20 mg capsule, hard
Fluoxetine hydrochloride

What Fluoxetine Accord is and what it is used for

Fluoxetine Accord contains fluoxetine, an antidepressant that belongs to the group of selective serotonin reuptake inhibitors.

The drug is used to treat the following conditions:

Adults:

  • Episodes of actual depression
  • Obsessive-compulsive disorder (a mental illness usually characterized by disturbing, repetitive thoughts that lead to compulsive behaviors and obsessive thoughts that the person feels compelled to act on)
  • Bulimia (binge eating): Fluoxetine Accord is used in combination with psychotherapy to reduce binge eating and self-cleansing

Children and adolescents from 8 years of age:

  • Moderate to severe actual depression, if 4-6 treatment sessions with psychological treatment have not yielded results.

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

This is how fluoxetine works

Everyone has a substance called serotonin in the brain. People who are depressed, have obsessive-compulsive disorder or bulimia nervosa have lower levels of serotonin than others. It is not entirely clear how fluoxetine or other SSRIs work, but they may help by increasing the levels of serotonin in the brain.

Treating these conditions is important to help you get better. If you do not receive treatment, your condition may 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 free of symptoms.

2. What you need to know before using Fluoxetine Accord

Do not take Fluoxetine Accord 20 mg if you are:

  • allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6). Fluoxetine Accord  (see section 6 ). Stop taking the medicine immediately if you get a rash or any other allergic reaction (eg itching, swollen lips or face, or shortness of breath) and contact a doctor immediately.
  • taking other medicines such as
  • are called irreversible, non-selective monoamine oxidase inhibitors ( MAOIs ), as severe and even life-threatening reactions can occur (eg iproniazid to treat depression).

Treatment with Fluoxetine Accord must not be started within 2 weeks after stopping treatment with an irreversible, non-selective MAOI.

Do not take any irreversible, non-selective MAOI until at least 5 weeks have elapsed since stopping treatment with Fluoxetine Accord. If Fluoxetine Accord has been used for a long time and/or in high doses, your doctor must consider a longer break.

  • take metoprolol (a medicine used to treat heart failure ) as there is an increased risk of the heart beating too slowly.

Warnings and cautions

Tell your doctor or pharmacist before taking Fluoxetine Accord if you:

  • have heart problems
  • get a fever, muscle stiffness, or tremors and change mentally such as confusion, irritability, and extreme anxiety. You may have had so-called serotonergic syndrome or malignant neuroleptic syndrome. Using Fluoxetine Accord with other medicines may lead to the serotonergic syndrome. This syndrome is rare but if it does occur it can give rise to potentially life-threatening conditions. Contact a doctor immediately as treatment with Fluoxetine Accord may need to be stopped (see “ Other medicines and Fluoxetine Accord” ).
  • have or have previously had mania. Contact a doctor immediately if you have a manic episode. Treatment with Fluoxetine Accord may need to be stopped
  • have previously had a bleeding disorder or bruising or unusual bleeding
  • ongoing treatment with blood thinners (see “ Other medicines and Fluoxetine Accord” )
  • have epilepsy or seizures. If you experience seizures or experience an increased frequency of seizures, contact your doctor immediately – treatment with Fluoxetine Accord may need to be stopped
  • receive electrical treatment (electroconvulsive treatment)
  • ongoing treatment with tamoxifen (used to treat breast cancer) (see “Other medicines and Fluoxetine Accord” )
  • begins to feel restless and can not sit still ( akathisia ). This may be worse if the dose of Fluoxetine Accord is increased
  • have diabetes (your doctor may need to adjust the dose of one of your insulin or other diabetes medicines)
  • have liver problems (your doctor may need to adjust dose one)
  • low heart rate at rest and/or if you know you have a salt deficiency as a result of prolonged diarrhea and vomiting (nausea) or use of diuretics ( diuretic tablets)
  • ongoing treatment with diuretics ( diuretics ), especially if you are elderly
  • have glaucoma (increased pressure in the eye)

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

Have suicidal thoughts and your symptoms of depression or anxiety worsen

People who are depressed and/or have anxiety disorders can sometimes have thoughts of harming themselves or committing suicide. Thoughts can be strengthened when you first start taking antidepressants, as it takes time for these drugs to start working, usually about two weeks but sometimes longer.

You are more likely to have such thoughts:

  • If you have previously had thoughts of committing suicide or harming yourself.
  • If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under the age of 25 with mental illness who were treated with an antidepressant drug.

Contact a doctor or go to the nearest hospital immediately if you have thoughts of harming yourself or committing suicide.

It can be helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is getting worse or if they are worried that your behavior is changing.

Use in children and adolescents aged 8 to 18 years

Patients under the age of 18 are at greater risk of side effects such as suicide attempts, suicidal thoughts, and hostile behavior (mainly aggression, defiant behavior, and anger) when taking this type of medicine. Fluoxetine Accord 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 to treat any other conditions.

Besides, only limited information is available on long-term safety with Fluoxetine Accord regarding growth, puberty, psychological, emotional, and behavioral development in this age group. Despite this, physicians may prescribe Fluoxetine Accord to patients under the age of 18 for treatment of moderate to severe major depression combined with psychological treatment if he/she considers it to be in the patient’s best interests. If your doctor has prescribed Fluoxetine Accord to a patient under the age of 18 and you want to discuss this, you should consult your doctor. You should inform your doctor if any of the above symptoms occur or worsen in patients under 18 years of age taking Fluoxetine Accord.

Fluoxetine Accord should not be used in the treatment of children under 8 years of age.

Other medicines and Fluoxetine Accord

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

Do not take Fluoxetine Accord with:

  • certain irreversible, non-selective monoamine oxidase inhibitors (MAOIs) used to treat depression. Irreversible, non-selective MAOIs must not be used with Fluoxetine Accord as serious side effects and even death (serotonergic syndrome) may occur (see section “Do not take Fluoxetine Accord”). Fluoxetine treatment should not be initiated until 2 weeks after the end of treatment with an irreversible, non-selective MAOI (eg tranylcypromine) inhibitor. Do not take irreversible, non-selective MAOIs until at least 5 weeks after the end of treatment with Fluoxetine Accord. If Fluoxetine Accord has been used for a long time and/or in high doses the doctor must consider a stay longer than 5 weeks.
  • metoprolol when used for heart failure; there is an increased risk of the heart beating too slowly.

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

  • tamoxifen (used to treat breast cancer). Because Fluoxetine Accord may alter the blood levels of this medicine, and possibly lead to a reduction in the effect of tamoxifen can not be ruled out, your doctor may need to consider another antidepressant treatment.
  • monoamine oxidase inhibitors A (MAO type A inhibitors) including moclobemide, linezolid (an antibiotic ), and methylthionine chloride (also known as methylene blue and used to treat methemoglobinemia caused by a drug or chemical product): due to the risk of serious and even fatal reactions (called serotonergic syndrome). Treatment with fluoxetine may be started the day after the end of treatment with reversible MAOIs, but your doctor may want to monitor you closely and use a lower dose of the MAOI inhibitor.
  • mequitazine (for allergies ); as taking this medicine with Fluoxetine Accord may increase the risk of changes in the electrical activity of the heart
  • Phenytoin (for epilepsy ): Because Fluoxetine Accord may affect the blood levels of this medicine, your doctor may need to insert phenytoin more carefully and make checks when given with Fluoxetine Accord.
  • lithium, selegiline, St. John’s wort, tramadol (painkiller), buprenorphine (a type of opioid ), triptans (for migraines ), and tryptophan  There is an increased risk of mild serotonergic syndrome when these medicines are taken with Fluoxetine Accord. The doctor can perform more frequent follow-ups.
  • drugs that can affect the heart rhythm, e.g. antiarrhythmics of Class IA and IIIantipsychotics (such as phenothiazine, pimozide, haloperidol), tricyclic antidepressive, some antimicrobial agents (such as sparfloxacin, moxifloxacin, erythromycin IV pentamidine, drugs against malaria, special halofantrine or some antihistamine s (astemizole, mizolastine), as taking one or more of these medicines with Fluoxetine Accord may increase the risk of changes in the electrical activity of the heart.
  • anticoagulants (eg, warfarin ), NSAIDS -preparat (eg ibuprofen, diclofenac ), aspirin, and other drugs with thin blood (including clozapine for treating certain mental disorders). Fluoxetine Accord may alter the effect of these medicines in the blood. If treatment with Fluoxetine Accord is started or stopped while you are taking warfarin, your doctor may need to take some samples, adjust your dose and check you more often.
  • cyproheptadine (for allergies ); as it may reduce the effect of Fluoxetine Accord
  • drugs that reduce the level of sodium in the blood (including drugs that lead to increased urination, desmopressin, carbamazepine, and oxcarbazepine); as these medicines may increase the risk of too low sodium levels when taking Fluoxetine Accord.
  • 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), and other antipsychotics such as phenothiazines or butyrophenones; as Fluoxetine Accord may increase the risk of seizures when taking these medicines
  • flecainide, propafenone, nebivolol or encainide (for heart problems), carbamazepine (for epilepsy ), atomoxetine or tricyclic antidepressants (eg imipramine, desipramine, and amitryptiline ) or risperidone (for schizophrenia) as Fluoxetine Accord may alter blood levels. Your doctor may need to reduce the dose of one of these when administered with Fluoxetine Accord.

Fluoxetine Accord with food, drink, and alcohol

  • You can take this medicine with or without food; what you prefer
  • You should not drink alcohol while taking 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.

There have been reports of an increased risk of heart defects in infants whose mothers used Fluoxetine Accord 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 Accord. 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 Accord.

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

However, caution should be exercised when using during pregnancy, especially during the later part of pregnancy or shortly before delivery as the following effects have been reported in newborns: irritability, tremors, muscle weakness, persistent crying, breastfeeding, and difficulty sleeping.

Breast-feeding

Fluoxetine is excreted in human milk and may cause side effects in breast-fed infants. You should only breast-feed if necessary. If you continue to breast-feed, your doctor may prescribe a lower dose of fluoxetine.

Fertility

In animal studies, fluoxetine has been shown to reduce sperm quality. In theory, this could affect fertility, but no such reducing effect of fluoxetine on fertility has yet been demonstrated in humans.

Driving and using machines

Your medicine may affect your judgment and coordination. Do not drive or use machines until you know how Fluoxetine Accord 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.

How to take Fluoxetine Accord

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

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

Adults:

The recommended dose is:

  • Depression: The recommended dose is 1 capsule (20 mg) daily. Your doctor will review and, if necessary, adjust the dose 3-4 weeks after 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. Patients with depression should be treated for at least 6 months.
  • Bulimia nervosa: The recommended dose is 3 capsules (60 mg) daily.
  • Obsessive-compulsive disorder: The recommended dose is 1 capsule (20 mg) daily. Your doctor will review and, if necessary, adjust the dose one after 2 weeks of treatment. If necessary, dose one can be gradually increased up to a maximum dose of 3 capsules (60 mg) daily. If no improvement has occurred within 10 weeks, treatment 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/day.

After 1 to 2 weeks, the doctor may increase the dose by one to 20 mg/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 further treatment after 6 months. If no improvement is seen, the treatment should be reconsidered.

Older:

The doctor will increase the dose with greater caution and the daily dose should generally not exceed 2 capsules (40 mg). The maximum dose is 3 capsules (60 mg) daily.

Hepatic impairment:

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

If you take more Fluoxetine Accord then you should

Do not take more capsules than your doctor has prescribed. 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. Take the pack and the remaining tablets to your doctor.

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

If you forget to take Fluoxetine Accord

  • If you miss a dose, do not worry. Take the next dose the next day at the usual time. Do not take a double dose to make up for a forgotten dose.
  • Taking the medicine at the same time each day may help you remember to take it regularly.

If you stop taking Fluoxetine 20 mg capsule

  • Do not stop taking Fluoxetine Accord without first asking your doctor, even if you feel better. You must continue to take your medicine.
  • Make sure you never run out of capsules.

You may experience the following when you stop taking Fluoxetine Accord: dizziness, tingling sensation such as ant crawling, difficulty sleeping (vivid dreams, nightmares, insomnia), feeling of restlessness or anxiety, unusual tiredness or weakness, anxiety, nausea/vomiting (nausea), tremors and headache.

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

When you stop taking Fluoxetine Accord, your doctor will help you reduce the dose slowly over one to two weeks to reduce the risk of withdrawal symptoms.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fluoxetine Accord can cause side effects, although not everybody gets them.

  • Contact a doctor as soon as possible or go to the nearest hospital if you have thoughts of injuring yourself or committing suicide (see section 2).
  • If you get a rash or allergic reaction such as itching, swollen lips/tongue, or wheezing/shortness of breath, stop taking Fluoxetine Accord capsules immediately and contact your doctor immediately.
  • If you get a rash or an allergic reaction such as itching, swollen lips/tongue, or wheezing when breathing/shortness of breath – stop taking fluoxetine immediately and tell your doctor immediately. If you feel restless and can not sit still, you may have something called akathisia. Increasing the dose of Fluoxetine Accord may make you feel worse. If this happens, consult your doctor.
  • Contact your doctor immediately if the skin turns red or you get 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) which i.a. includes unexplained fever with rapid breathing or rapid pulse, sweating, muscle stiffness or tremors, confusion, extreme anxiety, or fatigue (rare only)
  • feeling weak, drowsy, or confused, especially in the elderly and (elderly) people taking diuretics ( diuretics )
  • prolonged and painful erection
  • irritability and extreme anxiety
  • heart problems, e.g. rapid or irregular heartbeat, fainting, collapse, or dizziness when you get up and which may indicate a heart rate with abnormal function.

If you get any of the above side effects, talk to your doctor immediately.

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

Common may affect up to in 10 people )

  • poor appetite, weight loss
  • nervousness, anxiety
  • restlessness, difficulty concentrating
  • feel tense
  • decreased sexual drive or sexual problems (including difficulty maintaining an erection before sexual activity)
  • difficulty sleeping, 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
  • unexplained 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 yourself
  • grind teeth
  • muscle twitching, involuntary movements, or problems with balance and coordination
  • memory impairment
  • enlarged (dilated) pupil s
  • earring
  • low blood pressure
  • shortness of breath
  • nosebleed
  • difficulty swallowing
  • hair loss
  • increased tendency to get bruises
  • unexplained bruising or bleeding
  • cold sweats
  • difficulty urinating
  • feel hot or cold
  • abnormal liver function

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
  • agitation
  • 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
  • sore throat
  • liver inflammation ( hepatitis )
  • lung problem
  • sensitivity to sunlight
  • muscle pain
  • problems urinating

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.

In children and adolescents (8-18 years) – In addition to the possible side effects listed above, fluoxetine may reduce growth or possibly delay sexual maturity. Suicide-related behaviors (suicide attempts and suicidal thoughts), hostility, mania, and nosebleeds have also been reported as common in children.

5. How to store Fluoxetine Accord

Keep out of sight and reach of children.

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

Do not store above 30 ° C.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is fluoxetine hydrochloride. Each capsule contains 22.4 mg of fluoxetine hydrochloride equivalent to 20 mg of fluoxetine.

The other ingredients are pregelatinized starch (corn), purified talc, anhydrous silica, and magnesium stearate.

The capsule shell contains quinoline yellow (E104), erythrosine (E127), indigo carmine (E132), titanium dioxide (E171), and gelatin.

The printing ink contains shellac (E904), black iron oxide (E172), propylene glycol, and ammonium hydroxide.

What the medicine looks like and the contents of the pack

Fluoxetine Accord is a hard capsule. Each capsule contains 20 mg of fluoxetine.

The capsules are light green/yellow opaque, hard gelatin capsules, marked “BJ” on the top and “F20” on the bottom, containing a white to off-white powder.

Fluoxetine hydrochloride 20 mg capsules are packaged in PVC / aluminum blisters. Blister cards with 10, 14, 20, 28, 30, 50, 56, 60, 70, 90, 98 or 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare BV

Winthontlaan 200

3526 KV Utrecht

Netherlands

Manufacturer

Accord Healthcare Ltd.

Sage House, 319 Pinner Road

North Harrow, Middlesex

HA1 4HF,

UK

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

Muhammad Nadeem

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