Isosorbide mononitrate 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Isosorbide mononitrate

Available from:

DE Pharmaceuticals

ATC code:

C01DA14

INN (International Name):

Isosorbide mononitrate

Dosage:

20mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060100

Patient Information leaflet

PATIENT INFORMATION LEAFLET
ISOSORBIDE MONONITRATE
10MG, 20MG & 40MG TABLETS
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 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
medicine called nitrate vasodilators. It works by
improving the blood supply to the heart, by
enlarging the blood vessels in the heart muscle,
reducing the strain on the heart making it easier to
pump blood, and is used for preventing the pain in
your chest called angina. Isosorbide Mononitrate
tablets may be used to help control certain types of
heart failure.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ISOSORBIDE MONONITRATE
DO NOT TAKE Isosorbide Mononitrate tablets and TELL
your doctor if you:
•
are ALLERGIC (hypersensitive) to Isosorbide
Mononitrate or to other nitrates or to any of the
other ingredients in your tablets (see section 6).
An allergic reaction may include rash, itching or
difficulty breathing
•
have very low blood pressure
•
have a low blood volume
•
have glaucoma (increased pressure in the eye)
•
suffer from low cardiac filling pressure or any
serious heart or circulatory (vein/artery)
problems, other than angina
•
blood is not circulating properly (such as shock)
•
have angin

Summary of Product characteristics

OBJECT 1
ISOSORBIDE MONONITRATE 20MG TABLETS
Summary of Product Characteristics Updated 09-Sep-2014 | Accord
Healthcare Limited
•
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 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 Isosorbide mononitrate is 1 tablet of Isosorbide
mononitrate 20 mg, taken
asymmetrically (to allow a nitrate low period) 2 to 3 times daily. If
r