20 mg dispersible tablets
fluoxetine

What Fluoxetine Sandoz is and what it is used for

Fluoxetine Sandoz is an antidepressant drug that affects the central nervous system. Fluoxetine Sandoz contains the active substance fluoxetine.

Fluoxetine Sandoz 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 Sandoz should be given to children or adolescents with moderate to severe depression only in combination with psychological treatment.

How Fluoxetine Sandoz works

All people have a substance called serotonin in the brain. People who have depression or obsessive-compulsive disorder or bulimia have lower serotonin levels than others. It is not completely known how Fluoxetine Sandoz and other SSRIs work, but they can help by raising serotonin levels in the brain.

It is important to treat these conditions for you to feel better. If the condition is not treated, it may not go away and may become more serious and difficult to treat.

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

Please note that your doctor may have prescribed this medicine for a different purpose and/or with a different dosage than what is stated in the package leaflet. Always follow your doctor’s prescription and the instructions on the label on the package.

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

2. What you need to know before you use Fluoxetine Sandoz

Do not use Fluoxetine Sandoz

If you are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6).

• if you are taking medicines that belong to the group of so-called irreversible non-selective monoamine oxidase inhibitors (eg iproniazid) as serious side effects and even death can occur.

• if you are taking metoprolol for the treatment of heart failure.

Warnings and cautions

Talk to your doctor or pharmacist before taking Fluoxetine Sandoz

  • If you have diabetes, Fluoxetine Sandoz may increase or decrease your blood sugar. Your insulin dose or the oral antidiabetic medicines you may need may be dose adjusted.
  • if you have had seizures, epilepsy, impaired liver, kidney, or heart function, or have recently had a heart attack, tell your doctor as it may be necessary to prescribe a smaller dose for you.
  • if you have or have had mania.
  • if you have a low resting heart rate and/or know that you have a salt deficiency due to prolonged severe diarrhea and vomiting or the use of diuretics ( diuretics ).
  • if you are prone to bleeding.
  • if you have glaucoma (increased pressure in the eye).
  • if you are taking diuretics ( diuretics ), especially if you are older.
  • if you are taking other medicines or herbal preparations containing St. John’s wort ( Hypericum perforatum ) (see “Other medicines and Fluoxetine Sandoz”).
  • if you are receiving electric shock treatment.
  • if you have previously had problems with bleeding or the presence of bruising or unusual bleeding.
  • if you are taking blood-thinning medicines (see “Other medicines and Fluoxetine Sandoz”).
  • if you are taking tamoxifen (used to treat breast cancer) (see “Other medicines and Fluoxetine Sandoz”).

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 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 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.

Restlessness such as difficulty sitting or standing still, allergic reactions, or a combination of severe symptoms known as the serotonergic syndrome may occur during treatment with Fluoxetine Sandoz, see section 4.

Weight loss may occur during treatment with Fluoxetine Sandoz.

Children and young people

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 Sandoz 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 Sandoz, such as effects on height growth, puberty development, mental, emotional, and behavioral development. Despite this, Fluoxetine Sandoz is prescribed by a doctor to patients under the age of 18 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 Sandoz, 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 Sandoz should not be used to treat children under 8 years of age.

Withdrawal symptoms if you stop taking Fluoxetine Sandoz

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

Other medicines and Fluoxetine Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some other medicines may affect or be affected by Fluoxetine Sandoz. These drugs are:

  • metoprolol used to treat heart failure, and irreversible non-selective MAOIs (eg iproniazid) must not be taken concomitantly with Fluoxetine Sandoz (see above under “Do not use Fluoxetine Sandoz”). If your doctor changes your medicine from a so-called irreversible non-selective MAOI (eg iproniazid) to Fluoxetine Sandoz, there should be at least 2 weeks between treatments. If you stop taking Fluoxetine Sandoz and the medication changes to an irreversible non-selective MAOI, it should be at least 5 weeks before you start taking the MAOI.
  • warfarin, anti-inflammatory drugs ( NSAIDs ), or other blood-thinning drugs (eg clozapine used for certain mental disorders, or acetylsalicylic acid ). Concomitant use of Fluoxetine Sandoz with such drugs increases the risk of bleeding. If treatment with Fluoxetine Sandoz is started or stopped while you are taking warfarin, your doctor will need to take some samples.
  • Lithium or tryptophan is used to treat depressed mood. There is an increased risk of serotonergic syndrome when these medicines are taken with fluoxetine. Your doctor will perform more frequent check-ups.
  • phenytoin is used to treat epilepsy. Fluoxetine may affect the concentration of this medicine in the blood and your doctor may need to insert phenytoin more carefully and perform checks while Fluoxetine Sandoz is being given at the same time.
  • tramadol is used to treat pain or triptans is used to treat migraines. There is an increased risk of the serotonergic syndrome. Triptans can also lead to narrowing of the heart’s blood vessels and high blood pressure when used concomitantly.
  • Antiarrhythmics of Class 1A or class III or other drugs which can affect heart rhythm; antipsychotics used to treat schizophrenia (eg phenothiazines, pimozide, haloperidol ); tricyclic antidepressants used to treat depression; certain antimicrobial drugs used to treat infections (eg sparfloxacin, moxifloxacin, erythromycin IV, pentamidine); halofantrine for malaria; astemizole, mizolastine, and mequitazine used to treat allergy s
  • diuretics, desmopressin, carbamazepine, oxcarbazepine and other medicines that can cause low levels of sodium in the blood.
  • tricyclic antidepressants, other selective serotonin reuptake inhibitors, phenothiazines, butyrophenones, Floxin, chloroquine, bupropion, tramadol, and other drugs that may lower the seizure threshold.
  • St. John’s wort (Hypericum perforatum, a (traditional) herbal medicine used to treat depression), MAO-A inhibitors (eg linezolid or methylthionine chloride [methylene blue]), selegiline, and other serotonergic medicines. Concomitant treatment with Fluoxetine Sandoz may lead to serious side effects (serotonergic syndrome).
  • flecainide, propafenone, or nebivolol used to treat heart problems; carbamazepine used to treat epilepsy; tricyclic antidepressants (eg imipramine, desipramine, and amitriptyline); atomoxetine used to treat ADHD; risperidone used to treat psychotic illnesses. If they are taken with Fluoxetine Sandoz, the blood levels of these medicines may change and your doctor may need to reduce the dose of one of these medicines.
  • tamoxifen is used to treat breast cancer. Fluoxetine Sandoz may alter the concentration of this drug in the blood and a reduction in the effect of tamoxifen can not be ruled out. Your doctor may consider choosing another treatment for depression.
  • cyproheptadine (used to treat allergies ) may reduce the antidepressant effect of fluoxetine.

Fluoxetine Sandoz with food, drink, and alcohol

The tablets can be taken with or without food.

The combination of Fluoxetine Sandoz 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.

Fluoxetine Sandoz should not be used during pregnancy and breast-feeding unless your doctor has decided that the risk of not using the medicine is greater than using it.

Taking Fluoxetine Sandoz during both pregnancy and lactation may affect the fetus / newborn baby.

Pregnancy

There have been reports that there is 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 Sandoz.

Tell your midwife or doctor that you are using Fluoxetine Sandoz. When drugs such as Fluoxetine Sandoz 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 are taking Fluoxetine Sandoz, especially during the latter part of your pregnancy or just before birth, your baby may have some symptoms at birth. These symptoms are irritability, tremors, muscle weakness, persistent crying, difficulty sucking and sleeping. These symptoms may indicate so-called serotonergic effects or withdrawal symptoms. If your baby has any of these symptoms at birth, contact your midwife or doctor who can advise you.

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.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Fluoxetine Sandoz may impair judgment, thinking ability, and motor skills. This should be observed in situations where increased attention is necessary, e.g. when driving or when using dangerous machinery.

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 Sandoz contains lactose

Fluoxetine Sandoz 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.

3. How to use Fluoxetine Sandoz

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

Fluoxetine can be taken as a single dose or divided into multiple doses.

Fluoxetine Sandoz dispersible tablet can be dissolved in a glass of water, divided, or swallowed whole.

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, 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.

Obsessive-compulsive disorder and 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 Sandoz should be reconsidered.

Bulimia:

The recommended dose is 60 mg daily.

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 one to two weeks, your doctor may increase the dose to 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.

Your doctor will assess the need for continued treatment after 6 months. If you have not improved, the treatment should be reconsidered.

Hepatic impairment:

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

If you use more Fluoxetine Sandoz 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.

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

If you forget to use Fluoxetine Sandoz

  • 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 using Fluoxetine Sandoz

Do not stop taking Fluoxetine Sandoz 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 Sandoz: dizziness, tingling of needles, difficulty sleeping (sleepy dreams, insomnia), feeling of restlessness or anxiety, unusual tiredness or weakness, anxiety, nausea/vomiting (feeling sick), shaking, headache.

Most people who stop taking Fluoxetine Sandoz 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 Sandoz contact your doctor.

When treatment with Fluoxetine Sandoz is stopped, your doctor will help you reduce the dose slowly over one to two weeks so that the risk of symptoms after the end of treatment 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 immediately

• Contact a doctor as soon as possible or see the nearest hospital if you have thoughts of injuring yourself or committing suicide (see section 2) (uncommon, may affect up to 1 in 100 users).

• If you get a rash or allergic reactions such as itching, swollen lips/tongue, or wheezing / difficulty breathing. Allergic reactions can also include severe skin reactions (your skin starts to turn red and then blisters form or the skin flakes and loosens) or involve the kidneys, liver, or lungs (see section 2). Stop taking the tablets immediately and contact your doctor immediately ; (rare, may affect up to 1 in 1,000 people).

• If you feel restless and cannot stand or sit still, you may have akathisia (rare, may affect up to 1 in 1,000 users).

• If you get severe skin reactions with blisters, red or purple marks, or peeling. This can also occur in the mouth, eyes, and other mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiformat (rare, may affect up to 1 in 1,000 people).

• If you experience 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 (rare, may affect up to 1 in 1,000 people).

• If you experience weakness, drowsiness, or confusion. This mainly affects the elderly and (elderly) people taking diuretics ( diuretic tablets) (rare, may affect up to 1 in 1,000 people).

• If you get a prolonged and painful erection (rare, may occur in up to 1 in 1,000 users).

• If you experience irritability and extreme anxiety (rare, may affect up to 1 in 1,000 people).

• If you have heart problems, such as fast or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate heart rhythm disturbances (rare, may affect up to 1 in 1,000 people).

The following side effects have also been reported in patients taking Fluoxetine Sandoz:

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

• sleeping problems

• headache

• diarrhea

• nausea

fatigue

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

• feeling of fast and irregular heartbeat

• hot flashes

Yawns

• 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 themselves

• strange thoughts

• unusual elation

• orgasm problem

• suicidal or self-harming thoughts

• gnashing of teeth

• muscle twitching, involuntary movements, or problems with balance and coordination

• impaired memory

• enlarged (dilated) pupil s

• earrings

• low blood pressure

• shortness of breath

• nosebleeds

• swallowing difficulties

hair loss

• increased tendency to get bruises

• unexplained bruising or bleeding

cold sweats

• difficulty urinating

• feel hot or cold

• general malaise

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

• low levels of salt in the blood

• reduced platelet count, which increases the risk of bleeding or bruising

• low number of white blood cells, increasing the likelihood of infection s

• violent behavior

• hallucinations

• oro

• panic attacks

• confusion

Stuttering

• aggressiveness

• seizures

• vasculitis ( inflammation of a blood vessel)

• rapid swelling of the tissues around the neck, face, mouth, and/or throat

• pain in the esophagus

• hepatitis

• lung problem

• sensitivity to sunlight

• muscle aches

• inability to urinate

• milk flow from the breasts

• abnormal results in liver function tests

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

Most of these side effects are likely to go away with continued treatment.

Supplements for 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.

Withdrawal symptoms may occur if you stop treatment, especially if you stop taking Fluoxetine Sandoz abruptly. The risk of withdrawal symptoms may depend on the duration and dosage of treatment and the rapid dose reduction (see “How to use Fluoxetine Sandoz”).

5. How to store Fluoxetine Sandoz

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

No special storage instructions.

Used before the expiration date specified after the Expiration Date. on the box and EXP on the blister card.

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 hydrochloride equivalent to 20 mg fluoxetine.

The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, crospovidone, croscarmellose sodium, anhydrous colloidal silica, saccharin sodium, sodium cyclamate, magnesium stearate

Flavor: peppermint aroma, plum aroma

What the medicine looks like and the contents of the pack

Fluoxetine Sandoz 20 mg dispersible tablet is a white, round, biconvex tablet with a scoreline on one side and is available in the following blister pack sizes: 7, 10, 14, 20, 28, 30, 60, 70, 100, and 100 x 1 tablet.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Sandoz A / S

Edvard Thomsens Vej 14, 2300

Copenhagen S

Denmark

Manufacturer:

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

Muhammad Nadeem

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