SERDOLECT 12 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Serdolect, 4 mg, coated tablets
3. Serdolect, 12 mg, coated tablets
4. Serdolect, 16 mg, coated tablets
   1. You should read the contents of this leaflet carefully before taking the medicine, as it contains important information for you.
   2. Table of contents of the leaflet:
5. What is Serdolect and what is it used for
6. Important information before taking Serdolect
   1. Do not take Serdolect
   2. Warnings and precautions
   3. Monitoring before and during treatment
   4. Children and adolescents (under 18 years of age)
   5. Serdolect and other medicines
   6. Using Serdolect with food, drink, and alcohol
   7. Pregnancy, breastfeeding, and fertility
   8. Pregnancy
   9. Driving and using machines
   10. Serdolect contains lactose and sodium
7. How to take Serdolect
   1. Patient over 65 years of age
   2. Patient with liver dysfunction
   3. Patient with kidney dysfunction
   4. Dosing after previous use of other antipsychotic medicines
   5. Method of administration
   6. Duration of treatment
   7. Taking a higher dose of Serdolect than recommended
   8. Missing a dose of Serdolect
   9. Stopping Serdolect
8. Possible side effects
   1. Uncommon (may affect up to 1 in 100 people)
   2. Rare (may affect up to 1 in 1,000 people):
   3. Frequency not known (cannot be estimated from the available data):
   4. Other side effects that may occur with the following frequency:
   5. Very common (may affect more than 1 in 10 people)
   6. Common (may affect up to 1 in 10 people)
9. How to store Serdolect
10. Contents of the packaging and other information
    1. What Serdolect contains
    2. Appearance and contents of the packaging of Serdolect
    3. Marketing authorization holder and manufacturer
    4. Lundbeck Poland Sp. z o.o.
    5. Date of the last update of the leaflet:

Leaflet accompanying the packaging: patient information

Serdolect, 4 mg, coated tablets

Serdolect, 12 mg, coated tablets

Serdolect, 16 mg, coated tablets

Sertindole

You should read the contents of this leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again later.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Serdolect and what is it used for
• 2. Important information before taking Serdolect
• 3. How to take Serdolect
• 4. Possible side effects
• 5. Storage of Serdolect
• 6. Contents of the packaging and other information

1. What is Serdolect and what is it used for

Serdolect contains the active substance sertindole and belongs to a group of medicines called antipsychotics. It acts on nerve pathways in specific areas of the brain and helps to correct chemical imbalances that are responsible for the symptoms of the disease. Serdolect is used to treat schizophreniain patients who have not responded to other medicines.

2. Important information before taking Serdolect

Do not take Serdolect

If you

• are allergic to sertindole or any of the other ingredients of this medicine (listed in section 6)
• have untreated low levels of potassium or magnesium in the blood
• have significant heart disease
• have severe heart disease, such as:
• heart failure with swelling of tissues due to excess fluid
• enlargement of the heart
• irregular or slow heart rate
• have a congenital or acquired long QT syndrome, which can be detected in an ECG, or if rhythm disorders have been detected in a family member
• have significant liver dysfunction
• are taking medicines that prolong the activity of heart cells or affect certain enzymes of cytochrome P450 (see section 2 "Serdolect and other medicines").

Warnings and precautions

Before taking Serdolect, you should inform your doctor if you have or have had:

• if you are 65 years of age or older
• vomiting or diarrhea during treatment with Serdolect
• liver dysfunction
• Parkinson's disease
• diabetes or risk factors for its development
• risk factors for stroke, such as high blood pressure, previous stroke or heart attack, diabetes, high cholesterol, dementia, smoking
• cases of venous thrombosis in you or a family member, as taking medicines used to treat schizophrenia may be associated with the formation of thrombosis
• seizures
• abnormal movements of the mouth and tongue, which may be early symptoms of a nervous system disorder called tardive dyskinesia
• high fever, abnormal muscle stiffness, and changes in consciousness, especially if sweating and rapid heartbeat also occur. These symptoms may indicate a rare but serious condition called malignant neuroleptic syndrome.

At the beginning of treatment with Serdolect, dizziness may be experienced when getting up from bed or standing up. Your doctor will reduce this risk by starting treatment with a low dose, which will be gradually increased over a period of several weeks. These symptoms usually disappear when Serdolect is taken for a while.

Monitoring before and during treatment

Before starting treatment with Serdolect and during treatment, your doctor will perform tests, such as:

• ECG to check for prolongation of the QT interval. This test will be repeated after 3 weeks of treatment or after reaching a daily dose of sertindole of 16 mg. During maintenance treatment, this test should be performed every 3 months. Additionally, an ECG will be performed before and after increasing the dose. This also applies to changes in the use of other medicines that may affect the level of sertindole in the blood.
• measurement of potassium and magnesium levels in the blood
• in case of low potassium or magnesium levels, the doctor will start treatment to correct this abnormality. You should not take Serdolect if you have untreated low levels of potassium or magnesium in the blood. You should contact your doctor in case of vomiting, diarrhea, electrolyte disturbances, or taking medicines that increase water excretion. Your doctor may order a test to measure potassium levels in the blood.
• blood pressure monitoring

Children and adolescents (under 18 years of age)

Serdolect should not be used in this age group due to the lack of available data.

Serdolect and other medicines

You should inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Serdolect should not be takenat the same time as the following medicines, which may affect heart function or liver function, such as:

• certain medicines used to treat rhythm disorders, such as quinidine, amiodarone, sotalol, dofetilide
• certain medicines used to treat mental illnesses, such as thioridazine
• certain medicines used to treat bacterial infections from the group of macrolide antibiotics containing a substance with a name ending in "-mycin", such as erythromycin, clarithromycin
• certain medicines used to treat bacterial infections from the group of quinolone antibiotics containing a substance with a name ending in "-oxacin", such as gatifloxacin, moxifloxacin
• oral medicines used to treat fungal infections, such as ketoconazole, itraconazole
• certain medicines used to treat HIV infection, containing a substance with a name ending in "-navir", such as indinavir
• certain medicines used to treat allergies, such as terfenadine, astemizole
• cisapride: a medicine used to treat stomach and/or intestinal disorders
• lithium: a medicine used to treat depression and mental illnesses
• certain medicines used to treat high blood pressure and heart disease, called calcium channel blockers, such as diltiazem, verapamil
• cimetidine: a medicine used to reduce stomach acid production

Other medicines that may affect the action of Serdolect (and vice versa) include: medicines used to treat Parkinson's disease, called dopamine agonists; certain medicines used to treat depression and anxiety disorders, such as fluoxetine, paroxetine; rifampicin: a medicine used to treat tuberculosis or other infections; carbamazepine, phenytoin, phenobarbital: medicines used to treat epilepsy; diuretics that lower potassium levels in the blood

Using Serdolect with food, drink, and alcohol

You should avoidalcohol during treatment with Serdolect, even if you do not expect it to affect the action of the medicine.

Pregnancy, breastfeeding, and fertility

Pregnancy

It is not recommendedto take Serdolect during pregnancy. The following symptoms may occur in newborns of mothers who took Serdolect in the last trimester (last three months of pregnancy):

• tremors
• stiffness and/or muscle weakness
• sleepiness
• agitation
• breathing difficulties
• feeding difficulties. You should contact your doctor if your child experiences any of these symptoms.
• Do not breastfeed while taking Serdolect, unless your doctor considers it absolutely necessary. You should consider stopping breastfeeding if treatment is necessary, as Serdolect is excreted in breast milk.
• FertilitySerdolect may cause side effects that can affect sexual activity and fertility (see section 4 "Possible side effects"). These effects are reversible. You should consult your doctor if you experience problems with sexual activity.

Driving and using machines

You should not drive or operate machinery until you know how Serdolect affects you, even if it does not cause drowsiness.

Serdolect contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is considered "sodium-free".

3. How to take Serdolect

Serdolect should always be taken as directed by your doctor or pharmacist. If you are unsure, you should contact your doctor or pharmacist. The recommended dose is

• initial dose: 1 Serdolect 4 mg tablet once a day. The dose will be increased by 1 Serdolect 4 mg tablet every 4 to 5 days to reach the maintenance dose.
• maintenance dose: 1 Serdolect 12 mg tablet to a dose of 20 mg once a day
• maximum dose: 2 Serdolect 12 mg tablets once a day, which can only be considered in exceptional cases

Patient over 65 years of age

Usually, the dose is increased by the doctor over a longer period than usual. The doctor may also prescribe a lower maintenance dose than is usually recommended.

Patient with liver dysfunction

If you have been diagnosed with mild or moderate liver failure, your doctor may monitor your condition more closely and increase the dose over a longer period. Your doctor may also prescribe a lower maintenance dose than is usually recommended. Serdolect should not be used in patients with severe liver failure.

Patient with kidney dysfunction

Patient with kidney dysfunction may take Serdolect in the usual doses.

Dosing after previous use of other antipsychotic medicines

Treatment with sertindole can be started according to the recommended dosing schedule and other oral antipsychotic medicines can be stopped at the same time. In patients treated with antipsychotic medicines in the form of depot injections, the first dose of sertindole should be given instead of the next depot injection.

Method of administration

Serdolect should be taken whole, with a glass of water, at the same time every day. The tablet can be taken with or without food.

Duration of treatment

The tablets should be taken for as long as your doctor recommends. You should never change the dose of the medicine without consulting your doctor first. If you want to stop taking the medicine, you should consider the information contained in section 3 "Stopping Serdolect".

Taking a higher dose of Serdolect than recommended

In such a case, you should immediatelycontact your doctor or the emergency department of the nearest hospital. You should do this even if you do not experience any symptoms. Symptoms of overdose include:

• excessive fatigue
• slurred speech
• rapid heartbeat
• low blood pressure

Missing a dose of Serdolect

You should not take a double dose to make up for a missed dose. If you miss a daily dose of Serdolect, you should contact your doctor. Your doctor will inform you how to correctly resume treatment.

Stopping Serdolect

You should not stop taking Serdolect without your doctor's consent, even if you feel better. The disease may persist for a long time. If treatment is stopped too early, the symptoms of the disease may return. Involuntary movements may also occur. Your doctor will advise you when and how to stop treatment to avoid unwanted symptoms. Suddenly stopping Serdolect may cause withdrawal symptoms, such as: nausea, vomiting, sweating, difficulty sleeping. If you have any further questions about the use of this medicine, you should contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, Serdolect can cause side effects, although not everybody gets them. You should immediately contact your doctor or the emergency department of the nearest hospital ifyou experience side effects listed in the next four subsections:

Uncommon (may affect up to 1 in 100 people)

• very rapid, irregular, or strong heartbeat, dizziness, fainting, shortness of breath, or chest pain. These symptoms may indicate the occurrence of life-threatening heart rhythm disorders called Torsade de pointes.
• uncontrolled movements, especially of the mouth, tongue, or limbs. This may indicate the occurrence of nervous system disorders called tardive dyskinesia.

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

• a combination of high fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness. These symptoms may indicate the occurrence of a life-threatening nervous system disorder called malignant neuroleptic syndrome.

Frequency not known (cannot be estimated from the available data):

• formation of blood clots in the veins, especially in the legs (symptoms include: swelling, pain, and redness of the limb), which can move through the blood vessels to the lungs, causing chest pain and difficulty breathing.

Other side effects that may occur with the following frequency:

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

• inflammation inside the nose, which causes sneezing, itching, runny nose, and nasal congestion
• inability to ejaculate

Common (may affect up to 1 in 10 people)

• dizziness or sudden dizziness due to a drop in blood pressure when standing up;
• dry mouth;
• weight gain;
• shortness of breath;
• swelling of the hands or feet;
• strange sensations on the skin, such as pinpricks or needles;
• reduced ejaculate volume;
• impotence;
• changes in the electrical activity of the heart (called "prolonged QT interval"). A prolonged QT interval can cause symptoms such as palpitations or fainting;
• appearance of red and white blood cells in the urine.

Uncommon (may affect up to 1 in 100 people)

• increased blood sugar levels;
• increased levels of a hormone called prolactin in the blood.
• spontaneous milk secretion from the breast
• seizures, fainting

Pregnancy, puerperium, and perinatal period. Information on possible side effects related to pregnancy, breastfeeding, and fertility - see section 2. In elderly patients with dementia, a small increase in the number of deaths has been reported in patients taking antipsychotic medicines compared to those not taking antipsychotic medicines. If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Serdolect

Store in a place inaccessible and invisible to children. Do not use Serdolect after the expiry date stated on the carton. The expiry date refers to the last day of the month. Store in the original outer packaging to protect from light. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Serdolect contains

• The active substance is sertindole (Sertindolum).

Each coated tablet contains: 4 mg, 12 mg, or 16 mg of sertindole. The other ingredients of the medicine are:

• cornstarch
• hydroxypropylcellulose
• microcrystalline cellulose
• sodium carboxymethylcellulose
• magnesium stearate
• macrogol 400
• titanium dioxide. Serdolect 4 mg: yellow iron oxide. Serdolect 12 mg: yellow iron oxide, red iron oxide. Serdolect 16 mg: red iron oxide

Appearance and contents of the packaging of Serdolect

Serdolect is a coated tablet containing 4 mg, 12 mg, or 16 mg of sertindole. Description: The 4 mg coated tablets are oval, yellow, and biconvex, marked with "S4" on one side. The 12 mg coated tablets are oval, beige, and biconvex, marked with "S12" on one side. The 16 mg coated tablets are oval, dark pink, and biconvex, marked with "S16" on one side. Available packages: 4 mg coated tablets:available in packages containing 30 tablets, in three blisters of 10 tablets each. 12 mg and 16 mg coated tablets:available in packages containing 28 tablets, in two blisters of 14 tablets each. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

• H. Lundbeck A/S, Ottiliavej 9, DK-2500 Valby, Denmark

For more detailed information, you should contact the representative of the marketing authorization holder. Poland

Lundbeck Poland Sp. z o.o.

Marszałkowska 142, 00-061 Warsaw, Tel.: +48 22 626 93 00, Fax: +48 22 626 93 01

Date of the last update of the leaflet: