Thermalgin Gripe (Flu) 650/4/10 Mg 10 Envelopes Granulated Oral Solution

Thermalgin Gripe (Flu) 650/4/10 Mg 10 Envelopes Granulated Oral Solution

ACTION AND MECHANISM

- Anti-flu.

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

* Chlorphenamine: antihistamine H1 and anticholinergic. Reduces catarrhal symptoms such as sneezing, tearing or rhinorrhea.

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

INDICATIONS

- Symptomatic treatment of [COMMON COLD] or [INFLUENZA] with mild or moderate pain, fever, congestion and nasal discharge in adults and adolescents from 15 years.

POSOLOGY

- Adults and adolescents> 15 years: 1 about / 6-8 h. Maximum dose 4 envelopes / 24 h.

- Children <15 years: not recommended because the content of paracetamol is not adjusted at this age.

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

Duration of treatment: consult with the doctor and / or pharmacist if the 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.

Missed dose: administer the missed dose as soon as possible, unless there is little time left for the next. Administer the next dose at the usual time. Do not double the next dose.

POSOLOGY IN RENAL INSUFFICIENCY

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

POSOLOGY IN HEPATIC INSUFFICIENCY

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

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

RULES FOR THE CORRECT ADMINISTRATION

- Envelopes: dissolve the contents of the envelope 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 [PARACETAMOL ALLERGY]. There may be cross-hypersensitivity reactions between different antihistamines.

- Pathologies that could be aggravated by this medicine, such as [ARTERIAL HYPERTENSION], [FEOCROMOCITOMA], [HYPERTHROIDISM], [ISCHEMICAL CARDIOPATIA], [TACHYARD], [GLAUCOMA] or [DIABETES].

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

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

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

- Treatment with beta-blockers or with other sympathomimetics.

PRECAUTIONS

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

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

Assess your employment in the case of [HEPATITIC INSUFFICIENCY], [HEPATITIS] or [HEPATIC CIRROSIS], as well as in patients with other risks of liver damage, such as [CHRONIC ALCOHOLISM], [HYPOVOLEMIA], [DEHYDRATION] or [NURSING] with levels low glutathione, or treated with other hepatotoxic drugs.

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

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

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

- Patients with pathologies that may be aggravated by anticholinergic or sympathomimetic effects, such as [CONDEMINATION], [INTESTINAL OBSTRUCTION], [HERNIA DE HIATO], [GASTROESOFAGIC REFLUX DISEASE], [PEPTIC ULCERA] stenosante, [COLITIS [ULCERA] CARDIAC INSUFFICIENCY], [ATEROSCLEROSIS], [PERIPHERAL ARTERIOPATIA], [ANEURISM], [PROSTATIC HYPERPLASIA] or other causes of [URINARY RETENTION].

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

- Situations that could raise body temperature. Anticholinergic drugs may interfere with the body's thermoregulatory capacity, so they may favor the occurrence of heat strokes in patients exposed to extreme heat, especially the elderly, who perform intense physical exercise with clothing or at inappropriate times, or in drug treatment such as diuretics or others that favored [DEHYDRATION].

PATIENT ADVICE

- 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 with the doctor and / or pharmacist in case the pain continues after 5 days of treatment, the fever lasts for more than 3 days, or the symptoms worsen or new ones appear.

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

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

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

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

SPECIAL WARNINGS

- In case the patient experiences difficulty urinating or holding urine, it is recommended to stop the treatment.

- Patients who are going to undergo allergy tests with the use of allergenic extracts should suspend treatment at least 72 hours before, to avoid false negatives.

INTERACTIONS

- Ethyl alcohol. Ethyl alcohol may potentiate the sedative effects of this medicine. In addition, the intake of 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 (antimigraphic ergotamines, oxytocin). Simultaneous use is not recommended because an increase in vasoconstrictor effects may occur. Alpha blockers antihypertensives or benign prostatic hyperplasia, not blocking beta receptors can cause an increased risk of hypotension and tachycardia.

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

- Oral anticoagulants. Very rarely, normally with high doses, anticoagulant effects could be enhanced by inhibition of hepatic synthesis of coagulation factors by paracetamol. It is recommended to administer the minimum dose, with the treatment duration as low as possible, and control the INR.

- Anticholinergics (antiparkinsonians, tricyclic antidepressants, MAOIs, neuroleptics). Chlorphenamine may potentiate the anticholinergic effects, so it is recommended to avoid the association.

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

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

- Antihypertensives (beta blockers, diuretics, guanetidine, methyldopa). Phenylephrine could antagonize antihypertensive effects, and even lead to hypertensive crises, so it is recommended to monitor blood pressure. Propranolol could inhibit the metabolism of paracetamol, resulting in toxic effects.

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

- Active carbon. It can produce an 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 could be increased.

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

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

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

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

- Enzymatic inductors. Medicines such as barbiturates, carbamazepine, hydantoin, isoniazid, rifampicin or sulfinpyrazone, could induce paracetamol metabolism, reducing its effects and increasing the risk of hepatotoxicity.

- Lamotrigine. Paracetamol could reduce serum concentrations of lamotrigine, causing a decrease in therapeutic effect.

- Levodopa. The administration of levodopa together with sympathomimetics increases the risk of cardiac arrhythmias, so a dose reduction 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. Increases the plasma half-life of paracetamol, by decreasing the degradation and urinary excretion of its metabolites.

- Ionic exchange resins (cholestyramine). Decreased absorption of paracetamol, with possible inhibition of its effect, by fixing paracetamol in the intestine.

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

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

- Sympathomimetics. It can produce a potentiation of side effects, both of nervous and cardiovascular origin.

- Zidovudine. Although a possible potentiation of the toxicity of zidovudine (neutropenia, hepatotoxicity) has been described in isolated patients, it does not appear that there is any kinetic interaction between both medications.

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 evidenced cases of malformations or fetotoxic effects.

Safety in humans : adequate and well-controlled studies in humans are not available. Its administration is only accepted if there are no safer therapeutic alternatives, and the benefits outweigh the possible risks.

Fertility effects : no specific studies have been conducted in humans.

LACTATION

Milk excretion:

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

- Chlorphenamine: unknown. Other antihistamines do.

- Phenylephrine: limited excretion and reduced oral bioavailability.

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

CHILDREN

It can be used in adolescents from 15 years at the same doses as in adults.

Its use is not recommended in children and adolescents <15 years because the paracetamol doses are not adjusted at this age.

ELDERLY

No specific problems have been described in the elderly that require a dose adjustment.

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

EFFECTS ON DRIVING

It can cause significant sedation due to the presence of chlorfenamine. Patients should avoid operating dangerous machinery, including cars, until they are reasonably certain that drug treatment does not adversely affect them.

ADVERSE REACTIONS

Adverse reactions are described according to each frequency range, being considered very frequent (> 10%), frequent (1-10%), rare (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 OF TRANSAMINASES], [INCREASE OF ALKALINE PHOSPHATASE], [HYPERBILYRUBINEMIA]; very rare [HEPATOTOXICITY], with [ICTERICIA].

- Cardiovascular: rare [HYPOTENSION].

- Neurological / psychological: [MAREO], [DESORIENTATION], [EXCITABILITY].

- Genitourinary: very rare renal disorders such as turbidity of urine and renal disorders; frequency unknown [INCREASED SERIAL CREATININE], increased ammonia levels, [INCREASED UREIC NITROGEN].

- Allergic: very rare [HYPERSENSITIVITY REACTIONS], with symptoms from [EXANTEMATIC ERUPTIONS] and [URTICARY] to [ANAFILAXIA].

- Hematologic: very rare [THROMBOCYTOPENIA], [AGRANULOCITOSIS], [LEUCOPENIA], [NEUTROPENIA], [HEMOLITIC ANEMIA], [METAHEMOGLOBINEMIA]. Prothrombin time could be increased, although it does not seem significant.

- Metabolic: very rare [HYPOGLUCEMIA]; frequency unknown [INCREASE OF LACTATE DEHYDROGENASE].

- General: rare [GENERAL DISCOMFORT].

Chlorphenamine RAM:

- Digestive: frequency unknown [NAUSEAS], [VOMITOS], [DIARRHEA], [CONDENSATION], [ABDOMINAL PAIN], [MOUTH DROUGHT].

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

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

- Neurological / psychological: frequency unknown [SOMNOLENCE], [MAREO], [DISTONIA] facial, [ATAXIA], [TEMBLOR], [PARESTHESIA], [DYSGEUSIA], [PAROSMIA].

In children and the elderly, paradoxical reactions of excitability may occur, with [AGITATION], [INSOMNIUM], [NERVIOSISM], [DELUSION], [CONVULSIONS].

- Respiratory: frequency unknown [NASAL DROUGHT] or throat, [THROAT PAIN], thickening of the mucus, [TORACICA OPPRESSION], [SIBILANCES].

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

- Dermatological: frequency unknown [HYPERHIDROSIS].

- Allergic: frequency unknown [HYPERSENSITIVITY REACTIONS], with symptoms such as [TOS], [DYSPHAGIA], [TAQUICARDIA], [URTICARIA], [EDEMA] facial or [ANGIOEDEMA], [DISNEA], [FATIGUE]. Also [PHOTOSENSITIVITY REACTIONS].

- Osteomuscular: frequency unknown [MIASTENIA].

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

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

- Hematologic: frequency unknown [AGRANULOCITOSIS], [LEUCOPENIA], [APLASIC ANEMIA], [TROMBOCITOPENIA], [HEMORRAGY].

- Metabolic: frequency unknown [ANOREXIA].

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

Phenylephrine RAM:

- Digestive: frequency unknown [VOMITES], [HYPERERSALIVATION].

- Cardiovascular: frequency unknown [ARTERIAL HYPERTENSION], [HYPOTENSION], [RUBORIZATION], [BRADICARDIA], [TAQUICARDIA], [CHEST ANGINA], [PALPITATIONS], [CARDIAC STOP].

- Neurological / psychological: frequency unknown [CEFALEA], [CEREBRAL HEMORRAGY], [VERTIGO], [MAREO], dullness.

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

- Genitourinary: frequency unknown [MICTION VACILANTE], [URINARY RETENTION].

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

- Metabolic: frequency unknown [HYPERGLUCEMIA], [HYPOGLUCEMIA].

- General: frequency unknown feeling of cold skin.

ADVERSE REACTIONS CONCERNING EXCIPIENTS

- This medicine contains mannitol. Daily doses greater than 10 g may produce some mild laxative effect and result in [DIARRHEA].

OVERDOSE

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

In children there are also states of drowsiness and alterations in the way of walking.

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

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, arterial hypertension) 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, the gastric lavage and aspiration of the stomach contents will proceed initially, preferably within four hours after ingestion. The administration of active carbon 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, over a period of 20 hours and 15 hours. minutes, according to the following scheme:

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

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

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

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

The efficacy of the antidote is maximum if it is administered before 8 hours of ingestion. The effectiveness decreases progressively thereafter and is ineffective after 15 hours.

The administration of 20% N-acetylcysteine ​​may be interrupted when blood paracetamol levels are below 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 conduct a study of liver function and repeat the study at 24-hour intervals.

Termalgin (Gripe) Flu 650/4 / 15.58 Mg 10 Envelopes Granules Oral Solution