Indoramin 20 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

INDORAMIN HYDROCHLORIDE

Available from:

Chemidex Pharma Limited

ATC code:

C02CA; C02CA02

INN (International Name):

INDORAMIN HYDROCHLORIDE

Dosage:

20 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Alpha-adrenoreceptor antagonists; indoramin

Authorization status:

Marketed

Authorization date:

1989-02-21

Patient Information leaflet

IR4-1B/L/e/5
3. How to take
Always take Indoramin exactly as your doctor has told
you. You should check with your doctor or pharmacist
if you are not sure.
How much to take

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 take more Indoramin than you should

If you take more Indoramin than you should, talk to
a doctor or go to a hospital straight away. Take the
medicine pack with you.
If you forget to take your Indoramin

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 Indoramin

Do not stop taking Indoramin 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, Indoramin can cause side effects,
although not everybody gets them. The following side
effects may happen with this medicine:

when you start taking Indoramin 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, tiredness, 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
HPRA Pharmacovigila

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Indoramin 20 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains indoramin hydrochloride equivalent to 20 mg of
indoramin base.
Also contains 152mg of lactose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet (Tablet)
Pale yellow biconvex triangular film coated tablet, with a small
projection on each side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of urinary outflow obstruction due to benign
prostatic hyperplasia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration
Oral.
Hyperplasia
_Adult Males only:_
20 mg twice daily. Dosage may be increased in 20 mg increments at
two-weekly intervals up to maximum of 100 mg
per day if required.
_Elderly:_
20 mg at night may be adequate.
_Children:_
Not recommended.
4.3 CONTRAINDICATIONS
Use in patients with established cardiac failure.
Use in patients currently receiving monoamine oxidase inhibitors.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Indoramin should only be used with caution in patients with hepatic or
renal insufficiency or in those with Parkinson’s
disease, epilepsy or a history of seizures, or those with a history of
depression.
There is as yet no experience of use in patients with decreased renal
function or in those undergoing regular dialysis.
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