Isosorbide mononitrate 40mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Isosorbide mononitrate

Disponible des:

Dexcel-Pharma Ltd

Codi ATC:

C01DA14

Designació comuna internacional (DCI):

Isosorbide mononitrate

Dosis:

40mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 02060100; GTIN: 5033847000136

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
ISOSORBIDE MONONITRATE TABLETS 10MG
ISOSORBIDE MONONITRATE TABLETS 20MG
ISOSORBIDE MONONITRATE TABLETS 40MG
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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.
• You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1. What Isosorbide Mononitrate Tablets are and what they are used for
2. What you need to know before you take Isosorbide Mononitrate
Tablets
3. How to take Isosorbide Mononitrate Tablets
4. Possible side effects
5. How to store Isosorbide Mononitrate Tablets
6. Content of the pack and other information
1. WHAT ISOSORBIDE MONONITRATE TABLETS ARE AND WHAT THEY ARE USED FOR
Isosorbide Mononitrate Tablets belong to a group of medicines called
nitrate vasodilators. These work by
relaxing the blood vessels of the heart, reducing the strain on the
heart making it easier to pump blood.
Isosorbide Mononitrate Tablets are 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
TABLETS
Do not take Isosorbide Mononitrate Tablets if:
• you are allergic (hypersensitive) to isosorbide mononitrate,
isosorbide dinitrate or any of the other
ingredients of Isosorbide Mononitrate Tablets (see section 6). An
allergic reaction may include a rash,
itching or difficulty breathing
• you have severe anaemia (reduction in red blood cells which can
ma

Fitxa tècnica

OBJECT 1
ISOSORBIDE MONONITRATE TABLETS 40
MG
Summary of Product Characteristics Updated 02-Jan-2018 | Dexcel Pharma
Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Isosorbide Mononitrate Tablets 40 mg
2. Qualitative and quantitative composition
Each tablet contains Isosorbide Mononitrate, 40 mg.
Excipients with a known effect:
Each tablet contains approximately 218 mg of lactose and approximately
117 mg sucrose.
For the full list of excipients, see Section 6.1.
3. Pharmaceutical form
Tablets
White round tablets with an embossment "IM 40" on one side.
4. Clinical particulars
4.1 Therapeutic indications
Isosorbide Mononitrate Tablets is indicated for the prophylaxis of
angina pectoris.
4.2 Posology and method of administration
POSOLOGY
Dosage should be reduced in patients with renal or hepatic impairment.
ADULTS
One tablet to be taken asymmetrically (to allow a nitrate low period)
two or three times a day. Patients
already accustomed to prophylactic nitrate therapy ma