Serenace Liquid 2mg/Ml
PACKAGE LEAFLET: INFORMATION FOR THE USER
Serenace Liquid
Haloperidol
2mg/ml
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
• If you get side effects and they become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet
1. What Serenace liquid is and what it is used for
2. Before you use Serenace liquid
3. How to use Serenace liquid
4. Possible side effects
5. How to store Serenace liquid
6. Further information
1. What Serenace liquid is and what it is used for
Serenace Liquid is used to treat schizophrenia and other similar mental disorders such as mania and paranoia as well as violent or dangerous impulsive behaviour. It is also used to treat aggression or overactivity in patients who are mentally ill and are likely to behave dangerously. It is also used to treat Tourette's Syndrome and tics (repeated and largely involuntary movements), restlessness and agitation in the elderly, incurable hiccups, sickness and behavioural disorders in children.
2. Before you use Serenace liquid Do not use Serenace liquid if:
• You are allergic to anything in Serenace liquid (listed in section 6 below)
• You have, or have had, certain types of heart disease which cause your heart to beat with an abnormal rhythm (arrhythmia) or unusually slowly
• You are taking any medicines which affect your heart beat
• Your doctor tells you that the level of potassium in your blood is too low
• You have Parkinson’s disease
• Your doctor tells you that you have a condition that affects part of your brain called the ‘basal ganglia’
• You are breast-feeding
• You are less aware of things around you or your reactions become slower.
Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Serenace liquid.
Take special care with Serenace liquid
If you are elderly, as you may be more sensitive to the effects of Serenace.
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.
Check with your doctor or pharmacist before using Serenace liquid if you have:
• A heart problem or anyone in your close family has died suddenly of heart problems
• Ever had bleeding in the brain, or your doctor has told you that you are more likely than other people to have a stroke
• Lower than normal levels of minerals (electrolytes) in your blood. Your doctor will advise you
• Not been eating properly for a long time
• Liver or kidney problems
• Epilepsy or have ever had fits (convulsions) as you may need more medicine to control them
• Depression
• Problems with your thyroid gland
• A non-cancerous tumour of the adrenal gland (phaeochromocytoma)
You may need to be more closely monitored, and the amount of Serenace liquid you take may have to be altered. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Serenace liquid.
Medical check ups
Your doctor may want to take an electrocardiogram (ECG) before or during your treatment with Serenace liquid. The ECG measures the electrical activity of your heart.
Blood tests
Your doctor may want to check the levels of minerals (electrolytes) in your blood.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.
Special monitoring may be needed if you are taking lithium and Serenace liquid at the same time.
Tell your doctor straight away and stop taking both medicines if you get:
• Fever you can’t explain or movements you can’t control
• Confused, disoriented, a headache, balance problems and feel sleepy. These are signs of a serious condition
Serenace liquid can affect the way the following types of medicine work
Tell your doctor if you are taking medicines for:
• Calming you down or helping you to sleep (tranquillizers)
• Illnesses that affect the way you think, feel or behave (antipsychotics or neuroleptics)
• Pain, such as indomethacin (strong pain killers)
• Changes in your heart beat or are taking medicines that affect your heart beat
• Coughs and colds
• Epilepsy
• Depression, such as ’tricyclic antidepressants’ and 'tetracyclic antidepressants'
• Lowering blood pressure, such as guanethidine and methyldopa
• Severe allergic reactions, such as adrenaline
• Parkinson’s disease, such as levodopa
• Thinning the blood, such as phenindione
Talk to your doctor before taking Serenace liquid if you are taking any of these medicines.
Certain medicines may affect the way that Serenace liquid works
Tell your doctor if you are taking medicines for:
• Depression, such as fluoxetine and paroxetine
• Malaria, such as quinine and mefloquine
• Anxiety, such as buspirone
• Problems with your heart beat, such as quinidine, disopyramide and procainamide, amiodarone, sotalol and dofetilide
• Epilepsy, such as phenobarbital and carbamazepine
• Allergies, such as terfenadine
• Serious infections, such as rifampicin
• Lowering blood pressure, such as water tablets (diuretics)
• Infections such as sparfloxacin, moxifloxacin, erythromycin IV
• A fungal infection, such as ketoconazole
Your doctor may have to change your dose of Serenace liquid.
Taking Serenace liquid with food and alcohol
You can take Serenace liquid with or without food.
Drinking alcohol while you are taking Serenace liquid might make you feel drowsy and less alert. This means you should be careful how much alcohol you drink.
Pregnancy and breast-feeding
Talk to your doctor before using Serenace liquid if you are pregnant, think you may be pregnant or might become pregnant. The following symptoms may occur in newborn babies of mothers that have used Serenace in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.
You may still be able to use Serenace liquid if your doctor thinks you need to.
Do not use this medicine if you are breast-feeding. This is because small amounts may pass into the mother’s milk.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.
Elderly
If you suffer from a disorder with related memory loss, you should talk first to your doctor, who will decide if you can be given Serenace and will explain the possible risks of its use.
Driving and using machines
This medicine may affect you being able to drive. Do not drive or use any tools or machines without discussing this with your doctor first.
Important information about some of the ingredients of Serenace liquid
Serenace liquid contains methyl hydroxybenzoate. This may cause an allergic reaction. This reaction may happen some time after you have taken Serenace liquid.
Available safety data in the paediatric population indicate a risk of extrapyramidal symptoms, including tardive dyskinesia (involuntary, repetitive body movements), and sedation. No long-term safety data are available.
3. How to use Serenace liquid
You must take your liquid as your doctor has told you to. The label will tell you how much to take and how often to take it. The amount of liquid you take is called the 'dose'. The most common adult dose when taken for mental disorders is between 1.5mg and 20mg a day, taken as a single dose or two smaller doses. Your doctor may increase this dose up to 30mg a day in some cases. When your doctor is happy that you are responding to your treatment, he may gradually reduce the dose. This could be as low as 3mg to 10mg a day.
When used to treat tics, the starting dose is usually 2mg a day. Your doctor may increase this dose to between 6mg and 30mg a day in some cases. When your symptoms are controlled your doctor will gradually reduce your dose to around 4mg a day.
When used to cure hiccups, you will most likely take 3mg to 15mg a day split up into smaller doses. When used for sickness you will most likely take 1mg a day.
If you are elderly, your doctor will probably give you half the doses mentioned above.
Children can take Serenace Liquid. Your doctor will work out the dose depending on your child’s weight. The usual dose is 25 to 50 micrograms for each kilogram (kg) of body weight or up to a maximum of 10mg. Teenagers may be given up to 30mg a day in some cases.
If you take more Serenace liquid than you should
If you take more Haldol liquid than you were told to or if someone else has taken any Haldol liquid, talk to a doctor or go to the nearest hospital casualty department straight away.
If you forget to take Serenace liquid
• If you forget to take a dose, take your next dose as usual. Then keep taking your medicine as your doctor has told you
• Do not take a double dose
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Serenace liquid can cause side effects, although not everybody gets them.
Tell your doctor or nurse straight away if you notice or suspect any of the following. You may need
urgent medical treatment.
• 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.
• Sudden swelling of the face or throat. Hives (also known as nettle rash or urticaria), severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction. This only happens in a small number of people
• A serious problem called ‘neuroleptic malignant syndrome’. The signs may include:
• Fast heart beat, changing blood pressure and sweating followed by fever
• Faster breathing, muscle stiffness, reduced consciousness and coma
• Raised levels of a protein in your blood (an enzyme called creatine phosphokinase)
This can occur in fewer than 1 in 1,000 people
• Your heart may beat abnormally (arrhythmia). An arrhythmia can cause your heart to stop beating (cardiac arrest). In elderly people with dementia, a small increase in the number of deaths have been reported for patients taking neuroleptics compared with those not receiving neuroleptics. The precise frequency of how often this occurs is not known.
and feeling face, mouth, be given an
• Jerky movements and problems such as slowness, muscle stiffness, trembling restless. More saliva than normal, twitching or unusual movements of the tongue, jaw or throat, or rolling of the eyes. If you get any of these effects, you may additional medicine.
Tell your doctor or nurse if you notice or suspect any of the following side effects:
• Feeling agitated or having difficulty sleeping
• Headache
These can affect more than 1 in 10 people
• Trembling, rigid posture, mask-like face, slow movements and a shuffling, unbalanced walk
• Feeling restless, low or depressed or sleepy
• Feeling light headed or dizzy, particularly when standing up
• Symptoms of psychosis such as abnormal thoughts or visions, or hearing abnormal sounds
• Problems with sight including blurred vision and rapid eye movements
These can occur in fewer than 1 in 10 people
• Liver problems including yellowing of the skin and eyes, pale stools and dark coloured urine
• Feeling confused
• A fall in the number of white blood cells which can cause frequent infections
• Fits or seizures (convulsions)
• Difficulty breathing or wheezing
• Hormone changes which may lead to:
• Changes in weight
• Difficulties with sex such as erection problems
• Some men experiencing swelling of their breast or painful and prolonged erection
• Some people losing interest in sex
• Some women having irregular, painful or heavy periods or no monthly period
Some women unexpectedly producing breast milk, having painful breasts
These can occur in fewer than 1 in 100 people
• Being unable to open mouth
This can occur in fewer than 1 in 1000 people
• Bleeding or bruising more easily than normal. This can be caused by a fall in the number of small blood cells called platelets
• Fluid retention affecting the brain, resulting in weakness, tiredness or confusion The precise frequency of how often these occur is not known
Other side effects
Common side effects (affects fewer than 1 in 10 people)
• Rash
• Slow movements
• Dry mouth
• Feeling
• Constipation
• Difficulty passing water (urine)
Uncommon side effects (affects fewer than 1 in 100 people)
• Sensitivity of skin to sunlight
• Sweating more than usual
• Fever
• Swelling of the ankles
The following side effects have been reported, however the precise frequency cannot be identified and therefore how often they occur is classed as unknown:
• Flaking or peeling of the skin
• Inflamed skin (red, hot to the touch and tender)
• Low body temperature
• In newborn babies, of mothers that have used Serenace in the last trimester (last three months of pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.
Test results:
• Abnormal test results for liver function
• Low blood sugar levels (hypoglycaemia)
• Abnormal heart traces (electrocardiogram, ‘ECG’)
Reporting of side effects
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
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Serenace liquid
Keep your liquid in a safe place where children cannot see or reach them.
You should keep your liquid between 15°C and 25°C. Protect from light.
Keep it in the bottle it came in. Do not put it into another container.
Do not take the liquid after the 'use by' date.
You should take any liquid that is out of date or which you no longer need back to your pharmacist.
This liquid is only for you. Only a doctor can prescribe it for you. Never give it to anyone else.
This information refers only to Norton Healthcare Ltd Serenace Liquid 2mg/ml.
6. Further information
What Serence contains:
Each 1ml of liquid contains:
• Haloperidol BP 2 milligrams (mg) (active ingredient); and
• propylene glycol, methyl hydroxybenzoate, propyl hydroxybenzoate, lactic acid and purified water (inactive ingredients).
What Serenace looks like and contents of the pack:
Serenace Liquid is clear and colourless and comes in Amber glass bottles containing 100ml or 500ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is Norton Healthcare Ltd, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX.
Company responsible for manufacture: Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE.
This leaflet was last revised: July 2014
PL 00530/0374