severe cases.
Administration
May be taken with or without food.
Contraindications
Concomitant use of other sympathomimetic decongestants.
Pheochromocytoma.
Closed angle glaucoma.
Known hypersensitivity to Paracetamol or any of the other constituents, age under 12 years old, pregnancy and lactation.
Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, and heart disease. Patients taking tricyclic antidepressants, or beta-blocking drugs and those who are taking or who have taken within the last two weeks monoamine oxidase inhibitors.
Pheochromocytoma.
Closed angle glaucoma.
Known hypersensitivity to Paracetamol or any of the other constituents, age under 12 years old, pregnancy and lactation.
Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, and heart disease. Patients taking tricyclic antidepressants, or beta-blocking drugs and those who are taking or who have taken within the last two weeks monoamine oxidase inhibitors.
Special Precautions
The recommended dose should not exceed or the preparation should not be used for more than 5 days.
In the evening the preparation should be used few hours before going to bed. In case when symptoms of disease do not disappear within 5 days this medicine treatment should be discontinued and a doctor should be consulted. Other Paracetamol agents should not be used while this preparation usage. Due to possible vasoconstrictive action of Phenylephrine HCl the preparation is carefully used in hyperplasia of prostate gland, thyroid gland diseases and in patients over 70 years old with cardiovascular diseases.
For the attention of professional athletes: Phenylephrine HCl may induce false positive doping tests.
It is necessary to avoid alcohol during the preparation use, because alcohol combined with Paracetamol may cause toxic liver damage. Alcohol increases Chlorpheniramine maleate's sedative effect. Coffee, strong tea and other tonic drinks also should not be taken.
In long-term medicine use, development of psychological dependence is possible. Sudden discontinuation of the preparation may cause depression of central nervous system with the occurrence of sleepiness and depression.
Influence on ability to drive a car and to operate any other machines: Patients should be advised not to drive or operate machinery if affected by dizziness. The anticholinergic properties of Chlorphenamine Malate may cause drowsiness,dizziness, blurred vision and psychomotor impairment, which can seriously hamper the patients' ability to drive and use machinery.
In the evening the preparation should be used few hours before going to bed. In case when symptoms of disease do not disappear within 5 days this medicine treatment should be discontinued and a doctor should be consulted. Other Paracetamol agents should not be used while this preparation usage. Due to possible vasoconstrictive action of Phenylephrine HCl the preparation is carefully used in hyperplasia of prostate gland, thyroid gland diseases and in patients over 70 years old with cardiovascular diseases.
For the attention of professional athletes: Phenylephrine HCl may induce false positive doping tests.
It is necessary to avoid alcohol during the preparation use, because alcohol combined with Paracetamol may cause toxic liver damage. Alcohol increases Chlorpheniramine maleate's sedative effect. Coffee, strong tea and other tonic drinks also should not be taken.
In long-term medicine use, development of psychological dependence is possible. Sudden discontinuation of the preparation may cause depression of central nervous system with the occurrence of sleepiness and depression.
Influence on ability to drive a car and to operate any other machines: Patients should be advised not to drive or operate machinery if affected by dizziness. The anticholinergic properties of Chlorphenamine Malate may cause drowsiness,dizziness, blurred vision and psychomotor impairment, which can seriously hamper the patients' ability to drive and use machinery.
Use In Pregnancy & Lactation
Paracetamol/Caffeine Anhydrous/Phenylephrine HCl/Chlorpheniramine Maleate (Gripgo) is a combination drug with Phenylephrine HCl having vasoconstrictive action which can compromise fetal circulation and milk production. It is secreted in milk. Hence Paracetamol/Caffeine Anhydrous/Phenylephrine HCl/Chlorpheniramine Maleate (Gripgo) is not advised to be used during pregnancy and lactation.
Adverse Reactions
Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated as follows by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to Paracetamol are rare and serious reactions are very rare.
Paracetamol: See Table 1.
Paracetamol: See Table 1.
Caffeine anhydrous: Adverse reactions identified through post-marketing use with Caffeine anhydrous are listed as follows. The frequency of these reactions is unknown. (See Table 2.)
When the recommended Paracetamol-Caffeine anhydrous dosing regimen is combined with dietary Caffeine anhydrous intake, the resulting higher dose of Caffeine anhydrous may increase the potential for Caffeine anhydrous-related adverse effects such as insomnia, restlessness, anxiety, irritability, headache, gastrointestinal disturbances and palpitations.
Phenylephrine HCl: The following adverse events have been observed in clinical trials with Phenylephrine HCl and may therefore represent the most commonly occurring adverse events. (See Table 3.)
Phenylephrine HCl: The following adverse events have been observed in clinical trials with Phenylephrine HCl and may therefore represent the most commonly occurring adverse events. (See Table 3.)
Adverse reactions identified during post-marketing use are listed as follows. The frequency of these reactions is unknown: (See Table 4.)
Chlorphenamine Maleate: See Table 5.
Drug Interactions
Enzyme-inducing drugs may increase hepatic damage, as does excessive intake of alcohol. The speed of absorption of Paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. These interactions are considered to be of unlikely clinical significance in acute use at the dosage regimen proposed.
Medical advice should be sought before taking Paracetamol, Caffeine anhydrous, Phenylephrine HCl and Chlorphenamine Maleate in combination with the following drugs: See Table 6.
Medical advice should be sought before taking Paracetamol, Caffeine anhydrous, Phenylephrine HCl and Chlorphenamine Maleate in combination with the following drugs: See Table 6.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacotherapeutic group: Analgesic-Antipyretic/Antihistamine/Nasal Decongestant. ATC Code: N02BE51.
Pharmacology: Pharmacodynamics: Mechanism of action: Paracetamol/Caffeine Anhydrous/Phenylephrine HCl/Chlorpheniramine Maleate (Gripgo) is a combined medicine, the action of which is caused by its components.
Paracetamol is an analgetic-antipyretic that has anti-inflammatory and analgesic properties; that is related to the effect of Paracetamol on Hypothalamus center of heat regulation and its possibility to inhibit the synthesis of prostoglandins.
Caffeine anhydrous is an alkaloid from the group of methylxanthines that directly stimulates respiratory and vasomotor centers of brain, improves physical and emotional state of patients; therefore, the symptoms of asthenia accompanied to infectious diseases are decreased. Caffeine anhydrous intensifies the analgesic effect of Paracetamol.
Phenylephrine HCl is a sympathomimetic reducing edema and hyperemia of upper respiratory tract and in sinuses that promotes the improvement of nasal breathing. It stimulates mainly alpha-adrenoreceptors, due to which peripheral vessels contracts and their permeability is decreased; production of mucous is thus decreased.
Chlorpheniramine Maleate is an antihistaminic agent that reduces the allergic component of infectious diseases. It competitively blocks histamine H1-receptors and prevents the development of histamine effects, namely cold, itching of eyes and nose.
Pharmacokinetics: Paracetamol is metabolised by the hepatic microsomal enzymes. It is rapidly and completely absorbed from the gastro-intestinal tract. Plasma concentration reaches a peak in half to one hour, the plasma half-life is one to three hours and it is uniformly distributed throughout the body.
Phenylephrine HCl is irregularly absorbed from the gastro-intestinal tract. When injected intramuscularly it takes 10-15 minutes to act and subcutaneous and intramuscular injections are effective for about one hour. Intravenous injections are effective for about 20 minutes.
Caffeine anhydrous is readily absorbed from the gastro-intestinal tract.
Chlorphenamine Maleate is well absorbed from the gastro-intestinal tract, following oral administration. The effects develop within 30 minutes, are maximal within 1 to 2 hours and last 4 to 6 hours. The plasma half-life has been estimated to be 12 to 15 hours.
It is metabolised to the monodesmethyl and didesmethyl derivatives. About 22% of an oral dose is excreted unchanged in the urine. Only trace amounts have been found in the faeces.
Pharmacology: Pharmacodynamics: Mechanism of action: Paracetamol/Caffeine Anhydrous/Phenylephrine HCl/Chlorpheniramine Maleate (Gripgo) is a combined medicine, the action of which is caused by its components.
Paracetamol is an analgetic-antipyretic that has anti-inflammatory and analgesic properties; that is related to the effect of Paracetamol on Hypothalamus center of heat regulation and its possibility to inhibit the synthesis of prostoglandins.
Caffeine anhydrous is an alkaloid from the group of methylxanthines that directly stimulates respiratory and vasomotor centers of brain, improves physical and emotional state of patients; therefore, the symptoms of asthenia accompanied to infectious diseases are decreased. Caffeine anhydrous intensifies the analgesic effect of Paracetamol.
Phenylephrine HCl is a sympathomimetic reducing edema and hyperemia of upper respiratory tract and in sinuses that promotes the improvement of nasal breathing. It stimulates mainly alpha-adrenoreceptors, due to which peripheral vessels contracts and their permeability is decreased; production of mucous is thus decreased.
Chlorpheniramine Maleate is an antihistaminic agent that reduces the allergic component of infectious diseases. It competitively blocks histamine H1-receptors and prevents the development of histamine effects, namely cold, itching of eyes and nose.
Pharmacokinetics: Paracetamol is metabolised by the hepatic microsomal enzymes. It is rapidly and completely absorbed from the gastro-intestinal tract. Plasma concentration reaches a peak in half to one hour, the plasma half-life is one to three hours and it is uniformly distributed throughout the body.
Phenylephrine HCl is irregularly absorbed from the gastro-intestinal tract. When injected intramuscularly it takes 10-15 minutes to act and subcutaneous and intramuscular injections are effective for about one hour. Intravenous injections are effective for about 20 minutes.
Caffeine anhydrous is readily absorbed from the gastro-intestinal tract.
Chlorphenamine Maleate is well absorbed from the gastro-intestinal tract, following oral administration. The effects develop within 30 minutes, are maximal within 1 to 2 hours and last 4 to 6 hours. The plasma half-life has been estimated to be 12 to 15 hours.
It is metabolised to the monodesmethyl and didesmethyl derivatives. About 22% of an oral dose is excreted unchanged in the urine. Only trace amounts have been found in the faeces.
MedsGo Class
Cough & Cold Preparations
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