Xismox XL 60 tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Isosorbide mononitrate

Inapatikana kutoka:

Genus Pharmaceuticals Ltd

ATC kanuni:

C01DA14

INN (Jina la Kimataifa):

Isosorbide mononitrate

Kipimo:

60mg

Dawa fomu:

Modified-release tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 02060100; GTIN: 5030451001436

Taarifa za kipeperushi

PATIENT INFORMATION LEAFLET
XISMOX
® 60 XL
PROLONGED RELEASE TABLETS
(ISOSORBIDE MONONITRATE)
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING XISMOX 60 XL BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription.
However, you still need to use XISMOX 60 XL
Prolonged Release Tablets carefully to get the
best results from it.
•
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.
WHAT IS IN THIS LEAFLET:
1.
WHAT XISMOX 60 XL IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
XISMOX 60 XL
3. HOW TO TAKE XISMOX 60 XL
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE XISMOX 60 XL
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
1. WHAT XISMOX 60 XL IS AND WHAT IT IS
USED FOR
The name of your medicine is XISMOX 60 XL
Prolonged Release Tablets (referred to as
XISMOX 60 XL) throughout this leaflet.
XISMOX 60 XL contains the active ingredient
Isosorbide Mononitrate, which belongs to a
group of medicines called nitrates. IT IS USED
TO PREVENT AN ATTACK OF ANGINA PECTORIS
(CHEST PAIN) FROM HAPPENING. Angina is a
crushing pain or tightness in the chest,
although the pain may also be felt in the neck
or arm. The pain happens when the muscle in
the heart does not receive enough oxygen for
the work it has to do. XISMOX 60 XL works by
IMPROVING THE SUPPLY OF BLOOD AND OXYGEN
to the heart muscle. The tablets will release
your medicine slowly and will treat your
condition throughout the day.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE XISMOX 60 XL
DO NOT use these tablets TO TREAT SUDDEN
CHEST PAIN (acute agina). INSTEAD SEEK
IMMEDIATE MEDICAL ATTENTION. These tablets
work too slowly to treat this and are only used
to prevent symptoms of angina from
happening.
DO NOT TAKE XISMOX 60 XL IF:
•
you are allergic (hypersensitive) to
isosorbide mononitrate or any

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ISIB 60 XL Prolonged Release Tablets
XISMOX 60 XL Prolonged Release Tablets
TARDISC XL 60 Prolonged Release Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Isosorbide mononitrate 60 mg
Excipients with a known effect:
Each tablets contains approximately 98.5 mg of lactose
Each tablet contains approximately 43 mg of sucrose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged Release Tablets
Light yellow, biconvex, oval-shaped, scored on both sides and marked
"DX
31" on one side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylactic treatment of angina pectoris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS
The recommeded dose is one 60 mg tablet, once daily, given in the
morning.
The dose may be increased to 120 mg (two tablets) daily, both to be
taken
once daily in the morning. This will produce effective nitrate blood
levels
during the day with low blood levels at night to prevent the
development of
tolerance.
The dose can be titrated, to minimize the possibility of headache, by
initiating
treatment with 30mg (half a tablet) for the first 2-4 days.
Note that isosorbide mononitrate is not indicated for the relief of
acute attacks,
in the event of an acute attack, sublingual or buccal glyceryl
trinitrate tablets
should be used.
PAEDIATRIC POPULATION
The safety and efficacy of this medicine in children has not been
established.
ELDERLY
No evidence of a need for routine dosage adjustment in the elderly has
been
found, but special care may be needed in those with increased
susceptibility to
hypotension or marked hepatic or renal insufficiency.
There is a risk of tolerance developing when nitrate therapy is given.
For this
reason it is important that the tablets are taken once a day to
achieve an
interval with low nitrate concentration, thereby reducing the risk of
tolerance
development.
When necessary the product may be used in combin