Haldol Decanoate 50mg/Ml
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Haldol® Decanoate 50 mg/ml mce.15™ (haloperidol decanoate) PATIENT INFORMATION LEAFLET 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 nurse - 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 nurse The name of your medicine is Haldol Decanoate 50mg/ml but will be |
Certain medicines may affect the way that Haldol decanoate 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 Haldol decanoate. |
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referred to as Haldol decanoate throughout this leaflet. It is also available in the 100mg/ml strength. In this leaflet |
Haldol decanoate and alcohol Drinking alcohol while you are using Haldol decanoate might make you feel drowsy and less alert. This means you should be careful how much alcohol you drink. |
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1. What Haldol decanoate is and what it is used for 2. Before you are given Haldol decanoate 3. How Haldol decanoate is used 4. Possible side effects 5. How Haldol decanoate is stored 6. Further information 1. WHAT HALDOL DECANOATE IS AND WHAT IT IS USED FOR The name of your medicine is Haldol decanoate. |
Pregnancy and breast-feeding Talk to your doctor before being given Haldol decanoate 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 Haldol decanoate 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. |
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Haldol decanoate contains a medicine called haloperidol decanoate. This belongs to a group of medicines called ‘neuroleptics'. |
You may still be able to use Haldol decanoate if your doctor thinks you need to. |
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Haldol decanoate is used for illnesses affecting the way you think, feel or behave. These illnesses may make you: |
Ask your doctor for advice before you breast-feed. This is because small amounts of the medicine may pass into the mother's milk. |
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- Feel confused - See, hear or feel things that are not there (hallucinations) - Believe things that are not true (delusions) |
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding. |
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- Feel unusually suspicious (paranoia) - Feel very excited, agitated, enthusiastic or hyperactive - Feel very aggressive or violent 2. BEFORE YOU ARE GIVEN HALDOL DECANOATE |
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 Haldol decanoate and will explain the possible risks of its use. |
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Do not use Haldol decanoate if: - You are allergic to sesame oil. Haldol decanoate contains sesame oil. See ‘Important information about some of the ingredients of Haldol decanoate' below |
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. |
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- You are allergic to any of the other ingredients of Haldol decanoate (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 certain drugs which affect the rhythm of your heart beat |
Important information about some of the ingredients of Haldol decanoate Haldol decanoate contains sesame oil. This may rarely cause severe allergic reactions. See ‘Do not use Haldol decanoate if above. |
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- You have a low level of potassium in your blood - Your doctor tells you that you have a condition that affects part of your brain called the 'basal ganglia' - You have Parkinson's disease |
3. HOW HALDOL DECANOATE IS USED Your doctor or nurse will inject Haldol decanoate deep into a muscle. A single dose will normally last for one month. |
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- 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 nurse before being given Haldol decanoate. Take special care with Haldol decanoate If you are elderly, as you may be more sensitive to the effects of Haldol decanoate |
How much medicine will you be given Your doctor will decide how much Haldol decanoate you need and for how long. Your doctor will adjust the dose to suit you. Your dose will depend on: - Your age - How serious your symptoms are - Whether you have other medical problems - How you have reacted to similar medicines in the past |
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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 before being given Haldol decanoate 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 |
Adults - Your starting dose will normally be 50 mg every 4 weeks - Your doctor may increase the dose by 50 mg every 4 weeks - The dose may be increased to 300 mg every 4 weeks. In some cases higher doses might be needed The dose will be halved if your doctor thinks you should have the medicine every 2 weeks. |
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- Lower than normal levels of minerals (electrolytes) in your blood. Your doctor will advise you - Not been eating properly for a long time |
Children - Haldol decanoate should not be used in children |
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- Liver or kidney problems - Epilepsy or any other problem that can cause fits (convulsions) as you may need more medicine to control them. - Depression |
Elderly people - Elderly people are normally started on a lower dose - The dose is usually 12.5 mg to 25 mg every 4 weeks |
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- 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 Haldol |
Stopping Haldol decanoate The medicine should be used for as long as your doctor has told you. It may be some time before you feel the full effect of the medicine. |
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decanoate you are given may have to be altered. If you are not sure if any of the above apply to you, talk to your doctor or nurse before you are given Haldol decanoate. Medical check ups Your doctor may want to take an electrocardiogram (ECG) before or during |
Unless your doctor decides otherwise, Haldol decanoate will be stopped gradually. Stopping treatment suddenly may cause effects such as: - Feeling sick (nausea) or being sick (vomiting) - Difficulty sleeping Always follow your doctor's instructions carefully. |
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your treatment with Haldol decanoate. The ECG measures the electrical activity of your heart. Blood tests Your doctor may want to check the levels of minerals (electrolytes) in your |
If you miss a dose or have too much Haldol decanoate A doctor or nurse will give this medicine to you, so it is unlikely that you will miss a dose or be given too much. If you are worried, tell the doctor or nurse. |
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blood. Taking other medicines |
If you have any further questions on the use of this product, ask your doctor or nurse. |
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Please tell your doctor or nurse if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines. |
4. POSSIBLE SIDE EFFECTS Like all medicines, Haldol decanoate can cause side effects, although not everybody gets them. |
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Special monitoring may be needed if you are taking lithium and Haldol decanoate at the same time. Tell your doctor or nurse straight away and stop taking both medicines if you get: - Confused, disoriented, a headache, balance problems and feel sleepy. These are signs of a serious condition Haldol decanoate 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 (tranquillisers) - Illnesses that affect the way you think, feel or behave (antipsychotics or neuroleptics) - Pain (strong pain killers) - Coughs and colds - 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 or nurse before being given Haldol decanoate if you are taking any of these medicines. |
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 1000 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
- Jerky movements and problems such as slowness, muscle stiffness, trembling and feeling restless. More saliva than normal, twitching or unusual movements of the tongue, face, mouth, jaw or throat, or rolling of the eyes. If you get any of these effects, you may be given an 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 sick, being sick
- Constipation
- Difficulty passing water (urine)
- Reactions at the site of injection
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
- Abscess at the site of injection
In newborn babies of mothers that have used Haldol decanoate 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 HALDOL DECANOATE IS STORED
Keep of the sight and reach of children
Do not store above 25oC. Do not refrigerate or freeze.
Keep ampoule in outer carton. Protect from light.
Haldol decanoate should not be used after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
If stored for long periods in the cold, solid particles may form in Haldol decanoate. These may disappear when stored at room temperature. If these particles do not disappear, the ampoule should be thrown away.
6. FURTHER INFORMATION
The active substance in Haldol decanoate is haloperidol decanoate.
Each ml contains haloperidol decanoate 70.52mg equivalent to 50mg haloperidol.
The other ingredients are benzyl alcohol and sesame oil.
What Haldol decanoate looks like and contents of the pack
Haldol decanoate is a solution for injection. It is supplied in amber glass ampoules containing straw-coloured viscous solution. Each ampoule contains 1ml of solution. The ampoules are supplied in packs of 1 or 5.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Haldol Decanoate is manufactured by Janssen Pharmaceutica NV., Turnhoutseweg 30, B2340, Beerse, Belgium and is procured from within the EU by Product Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
| POM | | PL 20636/1524 ~
Leaflet revision and issue date (Ref) 10.08.15[10]
Haldol is a trademark of Janssen-Cilag Ltd