Ketesse - treatment of painful conditions 20 coated tablets 25 mg

Method of administration: The tablet should be swallowed with a sufficient amount of liquid (e.g. a glass of water). Concomitant administration of food delays the rate of absorption of the drug (see paragraph "Pharmacokinetic Properties"), therefore in case of acute pain it is recommended that administration takes place at least 30 minutes before meals.

Warnings

Read the package leaflet carefully before starting treatment.

Contraindications and side effects

Ketesse tablets should not be used in the following cases:

• patients with hypersensitivity to the active substance, or to other NSAIDs, or to any of the excipients listed in paragraph 6.1;
• patients in whom active substances with a similar action (e.g. acetylsalicylic acid, or other NSAIDs) trigger attacks of asthma, bronchospasm, acute rhinitis, or are the cause of nasal polyps, urticaria or edema angioneurotic;
• known photoallergic or phototoxic reactions during treatment with ketoprofen or fibrates;
• patients with a history of gastrointestinal bleeding or perforation related to previous NSAID therapy;
• patients with active peptic ulcer/gastrointestinal bleeding or a history of gastrointestinal bleeding, ulceration or perforation;
• patients with chronic dyspepsia;
• patients who have other active bleeding or coagulation disorders;
• patients with Crohn's disease or ulcerative colitis; patients with severe heart failure; patients with moderate to severe renal dysfunction (creatinine clearance ≤ 59 ml/min);
• patients with severely impaired hepatic function (Child-Pugh score 10-15);
• patients with haemorrhagic diathesis and other coagulation disorders; patients with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake);
• during the third trimester of pregnancy and breastfeeding (see section 4.6).

Pregnancy and breastfeeding

Ketesse tablets are contraindicated during the third trimester of pregnancy and during breastfeeding. (see section 4.3).

Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage, cardiac malformation, and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations is increased from less than 1% 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. Additionally, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. However, animal studies with dexketoprofen have not indicated reproductive toxicity (see section 5.3). During the first and second trimesters of pregnancy, dexketoprofen should not be administered unless clearly necessary. If dexketoprofen is used by a woman attempting to conceive, or during the first and second trimesters of pregnancy, the dose and duration of treatment should be kept as low 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 newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect that may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor.

Breastfeeding: It has not been established whether dexketoprofen is secreted in breast milk. Ketesse is contraindicated during breastfeeding (see section 4.3).

Fertility: As with other NSAIDs, the use of Ketesse may impair female fertility and is not recommended in women attempting to conceive. Discontinuation of treatment with dexketoprofen should be considered in women who have difficulties conceiving or who are undergoing investigation of infertility.

Format

20 tablets