20 mg hard capsules
fluoxetine

What Fluoxetine Orion is and what it is used for

Fluoxetine Orion contains the active substance fluoxetine which is part of a group of antidepressant medicines called selective serotonin reuptake inhibitors ( SSRIs ).

This medicine is used to treat the following diseases:

Adults:

Children and adolescents from 8 years of age:

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

How Fluoxetine Orion 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 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 Orion 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.

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

Do not use Fluoxetine Orion

  • if you are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6). Do not take more capsules 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 used to treat depression).
  • if you are using metoprolol (to treat heart failure ) as there is an increased risk that your heartbeat will be too slow.

Treatment with Fluoxetine Orion should only be started if 2 weeks have elapsed after treatment with an irreversible non-selective MAOI.

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

Warnings and cautions

Talk to your doctor or pharmacist before using Fluoxetine Orion if you:

  • have any heart disease
  • suddenly get a fever, muscle stiffness, or tremors and change mentally, e.g. 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. Treatment with Fluoxetine Orion may need to be stopped.
  • have or previously had mania. If you get a manic episode, contact your doctor immediately. Treatment with Fluoxetine Orion may need to be stopped.
  • previously had problems with bleeding or the presence of bruises or unusual bleeding
  • use blood thinners (see Other medicines and Fluoxetine Orion )
  • have epilepsy or previously had seizures. If you get cramps or experience that the number of seizures increases in number, contact your doctor immediately. Treatment with Fluoxetine Orion may need to be stopped.
  • receive electrical treatment (electroconvulsive treatment)
  • receive treatment with tamoxifen (used to treat breast cancer) (see Other medicines and Fluoxetine Orion )
  • begins to feel restless and can not sit still ( akathisia ). This can get worse if your 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 )
  • use diuretics ( diuretics ), especially if you are older
  • have glaucoma (increased pressure in the eye).

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

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

You who are depressed and/or suffer from worry/anxiety may 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 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 using drugs of this type. Fluoxetine Orion 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 in this age group regarding the long-term safety of fluoxetine, such as effects on height growth, puberty development, mental, emotional, and behavioral development. Despite this, Fluoxetine Orion can be prescribed by a doctor to you who are under 18 years of age for moderate to severe real 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 Orion, see your doctor again. You should also tell your doctor if you notice any of the above symptoms or if they get worse.

Fluoxetine Orion should not be used in children under 8 years of age.

Other medicines and Fluoxetine Orion

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

Do not use Fluoxetine Orion with:

  • some irreversible, non-selective MAO inhibitors, some are used to treat depression. Irreversible, non-selective MAOIs should not be used with Fluoxetine Orion as serious side effects and even death (serotonergic syndrome) may occur (see section Do not use Fluoxetine Orion ). Treatment with Fluoxetine Orion should only be started if 2 weeks have elapsed after treatment with an irreversible, non-selective MAOI (eg tranylcypromine). Do not use any irreversible, non-selective MAOIuntil at least 5 weeks have elapsed since stopping treatment with Fluoxetine Orion. If Fluoxetine Orion 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.

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

  • tamoxifen (used to treat breast cancer); Because Fluoxetine Orion 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 use this medicine with Fluoxetine Orion
  • phenytoin
  • 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 Orion. 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); as the use of one or more of these medicines with Fluoxetine Orion 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 Orion may alter the effect of these medicines on the blood. If you are starting or stopping treatment with Fluoxetine Orion 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 Orion
  • 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 sodium levels when taken with Fluoxetine Orion
  • 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 Orion 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 ), atomoxetine or tricyclic antidepressants (eg imipramine, desipramine, and amitriptyline ), or risperidone (for schizophrenia); as Fluoxetine Orion may change the blood concentration 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 Orion.

Fluoxetine Orion with food, drink, and alcohol

  • Fluoxetine Orion can be taken with or without food.
  • Avoid alcohol when using this medicine.

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 Orion 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 Orion.

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.

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

Psychotropic drugs (drugs for any mental illness) such as Fluoxetine Orion may impair judgment and coordination. Do not drive or use machines until you know how Fluoxetine Orion 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. 

3. How to use Fluoxetine Orion

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

Do not use more capsules than your doctor has prescribed.

Swallow the capsules with a glass of water. Do not chew the capsules.

Adults:

The recommended dose is:

  • Depression: The recommended dose is 1 capsule (20 mg) per day. Your doctor will review and, if necessary, adjust the dose within 3-4 weeks of starting treatment. If necessary, dose one can be increased gradually up to a maximum dose of 3 capsules (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.
  • Bulimia: The recommended dose is 3 capsules (60 mg) daily.
  • 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 Orion should be reconsidered.

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

Treatment should be initiated and supervised by a specialist. The starting dose is 10 mg per day. As a dose lower than 20 mg is not possible with Fluoxetine Orion, your doctor will choose another fluoxetine product for you or your child.

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. 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 2 capsules (40 mg). The maximum dose is 3 capsules (60 mg) per day.

Hepatic impairment:

If you have liver disease or are taking medicines that may affect Fluoxetine Orion, your doctor may prescribe a lower dose or instruct you to take Fluoxetine Orion every other day.

If you use more Fluoxetine Orion 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 packaging if you can.

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

If you forget to take Fluoxetine Orion

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 Orion

Do not stop using Fluoxetine Orion without first asking your doctor, even if you feel better. You must use the medicine without interruption.

Make sure you always have medicine at home.

The following symptoms may occur when you stop using Fluoxetine Orion: dizziness, tingling like needles, difficulty sleeping (nightmares, nightmares, insomnia), feeling restless or anxious, unusual tiredness or weakness, anxiety, nausea/vomiting (feeling sick), tremors, and headache.

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

When you stop taking Fluoxetine Orion, 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 skin rash or allergic reaction such as itching, swollen lips/tongue, or wheezing / difficulty breathing, stop using the capsules immediately and contact your doctor immediately.
  • If you feel anxious and can not stand or sit still, you may have something called akathisia. As does one of Fluoxetine Orion 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 using 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
  • 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
  • orgasm problem
  • 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
  • urination problem
  • milk flow from the breasts

Bone fractures – and increased risk of bone fractures have been seen in patients using this type of drug.

Most of these side effects disappear with continued treatment.

Children and adolescents (8 to 18 years)

In addition to the above-mentioned side effects, Fluoxetine Orion may reduce 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.

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

www.lakemedelsverket.se

5. How to store Fluoxetine Orion

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister, label, or carton after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

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. One hard capsule contains fluoxetine hydrochloride equivalent to 20 mg fluoxetine.

Other ingredients are:

Capsule contents: Pregelatinized maize starch, microcrystalline cellulose, anhydrous colloidal silica.

Capsule shell: Yellow iron oxide (E172), patent blue (E131), titanium dioxide (E171), gelatin, sodium lauryl sulfate.

Ink: Shellac, black iron oxide (E172).

What the medicine looks like and the contents of the pack

The upper part of the capsule is opaque green and the lower part is yellow, length 14 mm. Hard gelatin capsules filled with white to off-white powder and marked “J” with black ink on the opaque green upper part and “96” on the yellow lower part.

Pack sizes:

7, 10, 12, 14, 20, 28, 30, 50, 56, 60, 70, 90, 98, 100 and 500 in transparent blisters of PVC / PVdC aluminum foil.

28 and 500 in a high-density polyethylene (HDPE) tablet jar with a polypropylene screw cap with padding and induction seal.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

Muhammad Nadeem

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