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SERDOLECT 20MG FILM COATED TABLETS

Active substance(s): SERTINDOLE

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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

1.

What Serdolect is and what it is used for

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.

2.

What you need to know before you take Serdolect

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.

1

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

2


-

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.

3

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.

3.

How to take Serdolect

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”.

4

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.

4.

Possible side effects

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

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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.

6

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.

6.

Contents of the pack and other information

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:

7

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

Name of the medicinal
product
Serdolect
Serdolect
Serdolect
Serdolect
Serdolect
Serdolect
Serdolect
Serdolect
Serdolect
Serdolect
Serdolect
Serdolect
Serdolect
Serdolect
Serdolect
Serdolect
Serdolect
Serdolect
Serdolect
Serdolect
Serdolect

This leaflet was last revised in 02/2016.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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