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DISOPYRAMIDE PHOSPHATE 150 MG CAPSULES

Active substance(s): DISOPYRAMIDE PHOSPHATE

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Disopyramide
#150 mg
Capsules
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150 Disopyramide Phosphate
mg 150 mg Capsules
84 Capsules
Each capsule contains:
Disopyramide Phosphate equivalent to 150 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 04569/0027 POM
Mylan, Potters Bar, Herts,
EN6 1TL, U.K.

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intentionally blank

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01

150
mg

Package leaflet: Information for the patient

Disopyramide Phosphate
150 mg Capsules
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,

1 2221212

LL0449AF
544716

02

LL0449AF
544716

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Marketing Authorisation Holder –
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
Manufacturer –
Gerard Laboratories, Unit 35,
Baldoyle Industrial Estate, Grange Road,
Dublin 13, Eire.

• 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.

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.
Common side effects include:
• dry mouth
• blurred or double vision
• pain when urinating or difficulty urinating,
especially in men with prostate problems.

The leaflet was last revised in 03/2015

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.

04

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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3. How to take Disopyramide

Patients with liver or kidney problems –
Your doctor may give you a lower dose and will
closely monitor you.

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.

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• a fall in blood sugar level (hypoglycaemia), this
may make you have chills and cold sweats, look
pale, feel confused or anxious and unusually
tired or weak
• mood changes or mental problems
• problems with memory or attention span,
difficulty thinking clearly
• yellowing of the skin or whites of the eyes
(jaundice)
• headache
• impotence.
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).

Other side effects:
• stomach pain, feeling or being sick,
constipation or diarrhoea
• loss of appetite

• 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,
amiodarone, procainamide, lidocaine (See
Section 'Do not take' above)
• diuretics ('water' tablet) e.g. frusemide,
bendrofluazide
• amedicine 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
• an anti-nausea medicine tropisetron
• medicines used to help develop or maintain
an erection e.g. sildenafil
• pimozide, sertindole and thioridazine
(used for schizophrenia), cisapride (used for
heartburn), ciclosporin (used to help prevent
rejection of transplants), corticosteroids or
tetracosactrin (tetracosactide).

If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

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.

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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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 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.

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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.

05

Adults – The recommended dose is between
300 mg and 800 mg.
This should be taken divided up into doses
spaced evenly through the day.

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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.

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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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

03

yellow iron oxide (E172), titanium dioxide (E171).
The printing ink contains shellac, propylene
glycol, iron oxide black (E172) and ammonium
hydroxide.

Warnings and precautions
Talk to your doctor 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)

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84 Capsules

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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.
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

Each capsule contains:
Disopyramide Phosphate equivalent to 150 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.

FPO

heart problems apart from unusual heartbeats
e.g. heart block or heart failure
• are already taking any other medicine to
regulate your heartbeat.

5. How to store Disopyramide

Disopyramide Phosphate
150 mg Capsules

PL 04569/0027 POM
Mylan, Potters Bar, Herts,
EN6 1TL, U.K.

21

FPO

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

Disopyramide
#150 mg
Capsules

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.

2. What you need to know before you
take Disopyramide

6. Contents of the pack and other
information

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

The other ingredients are lactose, maize starch,
povidone, talc and magnesium stearate. The
capsule shell includes gelatin, red iron oxide (E172),

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If you forget to take Disopyramide – Take the
next dose as soon as you remember unless it is
less than 4 hours before for your next dose. Do not
take a double dose to make up for a forgotten dose.

What Disopyramide contains –
The active substance is disopyramide phosphate.

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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 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.

Date: 02 MAR 2015
Description DISOPYRAMIDE PHOSPHATE 150mg 84
Component Type Label Leaflet
Affiliate Item Code 544716

Pharma Code TBC
SAP No. NA

Superceded Affiliate Item Code 10005181

Vendor Job No. 243019

TrackWise PR No. 544716

Proof No. 3

MA No. 04569/0027
Packing Site/Printer NA
Supplier Code LL0449AF
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No. of colours

Time: 09:04

4

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Colours

Black

PMS 7725

Non-Print
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Keyline

Braille

Client Market UK

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with

Keyline/Drawing No. NA

Main Font

Myriad Pro

Dimensions

52 x 101mm

Barcode Info 5016695560199

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PMS 434

1

PMS 306

Varnish
Free

Body Text Size 7.5pt

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

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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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