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SPC, UK: METHOTREXATE Tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Methotrexate 2.5 mg Tablets.

Qualitative and quantitative composition

Methotrexate 2.5 mg tablet. Each tablet contains methotrexate 2.5 mg. Excipients with known effects: Each tablet contains 12.50 mg lactose (as lactose monohydrate). For the full list of excipients, see ...

Pharmaceutical form

Tablet. Methotrexate 2.5 mg tablet: Yellow, circular, biconvex uncoated tablets with dimension of 4.50 mm ± 0.20 mm plain on both sides.

Therapeutic indications

Active rheumatoid arthritis in adult patients. Severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids, and severe ...

Posology and method of administration

Important warning about the dosage Methotrexate tablets (methotrexate): In the treatment of rheumatic diseases or diseases of the skin requiring dosing once a week, Methotrexate tablets (methotrexate) ...

Contraindications

Hypersensitivity to methotrexate or to any of the excipients listed in section 6.1. Significantly impaired hepatic function. Alcoholism. Significantly impaired renal function. Pre-existing blood dyscrasias, ...

Special warnings and precautions for use

The patients should be informed clearly that in the treatment of psoriasis and rheumatoid arthritis the administration is once weekly. The prescriber should specify the day of intake on the prescription. ...

Interaction with other medicinal products and other forms of interaction

After absorption methotrexate binds partly to serum albumin. Certain medicinal products (e.g. salicylates, sulfonamides and phenytoin) decrease this binding. In such instances the toxicity of methotrexate ...

Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in males and females Women must not get pregnant during methotrexate therapy, and effective contraception must be used during treatment with methotrexate and ...

Effects on ability to drive and use machines

Central nervous system symptoms, such as fatigue and dizziness, can occur during treatment with methotrexate which have minor or moderate influence on the ability to drive and use machines.

Undesirable effects

Generally the frequency and severity of adverse reactions are dependent of the size of the dose, the dosing frequency, the method of administration and the duration of exposure. If adverse reactions occur, ...

Overdose

Cases of overdose have been reported, sometimes fatal, due to erroneous daily intake instead of weekly intake of oral methotrexate. In these cases, symptoms that have been commonly reported are haematological ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other immunosuppressive agents ATC code: L04AX03 Methotrexate (4-amino-10-methylfolic acid) is a folic acid antagonist which inhibits the reduction of folic acid and increase ...

Pharmacokinetic properties

The effect of orally administered methotrexate seems to be dependent on the size of the dose. Peak concentrations in serum are reached within 1–2 hours. Generally a dose of methotrexate of 30 mg/m² or ...

Preclinical safety data

Chronic toxicity studies in mice, rats and dogs showed toxic effects in the form of gastrointestinal lesions, myelosuppression and hepatotoxicity. Animal studies show that methotrexate impairs fertility, ...

List of excipients

Anhydrous calcium hydrogen phosphate Lactose monohydrate Sodium starch glycolate Microcrystalline cellulose Talc Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years.

Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Blister: keep the blister in the outer carton in order to protect from light. HDPE container: store in original container ...

Nature and contents of container

2.5 mg tablets: White high density polyethylene container with non CRC high density polyethylene cap with induction wad. Pack size: 25 or 100 tablets. Amber colour Polyvinylchloride (PVC)/Plain Aluminium ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, United Kingdom

Marketing authorization number(s)

PL 36390/0174

Date of first authorization / renewal of the authorization

23-Jan-15

Date of revision of the text

02.01.2019

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