Rythmodan®

disopyramide

What is in this leaflet

This leaflet answers some common questions about RYTHMODAN. It does not
contain all the available information. It does not take the place of talking to
your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed
the risks of you taking RYTHMODAN against the benefits they expect it will have
for you.

If you have any concerns about taking this medicine, ask your doctor or
pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Rythmodan is used for

RYTHMODAN belongs to a group of medications called antiarrhythmics. This
means it acts to correct irregular heartbeats to a normal rhythm and to slow an
overactive heart. This allows the heart to work more efficiently.

RYTHMODAN is used to treat and prevent ventricular arrhythmias (irregular
heartbeat).

Your doctor may have prescribed RYTHMODAN for another reason. Ask your doctor
if you have any questions about why RYTHMODAN has been prescribed for you.

This medicine is available only with a doctor's prescription.

Before you take Rythmodan

When you must not take it

Do not take RYTHMODAN if you have an allergy to RYTHMODAN or any of the
ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include swelling of the face, lips,
tongue, throat, hands or feet. You may get an itchy skin rash or another type of
skin problem or experience difficulty in breathing.

RYTHMODAN is not recommended for use during pregnancy, unless you and your
doctor or pharmacist have discussed the risks and benefits involved.

Do not take RYTHMODAN if you are breast-feeding or plan to breast-feed.

RYTHMODAN passes into breast milk and therefore there is a possibility that
the breast-fed baby may be affected.

RYTHMODAN is not recommended for use in children.

Do not take RYTHMODAN after the expiry date (EXP) printed on the pack.

If you take this medicine after the expiry date has passed, it may not work
as well.

Do not take RYTHMODAN if the packaging is torn or shows signs of
tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking RYTHMODAN, contact
your doctor or pharmacist.

Before you start to take it

Tell your doctor or pharmacist if you have allergies to:

• any other medicines
• any other substances, such as foods, preservatives or dyes

Tell your doctor or pharmacist if you are pregnant or intend to become
pregnant.

Your doctor or pharmacist will discuss the possible risks and benefits of
using RYTHMODAN during pregnancy.

Tell your doctor or pharmacist if you are breast-feeding or plan to
breast-feed.

RYTHMODAN is not recommended while you are breast-feeding.

Tell your doctor or pharmacist if you have or have had any medical
conditions, especially the following:

• Diabetes
• Glaucoma
• Chronic muscular weakness (Myasthenia Gravis)
• Kidney problems
• Liver problems
• Heart problems including heart failure, heart attack, chest pain
• Low blood pressure (dizziness or light-headedness)
• Low or high potassium levels in your blood
• Difficult urination or
• Enlarged prostate

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines,
including any that you buy without a prescription from your pharmacy,
supermarket or health food shop.

Some medicines and RYTHMODAN may interfere with each other. These include:

• Other antiarrhythmics used to treat heart conditions such as
  beta-blockers, amiodarone and calcium channel blockers
• Diuretics or antiangina medication
• Medicines used to treat epilepsy especially phenytoin and phenobarbitone
• Tricyclic antidepressants
• Antibacterials to treat infections such as rifampicin, erythromycin and
  clarithromycin
• Antihistamines such as terfenadine and astemizole
• Cisapride
• Pimozide
• Potassium supplements or laxatives for constipation
• Medicines for erectile dysfunction such as Viagra or Levitra

These medicines may be affected by RYTHMODAN, or may affect how well it
works. You may need different amounts of your medicine, or you may need to take
different medicines. Your doctor or pharmacist will advise you.

Your doctor and pharmacist may have more information on medicines to be
careful with or avoid while taking RYTHMODAN.

How to take Rythmodan

How much to take

The dose of RYTHMODAN may be different for each person. Your doctor will
decide the right dose for you.

How to take it

Swallow RYTHMODAN whole with plenty of fluid.

When to take it

Take RYTHMODAN at about the same time each day.

Taking your capsules at the same time each day will have the best effect. It
will also help you remember when to take your medicine.

It does not matter if you take RYTHMODAN before or after food.

This medicine works best when there is a constant amount in the blood. To
help keep the amount constant it is best to take the doses at evenly spaced
intervals day and night.

How long to take it

RYTHMODAN helps control your condition, but does not cure it. Therefore you
must take RYTHMODAN every day. Continue taking the capsules for as long as your
doctor or pharmacist tells you.

Do not stop taking your capsules because you are feeling better.

If you forget to take it

If it is almost time for your next dose (within 4 hours), skip the dose
you missed and take your next dose when you are meant to. Otherwise, take it as
soon as you remember, and then go back to taking your medicine as you would
normally.

Do not take a double dose to make up for the dose that you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist
for some hints.

If you take too much (overdose)

Immediately telephone your doctor or pharmacist or the Poisons Information
Centre (telephone 13 11 26 in Australia; and in New Zealand telephone 0800
POISON or 0800 764 766) or go to accident and emergency at your nearest
hospital, if you think that you or anyone else may have taken too much
RYTHMODAN. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

If you take too much RYTHMODAN, you may feel cold and dizzy, light-headed,
weak or you may faint. You may also experience palpitations (your heart may feel
like it "skips a beat") and have difficulty breathing. You may notice your pulse
is rapid and weak.

While you are using Rythmodan

Things you must do

Tell any other doctors, dentists, and pharmacists who are treating you
that you are taking RYTHMODAN.

If you are about to be started on any new medicine, tell your doctor,
dentist or pharmacist that you are taking RYTHMODAN. If you plan to have surgery
that needs a general anaesthetic, tell your doctor or dentist that you are
taking RYTHMODAN.

Avoid alcoholic beverages until you have discussed their use with your
doctor.

Alcohol may make the low blood sugar effect worse and/or increase the
possibility of dizziness or fainting.

RYTHMODAN may cause hypoglycaemia (low blood sugar) in some people.

Patients with congestive heart disease or diabetes should be aware of the signs
(see side effects) and if the signs appear, eat or drink a food containing sugar
and call your doctor.

RYTHMODAN may cause dryness of the mouth, nose and throat.

For temporary relief of mouth dryness melt bits of ice in your mouth.
However, if dryness continues for more than 2 weeks, check with your medical
doctor or dentist.

If you become pregnant while taking RYTHMODAN, tell your doctor or
pharmacist.

Things you must not do

Do not give RYTHMODAN to anyone else, even if they have the same condition
as you.

Do not take RYTHMODAN to treat any other complaints unless your doctor or
pharmacist tells you to.

Do not stop taking RYTHMODAN, or lower the dosage, without checking with
your doctor or pharmacist.

Things to be careful of

Be careful driving or operating machinery until you know how RYTHMODAN
affects you.

RYTHMODAN may cause dizziness, light-headedness or fainting in some people.
Make sure you know how you react to RYTHMODAN before you drive a car, operate
machinery, or do anything else that could be dangerous if you are dizzy or
light-headed. If this occurs do not drive. If you drink alcohol, dizziness or
light-headedness may be worse.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well
while you are taking RYTHMODAN.

RYTHMODAN helps most people, but it may have unwanted side effects in a few
people. All medicines can have side effects. Sometimes they are serious, most of
the time they are not. You may need medical treatment if you get some of the
side effects.

Tell your doctor or pharmacist if you notice any of the following and they
worry you:

• Dry mouth, eyes, nose or throat
• Bloating or stomach pain
• Blurred vision
• Constipation or diarrhoea
• Drowsiness
• Frequent urge to urinate
• Loss of appetite
• Nausea and vomiting
• Increased perspiration
• Increased skin sensitivity to light

These side effects are usually mild.

Tell your doctor or pharmacist as soon as possible if you notice any of
the following:

• Difficult urination
• Redness, itching, swelling, blistering, itchy or raised skin rash, and/or
  hives
• Chest pains
• Dizziness, light-headedness or fainting
• Fast or irregular heartbeat
• Muscle weakness
• Shortness of breath
• Swelling of feet or lower legs
• Rapid weight gain
• Frequent infections such as sore throat or fever
• Yellowing of the skin and/or eyes
• Hypoglycaemia (low blood sugar). The signs and symptoms of
  hypoglycaemia are: chills, cold sweats, confusion, cool and pale skin,
  drowsiness, headache, fast heartbeat, excessive hunger, nausea, shakiness,
  unusual tiredness/weakness.

These may be serious side effects. You may need urgent medical attention.
Serious side effects are rare.

Other side effects not listed above may occur in some patients. Do not be
alarmed by this list of possible side effects. You may not experience any of
them.

After using Rythmodan

Storage

Keep your capsules in the pack until it is time to take them.

Keep your capsules in a cool dry place where the temperature stays below
30°C. Do not store RYTHMODAN or any other medicine in the bathroom or near a
sink. Do not leave it in the car on hot days or on windowsills. Heat and
dampness can destroy some medicines.

Keep it 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.

Disposal

If your doctor or pharmacist tells you to stop taking RYTHMODAN or the
capsules have passed their expiry date, ask your pharmacist what to do with any
that are left over.

Product description

What it looks like

RYTHMODAN 100mg capsules are green and beige, marked with
RY on one part and RL on the other.

RYTHMODAN 150mg capsules are white, marked with RY
on one part and 150 on the other.

RYTHMODAN is available in blister packs of 100 capsules.

Ingredients

RYTHMODAN capsules contain either 100mg or 150mg of disopyramide, as the
active ingredient. Each capsule also contains: magnesium stearate, maize starch,
talc, gelatin, titanium dioxide. The 100mg capsules also contain yellow iron
oxide and indigo carmine.

RYTHMODAN does not contain lactose, sucrose, gluten, tartrazine or azo-dyes.