• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Fluoxetine is and what it is used for
2. What you need to know before you take Fluoxetine
3. How to take Fluoxetine
4. Possible side effects
5. How to store Fluoxetine
6. Contents of the pack and other information

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

• 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.

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

Treating these conditions is important to help you get better. If it’s not treated, your condition may not go away and may become more serious and more difficult to treat.

You may need to be treated for a few weeks or months to ensure that you are free from symptoms.

• 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 Fluoxetine 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 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. 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.

• taking metoprolol (to treat heart failure) because there is an increased risk of your heart beat becoming too slow.

Talk to your doctor or pharmacist before taking Fluoxetine 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 might need to be discontinued
• mania now or in the past; if you have a manic episode, contact your doctor immediately because Fluoxetine might need to be discontinued
• 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 ‘Other medicines and Fluoxetine’)
• epilepsy or fits. If you have a fit (seizures) or experience an increase in seizure frequency, contact your doctor immediately; Fluoxetine might need to be discontinued
• ongoing ECT (electro-convulsive therapy)
• ongoing treatment with tamoxifen (used to treat breast cancer) (see ‘Other medicines and Fluoxetine’)
• starting to feel restless and cannot sit or stand still (akathisia). Increasing your dose of Fluoxetine may make this worse
• 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)
• 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)
• medicines like Fluoxetine (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.

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.

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 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 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 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 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.

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

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

Do not take Fluoxetine 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 “Do not take Fluoxetine”). Treatment with Fluoxetine 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. If Fluoxetine 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 heart beat becoming too slow.

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

• tamoxifen (used to treat breast cancer); because Fluoxetine 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
• 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 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 may increase the risk of changes in the electrical activity of the heart
• phenytoin (for epilepsy); because Fluoxetine 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
• lithium, selegiline, St. John’s Wort, tramadol (a painkiller), triptans (for migraine) and tryptophan; there is an increased risk of mild serotonin syndrome when these drugs are taken with Fluoxetine. 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 derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine), antimalaria treatment particularly halofantrine or certain antihistamines (astemizole, mizolastine), because taking one or more of these drugs with Fluoxetine may increase the risk of changes in the electrical activity of the heart
• Anti-coagulants (such as warfarin), NSAID (such as ibuprofen, diclofenac), aspirin and other medicines which can thin the blood (including clozapine, used to treat certain mental disorders).
  Fluoxetine may alter the effect of these medicines on the blood. If Fluoxetine 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 (for allergies); because it may reduce the effect of Fluoxetine
• drugs that lower sodium levels in the blood (including, drug that causes 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
• anti-depressants 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 anti-psychotics such as phenothiazines or butyrophenones; because Fluoxetine may increase the 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 may possibly change the blood levels of these medicines, your doctor may need to lower their dose when administered with Fluoxetine.

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

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're planning to become pregnant.

In babies whose mothers took fluoxetine during the first 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 fluoxetine.

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 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 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.

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.

Fluoxetine may affect your judgment or coordination. Do not drive or use machinery without advice from your doctor or pharmacist.

This medicine also contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicine contains 9g of sucrose per dose (15ml).

This should be taken into account in patients with diabetes mellitus. May be harmful to the teeth.

The recommended dose is:

• Depression: The recommended dose is 5ml oral solution (20mg) 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 15ml oral solution (60mg) 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 15ml oral solution (60mg) daily.
• Obsessive-compulsive disorder: The recommended dose is 5ml oral solution (20mg) 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 15ml oral solution (60mg) daily. If no improvement is noted within 10 weeks, your doctor will reconsider your treatment.

Treatment should be started and be supervised by a specialist. The starting dose is 2.5ml oral solution (10mg) daily. After 1 to 2 weeks, your doctor may increase the dose to 5ml oral solution (20mg) daily. 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.

Your doctor will increase the dose with more caution and the daily dose should generally not exceed 10ml oral solution (40mg). The maximum dose is 15ml oral solution (60mg) daily.

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.

This medicinal product must be taken orally.

Use the measuring syringe provided in the pack to deliver the required dose.

Instructions for the use of syringe:

a) Open the bottle: press the cap and turn it anticlockwise (figure 1).

b) Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is properly fixed. Take the syringe and put it in the adaptor opening (figure 4).

c) Turn the bottle upside down. Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upwards in order to remove any possible bubble (figure 5B).
Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 5C).

d) Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).

e)Empty the contents of the syringe into the patient’s mouth by pushing the piston to the bottom of the syringe (figure 7).
Close the bottle with the plastic screw cap.
Wash the syringe with water (figure 8).

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

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

• 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.

• Do not stop taking Fluoxetine 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 medicine.

You may notice the following effects (withdrawal effects) when you stop taking Fluoxetine: 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 or being sick); tremor (shakiness); headaches.

Most people find that any symptoms on stopping Fluoxetine 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme Website 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.

The active substance is fluoxetine (as fluoxetine hydrochloride).

Each 5ml solution contains 20mg fluoxetine (as fluoxetine hydrochloride).

The other ingredients are benzoic acid (E210), sucrose, glycerol (E422), garden mint flavour (contains propylene glycol (E1520)) and purified water.

Fluoxetine oral solution is a clear, colourless to pale yellow to brownish colour solution with mint flavour supplied in amber glass bottles with tamper evident child resistant plastic cap.

The pack also contains a 10ml oral syringe with 0.5ml graduation mark and an adaptor.

Fluoxetine Oral Solution is supplied in bottles containing 60ml, 70ml and 140ml oral solution.

Not all pack sizes may be marketed.

POM

This medicinal product is authorised in the Member States of the EEA under the following name:

UK and IE: Fluoxetine 20mg/5ml Oral Solution