NEOOPTALIDON 8CPR RIV

NEO-OPTALIDON 200 MG+125 MG+25 MG COMPRESENT RIVESTATES

active ingredients

A coated tablet contains active ingredients: paracetamol 200 mg; propifenazone 125 mg; caffeine 25 mg sucrose 60 mg; hydrogenated peanut oil 0.132 mg. For the full list of excipients, see paragraph 6.1.

Excellent

Hydroxypropylcellulose; dimethylsilicone oil; crospovidone; hydrogenated vegetable oil; magnesium stearate; titanium dioxide; hydrogenated peanut oil; anidra colloidal silica; macrogol 6000; povidone; sucrose; stearic acid; talc; microcrystalline cellulose; cetilic alcohol; erythrosine (And 127); arab rubber.

Therapeutic indications

Syntomatic treatment of acute painful states (headache; toothache; neuralgies; menstrual pains) and fever states.

Contraindications

• Hypersensitivity to active ingredients or other substances closely related to chemical and/or any of the excipients listed in paragraph 6.1; • hemopaths such as granulocytopenia and intermittent porphyries;• patients with manifest glucose-6-phosphate dehydrogenase deficiency; • patients with severe hemolytic anemia; • severe hepatocellular and kidney failure; • for the presence of caffeine, the product should not be given to children under 12 years; • pregnancy and nursing (see paragraph 4.6). • peanut allergies or soya.

Population

Population 1-2 coated tablets; up to 4 tablets coated in 24 hours. Special popularity Senior patients should stick to the above minimum dosages. Do not administer the product for over 3 consecutive days. Do not exceed the recommended doses. Method of administration Consumer NEO-OPTALIDON with plenty of water or other liquids. Intake of oral analgesic preparations must take place on a full stomach.

Conservation

This medicine does not require any special condition of conservation.

Warnings

It is not recommended to use the product if the patient is in treatment with anti-inflammatory drugs. High or prolonged doses of the product may result in high-risk hepatopathy and alterations to the kidney and blood. Carefully administer in subjects with kidney or liver failure or hematopoietic dysfunction. 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. If fever, angina, skin or mucous membranes appear during treatment, suspend therapy and consult your doctor. Invite the patient to contact the doctor before associating any other medication (see paragraph 4.5). In rare cases of allergic reactions the administration of the product should be suspended. Special caution is required in patients with asthma, chronic rhinitis or chronic hives. There have been isolated cases of asthma attacks and anaphylactic shock associated with the taking of drugs containing propylphenazone and paracetamol in susceptible subjects. 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. Important information about some excipients NEO-OPTALIDON contains • sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine; • hydrogenated peanut oil: do not use in case of peanut allergies or soya.

Interactions

The product can interact with alcohol, some hypoglycemising (acetoesamide, chlorpropamide, tolbutamide), anticoagulants (warfarin), phenytoin. In the course of therapy with oral anticoagulants it is recommended to reduce doses. Drugs that slow gastric emptying (e.g. propantelin) can reduce the absorption rate of paracetamol, delaying the therapeutic effect; on the contrary, drugs that increase the rate of gastric emptying (e.g. metoclopramide, domperidone) involve an increase in the rate of absorption. Concurrent cloramfenicle administration can lead to an extension of the half-life of the paracetamol, with the risk of increasing its toxicity. Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of liver monoxygenases or in case of exposure to substances that may have such an effect (e.g. rifampin, cimetidine, antiepileptics such as glutethymmides, phenobarbital, carbamazepine). Paracetaminol administration may interfere with the determination of uricemia (by means of the method of phosphotungstic acid) and glycemia (by the method of glucose-oxidase-peroxidase). Concurrent use of paracetamol and AZT (zidovudine) increases the tendency to a reduction in the leukocytes count (neutropenia). NEO-OPTALIDON, therefore, should not be taken in association with AZT (zidovudine) except on prescription. The simultaneous administration of NSAIDs or opioids leads to a mutual strengthening of the analgesic effect. Paracetamol increases the AUC of Etinilestradiol by 22%. Paracetamol can reduce the plasma concentration of lamotrigine. You should pay attention 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

The following side effects were observed: Alterations of the skin and subcutaneous tissue: Skin rashes on an allergic basis. The use of paracetamol has rarely been reported multiform erythema, very rarely Stevens Johnson syndrome and epidermal necrolysis. Angioedema, itching, erythema, urticaria, dispnea, asthma, edema of the larynx, anaphylactic shock have been reported. Alterations of blood and lymphatic system: Trombocytopenia, leucopenia, anemia, agranulocytosis. Alterations of the hepatobiliary system: Alterations of liver and hepatitis functionality. Kidney and urinary tract alterations: Acute renal insufficiency, interstitial nephritis, hematuria, anuria. Alterations of the hearing apparatus and vestibular: Vertigo. Alterations of the gastrointestinal apparatus: Gastrointestinal disorders. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Erroneous intake of quantities greater than recommended can cause seizures. In case of overdose, the paracetamol can cause hepatic cytolysis that can evolve towards massive and irreversible necrosis. For the presence of caffeine, always for high doses, you can experience hyperstimulation with excitement, insomnia, muscle tremor, nausea, vomiting, increased diuresis, tachycardia, extrasistolia, scotoma.

Is not recommended NEO-OPTALIDON in case of pregnancy also presumed and especially in the first 3 months and during breastfeeding.

Source: Farmadati