Prozac (fluoksetin) 20 Mg 24 Tablets

• Active substance: Fluoxetine hydrochloride Each capsule contains fluoxetine hydrochloride equivalent to 20 mg of fluoxetine.

• Excipients: Fluid starch, dimethicone, gelatin, patent blue V (E131), yellow iron oxide (E172), titanium dioxide (E171), shellac, propylene glycol, ammonium hydroxide, black iron oxide (E172).

Before using this medicine, please read this INSTRUCTIONS carefully, as it contains important information for you.

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Keep these instructions for use. You can need to read again.

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If you have additional questions, please consult your doctor or pharmacist.

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This medicine has been prescribed for you personally, please do not give it to others.

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When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital.

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Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug.

In these Instructions for Use:

1. What is PROZAC and what is it used for? 2. Things to consider before using PROZAC 3. How to use PROZAC? 4. What are the possible side effects? 5. The PROZAC storage

headers are included.

1. What is PROZAC and what is it used for? PROZAC is in Lilly 3105 printed on green and yellow capsules and in two different forms in 16 and 24 capsulated blisters.

PROZAC is included in the drug group known as selective serotonin reuptake inhibitor (SSRI) antidepressants.

This drug is used in adults to treat any of the following:

• Major depression

• Obsessive-compulsive disorder (also known as OCD)

• Bulimia nervosa - Use of PROZAC in addition to psychotherapy to reduce overexpression and subsequent vomitingUnrestricted

•pre-menstrual dysphoric disorder

2.PROZAC should be considered before using

DO nOT uSE tHEprozac in the following cases

• you are allergic to any of fluoxetine prozac or other components (see hypersensitivity), if any. If there is rash or other allergic reactions (such as itching, swelling of the face or lips, or shortness of breath), stop taking your medication immediately and tell your doctor immediately.

• If you are using drugs known as non-selective monoamine oxidase inhibitors or recycled monoamine oxidase inhibitors type A (also known as MAOIs used in the treatment of depression), serious or even fatal reactions may occur in this case. Examples of MAOIs include nialamide, iproniazide, selegeline, moclobemide, phenelzine, tranylcypromine, isocarboxazide and toloxaton.

Fluoxetine treatment should be initiated only 2 weeks after discontinuation of non-reversible MAOI (eg tranylcypromine) treatment. However, treatment with fluoxetine may be initiated on the day after some MAOIs (eg moclobemide), which are called MAO1A, have been discontinued.

Do not take any of the MAOIs for at least five weeks after you stop taking PROZAC. If PROZAC is administered for a long period of time and / or at a high dose, your doctor should consider extending this interval.

• Do not take PROZAC if you are taking medicines containing thioridazine. Do not take threididine-containing medications within 5 days of discontinuing PROZAC. Drugs containing thioridazine cause severe heart rhythm problems and lead to sudden death.

• Do not take PROZAC if you are using drugs that contain antipsychotic pimozide.

USE PROZAC ATTENTION Should

•you have epileptic seizures or have had a seizure in the past, have a seizure or have an increased seizure frequency, tell your doctor immediately; The use of PROZAC may need to be discontinued.

• If you have experienced excessive feeling and mania before; notify your doctor immediately if you experience a manic attack; The use of PROZAC may need to be discontinued.

• If you have diabetes (your doctor may need to adjust the dose of insulin or other antidiabetic therapy).

• If you have liver problems (your doctor may need to adjust the dose of the drug).

• If you have problems with your heart.

• If you are receiving diuretic, especially if you are elderly.

• If you are receiving electroconvulsive therapy.

• If you have a history of bleeding disorder or if bruises or unusual bleeding occur.

• If you are using medicinal products that affect blood clotting (see 'Use with other drugs').

• If there are changes such as fever, stiffness or tremors in the muscles, changes in your mental state (confusion), hypersensitivity and extreme restlessness; You may be experiencing serotonin syndrome or neuroleptic malignant syndrome. Although this syndrome is rarely seen, it may cause life-threatening conditions, tell your doctor immediately, it may be necessary to discontinue PROZAC use.

• If you have suicidal thoughts or want to harm yourself. Suicidal thoughts, self-harm and suicide risk (suicide related events) increase in depression.This

risk may be increased when you first start using antidepressants. Because it usually takes longer than 2 weeks to show the effect of these drugs.

In this case, you may think of the following:

• If you have previously thought about suicide or self-harmIf you are a

•young adult. Data from clinical trials have shown an increased risk of suicidal behavior in adults with psychiatric conditions under the age of 24 treated with antidepressants.

If you have any thoughts of self-harm or suicide at any time, contact your doctor or go to the hospital immediately.

It may be useful to tell any of you that you have depression or anxiety disorder. Ask them to read this instruction. You may want to tell you that your depression or anxiety is getting worse or that you are worried about changes in your behavior.

• When patients under the age of 18 take drugs of this class, there is an increased risk of suicide attempts, suicidal thoughts, and increased adverse effects such as opposition (predominantly aggression, confrontation and anger). PROZAC's long-term safety knowledge on growth, adolescence, spiritual, emotional and behavioral development is limited. PROZAC is not recommended for use in children and adolescents.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

Use of PROZAC with food and drink You can purchase PROZAC with or without food according to your preference. You should avoid drinking alcohol while using this medicine.

Pregnancy Consult your doctor or pharmacist before using the medicine.

The information collected so far does not indicate an increased risk when the drug is used during pregnancy. However, care should be taken when using the drug during pregnancy, especially in the final period of pregnancy or before delivery, since the following effects have been reported in newborn babies: hypersensitivity, tremors, muscle weakness, constant crying, difficulty in sucking or sleeping, and newborn's resistant pulmonary hypertension.

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

Breastfeeding Consult your doctor or pharmacist before using the medication.

Fluoxetine passes into breast milk and can cause side effects in infants. However, when absolutely necessary, you should breastfeed your baby. If breastfeeding continues, your doctor may reduce the dose of fluoxetine.

machine and the machine This medication may affect your ability to make decisions or your compliance. Do not use tools or machines without consulting your doctor or pharmacist.

Use with other drugs This drug may affect the way some other drugs act (interaction). Interaction with the following drugs may occur:

• MAO-inhibitors (used in the treatment of depression). Non-selective MAO-inhibitors and MAO-inhibitors type A (moclobemide) should not be used in combination with PROZAC because severe, even fatal reactions (serotonin syndrome) may occur (see section-DO NOT USE PROZAC in the following cases Seç). MAO-inhibitors type B (selegeline) may be used in conjunction with PROZAC, provided your doctor closely follows you.

• Lithium, tryptophan; if these drugs are used in combination with PROZAC, the risk of serotonin syndrome increases. If used in combination with PROZAC lithium, your doctor will increase the frequency of general health checks.

• Phenytoin (used for sara); Because PROZAC may affect the blood levels of this drug, and it may be necessary to use phenytoin therapy more carefully and perform general health checks if it is to be used with PROZAC.

• Tramadol (painkiller) or triptans (for migraine); The risk of hypertension increases.

• Flekainid or enkainid (for heart problems), carbamazepine (for epilepsy), tricyclic antidepressants (eg, imipramine, desipramine and amitriptyline); Because PROZAC can change the blood levels of these drugs and they are used with PROZAC, your doctor may need to reduce the dose of these drugs.

• Tamoxifen (for breast cancer treatment); Because PROZAC can change the blood levels of these drugs. Your doctor may need to evaluate different antidepressant treatments.

• Warfarin or other drugs used to dilute blood (including clozapine used in the treatment of certain mental disorders); PROZAC can alter the effect of these drugs on blood. If you start or stop PROZAC treatment while you are using warfarin, your doctor will need to perform some tests.

• When treating with PROZAC, it is not recommended to start herbal treatment with St. John's wort, as this may cause an increase in undesirable effects. If you are using St. John's wort when you start PROZAC treatment, you should stop using this medicine and tell your doctor at the next visit.

Tell your doctor or pharmacist if you are currently using any prescription or non-prescription medicine, or if you have used it recently (up to 5 weeks).

3. How to use PROZAC?

Always take PROZAC exactly as your doctor told you. If in doubt, consult your doctor or pharmacist.

Instructions for appropriate use and dose / frequency of administration

• Depression: The recommended dose is one capsule per day (20 mg fluoxetine). Within 3-4 weeks of starting therapy, your doctor will review your dosage andif necessary

adjust. Where appropriate, the dose may be increased gradually up to a maximum of 3 capsules (60 mg fluoxetine). The dose should be carefully increased to ensure that you are receiving the lowest effective dose. When you first start taking your depression medication, you may not feel better. This is normal because depressive symptoms may not improve until the first few weeks have passed. Patients with depression should be treated for a period of at least 6 months.

• Bulimia nervosa: One capsule three times a day (20 mg fluoxetine) or once three capsules (60 mg fluoxetine).

• Obsessive compulsive disorder (OCD): The recommended dose is one capsule per day (20 mg fluoxetine). After 2 weeks of treatment, your doctor will review your dose and adjust it if necessary. Where appropriate, the dose may be increased gradually up to a maximum of three capsules (60 mg). If no improvement is observed within 10 weeks, PROZAC therapy should be re-evaluated.

• Pre-menstrual dysphoric disorder (PMDB): During the menstrual cycle, a dose of 20 mg daily or intermittently 14 days before the beginning of the menstrual period is recommended until the first day of the menstruation and every cycle.

Method and method of administration:

• Swallow capsules with some water.

• Do not break the capsules.

• Always follow your doctor's instructions for how many capsules you will take and how often you will take them.

• Do not take more capsules than your doctor has told you.

Different age groups: Use in children: The use of PROZAC in children and adolescents is not recommended.

Use in the elderly: If you are elderly, your doctor will be more careful when increasing the dose, and the daily dose should generally not exceed two capsules (40 mg fluoxetine). The maximum dose is 3 capsules per day (60 mg fluoxetine).

Special Use Cases: Kidney / Liver Failure: Patients with impaired renal function do not need a special dose adjustment other than the dose recommended by the doctor.

If you have a liver problem or are using other medications that may affect PROZAC, your doctor's decision may be to give you a lower dose or tell you to use PROZAC every two days.

Unless your doctor recommends otherwise follow these instructions.

Do not forget to take your medicine in time.

Your doctor will tell you how long your treatment will take with PROZAC. Do not cut the treatment early because you cannot get the desired result.

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

If you have used more PROZAC than you should use, talk to a doctor or pharmacist if you have used more than you should use from PROZAC.

If you have used too much medication, immediately contact the nearest hospital's emergency department or tell your doctor immediately.

If possible, take the PROZAC box with you.

Symptoms of overdose include: Nausea, vomiting, seizures, heart-related problems (such as heartbeat irregularities and cardiac arrest), lung-related problems, and changes in mood leading from unrest to coma.

If you forget to use PROZAC Do not worry if you forgot to take a dose. Take your next dose at normal time the next day.

Do not take double doses to compensate for forgotten doses.

Taking your medicine at the same time every day will help you to remember that you should take your medicine on a regular basis every day.

Effects that may occur when treatment with PROZAC is terminated

• Do not discontinue treatment with PROZAC unless your doctor tells you. It is important that you continue to take your medicine. Even if you feel better, do not leave your medicine without asking your doctor.

• Make sure you have enough capsules.

When you stop using PROZAC, you may notice the following effects: Drowsiness, tingling sensation (such as needles), sleep disturbances (living dreams, nightmares, sleeplessness), feeling uneasy or excited, unusual fatigue or weakness, feeling anxious, nausea / vomiting (feeling sick) he became ill too, trembling, headaches.

According to most people, all symptoms seen when PROZAC is released are mild and spontaneous within a few weeks. Consult with your doctor if you experience symptoms when you stop treatment.

Your doctor will help you reduce your dose gradually within a week or two when you leave PROZAC. This may help to reduce the risk of occurrence of the effects of termination of treatment.

Ask your doctor or pharmacist if you have additional questions about the use of PROZAC.

Tell your doctor if you experience any other or other disease.

4. What are the possible side effects?

As with all medications, side effects may occur in people who are sensitive to substances found in the content of PROZAC.

If you have any of the following, stop using PROZAC and IMMEDIATELY tell your doctor or contact the emergency department of your nearest hospital:

• If you have any thoughts of self-harm or suicide at any time

• If you notice rash or itching, swelling or wheezing in the lips / tongue / if an allergic reaction such as shortness of breath occurs,

• you feel uneasy and you cannot stand or sit still, a situation called akathisia may have arisen; Increasing the dose of PROZAC may make you feel worse.

• If your skin color begins to turn red or if various skin reactions develop or if your skin has blisters or peeling.

These are all very serious side effects.

If you have one of these, you have a serious allergy to PROZAC. You may need urgent medical attention or hospitalization.

All of these very serious side effects are very rare.

If you notice any of the following, report to your doctor immediately or contact the emergency department of your nearest hospital.

• A combination of various symptoms, including unexplained fever, sweating, stiffness or tremors, confusion, extreme restlessness or drowsiness (infrequently), with increased respiratory rate or heart rate (known as serotonin syndrome)

•weakness, drowsiness, or confusion in elderly and diuretic people (elderly)

• Long-term or painful stiffness

Severe• Excessive sensitivity and extreme restlessness

• Bleeding symptoms

These are all serious side effects. Emergency medical intervention may be required.

Serious side effects are very rare.

If you notice any of the following, tell your doctor.

• Dry mouth

• Excessive sweating

• Chills

• Shivering

• Sensitivity to sunlight

• Weight loss

• Severe and gastric disorder

• Nausea

• Vomiting

• Indigestion

• Difficulty in swallowing

• Throat inflammation

• Tightening of teeth

• Change in taste sense

• Abnormality of liver function

• Jaundice cases

• Serum sickness

• vasculitis

• Cardiovascular expansion

• expansion of pupil

• Headache<