TEVA

TEDOLFEN 200MG/30MG 12 FILM-COATED TABLETS

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Composition.

The active substances are ibuprofen (200 mg per tablet) and pseudoephedrine hydrochloride (30 mg per tablet, equivalent to 24.6 mg pseudoephedrine base). The other components are: microcrystalline cellulose, pregelatinized starch (corn), povidone K-30, anhydrous colloidal silicon dioxide, stearic acid 95, croscarmellose sodium, sodium lauryl sulfate, hypromellose 3 mPa.s, hypromellose 5 mPa.s, titanium dioxide (E 171), macrogol 400, yellow iron oxide (E 172), polysorbate 80, red iron oxide (E 172), black iron oxide (E 172), partially hydrolyzed polyvinyl alcohol, talc, macrogol 3350, MICA-BASED pigment (aluminum potassium silicate, titanium dioxide (E 171)).

Therapeutic indications.

Tedolfen contains the active substances ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), and pseudoephedrine, which is a nasal decongestant.

· Ibuprofen reduces pain, inflammation, and high temperature.

· Pseudoephedrine acts on the blood vessels in the nose to relieve nasal congestion.

Tedolfen is indicated for the relief of symptoms of nasal congestion with headache, fever and/or pain associated with common colds and flu.

Tedolfen is indicated for adults and adolescents over 15 years of age.

Take this medicine (this combination) only if you have a blocked nose with symptoms of pain or fever. If you only have one of these symptoms, do not use this medicine.

If after 3 days for adolescents and 5 days for adults you do not feel better or feel worse, you should consult a doctor.

Dosage and administration.

Always use this medicine exactly as your doctor or pharmacist has told you. Talk to your doctor or pharmacist if you are not sure.

Adults and adolescents aged 15 years and over: 1 tablet every 4-6 hours, as needed. For more severe symptoms, take 2 tablets every 6-8 hours, as needed. Do not exceed the maximum daily dose of 6 tablets.

Precautions.

Before taking Tedolfen, talk to your doctor or pharmacist:

- if you have bronchial asthma; risk of bronchial asthma attack

- if your doctor has told you that you have a blood clotting disorder

- if you are taking blood-thinning medicines such as warfarin, low-dose acetylsalicylic acid

- if you are taking medicines that may increase the risk of gastric ulcer or bleeding, such as steroids, antidepressants from the class of selective serotonin reuptake inhibitors (SSRIs) (e.g., fluoxetine, paroxetine) or non-steroidal anti-inflammatory drugs, including acetylsalicylic acid

Special warnings.

Pregnancy, breastfeeding and fertility

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. Tedolfen should not be administered during pregnancy or if you are breastfeeding. The active ingredients, ibuprofen and pseudoephedrine, can cause serious problems in unborn babies and have been shown to be present in breastfed infants of women who have taken them. Tedolfen contains ibuprofen, which belongs to a group of medicines (NSAIDs) that may affect female fertility. This effect is reversible upon discontinuation of the medicine.

Driving and using machines

Tedolfen has no known effects on the ability to drive and use machines. In exceptional cases, dizziness or hallucinations may occur, and this possibility should be taken into consideration.

Packaging. The tablets are available in blister packs of 12 film-coated tablets.

Page updated on: 09.06.2021