Quelept Side Effects and Prospectus Prospektus and Side Effects

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What is QUELEPT and what is it used for?

QUELEPT is a white, capsule-shaped, biconvex, film-coated tablet. Available in cardboard boxes containing 10 or 3 blisters with 6 film-coated tablets in each blister.

QUELEPT is a drug belonging to the group of drugs, the active substance of which is ketiapine, called antipsychotics (drugs used in the treatment of psychiatric diseases).

This group of drugs is effective in the treatment of certain psychiatric diseases, such as:

  • Hallucinations (such as hearing inexplicable sounds), strange and frightening thoughts, changes in behavior and thought, and states of confusion, including,
  • Extreme enthusiastic or excited mood. People in this mood; they need less sleep than usual, they are more talkative, they may notice that thoughts or ideas flow quickly. These people may be unusually nervous.
  • The grieving feeling situation. People with this mood may feel pessimism, guilt, loss of energy, decreased appetite and/or insomnia.

    • When your doctor feels better, they may continue to give you QUELEPT to prevent symptoms from recurring.

    It may be helpful to tell a friend or relative that you are uncomfortable with these symptoms and ask them to read this instruction. If they think your symptoms are getting worse or are concerned about other changes in your behavior, you can ask them to tell you about it.

    What are the Side Effects?

    Like all medicines, there may be side effects in people who are sensitive to substances contained in the QUELEPTin content.

    Stop using QUELEPTi if any of the following occurs and report it to your doctor immediatelyrefer to the trail or emergency department of the nearest hospital (these are also described below):

    Very common (> 1/10)

  • Dizziness (can cause fainting),
  • Sleepiness (may disappear when you continue to use the drug, may cause fainting)
  • Symptoms of discontinuation (symptoms that occur with discontinuation of the use of QUELEPT, such as vomiting, dizziness, nausea, headache, diarrhea, insomnia and restlessness. A gradual discontinuation of the drug is recommended for a period of 1 to 2 weeks).
  • Weight gain

    • Common (< 1/10)

  • Increase in heart rate (tachycardia),
  • Nasal congestion,
  • Constipation, stomach disorder (indigestion)
  • Feelings of weakness and powerlessness, and,

    • • shit on arms or legs,

    • When you get up to the feet, the blood pressure drops (orthostatic hypotension) and, accordingly, the feeling of dizziness or fainting (can cause fainting),

  • Elevation of blood sugar,
  • Blurred vision, the,
  • Abnormal muscle movements, such as difficulty with the onset of muscle movements, tremors, discomfort or painless muscle retention, etc,
  • Abnormal dreams and nightmares,
  • Feelings of hunger (increased appetite),
  • Asability,
  • Distortion in speech and pronunciation,
  • Fainting (may cause a fall),

    • Uncommon (< 1/100)

  • Seizures,
  • Allergic reactions, such as blisters on the skin and around the mouth.
  • Restless legs syndrome, the,
  • Difficulty swallowing
  • Involuntary movements, especially in percentage and language
  • Disorder in sexual activity

    • Infrequent (< 1/1000)

  • High fever status, prolonged sore throat, mouth ulcers, rapid breathing, sweating, hardening of the muscles, feeling faint or fainting
  • Yellowing on the skin and eyes
  • Priapism (long-lasting and painful erection)
  • Swelling in the breasts and unexpectedly producing breast milk (galactorrhea)
  • Menstrual irregularity
  • Along the blood vessels, causing chest pain and difficulty breathing

    • blood clotting in the leg veins, especially in the lungs (leg

    signs of swelling, pain and redness). If any of these symptoms occur, contact your doctor immediately.

    Very infrequent (< 1/10000)

  • Severe pre-existing diabetes (sugar disease),
  • Inflammation of the liver (hepatitis),
  • Severe puffiness, fluff and red blisters on the skin.
  • Severe allergic reactions that sometimes cause difficulty breathing and shock (Anaphylaxis)
  • Sudden blistering of the skin, especially around the eyes and in the lips and throat (Angyoedema)
  • Improper secretion of the hormone that regulates the volume of urine

    • • Rupture of muscle fibers and pain in muscles (Rabdomyolysis)

    The group of drugs, including QUELEPT 1, can cause severe and death-leading heart rhythm disorders.

    Some side effects can only be seen when a blood test is done. These include an increase in the amount of certain fats (triglycerides and total cholesterol), an increase in the amount of sugar in the blood, and, a decrease in the number of certain blood cells and an increase in the amount of the hormone called prolactin in the blood.Increases in the hormone prolactin can infrequently cause the following conditions:

  • Increase in the amount of prolactin hormone in the blood. Rarely, this condition may produce the following result:

    • Swelling in the breasts in women and men and unexpectedly producing breast milk

    Lack of menstrual bleeding or irregularity in women Children and nymphs during puberty:

    Some of the side effects that can be seen in adults can also occur in children and adolescents:

    The following side effects occur only in children and adolescents.

    Very common

  • Increase in blood pressure.

    • The following side effects are more common in children and adolescents.

    Very common

  • Increased hormone prolactin in the blood. Rarely, this can lead to the following consequences:
  • Swelling in the breasts in boys and girls and unexpectedly producing breast milk
  • The fact that girls do not have monthly periods or experience irregular periods
  • Increased feeling of hunger
  • Abnormal muscle movements such as difficulty in starting muscle movements, tremors, discomfort or muscle tension without pain

    • How is QUELEPT Used?

    Always strictly follow your doctor's instructions when using QUELEPT ‘i. Ask your doctor or pharmacist if you are unsure.

    Your doctor will decide what your starting dose will be and how many tablets you take each day.

  • The QUELEPT tablet is for oral use only.

    • • You will usually receive your tablets twice a day.

    • Swallow your tablets whole, with some water.

  • Do not stop taking the tablets even if you feel good without your doctor telling you.
  • If you suddenly stop using QUELEPT, you may develop nausea or vomiting or have insomnia.
  • do not drink grapefruit juice while taking QUELEPT treatment. It can change the way the medicine acts.

    • Use in children and adolescents:

    When using QUELEPTi in children and adolescents, always strictly follow your doctor's instructions. Ask your doctor or pharmacist if you are unsure.

    Your doctor will decide what your starting dose will be and how many tablets you take each day.

    Use in the elderly:

    It should be used with caution in the elderly, especially during the initial period of treatment. In elderly patients, treatment should be started with a low dose of 25 mg and then the dose should be increased slowly.

    Special Use Cases

    Kidney /Heavy insufficiency

    In patients with renal insufficiency, there is no need to adjust the dose. QUELEPT should be used with caution in patients known to have hepatic insufficiency, especially in the initial period of treatment. Treatment should be started with a low dose, 25 mg, then the dose should be increased slowly.

    If you have an impression that the effect of QUELEPT ‘in is too strong or weak, talk to your doctor or pharmacist.

    QUELEPT

    What to Do in case of Overdose?

    If you have used more than you should use from QUELEPT ‘, talk to a doctor or pharmacist immediately.

    In this case, you may experience drowsiness, lightheadedness, and abnormal heartbeats.

    What Should I Do When I Forget to Use QUELEPT?

    Do not take double doses to offset forgotten doses.

    Take the tablet you forgot, as long as it is not too close to the time of taking the next dose, as soon as you remember.

    post Treatment For Those Using QUELEPT

    If you suddenly stop using QUELEPT, you may develop nausea or vomiting or not be able to sleep.

    Your doctor may advise you to reduce the dose gradually before stopping treatment.Don't stop treatment without consulting your doctor.

    things to consider before using QUELEPT

    who should NOT use QUELEPT by?

    ■ If you are hypersensitive to the active ingredient ketiapine or to any component of QUELEPT (see list of auxiliary substances) (allergy).

    What Should QueLEPT Users Pay Attention to?

    If you are depressed and/or have another psychiatric illness, thoughts of self-harm or suicide may sometimes arise.

    Information from clinical trials in children, young or young adults, children treated with antidepressants, suicidal ideation in young and young adults under 25 years of age and/or it has shown an increase in suicidal behavior.

    QUELEPT is not approved in children under the age of 18 with Bipolar Depression and in adolescents.

    If suicidal thoughts or behaviors or thoughts of harming yourself occur, contact your doctor immediately.

    If you have heart disease,

    ■ If your blood pressure is low.

    If you have had ■ strokes and are especially old,

    If you have passed ■ remittance (convulsions), you,

    ■ If you feel discomfort in the arms, legs, you,

    ■ Especially if you have out-of-control movements on your face and tongue,

    ■ If you have fever, confusion and muscle stiffness in the mind, you,

    ■ If your number of aquaria has been found low for any reason that has been caused by drugs in the past or has nothing to do with them.

    ■ If you have diabetes (diabetes) or a risk of having diabetes, blood sugar elevation and hyperglycemia (high blood sugar) have been observed in studies with quetiapine. If you are at risk of diabetes (such as diabetes from the family, high blood sugar seen in pregnancy), you should report this condition to your doctor. If you have diabetes, you should be under follow-up to prevent your diabetes from getting worse

    ■ If your triglyceride and cholesterol levels are high,

    ■ Since this group of drugs is associated with the formation of blood clots, if you or your family have a history of blood clots in the vein, you can,

    ■ If you have a problem with liver.

    ■ If you have difficulty swallowing.

    ■ If you have cataract disease.

    If these warnings apply to you, even at any time in the past, please consult your doctor.

    Suicidal thoughts and worsening of your depression

    If you are depressed, you may have thoughts of harming yourself or killing yourself from time to time. Such thoughts may increase when treatment is first started. This is because these types of medications usually provide benefits within 2 weeks or sometimes longer. Such thoughts can also increase if you suddenly stop taking the drug.If you are a young adult, you are more likely to have such thoughts. Information from clinical studies suggests that the risk of suicidal thoughts and/or suicidal behavior increases in younger adults under the age of 25 with depression.

    If you have thoughts of harming or killing yourself at any time, tell your doctor or go to a hospital. It may be helpful to tell a friend or someone you are depressed and ask them to read this instruction. If they think your symptoms are getting worse or are concerned about other changes in your behavior, you can ask them to tell you about it.

    Food and Beverage Consumption Together With QUELEPT

    What are the foods and drinks that are inconvenient to be consumed with the specified medication? What should we eat or not eat?

    you can take QUELEPT ‘i with food or separately.

    It should be taken with alcohol. Because the combined effects of alcohol with QUELEPT can make you sleepy.

    Do not drink grapefruit juice while taking the UUELEPT treatment. It can change the way the medicine acts.

    Is it Used During Pregnancy (Pregnancy) Period?

    Consult your doctor or pharmacist before using the medicine.

    QUELEPT should be used only when absolutely necessary during pregnancy, if the benefit exceeds the potential risk to the baby.

    If you notice that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

    Can it be Used During Breastfeeding?

    Consult your doctor or pharmacist before using the medicine.

    Do not breastfeed your baby during the time you use the medicine.

    Vehicle and machinery use

    This medicine you use can bring your sleep. Do not use tools or machines before you know how these tablets affect you.

    What is the QUELEPT Active Agent?

    QUELEPT contains lactose, a type of sugar. If you have previously been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicinal product.

    This medicinal product contains less sodium than I mmol (23 mg)‘ in each tablet; no side effects due to sodium at this dose are expected.

    Is It Used With Other Drugs?

    In particular, if you are taking the following medications, tell your doctor:

  • Medications to treat anxiety or depression (such as imipramine.fluoxetine)
  • Sara (epilepsy) drugs such as phenytoin or carbamazepine
  • Blood pressure medications
  • Drugs used for insomnia treatment (barbiturate);
  • Some medications used to treat AIDS (HlV-protease inhibitors such as)
  • Tioridazine (another antipsychotic drug).
  • Medications that affect the heart rate
  • Diuretics (urine pill)

    • Tell your doctor if you are taking medications used to treat infection, such as the following, or if you will be discontinuing them in the near term.

  • Rifampicin for the treatment of tuberculosis
  • Ketoconazole for fungal infections
  • erythromycin or clarithromycin as antibiotics.

    • If you are currently taking any prescription or over-the-counter medications or have recently used them, please tell your doctor or pharmacist about them.

    Drug screening in urine

    If drug screening is performed in the urine, even if you are not using drugs called methadone or tricyclic antidepressants used for depression due to your use of QUELEPT, some test methods may cause a positive result for these drugs. With more specific tests, the results may need to be verified.

    To download the QUELEPT prospectus as a PDF file here
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