Paduden Cold and Flu 200 mg/30 mg, 10 film-coated tablets, Therapy

Paduden cold and flu 200 mg/30 mg, 10 film-coated tablets, Terapia

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:

Paduden cold and flu contains two active substances:

• Ibuprofen, which has anti-inflammatory, analgesic and antipyretic action (reduces fever)
• Pseudoephedrine hydrochloride, which has a decongestant action for the upper respiratory tract and sinuses.

Anti-inflammatory, analgesic, antipyretic and decongestant for the upper respiratory tract and sinuses:

• it is recommended to be used in cases where both the anti-inflammatory/analgesic/antipyretic action of ibuprofen and the decongestant action of pseudoephedrine hydrochloride are needed.

Composition:

Each tablet contains: ibuprofen 200 mg and pseudoephedrine hydrochloride 30 mg.

Administration method:

Grown ups:

• The recommended initial dose is 1-2 film-coated tablets. If necessary, the treatment will continue with 1 or 2 film-coated tablets every 4-6 hours
• The maximum recommended dose is 6 film-coated tablets in 24 hours (1200 mg ibuprofen).

Children under the age of 12:

• Do not administer to children under 12 years of age and weighing under 40 kg.

Contraindications:

Do not use Paduden cold and flu if you are hypersensitive to the active substances (ibuprofen and pseudoephedrine hydrochloride), acetylsalicylic acid, other non-steroidal anti-inflammatory drugs (NSAIDs) or any of the excipients of this medicine.

Precautions:

Before using Paduden cold and flu, talk to your doctor or pharmacist.

Pregnancy, breast-feeding and fertility:

Padusen Cold and Flu should not be administered during pregnancy or breastfeeding.

Task:

The drug should not be administered during pregnancy, taking into account that:

• Inhibition of prostaglandin synthesis by ibuprofen may have a negative influence on pregnancy and/or embryonic/fetal development
• Data from epidemiological studies suggest an increased risk of spontaneous abortion, cardiac malformations and gastroschisis after using a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformations increased from less than 1% to approximately 1.5%. It is assumed that the risk increases in proportion to the dose and duration of treatment. In animals, the administration of a prostaglandin synthesis inhibitor resulted in an increase in the number of pre- and post-implantation lost pregnancies and embryo-fetal lethality.
• In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered a prostaglandin synthesis inhibitor during organogenesis.

If ibuprofen is used by a woman who is trying to get pregnant, the dose should be as low as possible and the duration of treatment should be as short as possible. In 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 oligohydramnios

mother and newborn, at the end of pregnancy at:

• a possible prolongation of the bleeding time, an antiplatelet effect that can occur even at very low doses
• inhibition of uterine contractions, delaying or prolonging labor by ibuprofen.
• there is a possible relationship between the occurrence of fetal malformations and exposure to pseudoephedrine in the first trimester of pregnancy.

Breastfeeding:

Administration of the drug to breastfeeding women is contraindicated because:

• ibuprofen is excreted in human milk, although at therapeutic doses during short-term treatment, the risk of harm to the infant appears unlikely
• pseudoephedrine is excreted in breast milk in large quantities and may cause adverse cardiovascular and neurological reactions in the infant.

Fertility:

• The use of ibuprofen may affect fertility and is not recommended for women trying to conceive
• In women who have difficulty conceiving or who are being investigated for infertility, discontinuation of ibuprofen should be considered.

Driving vehicles and using machines:

• Less frequent side effects: headache, fatigue, drowsiness, nervousness, vertigo, asthenia, palpitations and visual disturbances have been reported with the administration of the combination of ibuprofen and pseudoephedrine hydrochloride.
• It is recommended to avoid administering PADUDEN Cold and Flu medicine to people who drive vehicles or use machines.

Presentation: 10 film-coated tablets