Cyclizine Lactate 50 mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cyclizine

Available from:

Ethypharm

ATC code:

R06AE; R06AE03

INN (International Name):

Cyclizine

Dosage:

50 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Therapeutic area:

Piperazine derivatives; cyclizine

Authorization status:

Not marketed

Authorization date:

2019-08-13

Patient Information leaflet

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WHAT IS IN THIS LEAFLET
1.
What Cyclizine Injection is and what is it used for
2.
What you need to know before you are given
Cyclizine Injection
3.
How to use Cyclizine Injection
4.
Possible side effects
5.
How to store Cyclizine Injection
6.
Contents of the pack and other information
1. WHAT CYCLIZINE INJECTION IS AND WHAT IT IS
USED FOR.
The name of your medicine is Cyclizine Injection.
Cyclizine Injection contains the active ingredient cyclizine
lactate, which belongs to a group of medicines called
antihistamines which can be used to help stop you feeling
sick (nausea) or being sick (vomiting).
Cyclizine Injection may be used by adults. Cyclizine
Injection may be used if you suffer from travel or
motion sickness; nausea caused by cancer treatment
(radiotherapy) or other medicines; or if you have had an
operation, as general anaesthetics can sometimes cause
sickness.
Cyclizine Injection can also be used to treat sickness
caused by some inner ear problems such as Meniere’s
disease.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN CYCLIZINE INJECTION
DO NOT TAKE THIS MEDICINE IF:
• If you are allergic to cyclizine lactate or any of the
other ingredients of this medicine (allergic reactions
include mild symptoms such as itching and/or rash.
More severe symptoms include swelling of the face,
lips,tongue and/or throat with difficulty in swallowing
or breathing)(listed in section 6)
• you have been drinking alcohol. The anti-vomiting
properties of Cyclizine Injection may increase the
toxicity of alcohol.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE BEING
TREATED WITH CYCLIZINE INJECTION IF YOU:
• suffer from an eye disease caused by a rise of pressure
within the eye (glaucoma);
• Suffer from Urinary retention (experience difficulty
passing urine);
• have an obstructive bowel condition;
• have any liver problems;
• suffer from phaeochromocytoma (tumor of the
medulla of the adrenal glands);
• suffer from high blood pressure;
• have epilepsy;
• are a man and you suffer

Summary of Product characteristics

Health Products Regulatory Authority
14 August 2019
CRN008LQ1
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cyclizine Lactate 50 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml ampoule contains 50 mg Cyclizine lactate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Clear, colourless solution for injection.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cyclizine is indicated in adults for the prevention and treatment of
nausea and vomiting including: -
- Motion sickness when the oral route cannot be used.
- 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.
- Cyclizine injection, by the intravenous route, is also indicated
pre-operatively in patients undergoing emergency surgery in
order to reduce the hazard of regurgitation and aspiration of gastric
contents during induction of general anaesthesia.
Cyclizine may be of value in relieving vomiting and attacks of vertigo
associated with Menière's disease and other forms of
vestibular disturbance when the oral route cannot be used.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For the prevention of postoperative nausea and vomiting, administer
the first dose by slow intravenous injection 20 minutes
before the anticipated end of surgery.
_Adults_
50 mg intramuscularly or intravenously up to three times daily.
When used intravenously, Cyclizine should be injected slowly into the
bloodstream, with only minimal withdrawal of blood into
the syringe.
For the prevention of postoperative nausea and vomiting, administer
the first dose by slow intravenous injection 20 minutes
before the anticipated end of surgery.
Cyclizine given intravenously, in half the recommended dose, increases
the lower oesophageal sphincter tone and thereby
reduces the hazard of regurgitation and aspiration of gastric contents