Actron Compound 20 Effervescent Tablets

Actron Compound 20 Effervescent Tablets

(267mg Acetylsalicylic Acid 133mg Paracetamol 40mg Caffeine)

ACTION AND MECHANISM

Analgesic, antipyretic and anti-inflammatory.

INDICATIONS

- Symptomatic relief of occasional mild or moderate [PAIN], such as headache, dental pain or menstrual pain, and [FEVER].

POSOLOGY

DOSAGE - Adults and adolescents from 16 years of age, oral: 1 tablet every 8 hours. Maximum dose: 3 tablets / 24 h. - Children and adolescents under 16 years: do not use this medicine due to its caffeine content.

RULES FOR CORRECT ADMINISTRATION

The tablets are taken dissolved in a glass of water and once the bubbling has stopped. Take the medicine with food or milk, especially if digestive discomfort is noted. It should not be taken on an empty stomach. If the fever persists for more than 3 days, the pain for more than 5 days, or the patient worsens or other symptoms appear, the clinical situation should be evaluated.

CONTRAINDICATIONS

- [ALLERGY TO SALICILATES] or [ALLERGY TO NSAIDs]. Hypersensitivity to any component of the drug, such as [SALICYLATE ALLERGY].
- Patients with [ASTHMA], [NASAL POLYPS] or [IDIOPATIC CHRONIC URTICARIA].
- [PEPTIC ULCER] active, chronic or recurrent, or in any other process that increases the risk of [GASTROINTESTINAL HEMORRHAGE], as well as in patients with a history of bleeding or [GASTRIC PERFORATION] associated with treatment with acetylsalicylic acid. Aspirin has an ulcerogenic effect, which increases the risk of upper gastrointestinal bleeding and gastric perforation.
- [COAGULATION DISORDERS], especially [HEMOPHILIA] or [HYPOPROTHROMBINEMIA], as well as [VITAMIN K DEFICIT].
- Severe renal failure (CLcr <30 ml / minute) or severe liver failure (Child-Pugh C).
- Children under 16 years of age with febrile processes, since in these cases the intake of acetylsalicylic acid has been associated with the appearance of Reye's syndrome.
- Third trimester of pregnancy.
- [HEPATOPATIA] (with or without liver failure), viral [HEPATITIS]: increases the risk of hepatotoxicity.
- Administration together with methotrexate.
- [INSOMNIA] or [ANXIETY], due to the stimulating action of caffeine on the Central Nervous System.
- Psychological disorders that occur with nervous excitement and [EPILEPSY], as it may increase the risk of seizures.

PRECAUTIONS

- [CHRONIC ALCOHOLISM]: The chronic consumption of alcoholic beverages (more than 3-4 drinks / day) can enhance the hepatic toxicity of paracetamol. Chronic alcoholics should avoid prolonged treatments or excessive doses of paracetamol (no more than 2 g / day should be administered). Increased incidence of hepatotoxicity and gastrointestinal bleeding has been observed in patients treated with fixed doses of paracetamol plus acetylsalicylic acid.
- [BLEEDING], [ULCERA] and [GASTRIC PERFORATION]. Treatment with non-steroidal anti-inflammatory drugs is associated with the development of bleeding, ulceration, and perforation of the upper digestive tract. If any of these episodes occur, treatment should be stopped immediately.
- [GLUCOSE 6 PHOSPHATE DEHYDROGENASE DEFICIT ANEMIA]: cases of hemolysis have been observed.
- Severe [KIDNEY INSUFFICIENCY] with creatinine clearance less than 10 ml / min, the interval between two intakes will be at least 8 h. In patients with moderate or severe renal impairment, there may be accumulation of conjugated paracetamol derivatives. Prolonged treatments with high doses increase the risk of renal toxicity.
- [ALLERGY TO SALICYLATES]: paracetamol as an analgesic and antipyretic is a very valid alternative in patients allergic to salicylate. However, bronchospastic reactions have been observed in some asthmatic patients who are hypersensitive to acetylsalicylic acid or other NSAIDs. Although the incidence of cross-reaction is low (less than 5%), clinical monitoring is advised in patients allergic to salicylates treated with paracetamol.
- Medicines containing acetylsalicylic acid should not be administered to children under 16 years of age and to adolescents suffering from viral illnesses with or without fever. In some viral diseases, especially influenza A, influenza B and chickenpox, there is a risk of Reye's Syndrome. The risk of suffering from this disease increases with the concomitant intake of acetylsalicylic acid, however no cause-effect relationship between them has been proven. If continuous vomiting or lethargy occurs, it could be a symptom of Reye's syndrome, so treatment should be discontinued and a specialist should be consulted.
- If the pain persists for more than 10 days (5 days for children) or the fever for more than 3 days, or worsens or other symptoms appear, the clinical situation should be reassessed.
- [DIABETES]. Caution is advised in diabetic patients, as caffeine can raise blood glucose levels.
- Patients sensitive to other xanthines (aminophylline, theophylline ...) can also be sensitive to caffeine, so they should not take this medicine.
- [HEPATOTOXICITY]. Due to paracetamol, it should not be taken at higher doses or for a period of time longer than those recommended. The use of paracetamol for periods of time longer than those recommended can cause serious liver sequelae, such as liver cirrhosis. Therapeutic doses of paracetamol can cause elevation of transaminases.
- [ISCHEMIC CARDIOPATIA]. In patients with a history of myocardial ischemia, especially when they perform physical exercise or are in high altitude places.
- In patients with thyroid hyperfunction and in those with a previous history of cardiac arrhythmias, peptic ulcer or gastritis, caffeine should be administered with caution.
- In some patients, despite the presence of caffeine, sedation or
drowsiness may occur . Sedation can be enhanced by other central nervous system depressants
.

WARNINGS ON EXCIPIENTS:

- This medicine contains sodium salts. To know the exact sodium content, it is recommended to review the composition. Oral and parenteral pharmaceutical forms with amounts of sodium greater than 1 mmol (23 mg) / maximum daily dose should be used with caution in patients with or on low sodium diets.

INTERACTIONS

Due to acetylsalicylic acid:
- NSAIDs. Simultaneous administration with an NSAID may increase the risk of gastrointestinal ulcers and bleeding, due to a synergistic effect. It should not be co-administered.
- Corticosteroids. Simultaneous administration with corticosteroids may increase the risk of
ulcers and gastrointestinal bleeding, due to a synergistic effect, therefore its concomitant administration is not recommended
- Diuretics. There is a decrease in glomerular filtration since it produces a decrease in the synthesis of renal prostaglandins. NSAIDs can cause acute kidney failure, especially in dehydrated patients. It is necessary to ensure
correct hydration of the patient and monitor renal function when starting treatment.
- Selective serotonin reuptake inhibitors. Increased risk of bleeding in general and upper gastrointestinal bleeding in particular due to a synergistic effect, therefore its concomitant use should be avoided.
- Anticoagulants. Increased risk of bleeding, therefore its concomitant use is not recommended.
- ACEI and ARA II. Reduction of glomerular filtration, which can be exacerbated in cases of impaired kidney function. Administration of this combination to elderly or dehydrated patients can lead to acute renal failure. Monitoring
of renal function is recommended when starting treatment as well as regular hydration of the patient.
- Beta-blockers. It can decrease the antihypertensive effect due to an inhibition of prostaglandins with a vasodilator effect.
- Antidiabetics. concomitant administration with insulin and sulfonylureas increases the hypoglycemic effect of the latter. Due to the hypoglycemic effect of acetylsalicylic acid, the displacement of sulfonylureas from their plasma-binding protein occurs at high doses of acetylsalicylic acid.
- Cyclosporine. Increased nephrotoxicity of cyclosporine due to renal prostaglandin-mediated effects. Monitoring of renal function is recommended, especially in elderly patients.
- Vancomycin. Increased risk of otoxicity from vancomycin.
- Alpha interferon. Decreased activity of interferon alpha.
- Ethyl alcohol. Increased risk of damage to the gastrointestinal mucosa and increased gastrointestinal bleeding time due to the additive effect of alcohol and acetylsalicylic acid.
- Lithium. Decreased excretion of lithium, increasing lithium levels in the blood, which can reach toxic values. Concomitant use of lithium is not recommended.
- Methotrexate. Decrease in the tubular secretion of methotrexate increasing its plasma concentrations and therefore its toxicity. Concomitant use is not recommended.
- Uricosuric. Decrease in the effect of uricosuric agents by competition of
the renal elimination of uric acid and decrease in the excretion of salicylic acid,
reaching high plasma levels.
- Antacids. Increased renal excretion of salicylates by alkalinization of the urine.
- Digoxin: Increase in plasma levels of digoxin that can reach
toxic values due to a decrease in renal excretion. Use is not recommended.
- Zidovudine. Increase plasma concentrations of zidovudine by competitively inhibiting glucuronidation or directly inhibiting
hepatic microsomal metabolism and therefore increasing its toxicity.
- Valproic acid. Decreased binding to plasma proteins and an inhibition of valproic acid metabolism increasing its toxicity.
- Phenytoin: Increased plasma levels of phenytoin due to the displacement of protein receptors.
Due to paracetamol:
- Ethyl alcohol: The toxicity of paracetamol is potentiated, due to the possible
induction of hepatic production of hepatotoxic products derived from paracetamol.
- Oral anticoagulants (acenocoumarol, warfarin). Potentiation of the anticoagulant effect by inhibiting the hepatic synthesis of coagulation factors with increased risk of bleeding. Paracetamol should not be taken for long periods without medical supervision.
- Anticonvulsants (phenytoin, phenobarbital, methylphenobarbital, primidone). Decreased
bioavailability of paracetamol as well as potentiation of hepatotoxicity to
overdose, due to the induction of hepatic metabolism.
- Metoclopramide and domperidone :. Increased absorption of paracetamol in the
small intestine , due to the effect of these drugs on gastric emptying and therefore, a delay in the onset of action.
- Zidovudine. Increased risk of neutropenia. It should not be administered.
- Propranolol: Increase in paracetamol plasma levels, due to possible inhibition of
its hepatic metabolism.
- Isoniazid: decreased clearance of paracetamol, with possible potentiation of its
action and / or toxicity, due to inhibition of its hepatic metabolism.
- Lamotrigine: Decrease in the bioavailability of lamotrigine, with possible reduction of
its effect, due to possible induction of its hepatic metabolism.
Due to caffeine:
- Oral contraceptives (estrogens): there are studies in which a decrease in caffeine clearance has been recorded, with possible potentiation of its action and / or toxicity, due to inhibition of its hepatic metabolism.
- Cimetidine: there are studies in which a decrease in caffeine clearance has been recorded with possible potentiation of its action and / or toxicity, due to inhibition of its hepatic metabolism.
- Clozapine: there is some study in which inhibition of the antipsychotic effect of clozapine has been recorded, due to antagonism of its actions at the level of dopamine receptors.
- Disulfiram: there is some study in which a decrease in caffeine clearance has been recorded, with possible potentiation of its action and / or toxicity, due to possible inhibition of its hepatic metabolism.
- Methoxalene: there is some study in which a decrease in caffeine clearance has been recorded, with possible potentiation of its action and / or toxicity, due to inhibition of its hepatic metabolism.
- Mexiletine: there are studies in which a decrease in caffeine clearance has been recorded, with possible enhancement of its action and / or toxicity.
- Quinolones (pipemidic acid, ciprofloxacin, enoxacin): there are studies in which an increase in plasma levels of caffeine has been recorded, with possible potentiation of its action and / or toxicity, due to inhibition of its hepatic metabolism.

PREGNANCY

Animal studies with salicylates have reported teratogenic and embryocidal effects. Salicylates quickly cross the placenta. Epidemiological studies suggest an increased risk of miscarriage and congenital malformations (including cardiac malformations and gastroschisis). During the first and second trimesters of pregnancy, acetylsalicylic acid should not be administered unless strictly necessary, with the lowest possible dose and the shortest possible duration of treatment. During the third trimester of pregnancy, the use of prostaglandin synthesis inhibitors can expose the fetus to cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension) and renal failure, which can lead to renal failure and oligohydroamniosis. Likewise,It can expose the mother and the child, at the end of pregnancy, to a possible prolongation of the bleeding time, an antiplatelet effect that can occur even at very low doses and to an inhibition of uterine contractions leading to a delay or prolongation of labor. Chronic treatment with high doses of salicylates during late pregnancy can prolong and complicate labor and increase the risk of maternal or fetal bleeding. Therefore, salicylates should only be taken during pregnancy after a strict benefit-risk assessment, being contraindicated during the third trimester of pregnancy.antiaggregant effect that can occur even at very low doses and an inhibition of uterine contractions leading to a delay or prolongation of labor. Chronic treatment with high doses of salicylates during late pregnancy can prolong and complicate labor and increase the risk of maternal or fetal bleeding. Therefore, salicylates should only be taken during pregnancy after a strict benefit-risk assessment, being contraindicated during the third trimester of pregnancy.antiaggregant effect that can occur even at very low doses and an inhibition of uterine contractions leading to a delay or prolongation of labor. Chronic treatment with high doses of salicylates during late pregnancy can prolong and complicate labor and increase the risk of maternal or fetal bleeding. Therefore, salicylates should only be taken during pregnancy after a strict benefit-risk assessment, being contraindicated during the third trimester of pregnancy.salicylates should only be taken during pregnancy after a strict evaluation of the benefit-risk ratio, being contraindicated during the third trimester of pregnancy.salicylates should only be taken during pregnancy after a strict evaluation of the benefit-risk ratio, being contraindicated during the third trimester of pregnancy.

LACTATION

Aspirin, salicylates, and their metabolites are excreted in human milk in small amounts. Paracetamol is excreted in human milk but not in a clinically significant amount. Caffeine is excreted in milk in very small amounts around 1%.
The administration of this medicine during lactation should be avoided as much as possible.

EFFECTS ON DRIVING

Some patients may experience drowsiness or dizziness with taking acetaminophen, so patients should exercise caution when engaging in activities that require alertness.

ADVERSE REACTIONS

Adverse reactions are described according to each frequency range, 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).
* Due to acetylsalicylic acid:
- Hematological: Common: [BLEEDING] (increased risk), perioperative bleeding, [HEMATOMA],, [GINGIVAL HEMORRHAGE], [GENITOURINARY HEMORRHAGE], [HYPOPROTHROMBINEMIA] (with high doses). Uncommon: [ANEMIA]. Rare: chronic post-hemorrhagic anemias due to bleeding or hidden bleeding, which will present typical symptoms such as [ASTENIA], [PALE], hypoperfusion. Very rare: [BRAIN HEMORRHAGE], especially in patients with uncontrolled hypertension taking concomitant anticoagulant agents.
- Respiratory: Common: [BRONCHIAL SPASM] paroxysmal, [DYSNEA] severe, [RHINITIS], [ASTHMA], [NASAL CONGESTION]. Very rare: [ANAPHYLAXY].
- Digestive: Common: [GASTRIC ULCER], [DUODENAL ULCER], [MELENA], [HEMATEMESIS], [ABDOMINAL PAIN], [DYSPEPSIA], [NAUSEA], [VOMITING]. Rare: [INFLAMMATION] gastrointestinal. Very rare: [GASTRIC PERFORATION]
- Dermatological: Frequent: [URTICARIA], [EXANTEMATIC ERUPTIONS], [ANGIOEDEMA], [PRURITO]. Unknown frequency: [EXCESS SWEATING]. 
- Hepatic: Uncommon: [HEPATITIS] (particularly in patients with juvenile arthritis). Very rare: [HEPATIC INSUFFICIENCY] transient with [INCREASED TRANSAMINASES].
- Neurological / psychological: Unknown frequency: [HEADACHE], [DIZZINESS], [CONFUSION]. 
- Optics: Unknown frequency: [TINNITUS], [DEAF].
- Genitourinary: Unknown frequency: [ACUTE KIDNEY INSUFFICIENCY], [ACUTE TUBULOINTERSTICIAL NEPHRITIS].       
- General: Uncommon: [REYE'S SYNDROME] (in children under 16 years of age with febrile processes, flu or chickenpox).
* Due to paracetamol:
- Hematological :: exceptionally, blood disorders, such as [THROMBOPENIA], [LEUCOPENIA], [PANCITOPENIA], [NEUTROPENIA], [AGRANULOCITOSIS] and [HEMOLYTIC ANEMIA] (in patients with G6PD deficiency).
- Dermatological: [EXANTEMATIC ERUPTIONS], [URTICARIA], [ALLERGIC DERMATITIS], [FEVER].
- Metabolic: exceptionally, [HYPOGLYCAEMIA], especially in children.
- Hepatic: rarely, [JAUNDICE], [INCREASED TRANSAMINASES], [HEPATOTOXICITY] (associated with cases of overdose, either due to the intake of 1 toxic dose or several intakes of excessive doses).
- Genitourinary: it can cause [NEFROPATIA] which in turn can evolve to a picture of renal failure, sterile [PIURIA] (cloudy urine), renal adverse effects (with high doses).
- Cardiovascular: rarely, [HYPOTENSION].
* Due to caffeine:
- Frequently: [INSOMNIA], [AGITATION] and [EXCITABILITY].
- Occasionally: [NAUSEA], [VOMITING], [DIARRHEA], [GASTRALGIA], [HEADACHE], [OTOTOXICITY], [TINNITUS], [DISORIENTATION], [EXTRASISTOLE], [PALPITATION], [TACHYCARDIA], [HEART ARRHYTHMIA ], [IRRITABILITY], [SOFOCOS], [TACHYPNEA], [POLYURIA]; with high doses: tables of [ANXIETY].

Actron Compound Leaflet 20 Effervescent Tablets

Actron Compound 20 Effervescent Tablets Datasheet