Serc 16 mg tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Betahistine dihydrochloride

Boleh didapati daripada:

PCO Manufacturing Ltd.

Kod ATC:

N07CA; N07CA01

INN (Nama Antarabangsa):

Betahistine dihydrochloride

Dos:

16 milligram(s)

Borang farmaseutikal:

Tablet

Kawasan terapeutik:

Antivertigo preparations; betahistine

Tarikh kebenaran:

2021-11-12

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
SERC
® 16 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 any further questions, ask your doctor or
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 becomes serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
WHAT IS IN THIS LEAFLET:
1.
What Serc is and what it is used for
2.
What you need to know before you take Serc
3.
How to take Serc
4.
Possible side effects
5.
How to store Serc
6.
Contents of the pack and other information
1.
WHAT SERC IS AND WHAT IT IS USED FOR
Serc contains betahistine. Serc is a type of medicine called a
“histamine analogue”.
Serc is used for:
Ménière’s disease – the signs of this include:

feeling dizzy (vertigo)

ringing in the ears (tinnitus)

hearing loss or hearing difficulty
This medicine works by improving blood flow in the inner ear.
This lowers the build up of pressure.
2.
BEFORE YOU TAKE SERC
DO NOT TAKE SERC IF:

you are allergic (hypersensitive) to betahistine or any of the
other ingredients in the tablets (see section 6 for further
details)

you have high blood pressure due to an adrenal gland
tumour (phaeochromocytoma)
If any of the above applies to you, do not take this medicine and
talk to your doctor.
TAKE SPECIAL CARE AND TELL YOUR DOCTOR IF:

you have ever had a stomach ulcer

you have asthma

you are pregnant or planning to become pregnant

you are breast-feeding.
If any of the above applies to you, talk to your doctor or
pharmacist before taking Serc. Your doctor may want to monitor
you more closely while you take Serc. Your doctor will tell you
whether it is safe for you to start taking this medicine.
CHILDREN
Serc is not recommended for those under 18 years old.
TAKI

Ciri produk

Health Products Regulatory Authority
09 January 2024
CRN00F1RL
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Serc 16 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 16 mg betahistine dihydrochloride, equivalent to
10.42 mg betahistine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from Spain:_
Round, biconvex, scored, white to almost white tablets imprinted `267'
on one face.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
As per PA23355/014/002
5 PHARMACOLOGICAL PROPERTIES
As per PA23355/014/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Microcrystalline cellulose
Mannitol (E421)
Citric acid monohydrate
Colloidal anhydrous silica
Talc
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expirydate of this product shall be the date shown on
the blister and outer packageof the product on the market
in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special temperature
storage conditions. Store in the original package.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister strips of 15 tablets.
The blister strips are made of PVC/PVDC film with a covering aluminium
foil.
Each carton contains 90 tablets.
Health Products Regulatory Authority
09 January 2024
CRN00F1RL
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/482/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 12
th
November 2021
10 DATE OF REVISION OF THE TEXT
January 2024