Chemydur 60XL tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Isosorbide mononitrate

Commercializzato da:

Advanz Pharma

Codice ATC:

C01DA14

INN (Nome Internazionale):

Isosorbide mononitrate

Dosaggio:

60mg

Forma farmaceutica:

Modified-release tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 02060100; GTIN: 5021730002046

Foglio illustrativo

102402/LF/011/01
1000011758
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CHEMYDUR
® 60XL TABLETS
Isosorbide-5-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, pharmacist or nurse 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,
pharmacist or nurse. 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 Chemydur 60XL Tablets are and what they are
used for
2.
What you need to know before you take Chemydur 60XL
Tablets
3.
How to take Chemydur 60XL Tablets
4.
Possible side effects
5.
How to store Chemydur 60XL Tablets
6.
Contents of the pack and other information
1.
WHAT CHEMYDUR 60XL TABLETS ARE AND WHAT
THEY ARE USED FOR
The name of your medicine is Chemydur 60XL Tablets. The
active ingredient is isosorbide-5-mononitrate. Chemydur
60XL Tablets belong to a group of medicines called nitrates.
Chemydur 60XL Tablets are used in adults to prevent angina
(chest pain) and work by opening up blood vessels and
reducing the pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
CHEMYDUR 60XL TABLETS
DO NOT TAKE CHEMYDUR 60XL TABLETS IF YOU:
•
are allergic to isosorbide-5-mononitrate or any of the
other ingredients of this medicine (listed in section 6).
(Allergic
reactions
include
mild
symptoms
such
as
itching and/or rash. More severe symptoms include
swelling of the face, lips, tongue and/or throat with
difficulty in swallowing or breathing);
•
have any inflammation of the heart such as pericarditis;
•
have been diagnosed with any of the following heart
conditions
-
Low cardiac filling pressure
-
Cardiac tamponade
-
Hypertrophic obstructive cardiomyopathy;
•
have had any serious damage to your

Scheda tecnica

OBJECT 1
CHEMYDUR 60XL TABLETS
Summary of Product Characteristics Updated 29-Jan-2020 | ADVANZ Pharma
•
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
Chemydur 60XL
Mitrate 60XL
2. Qualitative and quantitative composition
Each tablet contains 60 mg of isosorbide-5-mononitrate.
International non-proprietary name (INN): Isosorbide mononitrate.
Chemical name: 1,4 : 3,6 dianhydro-D-glucitol-5-nitrate.
Excipients with known effect:
Lactose (38.167 mg/ tablet)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablets (modified release).
Oval, cream coloured tablets, half scored on both sides and marked
with a crown and 60 on one side.
4. Clinical particulars
4.1 Therapeutic indications
Chemydur 60XL Tablets/Mitrate 60XL Tablets are indicated in adults for
the prophylactic treatment of
angina pectoris
4.2 Posology and method of administration
Posology
Adults
One tablet (60 mg) once daily given in the morning. The dose may be
increased to two tablets (120 m