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XOMOLIX 2.5MG/ML SOLUTION FOR INJECTION

Active substance(s): DROPERIDOL / DROPERIDOL / DROPERIDOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Xomolix® 2.5 mg/ml solution for injection
(Droperidol)
Read all of this leaflet carefully before you start using 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 or nurse.



This medicine has been prescribed for you. Do not pass it on to others.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Contact your doctor immediately if you experience any increase in your
body temperature, muscle stiffness, tremor, rapid swelling of the face or
throat, or if you get chest pains after having this medicine.
The following side effects have also been reported: If any of the side
effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor, nurse or pharmacist.
Common side effects (may affect up to 1 in 10 people)

It may harm them, even if their symptoms are the same as yours.


• Drowsiness
• Low blood pressure

If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes side effects not listed in this leaflet. See section 4.

Uncommon side effects (may affect up to 1 in 100 people)

What is in this leaflet:

3. How you will be given Xomolix






4. Possible side effects

Rare side effects (may affect up to 1 in 1,000 people)

5. How to store Xomolix








1. What Xomolix is and what it is used for
2. What you need to know before you are given Xomolix

6. Contents of the pack and other information

1. What Xomolix is and what it is used for
Xomolix is a solution of droperidol for injection, which is used to prevent you
feeling sick (nausea) or vomiting when you wake up after an operation or
when you receive morphine based painkillers after an operation.

• Blood disorders (usually diseases affecting red blood cells or platelets).
Your doctor can advise you.
• Change in mood towards sadness, anxiety, depression and irritability
• Involuntary muscle movements
• Convulsions or tremors
• Heart attack (cardiac arrest)
• Torsade de pointes (life-threatening irregular heartbeat)
• Prolonged QT interval in ECG (a heart condition affecting the
heartbeat)
• Sudden death

2. What you need to know before you are given Xomolix
You should not be given Xomolix if you:
are allergic (hypersensitive) to the active ingredient droperidol, or any of
the other ingredients in Xomolix. (A list of these can be found in
Section 6 of this leaflet.)


are allergic to a group of medicines used to treat psychiatric disorders,
called butyrophenones (e.g. haloperidol, triperidol, benperidol,



Serious allergic reaction known as anaphylaxis or anaphylactic shock
Confusion
Agitation
Irregular heartbeat
Rash
Neuroleptic malignant syndrome, symptoms include fever, sweating,
salivation, muscle stiffness and tremors

Very rare side effects (may affect up to 1 in 10,000 people)

The active substance in Xomolix is droperidol. Droperidol belongs to
a group of antipsychotics called butyrophenone derivatives.



Anxiety
Rolling of the eyes
Fast heartbeat e.g. more than 100 beats per minute
Dizziness

melperone, domperidone)

Other side effects which may occur are:

or anyone in your family have an abnormal electrocardiogram (ECG)

• Inappropriate anti-diuretic hormone secretion (too much of the hormone
is released leading to excess water and low sodium levels in the body)
• Hallucinations
• Epileptic seizures
• Parkinson’s disease
• Psychomotor hyperactivity
• Coma
• Fainting
• Breathing difficulties
• Blood clots in the veins, especially in the legs (symptoms include
swelling, pain and redness in the leg), which may travel through blood
vessels to the lungs causing chest pain and difficulty in breathing. If
you notice any of these symptoms seek medical advice immediately.

heart tracing


have low levels of potassium or magnesium in your blood



have a pulse rate of less than 55 beats per minute (the doctor or nurse
will check this), or are taking any medicines that could cause this to
happen



have a tumour in your adrenal gland (phaeochromocytoma)



are in a coma



have Parkinson’s disease



have severe depression

Take special care with Xomolix
Before you are given Xomolix injection, you should tell your doctor or nurse
if you:


have epilepsy, or a history of epilepsy



have any heart problems or if you have any history of heart problems



have a family history of sudden death



have kidney problems (especially if you are on long-term dialysis)



have lung disease and any breathing difficulties



have prolonged sickness or diarrhoea



are taking insulin



are taking potassium-wasting diuretics i.e. water tablets
(e.g. furosemide or bendroflumethiazide)



are taking laxatives



are taking glucocorticoids (a type of steroid hormone)



If you or someone else in your family has a history of blood clots, as
medicines like these have been associated with formation of blood clots



are or have been a heavy drinker (of alcohol).

Reporting of side effects
If you get any of the side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA IMB Pharmacovigilance,
Earlsfort Terrace,
IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.
Website: www.imb.ie www.hpra.ie
E-mail: medsafety@hpra.ie.
By reporting side effects you can help provide more information on the
safety of this medicine.

Other medicines and Xomolix

5. How to store Xomolix

Always tell your doctor or nurse if you are taking or have recently taken any
other medicines including those you have obtained without a prescription,
as a number of medicines cannot be mixed with droperidol.




Do not take Xomolix if you are taking any of the following medicines:





What the medicine is used for

Medicine (s)

Heart Conditions

Quinidine, disopyramide,
procainamide, amiodarone or sotalol

Antibiotics

Erythromycin, clarithromycin,
sparfloxacin

Allergies

Astemizole, terfenadine

Mental illnesses e.g. schizophrenia Chlorpromazine, haloperidol,
etc.
pimozide, thioridazine



Malaria

Chloroquine, halofantrine



Heartburn

Cisapride

Infection

Pentamidine

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton and ampoule after Exp. The expiry date refers to the last day of
that month.
Store in the original package.
The solution should be used immediately on first opening.
Compatibility of droperidol with morphine sulphate in 0.9% sodium
chloride (14 days at room temperature) has been demonstrated in plastic
syringes. From a microbiological point of view, the diluted product
should be used immediately. If not used immediately, in-use storage
times and conditions prior to use are the responsibility of the user and
would normally not be longer than 24 hours at 2 to 8°C, unless dilution
has taken place in controlled and validated aseptic conditions.
Do not use Xomolix if you notice signs of deterioration. The
product should be visually inspected prior to use and only clear solutions
practically free from particles should be used.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

Nausea (feeling sick) or vomiting

Domperidone

6. Contents of the pack and other information

Opiod dependence; pain

Methadone

What Xomolix contains

Metoclopramide and other neuroleptics should be avoided when taking
Xomolix since the risk of movement disorders induced by these medicines
is increased.
Droperidol, the active ingredient in Xomolix, can increase the effects of
sedatives such as barbiturates, benzodiazepines and morphine based
products. It can also increase the effects of medication used to lower high
blood pressure (antihypertensives) and a number of other medicines e.g.
certain antifungals, antivirals, and antibiotics. Some medicines may also
increase the effects of droperidol e.g. cimetidine (for gastric ulcers),
ticlopidine (to prevent blood-clotting) and mibefradil (for angina). If you are
in any doubt please talk to your doctor or nurse.
Xomolix with food and alcohol
Avoid drinking any alcohol for 24 hours before and after being given
Xomolix.
Pregnancy, breast-feeding and fertility
If you are pregnant, inform your doctor who will decide if you should receive
Xomolix.
If you are breast-feeding and are going to take Xomolix then it is
recommended that you receive only one administration of Xomolix.
Breast-feeding can be resumed on waking after your operation.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Droperidol has a major effect on the ability to drive and use machines.
Do not drive or use machinery for at least 24 hours after taking Xomolix.
Xomolix contains sodium




The active substance is droperidol, each millilitre of solution contains
2.5mg droperidol.
The other ingredients are mannitol, tartaric acid, sodium hydroxide,
water for injections.

What Xomolix looks like and contents of the pack
Xomolix is a clear, colourless solution for injection.
The solution is contained in amber coloured glass ampoules. Each
ampoule contains 1 millilitre of solution and packaged in cartons containing
10 ampoules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder

Manufacturer

Kyowa Kirin Limited
Galabank Business Park
Galashiels
TD1 1QH
United Kingdom

Delpharm Tours
rue Paul Langevin
37170 Chambray-les-Tours
France

This medicinal product is authorised in the Member States of the EEA
under the following names:
Xomolix
Austria, Czech Republic, Greece, Spain, Hungary, Ireland, Italy, Poland,
Portugal, Slovenia, Slovak Republic, UK.
Xomolix 2.5 mg/ml Injektionslösung
Germany
Dehydrobenzperidol

This medicinal product contains less than 1 mmol sodium (23 mg) per 1ml,
i.e. essentially ‘sodium-free’.

Belgium, Denmark, Finland

3. How you will be given Xomolix

Iceland and Norway

Xomolix will be given to you by your doctor by an injection into a vein.
The amount of Xomolix and the way in which it is given will depend on the
situation. Your doctor will determine how much Xomolix you need based on
a number of things including your weight, age and medical condition.

Dridol

This leaflet was last revised in May 2016.

The usual adult dosage is 0.625 to 1.25 mg, reduced to 0.625 mg for the
elderly (over 65 years) and those with renal and hepatic impairment. The
dosage in children (2 to 11 years) and adolescents (12 to 18 years) is based
on their body weight (10 to 50 microgram/kg) but up to a maximum of
1.25 mg. Xomolix is not recommended in children below 2 years.
If you have any further questions on the use of this product, please ask your
doctor or nurse.

LFT-DRO-GB-204

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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