Package Insert: Information for the Patient

Serdolect 12 mg Film-Coated Tablets

Sertindol

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Serdolect and how is it used

2. What you need to know before starting to take Serdolect

3. How to take Serdolect

4. Possible adverse effects

5. Storage of Serdolect

6. Contents of the package and additional information

Serdolect contains the active ingredient sertindol and belongs to a group of medications called antipsychotics. These act on nerve pathways in specific areas of the brain and help by correcting certain chemical imbalances in the brain that cause their symptoms.

Serdolect is indicated for treating schizophrenia in cases where another medication is not effective.

Do not take Serdolect :

if you are/ have

?allergy to sertindol or any of the other components of

?this medication (including those listed in section 6)

?low levels of potassium or magnesium in the blood that have not been treated

?significant heart disease

• serious heart disease, such as:

-heart failure with fluid buildup in the tissues

-enlargement of the heart

-irregular or slow heartbeats

?have been born or have had an episode ofprolonged ventricular cardiac activity, measured on an ECG, or someone in your family has this abnormal heart rhythm

?severely reduced liver function

?take medications that prolong ventricular activity or affect liver function. See the first two points in the section “Other medications and Serdolect” in section 2

Warnings and precautions

Consult your doctor before starting to take Serdolect if you are/ have:

•vomiting or diarrhea during treatment with Serdolect

•decreased liver function

•Parkinson's disease

•diabetes or risk factors for developing diabetes

•risk factors for stroke, such as high blood pressure, previous stroke or heart attack, diabetes, high cholesterol, dementia, smoker

•65 years of age or older

•history of blood clots or family history of blood clots in the veins, as medications for the treatment of schizophrenia have been associated with the formation of blood clots.

•seizures

•unusual movement of the mouth and tongue, which may be early signs of a nervous system disorder called tardive dyskinesia

•high fever, muscle stiffness, and changes in consciousness, especially if accompanied by sweating and rapid heartbeats. These may be signs of a rare but serious condition called neuroleptic malignant syndrome

When starting treatment with Serdolect, you may feel dizzy when getting up from bed or standing up. Your doctor may reduce this risk by starting with a low dose, gradually increasing it over several weeks. This feeling usually disappears when you have taken Serdolect for a while.

Monitoring before and during treatment

Before and during your treatment with Serdolect, your doctor may perform certain tests, such as:

•an electrocardiogram of your ventricular heart activity to check if there is prolongation of the QT interval

This test is repeated after 3 weeks of treatment or when you reach a daily dose of 16 mg of sertindol. During maintenance treatment, it is done every 3 months. In addition, an ECG is done before and after increasing the dose. This is also done if you change the dose of another medication you take that may affect the level of sertindol in the blood.

•potassium and magnesium level test in the blood

If potassium or magnesium levels decrease, your doctor will start treatment to correct it. Do not take Serdolect if you have untreated low levels of potassium or magnesium in the blood.

Contact your doctor if you have vomiting, diarrhea, electrolyte disturbances, or take medications to increase urine production. Your doctor may measure the amount of potassium in your blood.

•blood pressure monitoring

Children under 18 years

Serdolect should not be used in this age group as there are no available data.

Taking Serdolect with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Serdolectshould not be usedwhen the following medications are used:

• medications that can affect heart rhythm, such as:

• some medications used to treat irregular heartbeats, such as quinidine, amiodarone, sotalol, dofetilide
• some medications used to treat mental disorders, such as thioridazine
• some medications used to treat bacterial infections, with names of active ingredients ending in “micina”such as erythromycin
• some medications used to treat allergies, such as terfenadine, astemizole
• some medications used to treat bacterial infections, with names of active ingredients ending in “oxacina”such as gatifloxacin, moxifloxacin

• cisapride: medication for stomach or intestinal problems
• lithium: medication for depression and mental disorders

•medications that affect liver function, such as:

• medications taken orally to treat fungal infections, such as ketoconazole, itraconazole
• some medications used to treat bacterial infections with names of active ingredients ending in “micina”, such as erythromycin, clarithromycin
• medications used to treat HIV infections with names of active ingredients ending in “navir”such as indinavir
• some medications used to treat high blood pressure and heart disorders called calcium channel blockers, such as diltiazem, verapamil
• cimetidine: medication to reduce stomach acid

Other medications that may affect or be affected by Serdolect are:

•medications used to treat Parkinson's disease called dopamine agonists

•some medications used to treat depression and anxiety disorders, such as fluoxetine, paroxetine

•rifampicin: medication to treat tuberculosis or other infections

•carbamazepine, phenytoin, phenobarbital: medications used to treat epilepsy

•medications to increase urine production, which decreases potassium levels in the blood

Taking Serdolect with food and drinks

Avoid alcoholduring treatment with Serdolect, although no influence is expected from alcohol.

Pregnancy, breastfeeding, and fertility

• Pregnancy

Serdolectis not recommendedduring pregnancy.

The following symptoms may appear in newborns of mothers who have taken Serdolect during the last trimester (the last three months of pregnancy):

• shivering
• stiffness and/or muscle weakness

• drowsiness, restlessness
• breathing problems
• difficulty feeding.

Contact your doctor if your baby shows any of these symptoms.

• Breastfeeding

Serdolectshould not be usedduring breastfeeding unless your doctor says it is absolutely necessary. Considerinterrupting breastfeedingif treatment is necessary, as Serdolect is excreted in breast milk.

•Fertility

Serdolect may have adverse effects that may affect your sexual activity and fertility. These are reversible. Please talk to your doctor about any problems related to your sexual activity.

Driving and operating machinery

Do not drive or operate machinery until you know how Serdolect affects you, although it does not cause drowsiness.

Serdolect contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Serdolect contains sodium

This medication contains less than 1 mmol sodium (23mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

• Initial dose: 1 tablet of 4 mg of Serdolect once a day. Every 4 to 5 days, the dose will be increased by 1 tablet of 4 mg of Serdolect, until the maintenance dose is reached.

• Maintenance dose: 1 tablet of 12 mg of Serdolect to 1 tablet of 20 mg of Serdolect once a day.

• Maximum dose: 2 tablets of 12 mg of Serdolect once a day, which will be considered only in exceptional cases.

Alternatively, the maximum dose can be reached by taking 1 tablet of 20 mg of Serdolect plus 1 tablet of 4 mg of Serdolect.

Patients over 65 years old

It is very likely that your doctor will increase the dose of Serdolect over a longer period of time than usual. Your doctor may also prescribe a lower maintenance dose than normally recommended.

Patients with reduced liver function

Your doctor may monitor you more closely and increase your dose over a long period if you have mildly or moderately reduced liver function. Your doctor may also prescribe a lower maintenance dose than normally recommended.

Serdolect should not be used in patients with severely reduced liver function.

Patients with reduced renal function

Serdolect can be administered to patients with reduced renal function at the usual doses.

Administration

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

Treatment duration

Take the tablets for the recommended time by your doctor.

Never change the medication dose without consulting your doctor first.

If you want to stop using the medication, please note the information in the section 3 “If you interrupt treatment with Serdolect”.

If you take more Serdolect than you should

If this happens, contact your doctor or nearest hospital immediately. Do it even if you do not have any signs of discomfort.

The symptoms of overdose are:

• Increased fatigue.
• Difficulty speaking.
• Increased pulse.
• Low blood pressure.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Do it even when you do not observe discomfort or signs of intoxication. Bring the Serdolect packaging with you if you go to the doctor or hospital.

If you forgot to take Serdolect

Do not take a double dose to compensate for the missed doses.

If you forget to take your daily dose, contact your doctor. Your doctor will indicate how to continue your treatment correctly.

If you interrupt treatment with Serdolect

Do not stop taking Serdolect without your doctor's permission, even if you start feeling better. The underlying disease may persist for a long time. If you interrupt your treatment too soon, your symptoms may return and involuntary movements may also occur.

Your doctor will advise you on how and when to stop your treatment to avoid the unpleasant symptoms that may occur. If you stop taking Serdolect abruptly, you may experience discontinuation symptoms such as:

• Nausea, vomiting.
• Sweating.
• Difficulty sleeping.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Contact your doctor or hospital immediately if you have any of the side effects mentioned in the following 4 points:

Rare: may affect up to 1 in 100 people

• very fast, irregular, or strong heartbeats, dizziness, fainting, difficulty breathing, or chest pain

These symptoms may indicate life-threatening irregular heartbeats.

• uncontrollable movements mainly in the mouth, tongue, and limbs

This could indicate a nervous system disorder called tardive dyskinesia

Uncommon: may affect up to 1 in 1,000 people

• a combination of fever, rapid breathing, sweating, muscle stiffness, drowsiness, or lethargy

These symptoms may indicate a life-threatening nervous disorder called neuroleptic malignant syndrome.

Unknown: the frequency cannot be estimated from available data

• blood clots in the veins, particularly in the legs (symptoms include swelling, pain, and redness in the leg), which can move through the blood vessels to the lungs causing chest pain and breathing difficulties

Other possible side effects that may occur with the following frequencies are:

Very common: may affect more than 1 in 10 people

• inflammation in the nose causing sneezing, itching, nasal discharge, and blocked nose
• ejaculatory dysfunction

Common: may affect up to 1 in 10 people

• dizziness or sudden dizziness, resulting from a drop in blood pressure when standing up
• dry mouth
• weight gain
• difficulty breathing
• swelling of hands or feet
• tingling sensation in the skin
• decreased ejaculatory volume
• impotence
• changes in heart activity (called "prolongation of the QT interval"). Prolongation of the QT interval may cause symptoms such as palpitations and fainting
• white and red blood cells in urine

Rare:may affect up to 1 in 100 people:

• increased blood sugar
• irregular heartbeat, known as Torsade de Pointes
• increased levels of a hormone called prolactin in the blood
• spontaneous milk secretion from the breasts
• convulsions, fainting

In elderly patients with dementia, a small increase in the number of deaths in patients taking antipsychotics has been reported, compared to those not taking them.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: http;//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Serdolect

The active ingredient is sertindol.

Each film-coated tablet contains 12 mg of sertindol.

The other components are:

• cornstarchof maize
• lactose monohydrate
• hydroxypropylcellulose
• hypromellose
• microcrystalline cellulose
• sodium croscarmellose
• estearate of magnesium
• macrogol 400
• titanium dioxide
• yellow iron oxide (E172)
• red iron oxide (E172).

Appearance of the product and contents of the package

Serdolect 12 mg is presented in the form of film-coated tablets.

The tablets are beige, oval, rounded on the upper and lower faces, marked with the letters “S12” on one face.

Serdolect 12 mg is presented in packages of 7, 10, 14, or 28 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

H. Lundbeck A/S

Ottilliavej, 9

2500 Valby

Denmark

Tel: + 45 3630 1311

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Local representative:Lundbeck España, S.A.

Av. Diagonal, 605

08028 Barcelona

(Spain)

This medication is authorized in the following member states of the EU/European

Economic Area with the following names:

This leaflet was approved in April 2021

The detailed and updated information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/