10 mg soluble tablets
fluoxetine

What Fluoxetine Ratiopharm is and what it is used for

Fluoxetine Ratiopharm contains the active substance fluoxetine which belongs to a group of medicines called selective serotonin reuptake inhibitors ( SSRIs ).

Fluoxetine Ratiopharm is used to treat the following diseases:

In adults:

  • actually depression
  • obsessive-compulsive disorder
  • bulimia: Fluoxetine Ratiopharm is used in combination with psychotherapy to reduce binge eating and self-cleansing.

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

How Fluoxetine Ratiopharm 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 Ratiopharm 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 Ratiopharm may also be approved for the treatment of other conditions not mentioned in this product information. 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 take Fluoxetine Ratiopharm

Do not take Fluoxetine Ratiopharm:

  • if you are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6). Stop taking the 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 other medicines called irreversible, non-selective monoamine oxidase inhibitors ( MAOIs ), as serious side effects and even death can occur (eg iproniazid used to treat depression). Treatment with Fluoxetine Ratiopharm 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 Ratiopharm. If Fluoxetine Ratiopharm 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 Ratiopharm if you:

  • have any heart disease.
  • have or previously had mania.
  • previously had problems with bleeding or if you are pregnant (see “Pregnancy, breast-feeding and fertility ).
  • use blood-thinning drugs (see “Other drugs and Fluoxetine Ratiopharm”).
  • have epilepsy or previously had seizures.
  • receive electrical therapy (electroconvulsive therapy).
  • receive treatment with tamoxifen (used to treat breast cancer) (see “Other medicines and Fluoxetine Ratiopharm”).
  • have diabetes (your doctor may change the dose of insulin or other medicines to treat 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).
  • have ongoing treatment with any other medicine (see “Other medicines and Fluoxetine Ratiopharm”).

Talk to your doctor if you experience any of the following during treatment:

  • Heart problems
  • Presence of bruising or unusual bleeding.
  • If you suddenly have 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. Contact your doctor immediately as Fluoxetine treatment may need to be stopped.
  • If you get a manic episode, contact your doctor immediately. Fluoxetine treatment may need to be stopped.
  • If you experience seizures (epileptic seizures) or experience an increase in seizures, contact your doctor immediately. Fluoxetine treatment may need to be stopped.
  • If you start to feel restless and can not sit still ( akathisia ). This can get worse if your Fluoxetine dose is increased.

Suicidal ideation and worsening depression or anxiety disorder

You who are depressed and/or suffer from worry/anxiety may sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start using 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 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 Ratiopharm 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 for the treatment of other diseases.

Also, there are only limited data from 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 Ratiopharm 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 interest. If you are under 18 years of age and want to discuss why you received Fluoxetine Ratiopharm, consult your doctor again. You should also tell your doctor if you notice any of the above symptoms or if they get worse.

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

Sexual dysfunction 

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

Other medicines and Fluoxetine Ratiopharm

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

Do not take Fluoxetine ratiopharm with you

  • some irreversible, non-selective  MAO inhibitors, some of which are used to treat depression. Irreversible, non-selective MAOIs should not be used with Fluoxetine ratiopharm as serious side effects and even death (serotonergic syndrome) may occur (See section “Do not take fluoxetine ratiopharm”).
  • metoprolol, when used for heart failure; there is an increased risk that your heartbeat may become too slow.

Fluoxetine ratiopharm may affect the action of the following medicines ( interaction )

  • tamoxifen (used to treat breast cancer); Because Fluoxetine Ratiopharm may alter the blood levels of this medicine, which may lead to a reduction in the effect of tamoxifen, your doctor may need to consider another antidepressant treatment.
  • monoamine oxidase inhibitor  A  (MAO-A inhibitor ) 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 ratiopharm.
  • phenytoin (used to treat epilepsy ). Because Fluoxetine Ratiopharm may affect the blood levels of this medicine, your doctor may need to use phenytoin more carefully and perform regular check-ups as Fluoxetine Ratiopharm is given at the same time.
  • lithium, selegiline, (traditional) herbal medicines containing  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 Ratiopharm. 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, certain antimicrobial drugs (eg sparfloxacin, moxifloxacin, moxifloxacin, IV ) pentamidine), treatment against malaria particularly halofantrine, some antihistamine s (astemizole, mizolastine); as the use of one or more of these medicines together with Fluoxetine Ratiopharm 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 ratiopharm may alter the effect of these medicines on the blood. If you are starting or stopping treatment with Fluoxetine ratiopharm while taking warfarin, your doctor will need to take some samples, adjust your dose and check you more often.  
  • cyproheptadine (for allergies ); as it may reduce the effect of Fluoxetine ratiopharm.
  • 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 Ratiopharm.
  • 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 Ratiopharm may increase the risk of seizures if taken at the same time as these medicines.
  • flecainide, propafenone, nebivolol or encainide, (used in heart disease), carbamazepine (used in epilepsy ), atomoxetine or tricyclic antidepressants (eg imipramine, desipramine, and amitriptyline ), or risperidone (for schizophrenia); Because Fluoxetine Ratiopharm may change the blood concentration of these medicines, your doctor may need to lower the dose of one of these medicines as they are being given at the same time as Fluoxetine Ratiopharm.

Fluoxetine ratiopharm with food, drink, and alcohol

You can take Fluoxetine ratiopharm between meals or with a meal.
You should avoid alcohol while taking fluoxetine.

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

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 ratiopharm.

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 ratiopharm if you are pregnant or planning to become pregnant. However, depending on your situation, your doctor may suggest that you should continue treatment with Fluoxetine ratiopharm.

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, and difficulty in sucking or sleeping.

If you take Fluoxetine ratiopharm 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 ratiopharm 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.

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

Psychotropic drugs such as Fluoxetine ratiopharm may impair judgment and coordination. Do not drive or use machines until you know how Fluoxetine ratiopharm affects you. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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 ratiopharm contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to take Fluoxetine ratiopharm

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Do not take more tablets than your doctor has prescribed.

Adults

The recommended dose is

  • DepressionThe 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 daily. 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.
  • BulimiaThe recommended dose is 60 mg daily.
  • Obsessive-compulsive disorder 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 daily. If no improvement has occurred within 10 weeks, treatment with Fluoxetine ratiopharm should be reconsidered by your doctor.

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. After 1 to 2 weeks, your doctor may increase the dose by one to 20 mg 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.

Older

  • 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.

Hepatic impairment

  • 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 ratiopharm every other day.

How to take Fluoxetine ratiopharm

When you take half or a whole tablet, you should swallow the medicine with a glass of water. Alternatively, you can dissolve the medicine in ½ to 1 glass of water. Once the tablet has dissolved, you must drink everything in the glass as soon as possible.

If you take more Fluoxetine ratiopharm then you should

  • If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
  • Bring the Fluoxetine ratiopharm pack if you can.

Symptoms of overdose include: nausea, vomiting, seizures, heart problems (eg irregular heartbeat and cardiac arrest), lung problems and mental changes in everything from severe anxiety to unconsciousness.

If you forget to take Fluoxetine ratiopharm

  • 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 ratiopharm

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

The following symptoms (withdrawal symptoms) may occur when you stop taking Fluoxetine ratiopharm:

dizziness, tingling of needles, difficulty sleeping (vivid dreams, nightmares, insomnia), feeling of restlessness or anxiety, unusual tiredness or weakness, anxiety, nausea / vomiting (feeling sick), tremors and headache. Most people who stop taking Fluoxetine ratiopharm experience that the symptoms are mild and disappear within a few weeks. If you get symptoms when you stop taking Fluoxetine ratiopharm contact your doctor.

When treatment with Fluoxetine ratiopharm is stopped, your doctor will help you reduce the dose slowly over one to two weeks so that the risk of withdrawal 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 the tablets immediately and contact your doctor immediately .
  • If you feel anxious and cannot stand or sit still, you may have experienced akathisia . An increase in Fluoxetine ratiopharm dose one can make you feel worse. If this happens, consult your doctor.
  • Contact your doctor immediately if the skin turns red and blisters then form and the skin flakes or loosens. This is 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:

Common (may affect up to 1 in 10 people)

  • poor appetite, weight loss
  • nervousness, anxiety
  • restlessness, difficulty concentrating
  • feel tense
  • reduce 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 have chills

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
  • ringing in the ears
  • low blood pressure
  • respiratory distress
  • nosebleeds
  • difficulty swallowing
  • hair loss
  • increased tendency to get bruises
  • bleeding in the gastrointestinal tract
  • cold sweats
  • difficulty urinating
  • general malaise
  • feel abnormal
  • 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
  • reduction in the number of platelets 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 esophagus
  • inflammation of the throat
  • hepatitis (jaundice)
  • lung problem
  • sensitivity to sunlight
  • bleeding in the skin
  • muscle pain
  • difficulty urinating
  • milk flow from the breasts
  • bleeding in mucous membranes.

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.

Most of these side effects disappear with continued treatment.

Children and adolescents (8-18 years)

In addition to the side effects listed above, fluoxetine may slow the growth rate and possibly delay puberty. Suicide-related behaviors (suicide attempts and suicidal thoughts), hostility, mania and nosebleeds were also reported as common side effects in children.

5. How to store Fluoxetine ratiopharm

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.

No special storage instructions.

The medicine 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. Each soluble tablet contains 10 mg of fluoxetine (as hydrochloride).

The other ingredients are microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and anhydrous colloidal silica.

What the medicine looks like and the contents of the pack

White, round tablet

Pack sizes: 10, 10×1, 30, 30×1, 100 and 100×1 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany

Manufacturer:
Merckle GmbH
Ludwig-Merckle-Straβe 3
89143 Blaubeuren
Germany

Muhammad Nadeem

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