Nalgesin 220 mg, 10 tablets, Krka

Nalgesin 220 mg, 10 tablets, Krka

Read the leaflet carefully and completely before you start using this medicine, because it contains important information for you.
Always use this medicine as directed in this leaflet or as directed by your doctor or pharmacist.

Indications:
Nalgesin 220 mg film-coated tablets is indicated for adults and adolescents over 16 years of age:
- for the short-term symptomatic treatment of mild to moderate pain (such as headache, toothache, menstrual pain, joint pain, muscle pain).

Composition:
Each film-coated tablet contains naproxen sodium 220 mg, equivalent to naproxen 200 mg.

Administration method:
Doses and method of administration:
Dosage
Adverse reactions can be reduced by using the lowest effective dose for the shortest period necessary to control symptoms (see section 4.4).
Adults and adolescents over 16 years of age and with a body weight over 50 kg
The recommended dose for adults and adolescents over 16 years of age and with a body weight over 50 kg is 1 film-coated tablet every 8-12 hours.
As an alternative treatment scheme, the initial dose is 2 film-coated tablets, followed, if necessary, by the additional administration of one film-coated tablet after 8-12 hours.
The maximum daily dose is 3 film-coated tablets.
The duration of the treatment is 7 days. If the pain persists or if the symptoms change, a medical consultation is recommended.

Contraindications:
- Hypersensitivity to the active substance or to any of the excipients;

Precautions:
Before using Nalgesin, talk to your doctor or pharmacist.

Pregnancy, breast-feeding and fertility:
Task:
Inhibition of prostaglandin synthesis may affect pregnancy and/or embryofetal development. Data from epidemiological studies suggest the existence of an increased risk of abortion, cardiac malformation and gastroschisis after using a prostaglandin synthesis inhibitor in the first period of pregnancy.
The absolute risk of cardiovascular malformation was increased from less than 1% to approximately 1.5%. It is believed that the risk is dependent on increasing the dose and duration of treatment.
In animals, it has been shown that the administration of prostaglandin synthesis inhibitors increases the number of abortions in the pre- and post-implantation stage and the risk of embryo-fetal mortality.
Additionally, in animals that were administered an inhibitor of prostaglandin synthesis during the period of organogenesis, an increase in the incidence of various malformations, including cardiovascular ones, was observed. During the first and second trimesters of pregnancy, naproxen sodium is not recommended unless clearly necessary. If naproxen sodium is used by a woman trying to become pregnant or during the first or second trimester of pregnancy, the dose should be as low as possible, as should the duration of treatment.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to:
- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
- renal dysfunction, which can progress to renal failure with oligohydroamnios; and the mother and fetus, at the end of the pregnancy, at:
- possible prolongation of bleeding time, an antiplatelet effect that occurs even at very low doses.
- inhibition of uterine contractions, causing delay or prolongation of labor.
Consequently, naproxen sodium is contraindicated during the third trimester of pregnancy.
Breastfeeding:
The use of Nalgesin is not recommended during breastfeeding, as naproxen sodium is excreted in breast milk.
Fertility:
There is some data to suggest that cyclooxygenase/prostaglandin synthesis inhibitor drugs may cause female infertility by affecting ovulation. The effect is reversible upon discontinuation of treatment.

Driving vehicles and using machines:
Normally, Nalgesin has no or negligible influence on the ability to drive or use machines. Following the use of NSAIDs, dizziness, drowsiness, fatigue and visual disturbances may occur. If these reactions occur, patients should not drive or operate machinery.

Presentation:
10 tablets