20 mg hard capsules
fluoxetine

What Fluoxetine Teva is and what it is used for

Fluoxetine Teva is an antidepressant and belongs to a group of medicines called selective serotonin reuptake inhibitors.

Fluoxetine Teva capsules are used to treat the following diseases:

In adults:

In children and adolescents from 8 years of age:

  • moderate to severe actual depression, if the depression has not improved after 4-6 psychological treatment sessions. Fluoxetine Teva should be given to a child or adolescent with moderate to severe depression only in combination with psychological treatment.

Fluoxetine contained in Fluoxetine Teva may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Fluoxetine Teva

Do not use Fluoxetine Teva

  • if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6). Allergies can manifest as rash, itching, swollen face or lips, or difficulty breathing.
  • if you are taking medicines called non-selective monoamine oxidase inhibitors or reversible monoamine oxidase inhibitors type A (also called MAO inhibitors ), which are also used to treat depression, as serious side effects and even death can occur.

Examples of such MAO inhibitors are nialamide, iproniazide, moclobemide, phenelzine, tranylcypromine, isocarboxazid, toloxatone, linezolid (an antibiotic ), and methylthionine chloride (methylene blue). See “Other medicines and Fluoxetine Teva”.

Treatment with Fluoxetine Teva should only be started 2 weeks after the end of treatment with an irreversible MAOI (eg tranylcypromine).

However, treatment with Fluoxetine Teva may be started the day after the end of treatment with a reversible MAOI (eg moclobemide, linezolid, methylthionine chloride (methylene blue)).

Do not take any MAOI until at least 5 weeks after the end of treatment with Fluoxetine Teva. If Fluoxetine Teva has been used for a long time and/or in a high dose, your doctor may decide on a longer time interval

Warnings and cautions

Talk to your doctor or pharmacist before using Fluoxetin Teva if any of the following apply to you:

  • you have epilepsy or seizures. If you get cramps or experience that the number of seizures increases in number, contact your doctor immediately. Treatment with Fluoxetine Teva may need to be stopped.
  • you have or have previously had mania. If you get a manic episode, contact your doctor immediately. Treatment with Fluoxetine Teva may need to be stopped.
  • you have diabetes. Your doctor may change the dose of insulin or other medicines for diabetes.
  • you have liver problems. Your doctor may need to change dose one.
  • you have a heart condition.
  • you have a low resting heart rate and/or know that you have a salt deficiency due to prolonged severe diarrhea and vomiting or use diuretics ( diuretics ).
  • you have glaucoma (increased pressure in the eye).
  • you are taking diuretics ( diuretics ), especially if you are older.
  • receive electrical therapy (electroconvulsive therapy).
  • you have previously had problems with bleeding or if you are pregnant (see “Pregnancy, breast-feeding and fertility”) or the presence of bruising or unusual bleeding.
  • you are taking medicines that affect the coagulation of the blood (see “Other medicines and Fluoxetine Teva”).
  • you are being treated with tamoxifen (used to treat breast cancer) (see “Other medicines and Fluoxetine Teva”).
  • you begin to feel restless and unable to sit still ( akathisia ). This may be worse if your dose of Fluoxetine Teva is increased.
  • you suddenly get a fever, muscle stiffness, or tremors and change mentally, for example, become confused, irritated, and extremely anxious. You may have had so-called serotonergic syndrome or malignant neuroleptic syndrome. It is rare for this syndrome to occur but if it does occur it can give rise to potentially life-threatening conditions. Therefore, contact your doctor immediately. Treatment with Fluoxetine Teva may need to be stopped.

Drugs such as Fluoxetine Teva (so-called SSRIs / SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

If you start to feel worse and have thoughts of harming yourself
You who are depressed and/or suffer from worry/anxiety can sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start using antidepressants, as it takes time for drugs of this type to take effect, usually about 2 weeks, sometimes longer.

These thoughts may be common:

  • if you have previously had thoughts of harming yourself or committing suicide.
  • if you are younger than 25 years. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.

Contact a doctor as soon as possible or see the nearest hospital if you have thoughts of injuring yourself or committing suicide.
It may be helpful to tell a relative or close friend that you are depressed and/or suffering from anxiety. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.

Children and adolescents 8 to 18 years

The risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiance, and anger) is greater in patients under 18 years of age when taking drugs of this type. Fluoxetine Teva should only be used in children and adolescents aged 8 to 18 years for the treatment of moderate to severe major depression (in combination with psychological treatment) and should not be used in other indications.
Also, there are only limited data in this age group regarding the long-term safety of fluoxetine, such as effects on height growth, puberty development, mental, emotional, and behavioral development. Despite this, Fluoxetine canTeva is prescribed by a doctor to patients under the age of 18 for moderate to severe actual depression in combination with psychological treatment as the doctor considers this to be in the patient’s best interests. If you are under 18 years of age and want to discuss why you received Fluoxetine Teva, consult your doctor again. You should also tell your doctor if you notice any of the above symptoms or if they get worse.
Fluoxetine Teva should not be used to treat children under 8 years of age.

Other medicines and Fluoxetine Teva

Fluoxetine Teva may affect the effectiveness of other medicines. Tell your doctor or pharmacist if you are taking, have recently (5 weeks ago) taken, or might take any other medicines. Fluoxetine Teva may affect the effectiveness of certain other medicines ( interaction ). An interaction can arise with:

  • MAO inhibitors are used to treat depression. Non-selective MAOIs and type A MAOIs should not be used with Fluoxetine Teva as serious side effects and even death (serotonergic syndrome) may occur, see section “Do not use Fluoxetine Teva”. Treatment with Fluoxetine Teva should not be started until two weeks after stopping treatment with an irreversible MAOI (eg tranylcypromine). However, treatment with fluoxetine can be started the day after stopping treatment with a reversible MAOI(eg moclobemide, linezolid, methylthionine chloride (methylene blue)). Type B MAOIs ( selegiline ) can be used with Fluoxetine Teva if your doctor checks you carefully.
  • Lithium, tryptophan. The risk of the serotonergic syndrome is greater as these drugs are co-administered with Fluoxetine Teva. When fluoxetine is given in combination with lithium, your doctor will perform more frequent checks.
  • Phenytoin (used to treat epilepsy ). Because Fluoxetine Teva may affect the blood concentration of this medicine, your doctor may need to insert phenytoin more carefully and perform regular check-ups as Fluoxetine Teva is given at the same time.
  • Tramadol (painkiller)
  • Triptans (used in migraines ); which increases the risk of high blood pressure.
  • drugs that can affect the heart rhythm, such as Class IA and III antiarrhythmics (drugs for irregular heart activity), antipsychotics (eg phenothiazines, pimozide, haloperidol ), tricyclic antidepressants (drugs for depression), certain antimicrobial drugs (eg sparfloxacin, moxifloxacin, erythromycin IV, pentamidine), treatment against malaria, particularly halofantrine, some antihistamine s (astemizole, mizolastine).
  • Flecainide or encainide (used in heart disease), carbamazepine (used in epilepsy ), tricyclic antidepressants (eg imipramine, desipramine, and amitriptyline). Because Fluoxetine Teva may alter the blood levels of flecainide, encainide, carbamazepine, and tricyclic antidepressants and your doctor may need to lower the dose of one of these medicines when they are given at the same time as Fluoxetine Teva
  • Tamoxifen (used to treat breast cancer). Because Fluoxetine Teva may alter the blood levels of this medicine, and a reduction in the effect of tamoxifen cannot be ruled out, your doctor may need to consider another antidepressant treatment.
  • Warfarin, anti-inflammatory drugs (non-steroidal anti-inflammatory drugs ( NSAIDs )), and other blood-thinning medicines (including clozapine, which is used to treat certain mental disorders, and acetylsalicylic acid ). Fluoxetine Teva may alter the effect of these medicines on the blood. If you are starting or stopping treatment with Fluoxetine Teva while taking warfarin, your doctor will need to take some tests.
  • St. John’s wort. You should not start using St. John’s wort during treatment with Fluoxetine Teva as the side effects may increase. If you are already taking (traditional) herbal medicine containing St. John’s wort, stop taking it before starting your treatment with Fluoxetine Teva. Be sure to discuss this with your doctor before starting treatment with Fluoxetine Teva.

Fluoxetine Teva with food, drink, and alcohol

  • You can take this medicine with or without food, whichever you prefer.
  • You should avoid alcohol when taking this medicine.

Pregnancy, breastfeeding, and fertility

Pregnancy
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If Fluoxetine Teva is used during pregnancy, your doctor should closely monitor the treatment, especially during the latter part of pregnancy as the following effects have been seen in newborns: irritability, tremors, muscle weakness, persistent crying, difficulty breastfeeding, and sleeping.

There have been reports of an increased risk of heart defects in infants whose mothers used fluoxetine during the first months of pregnancy. In the population, approximately 1 in 100 babies is normally born with heart defects. This malformation increased in frequency to about 2 in 100 when mothers were treated with fluoxetine. You and your doctor may decide to gradually stop treatment if you are pregnant. Depending on the circumstances, however, your doctor may suggest that you should continue using Fluoxetine Teva.

Tell your midwife or doctor that you are being treated with Fluoxetine Teva. When drugs such as Fluoxetine Teva are used during pregnancy, especially during the last three months, they may increase the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN). This condition causes the baby to breathe faster and look blue. The symptoms usually appear within 24 hours of the baby being born. If this affects your baby, contact a midwife or doctor immediately.

If you take Fluoxetine Teva at the end of your pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be informed that you are taking Fluoxetine Teva so that they can advise you on this.

Breast-feeding
Fluoxetine passes into breast milk and may cause side effects in breast-fed infants. You should only breast-feed if necessary. If you continue to breast-feed, your doctor may prescribe a lower dose of Fluoxetine Teva.

Fertility
In animal studies, fluoxetine has been shown to reduce sperm quality. In theory, this could affect fertility, but no such reducing effect of fluoxetine on fertility has yet been demonstrated in humans.

Driving and using machines

This medicine may impair your judgment, vision, or coordination. If you feel affected, do not drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.

3. How to use Fluoxetine Teva

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Swallow the capsules with a glass of water. Do not chew the capsules. You can take this medicine with or without food, whichever you prefer.

The recommended dose is:
Adults

  • Depression: the recommended dose is 20 mg per day. Your doctor will review and, if necessary, adjust the dose 3-4 weeks after starting treatment. If necessary, the dose can be increased gradually up to a maximum dose of 60 mg. Dose one should be increased carefully to ensure that you receive the lowest effective dose. You may not feel better immediately after you start taking the medicine. This is common as an improvement in depressive symptoms may take a few weeks. Treatment for depression should last for at least 6 months.
  • Bulimia: the recommended dose is 60 mg daily.
  • Obsessive-compulsive disorder: the recommended dose is 20 mg per day. Your doctor will review and, if necessary, adjust the dose one after 2 weeks of treatment. If necessary, the dose can be increased gradually up to a maximum dose of 60 mg. If no improvement occurs within 10 weeks, treatment with Fluoxetine Teva should be reconsidered.

Use in children and adolescents aged 8 to 18 years with depression

  • Treatment should be initiated and supervised by a specialist. The starting dose is 10 mg per day (given as 2.5 ml of fluoxetine oral solution). After one to two weeks, your doctor may increase the dose one to 20 mg (one capsule) per day. Dose one should be increased carefully to ensure that you receive the lowest effective dose. Children with low body weight may need a lower dose.

If the treatment gives good results, your doctor should assess the need for continued treatment after 6 months. If you have not improved within 9 weeks, the treatment should be reconsidered.

Elderly people, people with liver disease, and people taking other medicines

  • Your doctor will be more careful with the dose increase if you are older. The daily dose should generally not exceed 40 mg. The maximum dose is 60 mg per day.
  • If you have liver disease or are taking medicines that may affect fluoxetine, your doctor may prescribe a lower dose or you should take Fluoxetine Teva every other day.

If you take more Fluoxetine Teva then you should

  • If you have ingested too much medicine, or if e.g. a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
  • Bring the pack of Fluoxetine Teva if you can.
  • Symptoms of overdose are nausea, vomiting, seizures, problems with the heart (eg irregular heartbeat and cardiac arrest), problems with the lungs, and mental changes in everything from severe anxiety to unconsciousness.

If you forget to take Fluoxetine Teva

  • Do not worry if you forgot to take a dose. Take the next dose the next day at the usual time. Do not take a double dose to make up for a forgotten dose.
  • Take your medicine at the same time each day and it will be easier for you to remember to take it.

If you stop taking Fluoxetine Teva

Do not stop taking Fluoxetine Teva until your doctor tells you to stop. You must take the medicine without interruption.

  • Do not stop taking the medicine without first asking your doctor, even if you feel better.
  • Make sure you always have medicine at home.

The following symptoms may occur when you stop taking Fluoxetine Teva:

  • dizziness, tingling of needles, difficulty sleeping (vivid dreams, insomnia), feeling of restlessness or anxiety, unusual tiredness or weakness, anxiety, nausea/vomiting (feeling sick), tremors, and headache.

These symptoms are called withdrawal symptoms. When you stop taking Fluoxetine Teva, your doctor will help you reduce the dose slowly over one to two weeks so that the risk of withdrawal symptoms after the end of treatment is reduced.

Most people who stop taking Fluoxetine Teva experience that the withdrawal symptoms are mild and go away on their own within a few weeks. If you get symptoms when you stop taking Fluoxetine Teva contact your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking the capsules immediately and contact a doctor immediately if you get:

  • skin rash or allergic reaction such as itching, swollen lips/tongue, or wheezing / difficulty breathing.

Contact your doctor immediately if you experience any of the following side effects:

  • thoughts of suicide or self-harm. Contact a doctor or go to the hospital immediately.
  • you feel anxious and can not stand or sit still, because you may have had something called akathisia.
  • the skin becomes red or blisters form and the skin flakes or loosens.
  • a collection of symptoms that include unexplained fever with rapid breathing or heart rate, sweating, muscle stiffness or tremors, confusion, extreme anxiety, or drowsiness (occurs only rarely). These symptoms may be signs of serotonergic syndrome or neuroleptic malignant syndrome, your doctor may need to stop treatment with fluoxetine.
  • Abnormal liver function has been reported in isolated cases, with a few cases of hepatitis, which may include symptoms such as fatigue, sore legs and joints, loss of appetite, fever, yellowing of the skin and whites of the eyes (so-called jaundice), dark urine and pale stools.
  • seizures or seizures.
  • feeling weak, drowsy or confused, (especially in the elderly or people taking diuretics ( diuretic tablets)).
  • prolonged and painful erection.
  • irritability and extreme anxiety.

These side effects have also been reported in patients taking fluoxetine:

Very common (may affect more than 1 in 10 people)

  • insomnia.
  • headache.
  • diarrhea, nausea.
  • fatigue.

Common (may affect up to 1 in 10 people)

  • poor appetite, weight loss.
  • nervousness, anxiety.
  • restlessness, difficulty concentrating.
  • feel tense.
  • decreased sexual desire or sexual problems (including difficulty maintaining an erection before sexual activity).
  • sleep problems, unusual dreams, fatigue, or drowsiness.
  • dizziness.
  • taste change.
  • uncontrolled shaking movements.
  • dimsyn.
  • the feeling of a fast and irregular heartbeat.
  • hot flashes.
  • yawning.
  • indigestion, vomiting.
  • dry mouth.
  • rash, hives, itching.
  • profuse sweating.
  • joint pain.
  • frequent urination.
  • unexpected vaginal bleeding.
  • feel shaky or get chills.

Uncommon (may affect up to 1 in 100 people)

  • feel isolated from oneself.
  • strange thoughts.
  • abnormal elation.
  • orgasm problem.
  • grind teeth.
  • muscle twitching, involuntary movements, or problems with balance and coordination.
  • enlarged (dilated) pupils.
  • low blood pressure.
  • respiratory distress.
  • difficulty swallowing.
  • hair loss.
  • increased tendency to get bruises.
  • cold sweats.
  • difficulty urinating.
  • feel hot or cold.
  • memory loss.
  • suicidal thoughts or thoughts of harming oneself.
  • ringing in the ears.
  • nosebleeds and another unexplained bleeding.

Rare (may affect up to 1 in 1000 people)

  • low levels of salt in the blood.
  • violent behavior.
  • hallucinations.
  • stark oro.
  • panic attacks.
  • attack.
  • vasculitis ( inflammation of a blood vessel).
  • rapid swelling of the tissues around the neck, face, mouth, and/or throat.
  • pain in the esophagus.
  • sensitivity to sunlight.
  • milk flow from the breasts.
  • muscle pain.
  • decreased number of red blood cells, which increases the risk of bleeding or bruising.
  • decreased white blood cell count.
  • difficulty urinating.
  • confusion.
  • stuttering.
  • aggression.
  • lung problem.
  • hepatitis (liver disease), abnormal liver function values.
  • abnormal heart rhythm.
  • sore throat.

Has been reported (occurs in an unknown number of users)

  • severe vaginal bleeding shortly after delivery ( postpartum hemorrhage), see “Pregnancy, breast-feeding and fertility” in section 2 for more information.

Bone Fractures – An increased risk of bone fractures has been seen in patients taking this type of medicine.

Additional side effects in children and adolescents (8-18 years) – In addition to the side effects mentioned above, fluoxetine may reduce growth and possibly delay puberty. Suicidal ideation, suicidal ideation, hostility, abnormal wild behavior, and nosebleeds were also reported as common side effects in children.

5. How to store Fluoxetine Teva

  • 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 carton after EXP. The expiration date is the last day of the specified month.
  • Store in the original package. Sensitive to light.
  • Do not store above 30 ° C.
  • 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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is fluoxetine hydrochloride. Each capsule contains the equivalent of 20 mg fluoxetine.
  • The other ingredients are colloidal anhydrous silica, pregelatinized starch, simethicone emulsion 30%, indigo carmine (E132), titanium dioxide (E171), gelatin, shellac (E904), black iron oxide (E172), and propylene glycol (E1520).

What the medicine looks like and the contents of the pack

  • The capsules have a dove blue upper part and a white lower part.
  • The capsules are packaged in blisters and are available in pack sizes of 12, 14, 20, 28, 30, 50, 60, 70, 90, 98, 100, or 500 capsules.

Not all pack sizes may be marketed.

Manufacturer
Teva Operations Poland Sp. zoo
ul. Mogilska 80,
31-546 Kraków
Poland

Muhammad Nadeem

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