Serc 8mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Betahistine dihydrochloride

Available from:

Viatris UK Healthcare Ltd

ATC code:

N07CA01

INN (International Name):

Betahistine dihydrochloride

Dosage:

8mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000; GTIN: 5012781055600

Patient Information leaflet

SERC
® 8MG TABLETS
(betahistine dihydrochloride)
_ _
Serc contains betahistine. This medicine is
called a histamine analogue. It is used to treat:

dizziness (vertigo)

ringing in the ears (tinnitus)

hearing loss suffered by people with
Ménière’s disease
This medicine works by improving blood flow in
the inner ear. This lowers the build up of
pressure.
DO NOT TAKE SERC IF:

You are allergic to any of the ingredients in
the tablets (see section 6 for further details).

You have high blood pressure due to an
adrenal 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 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 before taking this medicine.
Your doctor will tell you whether it is safe for you
to start taking this medicine.
Your doctor may also want to monitor your
asthma while you take Serc.
TAKING OTHER MEDICINES
Please tell your doctor or pharmacist if you are
taking or have taken any other medicines,
including medicines obtained without a
prescription. This includes herbal medicines.
In particular, tell your doctor or pharmacist if you
are taking any of the following medicines:

Anti-histamines - these may (in theory) lower
the effect of Serc. Also, Serc may lower the
effect of anti-histamines.

Monoamine-oxidase inhibitors (MAOIs) -
used to treat depression or Parkinson's
disease. These may increase the exposure of
Serc.
TAKING SERC WITH FOOD AND DRINK
You can take Serc with or without food.
PREGNANCY AND BREAST-FEEDING
Do not take Serc if you are pregnant unless your
doctor has decided that it is absolutely
necessary. Ask your doctor for advice.
Do not breast-feed while using Serc unless
instructed by your doctor. It is not known if Serc
passes into breast milk.
DRIVING AND USING MACHINES
Serc is not likely to affect your ability to drive or
us

Summary of Product characteristics

OBJECT 1
SERC - 8 MG TABLETS
Summary of Product Characteristics Updated 23-Feb-2018 | Mylan
•
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 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
Serc
®
-8
2. Qualitative and quantitative composition
Each tablet contains 8 mg betahistine dihydrochloride equivalent to
5.21 mg betahistine.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
A round, flat, white to almost white tablet. Serc-8 is imprinted '256'
on one face of the tablet.
4. Clinical particulars
4.1 Therapeutic indications
Vertigo, tinnitus and hearing loss associated with Ménière's
syndrome.
4.2 Posology and method of administration
_Adults (including the elderly):_ initially two tablets three times
daily taken preferably with meals.
Maintenance doses are generally in the range 24-48 mg daily.
_Paediatric population: _not recommended for use in children below 18
years due to insufficient data on
safety and efficacy.
_Geriatric population: _Although there are limited data from clinical
studies in this