Doralese Tiltab 20mg tablets

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Indoramin hydrochloride

Доступно од:

DE Pharmaceuticals

АТЦ код:

C02CA02

INN (Међународно име):

Indoramin hydrochloride

Дозирање:

20mg

Фармацеутски облик:

Oral tablet

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 07040100

Информативни летак

3. HOW TO TAKE DORALESE
Always take this medicine exactly as your doctor has
told you. 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 DORALESE THAN YOU SHOULD

If you take more Doralese 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, irregular heartbeat, changes to your
heartbeat (these symptoms can have potentially
serious, life-threatening consequences),
abnormally low blood pressure and fits.
IF YOU FORGET TO TAKE DORALESE

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
medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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 diseas

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Doralese Tiltab Tablets 20 mg
Indoramin 20 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains indoramin hydrochloride equivalent to
20 mg
of indoramin base.
Excipient with known effect
Each film-coated tablet contains 152 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets (tablets)
Pale yellow, triangular film-coated tablet, bearing a raised kite
shape on each
face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Conditions for which alpha blockade is indicated.
Management of urinary outflow obstruction due to benign prostatic
hyperplasia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Hyperplasia
_ _
_Adults_:
20 mg twice daily.
Dosage may be increased in 20 mg increments at two-weekly intervals up
to max.
100 mg per day if required.
_ _
_Elderly_:
20 mg at night may be adequate.
_ _
_Paediatric population: _
Not recommended.
Method of administration
For oral administration.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1
Patients with established heart failure.
Patients already under treatment with a monoamine oxidase inhibitor.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Incipient cardiac failure should be controlled before treatment with
indoramin.
Caution should be observed in prescribing indoramin for patients with
hepatic or
renal insufficiency.
A few cases of extrapyramidal disorders have been reported in patients
treated with
indoramin. Caution should be observed in prescribing indoramin in
patients with
Parkinson's disease.
In animals and in the one reported case of overdose in humans,
convulsions have
occurred. Due consideration should be given, and great caution
exercised in the use of
indoramin in patients with epilepsy.
The 'Intraoperative Floppy Iris Syndrome (IFIS, a variant of small
pupil syndrome)
has been observed during cataract surgery in some patients on