Information for Patients
Please read
this leaflet carefully before you start to take your
medicine. It contains important information about
Distamine tablets.
What's
in your medicine?
The tablets
come in two strengths (different sized tablets). Each
Distamine tablet contains either 125 milligrams (mg) or
250mg D-penicillamine base (active ingredient) in
bottles of 100 tablets. They all have a white coating.
The 125mg tablets are 8mm across and are marked DS on
one side and 125 on the other. The 250mg tablets are
10mm across and are marked DM on one side and 250 on the
other.
They also
contain the following inactive ingredients:
-
microcrystalline cellulose, povidone, sodium starch
glycolate (Type A) and magnesium stearate. The
coating contains glycerol, titanium dioxide (E171)
and hypromellose.
Penicillamine is one of a group of drugs called
disease-modifying antirheumatic drugs (DMARDS).
Distamine is a chelating agent. This means that it binds
to certain metals, including lead and copper, to help
remove them from your body if necessary. Distamine also
helps to relieve the pain and stiffness of rheumatoid
arthritis if other medicines and rest have not worked.
What's
this medicine used for?
Distamine is
used to treat serious, active rheumatoid arthritis,
including Still’s disease in children. It also treats
Wilson’s disease, a condition where the body cannot get
rid of copper properly; a kidney problem called
cystinuria; lead poisoning; and chronic active hepatitis
(a liver disease).
Distamine is
not a painkiller so you should not expect to feel better
straight away. After a few weeks you should feel better
and your joints will be less stiff and painful.
Before
taking your medicine
Your doctor
will ask you to have a blood test and have your kidneys
checked before you start taking Distamine. He or she
will test your blood and urine regularly while you are
taking your medicine. This is so that your doctor can
adjust your dose and look out for any side effects.
Tell your
doctor if any of the following applies to you.
- You
have ever had a rash or other possible allergic
reaction to penicillamine or related compounds, or
to any of the other ingredients in Distamine tablets
(these are listed in ‘What’s in your medicine?’).
- You
have ever had agranulocytosis (fever, mouth ulcers
and severe weakness) after taking penicillamine.
- You
have ever had lupus erythematosus (LE).
- You
are pregnant, trying to become pregnant or breast
feeding.
- You
suffer from kidney problems.
- You
have ever had side effects with gold.
- You
are taking any other medicines for arthritis,
including a non-steroidal anti-inflammatory drug (NSAID).
- You
are taking any other medicines (including those you
have bought yourself). Some medicines can interfere
with your treatment, so please check with your
doctor or pharmacist before you take any medicines.
Treatment with Distamine
Your doctor
will decide when and how to treat you with Distamine.
Distamine can help to treat rheumatoid arthritis but not
other kinds of arthritis.
Distamine
should be taken on an empty stomach, at least half an
hour before meals or at bedtime.
Usual doses: Adults
If you
have kidney problems your doctor will start you on a
lower dose.
Rheumatoid arthritis: take
125mg to 250mg a day for the first month. Your
doctor will then tell you how to increase the dose
gradually over several months until you are feeling
better. He or she may then change your dose to keep
you well. This new dose is usually 500mg to 750mg a
day, but it can be as high as 1500mg. It may be
several months before you feel better. If there is
no improvement you should stop taking the tablets
after a year. If you stay well for six months your
doctor may reduce your dose. If you are elderly, you
may be given a smaller dose. Do not take more than
1000mg a day.
Wilson’s disease: take
1500mg to 2000mg a day spread over three or four
doses. Once you are better, your doctor may reduce
your dose. It is best not to take 2000mg a day for
more than a year. If you are elderly, your dose will
depend on your weight. The usual dose is 20mg a day
for each kilogram of body weight.
Cystinuria: if you have
cystine stones your dose will be 1000mg to 3000mg a
day. If you are taking the tablets to prevent stones
you will take 500mg to 1000mg at bedtime. If you are
elderly, your dose may be smaller.
Lead poisoning: take
1000mg to 1500mg a day in three or four doses until
your doctor tells you that the amount of lead in
your urine is normal. If you are elderly, your dose
will depend on your weight. The usual dose is 20mg a
day for each kilogram of body weight.
Chronic active hepatitis:
start with 500mg a day. Your doctor will gradually
increase the dose over three months, to 1250mg a
day.
Children
The dose
depends on the weight of the child.
Rheumatoid arthritis: 15mg
to 20mg a day for each kilogram of body weight. You
will start with a low dose for the first month and
increase gradually.
Wilson’s disease: start
with 500mg a day. Your doctor will tell you when to
increase the dose to 20mg a day for each kilogram of
body weight.
Cystinuria: the dose will
depend on how ill the child is.
Lead poisoning: 20mg a day
for each kilogram of body weight.
If you
are not sure how many tablets to take, ask your
doctor or pharmacist or the staff at the hospital
you visit for tests and treatment.
-
Swallow the tablets with water
-
Always take your tablets at least half an hour
before a meal, or at bedtime
-
If you are taking iron tablets, take them at
least two hours after you have taken Distamine
-
Take your tablets for as long as your doctor
tells you to
-
Do not take more tablets than your doctor tells
you to
What
to do if you take too much Distamine
If you
accidentally take too many tablets, or someone else
takes any of your medicine, you should tell your
doctor at once or contact your nearest casualty
department. Show any left-over medicines or the
empty packet to the doctor.
What
to do if you miss a dose
If you
forget to take a dose, take it as soon as possible,
unless it is almost time to take the next dose.
DO NOT
take a double dose. Then go on as before. If you
miss several doses, tell your doctor.
Side
effects
Distamine
tablets sometimes cause the following side effects in
some people. Increasing the dose very slowly will help
to control these side effects.
When you
start taking the tablets you may feel sick or even be
sick. You may lose your appetite or notice that food
tastes different. These side effects usually wear off,
but tell your doctor if they trouble you.
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.
Tell your
doctor if you get any of the following.
-
Redness, a rash or itching
-
Fever or frequent infections
-
Boils
-
Blistery, swollen skin (pemphigus)
-
Unexplained bruising or bruising more easily
-
Muscle weakness
-
Painful, swollen joints
- Sore
mouth
-
Wrinkly skin
- Hair
loss
-
Rarely, both men and women have had swollen breast
tissue
-
Severe abdominal pain
-
Vomiting
Other side
effects that some patients have experienced: Allergic
reactions. Anaemia. Lung or kidney problems. Other skin
problems such as lupus erythematosus (LE), pancreatitis
or jaundice.
If you
suffer from Wilson’s disease and you experience a
worsening of muscle spasms, muscle stiffness, tremor or
slurred speech you should tell your doctor.
If your
medicine upsets you in any other way, tell your doctor.
Storing
your medicine
The expiry
date for this medicine is printed on the bottle and
carton. Do not use after this date.
Do not store
above 25°C. Keep the bottle tightly closed. Keep out of
the reach and sight of children. Your tablets could harm
them.
If your
doctor decides to stop your treatment, return any unused
medicine to the pharmacist. Only keep it if your doctor
tells you to.
Further
information
Remember:
This medicine is for you. Only a doctor can prescribe it
for you. Never give it to others. It may harm them, even
if their symptoms are the same as yours.
The
information in this leaflet applies only to Distamine.
If you have any questions or are unsure about anything,
ask your doctor or pharmacist.