Skip to Content

PENICILLAMINE 125 MG FILM-COATED TABLETS

Active substance(s): PENICILLAMINE / PENICILLAMINE / PENICILLAMINE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

125
mg

Penicillamine
film-coated tablets

penicillamine
tablets
#125 mg

56 tablets
Each film coated tablet contains:
Penicillamine 125 mg. Also contains: lactose.
Dosage: For oral use as directed by a doctor.
Read the enclosed leaflet. Keep out of the reach
and sight of children. Store in a cool, dry place
below 25°C.
PL 04569/0185 POM
LL0438AF

968955

Mylan, Potters Bar, Herts, EN6 1TL, U.K.

125
mg

Penicillamine
film-coated tablets
56 tablets

Each film coated tablet contains:
Penicillamine 125 mg. Also contains: lactose.
Dosage: For oral use as directed by a doctor.
Read the enclosed leaflet. Keep out of the reach
and sight of children. Store in a cool, dry place
below 25°C.
PL 04569/0185 POM
LL0438AF

968955

with ‘PC 125’ and marked ‘G’ on the reverse, the
250 mg is embossed with ‘PC 250’ on one side and
marked ‘G’ on the reverse.
Penicillamine film-coated tablets are available in
polypropylene containers with polyethylene caps in
packs of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84,
90, 100, 112, 120, 168, 180, 250 and 1000 tablets.
Not all pack sizes may be marketed.

30

Marketing Authorisation Holder

Mylan, Potters Bar, Herts, EN6 1TL, United Kingdom.

Manufacturer

Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.

This leaflet was last revised in 07/2016.

01

Not known: frequency cannot be estimated
from the available data

• if you are allergic to penicillamine or any of the
other ingredients of this medicine (listed in
section 6)
• if you have ever had agranulocytosis (reduction
in the number of white blood cells) after taking
penicillamine
• if you have ever had aplastic anaemia (a severe
reduction in blood cells which can cause weakness,
bruising or make infections more likely) after taking
penicillamine
• if you have ever had lupus erythematosus (LE), an
allergic condition which causes skin rashes
• if you suffer from kidney problems

06

02

What Penicillamine film-coated tablets contain

Penicillamine with food and drink

Penicillamine should be taken on an empty stomach,
and at least half an hour (one hour for children with
Wilson’s disease or cystinuria) before a meal, with a
drink of water.

Pregnancy and breast-feeding

The active substance is penicillamine. Each 125 mg
tablet contains 125 mg penicillamine. Each 250 mg
tablet contains 250 mg penicillamine.
The other ingredients are:
povidone, lactose, sodium starch glycollate,
magnesium stearate. The film-coat contains:
hydroxypropyl, methylcellulose (E464), titanium
dioxide (E171), polyethylene glycol, carnauba wax.

What Penicillamine looks like and contents of
the pack

Your medicine comes as a round, white film coated
tablet. On one side, the 125 mg tablet is embossed

11

• if you have thrombocytopenia (a blood disorder
which causes bleeding into your skin, bruising and
more bleeding than usual after an injury) after
taking penicillamine.
If any of the above applies to you, or if you are not
sure, talk to your doctor or pharmacist before you
take Penicillamine.

Package leaflet: Information for the patient

Penicillamine 125 mg
Film-coated Tablets
Penicillamine 250 mg
Film-coated Tablets

Warnings and precautions

Talk to your doctor or pharmacist before taking
Penicillamine, particularly if any of the following
applies to you:
• if you have ever had side effects with gold or you
are currently taking medicines that contain gold
• if you have protein in your urine
• if you are pregnant, trying to become pregnant or
breast-feeding

(penicillamine)

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.

29

07

• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Penicillamine is and what it is used for.
2. What you need to know before you take
Penicillamine.
3. How to take Penicillamine.
4. Possible side effects.
5. How to store Penicillamine.
6. Contents of the pack and other information.

www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the
safety of this medicine.

28

• blood in your urine.

Not known: frequency cannot be estimated
from the available data

5. How to store Penicillamine

• blood reactions that may cause unusual bleeding
or bruising of the skin, may reduction of the
number of white cells in your blood, causing more
infections than usual
• fever, severe chills, sore throat or mouth ulcer,
feeling of extreme tiredness or weakness, paleness
of the skin and more susceptible to infections.
These may be signs of anaemia
• breakdown of the tissues of your kidney (nephrotic
syndrome)
• blistering skin rash or severe skin reactions, blistering
of the skin, mouth, throat, nose, eyes and genitals
(Stevens-Johnson syndrome or pemphigus)

Keep this medicine out of the sight and reach of
children.
Store your tablets in a cool, dry place below 25°C.
Do not use this medicine after the expiry date which
is stated on the bottle after ‘EXP’. The expiry date
refers to the last day of that month.
Do not throw any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment.

03

• damage to your kidneys and bleeding in your
lungs caused by your body’s immune system
(Goodpasture’s syndrome)
• coughing up blood (pulmonary haemorrhage)
• inflammation of the pancreas with severe upper
stomach pain, feeling and being sick (pancreatitis).

24

Reporting of side effects

If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:

• 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.

2. What you need to know before you take
Penicillamine
Your doctor will ask you to have blood tests to check
your blood count and kidney function before you
start taking Penicillamine. He or she will test your
blood and urine regularly while you are taking

1. What Penicillamine is and what it is used for

04

Cystinuria:

The recommended starting dose is 20 mg to 30 mg
for each kilogram of body weight, in two or three
separate doses given 1 hour before meals. Your
doctor may change your dose depending on the
results of the tests on your urine.

• protein in your urine (this is detected by a urine
test).

Rare: may affect up to 1 in 1,000 people

• if you have blood in your urine
• if you have leucopenia (a blood disorder which
causes susceptibility to infection)
• if you are elderly.
Your doctor should carry out full blood and urine tests:
• weekly or fortnightly for the first 8 weeks of
treatment, and then monthly
• whenever your dose of penicillamine is increased.
If you are taking Penicillamine for Wilson’s disease or
for cystinuria, your doctor may carry out these tests
at less regular intervals.
Your doctor may tell you to stop taking Penicillamine if:
• your thrombocyte count or your white blood cell
count fall below certain levels, or
• either count falls for three tests in a row.

Other medicines and Penicillamine

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Penicillamine may increase the risk of side effects if
you also take the following medicines:
• gold (used to treat rheumatoid arthritis)
• NSAIDs (non-steroidal anti-inflammatory drugs)
e.g. ibuprofen or naproxen (used to treat arthritis
and for pain relief ) as there is an increased risk of
damaging your kidneys

4. Possible side effects

26

When taking Penicillamine:
• swallow the tablets with water
• always take your tablets at least half an hour (or
1 hour for children) before a meal, or at bedtime
• if you are taking iron tablets, antacids or digoxin
take them at least two hours before or after you
have taken penicillamine
• take your tablets as long as your doctor tells you to
• do not take more tablets than your doctor tells you to.

when you are pregnant or breast-feeding. This will
depend on your condition and the disease you have.
If you are pregnant or breast feeding, think you may be
pregnant or are planning to have baby, ask your
doctor or pharmacist for advice before taking this
medicine.

12

Driving and using machines

Penicillamine is not known to affect your ability to
drive or use machines.

Penicillamine contains lactose

08

3. How to take penicillamine

Lead poisoning:

Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
You will have regular blood and urine tests, especially
when you start taking the tablets and when you
increase the dose. These are to check for changes
in your blood cell counts and to look for protein or
blood in your urine.
The recommended dose for each condition is given
below.

Use in adults
Rheumatoid Arthritis:

Take 125 mg to 250 mg per day for the first month.
Your doctor will then tell you how to increase the

22

are feeling better. You should not take more than
1000 mg daily.
It may be several months before you feel better. If
there is no improvement after taking the tablets for
1 year, your doctor will tell you to stop taking the
tablets. If you stay well for six months your doctor
may reduce your dose.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

Contact your doctor or go to your nearest
hospital emergency department immediately
if you think you may have any of the following
serious side effects:
Common: may affect up to 1 in 10 people

Wilson’s disease:

Your dose will depend on your weight. The
recommended dose is 20 mg a day for each kilogram
of body weight in divided doses. Your doctor will
reduce the dose over time to find the minimum
necessary to control your disease.

• bruising more easily, nose bleeds and/or bleeding
gums more often. These may be signs of a blood
disorder called thrombocytopenia.

Rare: may affect up to 1 in 1,000 people

• allergic reactions which includes sudden
wheeziness, chest pain, difficulty in breathing,
sudden swelling, fever, skin rash or itching

18

Your dose will depend on your weight. The
recommended dose is 20 mg a day for each kilogram
of body weight in divided doses, until your doctor
tells you the amount of lead in your blood is normal.

Active Chronic Hepatitis:

Penicillamine is not recommended for the treatment
of active chronic hepatitis in the elderly.

Use in children

The dose may depend on the weight of the child. As
the smallest available tablet is 125 mg, it might be
too large for very small children.

Rheumatoid arthritis:

The recommended dose is 15 mg to 20 mg a day for
each kilogram of body weight. You will start with a
low dose for the first month and increase gradually.

dose gradually over several months until your
symptoms get better. Your doctor will monitor you
closely until a minimum daily dose is found that
controls your symptoms (your maintenance dose).
This may take some months. The usual maintenance
dose is 500 mg to 750 mg per day but may be as high
as 1500 mg per day.
It may be several months before you feel better. If
there is no improvement after taking the tablets for
1 year, your doctor will tell you to stop taking the
tablets. If your symptoms are controlled continuously
for 6 months, your doctor may reduce your daily
dose.

Cystinuria:

Wilson’s disease:

Your doctor will determine your dose.

The recommended dose is between 1500 mg to
2000 mg per day in divided doses. If your symptoms

are controlled, your doctor may reduce your dose.
You should not take a dose of 2000 mg or more per
day for more than 12 months.

Lead Poisoning:

14

17

If you take more Penicillamine than you should
If you accidentally take too many tablets, contact
your doctor or nearest hospital emergency
department immediately for advice.

If you forget to take Penicillamine
Unless it is almost time for the next dose, take it as
soon as you remember, then just carry on as before.
Do not take a double dose to make up for a forgotten
tablet.

If you stop taking Penicillamine
Do not stop or change your treatment before talking
to your doctor.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
21

Method of administration

19

09

and yellow or greenish-yellow in colour, chronic
swelling in the limbs (hand and feet) and chronic
breathing problem
• redness, a rash or itching (especially at the start of
treatment)
• fever (especially at the start of treatment) or
frequent infections
• muscle weakness and tiredness (sometimes with
skin rashes)
• worsening of the pain and swelling in your joints
• lupus erythmatosus (an allergic condition which
causes joint pain, skin rashes and fever)
• newly diagnosed rheumatoid arthritis.
After several months or years of therapy you may
develop a particular rash that makes your skin
fragile called acquired epidermolysis bullosa or

20

Penicillamine is not recommended for the treatment of
active chronic hepatitis in the paediatric population.
If you have kidney problems your doctor will start
you on a lower dose.

If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine.

The recommended dose is 15 mg to 20 mg a day
for each kilogram of body weight, in two or three
separate doses.

sore mouth, mouth ulcer
swollen breast tissue
hair loss
wrinkly skin

Active chronic hepatitis:

Lead poisoning:

13

If, after stopping your tablets your blood cell
counts return to normal, you may be able to restart
treatment at a lower dose. If, after restarting your
tablets at a lower dose you develop low blood
counts again, you should permanently stop taking
this medicine.

Penicillamine belongs to a group of medicines called
disease modifying antirheumatic drugs (DMARDS).
DMARDS work by reducing the body’s immune
response and the symptoms of rheumatoid arthritis.
Penicillamine helps to relieve the pain and stiffness
caused by rheumatoid arthritis. It is used when other
medicines for rheumatoid arthritis have not worked.
Penicillamine is also a chelating agent. This means
that it can bind to certain metals in your body,
including lead and copper, to help 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:

Other side effects that can occur:
Very common: may affect more than 1 in
10 people






You should not take Penicillamine if you are
pregnant.
Penicillamine may reach your baby through
the breast milk. Therefore, you should not take
Penicillamine if you are breast-feeding.
If your doctor considers that treatment is absolutely
essential, he may tell you to take Penicillamine even

For children under 12 years, 20 mg a day for each
kilogram of body weight in two or three separate
doses given 1 hour before meals. For older children
the usual dose is 750 mg to 1000 mg daily.

23

penicillamine dermopathy. If you get this your doctor
may tell you to take a lower dose.
If you suffer from rheumatoid arthritis you should
tell your doctor if your joints become more
painful, swollen, red or hot because medicines like
Penicillamine sometimes cause joint infections.
If you suffer from Wilson’s disease you should tell
your doctor if you experience:
• a worsening of muscle spasms
• muscle stiffness
• tremor or slurred speech.

Your doctor may give you pyridoxine (vitamin B6) if
you are taking Penicillamine long term, especially if
you are on restricted diet.

Do not take Penicillamine:

25

6. Contents of the pack and other
information

05

Penicillamine. This is so that your doctor can check
for any side effects and adjust your dose if necessary.

• loss of taste
• feeling sick (especially at the start of treatment) or
being sick
• loss of appetite (especially at the start of treatment)
• jaundice (yellowing of the skin or eyes) as a result
of liver or blood problems (this may include
changes in blood test which show how your liver
is working)
• lung problems (e.g. wheezing, coughing or
difficulty in breathing)
• a condition that causes nails to become thicker

Mylan, Potters Bar, Herts, EN6 1TL, U.K.

27

• abnormalities of the elastic fibres in the skin which
cause clusters of the small reddish bumps usually
on the neck or arms.

penicillamine
tablets
#125 mg

• clozapine (used to treat schizophrenia) as taking
Penicillamine with clozapine may increase the
potential side effects on the bone marrow.
The effectiveness of Penicillamine may be altered if
you also take the following medicines:
• iron therapy (used to treat low iron levels or
anaemia). Take the iron at least two hours before or
after taking Penicillamine
• antacids (used to neutralise acid in your stomach).
Take the antacids at least two hours before or after
taking Penicillamine
• zinc (used to treat low zinc levels), concomitant use
may reduce the effect of both medicine.
Penicillamine may affect how well the following
medicines work:
• digoxin (used for an irregular heartbeat).

10

Cystinuria:

Your doctor will take a sample to measure the
amount of cystine (an amino acid) in your urine. From
this he will be able to work out the lowest dose that
will still be effective for you.
Prevention of cystine stones: 500 mg to 1000 mg at
bedtime. It is important that you drink enough fluids
(not less than 3 litres per day).
Dissolving cystine stones: 1000 mg to 3000 mg per
day, in divided doses.

15

1000 mg to 1500 mg per day, in divided doses until
your doctor tells you that the amount of lead in your
urine is normal.

Active chronic hepatitis:

Your doctor should take a blood sample regularly to
check that your liver is working well.
For maintenance, initially 500 mg per day in divided
doses, increasing over 3 months to a maintenance
dose of 1250 mg per day.

Use in elderly
Rheumatoid Arthritis:

The recommended dose is 125 mg daily for the first
month. Your doctor will then tell you how to increase
the dose gradually over several months until you

16

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide