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SERDOLECT 4 mg. 30 tablets

Product Code: SERDOLECT 4 mg. 30 tablets
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SERDOLECT 4 mg. 30 tablets

How does Serdolect?
Serdolect belongs to a group of medicines known as antipsychotics. These medications help correct certain chemical imbalances in the brain that cause the symptoms of your illness.

What is Serdolect?
Serdolect is used to treat schizophrenia.
However, your doctor may prescribe this medicine for other purposes. Ask your doctor if you have any questions about why you have been prescribed Serdolect.


Do not take Serdolect
■ If you are allergic (hypersensitive) to sertindole or any of the other ingredients of Serdolect (see section 6)..
■ If you have impaired water-salt balance (too little potassium or magnesium in the blood), and your doctor is not treating you to correct this condition.
■ If you have a severe blood vessel disease or severe heart disease such as heart failure, cardiac hypertrophy (thickening of the heart muscle), irregular heart rhythm (arrhythmia) or unusually slow rate (less than 50 beats per minute).
■ If your doctor has checked your heartbeat electrocardiogram ECG and prolongation of QT-interval (a certain part of the ECG). This condition may be congenital or spontaneously appeared.
■ If you have severe liver disease.
■ If you are taking medications that can prolong the QT-interval or may alter the amount Serdolect in your blood. Examples of such drugs include: drugs used in the treatment of abnormal heart rhythm (eg. Quinidine, amiodarone, sotalol, dofetilide) antipsychotics (eg. Procainamide)
■ antibiotic macrolide (eg. Erythromycin, clarithromycin) quinolone antibiotics (eg. Gatifloxacin, moxifloxacin) antihistamines used to treat startled fever or other allergies (eg. Terfenadine, astemizole)
■ antifungal agents from the group of "azoles" (eg. Ketoconazole, igrakonazol)
■ drugs known as calcium channel blockers, used for the treatment of high blood pressure, or pain in the chest (e. Diltiazem, verapamil), drugs such as lithium (used for the treatment of manic-depressive illness), cisapride (used to treat stomach problems ), cimetidine (used to treat stomach ulcers) and indinavir (used for the treatment of IIIV infection)

Take special care with Serdolect

Before and during your treatment with Serdolect, your doctor must perform certain tests to determine whether treatment with Serdolect is safe for you. Tests may include:
■ electrocardiogram (ECG) of your heart to check that the QT-interval is not extended. This test will usually be repeated during the treatment with Serdolect approximately 3 weeks or when you reach a daily dose of 16 mg Serdolect and again after 3 months. This test will be repeated every three months and if the dose is increased or Serdolect dose of other medications you are taking changes.
■ A blood test to identify the beer of potassium and magnesium. If the amount of potassium or magnesium is too low, your doctor will need to treat this condition.
■ Track your blood pressure.
Patients suffering from dementia and treated with antipsychotics have an increased risk of stroke. Serdolect should be used with caution in these patients.
Take special care with Serdolect, or if you have diabetes.

Take special care with Serdolect:
• if you or another member of your family have had blood clots, as medicines and this is associated with formation of blood clots

During the intake Serdolect should contact your doctor:
■ if you develop fever, if it appears unusually stiff muscles or disturbance of consciousness, especially if it is accompanied by sweating and rapid heart beat. This may constitute a rare condition known as neuroleptic malignant syndrome. If such symptoms occur, please immediately contact your doctor. Most likely your doctor will discontinue Serdolect.
■ if any abnormal movements of the body, mouth or tongue. Contact your doctor immediately at the onset of such symptoms as they may be signs of a condition known as late diskiieziya. Your doctor may choose to reduce the dose or discontinue treatment with Serdolect.
■ If you have had seizures (convulsions) recently or in the past. In this case, caution should be exercised in the treatment with Serdolect.
■ If you experience palpitations (abnormal heart rate), you sick or have seizures. May be necessary for your doctor to monitor you more closely during treatment and may need making ECG.
■ If you experience vomiting or diarrhea or if you are taking medicines known as diuretics (water pills). Ge are commonly used to treat high blood pressure or edema (when your body retains more fluid). Your doctor may check the amount of potassium in your blood.
At the beginning of treatment with Serdolect may feel dizzy when getting out of bed or standing. This feeling will probably disappear as you continue taking Serdolect for some time. Your doctor will reduce the risk of dizziness when standing up starting treatment with a lower dose and increase it for several weeks.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines can affect the amount Serdolect in your blood. Therefore be careful when taking Serdolect with the following medications (See "// is take Serdolect" in section 2):
■ dopamine agonists (drugs used to treat Parkinson's disease) since their effect can be reduced by taking some antipsychotics.
■ fluoxetine and paroxetine (used to treat depression) as they can lead to an increase in the amount Serdolect your body above normal levels.
■ carbamazepine, phenytoin and phenobarbitone (used for the treatment of epilepsy) and rifampicin (antibiotic, most commonly used to treat tuberculosis) as they may reduce the effect of Serdolect.

If your doctor change the dose of any of your acceptance of medications may need to modify the dose of Serdolect and ECG.

Taking Serdolect with food and drink
Serdolect can be taken with or without food

Bremen post and lactation
If you are pregnant, ask your doctor or pharmacist for advice before taking any medicine.
Serdolect safety during pregnancy has not been established. Therefore Serdolect should not be used during pregnancy. Consult your doctor if you are pregnant or if you become pregnant during treatment with Serdolect.
The following symptoms may occur in newborn babies of mothers who used sertindole in the last quarter (last three months of pregnancy): shaking, muscle stiffness and / or weakness, sleepiness, agitation, breathing problems, and difficulty eating. If your baby develops any of these symptoms you may need to contact your doctor.
When breast-feeding, ask your doctor or pharmacist before taking any medicine. Sertindole is excreted in human milk. If it is found that treatment with Serdolect necessary, breast-feeding should be discontinued.

Driving and using machines
Serdolect does not cause drowsiness. However, as with any new product must be careful when driving or operating machinery until evaluate how it affects you.
Important information about some of the ingredients of Serdolect
This product contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

What you get?
Always take Serdolect exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.

Initial phase:
The usual starting dose is 4 mg daily.
Every 4 to 5 days, the dose will be increased by 4 mg until a maintenance dose. Maintenance treatment:
The usual maintenance dose is 12 to 20 mg once daily Serdolect. The dose prescribed by your doctor depends on how you respond to treatment with this medicine. Very rarely it may be necessary for your doctor to prescribe a maximum dose of 24 mg daily Serdolect.

Most likely your doctor will increase your dose at longer intervals than the recommended standard. It is also possible he can prescribe a lower maintenance dose of the recommended standard.

Children and adolescents (under 18 years):
Serdolect generally not be given to children and adolescents.

Kidney problems:
Serdolect can be given in usual doses to patients with kidney problems. Patients with special risks
If you have mild or moderate liver problems, your doctor may want to monitor you more closely and will most likely increase your dose Serdolect in longer intervals than recommended standard. It is also possible, your doctor can prescribe a lower maintenance dose of the recommended standard.

How and when to take Serdolect
Serdolect taken as a single daily dose. Serdolect can be taken with or without food. Swallow the tablets with water.

Duration of treatment
The duration of treatment is determined by your doctor. Take the tablets for as long as recommended by your doctor. Do not stop taking Serdolect, even if you begin to feel better, except in cases where you have been told by your doctor. Underlying disease can last a long time and if you stop your treatment too soon, your symptoms may reappear.
Never change the dose of your medicine without first talking to your doctor.

If you take more dose Serdolect
Symptoms of overdose may include Serdolect:
■ increased fatigue,
■ slurred speech,
■ rapid pulse,
■ low blood pressure.
If you think you or anyone else may have taken too many tablets Serdolect, immediately contact your doctor or pharmacist or go immediately to the nearest emergency medical care. Do this even if you have symptoms of discomfort or poisoning. Take the container with you Serdolect if you go to the doctor or hospital.

If you forget to take Serdolect
Do not take a double dose to make up the missed dose.
Talk to your doctor if you forget to take your daily dose Serdolect. Your doctor will take care to restart your treatment the right way.

If you are a cheese intake Serdolect
Your doctor will decide when and how to end your treatment, to avoid unpleasant symptoms that might arise in the event of sudden braking.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Serdolect can cause side effects, although not everybody gets them. At the beginning of treatment with Serdolect can be side effects, but usually they will disappear if you take Serdolect for some time.
If you are concerned about side effects or last more than a week or two, contact your doctor. Moreover, be sure to contact your doctor in case of appearing some of the symptoms listed in the "Take special care with Serdolect" in item 2.
Adverse events observed during treatment with Serdolect are listed below:
Very common (more than 1 in 10 patients): * rhinitis (stuffy nose)
Common (more than 1 in 100 patients):
■ lightheadedness or dizziness when standing up * dry mouth
■ weight gain
■ breathlessness
■ swelling of the extremities
■ specific sensation on the skin like needles
■ reduced ejaculatory volume
■ QT-interval prolongation (changes in the ECG)
■ more red and white blood cells in urine

Uncommon (less than 1 in 100 but more than 1 in 1000 patients):
■ increased blood sugar
■ fainting
■ seizures or convulsions
■ abnormal movements of the body or of the lips and tongue (this may be indicative of the condition known as tardive dyskinesia)
■ specific type of violation heart rhythm known as Torsades de pointes

Rare (less than 1 in 1000 is not more than 1 in 10,000 patients):
■ high temperature, unusual muscle stiffness, mental disorder, sweating and rapid heart beat (neuroleptic malignant syndrome - see "Take special care with Serdolect.")
Very rare (less than 1 in 10,000 patients)
Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please ask your doctor or pharmacist.

Keep out of reach of children.
Serdolect not use after the expiry date stated on the label or carton.
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.

What Serdolect?
The active substance is sertindole.
Each tablet contains Serdolect 4 mg, 12 mg, 16 mg or 20 mg of the active ingredient sertindole.
Other ingredients are:
Core: corn starch, lactose monohydrate, hyprolose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
Tablet coating: hypromellose, macrogol 400, titanium dioxide (white E171): 4 mg: iron oxide yellow (E172)
12 mg: iron oxide yellow (E172), iron oxide red (E172) 16 mg: iron oxide red (E172)

Serdolect looks like and contents of the pack
Serdolect is available as tablets of 4 mg, 12 mg, 16 mg and 20 mg.
4 mg: tablets are oval, yellow, biconvex tablets marked with "S4" on one side.
12 mg: tablets are oval, beige, biconvex film-coated tablets marked with "S12" on one side.
16 mg: tablets are oval, dark pink, biconvex tablets marked with "S16" on one side.

The following packages
4 mg 30 tablets in blister packs of 12 mg: 28 tablets in blister packs of 16 mg: 28 tablets in blister
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder



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