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DISOPYRAMIDE PHOSPHATE 100 MG CAPSULES

Active substance(s): DISOPYRAMIDE PHOSPHATE / DISOPYRAMIDE PHOSPHATE / DISOPYRAMIDE PHOSPHATE

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560182
016695
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PEEL HERE BUT DO NOT REMOVE

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84 Capsules
Each capsule contains:
Disopyramide Phosphate equivalent to 100 mg
of disopyramide.
Also contains: lactose.
Dosage: Take as directed by the physician.
Read the package leaflet before use.
Keep out of the sight and reach of children.
Store in a dry place below 25°C.
PL 04569/0026 POM
Mylan, Potters Bar, Herts,
EN6 1TL, U.K.

PEEL HERE BUT DO NOT REMOVE

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100 Disopyramide Phosphate
mg 100 mg Capsules

100
mg

222112211

LL0450AH
932089

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02

Disopyramide Phosphate
100 mg Capsules
84 Capsules

Each capsule contains:
Disopyramide Phosphate equivalent to 100 mg
of disopyramide.
Also contains: lactose.
Dosage: Take as directed by the physician.
Read the package leaflet before use.
Keep out of the sight and reach of children.
Store in a dry place below 25°C.
PL 04569/0026 POM
Mylan, Potters Bar, Herts,
EN6 1TL, U.K.

222112211

This page is
intentionally blank

LL0450AH
932089

Package leaflet: Information for the patient

Disopyramide Phosphate
100 mg Capsules
Disopyramide Phosphate

03

LEAVE BLANK

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.
• 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.

6. Contents of the pack and other information
What Disopyramide contains –
The active substance is disopyramide phosphate.
The other ingredients are lactose, maize starch,
povidone, talc and magnesium stearate. The
capsule shell includes gelatin, red iron oxide
(E172), yellow iron oxide (E172), titanium dioxide
(E171). The printing ink contains shellac,
propylene glycol, iron oxide black (E172) and
ammonium hydroxide.

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during an operation.
2. What you need to know before you take
Disopyramide
Do not take Disopyramide if you:
• are allergic (hypersensitive) to disopyramide
phosphate or any of the other ingredients of
this medicine (listed in section 6)
• have been told by your doctor you have other
heart problems apart from unusual heartbeats
e.g. heart block or heart failure
• are already taking any other medicine to
regulate your heartbeat.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Disopyramide if you:

• have a kidney or liver disease
• have low levels of potassium in your blood
(hypokalaemia)
• have low blood sugar levels. This can happen
if you have diabetes, a low body weight, a poor
diet or if you are elderly
• have an enlarged prostate
• suffer from glaucoma (increased eye pressure)
• suffer from a disease which causes muscle
weakness (myasthenia gravis)
• are elderly and have problems with your
memory or attention span or sometimes have
difficulty thinking clearly.
• suffer from heart disease or any other heart
condition.

• pain when urinating or difficulty urinating,
especially in men with prostate problems,
• stomach pain, feeling sick (nausea) or being
sick (vomiting), constipation or diarrhoea, loss
of appetite, dry mouth,
• difficulty in getting or maintaining an erection,
or in ejaculating (impotence),
• mood changes or mental problems,
• problems with memory or attention span,
difficulty thinking clearly,
• skin reactions: red spots on your skin called
rashes may appear very rarely.
Rarely:
• a fall in blood sugar level (hypoglycaemia), this
may make you have chills and cold sweats, look

need urgent medical treatment:
• if you have an allergic reaction. The signs may
include a skin rash, swallowing or breathing
problems, swelling of your lips, face, throat
or tongue.
Tell your doctor as soon as possible if you have
any of the following side effects:
• feeling faint, dizzy or light-headed,
• palpitations or an uneven, fast or slow heartbeat
that you have not had before or that gets worse.
Tell your doctor or pharmacist if any of the
following side effects gets serious or lasts longer
than a few days. Also tell them if you notice any
side effects not listed in this leaflet:
• blurred or double vision,

Other medicines and Disopyramide
Please tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines, including medicines obtained
without a prescription, or the following:
• antibiotics e.g. erythromycin, quinupristin,
dalfopristin, rifampicin, clarithromycin,
amphotericin, pentamidine, sparfloxacin
• antivirals e.g. ritonavir, indinavir, saquinavir
• an anti-malarial halofantrine
• anticholinergics, to relieve stomach cramps or
spasm, to prevent travel sickness and to treat
Parkinsons's disease e.g. atropine
• beta-blockers to treat a heart condition e.g.
atenolol, sotalol, propranolol, or other
anti-arrhythmics e.g. digoxin, verapamil,

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What Disopyramide looks like and contents
of the pack - Your medicine comes as a buff
coloured capsule. Disopyramide is available in
blisters or plastic bottles of 28, 30, 56, 60, 84, 90,
100, 112, 120, 168, 500 or 1000 capsules. Not all
pack sizes may be marketed.
Marketing Authorisation Holder Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
Manufacturer –
Gerard Laboratories, Unit 35,
Baldoyle Industrial Estate, Grange Road,
Dublin 13, Eire.

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The leaflet was last revised in 09/2016.

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• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.

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








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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.
5. How to store Disopyramide
Keep out of the sight and reach of children.
Store in a dry place below 25°C. Do not use
Disopyramide after the expiry date which is
stated on the label after 'EXP'. The expiry date
refers to the last day of that month. Do not throw
away 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.

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amiodarone, procainamide, lidocaine (See
Section 'Do not take' above)
diuretics ('water' tablet) e.g. frusemide,
bendrofluazide
a medicine used to treat glaucoma
acetazolamide
antidepressants e.g. amitriptyline, imipramine or
maprotilene,
anti-epileptics e.g. phenytoin, phenobarbital,
primidone
anticoagulants e.g. warfarin
laxatives to treat constipation
antihistamines terfenadine, mizolastine,
astemizole
an anti-nausea medicine tropisetron
medicines used to help develop or maintain an

Elderly - If you are elderly, your doctor may
prescribe a lower starting dose for you.
Children - Disopyramide is not
recommended for use in children.
If you take more Disopyramide than you
should - Contact your doctor or nearest hospital
emergency department immediately. Take the
container and any remaining capsules with you.
You may get the following side effects: dizziness,
feeling tired, uneven heartbeat, dry mouth,
difficulty passing urine, feeling or being sick,
stomach pain or fits.
If you forget to take Disopyramide - Take the
next dose as soon as you remember unless it is

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less than 4 hours before for your next dose. Do not
take a double dose to make up for a forgotten
dose.
If you stop taking Disopyramide – If you
suddenly stop taking Disopyramide you may
experience side effects. Speak to your doctor first
before stopping this medicine.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Disopyramide can cause side
effects, although not everybody gets them.
Tell your doctor straight away if you notice any
of the following serious side effects – you may

erection e.g. sildenafil
• pimozide, sertindole and thioridazine (used for
schizophrenia), cisapride (used for heartburn),
ciclosporin (used to help prevent rejection of
transplants), theophylline (used for wheezing
or difficulty in breathing), corticosteroids or
tetracosactrin (tetracosactide).
During treatment with Disopyramide
Talk to your doctor or pharmacist if you suffer
from a worsening of myasthenia gravis (a disease
which causes muscle weakness).
Pregnancy and breast-feeding – If you are
pregnant, think you may be pregnant or are
planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.

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Disopyramide
#100 mg
Capsules
If you are breast-feeding or planning to
breast-feed, talk to your doctor or pharmacist
before taking this medicine. This is because small
amounts of disopyramide can pass into breast
milk.
Driving and using machines - Do not drive or
operate machinery if you feel dizzy or drowsy, or
you have problems with your vision while taking
this medicine.
Disopyramide contains lactose. If your doctor has
told you that you have an intolerance to some
sugars, such as lactose, contact your doctor
before taking this medicine.

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1. What Disopyramide is and what it is used for
Disopyramide belongs to a group of medicines
called antiarrhythmic agents. Disopyramide is
used to treat an irregularity in the heartbeat
(known as an arrhythmia). It works by correcting
irregular heartbeats to a normal rhythm.
It is used for controlling your heartbeat in the
following situations:
• Arrhythmias - where your heartbeats are
uneven, or unusually fast or slow.
• To keep your heart beating at a normal
rhythm.
• To stop unusual heartbeats (arrhythmias)
happening after a heart attack.
• To stop unusual heartbeats (arrhythmias)

pale, feel confused or anxious and unusually
tired or weak.
Very Rarely:
• yellowing of the skin or whites of the eyes
(jaundice),
• headache,
• lightheadedness feeling,
• you may get more infections than usual. This
could be caused by a lowering in the number of
white blood cells in your blood (neutropenia).
Rapid infusion may lead to experience abundant
sweats.
Reporting of side effects
If you get any side effects talk to your doctor,
pharmacist or nurse. This includes any side

LOT and EXP details will appear in the
varnish free area beside the barcode

>

Disopyramide
#100 mg
Capsules

3. How to take Disopyramide
Always take Disopyramide exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.
Your doctor will choose the dose which best suits
your condition. Swallow the capsules whole with
a glass of water.
Do not chew or open the capsules.
Adults – The recommended dose is between
300 mg and 800 mg. This should be taken divided
up into doses spaced evenly through the day.
Patients with liver or kidney problems Your doctor may give you a lower dose and will
closely monitor you.

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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.

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