Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using D-PENAMINE?
D-PENAMINE contains the active ingredient D-penicillamine. D-PENAMINE is used to treat
severe, active rheumatoid arthritis, lead poisoning, Wilson's disease and cystinuria.
For more information, see Section
1. Why am I using D-PENAMINE? in the full CMI.
2. What should I know before I use D-PENAMINE?
Do not use if you have ever had an allergic reaction to D-penicillamine or any of
the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I use D-PENAMINE? in the full CMI.
3. What if I am taking other medicines?
4. How do I use D-PENAMINE?
Your doctor will tell you how many tablets you need to take each day and when to take
them.
This depends on your condition and whether or not you are taking any other medicines.
5. What should I know while using D-PENAMINE?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using D-PENAMINE.
If you plan to undergo any surgical procedures, especially vascular surgery tell your
doctor that you are taking D-PENAMINE.
If you are about to have any blood tests, tell your doctor that you are taking this
medicine.
|
|
Things you should not do
|
Do not stop taking D-PENAMINE, or change the dose, even if you are feeling better
without checking with your doctor.
Do not use D-PENAMINE to treat any other conditions unless your doctor tells you to.
Do not give D-PENAMINE to anyone else, even if they have the same condition as you.
|
|
Looking after your medicine
|
Keep the tablets in a cool, dry place (below 25°C) in its original packaging.
Keep the bottle tightly closed.
Do not store D-PENAMINE in the bathroom, near a sink, on a window sill or in the car.
Keep your tablets where children cannot reach it.
|
6. Are there any side effects?
Tell your doctor if you notice any of the following and they worry you: nausea, vomiting, diarrhoea, loss of appetite, impairment of taste, red or itchy
rash accompanied by fever, joint pain, loss of hair, ringing in the ears, red, splitting
lips, inflammation of the tongue, gums or mouth, swelling and redness along a vein
which is extremely tender when touched, visual disturbances, muscle weakness, drooping
eyelids, double vision, blisters on the skin, blisters containing dark blood, breast
enlargement, inflammation of the blood vessels, symptoms of iron deficiency such as pale complexion and lowered vitality.
Tell your doctor immediately if you experience fever, sore throat, chills, bleeding
or bruising more easily than normal.
Active ingredient(s):
D-penicillamine
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using D-PENAMINE. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using D-PENAMINE.
Where to find information in this leaflet:
1. Why am I using D-PENAMINE?
D-PENAMINE contains the active ingredient D-penicillamine. D-PENAMINE is a chelating agent. This means that it binds to certain metals in the
body including lead, copper, gold and mercury to help remove them from the body if
necessary. D-PENAMINE is also used to relieve the pain and stiffness of rheumatoid
arthritis if other medicines and rest have not helped.
D-PENAMINE is used to
treat the following conditions:
severe, active rheumatoid arthritis (painful joint disease)
lead poisoning
Wilson's disease (a condition which results in too much copper in the body)
cystinuria (a condition which can result in kidney stones).
Ask your doctor if you have any questions about why D-PENAMINE has been prescribed
for you.
Your doctor may have prescribed D-PENAMINE for another reason.
D-PENAMINE is available only with a doctor's prescription.
2. What should I know before I use D-PENAMINE?
Warnings
Do not use D-PENAMINE if:
you are allergic to D-PENAMINE or any of the ingredients listed at the end of this
leaflet. Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Always check the ingredients to make sure you can use this medicine.
you are receiving gold therapy or taking anti-malarial medicines.
the expiry date (EXP) printed on the pack has passed
If you take this medicine after the expiry date has passed, it may not work as well.
the packaging shows signs of tampering
the tablets do not look quite right
If you are not sure whether you should start taking this medicine, talk to your doctor.
Check with your doctor if you:
are allergic to any other medicines including penicillin, or any other substances
such as foods, dyes or preservatives
have, or have had, any medical conditions, especially the following:
kidney disease
liver disease
Your doctor may want to take special care if you have any of these conditions
If you have not told your doctor about any of the above, tell them before you start
taking D-PENAMINE.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Tell your doctor if you are pregnant, intend to become pregnant, are breast-feeding
or intend to breast-feed.
D-PENAMINE is not recommended for use during pregnancy. If there is a need to consider
D-PENAMINE during your pregnancy or breast-feeding, your doctor or pharmacist will
discuss with you the benefits and risks of using it.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may be affected by D-PENAMINE, or may affect how well it works. These
include:
isoniazid, a medicine used to treat tuberculosis.
Your doctor can tell you what to do if you are taking any of these medicines.
If you are not sure whether you are taking any of these medicines, check with your
doctor or pharmacist.
Take D-PENAMINE one hour apart from other medicines.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking D-PENAMINE.
4. How do I use D-PENAMINE?
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your doctor or pharmacist.
How much to take
Your doctor will tell you how many tablets you need to take each day and when to take
them. This depends on your condition and whether or not you are taking any other medicines.
The usual starting dose for rheumatoid arthritis is no more than 250 mg daily for
the first month. This dose is increased by the same amount at intervals of no less
than one month until a daily dose of 1500 mg has been reached.
For the treatment of Wilson's disease, the usual dose of D-PENAMINE is 1500 mg to
2000 mg a day.
For the treatment of cystinuria, the usual dose of D-PENAMINE is 750 mg to 1000 mg
a day in divided doses.
For the treatment of lead poisoning, the usual dose of D-PENAMINE is 250 mg to 1000
mg a day in divided doses.
When to take D-PENAMINE
Take D-PENAMINE on an empty stomach, for example, 1 hour before meals or 2 hours after
meals, and at least one hour apart from any other medicine, food or milk.
How to take D-PENAMINE
Swallow the tablets whole with a glass of water.
How long to take D-PENAMINE for
Keep taking D-PENAMINE for as long as your doctor recommends.
If you forget to use D-PENAMINE
D-PENAMINE should be used regularly at the same time each day.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Otherwise, take the missed dose as soon as you remember, and then go back to taking
your tablets as you would normally.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do or have any questions on this, ask your doctor or pharmacist.
If you use too much D-PENAMINE
If you think that you have used too much D-PENAMINE, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using D-PENAMINE?
Things you should do
Before starting any new medicine, tell your doctor or pharmacist that you are taking
D-PENAMINE.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking
D-PENAMINE.
If you become pregnant while taking D-PENAMINE, tell your doctor.
If you plan to undergo any surgical procedures, especially vascular surgery tell your
doctor that you are taking D-PENAMINE.
Treatment with D-PENAMINE should, if possible, be discontinued for at least six weeks
prior to surgery.
If you are about to have any blood tests, tell your doctor that you are taking this
medicine.
D-PENAMINE may affect the results of some tests.
Visit your doctor regularly so they can check on your progress.
Your doctor may do some tests to check your blood, liver and kidneys from time to
time, to make sure the medicine is working and to prevent unwanted side effects.
Things you should not do
Do not stop taking D-PENAMINE, or change the dose, even if you are feeling better
without checking with your doctor.
Do not use D-PENAMINE to treat any other conditions unless your doctor tells you to.
Do not give D-PENAMINE to anyone else, even if they have the same condition as you.
Looking after your medicine
Keep D-PENAMINE where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Keep your tablets in the bottle until it is time to take them.
If you take the tablets out of the bottle they will not keep well.
Keep the bottle tightly closed.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Do not store D-PENAMINE or any other medicine in the bathroom or near a sink.
Do not leave D-PENAMINE in the car or on window sills.
Heat and dampness can destroy this medicine.
Getting rid of any unwanted medicine
If your doctor tells you to stop taking D-PENAMINE, or your tablets have passed their
expiry date, ask your pharmacist what to do with any that are left over.
6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking D-PENAMINE.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Less serious side effects
|
Less serious side effects
|
What to do
|
|
nausea
vomiting
diarrhoea
loss of appetite
impairment of taste
red or itchy rash accompanied by fever, joint pain
loss of hair
ringing in the ears
The above list includes the more common side effects of D-PENAMINE.
red, splitting lips
inflammation of the tongue, gums or mouth
swelling and redness along a vein which is extremely tender when touched
visual disturbances
muscle weakness, drooping eyelids, double vision
blisters on the skin
blisters containing dark blood
breast enlargement
inflammation of the blood vessels
Goodpasture's syndrome, a syndrome characterised by coughing with production of mucous
containing frothy, bright red blood; nausea; constipation; itching; less frequent
urination
symptoms of iron deficiency such as pale complexion and lowered vitality.
All of the above side effects are very rare.
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Serious side effects
|
Serious side effects
|
What to do
|
|
Fever
sore throat
chills
bleeding
bruising more easily than normal
These are serious side effects which require medical attention.
|
Call your doctor straight away if you notice any of these serious side effects.
|
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety
of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What D-PENAMINE contains
|
Active ingredient
(main ingredient)
|
D-PENAMINE contains either 125 mg or 250 mg of D-penicillamine
|
|
Other ingredients
(inactive ingredients)
|
The tablets also contain:
povidone
microcrystalline cellulose
stearic acid
sodium starch glycollate.
The tablet coating contains:
hydroxypropyl methylcellulose
glycerol
titanium dioxide (E171)
|
|
Potential allergens
|
D-PENAMINE tablets contain sulfites.
|
Do not take this medicine if you are allergic to any of these ingredients.
What D-PENAMINE looks like
D-PENAMINE tablets are available in 2 strengths:
D-PENAMINE 125 mg tablets are round, white to off-white regular biconvex coated tablets,
upper surface embossed 'DS' lower surface embossed '125'. (AUST R 14625)
D-PENAMINE 250 mg tablets are round, white to off-white regular biconvex coated tablets,
upper surface embossed 'DM' lower surface embossed '250'. (AUST R 14626)
Each bottle contains 100 tablets.
Who distributes D-PENAMINE
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in July 2023.
D-PENAMINE® is a Viatris company trade mark
D-PENAMINE_cmi\Jul23/00