Couldina Paracetamol Effervescent Tablets offer effective pain and fever relief thanks to their paracetamol-based formula. Designed to dissolve quickly in water, it ensures fast and effective action, ideal for treating headaches, fever, general malaise and symptoms associated with the common cold . Perfect to include in your first aid kit.
Precio: €12.15
Couldina Paracetamol 20 Effervescent Tablets
- Combination of an [ANALGESIC] [ANTIPIRETIC], a [HISTAMINERGIC ANTAGONIST (H-1)] and a [NASO/FARYNGEAL DECONGESTIONANT]. Paracetamol exerts analgesic and antipyretic effects probably due to inhibition of prostaglandin synthesis at the central level. Phenylephrine is an alpha-1 adrenergic agonist, which causes vasoconstriction, reducing nasal congestion. Finally, chlorphenamine antagonises H1 and cholinergic receptors, eliminating catarrhal symptoms such as sneezing, whining and runny nose.
- COMMON COLD]. Symptomatic treatment of catarrhal processes and [FLU] with fever, moderate pain, headache, lacrimation, nasal congestion and rhinorrhoea.
- Adults, oral: 1 tablet/6-8 hours. Maximum dose: 6 tablets/24 h.
- Children, oral:
* Children from 15 years of age: 1 tablet/6-8 hours. Maximum dose: 6 tablets/24 hours.
* Children under 15 years of age: The safety and efficacy of this medicinal product have not been evaluated.
This medicinal product is not indicated for this population due to the dose of paracetamol.
IN HEPATIC IMPAIRMENT
Do not exceed 3 tablets and the minimum interval between doses is 8 hours.
- Hypersensitivity to any component of the medicinal product, including cases of [PARACETAMOL ALLERGY].
- HEPATOPATHY], such as severe hepatic insufficiency or [HEPATITIS]. Paracetamol may cause hepatotoxicity.
- Severe renal insufficiency.
- PORPHYRIA]. H1-antihistamines are not considered safe in these patients.
- Severe heart disease or uncontrolled diabetes mellitus. There is a risk of severe decompensation.
- HYPERTENSION].
- [HYPERTHYROIDISM].
- [TACHYCARDIA].
- Patients on treatment with MAOI antidepressants in the 14 days prior to initiating phenylephrine therapy (see Interactions).
- RENAL INSUFFICIENCY]. Accumulation of the active substances may occur. Renal adverse reactions to paracetamol are more frequent in these patients.
- Patients with [DIABETES], [GLAUCOMA], [CARDIOPATHY] ([CORONARY INSUFFICIENCY], [ISCHEMIC CARDIOPATHY]), [ARTERIAL HYPERTENSION], [CARDIAC ARRHYTHMIA], [HYPERTHYROIDISM], [PHEOCROMOCYTOMA], [PROSTATIC HYPERPLASIA] or [URINARY BLADDER OBSTRUCTION], [SERIOUS MYASTHENIA], stenosing [PEPTIC ULCER] or [INTESTINAL OBSTRUCTION]. Both phenylephrine and chlorphenamine may aggravate symptoms. In severe cases, it may be advisable to avoid administration.
- ASMA], [PULMONARY ILLNESS] or [CHRONIC OBSTRUCTIVE PULMONARY DISEASE]. Chlorphenamine may worsen these processes due to its anticholinergic effects. Bronchospastic reactions have been described when paracetamol is administered to asthmatic patients with [SALICYLATE ALLERGY], so special caution is recommended in these patients.
- EPILEPSIA]. Some H1-antihistamines have been associated with the occurrence of seizures.
- BLOOD DYSCRASIAS]. Paracetamol may occasionally lead to [ANEMIA], [LEUCOPENIA] or [TROMBOPENIA]. Extreme caution should be exercised, avoiding prolonged treatment, and regular blood counts should be performed in these cases.
- HEPATIC INSUFFICIENCY], Hepatotoxicity. The metabolism of paracetamol could give rise to hepatotoxic substances. It is recommended to avoid its use in patients with previous liver damage (see Contraindications), as well as to take extreme precautions in those with [CHRONIC ALCOHOLISM] or other factors that could trigger hepatotoxicity phenomena. It is advisable to avoid prolonged treatment and not to exceed doses of 2 g/24 hours in these patients. Similarly, it is recommended to monitor transaminase levels and discontinue treatment in the event of a significant increase in these levels.
- This medicinal product contains sodium salts. For exact sodium content, a review of the composition is recommended. Oral and parenteral dosage forms with sodium amounts higher than 1 mmol (23 mg)/maximum daily dose should be used with caution in patients with or on low sodium diets.
- It is advisable to drink plenty of water during treatment, avoiding the intake of alcoholic beverages as far as possible.
- It is recommended not to exceed the recommended daily doses and to avoid treatment for more than ten days without a prescription.
- If symptoms continue or worsen after five days, it is recommended to consult a doctor.
- The doctor or pharmacist should be notified of any illness the patient has or any medication he/she is taking.
- It may cause drowsiness, so caution is recommended when driving, and do not combine it with drugs or other sedative substances such as alcohol.
- In patients treated with anticoagulants, it is recommended to follow short treatments with low doses, monitoring coagulation parameters.
- Blood counts are recommended in patients treated with high doses or for prolonged periods of time.
- It is advisable to monitor transaminase levels in patients undergoing prolonged treatment or at risk of hepatotoxicity.
- In case of overdose, the specific antidote for paracetamol is N-acetylcysteine.
- Ethyl alcohol. Ethyl alcohol may potentiate the sedative effects of this medicinal product. In addition, drinking alcoholic beverages with paracetamol may 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). Concomitant use is not recommended because increased vasoconstrictor effects may occur. Antihypertensive or benign prostatic hyperplasia alpha-blockers, as they do not block beta-receptors, may cause increased risk of hypotension and tachycardia.
- Inhaled anaesthetics (halothane). May increase the risk of arrhythmias.
- Oral anticoagulants. In very rare cases, usually with high doses, anticoagulant effects may be potentiated by inhibition of hepatic synthesis of clotting factors by paracetamol. It is recommended to administer the lowest dose, with the shortest possible duration of treatment, and to monitor the INR.
- Anticholinergics (antiparkinsonians, tricyclic antidepressants, MAOIs, neuroleptics). Chlorphenamine could potentiate anticholinergic effects, so it is recommended to avoid the association.
- Oral contraceptives. They could increase the plasma clearance of paracetamol, decreasing its effects.
- Tricyclic antidepressants (amitriptyline, amoxapine, clomipramine, desipramine, doxepin, maprotiline). Their simultaneous use may potentiate the pressor effects of phenylephrine.
- Antihypertensives (beta-blockers, diuretics, guanethidine, methyldopa). Phenylephrine may antagonise antihypertensive effects, and may even lead to hypertensive crises, so blood pressure monitoring is recommended. Propranolol may inhibit the metabolism of paracetamol, leading to toxic effects.
- Atropine. Blocks reflex bradycardia caused by phenylephrine and increases the pressor response to phenylephrine.
- Activated charcoal. May cause adsorption of paracetamol, decreasing its absorption and pharmacological effects.
- Chloramphenicol. Chloramphenicol toxicity may be enhanced, probably by inhibition of its metabolism.
- Digitalis. May increase the risk of cardiac arrhythmias associated with phenylephrine.
- Diuretics that can produce hypokalaemia (furosemide). Hypokalaemia may be enhanced and arterial sensitivity to vasopressors such as phenylephrine may be decreased.
- Nerve stimulants (amphetamines, cocaine, xanthines). Nerve stimulation may be enhanced, resulting in intense excitability.
- Thyroid hormones. Potentiation of the effects of both drugs may occur, with risk of high blood pressure and coronary insufficiency.
- MAOIS. MAOIs may potentiate the effects of phenylephrine by inhibiting the metabolism of noradrenaline, increasing the risk of hypertensive crises and other cardiac phenomena. It is recommended to avoid the administration of this medicine in patients treated with MAOIs in the previous 14 days.
- Enzyme inducers. Medicines 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 may reduce serum concentrations of lamotrigine, leading to a decrease in therapeutic effect.
- Levodopa. The administration of levodopa together with sympathomimetics increases the risk of cardiac arrhythmias, so a decrease in the dose of the adrenergic agonist may be necessary.
- Metoclopramide and domperidone. Increase absorption of paracetamol in the small intestine, due to the effect of these drugs on gastric emptying.
- Probenecid. 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 fixation of paracetamol in the intestine.
- Nitrates. Phenylephrine could antagonise the antianginal effects of nitrates, so it is recommended to avoid the association.
- Sedatives (opioid analgesics, barbiturates, benzodiazepines, antipsychotics). Sedative effects may be potentiated.
- Sympathomimetics. Potentiation of side effects, both nervous and cardiovascular, may occur.
- Zidovudine. Although a possible potentiation of zidovudine toxicity (neutropenia, hepatotoxicity) has been reported in single patients, there does not appear to be any kinetic interaction between the two drugs.
Some active substances in this product are able to cross the placental barrier. The safety and efficacy of this medicinal product in pregnant women have not been evaluated. It is therefore recommended that its administration should be avoided unless safer therapeutic alternatives do not exist, and provided that the benefits outweigh the possible risks.
Some of the active substances of this medicinal product are excreted in milk. It is therefore recommended that breast-feeding be discontinued or that the use of this medicinal product be avoided in pregnant women.
Elderly patients may be more susceptible to the adverse effects of this medicinal product, therefore it is recommended to use with caution, and to discontinue administration if adverse reactions are not tolerable.
This medicinal product may substantially affect the ability to drive and/or operate machinery. Patients should avoid operating dangerous machinery, including automobiles, until they are reasonably certain that they are not adversely affected by drug treatment.
The adverse reactions described are:
- Digestive. Anticholinergic phenomena such as [DRY MOUTH] and [STRETCHINESS] may occur. Rarer is the appearance of [ANOREXIA].
- Hepatic. Occasionally [HEPATOPATHY] with or without [ICTERICIA] may occur.
- Cardiovascular. [ARTERIAL HYPERTENSION], [TACHYCARDIA].
- Neurological/psychological. SOMNOLENCE], mental [CONFUSION] and [EUPHORIA] may occasionally occur. The appearance of [EXCITABILITY] phenomena is very rare, with [NERVOSISM] and [INSOMNIA], being especially frequent in children and the elderly.
- Genitourinary. [URINARY RETENTION].
- Allergic/dermatological. Rarely [HYPERSENSITIVITY REACTIONS], with [DERMATITIS], [EXEMPTEMATIC ERUPTIONS], [PHOTOSENSITIVITY REACTIONS] and [EXCESS SWEATING].
- Ophthalmological. [MYDRIASIS], [BLURRED VISION], [OCULAR HYPERTENSION].
- Blood disorders. [ANEMIA], [HEMOLITIC ANEMIA], [LEUCOPENIA] with [NEUTROPENIA] or [GRANULOCYTHOPENIA], and [TROMBOPENIA].
- Metabolic. Rarely [HYPOGLYCEMIA].
Symptoms: Overdose by paracetamol products is a very serious and potentially fatal poisoning. Symptoms may not appear immediately, and may take up to three days to appear. Symptoms may include confusion, excitability, with 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, diarrhoea and liver failure.
In children, there is also a state of drowsiness and gait disturbance.
In severe cases, the patient may die from liver necrosis or acute renal failure.
The minimum toxic dose of paracetamol is 6 g in adults and 100 mg/kg in children. Doses above 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 overdose (excitability, convulsions, tachycardia, high blood pressure) may occur.
Treatment: In case of overdose, a medical centre should be consulted immediately, as paracetamol poisoning can be fatal, even if no symptoms appear. In children, early identification of paracetamol overdose is particularly important, due to the severity of the symptoms, as well as the existence of a possible treatment.
In any case, gastric lavage and aspiration of stomach contents should be performed initially, preferably within four hours of ingestion. Administration of activated charcoal may reduce the amount absorbed.
There is a specific antidote for paracetamol poisoning, N-acetylcysteine. It is recommended that a dose of 300 mg/kg N-acetylcysteine, equivalent to 1.5 ml/kg of 20% aqueous solution, pH 6.5, be administered intravenously over a period of 20 hours and 15 minutes, according to the following schedule:
- Adults. An initial shock dose of 150 mg/kg (0.75 ml/kg of 20% solution) should be administered slowly intravenously over 15 minutes, either directly or diluted in 200 ml of 5% dextrose.
This is followed by a maintenance dose of 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) in 1000 ml of 5% dextrose should be given as a slow intravenous infusion over 20 hours.
- Children. The same amounts per unit weight as in adults should be administered, but the volumes of dextrose should be adjusted according to the age and weight of the child in order to avoid vascular congestion.
The efficacy of the antidote is maximal if administered within 8 hours of ingestion. Effectiveness decreases progressively thereafter and is ineffective after 15 hours.
Administration of 20% N-acetylcysteine may be discontinued when blood levels of paracetamol are below 200 mcg/ml.
In addition to administration of the antidote, symptomatic treatment should be started, keeping the patient under clinical surveillance.
In the event of hepatotoxicity, it is advisable to perform a liver function test and repeat the test at 24-hour intervals.
