Vertigon 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Promethazine teoclate

Available from:

Manx Healthcare Ltd

ATC code:

R06AD02

INN (International Name):

Promethazine teoclate

Dosage:

25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000; GTIN: 5035559000343

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However,
you still need to take Vertigon
®
Tablets carefully to get the
best results from them.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or
advice.
You must contact a doctor if your symptoms worsen or
do not improve.
If any of the side effects gets serious, or if you notice
any side effect not listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET
1. WHAT VERTIGON
® TABLETS ARE AND WHAT THEY ARE USED
FOR
2. BEFORE YOU TAKE VERTIGON
® TABLETS
3. HOW TO TAKE VERTIGON
® TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE VERTIGON
® TABLETS
6. FURTHER INFORMATION 1. WHAT VERTIGON
® TABLETS ARE AND WHAT THEY ARE USED FOR
Vertigon
®
25mg Tablets (hereinafter referred to as
Vertigon
®
Tablets) are an anti-emetic (anti-sickness drug)
for the relief of vertigo.
Vertigon
®
Tablets contain promethazine which belongs to
a group of medicines called phenothiazines. It helps
relieve the symptoms of dizziness and nausea.
2. BEFORE YOU TAKE VERTIGON
® TABLETS
DO NOT GIVE TO A CHILD UNDER 2 YEARS OLD.
DO NOT TAKE VERTIGON
® TABLETS IF YOU HAVE:
ever had an allergic reaction to promethazine, any
phenothiazine or any of the ingredients (see section 6
for more details)
medicines for depression, known as Monoamine
Oxidase Inhibitors (MAOIs) within the last 14 days
CNS depression. People with CNS depression will
seem sleepy or unconscious (including coma).
TAKE SPECIAL CARE WITH VERTIGON
® TABLETS AND TELL YOUR
DOCTOR OR PHARMACIST IF YOU SUFFER WITH:
glaucoma (increased pressure in the eye)
epilepsy
heart problems
liver problems
kidney or bladder problems
a chest condition such as asthma or bronchitis
severe headaches with blurred vision, severe stomach
pains with vomiting, dizziness, difficulty with keeping
PATIENT INFORMATION LEAFLET - INFORMATION FOR THE USER
(continued overleaf)
VERTIGON 25MG TABLETS
your bal

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Vertigon
®
25mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Promethazine teoclate 25 mg.
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to pale cream, plain, circular biconvex tablets of 8.5 mm marked
“PT” on one
side with a score line on the reverse.
The tablet can be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Promethazine Teoclate is a long acting anti-emetic, indicated for:
- vertigo due to Meniere’s syndrome, labyrinthitis and other causes.
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _
_ _
Adults and the Elderly
One 25 mg tablet at night is often sufficient, but two or three
tablets are sometimes
necessary. Alternatively, more frequent administration such as 25 mg
two or three
times a day may be required for some patients. It is often not
necessary to give more
than four of the 25 mg Promethazine Teoclate tablets in 24 hours.
Children Over 10 years old
Give the lower adult dose (one tablet).
Children 5 – 10 years old
Give half the lower adult dose (half a tablet).
Tablets are not suitable for administration to children aged between 2
and 5 years. An
oral liquid preparation is recommended in this age group.
Not for use in children under 2 years of age (see section 4.3).
_Administration: _Oral.
4.3
CONTRAINDICATIONS
Promethazine Teoclate should not be used in patients with:
•
Hypersensitivity to promethazine or any of the excipients
•
Hypersensitivity to other phenothiazines
•
Coma or CNS depression of any cause
Promethazine Teoclate should not be used in children less than two
years of age
because of the potential for fatal respiratory depression.
Promethazine Teoclate should not be administered to patients who have
been taking
monoamine oxidase inhibitors within the previous 14 days.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Promethazine Teoclate may thicken or dry lung secretions and impair
expectoration, it should therefore be used with caution i