ANTIREUMINE 10CPR

ANTIREUM

active ingredients

Each tablet contains: Active ingredients: Acetyl acid 275 mg Paracetamol 175 mg Caffeine 25 mg

Excellent

Corn starch, Microcrystalline cellulose, Magnesium stearate, Silice precipitated

Therapeutic indications

Syntomatic treatment of headaches, nerves, toothache, menstrual pain, joint pain, fever states and cooling syndromes.

Contraindications

Individual hypersensitivity ascertained towards the components. Paracetamol-based products are contraindicated in patients with manifest insufficiency of glucose-6-phosphate dehydrogenase and those with severe haemolytic anemia. Severe hepatocellular failure. Trend in bleeding. Gastropathy (e.g. gastroduodenal ulcer). Asthma. Third quarter of pregnancy. The use of this medicine is contraindicated in children and children under the age of sixteen.

Population

Adults: 1 to 4 tablets per day. Do not exceed the recommended doses; in particular, elderly patients should comply with the above minimum dosages. The product should be taken on a full stomach.

Conservation

Store at room temperature.

Warnings

Do not administer for more than 3 consecutive days without consulting your doctor. It should also be consulted by patients with chronic or recurrent gastric or intestinal disorders. During treatment with paracetamol before taking any other medication check that does not contain the same active ingredient, since if the paracetamol is taken in high doses severe adverse reactions may occur. It is recommended caution if the paracetamol is administered in conjunction with flucloxacillin due to increased risk of metabolic acidosis with high anionic gap (HAGMA), in particular in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as in those using the daily maximum doses of paracetamine. Careful monitoring is recommended, including the measurement of 5-oxoproline urinary. The use of ANTIREUMINA, as of any drug inhibitor of the synthesis of prostaglandins and cycloxygenase, is not recommended in women who intend to start a pregnancy. The administration of ANTIREUMINA should be suspended in women who have fertility problems or who are subject to fertility surveys. Invite the patient to contact the doctor before associating any other medication. See also the voice “Interactions”. The use of the product is not recommended if the patient is in treatment with other anti-inflammatory drugs. Use carefully in subjects with liver or kidney failure. In rare cases of allergic reactions administration must be suspended. This medicinal product should not be used in children or children under 16 years of age (see contraindications). Subjects over 70 years of age, especially in the presence of concomitant therapies, must use this medicine only after consulting a doctor.

Interactions

Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monooxidases or in case of exposure to substances that may have such an effect (for example reampin, cimetidine, antiepileptics such as glutetimide, phenobarbital, carbamazepine). The drug can interact with anticoagulants, uricosurics, sulfaniluree, hypoglycemic. The administration of the product, due to the presence of paracetamol, can interfere with the determination of the urine (by means of the method of phosphotungstic acid) and with that of the blood sugar (by means of the method of glucose-oxidase-peroxidase). Preoperative use can prevent intraoperative hemostasis. Be careful when paracetamol is used in conjunction with flucloxacillin since concurrent intake was associated with metabolic acidosis with high anionic gap, especially in patients with risk factors (see paragraph 4.4).

Effects

Gastro-enteric disorders, dizziness, rashes on an allergic basis may occur. For the presence of acetylsalicylic acid, otovestibular disorders (ronzii, etc.), hemorrhagic phenomena, (epistaxes, gums, etc.), childbirth delay and reduction of the platelet count. With the use of paracetamol, skin reactions of various types and severity were reported including cases of multiform erythema, Stevens Johnson syndrome and epidermal necrolysis. Angioedema, larynx edema, anaphylactic shock have also been reported. The following side effects have also been reported: thrombocytopenia, leucopenia, anemia, agranulocytosis, alterations of liver and hepatitis functionality, alterations to the kidney (acute kidney failure, interstitial nephritis, hematuria, anuria), gastrointestinal reactions and dizziness. Undesirable effects not described must be communicated to your physician or pharmacist.

Overdosing

In case of overdose, due to the presence of paracetamol, hepatic cytolysis can be provoked, which can evolve towards the massive and irreversible necrosis. For the presence of caffeine, always for high doses, a hyperstimulation syndrome with excitement, insomnia, rhinthia, muscle tremor, nausea, vomiting, increased diuresis, tachycardia, extrasistolia, scotoma can occur.

Pregnancy The use of the product is contraindicated in the third quarter of pregnancy. ANTIREUMINE contains acetylsalicylic acid (ASA). Clinical studies indicate that doses of ASA up to 100 mg/die can be considered safe limited to obstetric use, requiring specialist monitoring. - ASA 100-500 mg/die doses. There are insufficient clinical data related to the use of doses greater than 100 mg/die up to 500 mg/die. Therefore, the recommendations below for doses of 500 mg/die and beyond also apply to this dosage range. - ASA doses 500 mg/die and beyond The inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre- and post-plant and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disorders, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second quarter of pregnancy, acetylsalicylic acid should not be administered if not in strictly necessary cases. If acetylsalicylic acid is used by a woman waiting for conception, or during the first and second trimester of pregnancy, the dose and duration of treatment must be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress in kidney failure with oligo-idroamnios. the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, and anti-aggregating effect that can also be necessary at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. Consequently, acetylsalicylic acid at doses > 100 mg/die is contraindicated during the third trimester of pregnancy. Paracetamol A large amount of data on pregnant women do not indicate either malformation toxicity, nor fetal/neonatal toxicity. Epidemiological studies on neurological development in children exposed to paracetamol in uterus show non-conclusive results. If clinically necessary, paracetamol can be used during pregnancy, however it should be used at the lowest effective dose for as short as possible and with the lowest frequency possible.

Source: Farmadati