ELANTAN LA 25 Milligram Prolonged Release Capsules
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
20-04-2024
Summary of Product characteristics
(SPC)
20-04-2024
Active ingredient:
ISOSORBIDE MONONITRATE
Available from:
UCB (Pharma) Ireland Limited
INN (International Name):
ISOSORBIDE MONONITRATE
Dosage:
25 Milligram
Pharmaceutical form:
Prolonged Release Capsules
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
CCDS ISOSORBIDE MONONITRATE
C2013-033
APPROVED: 25 MAR 2013
PROPOSED PIL JULY 2013
SUBMITTED TO IMB
ELANTAN® LA 25MG PROLONGED RELEASE CAPSULES, HARD.
ISOSORBIDE MONONITRATE
PATIENT INFORMATION LEAFLET
READ ALL OF THIS
LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE.
• 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. Do
not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
IN THIS LEAFLET:
1. What Elantan LA 25 is for
2. 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. Further information.
1. WHAT ELANTAN LA 25 IS 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. 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 Elantan LA 25
(see section 6)
• You suffer from severe anaemia
• You have had a heart attack (myocardial infarction)
• You have had a brain haemorrhage (bleeding)
• You have had a head injury (trauma)
• You have severely blood volume (hypovolaemia)
• You have severe low blood pressure
• You are suffering from “shock” as the blood
has
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Summary of Product characteristics
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: Each prolonged release capsule contains 6.71mg lactose monohydrate and 8.17-11.96mg sucrose
For a 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
For oral administration.
Elantan LA should be swallowed whole with water.
Elantan LA 25mg: one daily, or two capsules daily, together in the morning
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.
The lowest effective dose should be used.
ELDERLY
There is no evidence to suggest an adjustment of the dosage is necessary in elderly.
Children
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).
4.3 CONTRAINDICATIONS
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
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