PENICILLAMINE Film-coated tablet (2016)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Penicillamine 250 mg film-coated tablets.
Qualitative and quantitative composition
Each tablet contains 250 mg penicillamine. Excipient with known effects: Each tablet contains 96 mg lactose. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. A round, white normal biconvex film coated tablet embossed with PC 250 on one side and marked G on reverse.
Therapeutic indications
Severe active rheumatoid arthritis including juvenile forms. Wilsons disease (hepatolenticular degeneration) in adults and children (0 to 18 years). Cystinuria – dissolution and prevention of cystine stones ...
Posology and method of administration
Posology Rheumatoid Arthritis Adults A daily dose of 125-250 mg per day is recommended for the first month, increasing by the same amount every four to twelve weeks until remission occurs. The minimum ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Agranulocytosis, aplastic anaemia or severe thrombocytopenia due to penicillamine. Lupus erythematosus. Moderate ...
Special warnings and precautions for use
Full blood and platelet counts should be performed and renal function should be assessed prior to treatment with penicillamine. Monitoring of blood and platelet counts should be carried out at appropriate ...
Interaction with other medicinal products and other forms of interaction
Concomitant use of iron or antacids: oral absorption of penicillamine may be reduced by concomitant administration of iron or antacid (see section 4.4). Concomitant use of digoxin: oral absorption of digoxin ...
Pregnancy and lactation
Pregnancy The safety of penicillamine for use during pregnancy has not been established (see section 5.3). Wilsons disease There have been several cases of reversible cutis laxa in infants born to mothers ...
Effects on ability to drive and use machines
None known.
Undesirable effects
The most common of all side-effects are thrombocytopenia and proteinuria. Thrombocytopenia occurs commonly. The reaction may occur at any time during treatment and is usually reversible. Proteinuria occurs ...
Overdose
There are no reported cases of undesirable reactions to penicillamine overdosage and no special treatment is recommended.
Pharmacodynamic properties
Pharmacotherapeutic group: Antirheumatic drugs ATC code: M01CC01 Penicillamine is used to treat severe active rheumatoid arthritis not adequately controlled by NSAID therapy. Penicillamine is a chelating ...
Pharmacokinetic properties
Penicillamine is a thiol-group containing chelating agent, variably absorbed from the gastrointestinal tract. The drug undergoes a rapid distribution phase, followed by a slower elimination phase. Penicillamine ...
Preclinical safety data
Penicillamine has been shown to be teratogenic in rats when given in doses several times higher than those recommended for human use. There is no known LD<sub>50</sub> value for penicillamine. In studies ...
List of excipients
The tablet contains: Povidone Lactose Sodium starch glycollate Magnesium stearate The film-coat contains: Hydroxypropyl methylcellulose (E464) Titanium dioxide (E171) Polyethylene glycol Carnauba wax ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store in a cool, dry place below 25°C.
Nature and contents of container
Penicillamine Tablets are available in polypropylene containers with polyethylene caps (with optional polyethylene ullage filler) 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100, 112, 120, 168, ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Marketing authorization number(s)
PL 04569/0186
Date of first authorization / renewal of the authorization
4<sup>th</sup> December 1987 / 20<sup>th</sup> May 1998
Date of revision of the text
November 2016
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