Isosorbide mononitrate 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Isosorbide mononitrate

Available from:

Flamingo Pharma (UK) Ltd

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; GTIN: 5060464500671

Patient Information leaflet

FONTS SIZE :
Generic Name font size : 12 pt.
Composition fonts size : 9 pt.
FONTS : Zurich CnBT
330 mm
160 mm
160 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
ISOSORBIDE MONONITRATE 10 MG TABLETS
ISOSORBIDE MONONITRATE 20 MG TABLETS
ISOSORBIDE MONONITRATE 40 MG TABLETS
ISOSORBIDE MONONITRATE
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.
•
Ask your pharmacist if you need more information or advice.
•
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 are they 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. Contents of the pack and other information
Isosorbide mononitrate belongs to a group of medicines
called Organic Nitrates.
1. WHAT ISOSORBIDE MONONITRATE TABLETS ARE AND WHAT ARE THEY USED FOR
DO NOT TAKE ISOSORBIDE MONONITRATE TABLETS:
• if you are allergic (hypersensitive) to isosorbide
mononitrate or any of the other ingredients in the
product (see section 6)
• if you suffer from anaemia (reduction in red blood cells
which can make the skin pale and cause weakness or
breathlessness)
• 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 a low blood volume (hypovolaemia)
• if you have very low blood pressure
• if you are suffering from 'shock' as the blood has
stopped circulating properly around your body
(circulatory failure)
• if you take sildenafil

Summary of Product characteristics

OBJECT 1
ISOSORBIDE MONONITRATE 20 MG
TABLETS
Summary of Product Characteristics Updated 08-Apr-2020 | Flamingo
Pharma (UK) 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
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8. Marketing authorisation number(s)
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9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Isosorbide Mononitrate 20 mg Tablets
2. Qualitative and quantitative composition
Each tablet contains diluted isosorbide mononitrate equivalent to
isosorbide mononitrate 20 mg.
Excipient(s) with known effect:
Each tablet contains 64.50mg lactose monohydrate.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Tablet
Isosorbide mononitrate 20 mg Tablets are white to off white circular,
biconvex uncoated tablets debossed
with 'I' and '20' separated by break line on one side and plain on
other side.
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
Tablet should be swallowed whole with water.
Isosorbide mononitrate 20 mg Tablets: one tablet daily, twi