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New Proposed Ticlopidine hydrochloride; DE/H/0203/001; 01.02.1318.10.11-corr. Formatiert: Schriftart: 18 Pt., Nicht unterstrichen, Englisch new proposed SPC (Großbritannien) Formatiert: Zeilenabstand: einfach Page 1/16 Formatiert: Links: 2,5 cm, Rechts: 2,5 cm, Oben: 2 cm, Unten: 2 cm, Kopfzeilenabstand vom Rand: 1,3 cm, SUMMARY OF PRODUCT CHARACTERISTICS Fußzeilenabstand vom Rand: 1,3 cm Formatiert: Schriftart: Nicht Fett 1. NAME OF THE MEDICINAL PRODUCT Formatiert: Einzug: Links: 0 cm, Hängend: 1 cm, Tabstopps: Nicht an 0,75 cm /…/ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Formatiert: Einzug: Links: 0 cm, Hängend: 1 cm, Tabstopps: Nicht an 0,75 cm Each film-coated tablet contains 250 mg ticlopidine hydrochloride. Formatiert: Schriftart: Nicht Fett, Nicht Kursiv For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Formatiert: Einzug: Links: 0 cm, Hängend: 1 cm, Tabstopps: Nicht an 0,75 cm Film-coated tablets White to off-white, slightly convex. 4. CLINICAL PARTICULARS Formatiert: Einzug: Links: 0 cm, Hängend: 1 cm, Tabstopps: Nicht an 0,75 cm 4.1 Therapeutic indications Formatiert: Einzug: Links: 0 cm, Hängend: 1 cm, Tabstopps: Nicht an 0,75 cm For the prophylaxis of cerebral thrombotic infarct in patients after transient ischaemic attacks (TIA), reversible ischaemic neurological deficit (RIND) or for prophylaxis in patients who have suffered a cerebral thrombotic infarct (secondary prophylaxis). These indications apply only to patients for whom treatment with acetylsalicylic acid is not tolerated. Formatiert: Schriftart: Nicht Fett For inhibition of platelet aggregation in haemodialysis patients with shunt complications in cases of intolerance to preparations containing acetylsalicylic acid. 4.2 Posology and method of administration Formatiert: Einzug: Links: 0 cm, Hängend: 1 cm, Tabstopps: Nicht an 0,75 cm Posology Adults Formatiert: Vom nächsten Absatz trennen The usual dosage for adults for the given indications is 1 film-coated tablet /…/ twice daily (equivalent to 250 mg ticlopidine hydrochloride twice daily). A daily dose of 500 mg of ticlopidine hydrochloride should not be exceeded. In order to avoid or decrease possible gastrointestinal adverse reactions such as nausea and diarrhoea, the daily dose should at any rate be taken divided into only two doses, with two main meals, (after half the meal has been taken). Duration of treatment is determined by the clinical picture. Long-term treatment is generally indicated. Formatiert: Schriftart: Fett Ticlopidine hydrochloride; DE/H/0203/001; 01.02.1318.10.11-corr. Formatiert: Schriftart: 18 Pt., Nicht unterstrichen, Englisch new proposed SPC (Großbritannien) Formatiert: Zeilenabstand: einfach Page 2/16 Paediatric population The use in children and adolescents is not recommended. Special populations Formatiert: Schriftart: 12 Pt., Nicht unterstrichen Use in patients with impaired liver function Formatiert: PSUR Paragraph 1 Formatiert: Nicht unterstrichen In case of impaired liver function, ticlopidine should be used with special caution. Formatiert: Vom nächsten Absatz trennen Paediatric population Formatiert: Keine Absatzkontrolle The use in children and adolescents is not recommended due to lack of experience in clinical trials. Formatiert: Unterstrichen Method of administration In order to avoid or decrease possible gastrointestinal adverse reactions such as nausea and diarrhoea, the daily dose should at any rate be taken divided into only two doses, with two main meals (after half the meal has been taken). 4.3 Contraindications Formatiert: Einzug: Links: 0 cm, Hängend: 1 cm, Tabstopps: Nicht an 0,75 cm Ticlopidine must not be taken by patients with known hypersensitivityHypersensitivity to Formatiert ticlopidinethe active substance or to any of the excipients. Formatiert Ticlopidine must not be used listed in patients with haemorrhagicsection 6.1 Formatiert Haemorrhagic diathesis, disorders involving prolongation of bleeding time as well as organ Formatiert: Einzug: Links: 0 cm, Hängend: 1 cm, Aufgezählt lesions with risk of haemorrhage, such as acute peptic/intestinal ulcers or haemorrhagic + Ebene: 1 + Ausgerichtet an: 0,63 cm + Tabstopp nach: apoplectic stroke. 1,27 cm + Einzug bei: 1,27 cm, Leerraum zwischen asiatischem und westlichem Text nicht anpassen, Leerraum zwischen asiatischem Text und Zahlen nicht anpassen, In addition, ticlopidine must not be used in patients with pre-existing or a historyOrganic lesions Tabstopps: Nicht an 1,27 cm which are liable to bleed i.e. active gastroduodenal ulcer or haemorrhagic cerebrovascular Formatiert accident in the acute phase Formatiert Blood disease involving prolonged bleeding time History of blood count abnormalities, such as neutropenia, agranulocytosis orleucopenia, Formatiert: Einzug: Links: 0 cm, Hängend: 1 cm, Aufgezählt thrombocytopenia. or agranulocytosis + Ebene: 1 + Ausgerichtet an: 0,63 cm + Tabstopp nach: 1,27 cm + Einzug bei: 1,27 cm, Leerraum zwischen asiatischem und westlichem Text nicht anpassen, Leerraum 4.4 Special warnings and precautions for use zwischen asiatischem Text und Zahlen nicht anpassen, Tabstopps: Nicht an 1,27 cm It is essential to comply strictly with the indications, contraindications and warnings and precautions Formatiert for use. Formatiert Formatiert Severe, sometimes fatal forms of undesirable haematological or Haematological and haemorrhagic Formatiert: Einzug: Links: 0 cm, Hängend: 1 cm adverse effects are most likely to can occur in cases in which. Agranulocytosis, pancytopenia and rare cases of leukaemia have been reported in postmarketing experience. Formatiert: Einzug: Links: 0 cm, Hängend: 1 cm, Tabstopps: Nicht an 0,75 cm monitoring is not appropriately conducted, diagnosis is made too late and unsuitable measures are taken to treat the undesirable effects, Formatiert other medicinal products which increase the risk of haemorrhage, e.g. Formatiert Serious, sometimes fatal haematological and haemorrhagic adverse effects (see section 4.8) may Formatiert occur, especially associated with: Formatiert Inadequate monitoring, late diagnosis and inappropriate therapeutic measures for adverse effects Concomitant administration of anticoagulants or antiplatelet agents such as acetylsalicylic acid or non-aspirin and nonsteroidal anti-inflammatory drugs medicinal products (NSAIDs) (see section 4.5), are used concomitantly). However, in case of STENT implantation, ticlopidine should be combined with aspirin (100 to 325 mg per day) for about one month following implantation. Ticlopidine hydrochloride; DE/H/0203/001; 01.02.1318.10.11-corr. Formatiert: Schriftart: 18 Pt., Nicht unterstrichen, Englisch new proposed SPC (Großbritannien) Formatiert: Zeilenabstand: einfach Page 3/16 All patients should be carefully monitored for clinical signs and symptoms of adverse reactions, Formatiert: Leerraum zwischen asiatischem und westlichem especially in the first 3 months of treatment.Haematological monitoring Text nicht anpassen, Leerraum zwischen asiatischem Text und Zahlen nicht anpassen Blood count alterations Formatiert: Schriftart: Kursiv, Unterstrichen, Schriftfarbe: Schwarz Regular controls of cell counts (BCCs) with differential blood counts and platelet counts at 14 days Formatiert: Schriftart: Nicht Kursiv, Nicht unterstrichen intervals are necessary prior to initiation of therapy with ticlopidine and during the first 3 months of treatment, should be performed at the start of treatment and then every two weeks for the first three months of therapy to ensure that any blood count alterations are detected at the earliest point of time. If the neutrophil count falls below 1,500/mm3, a second blood analysis should immediately be performed. If laboratory analysis confirms the presence of neutropenia (<1,500 neutrophilic granulocytes/mm3) or thrombopenia (<100,000 platelets/mm3), treatment with ticlopidine should be discontinued. If therapy with ticlopidine is discontinued , and within the first 3 months for any other reason, Formatiert: Schriftfarbe: Schwarz differential blood counts should be monitored 1415 days after termination of the course of therapy. Formatiert: Schriftfarbe: Schwarz Usually blood counts will normalise with discontinuation of the treatment (it is advisable to monitor Formatiert: Tabstopps: 0 cm, Links differential blood counts until the numbers of neutrophils and platelets have returned to normal Formatiert: Schriftfarbe: Schwarz levels)ticlopidine, should the treatment be stopped within the first three months of therapy. Formatiert: Schriftfarbe: Schwarz These bloodBlood count alterations generally occur during the first 3 months after the beginning of treatment and are not always accompanied by signs of an infection or other clinical symptoms. Formatiert: Tabstopps: 0 cm, Links 3 Haemorrhagic complications and surgeryWhen the neutrophil numbers have fallen below 1,500/mm , Formatiert: Vom nächsten Absatz trennen the values should be confirmed. If the presence of neutropenia (neutrophils <1,500/mm3) or 3 thrombocytopenia (platelets <100,000/mm ), are confirmed, the drug should be discontinued. Formatiert: Schriftart: Nicht Kursiv, Nicht unterstrichen Patients with an increased risk of haemorrhage, e.g. after trauma, surgery or due to other pathological conditions should be closely monitoredBecause of the long plasma half-life of ticlopidine hydrochloride, it is recommended that any patient who discontinues ticlopidine for any reason within the first 90 days have an additional CBC with white cell differential count obtained two weeks after discontinuation
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