Package leaflet: Information for the patient

Serdolect 4 mg, 12 mg, 16 mg and 20 mg film-coated tablets

Sertindole

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, 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 signs of illness are the same as yours.

•    If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Serdolect is and what it is used for

2.    What you need to know before you take Serdolect

3.    How to take Serdolect

4.    Possible side effects

5.    How to store Serdolect

6.    Contents of the pack and other information

Serdolect contains the active substance sertindole and belongs to a group of medicines known as antipsychotics. It acts on nerve pathways in specific brain areas and helps there to correct chemical imbalances that cause your symptoms.

Serdolect is used to treat schizophrenia in cases where another medicine was not effective.

Do not take Serdolect

if you are/have:

•    allergic to sertindole or any of the other ingredients of this medicine (listed in section 6).

•    untreated low potassium or magnesium in the blood

•    a significant heart and blood circulation disease

•    a severe heart disease such as

-    heart failure with tissue swelling caused by excess fluid

-    enlargement of the heart

-    irregular or slow heartbeat

•    born with or have had an episode of prolonged heart ventricle activity, measured in an ECG, or someone in your family has this abnormal heart rhythm

•    severely reduced liver function

•    taking medicines that prolong the time of the heart ventricle activity or affect the liver function. See the first two bullet points under "Other medicines and Serdolect” in section 2.

Warnings and precautions

Talk to your doctor before taking Serdolect if you are/have:

•    vomiting or diarrhoea during treatment with Serdolect

•    reduced 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, smoking

•    over 65 years of age

•    a history of blood clots in a vein, or a family history of such blood clots, as medicines for treatment of schizophrenia have been associated with formation of blood clots

•    had fits

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

•    high fever, unusual muscle stiffness and changes in consciousness, especially if occurring with sweating and fast heartbeat. These may be signs of a rare but serious condition called neuroleptic malignant syndrome

At the beginning of treatment with Serdolect, you may feel dizzy when you get out of bed or stand up. Your doctor will reduce this risk by starting with a low dose, to increase gradually over several weeks. This feeling usually goes away when you have taken Serdolect for a while.

Monitoring before and during treatment

Your doctor will conduct examinations before and during treatment with Serdolect, such as:

•    an ECG of your heart ventricle activity to check for QT interval prolongation This test is repeated after 3 weeks of treatment or when you reach a daily dose of 16 mg sertindole. During maintenance treatment, it should be performed every 3 months. In addition, an ECG will be performed before and after dose increase. This also applies after changes to other medicines that may affect the sertindole blood level.

•    a test of potassium and magnesium blood levels

If the level of potassium or magnesium is reduced, your doctor will initiate treatment to correct this. Do not take Serdolect if you have an untreated low potassium or magnesium blood level.

Contact your doctor if you experience vomiting, diarrhoea, electrolyte disturbances or take medicines to increase water output. 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 no data are available.

Other medicines and Serdolect

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

Serdolect must not be used when using the following medicines:

•    medicines that may affect the heart rhythm, such as:

-    certain medicines to treat irregular heartbeats, like quinidine, amiodarone, sotalol, dofetilide

-    certain medicines to treat mental disorders, like thioridazine

-    certain medicines to treat bacterial infections with active substance names ending in “mycin”, like erythromycin

-    certain medicines to treat allergies, like terfenadine, astemizole

-    certain medicines to treat bacterial infection with active substance names ending in “oxacin”, like gatifloxacin, moxifloxacin

-    cisapride: a medicine to treat stomach and/or bowel problems

-    lithium: a medicine to treat depression and mental disorders

•    medicines known to affect the liver function, such as:

-    medicines taken orally to treat fungal infections, like ketoconazole, itraconazole

-    certain medicines to treat bacterial infections with active substance names ending in “mycin”, like erythromycin, clarithromycin

-    medicines to treat HIV infections with active substance names ending in “navir”, like indinavir

-    certain medicines to treat high blood pressure and heart disorders called calcium channel blockers, like diltiazem, verapamil

-    cimetidine: a medicine to reduce stomach acid

Other medicines that can affect or be affected by Serdolect are:

•    medicines to treat Parkinson’s disease called dopamine agonists

•    certain medicines to treat depression and anxiety disorders, like fluoxetine, paroxetine

•    rifampicin: a medicine to treat tuberculosis or certain other infections

•    carbamazepine, phenytoin, phenobarbital: medicines to treat epilepsy

•    medicines to increase water output, which decrease potassium levels in the blood

Serdolect with food and drink

Avoid alcohol during treatment with Serdolect, even though it is not expected to be influenced by alcohol

Pregnancy, breast-feeding and fertility

•    Pregnancy

Serdolect is not recommended during pregnancy.

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

-    shaking

-    muscle stiffness and/or weakness

-    sleepiness, restlessness

-    breathing problems

-    difficulty feeding

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

•    Breast-feeding

Serdolect should not be used during breast-feeding unless the doctor says it is absolutely necessary. Consider discontinuing breast-feeding if treatment is necessary as Serdolect is excreted in breast milk.

•    Fertility

Serdolect can have side effects that may affect your sexual activity and fertility. These are reversible. Please discuss any problems related to your sexual activity with your doctor.

Driving and using machines

Do not drive or use machines until you know how Serdolect affects you, even though it does not cause drowsiness.

Serdolect contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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

The recommended dose is

•    starting dose: 1 Serdolect 4 mg tablet once daily

Every 4 to 5 days the dose will be increased by 1 Serdolect 4 mg tablet until the maintenance dose has been reached.

•    maintenance dose: 1 Serdolect 12 mg tablet to 1 Serdolect 20 mg tablet once daily

•    maximum dose: 2 Serdolect 12 mg tablets once daily, which will be considered only in exceptional cases

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

People over 65 years of age

Most likely, 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 longer period if you have mildly or moderately reduced liver function. Your doctor may also prescribe a lower maintenance dose than normally recommended.

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

Patients with reduced kidney function

Serdolect can be used in usual doses in patients with reduced kidney function. Method of use

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

Duration of use

Take the tablets for as long as your doctor recommends.

Never change the dose of the medicine without talking to your doctor first.

If you want to stop using the medicine, please consider the information in section 3 under "If you stop taking Serdolect”.

If you take more Serdolect than you should

Contact your doctor or nearest hospital immediately if this occurs. Do this even if there are no signs of discomfort. Signs of an overdose are:

•    increased fatigue

•    slurred speech

•    increased pulse

•    low blood pressure

If you forget to take Serdolect

Do not take a double dose to make up for a forgotten dose. Contact your doctor if you forget to take your daily dose. Your doctor will make sure you restart your treatment the right way.

If you stop taking Serdolect

Do not stop taking Serdolect without your doctor’s permission, even if you begin to feel better. The underlying illness may persist for a long time. If you stop treatment too soon the symptoms of your illness may return and involuntary movements might also occur.

Your doctor will advise on when and how to stop your treatment to avoid any unpleasant symptoms that might occur. Abruptly stopping Serdolect use may cause discontinuation symptoms, such as:

•    nausea, vomiting

•    sweating

•    sleeping difficulties

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor or the hospital immediately if you get any of the side effects provided in the next four bullet points:

Uncommon: may affect up to 1 in 100 people

•    very fast, uneven or forceful heartbeats, dizziness, fainting, shortness of breath or chest pain

These symptoms could indicate a life-threatening irregular heartbeat.

•    uncontrollable movements mainly of the mouth, tongue and limbs

These could indicate the nervous system disorder called tardive dyskinesia.

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

•    a combination of fever, fast breathing, sweating, muscle stiffness and drowsiness or sleepiness

These symptoms may indicate the life-threatening nervous system condition called neuroleptic malignant syndrome.

Not known: frequency cannot be estimated from the available data

•    blood clots in the veins especially the legs (symptoms include swelling, pain and redness in the leg), which may travel through 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 inside the nose which causes sneezing, itching, runny and blocked nose

•    inability to ejaculate

Common: may affect up to 1 in 10 people

•    dizziness or sudden dizziness resulting from fall in blood pressure when standing up

•    dry mouth

•    weight gain

•    shortness of breath

•    swelling of hands or feet

•    peculiar sensation in the skin    like    pins and    needles

•    decreased ejaculatory volume

•    impotence

•    changes in the electrical activity of your heart (Called    "QT prolongation”). QT

prolongation can give rise to symptoms such as palpitation and fainting

•    red and white blood cells in the urine

Uncommon: may affect up to 1 in 100 people

•    high blood sugar

•    irregular heartbeat known as    Torsades de    pointes

•    increased blood levels of the hormone called    prolactin

•    spontaneous flow of milk from the breast

•    fits, fainting

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Serdolect

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

Do not use this medicine after the expiry date, which is stated on the label or carton after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Serdolect contains

•    The active substance is sertindole.

Each film-coated tablet contains 4 mg, 12 mg, 16 mg or 20 mg sertindole.

•    The other ingredients are:

-    maize starch

-    lactose monohydrate

-    hyprolose

-    hypromellose,

-    microcrystalline cellulose

-    croscarmellose sodium

-    magnesium stearate

-    macrogol 400

-    titanium dioxide

-    iron oxide (E172)

Serdolect 4 mg: iron oxide yellow (E172)    Serdolect 12 mg: iron

oxide yellow (E172), iron oxide red (E172)

Serdolect 16 mg: iron oxide red (E172)

Serdolect 20 mg: iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172)

What Serdolect looks like and contents of the pack

Serdolect is presented as 4 mg, 12 mg, 16 mg and 20 mg film-coated tablets.

4 mg film-coated tablets are oval, rounded on the upper and lower side, yellow and marked with "S4" on one side

12 mg film-coated tablets are oval, rounded on the upper and lower side, beige and marked with "S12" on one side

16 mg film-coated tablets are oval, rounded on the upper and lower side, rose and marked with "S16" on one side

20 mg film-coated tablets are oval, rounded on the upper and lower side, pink and marked with "S20" on one side.

Serdolect is available in packs containing 7, 10, 14, 20, 28, 30, 50, 98, or 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

H. Lundbeck A/S Ottiliavej 9 2500 Valby Denmark

Tel: +45 4371 4270

This medicinal product is authorised in the following member states of the EU/EEA under the following name:

Name of the member	Name of the medicinal
state	product
Austria	Serdolect
Belgium	Serdolect
Bulgaria	Serdolect
Croatia	Serdolect
Czech Republic	Serdolect
Denmark	Serdolect
Estonia	Serdolect
Finland	Serdolect
Germany	Serdolect
Greece	Serdolect
Hungary	Serdolect
Iceland	Serdolect
Latvia	Serdolect
The Netherlands	Serdolect
Norway	Serdolect
Poland	Serdolect
Romania	Serdolect
Slovakia	Serdolect
Spain	Serdolect
Sweden	Serdolect
United Kingdom	Serdolect

This leaflet was last revised in 02/2016.

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