50 and 100 mg/ml injection solution
haloperidol

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects , talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about:
1. What Haldol Depot is and what it is used for
2. What you need to know before you get Haldol Depot
3. How to use Haldol Depot
4. Possible side effects
5. How to store Haldol Depot
6. Contents of the packaging and other information

1. What Haldol Depot is and what it is used for

The name of your medicine is Haldol Depot.

Haldol Depot contains the active substance haloperidol (in the form of haloperidol decanoate). It belongs to a group of drugs called “antipsychotic drugs”.

Haldol Depot is used in adults who have previously had their disease treated with haloperidol taken by mouth. It is used for diseases that affect how one thinks, feels, and behaves. These include mental health problems (such as schizophrenia). These diseases can cause you to:

  • feel confused ( delirium )
  • see, hear, feel, or smell the smell of things that do not exist (hallucinations)
  • believe things that are not true (delusions)
  • feel unusually suspicious ( paranoia )
  • feel very playful, excited, enthusiastic, impulsive or hyperactive
  • feel very aggressive, threatening or violent.

Haloperidol contained in Haldol Depot may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you get Haldol Depot

Do not use Haldol Depot

  • if you are allergic to haloperidol or any of the other ingredients of this medicine (listed in section 6)
  • if you are less aware of things around you and your reactions become unusually slow
  • if you have Parkinson’s disease
  • if you have a type of dementia called “Lewy body dementia”
  • if you have a condition called progressive supranuclear palsy (PSP)
  • if you have a heart condition called a “prolonged QT interval” or any other problem with your heart rhythm that can be seen as an abnormal curve on an ECG ( electrocardiogram )
  • if you have heart failure or have recently had a heart attack
  • if you have a low level of potassium in your blood and this has not yet been treated.
  • if you are taking any of the medicines mentioned under “Other medicines and Haldol Depot – Do not use Haldol Depot if you are taking medicines”.

This medicine should not be used in any of the above apply to you. If you have any further questions, ask your doctor, pharmacist, or nurse before taking Haldol Depot.

Warnings and cautions

Serious side effects are

Haldol Depot can cause problems with the heart, problems with control of body movements or movements in the arms and legs, and a serious side effect called “malignant neuroleptic syndrome”. It can also cause severe allergic reactions and blood clots. You must be aware that serious side effects can occur when you take Haldol Depot, as you may need immediate medical attention. See “Beware of serious side effects” in section 4.

Elderly people and people with dementia

A small increase in deaths and strokes has been reported in elderly people with dementia taking antipsychotic drugs. Talk to your doctor before receiving Haldol Depot if you are older, especially if you have dementia.

Talk to your doctor if you have:

  • slow heartbeat, heart disease or if someone in your immediate family has died suddenly due to heart problems.
  • low blood pressure or feeling dizzy when you sit up or stand up.
  • a low level of potassium or magnesium (or other “electrolyte”) in your blood. Your doctor will decide how to treat this.
  • Have you ever had a cerebral haemorrhage or if your doctor has told you that you have a higher risk of having a stroke than other people.
  • epilepsy or if you have had seizures (seizures).
  • problems with the kidneys, liver or thyroid gland.
  • a high level of the hormone a prolactin in the blood or cancer that may have arisen due to high prolactin levels (such as breast cancer).
  • had blood clots, or if someone else in your family has had blood clots.
  • Depression.

You may need to go through thorough checks and the amount of Haldol Depot you receive may need to be changed.

If you are not sure if any of the above applies to you, talk to your doctor or nurse before taking Haldol Depot.

Medicinal studies

Your doctor may perform an electrocardiogram ( ECG ) before or during your treatment with Haldol Depot. ECG measures the electrical activity of your heart.

Blood tests

Your doctor may check your potassium or magnesium (or other “electrolyte”) levels in your blood before and during your treatment with Haldol Depot.

Children and young people

Haldol Depot should not be used in children and adolescents under 18 years of age. This is because it has not been studied in these age groups.

Other medicines and Haldol Depot

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

Do not use Haldol Depot if you are taking medicines for:

  • problems with your heart rhythm (eg amiodarone , dofetilide, disopyramide , dronedarone, ibutilide, quinidine and sotalol)
  • depression (eg citalopram and escitalopram)
  • psychosis (eg flufenazine, levomepromazine, perfenazine, pimozide, proclorperazine, promazine, sertindole, thiorizadine, trifluoperazine, triflupromazine and ziprasidone)
  • bacterial infections (eg azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin and telithromycin)
  • fungal infections (eg pentamidine)
  • malaria (eg halofantrine)
  • nausea and vomiting (eg dolasetron)
  • cancer (eg toremifene and vandetanib).

Tell your doctor if you are taking bepridil (for chest pain or to lower your blood pressure ) or methadone (for painkillers or to treat drug addiction).

These medicines may increase the risk of heart problems, so talk to your doctor if you are taking any of these and do not use Haldol Depot (see ‘Do not use Haldol Depot’).

Special care may be required if you use lithium and Haldol Depot at the same time. Tell your doctor immediately and stop taking both medicines if you suffer from:

  • fever you can not explain or movements you can not control
  • confusion, disorientation, headaches, balance problems and feeling sleepy.

These are signs of a serious illness.

Some medicines may affect the way Haldol Depot works or increase the risk of heart problems.

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 quit smoking)
  • carbamazepine, phenobarbital or phenytoin (for epilepsy )
  • rifampicin (against bacterial infections)
  • itraconazole, posaconazole or voriconazole (for fungal infections)
  • ketoconazole tablets (for the treatment of Cushing’s syndrome)
  • indinavir, ritonavir or saquinavir (against 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 your blood pressure, such as diuretics ( diuretics ).

Your doctor may need to change your dose of Haldol Depot if you are taking any of these medicines.

Haldol Depot may affect the way the following medicines work

Tell your doctor if you are taking the following medicines:

  • sedatives, or medications that help you sleep
  • strong painkillers
  • antidepressants (“tricyclic antidepressants”)
  • antihypertensive drugs (eg guanetidine and methyldopa)
  • drugs for severe allergic reactions ( adrenaline )
  • drugs for ADHD (Attention deficit hyperactivity disorder) or narcolepsy (known as “stimulants”)
  • medicines used to treat Parkinson’s disease (eg levodopa )
  • blood thinners (phenindione).

Talk to your doctor or nurse before receiving Haldol Depot if you are taking any of these medicines.

Haldol Depot and alcohol

If you drink alcohol while using Haldol Depot, you may feel sleepy and less alert. This means that you should be careful about how much alcohol you drink. Talk to your doctor about drinking alcohol while using Haldol Depot, and let your doctor know how much you drink.

Pregnancy, breastfeeding 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 Haldol Depot while you are pregnant.

In newborns whose mothers use Haldol Depot during the last 3 months of pregnancy (the last trimester), the following problems may occur:

  • muscle tremors, stiff or weak muscles
  • drowsiness or restlessness
  • breathing problems or difficulty eating.

It is unknown how often these problems occur. If you used Haldol Depot when you were pregnant and your baby gets any of these side effects, talk to your doctor.

Breast-feeding – Tell your doctor if you are breastfeeding or planning to breastfeed. The reason for this is that small amounts of the drug can pass into the breast milk and on to the baby. Your doctor will discuss the risks and benefits of breastfeeding when you use Haldol Depot.

Fertility – Haldol Depot may increase your levels of the hormone “prolactin”, which may affect the fertility of men and women. Talk to your doctor if you have any questions about this.

Driving and using machines

Haldol Depot can affect your ability to drive and use tools or machines. Side effects such as drowsiness can affect your attention, especially at the beginning of drug treatment or after a high dose. Do not drive or use any tools or machines without first discussing this with your doctor.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Haldol Depot contains benzyl alcohol and sesame oil

This medicine contains 15 mg of benzyl alcohol in each ml of solution. Benzyl alcohol can cause allergic reactions. Ask your doctor or pharmacist for advice if you have liver or kidney disease, or if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in the body and cause side effects (so-called “metabolic acidosis”).

The medicine also contains sesame oil, which in rare cases can cause severe allergic reactions.

3. How to use Haldol Depot

How much medicine you should get

Your doctor will decide how much Haldol 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
  • if you have kidney or liver problems
  • if you have previously reacted to haloperidol
  • what other medicines you are taking.

Adults

  • Your starting dose will usually be between 25 mg and 150 mg.
  • Your doctor may adjust a dose of up to 50 mg every 4 weeks to find the dose that works best for you (usually between 50 mg and 200 mg every 4 weeks).
  • You will not receive more than 300 mg every 4 weeks.

Elderly

  • Elderly people usually receive a lower dose first , usually 12.5 mg to 25 mg every 4 weeks.
  • Dose one can then be adjusted until your doctor finds the dose that suits you best (usually 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 that it is safe to do so.

How Haldol Depot is given

You will receive Haldol Depot from a doctor or nurse. It should be used intramuscularly and given as an injection deep into a muscle. A single dose is usually enough for 4 weeks. Haldol Depot must not be injected into a vein.

If you take more Haldol Depot than you should

A doctor or nurse will give you the medicine, so it is unlikely that you will receive too much. If you are worried, talk to your doctor or nurse.

If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you miss a dose or stop using Haldol Depot

You should not stop taking this medicine unless your doctor tells you to because your symptoms may return. If you miss a doctor’s appointment, contact your doctor immediately to schedule a new appointment.

If you have any further questions on the use of this product, 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 that are 

Tell a doctor or nurse immediately if you experience any of the following. You may need immediate medical attention.

Heart problems :

  • Abnormal heart rhythm – this prevents the heart from functioning normally and can make you unconscious
  • abnormally fast heartbeats
  • extra heartbeat.

Heart problems are less common in people receiving Haldol Depot (may affect up to 1 in 100 people). Sudden death has occurred in patients using this medicine, but it is unknown how often these deaths occur. Cardiac arrest (the heart stops beating) has occurred in people taking antipsychotic drugs.

A serious problem is called “malignant neuroleptic syndrome”. This causes high fever, severe muscle stiffness, confusion, and unconsciousness. It is not known how often this side effect occurs in people taking Haldol Depot.

Problems with controlling body movements or movements in the arms and legs (extrapyramidal side effects ), such as:

  • movements of the mouth, tongue, jaw and sometimes arms and legs ( tardive dyskinesia )
  • restlessness or difficulty sitting still, more body movements
  • slow or reduced body movements, jerking or twisting movements
  • muscle tremors or stiffness, a lingering gait
  • inability to move
  • impaired facial expressions, which sometimes look like a mask

These are very common in people using Haldol Depot (may affect more than 1 in 10 people). If you get any of these side effects , you may need to get another medicine.

The severe allergic reaction may include:

  • swelling of the face, lips, mouth, tongue or throat
  • difficulty swallowing or breathing
  • itchy rash, hives.

It is unknown how often allergic reactions occur in people using Haldol Depot.

Blood clots in veins, especially in the legs (deep vein thrombosis or DVT). These have been reported in people taking antipsychotic drugs. Signs of DVT in the leg include swelling, pain and redness in the leg, but the blood clot can move to the lungs and cause chest pain and difficulty breathing. Blood clots can be very serious, so tell your doctor immediately if you get any of these problems.

Tell your doctor immediately if you get any of the serious side effects described above.

Other side effects are

Tell your doctor if you have or suspect you may have any of the following side effects .

Common (may affect up to 1 in 10 people):

  • Depression
  • difficulty sleeping or drowsiness
  • constipation
  • dry mouth or more saliva
  • problems with having sex
  • irritation, pain or abscess at the injection site
  • weight gain.

Uncommon (may affect up to 1 in 100 people):

  • abnormal muscle tension
  • headache
  • upward movement of the eyes or rapid eye movements that you cannot control
  • visual disturbances, such as blurred vision.

The following side effects have also been reported but it is unknown how often they occur:

  • serious mental health problems, such as believing things that are not true (delusions) or seeing, feeling, hearing, or smelling something that does not exist (hallucinations)
  • feeling of anxiety or confusion
  • seizures
  • dizziness, e.g. when you sit up or stand up
  • low blood pressure
  • Problems that can cause breathing difficulties, such as:
    • swelling around the speech machine or short-term spasms in the vocal cords that affect your speech
    • narrower airways in the lungs
    • respiratory distress
  • nausea, vomiting
  • Changes in the blood, such as:
    • effect on blood cells – low number of all blood cells, including severe decrease in the number of white blood cells and low number of platelets (cells that help the blood to clot)
    • high levels of certain hormones in your blood – “prolactin” and “antidiuretic hormone” (syndrome called “inadequate secretion of antidiuretic hormone”)
    • low blood sugar levels
  • Changes seen in liver function tests and other liver problems, such as:
    • yellow skin and eyes (jaundice)
    • inflammation of the liver
    • sudden liver failure
  • decreased flow of bile in the bile duct
  • skin problems, such as:
    • skin rash or itching
    • increased sensitivity to sunlight
    • peeling or flaking of the skin
    • inflamed, small blood vessels, which give skin rashes with small red or purple nodules
  • heavy sweating
  • degradation of muscle tissue ( rhabdomyolysis )
  • muscle spasms, twitches or contractions that you can not control, including spasms in the neck that cause the head to turn to one side
  • difficulty or inability to open the mouth
  • stiff muscles and joints
  • inability to urinate or empty the bladder properly
  • persistent and painful penile erections
  • difficulty getting and maintaining an erection ( impotence )
  • lost sex drive or decreased sex drive
  • changes in the menstrual cycle, such as missed 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 accumulation of fluid in the body
  • low or high body temperature
  • trouble walking
  • weight loss.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Haldol 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 label and carton after EXP. The expiration date is the last day of the specified month.

Store in the original package. Sensitive to light.

6. Contents of the packaging and other information

Content declaration

50 mg / ml solution:

The active substance is haloperidol.

1 ml solution for injection contains 70.52 mg of haloperidol decanoate equivalent to 50 mg of haloperidol . The other ingredients are benzyl alcohol and sesame oil.

100 mg / ml solution:

The active substance is haloperidol. 1 ml solution for injection contains 141.04 mg haloperidol decanoate equivalent to 100 mg haloperidol . The other ingredients are benzyl alcohol and sesame oil.

What the medicine looks like and contents of the pack

50 mg / ml solution:

Haldol Depot is a slightly yellowish, slightly viscous solution, without visible particles. It is supplied in yellow glass ampoules containing 1 ml solution in packs of 1, 3 or 5 ampoules , or 3 ml solution in packs of 1, 5 or 50 (10 packs of 5) ampoules .

100 mg / ml solution:

Haldol Depot is a slightly yellowish, slightly viscous solution, without visible particles. It is delivered in yellow glass ampoules containing 1 ml of solution in packs of 1 or 5 ampoules .

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Janssen-Cilag AB

Box 4042

SE-169 04 Solna

Tel: +46 8 626 50 00

jacse@its.jnj.com

Manufacturer

Janssen Pharmaceutica NV, Turnhoutseweg 30, B – 2340 Beerse, Belgium.

GlaxoSmithKline Manufacturing SpA, Strada Provinciale Asolana N. 90 (loc. San Polo), 43056 Torrile, Parma, Italy.

Muhammad Nadeem

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