Document: Fluoxetine Accord capsule, hard ENG PL change

• Fluoxetine Accord capsule, hard PL
• Fluoxetine Accord capsule, hard ENG PL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluoxetine Accord 20mg capsule, hard

Fluoxetine hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor, pharmacist or nurse.

• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Fluoxetine hard capsule is and what it is used for

2. What you need to know before you take Fluoxetine hard capsule

3. How to take Fluoxetine hard capsule

4. Possible side effects

5. How to store Fluoxetine hard capsule

6. Contents of the pack and other information

1. What Fluoxetine hard capsule is and what it is used for

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

This medicine is used to treat the following conditions:

Adults:

• To relieve symptoms of depression

• Obsessive-compulsive disorder (is a mental disorder most commonly characterized by intrusive, repetitive thoughts resulting in compulsive behaviours and mental acts that the person feels driven to perform)

• Bulimia nervosa (eating disorder): Fluoxetine 20 mg Capsule 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 20 mg Capsule 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 hard capsule

Do not take Fluoxetine 20 mg Capsules if you:

• are allergic (hypersensitive) to fluoxetine or any of the other ingredients of Fluoxetine Capsules (see 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 metoprolol (a medicine used in heart failure). The side effects of metoprolol may be increased including slowing your heart beat excessively.

• taking other medicines known as non-selective monoamine oxidase inhibitors or reversible monoamine oxidase inhibitors type A (MAOIs), since serious or even fatal reactions can occur. Examples of such MAOIs include medicines used to treat depression such as nialamide, iproniazide, 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).

Treatment with Fluoxetine Capsules should only be started 2 weeks after discontinuation of an irreversible MAOI (for instance tranylcypromine).

However, treatment with fluoxetine can be started the following day after discontinuation of certain reversible MAOIs (for instance moclobemide moclobemide, linezolid, methylthioninium chloride

(methylene blue)

Do not take any 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 needs to be considered by your doctor.

Warnings and precautions

Tell your doctor if any of the following applies to you:

• have epilepsy or fits (seizures) or experience an increase in seizure frequency, contact your doctor immediately; 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.

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

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

• heart problems

• are taking diuretics (water tablets), especially if you are elderly

• are having ECT (electro-convulsive therapy) treatment

• have a history of bleeding disorders or you develop bruises or unusual bleeding

• are taking medicines that thin the blood (see ‘Taking other medicines’)

• are undergoing treatment with tamoxifen (used to treat breast cancer) (see ‘Taking other medicines’);

• start to feel restless and cannot sit or stand still (akathisia). Increasing your dose of Fluoxetine may make this worse;

• start to experience 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 condition; contact your doctor immediately, Fluoxetine Capsules might need to be discontinued.

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.

Youmay be more likely to think like this:

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 friendthat 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.

Use in 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 Capsule 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, your doctor may prescribe Fluoxetine Capsule for patients under 18 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 should not be used in the treatment of children under the age of 8 years.

Other medicines and Fluoxetine hard capsule

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, (up to 5 weeks ago) including medicines obtained without a prescription.

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

• Certain MAO-inhibitors (used to treat depression). Non-selective MAO-inhibitors and MAO-inhibitors type A (moclobemide) must not be used with Fluoxetine Capsules 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 MAOI (for instance tranylcypromine). However, treatment with fluoxetine 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 Capsules provided that your doctor monitors you closely.

• metoprolol (used in heart failure) see section ‘Do not take Fluoxetine Accord’

• mequitazine (an antihistamine); Fluoxetine Accord may increase the risk of side effects associated with this medicine.

• lithium, tryptophan: there is an increased risk of serotonin syndrome when these drugs are taken with Fluoxetine Capsules. Your doctor will carry out more frequent check-ups.

• 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.

• clozapine (used to treat certain mental disorders), tramadol (a painkiller) or triptans (for migraine); there is an increased risk of hypertension (raised blood pressure).

• flecainide or encainide (for heart problems), carbamazepine (for epilepsy), tricyclic antidepressants

(for example imipramine, desipramine and amitriptyline); because Fluoxetine Capsules may possibly change the blood levels of these medicines, your doctor may need to lower their dose when administered with Fluoxetine Capsule.

• 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.

• warfarin or other medicines used to thin the blood; 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.

• You should not start to take the herbal remedy St John’s wort while you are being treated with Fluoxetine 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 Capsules, stop taking St John’s wort and tell your doctor at your next visit.

Fluoxetine Capsule with food and drink

• You can take this medicine with or without food

• You are advised NOT to drink alcohol with this medicine.

Pregnancy and breast-feeding

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.

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. Ask your doctor or pharmacist for advice before taking any medicine.

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.

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.

Driving and using machines:

Your medicine can affect your judgement or co-ordination. Do not drive or use machinery without advice from your doctor or pharmacist.

3. How to take Fluoxetine hard capsule

Always take Fluoxetine 20 mg Capsule exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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

Adults:

The usual dose is:

• Depression: The recommended dose is 1 capsule (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 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.

• OCD (Obsessive thoughts and obsessive actions): The recommended dose is 1 capsule (20 mg) daily. Yourdoctor 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 10mg/day

After 1 to 2 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. Your doctor will review the need for continuing treatment beyond 6 months, and treatment will be reassessed if no improvement is seen.

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 Capsule every other day.

If you take more Fluoxetine Capsules than you should:

Do not take more capsules than your doctor tells you to. If you ever take too many go to the nearest hospital casualty unit or tell your doctor immediately. Take the container and any remaining capsules with you to show to the doctor.

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 forget to take your medicine at any time, take it as soon as you remember; then continue to take it at the usual times. Do not take a double dose to make up for a forgotten dose.

If you are worried ask your pharmacist or doctor for advice.

If you stop taking Fluoxetine 20 mg Capsule

You may notice the following 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 or 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 symptoms when you stop 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 this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fluoxetine 20 mg Capsule 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 Fluoxetine capsules straight away and tell your doctor immediately.

dose of Fluoxetine Capsules may make you feel worse. If you feel like this, contact your doctor.

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.

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

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

Very common (seen in more than 1 in every 10 patients)

- insomnia

- headache

- diarrhoea, feeling sick (nausea)

- fatigue

Common (seen in 1 to 10 in every 100 patients)

- not feeling hungry, weight loss

- nervousness, anxiety

- restlessness, poor concentration

- feeling tense

- decreased sex drive or sexual problems (including difficulty maintaining an erection for sexual activity)

- sleep problems, unusual dreams, tiredness or sleepiness

- dizziness

- change in taste

- uncontrollable shaking movements

- blurred vision

- rapid and irregular heartbeat sensations

- 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 (seen in 1 to 10 in every 1,000 patients)

- feeling detached from yourself

- strange thinking

- abnormally high mood

- orgasm problems

- teeth grinding

- muscle twitching, involuntary movements or problems with balance or co-ordination

- enlarged (dilated) pupils

- low blood pressure

- shortness of breath

- difficulty swallowing

- hair loss

- increased tendency to bruising

- cold sweat

- difficulty passing urine

- feeling hot or cold

Rare (seen in 1 to 10 in every 10,000 patients)

- low levels of salt in the blood

- untypical wild behaviour

- hallucinations

- agitation

- panic attacks

- 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

- sensitivity to sunlight

- producing breast milk

- reduction in white blood cells or neutrophils in the blood

Very rare (seen in less than 1 to 10,000 patients)

- reduction in blood platelets, which increases risk of bleeding or bruising

Other (frequency cannot be estimated)

- thoughts of suicide or harming yourself

- memory impairment

- lung problems

- hepatitis, abnormal liver function test results

- muscle pain

- problems urinating

- confusion

- stuttering

- nose bleeds

- ringing in the ears

- unexplained bruising or bleeding Most of these side effects are likely to disappear with continued treatment.

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

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.

In children and adolescents (8-18 years)– fluoxetine may slow growth or possibly delay sexual maturity. Nose bleeds were also commonly reported in children.

Withdrawal effects when stopping treatment may occur, particularly Fluoxetine Accord is stopped abruptly. The risk of withdrawal symptoms may be dependent on the duration of therapy and dosage and the rate of dose reduction (see “How to take Fluoxetine Hard Capsule”).

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 national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Fluoxetine hard capsule

Keep out of the reach and sight of children.

Do not use Fluoxetine 20 mg Capsule after the expiry date which is stated on the label & carton after ‘EXP ‘. The expiry date refers to the last day of that month.

Do not store the capsules above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Fluoxetine 20mg Capsules contains:

The active substance is Fluoxetine hydrochloride. Each capsule contains 22.4 mg fluoxetine Hydrochloride equivalent to 20 mg fluoxetine.

The other ingredients are: starch pregelatinised (maize), talc purified, silica colloidal anhydrous and magnesium stearate.

The capsule shell contains: quinoline yellow (E104), erythrosine (E127), indigo carmine (E132), titanium dioxide (E171) and gelatin.

The printing ink contains: shellac glaze (E904), black iron oxide (E 172), propylene glycol and

ammonium hydroxide.

What Fluoxetine hard capsule looks like and contents of the pack

Fluoxetine Capsule is a hard capsule. Each capsule contains 20mg fluoxetine.

The capsules are Light green opaque / standard yellow opaque, hard gelatin capsules with imprinting “BJ” on cap and “F20” on body containing white to off-white powder

Fluoxetine hydrochloride 20 mg capsules are packed in PVC / Aluminum blisters. Blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 70, 90, 98, and 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

For SE

Accord Healthcare Ltd.

Sage House, 319 Pinner Road

North Harrow, Middlesex

HA1 4HF,

United Kingdom

For other member states:

To be completed nationally

This medicinal product is authorized in the Member States of the EEA under the following names:

Country name	Proposed Name
Italy	Fluoxetina Accord Healthcare 20 mg Capsule Rigide
Portugal	Fluoxetina Accord
Spain	Fluoxetina Apotex 20 mg cápsulas duras EFG
Sweden	Fluoxetine Accord 20mg Kapsel, hård

This leaflet was last revised in 1 October 2015.