Patient leaflet - Haloperidol Depot 50 mg/ml solution for injection
1. WHAT HALOPERIDOL DEPOT IS AND WHAT IT IS USED FOR
The name of your medicine is Haloperidol Depot. Haloperidol Depot contains the active substance haloperidol (as haloperidol decanoate). This belongs to a group of medicines called ‘antipsychotics’.
Haloperidol Depot is used in adults whose condition has previously been treated with haloperidol taken by mouth. It is used for illnesses affecting the way you think, feel or behave. These include mental health problems (such as schizophrenia). These illnesses may make you:
- Feel confused (delirium)
- See, hear, feel or smell things that are not there (hallucinations)
- Believe things that are not true (delusions)
- Feel unusually suspicious (paranoia)
Feel very excited, agitated, enthusiastic, impulsive
or hyperactive
- Feel very aggressive, hostile or violent.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HALOPERIDOL DEPOT
Do not use Haloperidol Depot if:
You are allergic to haloperidol or any of the other
ingredients of this medicine (listed in section 6)
You are allergic to sesame oil. Haloperidol Depot
contains sesame oil. See ‘Haloperidol Depot contains’ below
You are less aware of things around you or your
reactions become unusually slow
- You have Parkinson’s disease
- You have a type of dementia called ‘Lewy body dementia’
- You have progressive supranuclear palsy (PSP)
You have a heart condition called ‘prolonged QT
interval’, or any other problem with your heart rhythm that shows as an abnormal tracing on an ECG (electrocardiogram)
- You have heart failure or recently had a heart attack
You have a low level of potassium in your blood,
which has not been treated
You take any of the medicines listed under ‘Other
medicines and Haloperidol Depot – Do not use Haloperidol Depot if you are taking certain medicines for’.
This medicine must not be used if any of the above applies to you. If you are not sure, talk to your doctor, pharmacist or nurse before being given Haloperidol Depot.
Warnings and precautions
Serious side effects
Haloperidol Depot can cause problems with the heart, problems controlling body or limb movements and a serious side effect called ‘neuroleptic malignant syndrome’. It can also cause severe allergic reactions and blood clots. You must be aware of serious side effects while you are using Haloperidol Depot because you may need urgent medical treatment. See ‘Look out for serious side effects’ in section 4.
Elderly people and people with dementia
A small increase in deaths and strokes has been reported for elderly people with dementia who are taking antipsychotic medicines. Talk to your doctor before being given Haloperidol Depot if you are elderly, particularly if you have dementia.
Talk to your doctor if you have:
A slow heart beat, heart disease or anyone in your
close family has died suddenly of heart problems
Low blood pressure, or feel dizzy upon sitting up or
standing up
A low level of potassium or magnesium (or other
‘electrolyte’) in your blood. Your doctor will decide how to treat this
Ever had bleeding in the brain, or your doctor has
told you that you are more likely than other people to have a stroke
- Epilepsy or have ever had fits (convulsions)
- Problems with your kidneys, liver or thyroid gland
A high level of the hormone ‘prolactin’ in your
blood, or cancer that may be caused by high prolactin levels (such as breast cancer)
A history of blood clots, or someone else in your
family has a history of blood clots
- Depression.
You may need to be more closely monitored, and the amount of Haloperidol Depot you are given may have to be altered.
If you are not sure if any of the above applies to you, talk to your doctor or nurse before you are given Haloperidol Depot.
Medical check ups
Your doctor may want to take an electrocardiogram (ECG) before or during your treatment with Haloperidol Depot. The ECG measures the electrical activity of your heart.
Blood tests
Your doctor may want to check the levels of potassium or magnesium (or other ‘electrolyte’) in your blood before or during your treatment with Haloperidol Depot.
Children and adolescents
Haloperidol Depot should not be used in children and adolescents below 18 years. This is because it has not been studied in these age groups.
Other medicines and Haloperidol Depot
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Do not use Haloperidol Depot if you are taking certain medicines for:
- Problems with your heart beat (such as amiodarone, dofetilide, disopyramide, dronedarone, ibutilide, quinidine and sotalol)
- Depression (such as citalopram and escitalopram)
- Psychoses (such as fluphenazine, levomepromazine, perphenazine, pimozide, prochlorperazine, promazine, sertindole, thiorizadine, trifluoperazine, triflupromazine and ziprasidone)
- Bacterial infections (such as azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin and telithromycin)
- Fungal infections (such as pentamidine)
- Malaria (such as halofantrine)
- Nausea and vomiting (such as dolasetron)
- Cancer (such as toremifene and vandetanib). Also tell your doctor if you are taking bepridil (for chest pain or to lower blood pressure) or methadone (a pain killer or to treat drug addiction).
These medicines may make heart problems more likely, so talk to your doctor if you are taking any of these and do not use Haloperidol Depot (see ‘Do not use Haloperidol Depot if’).
Special monitoring may be needed if you are using lithium and Haloperidol Depot 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.
Certain medicines may affect the way that Haloperidol Depot works or may make heart problems more likely
Tell your doctor if you are taking:
- Alprazolam or buspirone (for anxiety)
- Duloxetine, fluoxetine, fluvoxamine, nefazodone, paroxetine, sertraline, St John’s Wort (Hypericum perforatum) or venlafaxine (for depression)
- Bupropion (for depression or to help you stop smoking)
- Carbamazepine, phenobarbital or phenytoin (for epilepsy)
- Rifampicin (for bacterial infections)
- Itraconazole, posaconazole or voriconazole (for fungal infections)
- Ketoconazole tablets (to treat Cushing’s syndrome)
- Indinavir, ritonavir or saquinavir (for human immunodeficiency virus or HIV)
- Chlorpromazine or promethazine (for nausea and vomiting)
- Verapamil (for blood pressure or heart problems). Also tell your doctor if you are taking any other medicines to lower blood pressure, such as water tablets (diuretics).
Your doctor may have to change your dose of Haloperidol Depot if you are taking any of these medicines.
Haloperidol Depot 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)
- Pain (strong pain killers)
- Depression (‘tricyclic antidepressants’)
- Lowering blood pressure (such as guanethidine and methyldopa)
- Severe allergic reactions (adrenaline)
- Attention deficit hyperactivity disorder (ADHD) or narcolepsy (known as ‘stimulants’)
- Parkinson’s disease (such as levodopa)
- Thinning the blood (phenindione).
Talk to your doctor or nurse before being given Haloperidol Depot if you are taking any of these medicines.
Haloperidol Depot and alcohol
Drinking alcohol while you are using Haloperidol Depot might make you feel sleepy and less alert. This means you should be careful how much alcohol you drink. Talk to your doctor about drinking alcohol while using Haloperidol Depot, and let your doctor know how much you drink.
Pregnancy, breast-feeding and fertility Pregnancy – if you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice. Your doctor may advise you not to use Haloperidol Depot while you are pregnant.
The following problems may occur in newborn babies of mothers that use Haloperidol Depot in the last 3 months of their pregnancy (the last trimester):
- Muscle tremors, stiff or weak muscles
- Being sleepy or agitated
- Problems breathing or feeding.
The exact frequency of these problems is unknown. If you used Haloperidol Depot while pregnant and your baby develops any of these side effects, contact your doctor.
Breast-feeding – talk to your doctor if you are breast‑feeding or planning to breast‑feed. This is because small amounts of the medicine may pass into the mother’s milk and on to the baby. Your doctor will discuss the risks and benefits of breast‑feeding while you are using Haloperidol Depot.
Fertility – Haloperidol Depot may increase your levels of a hormone called ‘prolactin’, which may affect fertility in men and women. Talk to your doctor if you have any questions about this.
Driving and using machines
Haloperidol Depot can affect your ability to drive and use tools or machines. Side effects, such as feeling sleepy, may affect your alertness, particularly when you first start using it or after a high dose. Do not drive or use any tools or machines without discussing this with your doctor first.
Haloperidol Depot contains benzyl alcohol and sesame oil
This medicine contains 12 mg of benzyl alcohol in each ml of the solution. Benzyl alcohol may cause allergic reactions. Ask your doctor or pharmacist for advice if you have liver or kidney disease, or if you are pregnant or breast‑feeding. This is because large amounts of benzyl alcohol can build‑up in your body and may cause side effects (called ‘metabolic acidosis’).
This medicine also contains sesame oil, which may rarely cause severe allergic reactions.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Haloperidol Depot 50 mg/ml Haloperidol Depot 100 mg/ml
solution for injection
3. HOW TO USE HALOPERIDOL DEPOT How much medicine will you be given
Your doctor will decide how much Haloperidol Depot you need and for how long. Your doctor will adjust the dose to suit you, and may also give you a type of haloperidol that you take by mouth. Your dose of haloperidol decanoate will depend on:
- Your age
- Whether you have problems with your kidneys or liver
- How you have reacted to haloperidol in the past
- Other medicines you are taking.
Adults
Your starting dose will normally be between 25 mg
and 150 mg.
Your doctor may adjust the dose by up to 50 mg
every 4 weeks to find the dose that suits you best (normally between 50 mg and 200 mg every 4 weeks).
- You will not be given more than 300 mg every 4 weeks.
Elderly people
Elderly people will normally start on a lower dose,
usually 12.5 mg to 25 mg every 4 weeks.
The dose may be adjusted until the doctor finds the
dose that suits you best (normally between 25 mg and 75 mg every 4 weeks).
You will only be given a higher dose than 75 mg
every 4 weeks if your doctor decides it is safe to do so.
How Haloperidol Depot is given
Haloperidol Depot will be given by a doctor or nurse. It is for intramuscular use, and is given as an injection deep into a muscle. A single dose of Haloperidol Depot will normally last for 4 weeks. Haloperidol Depot must not be injected into a vein.
If you have too much Haloperidol Depot
A doctor or nurse will give this medicine to you, so it is unlikely that you will be given too much. If you are worried, tell the doctor or nurse.
If you miss a dose or stop using Haloperidol Depot
You should not stop this medicine unless told to do so by your doctor as your symptoms may return. If you miss an appointment, contact your doctor right away to make a new appointment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Look out for serious side effects
Tell your doctor or nurse straight away if you notice or suspect any of the following. You may need urgent medical treatment.
Problems with the heart:
Abnormal heart rhythm – this stops the heart
working normally and may cause loss of consciousness
- Abnormally fast heart beat
- Extra heart beats.
Heart problems are uncommon in people using Haloperidol Depot (may affect up to 1 in 100 people). Sudden deaths have occurred in patients using this medicine, but the exact frequency of these deaths is unknown. Cardiac arrest (the heart stops beating) has also occurred in people taking antipsychotic medicines.
A serious problem called ‘neuroleptic malignant syndrome’.
This causes a high fever, severe muscle stiffness, confusion and loss of consciousness. The exact frequency of this side effect in people using Haloperidol Depot is unknown.
Problems controlling movements of the body or limbs (extrapyramidal disorder), such as:
Movements of the mouth, tongue, jaw and
sometimes limbs (tardive dyskinesia)
Feeling restless or difficulty sitting still, increased
body movements
Slow or reduced body movements, jerking or
twisting movements
- Muscle tremors or stiffness, a shuffling walk
- Being unable to move
Lack of normal facial expression that sometimes
looks like a mask.
These are very common in people using Haloperidol Depot (may affect more than 1 in 10 people). If you get any of these effects, you may be given an additional medicine.
Severe allergic reaction that may include:
- A swollen face, lips, mouth, tongue or throat
- Difficulty swallowing or breathing
- Itchy rash (hives).
The exact frequency of an allergic reaction in people using Haloperidol Depot is unknown.
Blood clots in the veins, usually in the legs (deep vein thrombosis or DVT). These have been reported in people taking antipsychotic medicines. The signs of a DVT in the leg include swelling, pain and redness in the leg, but the clot may move to the lungs causing chest pain and difficulty in breathing. Blood clots can be very serious, so tell your doctor straight away if you notice any of these problems.
Tell your doctor straight away if you notice any of the serious side effects above.
Other side effects
Tell your doctor if you notice or suspect any of the following side effects.
Common (may affect up to 1 in 10 people):
- Depression
- Difficulty sleeping or feeling sleepy
- Constipation
- Dry mouth or increased saliva
- Problems having sex
Irritation, pain or collection of pus (abscess) where
the injection is given
- Weight gain.
Uncommon (may affect up to 1 in 100 people):
- Abnormal muscle tension
- Headache
Upward movement of the eyes or fast eye
movements that you cannot control
- Problems with vision, such as blurred vision.
The following side effects have also been reported, but their exact frequency is unknown:
Serious mental health problem, such as believing
things that are not true (delusions) or seeing, feeling, hearing or smelling things that are not there (hallucinations)
- Feeling agitated or confused
Fits (seizures)
- Feeling dizzy, including upon sitting up or standing up
- Low blood pressure
Problems that could cause difficulty breathing, such as:
‑ Swelling around the voice box, or brief spasm of the vocal cords that affects speaking ‑ Narrowed airways in the lungs
‑ Being short of breath
- Nausea, vomiting
Changes in the blood, such as:
‑ Effects on blood cells – low number of all types of blood cells, including severe decreases in white blood cells and low number of ‘platelets’ (cells that help blood to clot)
‑ High level of certain hormones in the blood – ‘prolactin’ and ‘antidiuretic hormone’ (syndrome of inappropriate antidiuretic hormone secretion)
‑ Low level of sugar in the blood
Changes that show up in blood tests of the liver and other liver problems, such as:
‑ Yellowing of the skin or whites of the eyes (jaundice)
‑ Inflamed liver
‑ Sudden liver failure
- Decreased bile flow in the bile duct
Skin problems, such as:
‑ Rash or itching
‑ Increased sensitivity to sunlight
‑ Flaking or peeling skin
‑ Inflamed small blood vessels, leading to a skin rash with small red or purple bumps
- Excessive sweating
- Breakdown of muscle tissue (rhabdomyolysis)
- Muscle spasms, twitching or contractions that you cannot control, including a spasm in the neck causing the head to twist to one side
- Difficulty or being unable to open the mouth
- Stiff muscles and joints
- Being unable to pass urine or empty the bladder completely
- Persistent and painful erection of the penis
- Difficulty getting and keeping an erection (impotence)
- Loss of sex drive or decreased sex drive
- Changes in menstrual cycle (periods), such as no periods, or long, heavy, painful periods
Breast problems, such as:
‑ Pain or discomfort
‑ Unexpected production of breast milk ‑ Enlarged breasts in men
- Swelling caused by fluid build up in the body
- High or low body temperature
- Problems walking
- Weight loss.
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, Website: 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.
5. HOW TO STORE HALOPERIDOL DEPOT
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 vial label and carton box after EXP. The expiry date refers to the last day of that month. Keep vial in the outer carton to protect from light. The product should be used immediately after opening.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Haloperidol Depot contains
- The active substance is haloperidol decanoate.
- The other excipient(s) are: benzyl alcohol and sesame oil.
What Haloperidol Depot looks like and contents of the pack
50 mg/ml solution:
Clear pale yellow to yellow, viscous solution in a glass vial
Each ml of solution contains 70.52 mg of haloperidol decanoate, equivalent to 50 mg of haloperidol base. 1 ml vial: packs of 10 vials.
3 ml vial: packs of 1 vial.
100 mg/ml solution:
Clear pale yellow to peach, viscous solution in a glass vial.
Each ml of solution contains 141.04 mg of haloperidol decanoate, equivalent to 100 mg of haloperidol base. 1 ml vial: packs of 1 vial.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, 8, 8A e B – Fervença 2705‑906 Terrugem SNT
Portugal