Fluoxetine 30 mg capsules hard – patient leaflet, side effects, dosage

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

Fluoxetine Capsules contain the active substance fluoxetine which is one of a group of medicines called selective serotonin re-uptake inhibitors (SSRI) antidepressants.

This medicine is used to treat the following conditions: Adults:

• Major depressive episodes
• Obsessive-compulsive disorder
• The eating disorder bulimia nervosa Fluoxetine Capsules is used alongside psychotherapy for the reduction of binge-eating and purging

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 Capsules 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 Fluoxetine 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.
• Taking other medicines known as irreversible, non-selective monoamine oxidase inhibitors (MAOIs), since serious or even fatal reactions can occur (e.g. iproniazid used to treat depression).

Treatment with Fluoxetine Capsules should only be started at least 2 weeks after discontinuation of an 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 Capsules have been prescribed for a long period and/or at a high dose, a longer interval needs to be considered by your doctor.

• Taking metoprolol (to treat heart failure) since there is an increased risk of your heartbeat becoming too slow.

Warnings and Precautions

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

• heart problems;
• 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 Capsules might need to be discontinued.
• mania now or in the past; if you have a manic episode, contact your doctor immediately because Fluoxetine Capsules might need to be discontinued;
• history of bleeding disorders or appearance of bruises or unusual bleeding;
• ongoing treatment with medicines that thin the blood (see 'Other medicines and Fluoxetine Capsules');
• epilepsy or fits. If you have fits (seizures) or experience an increase in seizure frequency, contact your doctor immediately; Fluoxetine Capsules might need to be discontinued;
• ongoing ECT (electro-convulsive therapy);
• history of mental illness
• 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 Fluoxetine Capsules may make this worse;
• diabetes (your doctor may need to adjust your dose of insulin or other anti-diabetic treatment);
• liver problems (your doctor may need to adjust your dosage);
• low resting heart-rate and/or if you know that 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;
• glaucoma (increased pressure in the eye).

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 first 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 about 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 of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

  You may find it 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 might ask them to tell you if they think your depression or anxiety 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 attempt, 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 Fluoxetine Capsules on growth, puberty, mental, emotional and behavioural development in this age group is available.

  Despite this, and if you are a patient under 18, your doctor may prescribe Fluoxetine Capsules for moderate to severe major depressive episodes, in combination with psychological therapy, because he/she decides that this is in your best interests.

  If your doctor has prescribed Fluoxetine Capsules for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Fluoxetine Capsules.

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

  Sexual dysfunction

  Medicines like Fluoxetine Capsules (so called SSRIs/SNRIs) 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, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

  Do not take Fluoxetine Capsules with

  • Certain irreversible, non-selective monoamine oxidase inhibitors (MAOIs), some used to treat depression. Irreversible, non-selective MAOIs must not be used with Fluoxetine as serious or even fatal reactions (serotonin syndrome) can occur (see section 2 "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 has 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 heart failure; there is an increased risk of your heartbeat becoming too slow.

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

• 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 prescribing a different antidepressant treatment.
• certain medicines known as monoamine oxidase inhibitors A (MAOI - A, used to treat conditions such as depression and Parkinson’s disease) 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 fluoxetine 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 (for allergies); because taking this drug with Fluoxetine Capsules may increase the risk of changes in the electrical activity of the heart.
• phenytoin (for epilepsy); because Fluoxetine Capsules may influence 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, tryptophan, buprenorphine, tramadol, selegiline, the herbal remedy St. John’s wort or medicines known as ‘triptans’ (e.g. sumatriptan, zolmitriptan); there is an increased risk of serotonin syndrome when these drugs are taken with fluoxetine. Your doctor will carry out more frequent check-ups.
• medicines that affect the heart’s rhythm (antiarrhythmics) e.g. procainamide, disopyramide, sotalol, anti-psychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine), anti-malaria treatment particularly halofantrine or certain anti-histamines (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, and aspirin); 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.

• medicines that lower sodium levels in the blood e.g. oxcarbazepine, used to treat epilepsy, desmopressin, used to treat certain hormone problems, diuretics (water tablets).
• medicines that can increase the chance of seizures, such as other SSRI antidepressants (e.g. sertraline, citalopram, paroxetine), medicines for nausea and vertigo (e.g. perphenazine, prochlorperazine, chlorpromazine), certain medicines for mental illness called butyrophenones (e.g. benperidol, haloperidol), mefloquine or chloroquine (for malaria), or bupropion (for depression or nicotine dependence).
• 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 Capsules with or without food, whatever you prefer.
• You should avoid alcohol while you are 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, pharmacist or nurse 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’re planning to become pregnant.

In babies whose mothers took fluoxetine during the first few months of pregnancy, there have been some studies describing 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 fluoxetine.

When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like fluoxetine may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.

It is preferable not to use this treatment during pregnancy unless the potential benefit outweighs the potential risk. Thus, you and your doctor may decide to

gradually stop taking Fluoxetine Capsules while you are pregnant or before being pregnant.

However, depending on your circumstances, your doctor may suggest that it is better for you to keep taking Fluoxetine Capsules.

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.

If you take Fluoxetine 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 so they can advise you.

Breast-feeding

Fluoxetine is excreted in breast milk and can cause side effects in babies. You should only breast-feed if it is clearly necessary. If breast-feeding is continued, your doctor may prescribe a lower 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 may affect your judgment or co-ordination. Do not drive or use machinery without advice from your doctor, pharmacist or nurse.

3. How to take Fluoxetine Capsules

Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse 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 (30 mg) daily. Your doctor will review and adjust your dosage if necessary within 3 to 4 weeks of the start of treatment. 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 first start taking your medicine for depression. This is usual because an improvement in depressive symptoms may not occur until after the first 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 (30 mg) daily.

  Your doctor will review and adjust your dosage if necessary after 2 weeks of treatment. If required, the dosage can be gradually increased up to a maximum of 3 capsules (60 mg) daily. If no improvement is noted within 10 weeks, your doctor will reconsider your treatment.

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 (given as 2.5 ml of Fluoxetine oral solution). After 1 to 2 weeks, your doctor may increase the dose to 30 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:

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

Liver impairment:

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

If you take more Fluoxetine Capsules than you should

• If you take too many capsules, go to your nearest hospital emergency department (or casualty) or tell your doctor straight away.
• Take the pack of Fluoxetine Capsules with you if you can.

Symptoms of an overdose include nausea, vomiting, seizures, heart problems (like irregular heartbeat and cardiac arrest), lung problems and change in mental condition ranging from agitation to coma.

If you forget to take Fluoxetine Capsules

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

If you stop taking Fluoxetine Capsules

• Do not stop taking Fluoxetine Capsules without asking your doctor first, 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.

You may notice the following effects (withdrawal effects) when you stop taking Fluoxetine Capsules: dizziness, tingling feelings like pins and needles, sleep disturbances (vivid dreams, nightmares, inability to sleep); feeling restless or agitated; unusual tiredness or weakness; feeling anxious; nausea/vomiting (feeling sick/being sick); tremor (shakiness); headaches.

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

When stopping Fluoxetine Capsules, 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 Fluoxetine Capsules, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

If you have any of the following side effects, you should tell you doctor immediately or go to the nearest hospital straight away.

Uncommon (may affect up to 1 in 100 people)

• thoughts of harming or killing yourself at any time (see section 2, “Thoughts of suicide and worsening of your depression or anxiety disorder”)

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

• serious allergic reaction. Such reactions may appear in the form of anaphylaxis (a severeform of allergic reaction) with symptoms such as:

  • rash

  • swelling of the face, lips, mouth, tongue or throat

    (angioedema)

  • sudden wheezing, fainting or difficulties in

    swallowing

• fever, rapid swelling of the tissues around the neck, face, mouth and/or throat, skin rash, enlargement of the lymph nodes (serum sickness)
• if you feel restless and cannot sit or stand still, you may have akathisia; increasing your dose of fluoxetine may make you feel worse
• skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with dark ring around the edge) (erythema multiforme)
• widespread rash with blisters and peeling skin, particularly around the body surface, mouth, nose, eyes and genitals (toxic epidermal necrolysis, Stevens-Johnson syndrome).
• fits (convulsions)
• a lower than normal level of sodium in the blood, which may make you feel weak and confused with aching of muscles. This may be due to inappropriate ADH secretion, a hormone that causes the body to retain water and dilute the blood, reducing the amount of sodium
• frequent infections with fever, chills, sore throat or mouth ulcers (reduced number of white blood cells)
• lung problems, scarring and thickening in the lungs with shortness of breath
• liver disease with the following signs; feeling or being sick, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine

• a combination of symptoms (known as “serotonin syndrome”) including unexplained fever with faster breathing or heart rate, sweating, muscle stiffness or tremor, confusion, irritability and extreme agitation or sleepiness

  • prolonged and painful erection;
  • heart problems, such as fast or irregular heart rate, fainting, collapsing or dizziness upon standing which may indicate abnormal functioning of the heart rate.

Other possible side effects

Very common: may affect more than 1 in 10 people

• difficulty sleeping (insomnia)
• headache
• diarrhoea, feeling sick (nausea)
• tiredness (fatigue), feeling unusually weak

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 and problems with ejaculation)
• sleep problems, unusual dreams (including nightmares)
• tiredness or sleepiness
• dizziness
• change in taste
• uncontrollable shaking movements
• blurred vision
• rapid and irregular heartbeat sensations, other changes to the electrical activity of the heart called QT prolongation, which can be seen on an ECG, an electrical recording of the heart.
• flushing
• 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 hot or cold
• abnormal liver 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 cell count
• untypical wild behaviour
• hallucinations
• agitation
• panic attacks
• confusion
• stuttering
• aggression
• fits
• vasculitis (inflammation 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, breast-feeding, fertility 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 store your capsules above 25°C.

Store in the original package in order to protect from moisture.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

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 to protect the environment.

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

The active substance in this medicine is called Fluoxetine and is available as 30 mg capsules. Fluoxetine 30 mg Capsules contain 30 mg Fluoxetine (as hydrochloride) in each capsule.

The other ingredients are: Pregelatinised maize starch.

The capsule shell is made of gelatin, light red iron oxide (E172), titanium dioxide (E171) and black edible printing ink, which contains shellac, black iron oxide (E172), and potassium hydroxide.

What Fluoxetine Capsules look like and contents of the pack

Fluoxetine Capsules are hard capsules.

A White powder in size “2” Hard Gelatin Capsules with Light Red Opaque / White Opaque, radially printed “FL30” on cap and body. They are supplied in blister packs of 30 capsules

Marketing Authorisation Holder and Manufacturer

Relonchem Limited, Cheshire House,

Gorsey Lane, Widnes, Cheshire, WA8 0RP, UK.

Product License Number.: PL 20395/0366.

This leaflet was last revised in September 2025.

PRODUCT NAME PRODUCT LICENCE NO.

COMPONENT DIMENSION STRENGTH PACK SIZE

FONT & SIZE REMARKS REASON FOR CHANGE

COUNTRY

MANUFACTURER

SOFTWARE

ARTIST

Fluoxetine 30 mg Capsules

20395-0366

Pil

150 x 650 mm

30 mg

Nil

Arial Narrow (15pt, 9pt)

NA

Comments received from Channaya on 01.09.2025.

UK (English)

Marksans (South)

Adobe illustrator CC

Bhuddish

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VERSION XXXXX DATE 01.09.2025 Relon@hem

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