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DORALESE TILTAB TABLETS 20MG

Active substance(s): INDORAMIN HYDROCHLORIDE

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Doralese®
Tiltab® Tablets 20 mg

3. How to take

F1236

Indoramin

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5. How to store

Always take Doralese exactly as your doctor has told
you. You should check with your doctor or pharmacist
if you are not sure.

How much to take

Read all of this leaflet carefully before you start using this medicine.
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. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What this medicine is and what it is used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information

1. What this medicine is and what
it is used for
Doralese Tiltab Tablets (called 'Doralese' in this
leaflet) contain a medicine called indoramin (as
indoramin hydrochloride). This belongs to a group of
medicines called 'alpha-blockers' (also called alpha
adrenoceptor antagonists).

What Doralese is used for
Doralese is used to treat a condition where your

prostate becomes bigger, called 'benign prostatic
hyperplasia' or BPH. The prostate is a gland found
underneath the bladder in men. It surrounds the
tube (called the urethra) which carries urine from
the bladder to the outside of the body
if the prostate gland becomes bigger, it may
squeeze on the urethra and make it hard for you to
pass urine. When your prostate grows:
- the flow of your urine may be weaker or you may
have to pass urine more often than before
- this can happen during the day or you can find
you have to get up more often during the night
- you may have to wait for the flow of your urine to
start
- you may find it difficult to stop the flow of your
urine completely
as men get older their prostate grows in size and
some men will suffer these symptoms
Doralese
can be used for patients who do not need

or want an operation and also for patients waiting
for an operation.

How Doralese works
Doralese relaxes muscles in your bladder, prostate

gland and the tube that carries urine from the
bladder to the outside of the body
this will help your urine flow better.

2. Before you take
Do not take Doralese
if you are allergic (hypersensitive) to indoramin or

any of the ingredients of Doralese (listed in Section
6)
if you have heart failure.

Take special care with Doralese
Check with your doctor or pharmacist before taking
your medicine if:
you have liver or kidney problems
you have Parkinson's disease
you have epilepsy
you have ever had depression.

The usual dose is one tablet (20 mg) twice a day.
The tablet should be swallowed with water.
Some elderly patients may need just one tablet at

night.

Your doctor may increase your dose to a maximum

total daily dose of 100 mg.
Do
not take more than your doctor has

recommended.

If you are not sure if any of the above apply to you, talk
to your doctor or pharmacist before taking Doralese.
You may need to be given another medicine or your
dose may need to be lowered.

If you take more Doralese than you should

Taking other medicines

If you forget to take your Doralese

Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines. This
includes medicines obtained without a prescription,
including herbal preparations. This is because
Doralese can affect the way some other medicines
work. Also some other medicines can affect the way
Doralese works.
In particular tell your doctor or pharmacist if you are
taking any of the following medicines:
Monoamine oxidase inhibitors, sometimes called
'MAOls', used for depression. Do not take
Doralese if you are already taking a MAOI
medicines
used for high blood pressure such as

water tablets (diuretics) or beta-blockers
medicines that can lower blood pressure such as
water tablets (diuretics), moxisylytes (medicines
used for circulation problems) and medicines used
for depression, anxiety or to help you sleep
medicines that may make you sleepy such as pain
killers, antidepressants, tablets for your nerves and
antihistamines.

Cataract eye surgery patients
If you are due to have eye surgery because of a
cataract (cloudiness of the lens):
Tell your eye specialist before the operation that you
are using or have previously used Doralese.
Doralese and other medicines of the same type
(alpha-blockers) may cause problems during the
surgery which can be managed if your specialist is
told before your operation.

Taking Doralese with food and drink
Do not drink alcohol if Doralese makes you feel
drowsy. Alcohol can increase the amount of Doralese
that gets from your stomach into your blood stream.
This could make you feel more drowsy.

Pregnancy and breast-feeding
Occasionally a doctor may prescribe Doralese for a
woman. Talk to your doctor before taking this medicine
if you are pregnant, might become pregnant, or are
breast-feeding.

If you take more Doralese than you should, talk to a

doctor or go to a hospital straight away. Take the
medicine pack with you.

If you forget a dose, take it as soon as you

remember. However, if it is nearly time for the next
dose, skip the missed dose.
Do not take a double dose to make up for a
forgotten dose.

If you stop taking Doralese
Do not stop taking Doralese without talking to your

doctor. If you stop taking your tablets, your
symptoms may come back.

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

4. Possible side effects
Like all medicines, Doralese can cause side effects,
although not everybody gets them. The following side
effects may happen with this medicine:
when you start taking Doralese you may feel sleepy.
This will usually go after a few days
other less common side effects include dry mouth,
stuffy nose, weight gain, dizziness, failure to
ejaculate, depression, headache and dizziness
caused by low blood pressure, which can occur on
standing. The dizziness may or may not be
accompanied by fainting.
Rare (affects less than 1 in 1,000 people)
allergic (hypersensitivity) reactions, such as a rash
and itching
Parkinson's disease may get worse.

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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Driving and using machines
You may feel sleepy while taking Doralese. If this
happens, do not drive or use any tools or machines.
If you feel very sleepy, tell your doctor.

Important information about some of the
ingredients of Doralese
Doralese contains lactose (a type of sugar). If you
have been told by your doctor that you cannot tolerate
or digest some sugars, talk to your doctor before
taking this medicine.

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BACK

Keep out of the reach and sight of children.
Do not use Doralese after the expiry date which is

stated on the carton. The expiry date refers to the
last day of the month stated.
Store your tablets below 25°C.
Medicines should not be disposed of
via wastewater or household waste.
Ask your pharmacist how to dispose
of medicine no longer required. These
measures will help to protect the
environment.

6. Further information
What Doralese contains
The active ingredient is indoramin (as indoramin
hydrochloride).
Each tablet contains 20 mg of indoramin.
The other ingredients are:
lactose, magnesium stearate (E572),
microcrystalline cellulose, hydroxypropylmethyl
cellulose, titanium dioxide (E171), yellow iron
oxide (E172), black iron oxide (E172),
polyethylene glycol 400, polacrilin potassium,
butterscotch flavour and carnauba wax.
The film-coating is made of Opadry OY- 3736 and
purified water.

What Doralese looks like and contents of the
pack
Doralese Tiltab are coated tablets. The special
'Tiltab' design helps you to pick up your tablets
more easily.
They are available in packs of 60 tablets.

Marketing Authorisation Holder
Chemidex Pharma Ltd, Chemidex House, Egham
Business Village, Crabtree Road, Egham, Surrey
TW20 8RB.

Manufacturer
Dales Pharmaceuticals Ltd, Snaygill Industrial Estate,
Keighley Road, Skipton BD23 2RW.

This leaflet was last revised in
May 2015
'Doralese', 'Chemidex' and the Chemidex logo are
trademarks of Chemidex Pharma Ltd.
'Tiltab' is a trademark of, and used under licence from,
the GlaxoSmithKline group of companies.

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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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