Prosinus 500 mg/30 mg, 20 film-coated tablets, Fiterman

Paracetamol is used to relieve mild to moderate pain and fever.

Pseudoephedrine shows efficacy as a nasal decongestant.

Prosinus film-coated tablets are indicated for the symptomatic treatment of mild-to-moderate pain (e.g. headache, sore throat, sinus pain), febrile conditions, nasal congestion and nasal hypersecretion.

Composition:

• Each film-coated tablet contains paracetamol 500 mg and pseudoephedrine hydrochloride 30 mg
• The other components are: microcrystalline cellulose core PH 102, polyvinylpyrrolidone K 30, sodium starch glycolate type A, talc, corn starch, colloidal anhydrous silicon dioxide, magnesium stearate; film-Opadry II white 85F18422, partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol/PEG 3350, talc.

How to use:

• Adults (including the elderly) and adolescents over 12 years of age: the recommended dose is 2 Prosinus® film-coated tablets up to 3 times a day, as needed, to relieve symptoms
• The minimum interval between administrations is 4 hours. No more than 3 doses will be given in 24 hours.

Contraindications:

Do not use Prosinus if you are allergic to paracetamol and pseudoephedrine or to any of the other components of this medicine.

Precautions:

Before using Prosinus, talk to your doctor or pharmacist.

Pregnancy, breast-feeding and fertility:

• If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:

• Data from the use of paracetamol in pregnant women are limited
• Human and animal studies have not identified any risk to pregnancy or embryofetal development
• Epidemiological studies during pregnancy did not show the occurrence of teratogenic and fetotoxic effects due to paracetamol in the recommended doses
• As a precautionary measure, it is preferable to avoid the use of paracetamol during pregnancy
• However, as with other drugs, caution is recommended in the administration of paracetamol in the first trimester of pregnancy.

Breastfeeding:

• In humans, paracetamol is excreted in milk, but at therapeutic doses no effects are expected in newborns/breastfed infants.

Fertility:

• Nonclinical toxicity studies have shown toxic effects on reproductive function.

Driving vehicles and using machines:

• The medicine does not influence the ability to drive vehicles and use machines.

Presentation: 20 film-coated tablets