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INDORAMIN 20MG FILM-COATED TABLETS

Active substance(s): INDORAMIN HYDROCHLORIDE

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Indoramin
Film-Coated
Tablets

mg

60

film-coated Tablets Oral use
Each film-coated tablet contains: 20 mg of Indoramin
as Indoramin Hydrochloride. Also contains lactose.
See leaflet for further information. Read the package
leaflet before use. Keep out of the sight and
POM
reach of children.
Do not store above 25°C. Keep container tightly closed.

60

LL0509AB 326489 A0028a/2 PL 4569/0473
MA Holder: Mylan, Potters Bar,
Hertfordshire, EN6 1TL, U.K.

LL0509AB 326489 A0028a/2 PL 4569/0473
MA Holder: Mylan, Potters Bar,
Hertfordshire, EN6 1TL, U.K.

1

Page24

• 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.
• If you get any side effects talk to your
doctor or pharmacist. This includes
any possible side effects not listed in
this leaflet. See section 4.
What is in this leaflet
1. What Indoramin is and what it is
used for
2. What you need to know before you
take Indoramin

Keep this medicine out of the sight and
reach of children.
Do not use this medicine 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 store above 25ºC. Keep the
container tightly closed.
Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how to throw away

6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Indoramin contains
• The active substance is indoramin as
indoramin hydrochloride.
• The other ingredients are lactose
monohydrate, microcrystalline
cellulose, polacrilin potassium
(amberlite IRP88) and magnesium

following:
• diuretics (water tablets) e.g. furosemide
• medicines that lower blood pressure
(e.g. atenolol, doxazosin, alfuzosin),
moxisylyte), hypnotics (e.g.
temazepam) and some medicines
used to treat anxiety or depression.
Indoramin and alcohol
You should not drink alcohol if
Indoramin makes you feel drowsy.
Alcohol can increase the amount of
Indoramin absorbed by the body, so you
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twice a day. If needed, the dose may be
Use in older people: The recommended
taken at night.
Use in children: Indoramin is not
recommended for use in children.

15

REVISED ARTWORK FOR MHRA APPROVAL
VERSION: 2 (MYLAN)
DRAFT ISSUE: 2
REASON FOR CHANGE: UPDATING TEXT IN LINE WITH QRD TEMPLATE
SUPPLIER ISSUE DATE: 23.1.2014

BARCODE 5055382300281
PHARMA CODE 421
ALMUS CODE A0028a/2
SUPPLIER CODE LL0509AA
SUPPLIER CODE 10003107

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1. WHAT INDORAMIN IS AND
WHAT IT IS USED FOR

2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE INDORAMIN

Indoramin belongs to a group of
medicines called alpha-blockers.
Indoramin can treat high blood pressure
(hypertension) by relaxing the blood
vessels in the body and lowering blood

Do not take Indoramin:
• if you have taken medicine containing
indoramin or a similar medicine
(e.g. prazosin, alfuzosin, terazosin,
tamsulosin, doxazosin) and you

when getting up from a sitting or lying
position (which may or may not be
accompanied by fainting).
Reporting of side effects
If you get any side effects, talk to
your doctor, pharmacist or nurse. This
includes any possible side 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.
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6

4. POSSIBLE SIDE EFFECTS

If you are undergoing eye surgery
because of cataract (cloudiness of the
lens) please inform your eye specialist
before the operation that you are taking
or have previously taken Indoramin.
This is because Indoramin may cause
complications during the surgery which
can be managed if your specialist is
prepared in advance.
Other medicines and Indoramin
Tell your doctor or pharmacist if you are
taking, have recently taken or might
take any other medicines, including the

unless it is almost time for your next
dose. Do not take a double dose to
make up for a forgotten dose.
If you stop taking Indoramin
Do not suddenly stop taking your
medicine as this may cause serious
changes in your blood pressure. If you
want to stop the treatment or you have
any further questions on the use of this
medicine, ask your doctor
or pharmacist.

Like all medicines, this medicine
can cause side effects, although not
everybody gets them.
If any of the following happen, stop
taking Indoramin and tell your doctor
immediately or go to your nearest
hospital emergency department:
• Allergic reactions such as rash, itching,
swelling of the face, lips, tongue or
throat, shortness of breath or difficulty
breathing

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16

3. HOW TO TAKE INDORAMIN

Do not drive, operate machinery or
perform any hazardous tasks if you feel
drowsy. This is more likely to occur at
the beginning of the treatment, or when
dosage is increased rapidly.
Indoramin contains lactose
If you have been told by your doctor
that you have an intolerance to some
sugars, contact your doctor before
taking this medicinal product.

could feel more drowsy.
Pregnancy and breast-feeding
Indoramin should not be given to
pregnant or breast-feeding mothers
unless the benefits to the mother
outweigh the risks to the baby. If you are
pregnant or breast-feeding, think you
may be pregnant or are planning to have
a baby, ask your doctor or pharmacist for
advice before taking this medicine.
Driving and using machines
Indoramin may make you feel drowsy.

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DIMENSIONS 52 x 101mm

(indoramin)
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.

pressure. Indoramin can also be given
to men suffering from an enlarged
prostate gland, as it can relax the
muscles allowing urine to be passed
more easily.

17

Use in adults: The recommended dose

mg
ABLETS

22

3. How to take Indoramin
4. Possible side effects
5. How to store Indoramin
6. Contents of the pack and
other information

8

If you take more Indoramin than you
should
If you take more Indoramin than you
should, contact your doctor or nearest
hospital emergency department
immediately. Take the container
and any remaining tablets with you.
Symptoms of overdose have included
deep sedation leading to coma,
abnormally low blood pressure and fits.
If you forget to take Indoramin
If you forget to take Indoramin take the
next dose as soon as you remember

Package leaflet: Information for the user

This leaflet was last revised in: November 2013

5

• if you suffer from swollen ankles and
breathlessness. These symptoms
should be treated before treatment
with Indoramin
• if you have liver or kidney problems
• if you have Parkinson's disease
• if you have epilepsy
• if you have suffered from depression.
If you are an older person, your doctor
may tell you to take a lower or less
frequent dose of Indoramin.
7

Industrial Estate, Grange Road, Dublin
13, Ireland

20

suffered an allergic reaction
• if you are allergic to any of the other
ingredients of this medicine (listed in
section 6)
• if you have established heart failure
• if you are being treated for depression
with a type of medicine called a
monoamine oxidase inhibitor (MAOI)
e.g. phenelzine, tranylcypromine,
moclobemide.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Indoramin:

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Manufacturer
Generics [UK] Limited, Potters Bar,

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5. HOW TO STORE INDORAMIN

21

stearate. The coating includes titanium
dioxide (E171), lactose monohydrate,
macrogol 4000, hypromellose and
purified water.
What Indoramin looks like and
contents of the pack
Indoramin tablets are white, shield
shaped, normal convex film-coated
tablets, debossed 'G' on one side and 'IR
20' on the other.
Indoramin tablets are available in

2

medicines you no longer use. These
measures will help protect
the environment.

4

• worsening of existing Parkinson's
disease.
Other side effects
The most common side effects are
feeling drowsy or sedated. This is most
likely to occur at the start of treatment
and if dosage is increased too quickly.
Less common side effects are: dry mouth,
nasal congestion, weight gain, dizziness,
failure of ejaculation, depression, fatigue,
headache, low blood pressure including
dizziness on standing up, especially

mg

film-coated Tablets Oral use
Each film-coated tablet contains: 20 mg of Indoramin
as Indoramin Hydrochloride. Also contains lactose.
See leaflet for further information. Read the package
leaflet before use. Keep out of the sight and
POM
reach of children.
Do not store above 25°C. Keep container tightly closed.

Leave Blank

TOP VARNISH AREA
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire,

20
Almus ® is a registered trademark

20
Almus ® is a registered trademark

PEEL HERE BUT DO NOT REMOVE

BASE LABEL

Indoramin
Film-Coated
Tablets

Braille Translation:
Indoramin
#20 mg
tablets

indoramin
#20 mg
tablets

5 055382 300281

indoramin
#20 mg
tablets

11

Always take this medicine exactly as
your doctor or pharmacist has told you.
Check with your doctor or pharmacist if
you are not sure.
Tablets should be swallowed whole
with a glass of water. If you need to take
two different doses each day, the higher
dose should be taken at night to stop
you feeling sleepy during the day.
Indoramin can be taken with or without
food.

12

13

LASER COPIES SUPPLIED AS VISUAL REFERENCE ONLY. DO NOT MATCH FOR COLOUR
Client:

Almus UK

Project:

9332 / A / UK
Indoramin 20mg x 56

Item(s):

Label Leaflet

Special
Colours:

Checked
by:
PMS
424

PMS
1788

BRAILLE

Lower Test Studios, Old Hambledon Racecourse, Sheardley Lane, Droxford, Hampshire SO32 3QY

PMS
349

CUTTER

tel +44 (0)1489 878780

Paul Adams. Queries regarding this artwork, please
contact: Paul Adams or Steve Hobbs
23.1.2014

Special Instructions:
Cutter shown as Special Colour ‘CUTTER’,
do not print.

fax +44 (0)1489 878265

e-mail mail@pmdc.co.uk

www.pmdc.co.uk

pmdc

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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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