Fluoxetine 20 mg Capsules – patient leaflet, side effects, dosage

1. What Fluoxetine Capsules are and what they are used for

Fluoxetine is one of a group of medicines called selective serotonin reuptake inhibitor (SSRI) antidepressants.

Fluoxetine Capsules are used in the treatment of:

Adults:

• Severe depression
• Obsessive- compulsive disorder.

• Bulimia nervosa:Fluoxetine is used alongside psychotherapy, in order

  to avoid binge-eating and vomiting.

Children and adolescents aged 8 years and above:

• Moderate to severe major depressive disorder, if the depression does

  not respond to psychological therapy after 4-6 sessions. Fluoxetine should be offered to a child or young person with moderate to severe major depressive disorder only in combination with psychological therapy.

2. What you need to know before you take Fluoxetine Capsules

Do not take Fluoxetine Capsules:

• If you are allergic to uoxetine or any of the other ingredients of this

  medicine (listed in Section 6). If you develop a rash or other allergic reactions (like itching, swollen lips or face or shortness of breath), stop taking the capsules straight away and contact your doctor immediately.

• If you are taking other medicines known as irreversible non-selective

  monoamine oxidase inhibitors (non-selective MAOI), since serious or even fatal reactions can occur (e.g. iproniazid used to treat depression).

  Treatment with Fluoxetine should only be started 2 weeks after discontinuation of irreversible non-selective MAOI.

  Do not take any irreversible non-selective MAOIs for at least 5 weeks after you stop taking Fluoxetine capsules. If Fluoxetine has been prescribed for a long period and/or at a high dose, a longer interval needs to be considered by your doctor.

• If you are taking metoprolol (to treat heart failure) since there is an

  increased risk of your heart beat becoming too slow.

Warnings and precautions

Talk to your doctor or pharmacist before taking Fluoxetine Capsules if any of the following applies to you:

• epilepsy or ts. If you have a t (seizures) or experience an increase in

  seizure frequency, contact your doctor immediately; Fluoxetine might need to be discontinued.

• mania now or in the past; if you have a manic episode, contact your

  doctor immediately, since Fluoxetine capsules might need to be discontinued.

• diabetes (your doctor may need to adjust your dose of insulin or other

  antidiabetic treatment).

• liver problems (your doctor may need to adjust your dosage)
• heart problems

• low resting heart rate and/or if you know you may have salt depletion

  as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets).

• ongoing treatment with diuretics (water tablets), especially if you are

  elderly.

• ongoing ECT (electro-convulsive therapy) treatment.

• history of bleeding disorders or appearance of bruises or unusual

  bleeding or if you are pregnant (see 'Pregnancy,breast-feeding and fertility').

• ongoing treatment with medicines that thin the blood (see taking

  'Other medicines and Fluoxetine Capsules).

• glaucoma (increased pressure in the eye)

• ongoing treatment with tamoxifen (used to treat breast cancer) (see

  'Other medicines and Fluoxetine Capsules').

• starting to feel restless and cannot sit or stand still (akathisia).

  Increasing your dose of uoxetine may make this worse.

• appearance of fever, muscle stiffness or tremor, changes in your

  mental state like confusion, irritability and extreme agitation; you may suffer from the so-called “serotonin syndrome” or “neuroleptic malignant syndrome”. Although this syndrome occurs rarely it may result in potentially life threatening conditions; contact your doctor immediately, since Fluoxetine might need to be discontinued.

Thoughts of suicide and worsening of your depression or anxiety disorder.

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when rst starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

§ if you have previously had thoughts of killing or harming yourself. § if you are a young adult. Information from clinical trials has shown an

increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant. If you have thoughts about harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

You may nd it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this lea et. You might ask them to tell you if they think that your depression or anxiety disorder is getting worse, or if they are worried about changes in

your behaviour.

Children and adolescents aged 8 to 18 years

Patients under 18 have an increased risk of side effects such as suicide attempts, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Fluoxetine capsules should only be used in children and adolescents aged 8 to 18 years for the treatment of moderate to severe major depressive episodes (in combination with psychological therapy) and it should not be used to treat other conditions. Additionally, only limited information concerning the long-term safety of uoxetine on growth, puberty, mental, emotional and behavioural development in this age group is available. Despite this your doctor may prescribe Fluoxetine Capsules to patients under 18 years for moderate to severe major depressive episodes in combination with psychological therapy because it is in the patients' interest. If your doctor has prescribed Fluoxetine Capsules to a patient who is under 18 years, and you want to discuss this, you are requested to contact your doctor. If one of the symptoms listed above develops or worsens in patients under 18 years while they are taking Fluoxetine Capsules, you are requested to inform your doctor of this. Fluoxetine should not be used in the treatment of children under the age of 8 years.

Sexual dysfunction

Medicines like Fluoxetine Capsules (so called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.

Other medicines and Fluoxetine Capsules

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

Do not take Fluoxetine Capsules with:

• Certain irreversible, non-selective monoamine inhibitors

  (MAOIs)(some used to treat depression). Irreversible non-selective MAO-inhibitors must not be used with uoxetine as serious or even fatal reactions (serotonin syndrome) can occur (see section 'Do not take Fluoxetine Capsules'). Treatment with Fluoxetine Capsules should only be started at least 2 weeks after discontinuation of an irreversible non-selective MAOI (for instance tranylcypromine). Do not take any irreversible, non-selective MAOIs for at least 5 weeks after you stop taking Fluoxetine Capsules. If Fluoxetine Capsules have been prescribed for a long period and/or at a high dose, a longer interval than 5 weeks may need to be considered by your doctor.

• Metoprolol when used for the treatment of heart failure, there is an increased risk of your heart beat becoming too slow.

Fluoxetine Capsules may affect the way the following medicines work (interactions);

• Tamoxifen (used to treat breast cancer), because Fluoxetine Capsules may change the blood levels of this drug, resulting in the possibility of a reduction in the effect of tamoxifen, your doctor may need to consider different antidepressant treatments.
• Monoamine oxidase inhibitors A (MAOI-A) including moclobemide, linezolid (an antibiotic) and methylthioninium chloride (also called methylene blue, used for the treatment of medicinal or chemical product induced methemoglobinemia): due to the risk of serious or even fatal reactions (called serotonin syndrome). Treatment with uoxetine can be started the day after stopping treatment with reversible MAOIs but the doctor may wish to monitor you carefully and use a lower dose of the MAOI-A drug.
• Mequitazine (used to treat allergies), increases the risk of changes in the electrical activity of the heart. Phenytoin (for epilepsy) because Fluoxetine may in uence the blood levels of this drug, your doctor may need to introduce phenytoin more carefully and carry out check-ups when given with Fluoxetine capsules.
• Lithium, selegiline, St. John's Wort, tramadol (a pain killer), triptans (for migraine), tryptophan and buprenorphine; there is an increased risk of mild serotonin syndrome when these drugs are taken with Fluoxetine Capsules. Your doctor will carry out more frequent check-ups.
• Medicines that may affect the heart's rhythm, e.g. Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derviatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. spar oxacin, moxi oxacin, erythromycin IV, pentamidine), anti-malaria treatment particularly halofantrine or certain antihistamines (astemizole, mizolastine) because taking one or more of these drugs with Fluoxetine Capsules may increase the risk of changes in the electrical activity of the heart.
• Anti-coagulants (such as warfarin), NSAIDs (such as ibuprofen, diclofenac), aspirin and other medicines which can thin the blood (including clozapine, used to treat certain mental disorders); Fluoxetine Capsules may alter the effect of these medicines on the blood. If Fluoxetine Capsules treatment is started or stopped when you are taking warfarin, your doctor will need to perform certain tests, adjust your dose and check on you more frequently.
• Cyproheptadine (used to treat allergies), reduces the antidepressant effect of Fluoxetine Capsules.
• Medicines that lower sodium levels in the blood (including medicines that cause an increase in urination, desmopressin, carbamazepine and oxcarbazepine) because these drugs may increase the risk of sodium levels in the blood becoming too low when taken with Fluoxetine Capsules.
• Antidepressants such as tricyclic anti-depressants, other selective serotonin reuptake inhibitors (SSRIs) or bupropion, me oquine or chloroquine (used to treat malaria), tramadol (used to treat severe pain) or anti-psychotics such as phenothiazines or butyrophenes; because Fluoxetine Capsules may increase risk of seizures when taken with these medicines.
• Flecainide, propafenone, nebivolol or encainide (for heart problems), carbamazepine (for epilepsy), atomoxetine or tricyclic antidepressants (for example imipramine, desipramine and amitriptyline) or risperidone (for schizophrenia); because Fluoxetine Capsules may possibly change the blood levels of these medicines, your doctor may need to lower their dose when administered with Fluoxetine Capsules.

Fluoxetine Capsules with food, drink and alcohol

• You can take Fluoxetine with or without food, whatever you prefer. · You should avoid alcohol while taking this medicine.

Pregnancy, breast-feeding 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

Talk to your doctor as soon as possible if you're pregnant, if you might be pregnant, or if you are planning to become pregnant.

In babies whose mothers took uoxetine during the rst few months of pregnancy, there have been some reports suggesting an increased risk of birth defects affecting the heart. In the general population, about 1 in 100 babies are born with a heart defect. This increased to about 2 in 100 babies in mothers who took uoxetine. You and your doctor may decide that it is better for you to gradually stop taking Fluoxetine while you are pregnant. However, depending on your circumstances, your doctor may suggest that it is better for you to keep taking Fluoxetine. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Fluoxetine 20 mg Capsules may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the new born (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the rst 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.

Caution should be exercised when used during pregnancy, especially during late pregnancy or just before giving birth since the following effects have been reported in new born children: irritability, tremor, muscle weakness, persistent crying, and difficulty in sucking or in sleeping.

Eight important things you need to know about Fluoxetine capsules

• Fluoxetine Capsules treats depression

  and anxiety disorders. Like all medicines, it

  can have unwanted effects. It is therefore

  important that you and your doctor weight

  up the bene ts of treatment against the

  possible unwanted effects, before starting

  treatment.

• Fluoxetine Capsules won't work straight

  away. Some people taking antidepressants

  feel worse before feeling better. Your doctor

  should ask to see you again a couple of weeks after you rst start treatment. Tell your doctor if you haven't started feeling better. See section 3, How to take Fluoxetine capsules.

• Fluoxetine Capsules is not for use in children and adolescents

  under 18. See Section 2, Use in children & adolescents aged 8 to 18 years.

• Some people who are depressed or anxious think of harming or

  killing themselves. If you start to feel worse or think of harming or killing yourself, see your doctor or go to a hospital straight away. See Section 2.

• Don't stop taking Fluoxetine Capsules without talking to your

  doctor. If you stop taking Fluoxetine suddenly or miss a dose, you may get withdrawal effects. See Section 3 for further information.

• If you feel restless and feel like you can't sit or stand still, tell

  your doctor. Increasing the dose of Fluoxetine may make these feelings worse. See section 4, Possible side-effects.

• Taking some other medicines with Fluoxetine Capsules can

  cause problems. You may need to talk to your doctor. See Section 2, Other medicines and Fluoxetine Capsules.

• If you are pregnant or planning to get pregnant, talk to your

  doctor. See section 2 Pregnancy, breast-feeding and fertility If you take Fluoxetine Capsules near the end of your pregnancy there may be an increased risk of heavy vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Fluoxetine Capsules so they can advise you.

Breast-feeding

Fluoxetine passes into the breast-milk and can cause adverse effects in babies. If you are breast-feeding your baby, you must consider stopping breast-feeding. If you continue to breast-feed your doctor will prescribe the lowest possible effective dose of Fluoxetine.

Fertility

Fluoxetine has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.

Driving and using machines

Fluoxetine 20 mg Capsules can cause side effects which may affect judgement and/or co-ordination. Do not drive or operate machines until you are sure that Fluoxetine has no effect on your ability to drive or use machines.

Fluoxetine Capsules contain lactose

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

3. How to take Fluoxetine Capsules

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Do not take more capsules than your doctor tells you.

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

Adults

The recommended dose is:

Depression:

The recommended dose is 1 capsule (20 mg) per day. After 3 to 4 weeks the doctor may increase the dosage if the effect is not adequate. If required the dosage can be gradually increased up to a maximum of 3 capsules (60 mg) daily. The dose should be increased carefully to ensure that you receive the lowest effective dose. You may not feel better immediately when you rst start taking your medicines for depression. This is usual because an improvement in depressive symptoms may not occur after the rst few weeks. Patients with depression should be treated for at least 6 months.

Obsessive compulsive disorders

The recommended dose is 1 capsule (20 mg) per day. After 2 weeks the doctor may review and adjust your dosage. If required, the dosage can be gradually increased up to a maximum of 3 capsules (60 mg) daily. If the treatment has not had any effect after 10 weeks, the doctor will reconsider your treatment.

Binge-eating (bulimia nervosa)

The recommended dosage is 60 mg (3 capsules per day).

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

Treatment should be started and be supervised by a specialist. The starting dose is 10 mg/day. After 1 to 2 weeks, your doctor may increase the dose to 20 mg/day. The dose should be increased carefully to ensure that you receive the lowest effective dose. Lower weight children may need lower doses. If there is a satisfactory response to treatment, your doctor will review the need for continuing treatment beyond 6 months. If you have not improved within 9 weeks, your doctor will reassess your treatment.

Elderly

For older people the recommended maximum dosage is 40 mg, and in exceptional cases 60 mg per day.

If you notice that Fluoxetine Capsules are too strong or not strong enough, ask your doctor or pharmacist for advice

Liver impairment

If you have a liver problem or are using other medication that might affect Fluoxetine, your doctor may decide to prescribe a lower dose or tell you to use Fluoxetine every other day.

If you take more Fluoxetine Capsules than you should

If you have taken too many capsules, you should tell your doctor or go to your local hospital immediately. Take the pack of Fluoxetine with you if you can.

The following symptoms may occur: nausea, vomiting, seizures, heart problems (like irregular heartbeat to cardiac arrest), lung probelms and changes in mental condition ranging from agitation to coma.

If you forget to take Fluoxetine Capsules

If you have forgotten a dose, the effectiveness will usually be maintained. Take the next capsule at the usual time. Do not take a double dose to make up for a forgotten capsule. If you are not sure, ask your doctor or pharmacist.

If you stop using Fluoxetine Capsules

Do not stop taking Fluoxetine without asking your doctor rst, even when you start to feel better. It is important that you keep taking your medicine. Make sure you do not run out of capsules.

Withdrawal symptoms often occur, especially if you stop suddenly. These symptoms also depend on how much and how long you have used Fluoxetine. The following symptoms can occur: dizziness; sensory disturbances such as pins and needles for no reason; insomnia, vivid dreams or other sleep disturbances; weakness, irritability or anxiety; nausea and/or vomiting; tremors and headache.

Most people nd that any symptoms on stopping Fluoxetine capsules are mild and disappear within a few weeks. If you experience symptoms when you stop treatment, contact your doctor.

When stopping Fluoxetine, your doctor will help you to reduce your dose slowly over one or two weeks- this should help reduce the chance of withdrawal effects

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• If you have thoughts of harming or killing yourself at any time,

  contact your doctor or go to a hospital straight away.

• If you develop a rash/itching or allergic reaction such as swollen

  lips/tongue/eyelids or difficulty breathing, stop taking the capsules immediately and contact your doctor straight away.

• If you experience restlessness and cannot sit or stand still, you may

  have something called 'akathisia'; increasing your dose of Fluoxetine may make these feelings worse. If you feel like this, contact your doctor.

• If your skin starts to peel or blister or you develop a varied skin

  reaction or redness, you should contact your doctor immediately, although this is very rare.

The most frequent sides effects (very common side effects that may affect more than 1 user in 10) are insomnia, headache, diarrhoea, feeling sick (nausea) and fatigue.

Some patients have had:

• a combination of symptoms (known as “serotonin syndrome”)

  including unexplained fever with faster breathing or heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation or sleepiness (only rarely);

• feelings of weakness, drowsiness or confusion mostly in elderly

  people and in (elderly) people taking diuretics (water tablets);

• prolonged and painful erection;
• irritability and extreme agitation;

• heart problems, such as fast or irregular heart rate, fainting, collapsing

  or dizziness upon standing which may indicate abnormal functioning of the heart rate.

  If you have any of the above side effects, you should tell your doctor immediately.

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

  Common (may affect up to 1 in 10 people)

  • not feeling hungry, weight loss
  • nervousness, anxiety
  • restlessness, poor concentration
  • feeling tense

  • decreased sex drive or sexual problems

    (including difficulty maintaining an erection for sexual activity)

  • sleep problems, unusual dreams, tiredness or sleepiness
  • dizziness
  • change in taste
  • uncontrollable shaking movements
  • blurred vision
  • rapid and irregular heartbeat sensations
  • ushing
  • yawning
  • indigestion, vomiting
  • dry mouth
  • rash, urticaria, itching
  • excessive sweating
  • joint pain
  • passing urine more frequently
  • unexplained vaginal bleeding
  • feeling shaky or chills

Uncommon (may affect up to 1 in 100 people)

• feeling detached from yourself
• strange thinking
• abnormally high mood
• sexual problems, including orgasm problems, occasionally persisting after treatment discontinuation.
• thoughts of suicide or harming yourself
• teeth grinding
• muscle twitching, involuntary movements or problems with balance or co-ordination
• memory impairment
• enlarged (dilated) pupils
• ringing in the ears
• low blood pressure
• shortness of breath
• nose bleeds
• difficulty swallowing
• hair loss
• increased tendency to bruising
• unexplained bruising or bleeding
• cold sweat
• difficulty passing urine
• feeling weak, feeling hot or cold
• abnormal liver function test results

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

• low levels of salt in the blood
• reduction in blood platelets, which increases risk of bleeding or bruising
• reduction in white blood cells or neutrophils in the blood
• imbalance of the uid and chemicals in the body
• untypical wild behaviour
• hallucinations
• agitation
• panic attacks
• confusion
• stuttering
• aggression
• ts
• interruptions to the heart rhythm
• vasculitis (in ammation of a blood vessel)
• rapid swelling of the tissues around the neck, face, mouth and/or throat
• pain in the tube that takes food or water to your stomach
• hepatitis
• lung problems
• sensitivity to sunlight
• muscle pain
• problems urinating
• producing breast milk

Not known (frequency cannot be estimated from the available data)

• heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see Pregnancy in section 2 for more information

Bone fractures - an increased risk of bone fractures has been observed in patients taking this type of medicines.

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

In children and adolescents (8-18 years) – In addition to the possible side effects listed above, Fluoxetine Capsules may slow growth or possibly delay sexual maturity. Suicide-related behaviours (suicide attempt and suicidal thoughts), hostility, mania, and nose bleeds were also commonly reported in children.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this lea et. You can also report side effects directly via the Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Fluoxetine Capsules

Keep this medicine out of the sight and reach of children. Do not take this medicine after the expiry date which is stated on the carton and on the blister strip after EXP. The expiry date refers to the last day of the month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Fluoxetine Capsules contain

• The active substance is uoxetine hydrochloride. Each capsule contains uoxetine hydrochloride equivalent to 20mg uoxetine.

The other ingredients are:

Lactose monohydrate, microcrystalline cellulose, magnesium stearate and crospovidone.

Each capsule shell contains gelatin, yellow and black iron oxide (E172), indigo carmine (E132) and titanium dioxide (E171).

The printing ink contains shellac, black iron oxide (E172) propylene glycol (E1520) and ammonium hydroxide (E527)

What Fluoxetine Capsules look like and contents of the pack

Fluoxetine 20 mg Capsules are olive/green capsules marked FLE 20. The capsules are packed in blister packs.

A carton may contain 10, 14, 20, 28, 30, 50, 60, 100, 200, 250, 500 or 1000 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Ipca Laboratories UK Ltd.

Unit 97-98, Silverbriar, Sunderland Enterprise Park East, Sunderland, SR5 2TQ

United Kingdom

This lea et was last revised in 07/2026.