FLUOXETINE 40 MG CAPSULES HARD - patient leaflet, side effects, dosage

2. what you need to know before you take fluoxetine capsules

Do not take Fluoxetine capsules

• If you are allergic to fluoxetine hydrochloride 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 (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.

• If you are taking metoprolol (to treat heart failure) since there is an increased risk of your heartbeat becoming too slow

These capsules are available in different strengths from what you may be used to. This is to allow your doctor to more finely control your dose of fluoxetine so that you can take the smallest dose needed for you. Please make sure that you know exactly what strength and how many of each capsule you are to take and take care to ensure that you do not take more or less than the prescribed dose. If you are at all unsure please talk with your doctor or pharmacist, you might want to ask them to give you written instructions based on the sizes and markings of the capsule shells.

Warnings and precautions

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

• Epilepsy or fits. If you have a fit (seizures) or experience an increase in the seizure frequency, contact your doctor immediately; Fluoxetine capsules might need to be discontinued
• Mania (overactive behaviour or thoughts) now or in the past; if you have a manic episode, contact your doctor immediately because 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 that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets)
• Glaucoma (increased pressure in the eye)
• Ongoing treatment with diuretics (water tablets), especially if you are elderly
• Ongoing ECT (electroconvulsive therapy)
• 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 capsules”)
• 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
• 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
• 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

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

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.

Other medicines and Fluoxetine capsules Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

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 “Do not take Fluoxetine capsules” ). 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 heartbeat becoming too slow

Fluoxetine may affect the way some other medicines work (interaction), especially the following:

• 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
• Tramadol (a painkiller) or triptans (for migraine); there is an increased risk of hypertension (raised blood pressure)
• You should not start to take the herbal remedy St John’s wort while you are being treated with fluoxetine since this may result in an increase in side effects. If you are already taking St John’s wort when you start on fluoxetine, stop taking St John’s wort and tell your doctor at your next visit
• 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

• 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 capsules may increase the risk of changes in the electrical activity of the heart

• 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

• Tamoxifen (used to treat breast cancer), because Fluoxetine capsules may change the blood levels of this drug and a reduction of the effect of tamoxifen cannot be excluded, your doctor may need to consider different antidepressant treatments
• Anticoagulants (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
• 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 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
• Mequitazine (for allergies); because taking this drug with Fluoxetine capsules may increase the risk of changes in the electrical activity of the heart
• Cyproheptadine (for allergies); because it may reduce the effect of fluoxetine
• Drugs that lower sodium levels in the blood (including drugs 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

• Antidepressants such as tricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRIs) or bupropion, mefloquine or chloroquine (used to treat malaria), tramadol (used to treat severe pain) or antipsychotics such as phenothiazines or butyrophenones;

because Fluoxetine capsules may increase the risk of seizures when taken with these medicines

50 mm

Space for

Fluoxetine Capsules 10/30/40/60 mg - PIL - Cutterguide Dim: 110 x 640 mm (Open size)

Fluoxetine capsules with food, drink and alcohol

• You can take fluoxetine 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 or pharmacist for advice before taking this medicine.

Pregnancy

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

In babies whose mothers took fluoxetine 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. You and your doctor may decide that it is better for you to gradually stop taking fluoxetine while you are pregnant.

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. 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 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.

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.

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 capsules may affect your judgment or co-ordination. Do not drive or use machinery until you know how fluoxetine affects you.

Fluoxetine 10 mg capsules contain sodium This medicine contains less than 1 mmol sodium (23 mg) per 10mg capsule, that is to say fluoxetine 10mg capsules are essentially ‘sodium-free’.

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. The instructions will also be on the label on the pack. Do not take more capsules than your doctor tells you.

Taking Fluoxetine capsules

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

Dose

Adults:

The recommended dose is:

• Depression: The recommended dose is 20 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 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 60 mg daily
• Obsessive compulsive disorder: The recommended dose is 20 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 60 mg daily. If no improvement is noted within 10 weeks, your doctor will reconsider your treatment

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 10mg/day (given as 2.5 ml of fluoxetine 20mg/5ml oral solution). 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:

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

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 take too many capsules, go to your nearest hospital emergency department (or casualty) or tell your doctor straight away
• Take the pack 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 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 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: 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 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 (see section 2)
• If you get a rash or allergic reaction such as itching, swollen lips/tongue or wheezing/shortness of breath, stop taking the capsules straight away and tell your doctor immediately
• If you feel restless and cannot sit or stand still, you may have akathisia; increasing your dose of fluoxetine may make you feel worse. If you feel like this, contact your doctor
• Tell your doctor immediately if your skin starts to turn red or you develop a varied skin reaction or your skin starts to blister or peel. This is very rare

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:

Very common (may affect more than 1 in 10 people)

• – Insomnia

• – Headache

• – Diarrhoea, feeling sick (nausea)

• – Fatigue

Common (may affect up to 1 in 10 people)

• – Not feeling hungry, weight loss

• – Nervousness, anxiety

• – Restlessness, poor concentration

• – Feeling tense

• – Dizziness

• – Change in taste

• – Uncontrollable shaking movements

• – Blurred vision

• – Yawning

• – Rash, urticaria, itching

• – Excessive sweating

• – Joint pain

• – Dry mouth

• – Indigestion, vomiting

• – Passing urine more frequently

• – Unexplained vaginal bleeding

• – Feeling shaky or chills

• – Sleep problems, unusual dreams, tiredness or sleepiness

• – Flushing

• – Rapid and irregular heartbeat sensations

• – Decreased sex drive or sexual problems (including difficulty maintaining an erection for sexual activity)

Uncommon (may affect up to 1 in 100 people)

• – Feeling detached from yourself

• – Strange thinking

• – Abnormally high mood

• – Orgasm problems

• – Teeth grinding

• – Enlarged (dilated) pupils

• – Low blood pressure

• – Shortness of breath

• – Difficulty swallowing

• – Hair loss

• – Increased tendency to bruising

• – Cold sweat

• – Discomfort or pain when passing urine

• – Feeling hot or cold

• – Muscle twitching, involuntary movements or problems with balance or co-ordination

• – Memory impairment

• – Ringing in the ears

• – Nose bleeds

• – Abnormal liver test results

• – Sexual dysfunction

• – Malaise

• – Feeling abnormal

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

• – Low levels of salt in the blood

• – Untypical wild behaviour

• – Hallucinations

• – Agitation

• – Panic attacks

• – Fits (epileptic)

• – Widening of blood vessels

• – Sensitivity to sunlight

• – Producing breast milk

• – Difficulty in passing urine

• – Raised prolactin levels in the blood

• – Vasculitis (inflammation of a blood vessel) – Unusual bleeding or bruising

• – Reduction in white blood cell count

• – 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

• – Reduction in blood platelets, which increase risk of bleeding or bruising

• – Confusion

• – Stuttering

• – Aggression

• – Hepatitis

• – Lung problems

• – Muscle pain

• – Problems urinating

• – Gastrointestinal bleeding

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

• – Heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see ‘Pregnancy, breast-feeding and fertility’ in section 2 for more information

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

If you have any of the symptoms listed and they bother you, or last for some time, tell your doctor or a pharmacist.

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

Additional side effects in children and adolescents

In addition to the possible side effects listed above, fluoxetine 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 leaflet. You can also report side effects directly via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side affects 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 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 protect the environment.

6.contents of the pack and other information

What Fluoxetine capsules contain

• The active substance is fluoxetine. Each capsule contains fluoxetine hydrochloride equivalent to 10, 30, 40 or 60 mg of fluoxetine
• The other ingredient is pregelatinised starch. The capsule shell contains gelatin and is coloured with iron oxide yellow (E172), patent blue V (E131) and titanium dioxide (E171). The 10mg strength capsules shell also contains sodium lauryl sulfate
• The black ink contains shellac (E904), dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide

What Fluoxetine capsules look like and contents of the pack

Fluoxetine capsules are hard gelatin capsules. The 10 mg capsules have a white body marked ‘F10’ and a dark green opaque cap marked ‘F 10’ containing a white to off-white powder.

The 30 mg capsules have an off-white opaque body marked ‘F30’ and a green opaque cap marked ‘F 30’ containing a white to off-white powder.

The 40 mg capsules have an off-white opaque body marked ‘F40’ and a green opaque cap marked ‘F 40’ containing a white to off-white powder.

The 60 mg capsules have an off-white opaque body marked ‘F60’ and a green opaque cap marked ‘F 60’ containing a white to off-white powder.

Fluoxetine capsules are available in aluminium/PVC blister packs of 30 capsules.

Marketing Authorisation Holder

Key Pharmaceuticals Limited

Galen House, 83 High Street, Somersham, Cambridgeshire, PE28 3JB, United Kingdom

Manufacturer

Medreich Plc

Warwick House, Plane Tree Crescent, Feltham, TW13 7HF,

United Kingdom

Other sources of information

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This leaflet was last revised in March 2021.