TERAPIA

PADUDEN CAISE 20MG/ML ORAL SUSPENSION 100ML

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Composition

The active substance is ibuprofen. 1 ml oral suspension contains 20 mg ibuprofen

Therapeutic indications

This medicine contains ibuprofen. Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), which relieve pain, reduce inflammation, and lower body temperature when you have a fever.

Paduden is used in children aged at least 3 months (and weighing at least 5 kg) for the short-term symptomatic treatment of:

• Mild to moderate pain, such as headache and toothache
• Fever
• Febrile conditions and cold and flu symptoms

Contraindications/Warnings

Before administering Paduden to your child, consult your doctor or

pharmacist if they:

• have or have had bronchial asthma or an allergic disease, as difficulty breathing may occur;
• have kidney or liver problems;
• have or have ever had high blood pressure or heart failure;
• have or have ever had stomach or intestinal disorders (including ulcerative colitis or Crohn's disease);
• have systemic lupus erythematosus (SLE) or mixed connective tissue diseases - conditions that affect the immune system causing joint pain, skin changes, and disorders in other organs

Dosage and administration

Always use exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

It is recommended that patients with stomach disorders take Paduden with food.

Doses should be administered at intervals of 6-8 hours. An interval of at least 4 hours should be left between doses. The interval between doses should be determined according to symptoms. The maximum recommended daily dose should not be exceeded.

3 – 6 months (5 – 7.6 kg) 3 times a day 50 mg (2.5 ml) = 150 mg (7.5 ml)

6 – 12 months (7.7 – 9 kg) 3-4 times a day 50 mg (2.5 ml) = 150–200 mg (7.5- 10 ml)

1 - 3 years (10 – 15 kg) 3 times a day 100 mg (5 ml) = 300 mg (15 ml)

4 - 6 years (16 – 20 kg) 3 times a day 150 mg (7.5 ml) = 450 mg (22.5 ml)

7 - 9 years (21 – 29 kg) 3 times a day 200 mg (10 ml) = 600 mg (30 ml)

10-12 years (30-40 kg) 4 times a day 200 mg (10 ml) = 800 mg (40 ml)

Special warnings

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not advisable to administer this medicine during pregnancy.

Driving vehicles and operating machinery

For short-term administration and at the recommended dose, this medicine has little or no influence on the ability to drive vehicles and operate machinery. If side effects such as fatigue, dizziness, drowsiness, and visual disturbances occur, do not drive vehicles or operate machinery. Alcohol consumption increases the risk of these side effects.

Packaging

The 100 ml oral suspension is contained in a primary package consisting of a 125 ml brown neutral glass bottle, fitted with a polypropylene screw cap with a polyethylene seal or with an alternative child-resistant closure system provided with a polypropylene screw cap and a visible engraved ring and gasket.

The cardboard box contains one (1) bottle, a 5 ml graduated plastic oral dosing syringe,