Itamifast 25 mg - anti-inflammatory and painkiller 10 coated tablets

Product Description

Fidia

Anti-inflammatory and Painkiller

Itamifast is used:

• In adults, acute painful conditions, such as headache, toothache, muscle or joint pain, back pain and primary dysmenorrhea.
• In children and adolescents, short-term symptomatic treatment of pain associated with painful inflammations of the ear, nose or throat, e.g. pharyngitis, tonsillitis, otitis
• In children and adolescents, short-term symptomatic treatment of postoperative pain after minor surgery.

Dosage and method of use

Itamifast is used according to the following indications:

• Adults and adolescents over 16 years: 25 mg every 4-6 hours, as indicated. The highest recommended daily dose is 25 mg every 4-6 hours. The highest dose is 150 mg.
• Children and adolescents: Children aged 9 years and older (min. 35 kg body weight) and adolescents should be treated with doses up to 2 mg/kg body weight per day in 3 divided doses, depending on the severity of the disorder.

Contraindications

• Known hypersensitivity to the active substance or to any of the excipients.
• Active gastric or intestinal ulcer, bleeding or perforation.
• History of gastrointestinal bleeding or perforation related to previous NSAID therapy.
• History of recurrent peptic ulcer/haemorrhage or recurrent peptic ulcer/active haemorrhage (two or more distinct episodes of ulceration or bleeding).
• Last trimester of pregnancy.
• Conditions causing an increased bleeding tendency.
• Severe hepatic insufficiency.
• Hepatic porphyria.
• Severe renal insufficiency (glomerular filtration rate > 30 ml/min).
• As with other nonsteroidal anti-inflammatory drugs (NSAIDs), diclofenac is also contraindicated in patients in whom attacks of asthma, urticaria or acute rhinitis are exacerbated by acetylsalicylic acid or other NSAIDs.
• Obvious congestive heart failure (NYHA class II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.

Special warnings

Undesirable effects can be minimized by administering the lowest effective dose for the shortest duration necessary to control the symptoms. Symptoms

The concomitant use of Itamifast with systemic NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to the absence of any evidence demonstrating synergistic benefits and the possibility of additive adverse effects. For medical reasons, caution is advised in elderly patients. In particular, the use of the lowest effective dose is recommended in frail elderly patients or those with low body weight. Elderly patients are at increased risk of adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, which may be fatal. Furthermore, elderly patients are more likely to suffer from renal, cardiac, or hepatic impairment.

As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, may occur with diclofenac in rare cases without recent exposure
to the drug. As with other NSAIDs, due to its pharmacodynamic properties, Itamifast may cause allergic reactions. mask the signs and symptoms of infections.

Pregnancy and breastfeeding

• Pregnancy

The systemic concentration of diclofenac, compared to oral formulations, is lower after topical administration. Based on experience with treatment with systemically administered NSAIDs, the following is recommended: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1%, up to approximately 1.5%.

The risk is believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to
result in increased pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimesters of pregnancy, diclofenac should not be administered unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimesters of pregnancy, the dose should be kept as low as possible and the duration of treatment as short as possible. short as possible.

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 may progress to renal failure with oligohydramnios;

The mother and the newborn, at the end of pregnancy, may be exposed to:

• possible prolongation of bleeding time, and antiaggregant effect which may may occur even at very low doses;
• inhibition of uterine contractions resulting in delayed or prolonged labor.

Consequently, diclofenac is contraindicated during the third trimester of pregnancy.

• Breastfeeding

Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of Itaminon, effects on the infant are expected. Due to the lack of controlled studies in breastfeeding women, the product should be used during breastfeeding only under the advice of a healthcare professional. In this circumstance, Itaminon should be applied to the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time.

Expiry and storage

Check the expiry date indicated on the package. The expiry date indicated on the package refers to the product in its intact packaging, stored correctly. Store in the original packaging to protect from moisture.

Composition

Itamifast contains:
Active ingredient: 25 mg of diclofenac potassium.
Excipients: Mannitol, Potassium hydrogen carbonate, Sodium lauryl sulfate, Macrogol, Crospovidone, Magnesium stearate.

Format

Pack with 10 coated tablets.