Isosorbide mononitrate 20mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Isosorbide mononitrate

Dostopno od:

Accord-UK Ltd

Koda artikla:

C01DA14

INN (mednarodno ime):

Isosorbide mononitrate

Odmerek:

20mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 02060100; GTIN: 5055565705315

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR
THE USER
ISOSORBIDE MONONITRATE
20 MG TABLETS
ISOSORBIDE MONONITRATE
40 MG TABLETS
Isosorbide mononitrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING 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, pharmacist or nurse.
- 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, tell 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 Isosorbide mononitrate is and what it
is used for
2. What you need to know before you take
Isosorbide mononitrate
3. How to take Isosorbide mononitrate
4. Possible side effects
5. How to store Isosorbide mononitrate
6. Contents of the pack and other information
1.
WHAT ISOSORBIDE MONONITRATE
IS AND WHAT IT IS USED FOR
Isosorbide mononitrate belongs to a group of
medicines called organic nitrates. Organic
nitrates work by widening the blood vessels in
your heart to allow an increased amount of
blood to flow to areas which need it.
Isosorbide mononitrate is used to prevent
angina pectoris. Angina usually feels like a
tight pain in the chest, neck or arm area. The
pain comes from the heart muscle and is a
sign that part of it is not getting enough oxygen
for the amount of work it is doing.
2.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE ISOSORBIDE
MONONITRATE
DO NOT TAKE ISOSORBIDE MONONITRATE
- if you are allergic to the isosorbide
mononitrate or to any of the other ingredients
of this medicine (listed in section 6).
- if you suffer from severe disorders of the
heart muscle or the pericardium causing
severe impairment of the heart function is
severely impaired (called constrictive
pericarditis, pericardial tamponade or
restrictive cardiomyopathy); You have been
diagnosed with any of the following heart
conditions: h

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Isosorbide mononitrate 20mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of isosorbide mononitrate.
Excipient with known effect: 5 mg of lactose monohydrate/tablet
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
TABLET
ISOSORBIDE MONONITRATE 20MG TABLETS:
White to off white, round, flat, bevelled edge uncoated tablets,
debossed with ‘AS’ on
one side and break line on the other side. The tablets can be divided
in to equal
halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylactic treatment of angina pectoris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
The usual dose of Isosorbidemononitrate is 1 tablet of
Isosorbidemononitrate 20 mg, taken
asymmetrically (to allow a nitrate low period) 2 to 3 times daily. If
result is not adequate, the
dose may be increased to 1 tablet of Isosorbidemononitrate 40 mg, 2 to
3 times daily.
The dosage may be increased to 120mg per day.
Dosage regime should be designed according to the clinical response of
the patient.
The lowest effective dose should be used.
In patients taking isosorbidemononitrate twice daily, the second dose
should be taken 8 hours
after the 1st dosage. If the dose is one three times daily, take one
every 6 hours. This provides
a nitrate-free period of 6 – 8 hours.
The maximum dose is 3 tablets isosorbidemononitrate 40 mg per day.
In order to prevent possible initial undesirable effect, it may be
adequate to initiate treatment
with possible lowest dose and slowly increase to the required dose.
To prevent tolerance, it is recommended that the dosage be kept as low
as possible and that a
sufficiently long nitrate-free interval is ensured to restore
sensitivity (first dose in the morning
and last dose late in the afternoon, e.g. at 8 am and 15 pm).
The duration of application is decided by the treating physician.
Treatment with isosorbidemononitrate, as with any other nitrate,
should not be stopped
suddenly. Both