Elantan LA 25mg Prolonged Release Capsules

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

ISOSORBIDE MONONITRATE

Tersedia dari:

Merus Labs Luxco II S.à.R.L.

Kode ATC:

C01DA; C01DA14

INN (Nama Internasional):

ISOSORBIDE MONONITRATE

Dosis:

25 milligram(s)

Bentuk farmasi:

Prolonged-release capsule, hard

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

Organic nitrates; isosorbide mononitrate

Status otorisasi:

Marketed

Tanggal Otorisasi:

1995-05-18

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ELANTAN® LA 25 MG PROLONGED RELEASE CAPSULES, HARD
ISOSORBIDE MONONITRATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or pharmacist.
−
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, talk to 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 Elantan LA 25 is and what it is used for
2. What you need to know before you take Elantan LA 25
3. How to take Elantan LA 25
4. Possible side effects
5. How to store Elantan LA 25
6. Contents of the pack and other information.
1. WHAT ELANTAN LA 25 IS AND WHAT IT IS USED FOR
Elantan LA 25 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.
Elantan LA 25 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 ELANTAN LA 25
DO NOT TAKE ELANTAN LA 25:
• if you are allergic to isosorbide mononitrate, other nitrates or
any of the other
ingredients of this medicine (listed in section 6)
• if you suffer from severe anaemia
• if you have had a heart attack (myocardial infarction)
• if you have had a brain haemorrhage (bleeding)
• if you have had a head injury (trauma)
• if you have severely blood volume (hypovolaemia)
• if you have severe low blood pressure
• if you are suffering from “shock” as the blood has stopped
circulating properly around
your bo

Karakteristik produk

Health Products Regulatory Authority
27 March 2023
CRN00DG89
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Elantan LA 25mg Prolonged Release Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release capsule contains 25 mg isosorbide mononitrate.
Excipients with known effect: lactose monohydrate 6.71mg and sucrose
8.17-11.96mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged- release capsule, hard
Hard capsule with brown cap and white body, containing white to
off-white pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prophylaxis and long term management of angina pectoris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
One capsule to be taken in the morning.
The dose may be increased up to two capsules per day for patients with
higher nitrate requirements.
Dosage regime should be designed according to the clinical response of
the patient. The lowest effective dose should be used.
_Elderly_There is no evidence to suggest an adjustment of the dosage
is necessary in elderly.
_Paediatric population_
The safety and efficacy of Elantan LA has yet to be established in
children.
Attenuation of effect has occurred in some patients being treated with
prolonged release preparations. In such patients
intermittent therapy may be more appropriate (see section 4.4).
Treatment with Elantan LA, as with any other nitrate, should not be
stopped suddenly. Both dosage and frequency should be
tapered gradually (see section 4.4).
Method of administration
For oral administration.
Health Products Regulatory Authority
27 March 2023
CRN00DG89
Page 2 of 8
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Elantan LA should not be used in cases of acute myocardial infarction
with low filling pressure, acute circulatory failure (shock,
vascular collapse), or very low blood pressure (systolic blood
pressure below 90 mmHg), hypertrophic obstructive
cardiomyopathy (HOCM)