Valoid 50 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CYCLIZINE HYDROCHLORIDE

Available from:

Amdipharm Limited

ATC code:

R06AE; R06AE03

INN (International Name):

CYCLIZINE HYDROCHLORIDE

Dosage:

50 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Piperazine derivatives; cyclizine

Authorization status:

Marketed

Authorization date:

1979-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VALOID® 50 MG TABLETS
(cyclizine hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it to
others. It may harm
them, even if their signs of illness are the same as yours.

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.
The name of your medicine is Valoid 50 mg Tablets. It will be referred
to as Valoid Tablets for
ease hereafter.
WHAT IS IN THIS LEAFLET
1.
What Valoid Tablets are and what they are used for
2.
What you need to know before you take Valoid Tablets
3.
How to take Valoid Tablets
4.
Possible side effects
5.
How to store Valoid Tablets
6.
Contents of the pack and other information
1. WHAT VALOID TABLETS ARE AND WHAT THEY ARE USED FOR
Each tablet contains 50 mg of the active ingredient, cyclizine
hydrochloride.
Valoid Tablets belongs to a group of medicines called antihistamines.
These are used in adults
and
children
aged
over
6
years
to
block
the
effects
of
substances
called
histamine
and
acetylcholine in your body, which can make you feel sick (nausea) or
actually vomit. Valoid
Tablets are used for travel or motion sickness, and nausea which can
be caused by radiotherapy
or some medicines.
Some ear disorders, for example Meniere’s disease, can cause loss of
balance. Valoid Tablets are
used to treat the dizziness and vomiting which can come with this.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALOID TABLETS
DO NOT TAKE VALOID TABLETS IF YOU:

are allergic to cyclizine hydrochloride 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 fac

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valoid 50 mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg of cyclizine hydrochloride.
Excipient with known effect:
Lactose
(60mg/tablet)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, biconvex, uncoated tablet, scored; coded T4A.
The scoreline is to facilitate breaking for ease of swallowing and to
divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Valoid is indicated in adults and children aged 6 years and over for
the prevention and treatment of nausea and
vomiting, including:
Motion sickness.
Nausea and vomiting caused by narcotic analgesics and by general
anaesthetics in the post-operative period.
Vomiting associated with radiotherapy, especially for breast cancer
since cyclizine does not elevate prolactin
levels.
Valoid may be of value in relieving vomiting and attacks of vertigo
associated with Meniere's disease and other forms
of vestibular disturbance.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
To prevent motion sickness Valoid Tablets should be taken about one to
two hours before departure.
_Elderly_
There have been no specific studies of Valoid Tablets in the elderly.
Experience has indicated that normal adult dosage
is appropriate.
_Paediatric population_
Children less than 6 years of age:
Valoid Tablets are not recommended for children less than 6 years of
age.
Children 6 to 12 years of age:
25 mg orally, which may be repeated up to three times a day.
Children over 12 years of age:
50 mg orally, which may be repeated up to three times a day.
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