Sinutab 500 mg - 30 mg tabl. 15

Sinutab 500/30 15 tabl

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Indications:

Symptomatic treatment of nasal congestion with a headache and / or fever.

Composition:

Sinutab 500/30 mg tablets.
Active substances: Paracetamol 500 mg - 30 Pseudo Ephedrine, mg.
Excipients: Sodium amylum glycollatum - Cellulosum microcristallinum - Povidonum - Crospovidonum - Magnesium stearas - Stearicum acidum - Amylum maidis pregelatinum.
Sinutab Forte 500/60 mg tablets .
Active substances: Paracetamol 500 mg - 60 mg of pseudoephedrine.
Excipients: Croscarmellose Sodium - Cellulosum microcristallinum - Povidonum - Crospovidonum -- Magnesium stearas - Stearicum acidum - Amylum maidis pregelatinum.

Posology and method of use:

Sinutab Forte 500/60 mg tablets.
Adults and children over 12 years.
1 tablet, 2 to 3 times per day. Between the intakes by a time interval of at least 4 hours are respected.
The maximum treatment period is 5 days. In case of a bacterial infection may need an antibiotic therapy.
Sinutab 500/30 mg tablets.
Adults and children over 12 years.
1 to 2 tablets, 2 to 3 times per day. Between the intakes by a time interval of at least 4 hours are respected.
The maximum treatment period is 5 days. In case of a bacterial infection may need an antibiotic therapy.

This is a medicine, no prolonged use without medical advice, keep away from children, read the leaflet carefully . Ask your doctor or pharmacist. In case of side effects, contact your doctor.

Contraindications:

Sinutab 500 / Sinutab Forte 500/60 mg and 30 mg tablets are contraindicated in individuals with known hypersensitivity to the product or its components.
It is also contraindicated in patients with severe hepatic insufficiency, severe hypertension or diseases of the coronary arteries. Concomitant use with MAO inhibitors or use in the past 14 days of MAO inhibitors is contraindicated because the risk of possible fatal run against hypertension and hyperthermia.
Also contraindicated in children younger than 12 years and during pregnancy and lactation.

Special precautions:

treatment interruption in cases of tachycardia, palpitations, nausea. Athletes should be aware that pseudoephedrine can lead to a positive response to the doping.
Just like any other sympathomimetic pseudoephedrine should be used with caution in cases of coronary insufficiency (ischemia), arterial hypertension, hyperthyroidism, diabetes and psychoses.
People with micturition disorders and especially other people who suffer from a prostate disorder, should be closely monitored (because alfasympathicomimetica the blaassfincter act). In case of surgery: it is desirable to treat several days before surgery to interrupt because of risk of hypertension-run against the use of volatile halogens.
When both antihypertensives, amphetamines or sympathomimetic agents are administered, the blood pressure soon after start of treatment to be monitored.
Caution is advised in glaucoma. In case of severe disturbances of liver and renal function the dosage should be adjusted. Chronic alcohol use can increase the risk of liver damage

Pregnancy and lactation:

Caution should be exercised when administered to pregnant women or nursing mothers: in humans, the use of pseudoephedrine during pregnancy associated with a higher frequency of gastroschisis (= defect of the anterior abdominal wall with an intestinal hernia). Consequently, pseudo ephedrine contraindicated during pregnancy.
Pseudo Ephedrine in small quantities in breast milk. Use during lactation is contraindicated.

Undesirable effects:

Allergy.
Some rare cases of allergic accidents which were manifested in the form of a simple skin rash with urticaria and erythema or discontinuation of treatment requirements were reported, and some very rare cases of thrombocytopenia. Quincke edema and other signs of anaphylaxis have been rarely reported.
CNS. Comments
as dry mouth, dysgueusie, insomnia, migraine, anxiety and nervousness were observed.
Tgv pseudo ephedrine excitation of the CNS may act as sleep and rarely hallucinations.
Kidney.
Urinary retention was occasionally observed in men prostatic which proved to be a predisposing factor.
Heart.
Tachycardia and increased blood pressure may occasionally occur.
Lever.
Signs of liver toxicity after a prolonged treatment with high doses were reported. This may be enhanced by alcohol and inducing microsomal enzymes.

Driving vehicles:

The intake of paracetamol and pseudoephedrine tablets does not affect the driving or using machinery.

Overdose:

Paracetamol.
Symptoms : nausea, vomiting, anorexia, pallor, abdominal pain, usually within the first 24 hours. From 10 g of acetaminophen overdose (150 mg / kg body weight in children) may cause hepatic cytolysis and lead to a complete and irreversible necrosis. This is expressed in liver, metabolic acidosis and encephalopathy leading to coma and death can evolve. They also increase
an increase in the liver, the lactic dehydrogenase and bilirubin and a decrease in the protrombinegehalte true that 12 to 48 hours after ingestion may appear.
Order to protect the patient, the hepatotoxicity overdose of paracetamol as soon as possible be limited (gastric lavage with activated charcoal) followed by intravenous N-acetylcysteine.
Pseudo Ephedrine.
Following overdose of pseudo ephedrine, are irritability, restlessness, tremors, convulsions, palpitations, hypertension and micturition disorders occur. Also mydriasis, hallucinations, vomiting, cardiac arrhythmias.
Treatment: Immediately transfer to a hospital. Rapid evacuation of the product taken from gastric lavage. The treatment includes administration of activated charcoal. Symptomatic treatment: hypertension control by administration of an alpha-blocker, tachycardia with a beta blocker. Treat seizures with diazepam (adults: 10 mg IV or IM, children: 0.2 to 0.5 mg / kg rectally.)
Cardiorespiratory support.

Interactions:

Due to pseudoephedrine.
Sympathomimetics such as pseudoephedrine cause a release of norepinephrine. When simultaneously MAO inhibitors are used, increases the concentration of norepinephrine at halt nerve endings even more because the degradation of catecholamines is inhibited. Because of the long duration of the MAO-inhibitor interaction is still possible that 15 days after discontinuation of treatment with the MAO inhibitor. A pronounced increase in sympathomimetic activity are therefore determined to risk of severe hypertension, associated with fever, headache and tachycardia.
Pseudo Ephedrine can reverse the hypotensive activity of drugs with sympathetic activity including bretylium, bethanidine, guanethidine, debrisoquine, methyldopa, alpha - and beta-adrenergic blockers. The combination of volatile halogens require special precautions for anesthesia: preoperative risk of hypertension-uppercut. If a planned surgery is appropriate treatment several days before surgery to interrupt.
Risk of hypertension, tachycardia, arrhythmias with tricyclic antidepressants.
The absorption of pseudoephedrine may increase when co-administered with a drug based on aluminum hydroxide. Administration of pseudoephedrine in patients treated with metformin increases the risk of hyperglycemia. The glucose must be monitored regularly in case of association. By use of trazodone (250 mg per day) after ingestion of pseudoephedrine were described following symptoms: confusion, fear, panic and depersonalization.
Interactions between pseudoephedrine and dihydroergotamine, linezolid, methyldopa, sodium and diflunisal are described.
Due to paracetamol:
Interactions with para clinical trials, the dose of paracetamol in uric acid in the blood via the fosfowolframaatreductiemethode glycaemia and assay the glucose oxidase-peroxidase method distort.
An interaction of paracetamol with coumarin derivatives is possible. In any case, the intake of more than 2 g paracetamol per day for a long period (more than one weeks) the risk of bleeding and the regular monitoring of the International Normalized Ratio (INR) are required.
If overdose of alcohol can, barbiturates, phenytoin, carbamazepine and isoniazid increase the risk of liver damage. A special caution and eight in particular from the recommended dose is needed in children with epilepsy treated with barbiturates, phenytoin, carbamazepine or lamotrigine.