Valoid 50 mg/ml Injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor 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/ml Injection. It will be referred to as Valoid Injection for ease hereafter.

1. What Valoid Injection is and what it is used for
2. What you need to know before you are given Valoid Injection
3. How Valoid Injection will be given to you
4. Possible side effects
5. How to store Valoid Injection
6. Contents of the pack and other information

• if you are allergic to cyclizine lactate or any of the other ingredients of this medicine (listed in section 6)
• if you have allergic reactions which 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
• if you have been drinking alcohol. The anti-vomiting properties of Valoid Injection may increase the toxicity of alcohol.

Talk to your doctor or nurse before you are given Valoid 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 (tumour of the medulla of the adrenal glands)
• suffer from high blood pressure
• have epilepsy
• are a man and you suffer from an enlarged prostate gland (difficulty or slowness passing urine)
• have been told your heart is not working properly (heart failure)
• suffer from an inherited disorder which can lead to a sensitivity to sunlight (porphyria)
• suffer from low blood pressure.

Tell your doctor if you are taking any other medicines especially the following:

• medicines for problems such as depression, anxiety or difficulty in sleeping
• strong painkillers such as pethidine
• any medicine which belong to a group of medicines called anticholinergics.

Please tell your doctor if you are taking or have recently taken any other medicines including those you have obtained without a prescription.

Alcohol should be avoided when you are being treated with Valoid Injection.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.

You can drive while being treated with Valoid Injection but do not drive until you know how it affects you. It may make you feel dizzy. If it affects you in this way, do not drive or operate any machinery.

As this medicine is given to you by a doctor, it is very unlikely that an overdose will happen. Should an overdose occur, the doctor will treat any symptoms that follow. Symptoms of overdose include dry mouth, nose and throat, blurred vision, fast or irregular heartbeat, difficulty passing urine, drowsiness, dizziness, lack of balance and coordination, weakness, excitability, disorientation, impaired judgement, hallucinations, muscle spasm, involuntary movements, convulsions, high temperature and difficulty breathing.

• itching or skin rashes
• swelling of the face, lips or throat
• difficulty in breathing or wheeziness.

Tell your doctor immediately. These may be signs of an allergic reaction.

The following side effects are reported for either compound with a not known frequency (frequency cannot be estimated from the available data)

Side effects may include

• skin rashes or itching
• muscle twitches, spasms or tremors
• restlessness
• decrease in muscle tone that can cause irregular body movements
• unusual body movements, particularly of your hands, arms or legs
• lack of coordination
• blurred vision or involuntary rolling of the eyes
• paralysis especially in patient who are already suffering from disorder of nerves and muscles
• convulsions, seizures
• nervousness
• seeing or hearing things that are not really there (hallucinations)
• ringing in the ears
• euphoria
• headache
• fast heartbeat, irregular heartbeat
• drowsiness or general feelings of weakness/tiredness
• a dry mouth, nose or throat
• heartburn (reflux)
• stomach pain
• nausea
• vomiting
• diarrhoea
• loss of appetite
• difficulty in passing water
• constipation
• difficulty in sleeping
• being confused, disorientated or unaware
• dizziness
• decreased consciousness/loss of consciousness
• temporary difficulty in speaking
• high blood pressure
• low blood pressure
• pins and needles
• yellowing of the skin and the whites of your eyes (jaundice)
• a red or brownish patch which appears at the same spot each time you take the medicine
• inflammation of the liver (hepatitis) or problems with the liver
• injection site reactions such as redness, pain, swelling or blistering
• sensations of heaviness, flushing, feeling cold or agitated or experiencing a decrease in blood pressure
• reduced rate of breathing (apnoea)
• reduction in the production of a type of white blood cell making infection more likely (agranulocytosis)
• unpleasant sensation or an overwhelming urge to move the legs (also called Restless Legs Syndrome).

If you feel very tired, experience unexpected bruising or bleeding or more infections (e.g. colds and sore throats) than usual please tell your doctor. Your doctor may decide to conduct tests on your blood periodically as a result of these symptoms.

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

You can also report side effects directly via the Yellow Card Scheme, at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By Reporting side effects, you can help provide more information on the safety of this medicine.

Valoid injection comes as a 1 ml ampoule containing 50 mg of the active ingredient, cyclizine lactate, dissolved in sterile water.

The injection also contains the inactive ingredient, lactic acid.

Valoid Injection is a clear, colourless solution. Each pack contains 5 ampoules.

Alternative Manufacturer

Valoid is a registered trademark of Amdipharm Mercury International Limited.