Gelocatil Gripe (Flu) Forte with Phenylephrine 10 Sachets Granules for Oral Solution

Gelocatil Gripe Forte With Phenylephrine (650/4/10 Mg 10 Powder Sachets Oral Solution)

Paracetamol / Phenylephrine bitartrate / Chlorphenamine maleate

ACTION AND MECHANISM

- Anti-flu.

* Paracetamol: analgesic and antipyretic, probably due to the inhibition of cyclooxygenase at a central level, especially COX-2, decreasing the synthesis of prostaglandins.

* Chlorphenamine: H1 antihistamine and anticholinergic. Reduces cold symptoms such as sneezing, watery eyes or rhinorrhea.

* Phenylephrine: alpha-1 adrenergic agonist. It produces vasoconstriction, reducing nasal congestion.

INDICATIONS

- Symptomatic treatment of [COMMON COLD] or [FLU] that present with mild or moderate pain, fever, congestion and runny nose in adults and adolescents > 14 years of age.

POSOLOGY

- Adults and adolescents > 14 years: 1 sachet/6-8 hours. Maximum dose 4 sachets/24 hours.

- Children < 12 years: not recommended because the paracetamol content is not adjusted for this age.

- Elderly: no specific dosage recommendations have been made. Use with caution.

Duration of treatment: consult your doctor and/or pharmacist if symptoms continue for more than 3 days (fever) or 5 days (pain and other symptoms), or if new symptoms appear. Stop treatment when symptoms disappear.

Forgotten dose: administer the forgotten dose as soon as possible, unless there is little time until the next one. Administer the next dose at the usual time. Do not double the next dose.

DOSAGE IN KIDNEY FAILURE

It is not recommended since the paracetamol content exceeds the recommended dose in these patients.

DOSAGE IN LIVER FAILURE

- Mild to moderate liver failure (Child-Pugh classes A and B): maximum dose 3 sachets/24 hours, with a minimum interval between doses of 8 hours.

- Severe hepatic insufficiency (Child-Pugh class C): contraindicated.

RULES FOR CORRECT ADMINISTRATION

- Sachets: dissolve the contents of the sachet in half a glass of liquid, preferably water.

Administration with food: can be taken with or without food.

CONTRAINDICATIONS

- Hypersensitivity to any component of the medication, including [ALLERGY TO PARACETAMOL]. Cross hypersensitivity reactions may exist between different antihistamines.

- Pathologies that could be aggravated by this medication, such as [ARTERIAL HYPERTENSION], [PHEOCHROMOCYTOMA], [HYPERTHYROIDISM], [ISCHEMIC CARDIOPATHY], [TAchyCARDIA], [GLAUCOMA] or [DIABETES].

- Severe renal failure (ClCr < 30 ml/min) or severe liver failure (Child-Pugh class C).

- [POPHYRIA]. H1 antihistamines have been associated with the appearance of porphyric outbreaks, so they are not considered safe in these patients.

- Patients treated with an MAOI in the previous 14 days (see Interactions; antidepressants).

- Treatment with beta-blockers or other sympathomimetics.

PRECAUTIONS

- [RENAL INSUFFICIENCY]. In general, use is not recommended in patients with renal failure, since a dosage readjustment is required that would not be possible with this medication (see Dosage in renal failure for more information).

- [HEPATOTOXICITY]. Paracetamol has been related to hepatotoxicity phenomena when used at high doses (> 4 g/24 h) or for prolonged periods of time.

Consider its use in cases of [LIVER FAILURE], [HEPATITIS] or [LIVER CIRRHOSIS], as well as in patients with other risks of liver damage, such as [CHRONIC ALCOHOLISM], [HYPOVOLEMIA], [DEHYDRATION] or [MALNUTRITION] with levels low in glutathione, or treated with other hepatotoxic drugs.

Paracetamol doses should generally not exceed 3 g/24 h.

Avoid the administration of other medications that contain paracetamol, as well as the consumption of alcoholic beverages during treatment.

- [ALLERGY TO SALICYLATES]. Patients allergic to acetylsalicylic acid do not usually present cross-hypersensitivity reactions with paracetamol, but cases of mild bronchospasm have been reported, so caution is advised in case of [ASTHMA].

- Patients with pathologies that could be aggravated by anticholinergic or sympathomimetic effects, such as [CONSTIPATION], [INTESTINAL OBSTRUCTION], [HIATAL HERNIA], [GASTROESOPHAGIC REFLUX DISEASE], stenosing [PEPTICA ULCER], [ULCEROUS COLITIS], [ HEART FAILURE], [ATHEROSCLEROSIS], [PERIPHERAL ARTERIOPATHY], [ANEURYSM], [PROSTATIC HYPERPLASIA] or other causes of [URINARY RETENTION].

- Skin tests for hypersensitivity to allergenic extracts. Due to their antihistamine effects, they could give false negatives in diagnostic tests using these extracts. It is recommended to stop administration at least 72 hours before performing the test.

- Situations that could raise body temperature. Anticholinergic drugs could interfere with the body's thermoregulatory capacity, which could favor the appearance of heat stroke in patients exposed to extreme heat, especially the elderly, who perform intense physical exercise in inappropriate clothing or at inappropriate hours, or who are being treated with drugs. such as diuretics or others that promote [DEHYDRATION].

PRECAUTIONS RELATING TO EXCIPIENTS

- This medicine contains sucrose. Patients with hereditary [FRUCTOSE INTOLERANCE], glucose or galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medication.

ADVICE TO THE PATIENT

- Avoid drinking alcohol during treatment.

- Do not exceed the recommended doses. The administration of other drugs with paracetamol could lead to very serious poisoning.

- Consult your doctor and/or pharmacist if the pain continues after 5 days of treatment, the fever lasts more than 3 days, or the symptoms worsen or new ones appear.

- Avoid driving or doing activities that require your attention until you verify that the treatment does not negatively affect you.

- Inform your doctor and/or pharmacist if you are going to undergo allergy diagnostic tests.

- Tell your doctor and/or pharmacist if you experience any of these symptoms:

* Dry mouth, visual disturbances, constipation or inability to urinate.

SPECIAL WARNINGS

- If the patient experiences difficulty urinating or urine retention, it is recommended to suspend treatment.

- Patients who are going to undergo allergy tests using allergenic extracts must stop treatment at least 72 hours before, to avoid false negatives.

INTERACTIONS

- Ethyl alcohol. Ethyl alcohol may enhance the sedative effects of this medication. Additionally, ingesting alcoholic beverages along with paracetamol could cause liver damage. It is recommended to avoid alcohol intake during treatment. In chronic alcoholics, no more than 2 g/24 hours of paracetamol should be administered.

- Alpha blockers (anti-migraine ergotamines, oxytocin). Simultaneous use is not recommended because increased vasoconstrictive effects may occur. Antihypertensive alpha blockers or those for benign prostatic hyperplasia, by not blocking beta receptors, may cause an increased risk of hypotension and tachycardia.

- Inhaled anesthetics (halothane). They may increase the risk of arrhythmias.

- Oral anticoagulants. In very rare cases, usually with high doses, the anticoagulant effects could be enhanced by paracetamol's inhibition of hepatic synthesis of coagulation factors. It is recommended to administer the minimum dose, with the lowest possible treatment duration, and control the INR.

- Anticholinergics (antiparkinsonian, tricyclic antidepressants, MAOIs, neuroleptics). Chlorphenamine could potentiate anticholinergic effects, so it is recommended to avoid the combination.

- Oral contraceptives. They could increase the plasma clearance of paracetamol, reducing its effects.

- Tricyclic antidepressants (amitriptyline, amoxapine, clomipramine, desipramine, doxepin, maprotiline). Its simultaneous use can enhance the pressor effects of phenylephrine.

- Antihypertensives (beta blockers, diuretics, guanethidine, methyldopa). Phenylephrine could antagonize the antihypertensive effects, and even lead to hypertensive crises, so monitoring blood pressure is recommended. Propranolol may inhibit the metabolism of paracetamol, leading to toxic effects.

- Atropine. It blocks reflex bradycardia caused by phenylephrine and increases the pressor response to phenylephrine.

- Active carbon. It can produce adsorption of paracetamol, reducing its absorption and pharmacological effects.

- Chloramphenicol. The toxicity of chloramphenicol could be enhanced, probably by inhibition of its metabolism.

- Digital. The risk of cardiac arrhythmias associated with phenylephrine may be increased.

- Diuretics that can cause hypokalemia (furosemide). Hypokalemia may be enhanced and arterial sensitivity to vasopressors such as phenylephrine may be decreased.

- Nerve stimulants (amphetamines, cocaine, xanthines). Nerve stimulation could be enhanced, leading to intense excitability.

- Thyroid hormones. There could be a potentiation of the effects of both drugs, with the risk of high blood pressure and coronary insufficiency.

- MAOI. MAOIs could potentiate the effects of phenylephrine by inhibiting the metabolism of norepinephrine, increasing the risk of hypertensive crises and other cardiac phenomena. It is recommended to avoid the administration of this medication in patients treated with MAOIs in the previous 14 days.

- Enzyme inducers. Medications such as barbiturates, carbamazepine, hydantoin, isoniazid, rifampicin or sulfinpyrazone could induce the metabolism of paracetamol, decreasing its effects and increasing the risk of hepatotoxicity.

- Lamotrigine. Paracetamol could reduce the serum concentrations of lamotrigine, leading to a decreased therapeutic effect.

- Levodopa. The administration of levodopa together with sympathomimetics increases the risk of cardiac arrhythmias, so a reduction in the dose of the adrenergic agonist may be necessary.

- Metoclopramide and domperidone. They increase the absorption of paracetamol in the small intestine, due to the effect of these medications on gastric emptying.

- Probenecid. It increases the plasma half-life of paracetamol, by decreasing the degradation and urinary excretion of its metabolites.

- Ion exchange resins (cholestyramine). Decrease in the absorption of paracetamol, with possible inhibition of its effect, due to paracetamol binding in the intestine.

- Nitrates. Phenylephrine could antagonize the antianginal effects of nitrates, so it is recommended to avoid the combination.

- Sedatives (opioid analgesics, barbiturates, benzodiazepines, antipsychotics). The sedative effects could be enhanced.

- Sympathomimetics. There may be an increase in side effects, both of nervous and cardiovascular origin.

- Zidovudine. Although a possible potentiation of zidovudine toxicity (neutropenia, hepatotoxicity) has been described in isolated patients, there does not appear to be any kinetic interaction between both drugs.

PREGNANCY

Safety in animals : Phenylephrine was associated with increased fetal mortality and premature birth in rabbits, as well as decreased blood flow to the uterus in sheep.

Studies with paracetamol in animals have not shown cases of malformations or fetotoxic effects.

Safety in humans : There are no adequate and well-controlled studies in humans. Its administration is only accepted if there are no safer therapeutic alternatives, and the benefits outweigh the possible risks.

Effects on fertility : No specific studies have been performed in humans.

LACTATION

Excretion in milk:

- Paracetamol: small amounts (similar to maternal cp).

- Chlorphenamine: unknown. Other antihistamines do.

- Phenylephrine: limited excretion and reduced oral bioavailability.

The consequences it could have for the infant are unknown. It is recommended to avoid its administration during breastfeeding.

CHILDREN

It can be used in adolescents from 14 years of age at the same doses as in adults.

Its use is not recommended in children and adolescents < 14 years of age because the doses of paracetamol are not adjusted to this age.

SENIORS

No specific problems have been described in the elderly that require dosage readjustment.

However, these patients could be more sensitive to the side effects of this medication, so it is advisable to use it with caution, especially monitoring the appearance of anticholinergic effects.

EFFECTS ON DRIVING

It may produce significant sedation due to the presence of chlorphenamine. Patients should avoid operating dangerous machinery, including automobiles, until they are reasonably certain that the drug treatment does not adversely affect them.

ADVERSE REACTIONS

Adverse reactions are described according to each frequency interval, being considered very common (>10%), common (1-10%), uncommon (0.1-1%), rare (0.01-0.1%). , very rare (<0.01%) or of unknown frequency (cannot be estimated from the available data).

Paracetamol RAM:

- Hepatic: rare [INCREASE IN TRANSAMINASES], [INCREASE IN ALKALINE PHOSPHATASE], [HYPERBILIRUBINEMIA]; very rare [HEPATOTOXICITY], with [JAUNDERY].

- Cardiovascular: rare [HYPOTENSION].

- Neurological/psychological: [DIZZY], [DISORIENTATION], [EXCITABILITY].

- Genitourinary: very rare renal alterations such as urine turbidity and kidney disorders; unknown frequency [INCREASE IN SERUM CREATININE], increase in ammonia levels, [INCREASE IN UREAIC NITROGEN].

- Allergic: very rare [HYPERSENSITIVITY REACTIONS], with symptoms ranging from [EXANTEMATIC ERUPTIONS] and [URTICARIA] to [ANAPHYLAXIA].

- Hematological: very rare [THROMBOCYTOPENIA], [AGRANULOCYTOSIS], [LEUCOPENIA], [NEUTROPENIA], [HEMOLYTIC ANEMIA], [METAHEMOGLOBINEMIA]. The prothrombin time could be increased, although it does not seem significant.

- Metabolic: very rare [HYPOGLYCEMIA]; unknown frequency [INCREASE IN LACTATE DEHYDROGENASE].

- General: rare [GENERAL DISCOMFORT].

Chlorphenamine RAM:

- Digestive: unknown frequency [NAUSEA], [VOMITING], [DIARRHEA], [CONSTIPATION], [ABDOMINAL PAIN], [DRY MOUTH].

- Hepatic: unknown frequency [HEPATITIS], [CHOLESTASIS].

- Cardiovascular: unknown frequency [PALPITATIONS], [HYPOTENSION], [ARTERIAL HYPERTENSION].

- Neurological/psychological: unknown frequency [SOMNOLENCE], [DIZZY], facial [DYSTONIA], [ATAXIA], [TREMOR], [PARESTHESIA], [DYSGEUSIA], [PAROSMIA].

Paradoxical reactions of excitability may appear in children and the elderly, with [AGITATION], [INSOMNIA], [NERVIOSISM], [DELIRIUM], [CONVULSIONS].

- Respiratory: unknown frequency [NASAL DRYNESS] or throat, [SORE THROAT], thickening of mucus, [CHEST PRESSURE], [WHEELS].

- Genitourinary: unknown frequency [URINARY RETENTION] or difficulties when urinating, [SEXUAL IMPOTENCE], early menstruation.

- Dermatological: unknown frequency [HYPERHYDROSIS].

- Allergic: unknown frequency [HYPERSENSITIVITY REACTIONS], with symptoms such as [COUGH], [DYSPHAGIA], [TAchyCARDIA], [URTICARIA], facial [EDEMA] or [ANGIOEDEMA], [DYSSPNEA], [FATIGA]. Also [PHOTOSENSITIVITY REACTIONS].

- Osteomuscular: unknown frequency [MYASTHENIA].

- Ophthalmological: unknown frequency [BLURRY VISION], [DIPLOPIA].

- Optic: unknown frequency [TINNITUS], [LABERINTITIS].

- Hematological: unknown frequency [AGRANULOCYTOSIS], [LEUCOPENIA], [APLASTIC ANEMIA], [THROMBOCYTOPENIA], [HEMORRHAGE].

- Metabolic: unknown frequency [ANOREXIA].

- General: unknown frequency [FATIGUE], [EDEMA].

Phenylephrine RAM:

- Digestive: unknown frequency [VOMITING], [HYPERSALIVATION].

- Cardiovascular: unknown frequency [ARTERIAL HYPERTENSION], [HYPOTENSION], [BLUSHING], [BRADYCARDIA], [TACHYCARDIA], [ANGINA PEST], [PALPITATIONS], [CARDIAC ARREST].

- Neurological/psychological: unknown frequency [HEADACHE], [CEREBRAL HEMORRHAGE], [VERTIGO], [DIZZY], dullness.

- Respiratory: unknown frequency [DYSSNEA], [PULMONARY EDEMA].

- Genitourinary: unknown frequency [hesitant micturition], [URINARY RETENTION].

- Dermatological: unknown frequency [HYPERHYDROSIS], [PARESTHESIA].

- Metabolic: unknown frequency [HYPERGLYCEMIA], [HYPOGLYCEMIA].

- General: unknown frequency sensation of cold on the skin.

OVERDOSE

Symptoms: Overdose with paracetamol products is a very serious and potentially fatal poisoning. Symptoms may not appear immediately, and may even take up to three days to appear. These symptoms include confusion, excitability, with restlessness, nervousness and irritability, dizziness, nausea and vomiting, loss of appetite and liver damage. Hepatotoxicity usually manifests within 48-72 hours with nausea, vomiting, anorexia, malaise, diaphoresis, jaundice, abdominal pain, diarrhea, and liver failure.

In children, states of drowsiness and alterations in the way of walking also appear.

In the most severe cases, the patient's death may occur due to liver necrosis or acute renal failure.

The minimum toxic dose of paracetamol is 6 g in adults and 100 mg/kg in children. Doses greater than 20-25 g of paracetamol are potentially fatal.

In addition to the symptoms of paracetamol overdose, symptoms of chlorphenamine overdose (deep sedation, anticholinergic symptoms) and phenylephrine (excitability, seizures, tachycardia, high blood pressure) may appear.

Treatment: In case of overdose, you should immediately go to a medical center, since paracetamol poisoning can be fatal, even if no symptoms appear. In children, early identification of paracetamol overdose is especially important, due to the severity of the condition, as well as the existence of a possible treatment.

In any case, gastric lavage and aspiration of the stomach contents will initially proceed, preferably within four hours following ingestion. The administration of activated charcoal can reduce the amount absorbed.

There is a specific antidote in case of paracetamol poisoning, N-acetylcysteine. It is recommended to administer a dose of 300 mg/kg of N-acetylcysteine, equivalent to 1.5 ml/kg of 20% aqueous solution, with a pH of 6.5, intravenously, for a period of 20 hours and 15 minutes, according to the following scheme:

- Adults. A shock dose of 150 mg/kg (0.75 ml/kg of 20% solution) will be initially administered slowly intravenously over 15 minutes, either directly or diluted in 200 ml of 5% dextrose.

A maintenance dose will then be instituted with 50 mg/kg (0.25 ml/kg of 20% solution) in 500 ml of 5% dextrose as a slow intravenous infusion over 4 hours.

Finally, 100 mg/kg (0.50 ml/kg of 20% solution) will be administered in 1000 ml of 5% dextrose in slow intravenous infusion over 20 hours.

- Children. The same amounts per unit of weight will be administered as in the adult, but the volumes of dextrose must be adjusted based on the age and weight of the child in order to avoid vascular congestion.

The effectiveness of the antidote is maximum if it is administered within 8 hours of ingestion. The effectiveness decreases progressively from then on and is ineffective after 15 hours.

Administration of 20% N-acetylcysteine ​​may be stopped when paracetamol blood levels are less than 200 mcg/ml.

In addition to the administration of the antidote, symptomatic treatment will be instituted, keeping the patient under clinical surveillance.

In the event that hepatotoxicity occurs, it is advisable to perform a liver function study and repeat the study at 24-hour intervals.

Gelocatil Influenza Forte Leaflet With Phenylephrine 10 Envelopes Granules For Oral Solution