Skip to Content

PENICILLAMINE 125 MG FILM-COATED TABLETS

Active substance(s): PENICILLAMINE

View full screen / Print PDF » Download PDF ⇩
Transcript
penicillamine
tablets
#125 mg
penicillamine
tablets
#125 mg

125 Penicillamine film
mg 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 315904
Mylan, Potters Bar, Herts, EN6 1TL, U.K.

TBC

125 Penicillamine film
mg 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 315904
Mylan, Potters Bar, Herts, EN6 1TL, U.K.

01

30

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.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United
Kingdom.
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
This leaflet was last revised in 10/2013.

TBC

29

• T his 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.
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.

06

• 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.
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

• 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 sever upper
stomach pain, feeling and being sick (pancreatitis).
Other side effects that can occur:
Very common: may affect more than 1 in 10 people
• protein in your urine (this is detected by a urine test).
Rare: may affect up to1 in 1,000 people
• sore mouth, mouth ulcer
• swollen breast tissue
• hair loss
• wrinkly skin

• blood in your urine.
Not known: frequency cannot be estimated from
the available data
• 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)

• 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.

Package leaflet: Information for the user

Penicillamine 125 mg
film-coated tablets
Penicillamine 250 mg
film-coated tablets
(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.

07
28

5. How to store Penicillamine
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.

24

1. What Penicillamine is and what it is used for
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

27

04

08

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.
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

22

4. Possible side effects
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
• 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 to1 in 1,000 people
• allergic reactions which includes sudden
wheeziness, chest pain, difficulty in breathing,
sudden swelling, fever, skin rash or itching

09

• 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

• 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 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

26

Active chronic hepatitis:
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.
Method of administration
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.

Wilson’s disease:
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.
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.
Lead poisoning:
The recommended dose is 15 mg to 20 mg a
day for each kilogram of body weight, in two or
three separate doses.

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.
Driving and using machines
Penicillamine is not known to affect your ability to
drive or use machines.
Penicillamine contains lactose
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine.

3. How to take Penicillamine

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.

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 dose

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.
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.
Cystinuria:
Your doctor will determine your dose.
Lead poisoning:
Your dose will depend on your weight.

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.
Wilson’s disease:
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.
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.
Lead Poisoning:
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
are feeling better. You should not take more than
1000 mg daily.

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

• 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).

Date: 29 Oct 2013
Description Penicillamine 125mg 56
Component Type Label Leaflet
Affiliate Item Code 315904
TrackWise PR No. N/A
MA No. 04569/0185
Packing Site/Printer Gerard
Supplier Code TBC
Pharma Code TBC
Sign-offs

Vendor Job No. 218456

No. of colours
Colours

Keyline/Drawing No. N/A
Barcode Info 5016695680163
Dimensions 101 x 52mm

Non-Print
Colours
Main Font

10

15

Time: 09:32

4

Page Count
Black

PMS
306

Keyline

Braille

Proof No. 2
Client Market UK

20

12

19

23

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

Your doctor may give you pyridoxine (vitamin B6) if
you are taking Penicillamine long term, especially if
you are on restricted diet.
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
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
11

02

03

05

Penicillamine. This is so that your doctor can check for
any side effects and adjust your dose if necessary.
Do not take Penicillamine:
• 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

25

6.Contents of the pack and other information
What Penicillamine film-coated tablets contain
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 with ‘PC 125’ and marked ‘G’ on the reverse,
the 250 mg is embossed with ‘PC 250’ on one side and

• abnormalities of the elastic fibres in the skin which
cause clusters of the small reddish bumps usually
on the neck or arms.
Not known: frequency cannot be estimated from
the available data
• 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)
• redness, a rash or itching (especially at the start of
treatment)

Myriad Pro

PMS
7415

1/1

PMS
498

Body Text Size 7 pt

18

14

16

Expand view ⇕

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