20 mg dispersible tablet
What Fluoxetine Orifarm is and what it is used for
Fluoxetine Orifarm contains the active substance fluoxetine, which is part of a group of antidepressant medicines called selective serotonin reuptake inhibitors ( SSRIs ).
Fluoxetine Orifarm is used to treat:
- obsessions and compulsions
- bulimia (hunger); Fluoxetine Orifarm is used in combination with psychotherapy to reduce binge eating and self-cleansing.
Children and adolescents from 8 years of age:
- Moderate to severe major depression, if depression does not improve after 4-6psychological treatment sessions. Fluoxetine Orifarm should be given to a child or adolescent with moderate to severe depression only in combination with psychological treatment.
How Fluoxetine Orifarm 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 Orifarm 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 Orifarm 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.
What you need to know before you use Fluoxetine Orifarm
Do not use Fluoxetine Orifarm
- if you are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6).
- if you are taking or have recently taken 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 taking metoprolol (to treat heart failure ), as there is an increased risk that your heartbeat will be too slow.
Treatment with Fluoxetine Orifarm should be started only 2 weeks after the end of 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 Orifarm. If Fluoxetine Orifarm 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, pharmacist, or nurse before using Fluoxetine Orifarm
- if you have any heart disease.
- if you suddenly have a fever, muscle stiffness, or tremor and change mentally, e.g. becomes confused, irritated, and extremely anxious. You may have had serotonergic syndrome or malignant neuroleptic syndrome. It is rare for this syndrome to occur but if it does occur it can give rise to potentially life-threatening conditions. Therefore, contact your doctor immediately. Fluoxetine treatment may need to be stopped.
- if you have or have previously had mania. If you get a manic episode, contact your doctor immediately. Fluoxetine treatment may need to be stopped.
- if you have a history of bleeding disorders, bruising, or unusual bleeding or if you are pregnant (see “Pregnancy, breast-feeding and fertility ”).
- if you are taking blood-thinning medicines (see “Other medicines and Fluoxetine Orifarm”).
- if you have epilepsy or a history of seizures. If you get cramps or experience that the number of seizures increases in number, contact your doctor immediately. Fluoxetine treatment may need to be stopped.
- if you are receiving electrical therapy (electroconvulsive therapy).
- if you are being treated with tamoxifen (used to treat breast cancer) (see “Other medicines and Fluoxetine Orifarm”).
- if you start to feel restless and can not sit still ( akathisia ). This may get worse if your fluoxetine dose is increased.
- if you have diabetes. Your doctor may change the dose of insulin or other medicines for diabetes.
- if you get a rash or other allergic reactions (such as itching, swollen face or lips, or difficulty breathing).
- if you have liver problems.
- if you have glaucoma (increased pressure in the eye).
Medicines such as Fluoxetine Orifarm ( SSRI / SNRIs) may 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 taking drugs of this type. Fluoxetine Orifarm 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, such as effects on height growth, puberty development, mental, emotional, and behavioral development. Despite this, Fluoxetine Orifarm 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 Orifarm, consult your doctor again. You should also tell your doctor if you notice any of the above symptoms or if they get worse.
Fluoxetine Orifarm should not be used in the treatment of children under 8 years of age.
Withdrawal symptoms if you stop taking Fluoxetine Orifarm
When you stop taking Fluoxetine Orifarm, especially if it happens abruptly, you may experience withdrawal symptoms (see “How to use Fluoxetine Orifarm”).
Other medicines and Fluoxetine Orifarm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Fluoxetine Orifarm with:
- irreversible non-selective MAOIs as severe side effects and even death (serotonergic syndrome) can occur. An example of such an MAO inhibitor is iproniazid which is used to treat depression. Treatment with Fluoxetine Orifarm should be started only 2 weeks after the end of 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 Orifarm. See also section “Do not use Fluoxetine Orifarm ”.
- Metoprolol for heart failure should not be used with Fluoxetine Orifam as serious side effects may occur.
Fluoxetine Orifarm may affect the way the following medicines work ( interaction ):
- Tamoxifen (used to treat breast cancer). Because Fluoxetine Orifarm may alter the blood levels of this medicine, and a reduction in the effect of tamoxifen cannot be ruled out, your doctor may need to consider another antidepressant treatment.
- MAO-A inhibitors such as 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).
- Mequitazine (for allergies ); as there is an increased risk of changes in the electrical activity of the heart if you take this medicine with Fluoxetine Orifarm.
- Phenytoin (for epilepsy ); Because Fluoxetine Orifarm may affect the blood levels of this medicine, your doctor may need to insert phenytoin more carefully and perform regular check-ups as Fluoxetine Orifarm is given at the same time.
- Lithium (used in mono depressive disease), selegiline, tramadol (painkiller), triptans (drug group for migraines ), tryptophan (used in depression), selegiline (used in Parkinson’s disease ), St. John’s wort ((traditional) herbal medicine). There is an increased risk of the mild serotonergic syndrome as these medicines are given at the same time as Fluoxetine Orifarm. Your doctor will perform more frequent check-ups.
- 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 given intravenously, pentamidine), treatment against malaria particularly halofantrine or some antihistamine s (astemizole, mizolastine); because the use of one or more of these medicines together with Fluoxetine Orifarm 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 Orifarm may alter the effect of these medicines on the blood. If you are starting or stopping treatment with Fluoxetine Orifarm while taking warfarin, your doctor will need to take some samples, adjust your dose and check you more often.
- Cyproheptadine (for allergies ); may reduce the effect of fluoxetine.
- Drugs that lower the level of sodium in the blood (including drugs that increase the excretion of urine, desmopressin, carbamazepine, and oxcarbazepine); increase the risk of too low a sodium level in the blood when taken with Fluoxetine Orifarm.
- 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 butyrophenones and phenothiazines); as Fluoxetine Orifarm may increase the risk of seizures if taken at the same time as these medicines.
- Flecainide, propafenone, and nebivolol (used to treat heart disease), atomoxetine (used for ADHD ), carbamazepine (used for epilepsy ), tricyclic antidepressants (eg imipramine, desipramine, and amitriptyline), or risperidone (for schizophrenia); as Fluoxetine Orifarm may alter the blood levels of these medicines and your doctor may need to lower the dose of one of these medicines as they are being given at the same time as Fluoxetine Orifarm.
Fluoxetine Orifarm with food, drink, and alcohol
The tablets can be taken with or without food.
You should avoid using alcohol during treatment with 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.
Tell your doctor as soon as possible that you are pregnant, think you may be pregnant, or are planning to become pregnant.
Reports of increased risk of heart defects in infants have been reported in mothers who used Fluoxetine Orifarm 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 Orifarm.
When medicines such as Fluoxetine Orifarm 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 Orifarm if you are pregnant or planning to become pregnant. However, depending on the circumstances, your doctor may suggest that you should continue treatment with Fluoxetine Orifarm.
Caution should be exercised when using during pregnancy, especially during the latter part of pregnancy or just before delivery as the following effects have been observed in newborns: irritability, tremors, muscle weakness, persistent crying, difficulty in sucking, and sleeping.
If you take Fluoxetine Orifarm 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 Orifarm so that they can advise you on this.
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.
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
This medicine may impair your judgment and coordination. Do not drive or use machines until you know how Fluoxetine Orifarm affects you.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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 Orifarm
Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor, pharmacist, or nurse. Do not take more tablets than your doctor has prescribed.
The whole or half dispersible tablet is swallowed together with water, or dissolved in ½ – 1 glass of water. Immediately swallow the entire contents.
The recommended dose is:
Dose one should be determined by a doctor, who will tailor it individually for you.
Depression: The recommended dose is 1 tablet (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 3 tablets (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 tablets (60 mg) daily.
Obsessive-compulsive disorder: The recommended dose is 1 tablet (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 3 tablets (60 mg) daily. If no improvement occurs within 10 weeks, treatment with Fluoxetine Orifarm 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. 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.
Your doctor will be more careful with the dose increase if you are older. The daily dose should generally not exceed 2 tablets (40 mg). The maximum dose is 3 tablets (60 mg) per day.
If you have liver disease or are taking medicines that may affect Fluoxetine Orifarm, your doctor may prescribe a lower dose or instruct you to take Fluoxetine Orifarm every other day.
If you use more Fluoxetine Orifarm 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 Orifarm 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 Orifarm:
- 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 do.
- 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 Orifarm:
- Do not stop taking the medicine 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 may occur when you stop taking Fluoxetine Orifarm: dizziness, tingling like needles, difficulty sleeping (vivid dreams, nightmares, insomnia), feeling restless or anxious, unusual tiredness or weakness, anxiety, nausea/vomiting (feeling sick), tremors and headache.
Most people who stop taking Fluoxetine Orifarm experience symptoms that are mild and go away on their own within a few weeks. If you get symptoms when you stop taking Fluoxetine Orifarm contact your doctor.
When treatment with Fluoxetine Orifarm 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, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if you get any of the following symptoms:
- if you have thoughts of harming or committing suicide (see section 2) ( Uncommon )
- swelling of the face, tongue, or throat; difficulty swallowing; hives, and difficulty breathing ( angioedema ). Stop taking Fluoxetine Orifarm ( Rare )
- itching and rash with swelling of the skin, redness, swelling of the lips, throat, and tongue, wheezing, shortness of breath, difficulty swallowing, low blood pressure, anxiety, cough and hoarseness, nausea, vomiting, abdominal pain ( anaphylactic reaction ) ( Rare )
- severe skin damage (dermal detachment of the epidermis and superficial mucous membranes) (Lyellerms syndrome, toxic epidermal necrolysis ). Stop taking Fluoxetine Orifarm ( Rare )
- an extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as genitals ( Stevens-Johnson syndrome ). Stop taking Fluoxetine Orifarm ( Rare )
- a severe skin disease that may cause redness of the skin and may affect the mouth and other parts of the body (Erythema multiforme). Stop taking Fluoxetine Orifarm ( Rare )
- you feel anxious and can not stand or sit still ( akathisia ). As the dose of Fluoxetine Orifarm is increased, you may feel worse ( Rare )
- a collection of symptoms that include unexplained fever with rapid breathing or heart rate, sweating, muscle stiffness or tremors, confusion, extreme anxiety, or drowsiness (Serotonergic syndrome) ( Rare )
- a prolonged painful erection ( Rare )
- heart problems, such as fast or irregular heartbeat, fainting, collapse, or dizziness when standing up which may indicate heart rhythm disturbances ( Rare )
Other side effects include:
Very common: may affect more than 1 user in 10
Common: may affect up to 1 in 10 users
- Loss of appetite, weight loss
- Anxiety, nervousness, restlessness, uncontrolled shaking movements, tension, decreased sexual desire or sexual problems (including difficulty maintaining an erection before sexual activity), sleep problems, unusual dreams
- Dizziness, taste change, listlessness, need for sleep, impaired ability to concentrate feeling of fast and irregular heartbeat
- Vomiting, indigestion, dry mouth
- Rash, hives, itching, sweating
- Joint pain
- Frequent urination
- Bleeding from the abdomen, disorders of ejaculation
Uncommon: may affect up to 1 in 100 people
- Feeling isolated from oneself, abnormal elation, strange thoughts, elevated mood, gnashing of teeth
- Problems with balance and coordination, impaired memory, abnormal movements of short duration such as muscle twitching, tremors, muscle cramp,s, and involuntary movements
- Enlarged (dilated) pupil s
- Respiratory distress
- Low blood pressure
- Difficulty swallowing
- Bleeding from the gastrointestinal tract
- Hair loss, cold sweats, bruising,g,, or bleeding
- Difficulty urinating.
- Sexual problems, orgasm problems including missed orgasm
- Feeling sick, feeling abnormal, feeling cold, feeling hot
Rare (may affect up to 1 in 1,000 people)
- Serum disease (fever, ras,h, and joint pain that may occur as a delayed allergic reaction )
- Decreased platelet count, which increases the risk of bleeding or bruising
- Decreased white blood cell count
- Bleeding under the skin in the form of flat shaped spots ( ecchymosis )
- Red or purple discolorations on the skin in the form of small spots (purpura)
- Altered levels of antidiuretic hormone
- Low levels of salt in the blood
- Mania, violent behavior, stuttering, hallucinations, manic reaction, confusion, agitation, anxiety,y, and panic attacks
- Vasculitis ( inflammation of blood vessels), dilation of blood vessels
- Lung problems, which can cause shortness of breath; inflammation of the pharynx
- Pain in the esophagus
- Hepatitis (liver disease)
- Muscle pain
- Bladder emptying difficulties, difficulty urinating
- Increased levels of prolactin in the blood
- Abnormal liver function values
- Buccoglossal syndrome (uncontrolled movements)
- Mucosal bleeding
- Milk flow from the breasts
Has been reported (occurs in an unknown number of users):
- Severe vaginal bleeding shortly after delivery ( postpartum hemorrhage), see “Pregnancy, 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 above-mentioned side effects , Fluoxetine Orifarm may reduce the growth rate and possibly delay puberty. Suicide-related behaviors (suicide attempts and suicidal thoughts), hostility, mani, a and nosebleeds were also reported as common side effects in children.
5. How to store Fluoxetine Orifarm
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.
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
- The active substance is fluoxetine hydrochloride equivalent to fluoxetine 20 mg
- The other ingredients are microcrystalline cellulose, croscarmellose sodium, magnesium stearate,e, and anhydrous colloidal silica.
What the medicine looks like and the contents of the pack
The tablets are white, round with a notch on one side, and 10.5 mm in diameter.
Blister: 10, 14, 28, 30, 98, 100 st
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orifarm Generics A / S
5260 Odense S
Orifarm Generics AB
102 17 Stockholm