情報リーフレット
PACKAGE LEAFLET: INFORMATION FOR THE USER
BETASERC 8 MG TABLETS
BETASERC 16 MG TABLETS
BETASERC 24 MG TABLETS
Betahistine dihydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor or your pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
_ _
IN THIS LEAFLET:
1.
What Betaserc is and what it is used for
2.
Before you take Betaserc
3.
How to use Betaserc
4.
Possible side effects
5.
How to store Betaserc
6.
Further information
1.
WHAT BETASERC IS AND WHAT IT IS USED FOR
Betaserc contains betahistine. This medicine is called a histamine analogue. This medicine works
by improving blood flow in the inner ear. This lowers the build up of pressure.
Betaserc is used to treat Ménière’s disease, which mainly shows through:
- Dizziness (vertigo)
- Ringing in the ears (tinnitus)
- Hearing loss
Betaserc is also used to treat dizziness caused by malfunction of the balance organ in the inner
ear (vestibular vertigo)
2.
BEFORE YOU TAKE BETASERC
DO NOT TAKE BETASERC IF:
-
you are allergic to betahistine or any of the ingredients of Betaserc.
-
you have pheochromocytoma (tumour of adrenal medulla)
TAKE SPECIAL CARE WITH BETASERC:
-
if you suffer from bronchial asthma
-
if you suffer from peptic ulcer
PREGNANCY
Consult your doctor or pha
完全なドキュメントを読む
製品の特徴
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Betaserc
®
8 mg tablets
Betaserc
®
16 mg tablets
Betaserc
®
24 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Betaserc
®
tablets contain 8, 16 or 24 mg betahistine dihydrochloride.
For a full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Betaserc
®
tablet, 8 mg:
A round, flat, white to almost white tablet with bevelled edges. The diameter is 7 mm; the
tablet weight is about 125 mg. The inscription is 256 on one tablet-side
Betaserc
®
tablet, 16 mg:
A round, biconvex, scored, white to almost white tablet with bevelled edges. The diameter
is 8.5 mm; the tablet weight is about 250 mg. The inscription is 267 on either side of the
score on one tablet-side._ _
The tablet can be divided into equal halves
Betaserc
®
tablet, 24 mg:
A round, biconvex, scored, white to almost white tablet with bevelled edges and relevant
inscriptions. The diameter is 10 mm; the tablet weight is about 375 mg. The inscription
is
289 on either side of the score on one tablet-side.
_ _
The scoreline is only to facilitate breaking for ease of swallowing and not to
divide into
equal doses
4.
CLINICAL PARTICULARS
Page 2 of 8
4.1
THERAPEUTIC INDICATIONS
Ménière's Syndrome as defined by the following trias of core symptoms:
- vertigo (with nausea/vomiting)
- hearing loss (hardness of hearing)
- tinnitus
Symptomatic treatment of vestibular vertigo.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Betaserc
®
tablets 8mg/ Betaserc
®
tablets 16mg:
The dosage for adults is 24-48 mg divided over the day.
_8 mg tablets _
_16 mg tablets _
1-2 tablets
3 times
完全なドキュメントを読む