Serdolect (Sertindole) Tablets

1. What is SERDOLECT and what is it used for?

SERDOLECT 16 mg Film Coated Tablet contains 16 mg sertindole.

SERDOLECT 16 mg Film Coated Tablet is in cardboard box in 28 tablet blister package.
Oval, pinkish red, biconvex film-coated tablets printed on one side "S16".

SERDOLECT is included in a group of drugs known as antipsychotics. These drugs work by correcting chemical imbalances in the brain. Too much dopamine or very little serotonin in the body's chemicals can cause symptoms of mental illness. Sertindole, the active ingredient of SERDOLECT, corrects this imbalance.
SERDOLECT is used in the treatment of schizophrenia. SERDOLECT will affect your heart, but your doctor will prescribe SERDOLECT if you do not continue to take another antipsychotic drug.
If you have no problem about why SERDOLECT is prescribed to you, do not worry about your doctor.

Use SERDOLECT ATTENTION:

Since drugs such as SERDOLECT are associated with blood clotting disorders, use caution if you or your family have a history of blood clotting disorders.
• If you have stroke risk factors such as high blood pressure, cardiovascular disorders, or cerebrovascular problems.
• You are over 65 years old.
• If you have Parkinson's disease (tremor, slowing of movements, muscle stiffness, gait disturbance and central nervous system disease with some other symptoms).
• If you have liver disease.
There is an increased risk of stroke in elderly patients with dementia using antipsychotic medication (those with impaired memory or loss of mental skills). The use of SERDOLECT in demented elderly patients is not recommended.
If you are a diabetic patient, the follow-up of your physical health also requires special attention. Your doctor will examine you and tell you if SERDOLECT is right for you.
Postural hypotension may occur at the onset of SERDOLECT use (postural hypotension is a blood pressure drop due to a change in position due to sudden onset of the foot when lying down or sitting).
If you have had seizures (convulsions) in the past or in the past, inform your doctor before using SERDOLECT. In this case, more careful treatment with SERDOLECT will be necessary.
As with other antipsychotics, involuntary abnormal movements (tardive dyskinesia) may occur during treatment with SERDOLECT in the limbs such as the body, face, arm, and leg. In this case, your doctor may consider reducing the drug dose or cutting the drug.
The use of antipsychotic medication may result in a high fever known as neuroleptic malignant syndrome (NMS), a change in consciousness level, and a hardening in the muscles. Your doctor may terminate your medication immediately.
If antipsychotic drugs are suddenly interrupted; Acute withdrawal reactions, including nausea, vomiting, sweating, and insomnia can occur, so it is advisable to consult your physician to gradually cut the medication.
Physical Health and SERDOLECT
Before SERDOLECT and during your treatment with your doctor SERDOLECT, some examinations will be conducted to decide if the treatment is safe for you. These reviews may include:
• Your heart's electrocardiogram (ECG) to check that the QT interval is not prolonged. This test will be performed when you have been treated with SERDOLECT for about 3 weeks or when you have reached the 16 mg daily dose of SERDOLECT and again after 3 months. This test will be repeated every 3 months and if the SERDOLECT dose is increased or your other medicines are changed.
• If your blood or magnesium level is too low, your doctor will need to treat it.
• Monitoring your blood pressure.
• Some medications used to treat depression, such as fluoxetine and paroxetine, can increase the incidence of sertindole by 2-3 mines. SERDOLECT should be used with these drugs very carefully and only if the potential benefit is higher than the risk (see also use with other drugs).
"Please consult your doctor if these warnings apply to you at any time in the past."
Use of SERDOLECT with food and beverage
SERDOLECT can be taken with or without food.

Pregnancy
If you are pregnant, consult your doctor or pharmacist before taking any medication.
SERDOLECT during pregnancy has not been proven safe. Therefore SERDOLECT should not be used during pregnancy.
Newborn babies who have used SERDOLECT during the last three months of their pregnancy may experience the following symptoms: chills, muscle stiffness and / or weakness, sleepiness, restlessness, respiratory problems, and difficulty in feeding. If you have any of these symptoms in your baby, contact your doctor.
Sertindole may have side effects that can affect sexual activity and reproductive ability. These effects are not permanent. We discuss any problems with your sexual activity with your doctor.
If you are planning to become pregnant or if you become pregnant while using SERDOLECT, consult your doctor.

Breast-feeding
Consult your doctor or pharmacist before taking any medicines while you are breastfeeding.
Sertindol is a mother. You should not continue to breastfeed if treatment with SERDOLECT is deemed necessary.
Vehicle and machine use
SERDOLECT does not cause drowsiness. But as with any new medication, you should be careful when using a vehicle or machine until you see how the medication affects you.
Important information about some of the auxiliary substances contained in SERDOLECT
This product contains lactose. If you have previously been told by your doctor that you have intolerance to certain sugars, you should consult your doctor before taking this medicinal product.

Use with other medicines
Some medications may affect the amount of SERDOLECT in your blood. Therefore SERDOLECT should be especially taken care when used with the following medicines:
• fluoxetine and paroxetine (used in the treatment of depression) as it may cause the amount of SERDOLECT in your body to rise above normal levels. Your doctor may decide to reduce the dose of SERDOLECT.
• phenytoin (a drug used to treat epilepsy), phenobarbitone (a drug that stops and stops epileptic seizures), and rifampicin (the most commonly used antibiotic in the treatment of tuberculosis (TB)), as it may reduce the SERDOLECT effect.
• Dopamine agonists (used in the treatment of Parkinson's disease) as they may be reduced by some antipsychotics.
If your doctor changes the dose of any medication, your doctor may also need to change the SERDOLECT dose and perform an ECG test.
Please inform your doctor or pharmacist if you are using or have recently used any medicine with or without a prescription.

3. How to use SERDOLECT
• Instructions for proper use and dose / application frequency:
Always use SERDOLECT exactly as your doctor tells you. If you are unsure, you should talk to your doctor or pharmacist.
Normal starting dose is 4 mg per day. The dose will be increased by 4 mg every 4-5 days until the dosage is reached.
The normal daily dose is 12 - 20 mg SERDOLECT once a day. The dose prescribed by your doctor is based on your gentle response. Very rarely, your doctor may need to prescribe a maximum dose of 24 mg per day.
Continue to use tablets for the duration recommended by your doctor. Even if you start to feel better, do not stop using the tablets without being told by your doctor. The underlying disease may last for a long time, and your symptoms may return very soon after you have stopped treatment. You should never change the dose of the medicine without talking to your doctor.
• Application route and method:
SERDOLECT is taken as a single daily dose once daily. You can take it with or without food, but if you take it with a meal it will remind you to take your medicine at about the same time each day. Drink the tablets with water.

• Different age groups:
Use in children (under 18 years of age):
SERDOLECT is not usually used in children and adolescents.

Use in the elderly:
Your doctor probably will raise your dose of your tablets longer than normally recommended. Your doctor will prescribe a prescription that is probably lower than normally recommended.
• Special use cases:
Kidney / Liver failure:
SERDOLECT patients with kidney problems can be given at normal doses.
If you have a mild to moderate hepatic problem, your doctor may want to monitor you more closely and possibly increase your SERDOLECT dose after a longer time than normally recommended. Your doctor will prescribe a prescription that is probably lower than normally recommended.
If you have an impression that the effect of SERDOLECT is too strong or weak, talk to your doctor or pharmacist.
If you use more SERDOLECT than you need:
If you use more from SERDOLECT than you should, talk to a doctor or pharmacist.
Overdose indication:
• Fatigue
• Speech impairment
• Pulse increase
• Blood pressure drop
If you or someone else think that you may have received too many SERDOLECT film coated tablets, contact your doctor or pharmacist immediately or go to the immediate area of your nearest hospital. Do this even if there is no sign of discomfort or poisoning. If you go to a doctor or a hospital, you will be taken to the SERDOLECT box.
If you forget to use SERDOLECT:
Do not take double doses to compensate for the forgotten taste.
If you forget to take the SERDOLECT daily dose, please contact your doctor. Your doctor will restart your treatment correctly.

Effects that can occur when treatment with SERDOLECT is terminated:

Your doctor will decide when and how to get your treatment done to prevent a symptom that may occur because the medicine is suddenly stopped.
If you have further questions about the use of this product, consult your doctor or pharmacist.

4. What are the possible side effects?
As with all medicines, people sensitive to substances in the SERDOLECT content may have side effects, though not herbaceous.
With SERDOLECT, you can be back at the beginning of treatment, when you are lying down, or when you stand up. This will most likely disappear after using SERDOLECT for a while. Your doctor will reduce the risk of dizziness by starting low doses on tablets and raising doses every few weeks.
If side effects are uncomfortable or if you continue for more than a week or two, consult your doctor. If any side effects become serious or you notice an effect that is not covered by these instructions for use, please contact your doctor or pharmacist.
The side effects are listed as shown in the following categories:
Very common: it can be seen in at least 1 of 10 patients.
Common: less than 1 in 10 patients, but more than 1 in 100 patients.
Uncommon: less than 1 in 100 patients, but more than 1 in 1,000 patients.
Rare: less than 1 in 1,000 patients, but more than 1 in 10,000 patients.
Very rare: less than 1 in 10,000 patients.
It is not known: the frequency can not be estimated.
If you experience any of the following symptoms, inform your doctor or go to the hospital immediately.
Unusual:
• Very fast or irregular or strong heartbeat, dizziness or faintness. You may also have shortness of breath or chest pain. These symptoms may be life threatening irregular heartbeat.
• Uncontrolled movements of the tongue and limbs, primarily the mouth (which may indicate a condition known as tardive dyskinesia)

Rare:
• Combination of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness (these symptoms may be the indication of Neuroleptic Malignant Syndrome)
Unknown:
• In particular, blood clots that form in the veins of your legs (which manifest with swelling, pain, and redness in the legs) can travel up to the lungs through the blood vessels and cause blockage of the chest pain and breathing difficulty.
In addition to the above, the following side effects have been reported:

Very common:
• Rhinitis (nasal obstruction)
• Ejaculation failure
Common:
• Dizziness or dizziness when the leg is raised
• Oral establishment
• Weight gain
• Shortness of breath
• Sweating of hands or feet
• Skin numbness or tingling
• Decrease in ejaculate volume (decrease in semen volume)
• Impotens (sexual weakness, impotence)
• Changes in your heart's electrical activity (called "QT prolongation"). QT prolongation may cause symptoms such as palpitation and fainting.
• Red and white blood cells in the urine. This can be tested by your doctor.
Unknown:
• Neonatal withdrawal syndrome (clinical picture of uncomfortable, muscle tension (hypertonia), muscle loosening (hypotony), tremor, sleepiness, respiratory distress, or malnutrition in newborns following birth)
Unusual:
• High blood sugar
• Irregular heartbeat known as "Torsades de pointes"
• Increase in the level of the prolactin
• Substantially similar or clear fluids from the breasts (galactore)
It has been reported that the mortality rate in demented elderly patients treated with antipsychotic treatment increased in a small amount compared to those who did not receive antipsychotic treatment.

If you are unwell or diarrhea, or if you are on diuretics, inform your doctor. Diuretics are often used to treat edema or high blood pressure that occurs when your body has excess water retention. Your doctor may measure the amount of potassium in your blood.
If any of the side effects become serious or if you experience any side effects that do not occur in the instructions for use, please inform your doctor or pharmacist.

Reporting side effects
Talk to your doctor, pharmacist or nurse if you have any side effects that are included or not in the Instructions for Use. You can also see the side effects you are encountering by clicking on the "Drug Side Effects" icon at www.titck.gov.tr ​​or
00 of 08 No. 0,800,314 by calling Turkey Pharmacovigilance Center line side impact statement (TÜFAM) 'What do you notice. By reporting side effects, you will contribute to learning more about the safety of the medicine you are using.
5. Storage of SERDOLECT
Keep SERDOLECT in places where children can not, can not reach, and in their packaging.
Store it in its original package at room temperature below 25 ° C to protect it from light.
Use in accordance with expiration dates.
Do not use SERDOLECT after the expiration date on its packaging.
The expiration date specifies the last day of the month.
Do not dispose of your household wastes or waste water in your home. Please contact your pharmacist to find out how to dispose of your pesticide. These measures are important for the protection of the environment.