20 mg capsule hard
fluoxetine

What Fluoxetine Mylan is and what it is used for

Fluoxetine Mylan is an antidepressant drug that affects the central nervous system. It belongs to a group of medicines called selective serotonin reuptake inhibitors ( SSRIs ).

Fluoxetine Mylan is used for:

Adults:

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 Mylan should be given to a child or adolescent with moderate to severe depression only in combination with psychological treatment.

How Fluoxetine Mylan works

Everyone has a substance called serotonin in the brain. People who are depressed, have obsessive-compulsive disorder or bulimia have lower levels of serotonin than others. It is not entirely clear how Fluoxetine Mylan and other SSRIs work, but they can help by increasing the level of serotonin in the brain. It is important to treat these conditions for you to feel better. If left untreated, these conditions will not go away and may become more serious and difficult to treat.

You may need to be treated for a few weeks or months to ensure that you are symptom-free.

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

What you need to know before you use Fluoxetine Mylan

Do not use Fluoxetine Mylan:

  • if you are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6). Do not take more tablets and contact your doctor immediately if you get a rash or other allergic reactions (such as itching, swollen face or lips, or difficulty breathing).
  • if you are taking medicines called irreversible non-selective monoamine oxidase inhibitors (also known as MAOIs ), serious side effects and even death can occur (eg iproniazid, phenelzine, tranylcypromine). Treatment with Fluoxetine Mylan should only be started if 2 weeks have elapsed after treatment with an irreversible non-selective MAOI.Do not take any irreversible non-selective MAOI until at least 5 weeks after the end of treatment with Fluoxetine Mylan. If Fluoxetine Mylan has been used for a long time and/or in a high dose, your doctor may decide on a longer time interval.
  • if you are taking metoprolol (to treat heart failure ) as there is an increased risk of your heart rate becoming too slow.

Warnings and cautions

Talk to your doctor or pharmacist before taking Fluoxetine Mylan if you:

  • have any heart disease.
  • suddenly gets a fever, muscle stiffness, or tremors and changes mentally, for example, becomes 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. Fluoxetine treatment may need to be stopped.
  • have other conditions treated with antidepressant drugs or treated with buprenorphine ( opioid ) or naloxone (opioid inhibitors). If these medicines are used together with Fluoxetine Mylan, this can lead to the serotonergic syndrome, a condition that can be life-threatening (see “Other medicines and Fluoxetine Mylan”).
  • have or previously had mania. If you get a manic episode, contact your doctor immediately. Fluoxetine treatment may need to be stopped.
  • have previously had bleeding disorders or bruising or unusual bleeding, or if you are pregnant (see “Pregnancy”).
  • use blood thinners (see “Other medicines and Fluoxetine Mylan”).
  • have epilepsy or previously had seizures. If you get cramps or experience that the number of seizures increases in number, contact your doctor immediately. Fluoxetine treatment may need to be stopped.
  • receive electrical therapy (electroconvulsive therapy).
  • receive treatment with tamoxifen (used to treat breast cancer) (see “Other medicines and Fluoxetine Mylan”).
  • begins to feel restless and can not sit still ( akathisia ). This may get worse if your fluoxetine dose is increased.
  • have diabetes. Your doctor may change the dose of insulin or other medicines for diabetes.
  • have liver problems. Your doctor may need to change dose one.
  • 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 ).
  • Take diuretics ( diuretic tablets), especially if you are older.
  • have glaucoma (increased pressure in the eye).

If you start to feel worse and have thoughts of harming yourself

You who are depressed can sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start taking antidepressants, as it takes time for this type of medicine 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 can be helpful to tell a relative or close friend that you are depressed. 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.

Weight loss may occur during treatment with Fluoxetine Mylan.

Withdrawal symptoms if you stop taking Fluoxetine Mylan

When you stop taking Fluoxetine Mylan, especially if it happens abruptly, you may experience withdrawal symptoms (see “How to use Fluoxetine Mylan”).

Children and young people

Children and young people aged 8 to 18 :

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 Mylan 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 Mylan, such as effects on height growth, puberty development, mental, emotional, and behavioral development. Despite this, Fluoxetine Mylan can be prescribed by a doctor to you who are under 18 years of age for moderate to severe major depression in combination with psychological treatment as the doctor considers this to be in your best interests. If you are under 18 years of age and want to discuss why you received Fluoxetine Mylan, you should consult your doctor again. You should also tell your doctor if you notice any of the above symptoms or if they get worse.

Fluoxetine Mylan should not be used to treat children under 8 years of age.

Sexual dysfunction

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

Other medicines and Fluoxetine Mylan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Fluoxetine Mylan with:

  • Some irreversible, non-selective MAO inhibitors, are used to treat depression. Irreversible, non-selective MAOIs should not be used with Fluoxetine Mylan as serious side effects and even death (serotonergic syndrome) may occur (see section “Do not use Fluoxetine Mylan”). Treatment with Fluoxetine Mylan should only be started 2 weeks after the end of treatment with an irreversible, non-selective MAOI (eg tranylcypromine). Do not take any irreversible, non-selective MAOIuntil at least 5 weeks have elapsed since the discontinuation of Fluoxetine Mylan. If Fluoxetine Mylan has been used for a long time and/or in a high dose, your doctor may decide on a longer time interval.
  • metoprolol when used for heart failure; there is an increased risk that your heartbeat may become too slow.

Some medicines may aggravate the side effects of Fluoxetine Mylan and in some cases may cause very serious reactions. Do not take any other medicines while you are taking Fluoxetine Mylan without first talking to a doctor, especially:

  • antidepressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. Do not take buprenorphine (an opioid ) or naloxone (an opioid inhibitor). These medicines can affect or be affected by Fluoxetine Mylan and you may experience symptoms such as involuntary rhythmic muscle twitching, even in the muscles that control eye movements, agitation, hallucinations, coma, heavy sweating, tremors, intensified reflexes, tense muscles, and body temperature above 38 ° C . Contact your doctor if you experience such symptoms.

Fluoxetine Mylan may affect the way the following medicines work ( interaction ):

  • tamoxifen (used to treat breast cancer); Because Fluoxetine Mylan may alter the blood levels of this medicine, which may lead to a decrease in the effect of tamoxifen, your doctor may need to consider another antidepressant treatment.
  • monoamine oxidase inhibitors A (MAO-A inhibitors) including moclobemide, linezolid (an antibiotic ), and methylthionine chloride (also known as methylene blue which is used to treat high levels of methemoglobin in the blood); due to the risk of serious and even fatal reactions (called serotonergic syndrome). Treatment with fluoxetine may be started the day after treatment with reversible MAOIs is stopped, but your doctor may want to monitor you closely and use a lower dose of MAO-A inhibitor.
  • mequitazine (for allergy ); as there is an increased risk of changes in the electrical activity of the heart if you take this medicine with Fluoxetine Mylan.
  • phenytoin (for epilepsy ); Because Fluoxetine Mylan may affect the blood concentration of this medicine, your doctor may need to insert phenytoin more carefully and perform regular check-ups as Fluoxetine Mylan is given at the same time.
  • lithium, selegiline, St. John’s wort, tramadol (painkillers), triptans (for migraines ), and tryptophan; the risk of the mild serotonergic syndrome is greater as these drugs are co-administered with Fluoxetine Mylan. Your doctor will perform more frequent check-ups.
  • 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 given intravenously, pentamidine), treatment against malaria, particularly halofantrine or some antihistamine s (astemizole, mizolastine); because the use of one or more of these medicines together with Fluoxetine Mylan may increase the risk of changes in the electrical activity of the heart.
  • anticoagulants (such as warfarin ), NSAIDs (such as ibuprofen, diclofenac ), acetylsalicylic acid, and other drugs that can make the blood thinner (including clozapine, which is used to treat certain mental disorders). Fluoxetine Mylan may alter the effect of these medicines on the blood. If you are starting or stopping treatment with Fluoxetine Mylan while taking warfarin, your doctor will need to take some samples, adjust your dose and check you more often.
  • cyproheptadine (for allergies ); because it may reduce the effect of Fluoxetine Mylan.
  • drugs that lower sodium levels in the blood (including drugs that increase urine output, desmopressin, carbamazepine, and oxcarbazepine); as they increase the risk of too low a sodium level in the blood when taken with Fluoxetine Mylan.
  • antidepressants such as tricyclic antidepressants, other selective serotonin reuptake inhibitors ( SSRIs ) or bupropion, mefloquine or chloroquine (used to treat malaria ), tramadol (used to treat severe pain), or antipsychotics (such as phenothiazines or butyrophenones); as Fluoxetine Mylan may increase the risk of seizures if taken at the same time as these medicines.
  • flecainide, propafenone, nebivolol or encainide (used to treat heart disease), carbamazepine (used to treat epilepsy ), tricyclic antidepressants (eg imipramine, desipramine, and amitriptyline ), or risperidone (for schizophrenia); as Fluoxetine Mylan may alter the blood levels of these medicines and your doctor may need to lower the dose of one of these medicines as they are being given at the same time as Fluoxetine Mylan.

Fluoxetine Mylan with food, drink, and alcohol

Food:

The tablets can be taken with or without food.

Alcohol:

Avoid alcohol while taking Fluoxetine Mylan.

Pregnancy, breastfeeding, and fertility

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.

Pregnancy

Tell your doctor as soon as possible that you are pregnant, think you may be pregnant, or are planning to become pregnant.

Studies have shown 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.

When drugs such as fluoxetine 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 possible, this medicine should not be used during pregnancy unless the benefit outweighs the potential risk. Thus, you and your doctor may decide to gradually stop taking Fluoxetine Mylan if you are pregnant or planning to become pregnant. Depending on your situation, however, your doctor may suggest that you should continue treatment with Fluoxetine Mylan.

Caution should be exercised when using during pregnancy, especially during the latter part of pregnancy or just before delivery as the following effects have been observed in newborns: irritability, tremors, muscle weakness, persistent crying, difficulty in sucking, and sleeping.

If you take Fluoxetine Mylan 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 Mylan 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.

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

Fluoxetine Mylan may impair judgment and coordination. Do not drive or use machines until you know how Fluoxetine Mylan affects you.

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

Fluoxetine Mylan contains lactose

Fluoxetine Mylan contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Fluoxetine Mylan contains sodium

Fluoxetine Mylan contains less than 1 mmol (23 mg) sodium per capsule, ie essentially ‘sodium-free’.

3. How to use Fluoxetine Mylan

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

Swallow the capsules with a little water. Do not chew the capsules.

Adults

The recommended dose is:

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, dose one can be gradually increased up to a maximum dose of 3 capsules (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.

Obsessive-compulsive disorder and obsessive-compulsive disorder: The recommended dose is 1 capsule (20 mg) per day.

Your doctor will review and, if necessary, adjust the dose one after 2 weeks of treatment. If necessary, dose one can be increased gradually up to a maximum dose of 3 capsules (60 mg) daily. If no improvement occurs within 10 weeks, treatment with Fluoxetine Mylan should be reconsidered.

Bulimia:

The recommended dose is 3 capsules (60 mg) daily.

Older:

Your doctor will be more careful with the dose increase if you are older. The daily dose should generally not exceed 2 capsules (40 mg). The maximum dose is 3 capsules (60 mg) per day.

Hepatic impairment:

If you have impaired liver function, your dose may need to be reduced by your doctor.

Use for children and adolescents

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

The treatment must be initiated and checked by a specialist. The starting dose is 10 mg per day. As the 20 mg capsule cannot be divided into equal doses, you can use other strengths and types of drugs that contain fluoxetine in cases where you need a dose lower than 20 mg. Your doctor may prescribe a lower dose for you with low-weight children. The treating physician will adjust the dose one carefully and individually so that the child or adolescent receives the lowest effective dose one. After one to two weeks, the doctor may increase the dose to one to 20 mg per day.

Your doctor will examine the need for continued treatment with Fluoxetine Mylan after 6 months, and reconsider treatment if your condition has not improved within 9 weeks of treatment.

If you take more Fluoxetine Mylan then you should

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Bring the Fluoxetine Mylan pack if you can.

Symptoms of overdose: nausea, vomiting, convulsions, heart problems (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 Mylan

Do not take a double dose to make up for a forgotten dose. Take the next dose the next day at the usual time.

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 Mylan

Do not stop taking Fluoxetine Mylan 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 Mylan: dizziness, tingling like needles, difficulty sleeping (sleepy dreams, insomnia), feeling restless or anxious, unusual tiredness or weakness, anxiety, nausea/vomiting (feeling sick), shaking, and headache.

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

When treatment with Fluoxetine Mylan is stopped, your doctor will help you reduce the dose slowly over one to two weeks so that the risk of post-treatment symptoms is reduced.

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.

  • Contact a doctor as soon as possible or go to the nearest hospital if you have thoughts of injuring yourself or committing suicide (see section 2).
  • If you get a rash or allergic reaction such as itching, swollen lips/tongue, or wheezing / difficulty breathing, stop taking Fluoxetine Mylan immediately and contact your doctor immediately.
  • If you feel anxious and can not stand or sit still, you may have something called akathisia. As the dose of Fluoxetine Mylan is increased, you may feel worse. If this happens, consult your doctor.
  • Contact your doctor immediately if the skin turns red or you have another skin reaction or blisters form and the skin flakes or comes off. This is very rare.

The most common side effects (very common side effects that may affect more than 1 in 10 people) are insomnia, headache, diarrhea, nausea, and fatigue.

Some patients have had:

  • a collection of symptoms (so-called serotonergic syndrome) that include unexplained fever with rapid breathing or heart rate, sweating, muscle stiffness or tremors, confusion, extreme anxiety, or drowsiness (occurs only rarely).
  • feeling weak, drowsy, or confused, especially in the elderly and (elderly) people taking diuretics ( diuretic tablets).
  • prolonged and painful erection
  • irritability and extreme anxiety
  • heart problems, such as rapid or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate heart rhythm disturbances.

If you get any of the side effects listed above, contact your doctor immediately.

These side effects have also been reported in patients taking Fluoxetine Mylan:

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 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 shivering

Uncommon (may affect up to 1 in 100 people)

  • feel isolated from oneself
  • strange thoughts
  • abnormal elation
  • sexual problems, including orgasm problems, which occasionally persist after stopping treatment
  • suicidal thoughts or thoughts of harming oneself
  • grind teeth
  • muscle twitching, involuntary movements, or problems with balance and coordination
  • impaired memory
  • enlarged (dilated) pupil s
  • noise in the ears
  • low blood pressure
  • respiratory distress
  • nosebleeds
  • difficulty swallowing
  • hair loss
  • increased tendency to get bruises
  • unexplained bruising or bleeding
  • cold sweats
  • difficulty urinating
  • feel hot or cold
  • abnormal liver test values

Rare (may affect up to 1 in 1,000 people)

  • low levels of salt in the blood
  • decreased platelet count, which increases the risk of bleeding or bruising
  • decreased white blood cell count
  • violent behavior
  • hallucinations
  • stark oro
  • panic attacks
  • confusion
  • stuttering
  • aggression
  • attack
  • vasculitis ( inflammation of a blood vessel)
  • rapid swelling of the tissues around the neck, face, mouth, and/or throat
  • pain in the duct that transports food and water to your stomach (esophagus)
  • hepatitis (liver disease)
  • lung problem
  • sensitivity to sunlight
  • muscle pain
  • difficulty urinating
  • milk flow from the breasts

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

  • severe vaginal bleeding shortly after delivery ( postpartum hemorrhage), see “Pregnancy” in section 2 for more information

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

Most of these side effects disappear with continued treatment.

5. How to store Fluoxetine Mylan

Keep this medicine out of the sight and reach of children.

Do not store above 25 ° C

Do not use this medicine after the expiry date which is stated on the label after EXP. or EXP.

The expiration date is the last day of the specified month.

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. 1 capsule contains fluoxetine hydrochloride equivalent to 20 mg fluoxetine.

The other ingredients are lactose monohydrate, maize starch, colloidal anhydrous silica, talc, magnesium stearate, brilliant blue (E133), quinoline yellow (E104), titanium dioxide (E171), erythrosine (E127), indigo carmine (E132), ammonia, propylene, concentrated and black iron oxide (E172).

What the medicine looks like and the contents of the pack

HDPE package with screw cap made of polypropylene (with pressure-sensitive wadding) containing 30, 100, and 250 capsules respectively.

PVC / PVDC / Al blister pack containing 100×1 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan AB

Box 23033

104 35 Stockholm

Manufacturer

McDermott Laboratories to Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

Muhammad Nadeem

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