Penicillamine 125mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Penicillamine

Disponible des:

Waymade Healthcare Plc

Codi ATC:

M01CC01

Designació comuna internacional (DCI):

Penicillamine

Dosis:

125mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 10010300

Informació per a l'usuari

WHAT PENICILLAMINE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Penicillamine 125mg Tablets or
Penicillamine 250mg Tablets. Penicillamine belongs to a group of
medicines called disease modifying anti-rheumatic drugs (DMARDS).
Penicillamine works by reducing the body’s immune response and
relieving pain, swelling and stiffness caused by rheumatoid arthritis.
Penicillamine is also a chelating agent. This means that it binds to
certain metals in your body, including lead and copper, to help to
remove them from your body.
PENICILLAMINE IS USED IN ADULTS AND CHILDREN TO TREAT:
• serious, active rheumatoid arthritis, including Still’s disease
in
children
• Wilson’s disease, a condition where the body cannot get rid of
copper properly
• a kidney problem called cystinuria
• lead poisoning
PENICILLAMINE IS USED IN ADULTS ONLY TO TREAT:
• chronic active hepatitis – a type of liver disease
Penicillamine is not a painkiller so you should not expect to feel
better straight away. It will be a few weeks before your joints feel
less
stiff and painful. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PENICILLAMINE TABLETS
Your doctor will ask you to have a blood test and urine test before
you start taking Penicillamine Tablets to check your blood count and
kidney function. Your doctor will continue to test your blood and
urine
regularly while you are taking Penicillamine Tablets. If the tests
show
a low blood count or evidence of kidney damage, your doctor may
decide to decrease your dose for a short time or stop your treatment
completely.
DO NOT TAKE PENICILLAMINE TABLETS IF YOU:
• are allergic (hypersensitive) to penicillamine or any of the other
ingredients in these tablets (See section 6, Contents of the pack
and other information). Signs of an allergic reaction include rash,
itching, swelling of the face, fainting and breathing problems.
• have severe kidney problems
• have lupus erythematosus (an auto-immune disorder)
• have a history of suffering from blood disorders after taking
penic

Fitxa tècnica

1.
NAME OF THE MEDICINAL PRODUCT
Pendramine 125mg Tablets
Penicillamine 125mg Tablets
1
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 125mg D-Penicillamine.
For excipients see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablets.
White, biconvex, oblong, film-coated tablets, plain on both sides
containing
125mg D-penicillamine.
4.1
THERAPEUTIC INDICATIONS
a)
Severe, active rheumatoid arthritis, including juvenile forms
b)
Wilson's disease (hepatolenticular degeneration) in adults and
children (0 to
18 years)
c)
Cystinuria-dissolution and prevention of cystine stones in adults and
children
(0 to 18 years)
d)
Lead poisoning in adults and children (0 to 18 years)
e)
Chronic active hepatitis in adults
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Penicillamine should be taken on an empty stomach at least half an
hour before meals, or
on retiring.
As the smallest available tablet is 125mg, this might not be suitable
for very young
children.
A) RHEUMATOID ARTHRITIS
_ _
_Adults:_ A dose of 125-250mg daily for the initial 4 week period.
Increase by the same
amount every 4 to 12 weeks until remission occurs. The minimum
maintenance dose to
achieve suppression of symptoms should be used and treatment should be
discontinued if
no benefit is obtained within 12 months. Improvement may not occur for
some months.
The usual maintenance dose is 500-750mg daily in divided dosages. A
few patients may
require up to 1500 mg_ _daily to obtain benefit.
When clinical assessment shows that suppression of disease activity
has been achieved,
the dose should be kept at this maintenance level for six months,
thereafter reducing the
daily dosage by 125 to 250mg amounts every 12 weeks may be attempted.
Relapse may
occur following withdrawal or when an inadequate dose level is
reached, usually within
three months, but most patients respond to further courses of
penicillamine.
_ _
_Children: _The usual maintenance dose is 15 to 20mg/kg/day. The
initial dose should be
lower (2.5 to 5mg/kg/day) and increased every four wee