Midon 2.5 mg Tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

MIDODRINE HYDROCHLORIDE

Boleh didapati daripada:

LTT Pharma Limited

Kod ATC:

C01CA; C01CA17

INN (Nama Antarabangsa):

MIDODRINE HYDROCHLORIDE

Dos:

2.5 milligram(s)

Borang farmaseutikal:

Tablet

Jenis preskripsi:

Product subject to prescription which may be renewed (B)

Kawasan terapeutik:

Adrenergic and dopaminergic agents; midodrine

Status kebenaran:

Authorised

Tarikh kebenaran:

2015-06-12

Risalah maklumat

TAKING OTHER MEDICINES
Please tell your doctor if you are taking, or have recently taken any
other
medicines, including medicines obtained without a prescription, but
particularly if you are taking:
*
high blood pressure medicines e.g. alpha blockers or beta blockers
*
glycosides to increase the force of your heart beat e.g. digitalis
*
tricyclic antidepressants for depression or monoamine oxidase
inhibitors
(MAOIs)
*
amiodarone (used to control heart arrhythmias). Midon may increase the
effect of this drug
*
metoclopramide (used to stop you feeling and being sick). Midon may
increase the effect of this drug
*
phenothiazines and atypical antipsychotics for schizophrenia or
psychosis
*
antihistamines for allergies
*
appetite suppressants
*
nasal/ sinus congestion relievers, especially those purchased without
a
prescription
*
thyroid hormones
*
steroids (for example, fludrocortisone). In combination with Midon
Tablets,
steroids may increase the risk of eye problems or a high blood
pressure
whilst lying down. (These drugs are sometimes used together with Midon
Tablets, and your doctor may have prescribed this combination for
you).
TAKING MIDON TABLETS WITH FOOD AND DRINK.
You can take these tablets with or without food.
PREGNANCY AND BREAST-FEEDING
Safe use during pregnancy and breastfeeding has not been established.
Tell your doctor if you are pregnant, think you may be pregnant or are
planning to become pregnant, or if you are breast-feeding.
Midon Tablets should not be taken by pregnant or breastfeeding women
unless advised to by a doctor.
Ask your doctor or pharmacist for advice before taking any medicine
during
pregnancy, or if you are breast-feeding.
DRIVING AND USING MACHINERY
Midon Tablets may make you feel dizzy or light headed; if this happens
to
you, do not drive or use machinery and ask your doctor for advice.
HOW TO TAKE MIDON TABLETS
Always take the tablets exactly as your doctor has told you. You
should check
with your doctor or pharmacist if you are not sure about the dose you
should
take.
*
Swallow

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Midon 2.5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg Midodrine hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from Hungary_
Round, white, biplanar tablets with bevelled edge. Scored on one side
with 'GU'
above and '2.5'
below the score.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
As per PA1547/006/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1547/006/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Magnesium stearate
Talc
Colloidal anhydrous silica
Microcrystalline cellulose
Corn starch
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Store in the original package.
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6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 100 tablets. The push-through blister comprises
aluminium foil faced with PVDC, with vinyl backing
also faced with PVDC.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED F