20 mg dispersible tablets
Fluoxetine

What Fluoxetine STADA is and what it is used for

Fluoxetine Stada is an antidepressant drug that belongs to a group called selective serotonin reuptake inhibitors ( SSRIs ).

Fluoxetine Stada is used

to adults to treat:

  • Depressive disorders (actual depression).
  • Obsessive-compulsive disorder (a repeated obsessive-compulsive disorder with uncontrolled behavior).
  • Bulimia (eating disorder): Fluoxetine Stada is used together with psychotherapy to reduce binge eating and so-called self-cleansing (a compensatory behavior to control weight with, for example, vomiting, taxation, or exercise).

For children and adolescents 8 years and older to treat:

moderate to severe actual depression, if the depression has not improved after 4-6 psychological treatment sessions. The doctor will only offer antidepressant medication to a child or a young person with moderate to severe major depression along with concomitant psychological treatment.

Fluoxetine contained in Fluoxetine Stada 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 use Fluoxetine STADA

Do not use Fluoxetine STADA

  • if you are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6)
  • if you are taking medicines called irreversible non-selective monoamine oxidase inhibitors ( MAOIs, which are also used to treat depression) such as iproniazid, or have been taking them at some point in the last two weeks. Your doctor will advise you on how to start taking Fluoxetine Stada after you have stopped taking MAOIs. Similarly, you must wait at least five weeks when switching treatment from Fluoxetine Stada to an MAOI. Ask your doctor
  • if you are taking a medicine called metoprolol that is used for heart failure 

Warnings and cautions

Talk to your doctor or pharmacist before taking Fluoxetine Stada, especially if you have or have had any of the following medical conditions or diseases:

  • Itching or other allergic (hypersensitivity) reactions. If you get an allergic reaction such as itching or swelling of the face, lips, tongue, and/or throat (sometimes with difficulty breathing or difficulty swallowing), treatment with Fluoxetine Stada must be stopped. Call your doctor or go to the nearest emergency room immediately.
  • If you have epilepsy or have had seizures in the past. If you have a seizure or experience an increase in the frequency of seizures, contact your doctor immediately as the use of fluoxetine may need to be stopped.
  • Electric shock treatment (ECT) Electric shock treatment is a treatment for depression. If you are taking fluoxetine while receiving ECT treatment, the cramps may be longer than usual. You must therefore tell your doctor that you are taking this medicine.
  • If you have had mania before. If you get a manic episode, contact your doctor immediately. The use of fluoxetine may need to be discontinued.
  • Impaired liver or kidney function. You may need to take a lower dose of Fluoxetine Stada if your liver does not function normally.
  • If you are being treated with tamoxifen (used to treat breast cancer). See “Other medicines and Fluoxetine Stada”.
  • Heart disease. If you have heart disease, you should take Fluoxetine Stada with caution. You may need to take a lower dose of Fluoxetine Stada.
  • Weight loss. You may lose weight while taking Fluoxetine Stada.
  • Diabetes. Treatment with Fluoxetine Stada may cause your blood sugar to drop too low. When you stop taking Fluoxetine Stada, your blood sugar levels may rise too much. Your doctor may therefore need to adjust the dose of your diabetes medicine.

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

  • Akathisia (inability to sit still) or psychomotor restlessness (an anxiety-creating restlessness with a constant need to move). You may develop an unpleasant or anxious restlessness and a constant need to move. You can often find that you can not sit or stand still at the same time. This is most likely to occur during the first few weeks of treatment. If you notice any of these symptoms, consult your doctor.
  • If you have a history of bleeding disorders or if you experience bruising or abnormal bleeding including vaginal bleeding, vomiting blood, or having blood in your stool or if you are pregnant (see Pregnancy, breast-feeding, and fertility ).
  • If you are taking medicines that affect the blood’s ability to coagulate (see “Other medicines and Fluoxetine Stada”).
  • If you have increased pressure in the eye ( glaucoma ). You may develop enlarged pupils ( mydriasis ). Caution should be exercised. Talk to your doctor.
  • If you start to have a fever, muscle stiffness or tremors, changes in your mental status such as confusion, irritation, and extreme anxiety, you may have a so-called serotonergic syndrome or malignant neuroleptic syndrome. Although this syndrome is uncommon, it can give rise to potentially life-threatening conditions. Therefore, contact your doctor immediately. Fluoxetine treatment may need to be stopped.
  • Treatment with certain monoamine oxidase inhibitors ( MAOIs ), some used to treat depression. Some cases of serious and sometimes fatal side effects have been reported in patients receiving SSRIs in combination with an irreversible non-selective MAOI. These cases are reminiscent of a serotonergic syndrome. Therefore, Fluoxetine Stada must not be used in combination with an irreversible non-selective MAOI. Because the effect of MAO inhibitors should be for two weeks, the treatment with fluoxetine should be only started 2 weeks after the end of treatment with an irreversible non-selective MAOI. Similarly, it should be at least 5 weeks after the end of treatment with Fluoxetine Stada before starting treatment with non-selective MAOIs (See “Other medicines and Fluoxetine Stada”).

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

Children and young people

Fluoxetine Stada should not normally be used in children and adolescents below 18 years of age except for the treatment of moderate to severe major depression in children and adolescents aged 8 to 18 years.

Also, you should know that patients under the age of 18 may be at increased risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiance,e, and anger) when taking this type of medicine. Despite this, Fluoxetine Stada can be prescribed by a doctor to patients under 18 years of age because he/she considers it to be in their best interests and/or to treat moderate to severe major depression in children and adolescents between 8 and 18 years of age. If your doctor has prescribed Fluoxetin Stada to a patient under the age of 18 and you want to discuss this, contact your doctor again. You should tell your doctor if any of the symptoms described above occur or get worse when patients under 18 years of age take FluoxetineStada. The long-term effects on growth, maturity, and cognitive and behavioral development have not yet been determined for children and adolescents under 18 years of age.

Other medicines and Fluoxetine STADA

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You should also tell your doctor if you are taking or have recently taken (traditional) herbal medicines.

Note that fluoxetine stays in your body for a long time after you stop taking the medicine. This means that it may cause reactions with other medicines up to 5 weeks after stopping treatment with fluoxetine.

The following medicines may affect or be affected by fluoxetine:

  • Some monoamine oxidase inhibitors (irreversible, non-selective MAOIs, see also “Do not take Fluoxetine Stada”) e.g. iproniazid. Some cases of serious and sometimes fatal side effects have been reported in patients receiving SSRIs in combination with an irreversible non-selective MAOI. These cases are reminiscent of the serotonergic syndrome. Symptoms of such an interaction are:
    • hyperthermia (abnormally high body temperature)
    • rigidity (muscle stiffness)
    • myoclonus (involuntary muscle contractions)
    • rapid changes of vital signs (sudden changes in your heart rate, respiratory rate, or blood pressure )
    • mental changes including confusion, irritability, and extreme agitation which turn into delirium (your mind wanders, with confusing speech and impaired consciousness) and unconsciousness ( coma ) (see also section 4 “Possible side effects”)

Therefore

Do not take Fluoxetine Stada for at least 2 weeks after stopping treatment with an irreversible MAOI (eg iproniazid). Similarly, you must also wait when switching from fluoxetine treatment to an MAOI. In this case, you should not take an MAOI for at least five weeks after the last dose of Fluoxetine Stada. If Fluoxetine Stada has been taken for a long time and/or in a high dose, a longer interval should be considered by your doctor. Do not change your medication without talking to your doctor.

  • Metoprolol used in heart failure; The risk of metoprolol side effects may increase.
  • Lithium (for bipolar disorder, a mental illness), tramadol (a painkiller), triptans e.g. almotriptan or naratriptan (for the treatment of migraine ), tryptophan (eg in sleeping pills), selegiline (for Parkinson’s disease), linezolid, methylthionine chloride (methylene blue), St. John’s wort (Hypericum perforatum, a plant product found in several (traditional) herbal medicines and certain medicines). There is an increased risk of serotonergic syndrome when these medicines are co-administered with Fluoxetine Stada. When Fluoxetine Stada is used in combination with these medicines, your doctor will perform more frequent checks. Your doctor may need to lower your doseone of certain drugs (eg MAO-A inhibitors including linezolid and methylthionine chloride (methylene blue)) when administered with Fluoxetine Stada and close clinical monitoring will be required.
  • Phenytoin for the treatment of epilepsy as Fluoxetine Stada may affect the blood levels of this medicine. Your doctor may need to inject phenytoin more carefully and perform regular check-ups as Fluoxetine Stada is given at the same time.
  • Flecainide and propafenone (for heart problems), nebivolol (for lowering blood pressure and for heart problems), atomoxetine (used to treat attention deficit hyperactivity disorder ADHD ), carbamazepine (for epilepsy ), tricyclic antidepressants (for depression), and risperidone (for mental illness). As Fluoxetin Stada may change the blood levels 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 Fluoxetin Stada.
  • Tamoxifen (used to treat breast cancer). Your doctor may need to consider another antidepressant treatment as fluoxetine may alter the blood levels of this medicine and a reduction in the effect of tamoxifen cannot be ruled out.
  • Mekitazine (for the treatment of allergies and colds). Fluoxetine may increase the risk of side effects of meclizine.
  • Drugs that can affect the heart rhythm, such as Class 1A and III antiarrhythmics (medicines for irregular heart activity), antipsychotics (eg phenothiazines, pimozide, haloperidol ), tricyclic antidepressants (medicines for depression), certain antimicrobial medicines (eg sparfloxacin moxifloxacin, erythromycin IV, pentamidine), treatment for malaria (especially halofantrine), certain antihistamines (astemizole, mizolastine).
  • Oral anticoagulants (to reduce the ability of the blood to clot, such as warfarin ).
  • Drugs that affect platelet function (they may increase the risk of bleeding) such as
    • phenothiazines and atypical antipsychotics (such as clozapine), used in mental illness
    • acetylsalicylic acid (to treat pain)
    • non-steroidal anti-inflammatory drugs ( NSAIDs), used to treat pain and inflammation ).
  • Cyproheptadine (for the treatment of allergic reactions).
  • Medicines that lower the level of sodium in the blood (eg diuretics ( diuretic tablets), desmopressin, carbamazepine, and oxcarbazepine).
  • Drugs that can lower the seizure threshold, e.g. tricyclic antidepressants, other SSRIs, phenothiazines, butyrophenones, mefloquine, chloroquine, bupropion, tramadol.

Fluoxetine STADA with alcohol

Concomitant use of Fluoxetine Stada and alcohol is not recommended.

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

There have been reports of an increased risk of heart defects in infants whose mothers used Fluoxetine Stada 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 approximately 2 in 100 when mothers were treated with Fluoxetine Stada. You and your doctor may decide to gradually stop treatment if you are pregnant. However, depending on the circumstances, your doctor may suggest that you continue to use Fluoxetine Stada.

Tell your midwife or doctor that you are using Fluoxetine Stada. When drugs such as Fluoxetine Stada 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.

Your doctor may decide if you can take fluoxetine during pregnancy, but caution should be exercised, especially during the latter part of pregnancy and before delivery. However, the following symptoms have been reported in newborns: irritation, tremors, hypotension (low blood pressure ), muscle weakness, persistent crying, difficulty in sucking or sleeping.

If you take Fluoxetine Stada 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 Stada so that they can advise you on this.

Breast-feeding

Fluoxetine passes into breast milk. Side effects have been reported from breast-fed infants. Your doctor may advise you not to breast-feed while taking Fluoxetine Stada. Alternatively, it may be possible to take the lowest effective dose of Fluoxetine Stada and continue breast-feeding. This reduces the side effects to a minimum.

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

You should avoid driving or using dangerous machines until you are reasonably sure that your ability to perform these tasks is not affected. Fluoxetine Stada, like other antidepressants, may affect your judgment or the reactivity required to perform these activities.

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 STADA contains lactose (milk sugar)

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

How to use Fluoxetine STADA

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

The usual dosage for adults and the elderly:

Treatment of major depression:

The recommended dose is 20 mg daily.

Your doctor may increase the dose one to three to four weeks if you do not respond to treatment. If needed, the dose can be gradually increased up to a maximum of 60 mg. Dose one should be increased carefully to ensure that you receive the lowest effective dose.

You may not feel better right away when you start taking your antidepressant. This is common because an improvement in depressive symptoms may not come until after the first few weeks.

Patients with depression should be treated for a period of at least 6 months.

Treatment of the obsessive-compulsive disorder

The recommended dose is 20 mg daily. Your doctor may increase the dose one after two weeks if you do not respond to treatment. If necessary, the dose can be increased gradually up to a maximum of 60 mg per day.

If your condition does not improve within 10 weeks, your doctor will evaluate whether to continue treatment with fluoxetine. If you have had a good effect, your doctor may continue your treatment beyond 10 weeks. Dose one will be adjusted individually for you so that you get the lowest effective dose one. At regular intervals, your doctor will evaluate whether you need further treatment.

Bulimia

For adults and the elderly, a dose of 60 mg daily is recommended.

For the treatment of all the above conditions:

The recommended dose can be increased or decreased. The safety and efficacy of treatment with doses of more than 80 mg per day have not been properly studied. High doses will therefore only be prescribed when your doctor feels that the benefits outweigh the risks.

Use in children and adolescents older than 8 years:

Treatment of moderate to severe major depression:

The treatment must be initiated and checked by a specialist.

The starting dose is 10 mg per day. 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.

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

Older:

Caution is advised when increasing dose one and the daily dose one should not exceed 40 mg. The maximum recommended dose is 60 mg.

Patients with hepatic impairment or patients with other medicines that may affect the levels of Fluoxetine Stada (your doctor knows these):

Your doctor may prescribe a lower dose or recommend a longer time between dosing sessions.

How to take the drug

You can take the tablet with or between meals. Fluoxetine Stada can be swallowed whole with water or dissolved in water. Swallow the reconstituted tablet immediately and completely. If you need to take more than one tablet a day, you can take them as a single dose or all at the same time as a single dose.

The tablet can be divided into two equal doses.

If you take more Fluoxetine STADA then you should

Symptoms of overdose include nausea, vomiting, seizures, heart problems from irregular heartbeat without symptoms to a heart attack; lungs that do not function properly which can cause difficulty breathing, changes in the brain and spinal cord such as arousal, and an altered level of consciousness or unconsciousness.

If you have ingested too much medicine or if e.g. a child inhaled the medicine accidentally contact a doctor, hospital,l or the Poison Information Center for risk assessment and advice. Bring the Fluoxetine Stada pack if you can.

If you forget to take Fluoxetine STADA

If you miss a dose, do not worry. Take your next dose the next day as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Fluoxetine STADA

Do not stop taking Fluoxetine Stada unless your doctor tells you to. At the end of treatment, your dose of Fluoxetine Stada should be gradually reduced over several weeks or months to reduce withdrawal symptoms (see section 4. “Possible side effects”).

Withdrawal symptoms

You may experience withdrawal symptoms when you stop taking Fluoxetine Stada. These are common especially if you abruptly stop taking Fluoxetine Stada. Withdrawal symptoms include dizziness, sensory disturbances (including tingling and numbness), sleep disturbances, including the inability to sleep ( insomnia ) and intense dreams, weakness, agitation or anxiety, nausea and/or vomiting, tremors, and headache.

Usually, these symptoms are mild to moderate. However, they can be difficult. They usually occur in the first few days after the end of treatment and get better within two weeks. However, they can be for 2-3 months or longer. Tell your doctor if any of these symptoms become severe or affect your daily life. He or she may ask you to start taking your tablets again and then reduce the dose even slower.

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.

Undesirable effects may occur less frequently and become less severe as your treatment continues. These side effects do not always mean that you have to stop treatment.

Like other medicines such as Fluoxetine Stada, the following side effects have been reported:

A very common side effect is (can occur in more than 1 in 10):

  • sleep disorders ( insomnia )
  • headache
  • loose stools (diarrhea), malaise (nausea)
  • mental or physical fatigue (exhaustion),

Common side effects are (may affect up to 1 in 10):

  • poor appetite
  • weight loss
  • nervousness, anxiety
  • feel tense
  • restlessness
  • sleep problems (sleep disorders), e.g. unusual dreams
  • fatigue ( somnolence )
  • poor concentration (attention deficit disorder), dizziness, lethargy
  • taste change ( dysgeusia )
  • uncontrolled shaking movements ( tremor )
  • dimsyn
  • the feeling of fast and irregular heartbeat (palpitations)
  • Sudden redness of the face ( flush )
  • yawning
  • nausea (vomiting), indigestion ( dyspepsia )
  • dry mouth
  • skin rash, hives ( urticaria ), itching ( pruritus )
  • profuse sweating ( hyperhidrosis )
  • joint pain ( arthralgia )
  • frequent urination
  • unexpected vaginal bleeding
  • sexual problems such as difficulty maintaining an erection for sexual activity ( erectile dysfunction ), premature ejaculation or delayed ejaculation (ejaculation disorder), decreased sex drive (decreased libido )
  • feel shaky or have chills.

Uncommon side effects (may affect up to 1 in 100 people):

  • feel isolated from oneself
  • strange thoughts
  • abnormal exhilaration (elevated mood, euphoric mood)
  • orgasm problem
  • grind teeth
  • suicidal thoughts or thoughts of harming oneself
  • a painful restlessness with a constant need to move ( psychomotor hyperactivity)
  • muscle twitching ( myoclonus ), involuntary movements ( dyskinesia ), or problems with balance and coordination ( ataxia )
  • enlarged pupils ( mydriasis )
  • difficulty remembering things (impaired memory)
  • ringing in the ears ( tinnitus )
  • low blood pressure ( hypotension )
  • shortness of breath ( dyspnoea )
  • epistaxis ( epistaxis )
  • difficulty swallowing ( dysphagia )
  • intestinal bleeding ( gastrointestinal bleeding)
  • hair loss ( alopecia )
  • increased tendency to get bruises
  • cold sweats
  • difficulty emptying the bladder ( dysuria )
  • sexual incapacity (sexual dysfunction )
  • general discomfort (feeling sick), abnormal feeling, feeling cold, feeling hot.

Rare side effects are (may affect up to 1 in 1000 people):

  • decreased platelet count, increasing the risk of bleeding or bruising ( thrombocytopenia )
  • the low number of certain white blood cells ( neutropenia )
  • decreased number of white block bodies ( leukopenia )
  • allergic reaction (anaphylactoid reaction)
  • rash with or without itching along with any of the following symptoms: fever, joint pain, muscle aches, swollen lymph nodes, and/or flu-like symptoms (serum sickness)
  • Low sodium levels in the blood ( hyponatremia ) including sodium levels below 110 mmol / l blood serum. This may in some cases be due to excessive secretion of antidiuretic hormone. This side effect is most likely if you are elderly and also taking diuretics. It usually gets better when you stop the treatment.
  • extremely elevated mood, a lot of energy, and unusual thought patterns (mania); persistent elated or irritable mood ( hypomania )
  • to see or feel something that does not exist (hallucinations)
  • stark oro
  • panic attacks
  • confusion
  • stuttering (dysphemia)
  • aggression
  • seizures (convulsions)
  • inability to sit still ( akathisia, see section 2 “Warnings and Precautions”)
  • uncontrollable movements of the mouth, tongue, and limbs (buccoglossal syndrome)
  • serotonergic syndrome, a reaction caused by an excess of the body’s own substance serotonin (for symptoms see section 2. “Warnings and precautions”)
  • life-threatening irregular heartbeat ( ventricular arrhythmia including torsades de pointes ), abnormal heart activity shown by ECG ( QT prolongation on ECG )
  • inflammation of a blood vessel ( vasculitis )
  • dilation of blood vessels ( vasodilation )
  • sore throat ( pharyngitis )
  • lung problems including pneumonia and fibrosis (the formation of fibrous tissue in the lungs). You may get shortness of breath before you get these signs of illness.
  • pain in the esophagus
  • rapid swelling of the throat, face, mouth, and/or throat ( angioedema )
  • bleeding under the skin ( ecchymosis )
  • sensitivity to sunlight (photosensitivity)
  • purple or red pin-sized dots on the skin (purple)
  • severe and life-threatening skin reactions including rash, redness, blisters on the lips, eyes, or mouth, dandruff, fever. This may be a sign of Erythema Multiforme and may develop into Stevens-Johnson syndrome or toxic epidermal necrolysis ( Lyell’s syndrome ). For symptoms of these side effects, see section 2. “Warnings and precautions”)
  • muscle pain ( myalgia )
  • difficulty urinating ( urinary retention, disorders of urination)
  • a persistent, painful erection (priapism)
  • high levels of a hormone called prolactin ( hyperprolactinemia ), excessive production of breast milk ( galactorrhea )
  • mucosal bleeding (mucosal bleeding)
  • yellowing of the skin and whites of the eyes are signs of hepatic impairment/hepatitis
  • abnormal liver function values ​​( transaminases, elevated gamma-glutamyltransferase).

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

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

Other possible side effects:

An increased risk of bone fractures has been seen in patients taking this type of drug.

Withdrawal symptoms

These occur especially if you suddenly stop using fluoxetine. The symptoms are:

  • ant crawling ( paresthesias ), tremors, headache
  • sleep disorders (including insomnia and intense dreams), weakness, anxiety,
  • dizziness, nau, sea, and/or vomiting.

(see also section 3. “If you stop taking Fluoxetine Stada”).

Use in children and adolescents under 18 years of age

In studies in children, the following additional side effects have been reported

  • suicidal thoughts and suicidal behavior and aggression
  • manic reactions, including extremely high mood, energy, and abnormal thought patterns (mania), and persistent hilarious or irritated mood ( hypomania ).
  • growth inhibition (reduced increase in height and weight)
  • delayed sexual maturation or sexual dysfunction
  • decreased levels of alkaline phosphatase (an enzyme found in the liver).

5. How to store Fluoxetine STADA

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.

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.

One Fluoxetine Stada 20 mg dispersible tablet contains 20 mg fluoxetine.

The other ingredients are lactose monohydrate, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica.

What the medicine looks like and the contents of the pack

White round tablet with a scoreline on both sides.

The tablet can be divided into two equal doses.

Fluoxetine Stada 20 mg dispersible tablets are available in blister packs of plastic and aluminum foil.

Pack sizes: 12, 14, 20, 28, 30, 50, 60, 70, 90, 98 and 100 tablets in blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Other manufacturers

STADApharm GmbH, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Vienna, Austria

Clonmel Healthcare Ltd., Waterford Road, Clonmel, Co. Tipperary, Ireland

Centrafarm Services BV, Nieuwe Donk 9, 4879 Etten-Leur, The Netherlands

Sanico NV, Industrial Zone IV, Veedijk 59, 2300 Turnhout, Belgium

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

Muhammad Nadeem

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