Fluoxetine 20mg Capsules

• Fluoxetine 20mg Capsules are used to treat depression and anxiety disorders.
  Like all medicines it can have unwanted effects. It is therefore important that you and your doctor weigh up the benefits of treatment against the possible unwanted effects, before starting treatment.
• Fluoxetine 20mg Capsules are not for use in children and adolescents under 18. See section 2, Use in children and adolescents aged 8 to 18 years.
• Fluoxetine 20mg 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 first start treatment. Tell your doctor if you haven’t started feeling better. See section 3, How to take Fluoxetine 20mg Capsules.
• 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 20mg Capsules without talking to your doctor. If you stop taking Fluoxetine 20mg Capsules 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 20mg Capsules may make these feelings worse. See section 4, Possible side-effects.
• Taking some other medicines with Fluoxetine 20mg Capsules can cause problems. You may need to talk to your doctor. See section 2, Taking other medicines.
• If you are pregnant or planning to get pregnant, talk to your doctor. See section 2 Pregnancy, breastfeeding and fertility.

• 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 symptoms 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 20 mg Capsules are and what they are used for
2. What you need to know before you take Fluoxetine 20mg Capsules
3. How to take Fluoxetine 20mg Capsules
4. Possible side effects
5. How to store Fluoxetine 20mg Capsules
6. Contents of the pack and other information

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 20mg Capsules 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. You must talk to a doctor if you do not feel better or if you feel worse.

• If you are allergic (hypersensitive) to Fluoxetine 20mg Capsules 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 face or lips 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 (MAOIs) used to treat depression (e.g. iproniazid) since serious or even fatal reactions can occur. Examples of MAOIs include medicines used to treat depression such as nialamide, iproniazid, moclobemide, phenelzine, tranylcypromine, isocarboxazid, toloxatone and also linezolid (an antibiotic) and methylthioninium chloride also called methylene blue (used to treat high levels of methaemoglobin in the blood).
• If you are taking metoprolol (to treat heart failure) since there is an increased risk of your heart beat becoming too slow.

Treatment with Fluoxetine 20mg Capsules should only be started at least 2 weeks after discontinuation of an irreversible non selective MAOI (such as tranylcypromine or iproniazid).

Do not take any irreversible non selective MAOIs for at least 5 weeks after you stop taking Fluoxetine 20mg Capsules. If Fluoxetine 20mg Capsules has been prescribed for a long period and/or at a high dose, a longer interval needs to be considered by your doctor.

Talk to your doctor or pharmacist before taking Fluoxetine 20mg 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 20mg Capsules might need to be discontinued.
• mania now or in the past; if you have a manic episode, contact your doctor immediately because Fluoxetine 20mg Capsules might need to be discontinued;
• history of bleeding disorders or appearance of bruises or unusual bleeding
• or if you are pregnant (see ‘Pregnancy’);
• ongoing treatment with medicines that thin the blood (see ‘Other medicines and Fluoxetine 20mg Capsules);
• epilepsy or fits. If you have a fit (seizures) or experience an increase in seizure frequency, contact your doctor immediately; Fluoxetine 20mg Capsules might need to be discontinued;
• ongoing ECT (electroconvulsive therapy);
• ongoing treatment with tamoxifen (used to treat breast cancer) (see ‘Other medicines and Fluoxetine 20mg Capsules’);
• starting to feel restless and cannot sit or stand still (akathisia). Increasing your dose of Fluoxetine 20mg Capsules 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 20mg Capsules (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.
• the use of Buprenorphine/opioid together with Fluoxetine 20mg Capsules can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Fluoxetine 20mg Capsules”).

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 young adults (less than 25 years old) 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.

In clinical trials some children and adolescents taking Fluoxetine 20mg Capsules were also reported feeling elated or over−excited, which causes unusual behaviour.

Fluoxetine 20mg 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 should not be used to treat other conditions.

Additionally, only limited information concerning the long-term safety of Fluoxetine 20mg Capsules on growth, puberty, mental, emotional and behavioural development in this age group is available. Fluoxetine 20mg Capsules may slow growth or possibly delay sexual maturity.

Despite this, your doctor may prescribe Fluoxetine 20mg Capsules for patients under 18 for moderate to severe major depressive episode in combination with psychological therapy because he/she decides that this is in their best interests. If your doctor has prescribed Fluoxetine 20mg 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 20mg Capsules.

Fluoxetine 20mg Capsules should not be used in the treatment of children under the age of 8 years.

If any of the above under ‘Do not take’ or ‘Take Special care’ applies to you, please consult your doctor or pharmacist.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, (up to five weeks ago) including medicines obtained without prescription. This medicine may affect the way some other medicines work (interaction).

Do not take Fluoxetine 20mg Capsules with:

• Certain irreversible non selective monoamine oxidase inhibitors (MAOIs), used to treat depression. Irreversible non selective MAO-inhibitors and MAO-inhibitors type A (moclobemide) must not be used with Fluoxetine 20mg Capsules as serious or even fatal reactions (serotonin syndrome) can occur. Treatment with Fluoxetine 20mg 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 20mg Capsules. If Fluoxetine 20mg 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 heart beat becoming too slow.

Fluoxetine 20mg Capsules may affect the way the following medicines work (interaction);

• Tamoxifen (used to treat breast cancer); because Fluoxetine 20mg 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.
• Monoamine oxidase inhibitor A (MAOI-A) including moclobemide, linezolid (an antibiotic) and methylthioninium chloride also called methylene blue (used to treat high levels of methaemoglobin in the blood): due to the risk of serious or even fatal reactions (called serotonin syndrome). Treatment with Fluoxetine 20mg Capsules 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. However, treatment with Fluoxetine 20mg Capsules can be started the following day after discontinuation of certain reversible MAOIs (for instance moclobemide, linezolid, methylthioninium chloride (methylene blue). Some MAO-inhibitors type B (selegiline) can be used with Fluoxetine 20mg Capsules provided that your doctor monitors you closely.
• Mequitazine (for allergies); because taking this drug with Fluoxetine 20mg Capsules may increase the risk of changes in the electrical activity of the heart.
• Phenytoin (for epilepsy); because Fluoxetine 20mg 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 20mg Capsules.
• Lithium, selegiline, Tramadol (a painkiller), triptans (for migraine) and tryptophan (used to treat mental illness); there is an increased risk of serotonin syndrome when these drugs are taken with Fluoxetine 20mg 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. fentiazine derviatives, phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine), anti-malaria treatment particularly halofantrine, or certain antihistamines (astemizole, mizolastine), because taking one or more of these drugs with Fluoxetine 20mg Capsules may increase the risk of changes in the electrical activity of the heart.
• Anti-coagulants (such as warfarin), NSAIDs (such as ibruprofen, diclofenac) aspirin and other medicines which can thin the blood (including clozapine, used to treat certain mental disorders). Fluoxetine 20mg Capsules may alter the effect of these medicines on the blood. If Fluoxetine 20mg 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 (for allergies); because it may reduce the effect of Fluoxetine 20mg Capsules.
• Drugs that lower sodium levels in the blood (including drugs that cause 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 20mg Capsules.
• Anti-depressants such as tricyclic anti-depressants, 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 20mg Capsules 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 20mg Capsules may possibly change the blood levels of these medicines, your doctor may need to lower their dose when administered with Fluoxetine 20mg Capsules.
• You should not start to take the herbal remedy St John’s wort while you are being treated with Fluoxetine 20mg Capsules since this may result in an increase in side effects. If you are already taking St John’s wort when you start on Fluoxetine 20mg Capsules, stop taking St John’s wort and tell your doctor at your next visit.
• Buprenorphine/opioids may interact with Fluoxetine 20mg Capsules and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.

• You can take Fluoxetine 20mg Capsules with or without food, whichever you prefer.
• You should avoid alcohol while you are taking this medicine

Although Fluoxetine 20mg Capsules does not increase the effect of alcohol, it might affect your judgment or coordination.

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 20mg Capsules during the first few months of pregnancy, there have been some reports showing an increased risk of birth defects, in particular those 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 20mg Capsules. You and your doctor may decide that it is better for you to gradually stop taking Fluoxetine 20mg Capsules while you are pregnant.

However, depending on your circumstances, your doctor may suggest that it is better for you to keep taking Fluoxetine 20mg Capsules.

Make sure your midwife and / or doctor know you are on Fluoxetine 20mg Capsules. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Fluoxetine 20mg 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 first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately. If you take Fluoxetine 20mg 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 20mg Capsules so they can advise you.

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.

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.

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 20mg Capsules.

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 20mg Capsules can impair judgement, thinking capacity and motor skills. This should be taken into account in situations where increased alertness is necessary, e.g. when driving or operating hazardous machinery. Do not drive or operate machinery unless you are sure you are not affected.

If you are taking Fluoxetine 20mg Capsules for depression, you may not feel any better for the first two weeks or more. You should keep taking your medicines until your doctor tells you to stop.

Adults:

The recommended dose is:

• Major depressive episodes: The recommended dose is 1 capsule (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 3 capsules (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 (eating disorder): The recommended dose is 3 capsules (60mg) daily.
• Anxiety disorder (Obsessive-compulsive disorder (OCD)): The recommended dose is 1 capsule (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 3 capsules (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 10mg/day.

After one to two weeks, your doctor may increase the dose to 20mg/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.

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

The maximum dose is 3 capsules (60mg) daily.

If you have a liver problem or are using other medication that might affect Fluoxetine 20mg Capsules, your doctor may decide to prescribe a lower dose or tell you to use Fluoxetine20mg Capsules every other day.

If you take too many capsules, or if a child has taken any, consult your doctor or go to the nearest hospital emergency department (or casualty) immediately. Take this leaflet and the container with you so they know what you have taken.

Symptoms of overdose: 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 time each day may help you to remember to take it regularly.

• Do not stop taking your medicine without asking your doctor first, even when 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 20 mg 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 or being sick); tremor (shakiness); headaches.

Most people find that any symptoms on stopping Fluoxetine 20mg Capsules are mild and go away on their own within a few weeks. If you experience symptoms when you stop treatment, contact your doctor.

When stopping Fluoxetine 20mg 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.

In addition to the possible side effects listed above, Fluoxetine 20mg 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.

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 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.

Fluoxetine 20mg Capsules are hard capsules with a light green cap and ivory body imprinted '20' on cap and 'FLUOX' on the body with black ink.