APAP pain and fever C plus, effervescent tablets, 10 pieces

Name: Apap C Plus
Form: tabl.mus.
Dose: 0.5g+0.3g
Package: 10 pills (5 blisters of 2).
Composition:

1 effervescent tablet contains as active substances :

Paracetamolum (paracetamol)

500 mg

ascorbicum (ascorbic acid)

300 mg

For excipients, see section 6.1.

Action: - analgesic,- antipyretic,- vitamin C replenishes the increased need for ascorbic acid.
Indications:

Short-term treatment of symptoms occurring in the course of a cold or flu, such as fever, headache, sore throat, muscle pain and osteoarticular pain.

Contraindications:

Hypersensitivity to the active substances or any of the excipients of the preparation. Congenital glucose-6-phosphate dehydrogenase deficiency. Severe hepatic or renal insufficiency. Urolithiasis. Viral hepatitis. Alcoholic disease. Phenylketonuria (due to aspartame content). Use of MAO inhibitors and the period of 2 weeks after their withdrawal. Use of zidovudine (AZT). Use in children under 12 years of age.

Side effects:

- Blood and lymphatic system disorders: rare: autoimmune-mediated thrombocytopenia, leukopenia, agranulocytosis, granulocytopenia, neutropenia, hemolytic anemia.

- Gastrointestinal disorders: nausea, vomiting.

- Renal and urinary tract disorders: renal colic, renal papillary necrosis,

acute renal failure, urolithiasis.

- Liver and biliary tract disorders: liver damage.

- Immune system disorders: rarely: allergic reactions such as Quincke's edema, shortness of breath, bronchospasm, profuse sweating, lowering of blood pressure up to symptoms of shock.

- Skin and subcutaneous tissue disorders: uncommon: erythematous, urticarial skin reactions and skin redness.

Interactions:

The drug should not be used concomitantly with other drugs containing paracetamol. Drugs that accelerate gastric emptying (e.g. metoclopramide) accelerate the absorption of paracetamol, while drugs that delay gastric emptying (propantheline), may delay the absorption of paracetamol. The use of paracetamol concomitantly with MAO inhibitor drugs, and within 2 weeks after treatment with these drugs, can cause agitation and fever.

The drug, when used short-term at a therapeutic dose, has no clinically significant interaction with anticoagulants.

Concomitant use of paracetamol with zidovudine (AZT) may increase the toxic effect of zidovudine on the bone marrow.

The drug may intensify the effect of anticoagulants (coumarin derivatives). Concomitant use of paracetamol and drugs that increase hepatic metabolism, i.e. some sleeping pills or antiepileptic drugs, e.g. phenobarbital, phenytoin, carbamazepine, isonicotinic acid hydrazide, as well as rifampicin may lead to liver damage. With the simultaneous administration of paracetamol and chlorzoxazone, the hepatotoxicity of both substances increases.

Paracetamol prolongs the half-life of chloramphenicol by about 5 times. Concomitant use of paracetamol with zidovudine (AZT) may increase the tendency to neutropenia.

Drinking alcohol during treatment with paracetamol leads to the formation of a toxic metabolite that causes liver cell necrosis, which may eventually lead to liver failure.

Ascorbic acid increases the absorption of aluminum from containing drugs, increases the absorption of iron.

The use of the drug can cause false results of some laboratory tests performed by oxidoreductive methods (determination of glucose, creatinine).

Dosage:

1 tablet at a time. Take every 4-6 hours. Do not take more than 3 tablets per day. Before taking, the tablet should be dissolved in ½ glass of water. Do not use in children under 12 years of age.

Dosage (adults): 1 tablet at a time. Take the drug every 4-6 hours.Do not take more than 3 tablets per day.Dissolve the tablet in ½ glass of water before taking.Do not use in children under 12 years of age.
Antidotes: If you take a higher dose of Apap C Plus than recommended, you may experience: - nausea, - vomiting, - excessive sweating, - drowsiness, - general weaknessThe treatment of paracetamol overdose is to provoke vomiting, if no more than an hour has elapsed since the intake, the administration of activated charcoal.In case of taking very large doses of the drug, immediately seek medical attention. Antidotes are administered: methionine and continue treatment with acetylcysteine in the intensive care unit.
Precautions:

The drug contains paracetamol. Because of the risk of overdose, check whether other medications you are taking contain paracetamol.

Use with caution in people with liver or kidney failure, bronchial asthma and hemochromatosis, as well as on a low-sodium diet. One tablet of APAP C Plus contains 167 mg of sodium. Do not drink alcohol while taking the drug due to the increased risk of toxic liver damage. There is a particular risk of liver damage in people who are starving and regularly drink alcohol.

Driving:

4.7 Effects on the ability to drive and operate moving machinery No effect.

Overdose:

Accidental or intentional overdose of the drug may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness and general weakness within a few, several hours. These symptoms may subside the next day, although liver damage begins to develop, which then makes itself known with epigastric distension, return of nausea and jaundice.

Whenever paracetamol in a dose of 5 g or more is taken at one time, vomiting should be provoked if no more than an hour has passed since ingestion. 60-100 g of activated charcoal, preferably mixed with water, should be administered orally. A reliable assessment of the severity of poisoning is provided by determining the concentration of paracetamol in the blood. The value of this concentration in relation to the time elapsed since taking paracetamol is a valuable indication of whether and how intensive antidote treatment will be necessary. If it is not possible to determine the blood concentration of paracetamol, and the likely dose of paracetamol ingested was high, more intensive antidote treatment should be implemented: give 2.5g of methionine and continue treatment with acetylcysteine or (i) methionine, which are very effective in the first 10-12 hours after poisoning, but are also likely to be effective after 24 hours. Treatment of paracetamol poisoning should take place in the hospital, in an intensive care unit setting.

Pregnancy:

Paracetamol crosses the placenta and also into the milk of breastfeeding women in an amount of about 1% of the dose taken by the mother. Ascorbic acid also crosses the placenta and into the milk. The drug can be used during pregnancy and lactation if definitely necessary.