Serenase

Italy
Brand name Serenase
Form tablets
Active substance / Dosage
HALOPERIDOL
Prescription type Prescription only
ATC code
N05AD01
Registration number 016805
Manufacturer ISTITUTO LUSO FARMACO D'ITALIA S.P.A.
Serenase tablets

Table of Contents

Patient Information Leaflet

SERENASE 1 mg tablets, 5 mg tablets, 10 mg tablets

haloperidol
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

  1. What SERENASE is and what it is used for
  2. What you need to know before taking SERENASE
  3. How to take SERENASE
  4. Possible side effects
  5. How to store SERENASE
  6. Contents of the pack and other information

1. What SERENASE is and what it is used for

The name of the medicine is SERENASE.
SERENASE contains the active substance haloperidol. This belongs to a group of medicines called "antipsychotics".
SERENASE is used in adults, adolescents, and children for illnesses affecting the way a person thinks, feels, and behaves. These include mental health disorders (such as schizophrenia and bipolar disorder) and behavioral disorders.
These conditions may cause:

  • feeling confused (delirium)
  • seeing, hearing, or smelling things that are not there (hallucinations)
  • believing things that are not true (delusions)
  • feeling unusually suspicious (paranoia)
  • feeling extremely excited, agitated, enthusiastic, impulsive, or hyperactive
  • feeling very aggressive, hostile, or violent.

In adolescents and children, SERENASE is used to treat schizophrenia in patients aged 13 to 17 years and to treat behavioral disorders in patients aged 6 to 17 years.
SERENASE is also used:

  • in adolescents and children aged 10 to 17 years and in adults, for movements or sounds that you cannot control (tics), for example in severe Tourette syndrome
  • in adults, to help control movements in Huntington's disease.

SERENASE is sometimes used when other medicines or treatments have not worked or have caused unacceptable side effects.

2. What you should know before taking SERENASE

Do not take SERENASE:

  • if you are allergic to haloperidol or to any of the other ingredients of this medicine (listed in section 6)
  • if you are less aware of things around you or your reactions become unusually slow
  • if you have Parkinson's disease
  • if you suffer from a type of dementia called "dementia with Lewy bodies"
  • if you have progressive supranuclear palsy (PSP)
  • if you have a heart condition called “prolonged QT interval”, or any other problem with your heart rhythm that shows as an abnormal trace on an ECG (electrocardiogram)
  • if you have heart failure or have recently had a heart attack
  • if you have low levels of potassium in your blood that have not been treated
  • if you are taking any of the medicines listed under “Other medicines and SERENASE - Do not use SERENASE if you are taking medicines for” Do not take the medicine if you experience any of the following conditions. If in doubt, consult your doctor or pharmacist before taking SERENASE.

Warnings and precautions
Serious side effects
SERENASE may cause heart problems, problems with body control or limb movements,
and a serious side effect called "neuroleptic malignant syndrome". It may also cause severe
allergic reactions and blood clots. You should be aware of serious side effects
while taking SERENASE because urgent medical treatment may be required. See
“Read carefully the serious side effects” in section 4.
Elderly people and people with dementia
A slight increase in death and stroke events has been reported in elderly patients with dementia taking antipsychotic medicines. Talk to your doctor or pharmacist before using SERENASE if you are elderly, especially if you have dementia.
Talk to your doctor or pharmacist if you have:

  • a slow heartbeat, heart disease, or if someone in your family has died suddenly from heart problems
  • low blood pressure, or feel confused when standing up or sitting down
  • low levels of potassium or magnesium (or another “electrolyte”) in your blood. Your doctor will decide how to treat you
  • ever had bleeding in the brain, or your doctor has told you that you are more likely than others to have a stroke
  • epilepsy or have ever had seizures (fits)
  • kidney, liver or thyroid problems
  • high levels of the hormone “prolactin” in your blood, or have a cancer that may be caused by high prolactin levels (such as breast cancer)
  • a history of blood clots, or if someone else in your family has a history of blood clots
  • depression or bipolar disorder and start feeling depressed.

You may need to be monitored more closely, and the dose of SERENASE
you take may need to be adjusted.
If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before taking SERENASE.
Medical checks
Your doctor may prescribe an electrocardiogram (ECG) before or during treatment with SERENASE. The ECG measures the electrical activity of the heart.
Blood tests
Your doctor may decide to check your levels of potassium or magnesium (or another “electrolyte”) in your blood before or during treatment with SERENASE.
Children under 6 years of age
SERENASE must not be used in children under 6 years of age. This is because it has not been adequately studied in this age group.
Other medicines and SERENASE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not use SERENASE if you are taking certain medicines for:

  • heart rhythm problems (such as amiodarone, dofetilide, disopyramide, dronedarone, ibutilide, quinidine, and sotalol)
  • depression (such as citalopram and escitalopram)
  • psychosis (such as fluphenazine, levomepromazine, perphenazine, pimozide, prochlorperazine, promazine, sertindole, thioridazine, 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 inform your doctor if you are taking bepridil (for chest pain or to lower blood pressure) or methadone (a painkiller or for treatment of drug dependence). These medicines may increase the risk of heart problems, so inform your doctor if you are taking any of these medicines and do not take SERENASE (see “Do not take SERENASE if”).

Special monitoring may be needed if you take lithium and SERENASE at the same time.
Inform your doctor immediately and stop taking both medicines if:

  • you have unexplained fever or uncontrollable movements
  • you are confused, disoriented, have a headache, problems with balance, and drowsiness. These are signs of a serious condition.

Some medicines may affect how SERENASE works or may cause heart or similar problems
Inform 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 stop smoking)
  • carbamazepine, phenobarbital, or phenytoin (for epilepsy)
  • rifampicin (for bacterial infections)
  • itraconazole, posaconazole, or voriconazole (for fungal infections)
  • ketoconazole tablets (for treatment of 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 inform your doctor if you are taking other medicines to lower blood pressure, such as medicines that make you urinate (diuretics).
Your doctor may adjust the dose of SERENASE if you are taking any of these medicines.
SERENASE may affect how the following types of medicines work
Inform your doctor if you are taking medicines for:

  • calming down or sleeping (tranquilizers)
  • pain (strong painkillers)
  • 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). Inform your doctor before taking SERENASE if you are taking any of these medicines.

SERENASE and alcohol
Drinking alcohol while taking SERENASE may make you feel drowsy and less alert.
This means you should be careful about how much alcohol you drink. Discuss with your doctor about alcohol use while taking SERENASE and inform your doctor about how much alcohol you drink.
Pregnancy, breastfeeding and fertility
Pregnancy – if you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice. Your doctor may advise you not to take SERENASE during pregnancy.
The following problems may occur in newborns whose mothers took SERENASE during the last 3 months of pregnancy (the third trimester):

  • muscle tremors, weakness or muscle stiffness
  • being drowsy or agitated
  • breathing or feeding problems. The exact frequency of these problems is unknown. If SERENASE was taken during pregnancy and the baby develops any of these side effects, contact your doctor.

Breastfeeding – inform your doctor if you are breastfeeding or planning to breastfeed.
This is because small amounts of the medicine may pass into breast milk and to the baby. Your doctor will inform you about the risks and benefits of breastfeeding while taking SERENASE.
Fertility – SERENASE may increase levels of a hormone called “prolactin”, which may affect fertility in both men and women. Inform your doctor if you have any questions about this.
Driving and using machines
SERENASE may affect your ability to drive and use tools or machinery. Side effects such as drowsiness may affect your attention, especially when you first start taking it or after a higher dose. Do not drive or operate tools or machinery without first discussing this with your doctor.
SERENASE contains
SERENASE tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take SERENASE

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How much medicine to take

Your doctor will tell you how many tablets to take and for how long. Your doctor will also tell you whether to take SERENASE once or several times a day. It may take some time before you feel the full effect of the medicine. Usually, your doctor will start you on a low dose and then adjust it to find the dose that is right for you. It is very important to take the correct amount.

The dose of haloperidol will depend on:

  • your age
  • what you are being treated for
  • whether you have kidney or liver problems
  • other medicines you are taking

Adults

  • The usual dose ranges between 0.5 and 10 mg per day.
  • Your doctor may adjust the dose to find the one that is right for you.
  • The maximum dose for adults depends on the condition being treated and varies between 5 and 20 mg per day.

Elderly patients

  • Elderly patients usually start with 0.5 mg per day or half the lowest adult dose.
  • The number of tablets will be adjusted until your doctor finds the right dose for you.
  • The maximum dose for elderly patients is 5 mg per day, unless your doctor decides a higher dose is necessary.

Children and adolescents aged 6 to 17 years

  • The usual dose is between 0.5 mg and 3 mg per day.
  • Adolescents up to 17 years of age being treated for schizophrenia or behavioural disorders may receive a higher dose, up to 5 mg per day.

Taking SERENASE

  • SERENASE is for oral use.
  • Swallow the tablets with a little water.

If you take more SERENASE than you should

If you take more SERENASE than prescribed, or if someone else has taken SERENASE, contact your doctor or go to the nearest hospital emergency department immediately.

If you forget to take SERENASE

  • If you forget to take a dose, take the next dose at the usual time. Then continue taking the medicine as your doctor has instructed.
  • Do not take a double dose.

If you stop taking SERENASE

Unless your doctor decides otherwise, you should stop taking SERENASE gradually.
Stopping treatment suddenly may cause effects such as:

  • nausea and vomiting
  • sleep disturbances

Always follow your doctor's instructions carefully.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Please read carefully the following serious side effects
Inform your doctor if you notice or suspect any of the following serious side effects. Urgent medical treatment may be required.

Heart problems

  • Abnormal heart rhythm – this prevents the heart from working properly and may cause loss of consciousness.
  • Heartbeat that is too fast.
  • Extra heartbeats. Heart problems are uncommon in people taking SERENASE (may affect up to 1 in 100 people). Sudden deaths have occurred in patients taking 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 condition called "neuroleptic malignant syndrome". This causes high fever, severe muscle stiffness, confusion and loss of consciousness. It is rare in people taking SERENASE (may affect up to 1 in 1,000 people).

Problems controlling body or limb movements (extrapyramidal disorders), such as:

  • Movements of the mouth, tongue, jaw, and sometimes limbs (tardive dyskinesia)
  • Feeling restless or unable to stay still, increased body movements
  • Slow or reduced body movements, spasms or twisting movements
  • Muscle tremors or stiffness, shuffling walk
  • Inability to move
  • Loss of normal facial expression, sometimes appearing as a mask-like face

These are very common in people taking SERENASE (may affect more than 1 in 10 people). If you experience any of these effects, you may be given an additional medicine.

Severe allergic reaction which may include:

  • Swelling of the face, lips, mouth, tongue or throat
  • Difficulty swallowing or breathing
  • Skin rash (hives)

A severe allergic reaction is uncommon in people taking SERENASE (may affect up to 1 in 100 people).

Blood clots in the veins, usually in the legs (deep vein thrombosis or DVT). These have been reported in people taking antipsychotic medicines. Signs of DVT in the leg include swelling, pain and redness in the leg, but the clot may travel to the lungs causing chest pain and difficulty breathing. Blood clots can be very serious, so inform your doctor immediately if you notice any of these problems.

Inform your doctor immediately if you notice any of the serious side effects listed above.

Other side effects
Inform your doctor if you notice or suspect any of the following side effects.

Very common (may affect more than 1 in 10 people)

  • Feeling restless
  • Difficulty sleeping
  • Headache

Common (may affect up to 1 in 10 people)

  • Severe mental health problems, such as believing things that are not true (delusions) or seeing, hearing, or smelling things that are not there (hallucinations)
  • Depression
  • Abnormal muscle tension
  • Dizziness, especially when standing up or sitting down
  • Drowsiness
  • Upward movement of the eyes or rapid, uncontrollable eye movements
  • Vision problems, such as blurred vision
  • Low blood pressure
  • Nausea, vomiting
  • Constipation
  • Dry mouth or increased salivation
  • Skin rash
  • Inability to urinate or empty the bladder completely
  • Difficulty achieving or maintaining an erection (impotence)
  • Weight gain or weight loss
  • Changes in liver blood tests

Uncommon (may affect up to 1 in 100 people)

  • Effects on blood cells – low number of all types of blood cells, including severe reduction in white blood cells and low platelet count (cells that help blood clotting)
  • Feeling confused
  • Loss of sexual desire or reduced sexual desire
  • Seizures (fits)
  • Stiff muscles and joints
  • Uncontrollable muscle spasms, spasms or contractions, including neck spasms causing the head to twist to one side
  • Walking difficulties
  • Shortness of breath
  • Inflammation of the liver or liver problems causing yellowing of the skin or eyes (jaundice)
  • Increased sensitivity of the skin to sunlight
  • Itching
  • Excessive sweating
  • Changes in menstrual cycle (periods), such as absence of periods, or long, heavy, painful periods
  • Unexpected production of milk from the breast
  • Breast pain or discomfort
  • High body temperature
  • Swelling due to fluid retention in the body

Rare (may affect up to 1 in 1,000 people)

  • High level of the hormone “prolactin” in the blood
  • Constriction of the airways in the lungs, causing breathing difficulties
  • Difficulty or inability to open the mouth
  • Problems with sexual intercourse

The following side effects have also been reported, but their exact frequency is unknown

  • High level of “antidiuretic hormone” in the blood (syndrome of inappropriate antidiuretic hormone secretion)
  • Low blood sugar levels
  • Swelling around the larynx, or brief spasm of the vocal cords causing difficulty speaking or breathing
  • Sudden liver failure
  • Reduced bile flow in the bile duct
  • Skin peeling or shedding (exfoliation or desquamation)
  • Inflammation of small blood vessels, leading to a skin rash with small red or purple spots
  • Breakdown of muscle tissue (rhabdomyolysis)
  • Persistent and painful erection of the penis (priapism)
  • Enlargement of the breasts in men
  • Low body temperature

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SERENASE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SERENASE contains
The active substance is haloperidol.
SERENASE 1 mg tablets
One tablet contains:
Active substance: haloperidol 1 mg
Excipients: lactose, maize starch, talc, hydrogenated vegetable oil.
SERENASE 5 mg tablets
One tablet contains:
Active substance: haloperidol 5 mg
Excipients: lactose, maize starch, talc, hydrogenated vegetable oil.
SERENASE 10 mg tablets
One tablet contains:
Active substance: haloperidol 10 mg
Excipients: lactose, maize starch, talc, hydrogenated vegetable oil.
Description of the appearance of SERENASE and contents of the pack
20 tablets of 1 mg
20 tablets of 5 mg
20 tablets of 10 mg
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
LUSOFARMACO
Istituto Luso Farmaco d'Italia S.p.A.
Milanofiori – Strada 6 – Edificio L – Rozzano (MI)
Manufacturer
Berlin-Chemie AG - Glienicker Weg, 125 – Berlin (Germany)

Patient Information Leaflet

SERENASE 2 mg/ml oral drops, solution, 10 mg/ml oral drops, solution

haloperidol
Please read this leaflet carefully before using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

  1. What SERENASE is and what it is used for
  2. What you need to know before taking SERENASE
  3. How to take SERENASE
  4. Possible side effects
  5. How to store SERENASE
  6. Contents of the pack and other information

1. What SERENASE is and what it is used for

The name of the medicine is SERENASE.
SERENASE contains the active substance haloperidol. This belongs to a group of medicines called "antipsychotics".
SERENASE is used in adults, adolescents and children for illnesses affecting the way a person thinks, feels and behaves. These include mental health disorders (such as schizophrenia and bipolar disorder) and behavioural disorders.
These illnesses may cause:

  • confusion (delusions)
  • seeing, hearing or smelling things that are not there (hallucinations)
  • believing things that are not true (delusions)
  • feeling unusually suspicious (paranoia)
  • feeling extremely excited, agitated, enthusiastic, impulsive or hyperactive
  • feeling very aggressive, hostile or violent.

In adolescents and children, SERENASE is used to treat schizophrenia in patients aged 13 to 17 years and to treat behavioural disorders in patients aged 6 to 17 years.
SERENASE is also used:

  • in adults, adolescents and children aged 10 to 17 years, and in adults, for movements or sounds that cannot be controlled (tics), for example in severe Tourette syndrome
  • in adults, to help control movements in Huntington's disease. SERENASE is sometimes used when other medicines or treatments have not worked or have caused unacceptable side effects.

2. What you should know before taking SERENASE

Do not take SERENASE:

  • 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 or your reactions become unusually slow after drinking alcohol or after taking other medicines
  • if you have Parkinson's disease
  • if you suffer from a type of dementia called “dementia with Lewy bodies”
  • if you have progressive supranuclear palsy (PSP)
  • if you have a heart condition called “prolonged QT interval”, or any other problem with your heart rhythm that shows as an abnormal trace on an ECG (electrocardiogram)
  • if you suffer from heart failure or have recently had a heart attack
  • if you have low levels of potassium in your blood that have not been treated
  • if you are taking any of the medicines listed below under “Other medicines and SERENASE – Do not use SERENASE if you are taking certain medicines”. The medicine must not be used if you have any of the following conditions. If you are in doubt, consult your doctor or pharmacist before taking SERENASE.

Warnings and precautions
Serious side effects
SERENASE may cause heart problems, problems with body control or limb movements, and a serious side effect called “neuroleptic malignant syndrome”. It may also cause severe allergic reactions and blood clots. You need to be aware of serious side effects while using SERENASE because urgent medical treatment may be required. See “Read carefully about serious side effects” in section 4.
Elderly people and people with dementia
A slight increase in death and stroke events has been reported in elderly patients with dementia who are taking antipsychotic medicines. Talk to your doctor or pharmacist before using SERENASE if you are elderly, especially if you have dementia.
Talk to your doctor or pharmacist if you have:

  • a slow heartbeat, heart disease, or if someone in your family has died suddenly from heart problems
  • low blood pressure, or feel dizzy or confused when standing up or sitting down
  • low levels of potassium or magnesium (or any other “electrolyte”) in your blood. Your doctor will decide how to treat you
  • ever had bleeding in the brain, or if your doctor has told you that you are more likely than others to have a stroke
  • epilepsy or have ever had seizures (fits)
  • kidney, liver, or thyroid problems
  • high levels of the hormone “prolactin” in your blood, or have a cancer that may be caused by high prolactin levels (such as breast cancer)
  • a history of blood clots, or if someone else in your family has a history of blood clots
  • depression, or if you have bipolar disorder and start feeling depressed.

You may need to be monitored more closely, and the dose of SERENASE you take may need to be adjusted.
If you are not sure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before taking SERENASE.
Medical checks
Your doctor may prescribe an electrocardiogram (ECG) before or during treatment with SERENASE. The ECG measures the electrical activity of the heart.
Blood tests
Your doctor may decide to check levels of potassium or magnesium (or any other “electrolyte”) in your blood before or during treatment with SERENASE.
Children under 6 years of age
SERENASE must not be used in children under 6 years of age. This is because it has not been adequately studied in this age group.
Other medicines and SERENASE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use SERENASE if you are taking certain medicines for

  • heart rhythm problems (such as amiodarone, dofetilide, disopyramide, dronedarone, ibutilide, quinidine, and sotalol)
  • depression (such as citalopram and escitalopram)
  • psychosis (such as fluphenazine, levomepromazine, perphenazine, pimozide, prochlorperazine, promazine, sertindole, thioridazine, 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 inform your doctor if you are taking bepridil (for chest pain or to lower blood pressure) or methadone (a painkiller or for treatment of drug addiction). These medicines can increase the risk of heart problems, so inform your doctor if you are taking any of these medicines and do not take SERENASE (see “Do not take SERENASE if”).

Special monitoring may be needed if you are taking lithium and SERENASE at the same time
Tell your doctor immediately and stop taking both medicines if:

  • you have unexplained fever or uncontrollable movements
  • you are confused, disoriented, have headaches, problems with balance, and drowsiness. These are signs of a serious condition.

Some medicines may affect how SERENASE works or may cause heart or similar 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 stop smoking)
  • carbamazepine, phenobarbital, or phenytoin (for epilepsy)
  • rifampicin (for bacterial infections)
  • itraconazole, posaconazole, or voriconazole (for fungal infections)
  • ketoconazole tablets (for Cushing's syndrome)
  • indinavir, ritonavir, or saquinavir (for human immunodeficiency virus or HIV)
  • chlorpromazine and promethazine (for nausea and vomiting)
  • verapamil (for blood pressure or heart problems).

Also inform your doctor if you are taking other medicines to lower blood pressure, such as diuretics ("water pills").
Your doctor may need to adjust the dose of SERENASE if you are taking any of these medicines.
SERENASE may affect how the following types of medicines work
Tell your doctor if you are taking medicines for:

  • calming or sleeping (tranquillisers)
  • pain (strong painkillers)
  • 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 before taking SERENASE if you are taking any of these medicines.

SERENASE and alcohol
Drinking alcohol while taking SERENASE may make you feel drowsy and less alert. This means you should be careful about how much alcohol you drink. Discuss with your doctor about alcohol use while taking SERENASE and inform your doctor about how much alcohol you consume.
Pregnancy, breastfeeding and fertility
Pregnancy – if you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice. Your doctor may advise you not to use SERENASE during pregnancy.
The following problems may occur in newborns of mothers who used SERENASE during the last 3 months of pregnancy (third trimester):

  • muscle tremors, weakness or muscle stiffness
  • drowsiness or restlessness
  • breathing or feeding problems. The exact frequency of these problems is unknown. If SERENASE was used during pregnancy and the baby develops any of these side effects, consult your doctor.
    Breastfeeding – inform your doctor if you are breastfeeding or planning to breastfeed. This is because small amounts of the medicine may pass into breast milk and reach the baby. Your doctor will discuss the risks and benefits of breastfeeding while taking SERENASE.
    Fertility – SERENASE may increase levels of a hormone called “prolactin”, which may affect fertility in both men and women. Inform your doctor if you have any questions about this.
    Driving and using machines
    SERENASE may affect your ability to drive and use tools or machinery. Side effects such as drowsiness may affect your attention, especially when you first start taking it or after a dose increase. This medicine may impair your ability to drive. Do not drive or operate tools or machinery without first discussing this with your doctor.
    SERENASE contains
    SERENASE oral drops contain parahydroxybenzoates. They may cause allergic reactions (including delayed reactions).

3. How to take SERENASE

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How much medicine to take

Your doctor will tell you how many tablets to take and for how long. Your doctor will also tell you whether to take SERENASE once or several times a day. It may take some time before you feel the full effect of the medicine. Usually, your doctor will start you on a low dose and then adjust it to find the dose that is right for you. It is very important to take the correct amount.

The dose of haloperidol will depend on:

  • your age
  • the condition being treated
  • whether you have kidney or liver problems
  • other medicines you are taking

Adults

  • The usual dose ranges between 0.5 and 10 mg per day.
    • Your doctor may adjust this dose to find the one that is right for you.
  • The maximum daily dose for adults depends on the condition being treated and varies between 5 and 20 mg per day.

Elderly patients

  • Elderly patients usually start with 0.5 mg per day or half the lowest adult dose.
  • The dose of SERENASE will be adjusted until your doctor finds the right dose for you.
  • The maximum daily dose for elderly patients is 5 mg, unless your doctor decides that a higher dose is necessary.

Children and adolescents aged 6 to 17 years

  • The usual dose is between 0.5 mg and 3 mg per day.
  • Adolescents up to 17 years of age being treated for schizophrenia or behavioural disorders may require a higher dose, up to 5 mg per day.

Taking SERENASE

  • SERENASE is for oral use.
  • SERENASE drops may be mixed with a small amount of water before taking. Do not mix with other liquids.
    • Remove the cap from the bottle by pushing down on the cap while turning it counterclockwise.
    • Turn the bottle upside down over a spoon.
    • Gently squeeze the sides of the bottle and count the number of drops required.
    • Take the solution immediately.
    • Close the bottle.

If you take more SERENASE than you should

If you take more SERENASE than prescribed, or if someone else has taken SERENASE, contact your doctor or go to the nearest hospital emergency department immediately.

If you forget to take SERENASE

  • If you forget to take a dose, take the next dose at the usual time. Then continue taking the medicine as your doctor has instructed.
  • Do not take a double dose.

If you stop taking SERENASE

Unless your doctor decides otherwise, you should stop taking SERENASE gradually.
Stopping treatment suddenly may cause effects such as:

  • nausea and vomiting
  • sleep disturbances.

Always follow your doctor's instructions carefully.

If you have any questions about 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 everyone gets them.
Read carefully about the serious side effects
Inform your doctor if you notice or suspect any of the following serious side effects. Urgent medical treatment may be required.

Heart problems

  • Abnormal heart rhythm – this prevents the heart from working properly and may cause loss of consciousness.
  • Excessively fast heartbeat
  • Extra heartbeats. Heart problems are uncommon in people taking SERENASE (may affect up to 1 in 100 people). Sudden deaths have occurred in patients taking 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 condition called "neuroleptic malignant syndrome". This causes high fever, severe muscle stiffness, confusion and loss of consciousness. It is rare in people using SERENASE (may affect up to 1 in 1,000 people).

Problems controlling body or limb movements (extrapyramidal disorders), such as:

  • Movements of the mouth, tongue, jaw and sometimes limbs (tardive dyskinesia)
  • Feeling restless or unable to stay still, increased body movements
  • Slowed or reduced body movements, spasms or twisting movements
  • Muscle tremors or stiffness, shuffling gait
  • Inability to move
  • Lack of normal facial expression, sometimes appearing as a mask-like face. These are very common in people taking SERENASE (may affect more than 1 in 10 people). If you experience any of these effects, you may be given an additional medicine.
    Severe allergic reaction which may include:
  • Swelling of the face, lips, mouth, tongue or throat
  • Difficulty swallowing or breathing
  • Skin rash (hives)

A severe allergic reaction is uncommon in people taking SERENASE (may affect up to 1 in 100 people).
Blood clots in the veins, usually in the legs (deep vein thrombosis or DVT). These have been reported in people taking antipsychotic medicines. Signs of DVT in the leg include swelling, pain and redness in the leg, but the clot may travel to the lungs causing chest pain and difficulty breathing. Blood clots can be very serious, so inform your doctor immediately if you notice any of these problems.
Inform your doctor immediately if you notice any of the serious side effects listed above.

Other side effects
Inform your doctor if you notice or suspect any of the following side effects.

Very common (may affect more than 1 in 10 people)

  • Feeling agitated
  • Difficulty sleeping
  • Headache

Common (may affect up to 1 in 10 people)

  • Severe mental health problems, such as believing things that are not true (delusions) or seeing, hearing or smelling things that are not there (hallucinations)
  • Depression
  • Abnormal muscle tension
  • Dizziness, even when standing up or sitting down
  • Drowsiness
  • Upward eye movement or rapid, uncontrollable eye movements
  • Vision problems, such as blurred vision
  • Low blood pressure
  • Nausea, vomiting
  • Constipation
  • Dry mouth or increased salivation
  • Skin rash
  • Inability to urinate or empty the bladder completely
  • Difficulty achieving or maintaining an erection (impotence)
  • Weight gain or weight loss
  • Changes seen in liver blood tests

Uncommon (may affect up to 1 in 100 people)

  • Effects on blood cells – low number of all types of blood cells, including severe reductions in white blood cells and low platelet count (cells that help blood clotting)
  • Confusion
  • Loss of sexual desire or decreased libido
  • Seizures (convulsions)
  • Stiff muscles and joints
  • Muscle spasms, spasms or contractions that cannot be controlled, including neck spasms causing the head to twist to one side
  • Walking difficulties
  • Shortness of breath
  • Inflammation of the liver or liver problems causing yellowing of the skin or eyes (jaundice)
  • Increased sensitivity to sunlight
  • Itching
  • Excessive sweating
  • Changes in menstrual cycle (periods), such as absence of periods, or long, heavy, painful periods
  • Unexpected production of milk from the breast
  • Breast pain or discomfort
  • High body temperature
  • Swelling due to fluid retention in the body

Rare (may affect up to 1 in 1,000 people)

  • High level of the hormone "prolactin" in the blood
  • Narrowing of the airways in the lungs, causing breathing difficulties
  • Difficulty or inability to open the mouth
  • Problems with sexual intercourse

The following side effects have also been reported, but their exact frequency is unknown

  • High level of "antidiuretic hormone" in the blood (syndrome of inappropriate antidiuretic hormone secretion)
  • Low blood sugar levels
  • Swelling around the larynx, or brief spasms of the vocal cords causing difficulty speaking or breathing
  • Sudden liver failure
  • Reduced bile flow in the bile duct
  • Skin peeling or shedding
  • Inflammation of small blood vessels, leading to a skin rash with small red or purple raised spots
  • Breakdown of muscle tissue (rhabdomyolysis)
  • Persistent and painful erection of the penis
  • Breast enlargement in men
  • Low body temperature

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store SERENASE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label or carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SERENASE contains
The active substance is haloperidol.
SERENASE 2 mg/ml oral drops, solution
One ml of oral solution contains:
Active substance: haloperidol 2 mg
Excipients: lactic acid, methyl-p-hydroxybenzoate, propyl-p-hydroxybenzoate, purified water.
SERENASE 10 mg/ml oral drops, solution
One ml of oral solution contains:
Active substance: haloperidol 10 mg
Excipients: lactic acid, methyl-p-hydroxybenzoate, propyl-p-hydroxybenzoate, purified water.
Description of the appearance of SERENASE and contents of the pack
15 ml oral drops, solution 2 mg/ml
15 ml oral drops, solution 10 mg/ml
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
LUSOFARMACO
Istituto Luso Farmaco d'Italia S.p.A.
Milanofiori – Strada 6 – Edificio L – Rozzano (MI)
Manufacturer
Berlin-Chemie AG - Glienicker Weg, 125 - Berlin (Germany)
<------------------------------------------------------------------------------------------------------------------------>
The following information is intended for healthcare professionals only.
Package leaflet for 2 mg/ml oral drops, solution – dropper container only.

SERENASE 2 mg/ml oral drops, solution in a dropper container is intended for

use in doses up to 2 mg of haloperidol (equivalent to 20 drops).
The number of drops required to achieve a given dose using SERENASE 2 mg/ml oral drops,
solution is shown below.
Conversion table for SERENASE 2 mg/ml oral drops, solution
mg of haloperidol Number of drops of
SERENASE
(dropper container)
0.1 mg 1 drop
0.2 mg 2 drops
0.3 mg 3 drops
0.4 mg 4 drops
0.5 mg 5 drops
1 mg 10 drops
2 mg 20 drops
Package leaflet for 10 mg/ml oral drops, solution – dropper container only.
SERENASE 10 mg/ml oral drops, solution in a dropper container is intended for
use in doses up to 10 mg of haloperidol (equivalent to 20 drops).
The number of drops required to achieve a given dose using SERENASE 10 mg/ml oral drops,
solution is shown below.
Conversion table for SERENASE 10 mg/ml oral drops, solution
mg of haloperidol Number of drops of
SERENASE
(dropper container)
0.5 mg 1 drop
1 mg 2 drops
2 mg 4 drops
3 mg 6 drops
4 mg 8 drops
5 mg 10 drops
10 mg 20 drops

Patient Information Leaflet

SERENASE 2 mg/2 ml injectable solution, 5 mg/2 ml injectable solution

haloperidol
Please read this leaflet carefully before using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4. Contents of this leaflet
    1. What SERENASE is and what it is used for
    2. What you need to know before taking SERENASE
    3. How to use SERENASE
    4. Possible side effects
    5. How to store SERENASE
    6. Package contents and other information

1. What SERENASE is and what it is used for

The name of the medicine is SERENASE.
SERENASE contains the active substance haloperidol. This belongs to a group of medicines
called “antipsychotics”.
SERENASE is used in adults for illnesses that affect the way a person thinks, feels, and
behaves. These include mental health disorders (such as schizophrenia and bipolar disorder) and behavioural disorders.
These illnesses may cause:

  • confusion (delirium)
  • seeing, hearing or smelling things that are not there (hallucinations)
  • believing things that are not true (delusions)
  • feeling unusually suspicious (paranoia)
  • feeling very excited, agitated, enthusiastic, impulsive or hyperactive
  • feeling very aggressive, hostile or violent.

SERENASE is also used in adults:

  • to help control movements in Huntington's disease
  • to prevent or treat nausea and vomiting (feeling sick or being sick) after surgery.

SERENASE may be used alone or together with other medicines, and sometimes it is used when other medicines or
treatments have not worked, have caused unacceptable side effects, or cannot be taken by mouth.

2. What you should know before receiving SERENASE

Do not use SERENASE:

  • 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 or your reactions become unusually slow
  • if you have Parkinson's disease
  • if you suffer from a type of dementia called “dementia with Lewy bodies”
  • if you have progressive supranuclear palsy (PSP)
  • if you have a heart condition called “prolonged QT interval”, or any other problem with your heart rhythm that shows as an abnormal trace on an ECG (electrocardiogram)
  • if you suffer from heart failure or have recently had a heart attack
  • if you have low levels of potassium in your blood that have not been treated
  • if you are taking any of the medicines listed in the section “Other medicines and SERENASE - Do not use SERENASE if you are taking certain medicines for”. The medicine must not be used if you have any of the conditions listed above. If you are in doubt, consult your doctor, pharmacist or nurse before receiving SERENASE.

Warnings and precautions
Serious side effects
SERENASE may cause heart problems, problems with body control or limb movements,
and a serious side effect called “neuroleptic malignant syndrome”. It may also cause severe
allergic reactions and blood clots. You need to be aware of serious side effects
during treatment with SERENASE, as urgent medical treatment may be required. See
“Read carefully about serious side effects” in section 4.
Elderly people and people with dementia
A slightly increased risk of death and stroke has been reported in elderly patients with dementia who are taking
antipsychotic medicines. Talk to your doctor before using SERENASE if you are elderly, especially if
you have dementia.
Talk to your doctor if you have:

  • a slow heartbeat, heart disease, or if someone in your family has died suddenly from heart problems
  • low blood pressure, or feel confused when standing up or sitting down
  • low levels of potassium or magnesium (or another “electrolyte”) in your blood. Your doctor will decide how to treat you
  • ever had bleeding in the brain, or your doctor has told you that you are more likely than others to have a stroke
  • epilepsy or have ever had seizures (fits)
  • kidney, liver or thyroid problems
  • high levels of the hormone 'prolactin' in your blood, or a cancer that may be caused by high prolactin levels (such as breast cancer)
  • a history of blood clots, or if someone else in your family has a history of blood clots
  • depression or if you have bipolar disorder and start feeling depressed.

You may need to be monitored more closely, and it may be necessary to adjust
the dose of SERENASE you are given.
If you are unsure whether any of the conditions listed above apply to you, consult your doctor or
nurse before SERENASE is administered.
Medical checks
Your doctor may prescribe an electrocardiogram (ECG) before or during treatment with
SERENASE. The ECG measures the electrical activity of the heart.
Blood tests
Your doctor may decide to check your levels of potassium or magnesium (or another “electrolyte”) in
your blood before or during treatment with SERENASE.
Children and adolescents
SERENASE must 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 SERENASE
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicine.
Do not use SERENASE if you are taking certain medicines for:

  • heart rhythm problems (such as amiodarone, dofetilide, disopyramide, dronedarone, ibutilide, quinidine and sotalol)
  • depression (such as citalopram and escitalopram)
  • psychosis (such as fluphenazine, levomepromazine, perphenazine, pimozide, prochlorperazine, promazine, sertindole, thioridazine, 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 inform your doctor if you are taking bepridil (for chest pain or to lower blood pressure) or methadone (a painkiller or for treatment of drug dependence). These medicines can increase the risk of heart problems, so inform your doctor if you are taking any of these medicines and do not use SERENASE (see section “Do not use SERENASE if”).

Special monitoring may be needed if you are using lithium and SERENASE at the same time
Tell your doctor immediately and stop taking both medicines if:

  • you have unexplained fever or uncontrollable movements
  • you are confused, disoriented, have a headache, problems with balance and drowsiness. These are signs of a serious condition.

Some medicines may affect how SERENASE works or cause heart or similar 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 stop smoking)
  • carbamazepine, phenobarbital or phenytoin (for epilepsy)
  • rifampicin (for bacterial infections)
  • itraconazole, posaconazole or voriconazole (for fungal infections)
  • ketoconazole tablets (for 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 inform your doctor if you are taking other medicines to lower blood pressure, such as
diuretics (medicines to increase urine production).
Your doctor may adjust the dose of SERENASE if you are taking any of these medicines.
SERENASE may affect how the following types of medicines work:
Tell your doctor if you are taking medicines for:

  • calming or sleeping (tranquillisers)
  • pain (strong painkillers)
  • 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). Inform your doctor or nurse before SERENASE is administered if you are taking any of these medicines.

SERENASE and alcohol
Drinking alcohol while taking SERENASE may make you feel drowsy and less alert. This
means you should be careful about how much alcohol you drink. Discuss alcohol use with your doctor while taking SERENASE and inform your doctor about how much alcohol you consume.
Pregnancy, breastfeeding and fertility
Pregnancy – If you are pregnant, think you may be pregnant or are planning a pregnancy, ask
your doctor for advice. Your doctor may advise you not to use SERENASE during pregnancy.
The following problems may occur in newborn babies of mothers who have used SERENASE during the last 3
months of pregnancy (the third trimester):

  • muscle tremors, muscle weakness or stiffness
  • being drowsy or agitated
  • breathing or feeding problems. The exact frequency of these problems is unknown. If SERENASE has been used during pregnancy and the baby develops any of these side effects, contact your doctor. Breastfeeding – inform your doctor if you are breastfeeding or planning to breastfeed. This is because small amounts of the medicine may pass into breast milk and reach the baby. Your doctor will assess the risks and benefits of breastfeeding while using SERENASE.

Fertility – SERENASE may increase levels of a hormone called 'prolactin', which may
affect fertility in both men and women. Inform your doctor if you have any questions about this.
Driving and using machines
SERENASE may affect your ability to drive and use tools or machinery. Side effects such as drowsiness may affect your attention, especially when you first start treatment or after a high dose. This medicine may impair the ability to drive. Do not drive or operate tools or machinery without first discussing this with your doctor.
SERENASE contains
The 2 mg/2 ml injectable solution of SERENASE contains parahydroxybenzoates. These may cause
allergic reactions (including delayed reactions) and, rarely, bronchospasm.

3. How to use SERENASE

How much medicine will be administered to you
Your doctor will decide how much SERENASE you need and for how long. It may take some time before you feel the full effect of the medicine. Usually, your doctor will start with a low dose and then adjust it to the right level for you. The dose of haloperidol will depend on:

  • your age
  • the condition being treated
  • whether you have kidney or liver problems
  • other medicines you are taking.

Adults

  • The starting dose will usually be between 1 and 5 mg. Additional doses may be given, usually at intervals of 1 to 4 hours.
  • You will not be given more than 20 mg in total per day.

Elderly

  • Elderly patients usually start with half of the lowest adult dose.
  • The dose will be adjusted until your doctor finds the right dose for you.
  • You will not be given more than 5 mg in total per day, unless your doctor decides that a higher dose is necessary.

How SERENASE will be administered
SERENASE will be administered by a doctor or nurse. It is for intramuscular use and will be given as an injection into a muscle.

If a dose is forgotten or too much SERENASE is administered
Since a doctor or nurse will administer the medicine, it is unlikely that a dose will be forgotten or that too much will be given. If you are concerned, inform your doctor or nurse.

If you stop using SERENASE
Unless your doctor decides otherwise, SERENASE will be discontinued gradually. Stopping treatment suddenly may cause effects such as:

  • nausea and vomiting
  • sleep disturbances. Always follow your doctor's instructions carefully.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Read carefully about the serious side effects
Tell your doctor or nurse if you notice or suspect any of the following serious side effects. You may need urgent medical treatment.
Heart problems

  • Abnormal heart rhythm – this stops the heart working normally and may cause loss of consciousness.
  • Heartbeat that is too fast.
  • Extra heartbeats. Heart problems are uncommon in people using SERENASE (may affect up to 1 in 100 people). Sudden deaths have occurred in patients taking this medicine, but the exact frequency of these deaths is unknown. Cardiac arrest (heart stops beating) has also occurred in people taking antipsychotic medicines.

A serious condition called "neuroleptic malignant syndrome". This causes high fever, severe muscle stiffness, confusion and loss of consciousness. It is rare in people using SERENASE (may affect up to 1 in 1,000 people).
Problems controlling body or limb movements (extrapyramidal disorders), such as:

  • Movements of the mouth, tongue, jaw and sometimes limbs (tardive dyskinesia)
  • Feeling restless or unable to stay still, increased body movements
  • Slowed or reduced body movements, spasms or twisting movements
  • Muscle tremors or stiffness, shuffling walk
  • Inability to move
  • Lack of normal facial expression, sometimes appearing like a mask. These are very common in people using SERENASE (may affect more than 1 in 10 people). If you experience any of these effects, you may be given an additional medicine.

Severe allergic reaction which may include:

  • Swelling of the face, lips, mouth, tongue or throat
  • Difficulty swallowing or breathing
  • Skin rash (urticaria). Allergic reaction is uncommon in people using SERENASE (may affect up to 1 in 100 people).

Blood clots in the veins, usually in the legs (deep vein thrombosis or DVT). These have been reported in people taking antipsychotic medicines. Signs of deep vein thrombosis in the leg include swelling, pain and redness in the leg, but the clot may travel to the lungs causing chest pain and difficulty breathing. Blood clots can be very serious, so tell your doctor immediately if you notice any of these problems.
Tell your doctor immediately if you notice any of the serious side effects listed above.
Other side effects
Tell your doctor if you notice or suspect any of the following side effects.
Very common (may affect more than 1 in 10 people)

  • Feeling restless
  • Difficulty sleeping
  • Headache Common (may affect up to 1 in 10 people)
  • Serious mental health problem, such as believing things that are not true (delusions) or seeing, hearing or smelling things that are not there (hallucinations)
  • Depression
  • Abnormal muscle tension
  • Feeling dizzy, even when standing up or sitting down
  • Drowsiness
  • Upward movement of the eyes and rapid eye movements that cannot be controlled
  • Vision problems, such as blurred vision
  • Low blood pressure
  • Nausea, vomiting
  • Constipation
  • Dry mouth or increased salivation
  • Skin rash
  • Inability to urinate or empty the bladder completely
  • Difficulty in getting and maintaining an erection (impotence)
  • Weight gain or weight loss
  • Changes seen in liver blood tests

Uncommon (may affect up to 1 in 100 people)

  • Effects on blood cells – low number of all types of blood cells, including severe reduction in white blood cells and low number of "platelets" (cells that help blood clotting)
  • Feeling confused
  • Loss of sexual desire or decreased sexual desire
  • Seizures (fits)
  • Stiff muscles and joints
  • Muscle spasms, spasms or contractions that cannot be controlled, including neck spasm causing the head to twist to one side
  • Walking difficulties
  • Shortness of breath
  • Inflammation of the liver or liver problem causing yellowing of the skin or eyes (jaundice)
  • Increased sensitivity to sunlight
  • Itching
  • Excessive sweating
  • Changes in menstrual cycle (periods), such as no periods, or long, heavy, painful periods
  • Unexpected production of breast milk
  • Breast pain or discomfort
  • High body temperature
  • Swelling due to fluid retention in the body

Rare (may affect up to 1 in 1,000 people)

  • High level of the hormone "prolactin" in the blood
  • Narrowing of the airways in the lungs, causing difficulty breathing
  • Difficulty or inability to open the mouth
  • Problems during sexual intercourse

The following side effects have also been reported, but their exact frequency is unknown

  • High level of the "antidiuretic hormone" in the blood (syndrome of inappropriate antidiuretic hormone secretion)
  • Low blood sugar level
  • Swelling around the larynx, or brief spasm of the vocal cords affecting speech
  • Sudden liver failure
  • Decreased bile flow in the bile duct
  • Skin peeling or desquamation
  • Inflammation of small blood vessels, leading to a skin rash with small red or purple lumps
  • Breakdown of muscle tissue (rhabdomyolysis)
  • Persistent and painful erection of the penis
  • Breast enlargement in men
  • Low body temperature

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SERENASE

Keep this medicine out of the sight and reach of children.
SERENASE must not be used after the expiry date stated on the label and the carton.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help
protect the environment.

6. Package contents and other information

What SERENASE contains
The active substance is haloperidol.
SERENASE 2 mg/2 ml injectable solution
Each vial contains:
Active substance: haloperidol 2 mg
Excipients: methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, lactic acid, water for injectable preparations.
SERENASE 5 mg/2 ml injectable solution
Each vial contains:
Active substance: haloperidol 5 mg
Excipients: lactic acid, water for injectable preparations.

Description of the appearance of SERENASE and contents of the pack
5 vials of 2 ml injectable solution 2 mg/2 ml
5 vials of 2 ml injectable solution 5 mg/2 ml

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
LUSOFARMACO
Istituto Luso Farmaco d'Italia S.p.A.
Milanofiori – Strada 6 – Edificio L – Rozzano (MI)
Manufacturer
Famar SA Manufacturing Chemists – Alimos Attikis (Greece)