4 mg and 12 mg film-coated tablets
Sertindol
What Serdolect is and what it is 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 cause your symptoms.
Serdolect is used to treat schizophrenia in cases where other medicines have not been effective.
Sertindole contained in Serdolect may also be approved for the treatment of other conditions not mentioned in this information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Serdolect
Do not use Serdolect
if you are/have
- allergic to sertindole or any of the other ingredients of this medicine (listed in section 6)
- low levels of potassium or magnesium in the blood and not treated for this
- a cardiovascular disease
- serious heart disease such as
- heart failure with tissue swelling caused by fluid retention
- heart enlargement
- irregular or slow pulse
- a congenital QT interval or have had an extended QT interval, measured with an ECG, or if someone in your family has this abnormal heart rhythm
- very impaired liver function
- taking drugs that prolong the QT interval or affect liver function. See the first two points under “Other medicines and Serdolect” in section 2.
Warnings and cautions
Talk to your doctor before taking Serdolect if you are/have:
- vomited or had diarrhea during treatment with Serdolect
- hepatic impairment
- 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, or smoking
- over 65 years
- or someone in your family has had a blood clot before as anti-schizophrenia drugs have been linked to blood clots
- had seizures
- had unusual movements with the mouth and tongue as this may be early signs of a condition of the central nervous system called tardive dyskinesia
- high fever, unusual muscle stiffness, and changes in the level of consciousness, especially if it occurs in connection with sweating and rapid pulse. These symptoms may be signs of a rare but serious condition called a malignant neuroleptic syndrome.
At the beginning of treatment with Serdolect, you may become dizzy when you get out of bed or get up. Your doctor will reduce the risk of this by starting your treatment with a low dose and gradually increasing the dose over several weeks. These symptoms usually go away after taking Serdolect for a while.
Examination before and during treatment
Before and during your treatment with Serdolect, your doctor will perform certain tests, such as:
- a cardiac examination ( ECG ) to check if the QT interval has been extended. This test is repeated when you have been treated with Serdolect for 3 weeks or when you reach a daily dose of 16 mg of sertindole. During maintenance treatment, the test should be repeated every 3 months and before and after a dose increase. This also applies to changes in other medicines that may affect the level of sertindole in the blood.
- a blood test to check the amount of potassium and magnesium in your blood. If the amount of potassium or magnesium is too low, your doctor will need to treat this condition. Do not take Serdolect if you have low levels of potassium or magnesium in your blood and are not being treated for it. Contact your doctor if you experience vomiting, diarrhea, electrolyte disturbances or are taking anticoagulants. Your doctor may need to measure the amount of potassium in your blood.
- blood pressure measurement.
Children and young people
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 with the following medicines:
- drugs that can affect the heart rhythm, such as:
- certain medicines for irregular heartbeat, such as quinidine, amiodarone, sotalol, dofetilide
- certain medicines for mental illness, such as thioridazine
- some medicines for the bacterial infection you with an active substance that ends in “mycin”, such as erythromycin
- certain medicines for allergies, such as terfenadine, astemizole
- some medicines for the bacterial infection you with an active substance ending in “oxacin”, such as gatifloxacin, moxifloxacin
- cisapride: a medicine for stomach and/or intestinal problems
- lithium: a drug for depression and mental illness
- Drugs that are known to affect liver function, such as:
- oral medications for fungal infections such as ketoconazole, itraconazole
- some medicines for the bacterial infection you with an active substance that ends in “mycin”, such as erythromycin, clarithromycin
- medicines for HIV infection you with an active substance that ends in “never”, such as indinavir
- certain medicines for high blood pressure and heart disease called calcium channel blockers, such as diltiazem, verapamil
- cimetidine: a drug used to reduce the amount of stomach acid
Other medicines that may or may not affect Serdolect are:
- medicines for Parkinson’s disease called dopamine agonists
- certain medicines for depression and anxiety disorders, such as fluoxetine, paroxetine
- rifampicin: a medicine for tuberculosis or some other infection
- carbamazepine, phenytoin and phenobarbital: antiepileptic drugs
- drugs that are diuretics, which can reduce potassium levels in the blood.
Serdolect with food, drink, and alcohol
Avoid alcohol during treatment with Serdolect, even if alcohol is not expected to affect Serdolect.
Pregnancy, breastfeeding, and fertility
- Pregnancy
Serdolect is not recommended during pregnancy.
The following symptoms may occur in newborns of mothers who have used Serdolect during the last trimester (last three months of pregnancy):
- shaking
- muscle stiffness and/or weakness
- drowsiness, anxiety
- breathing problems
- difficulty eating
Contact your doctor if your child has any of these symptoms.
- Breast-feeding
Serdolect should not be used during breastfeeding unless your doctor considers it necessary. Consider stopping breastfeeding if treatment with Serdolect is necessary as Serdolect passes into breast milk.
- Fertility
Serdolect may have side effects that may affect your sexual activity and your ability to have children. These side effects are transient. 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 if Serdolect does not cause drowsiness.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Serdolect contains excipients
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Serdolect
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is
- starting dose: 4 mg once daily. The dose is then increased by 4 mg at a time every 4-5 days until the maintenance dose is reached.
- maintenance dose: 12 mg-20 mg once daily
- maximum daily dose: 24 mg once daily and should only be considered in exceptional cases.
Patients over 65 years
Your doctor will probably increase the dose of one of Serdolect for a longer period than is normally recommended. Your doctor may also prescribe a lower maintenance dose than what is normally recommended.
Patients with hepatic impairment
If you have mild or moderate liver problems, your doctor may want to examine you more often and will probably increase your dose of Serdolect for a longer period than is normally recommended. Your doctor may also prescribe a lower maintenance dose than what is normally recommended.
Serdolect should not be used in patients with severe hepatic impairment.
Patients with renal impairment
Serdolect can be used in normal doses in patients with renal impairment.
Treatment method
Swallow the tablet whole with a glass of water at the same time each day. Take the tablets with or without food.
Duration of treatment
Take the tablets as long as your doctor recommends them.
Never change your dose without first talking to your doctor.
If you want to stop taking the medicine, read section 3 “If you stop taking Serdolect”.
If you use more Serdolect than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice. Do this even if you do not experience any discomfort or signs of poisoning.
Symptoms of overdose may include:
- increased fatigue
- slurred speech
- increased heart rate
- low blood pressure
If you forget to use Serdolect
Do not take a double dose to make up for a forgotten dose. Contact your doctor if you have missed your daily dose of Serdolect. Your doctor will help you resume your treatment properly.
If you stop using Serdolect
Do not stop taking Serdolect without talking to your doctor, even if you feel better. The underlying disease can persist for a long time. If you stop treatment too soon, your symptoms may return and you may also experience involuntary movements.
Your doctor will decide when and how to stop your treatment, to avoid unpleasant symptoms that may occur. Abrupt discontinuation of Serdolect treatment may cause withdrawal symptoms, such as:
- nausea, vomiting
- sweating
- difficulty sleeping.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
This medicine can cause side effects like all medicines, although not everybody gets them.
Contact your doctor immediately or go to the nearest hospital if you experience any of the following symptoms as described in the following four points:
Uncommon (may affect up to 1 in 100 people):
- very fast, irregular or powerful heartbeat, dizziness or fainting, shortness of breath, or chest pain. These symptoms may be signs of a life-threatening heart rhythm disorder.
- uncontrollable movements, mainly in the mouth, tongue, and arms, and/or legs. This may be a sign of a central nervous system disorder called tardive dyskinesia.
Rare (may affect up to 1 in 1,000 people):
- a combination of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or drowsiness. These symptoms may be signs of the malignant neuroleptic syndrome.
Has been reported (occurs in an unknown number of users):
- blood clots in the veins, especially in the legs (symptoms may be swelling, pain, and redness of the legs) can be transported via blood vessels to the lungs and cause chest pain and difficulty breathing.
Other possible side effects that may occur with the following frequency are:
Very common (may affect more than 1 user in 10):
- inflammation of the nose that causes sneezing, itching, runny and stuffy nose
- absent ejaculation
Common (may affect up to 1 in 10 people):
- dizziness or sudden dizziness due to a drop in blood pressure when you stand up
- dry mouth
- weight gain
- respiratory distress
- swollen hands and feet
- strange stinging / creeping feeling in the skin
- reduced ejaculation volume
- impotence
- changes in the electrical activity of the heart (called QT prolongation). QT prolongation can cause symptoms such as palpitations and fainting
- red and white blood cells in the urine
Uncommon (may affect up to 1 in 100 people):
- elevated blood sugar
- irregular heartbeat called Torsade de Pointes
- increased blood levels of a hormone called prolactin
- spontaneous milk secretion from the breasts
- seizures, fainting
A small increase in the number of deaths in elderly people with dementia treated with mental illness drugs has been reported.
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 expiration date is the last day of the specified month.
Store in the original package to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is sertindole.
Each Serdolect film-coated tablet contains 4 mg or 12 mg of sertindole.
- Other ingredients are:
- corn starch
- lactose monohydrate
- hydroxypropylcellulose, hypromellose
- microcrystalline cellulose
- croscarmellose sodium
- magnesium stearate.
- macrogol 400
- titanium dioxide
- iron oxide (E172):
Serdolect 4 mg: yellow iron oxide (E172)
Serdolect 12 mg: yellow iron oxide (E172), red iron oxide (E172).
What the medicine looks like and the contents of the pack
Serdolect is available as 4 mg and 12 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
Serdolect is available in packs of 7, 10, 14, 20, 28, 30, 50, 98 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
H. Lundbeck A / S
Ottiliavej 9
2500 Valby
Denmark
Contact the representative of the marketing authorization holder to find out more about this medicine:
Agent
H. Lundbeck AB
Hyllie Boulevard 34
215 32 Malmö
Tel: 040-699 82 00
This medicinal product is authorized under the European Economic Area under the names:
Belgium: Serdolect
Bulgaria: Serdolect
Denmark: Serdolect
Estonia: Serdolect
Finland: Serdolect
Greece: Serdolect
Holland: Serdolect
Iceland: Serdolect
Croatia: Serdolect
Latvia: Serdolect
Norway: Serdolect
Poland: Serdolect
Romania: Serdolect
Slovakia: Serdolect
Spain: Serdolect
Sweden: Serdolect
Czech Republic: Serdolect
Germany: Serdolect
Hungary: Serdolect
Austria: Serdolect