10

mm

180mm

£

MercuryPharma

PATIENT INFORMATION LEAFLET

Olena® 20 mg Dispersible Tablets

Fluoxetine

What is in this leaflet:

1.    What Olena tablets are and what they are used for

2.    What you need to know before you take Olena tablets

3.    How to take Olena tablets

4.    Possible side effects

5.    How to store Olena tablets

6.    Contents of the pack and other information

1. What Olena tablets are and what they are used for

Olena tablets belong to a group of medicines called antidepressants that will relieve the symptoms of depression. They may also be used to treat the eating disorder bulimia nervosa and the condition obsessive compulsive disorder.

2. What you need to know before you take Olena tablets

Do not take Olena tablets and tell your doctor if:

•    you are allergic (hypersensitive) to fluoxetine or any of the other ingredients of this medicine (listed in section 6)

•    you are taking or have taken within the last two weeks any monoamine oxidase inhibitors (MAOIs). MAOIs include phenelzine, tranylcypromine, isocarboxazide, nialamide, iproniazide, moclobemide, toloxatone

•    you are taking linezolid (an antibiotic)

•    you are taking methylthioninium chloride also called methylene blue.

Warnings and precautions

Talk to your doctor or pharmacist before using Olena tablets if:

•    you have a heart, liver or kidney disorder. Your doctor may decide you need a lower dose.

•    you are pregnant or planning to become pregnant (see Pregnancy section below).

Please tell your doctor or pharmacist before taking Olena tablets if you:

•    suffer from epilepsy or if you have had a fit in the past. Olena tablets may increase the likelihood of an epileptic fit.

If after taking this medicine, you develop a fit for the first time or get more fits than usual, seek medical advice from your doctor.

•    have a history of mental illness known as mania or hypomania

•    suffer from heart, kidney or liver problems

•    suffer from diabetes. Olena tablets may alter your blood sugar levels. Your doctor may need to alter the dose of your insulin or other diabetes control medicine.

•    have a history of bleeding disorders or develop unexpected bruising, reddening under the skin or bleeding from any other part of the bo<dy.

•    are having Electroconvulsive Therapy (ECT).

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 you first start taking 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.

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. Olena tablets 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 Olena tablets on growth, puberty, mental, emotional and behavioural development in this age group is available. Despite this, and if you're a patient under 18 your doctor may prescribe this medicine 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 Olena tablets 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 this medicine.

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

Other medicines and Olena tablets Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicine obtained without a prescription. Especially:

•    lithium or phenothiazines (e.g. chlorpromazine) for mental illness

•    flecainide or encainide for the heart

•    carbamazepine or phenytoin for epilepsy or other conditions

•    any other medicines for depression

•    selegeline for Parkinson's disease

•    tramadol for pain relief

•    triptans (e.g.sumatriptan) for migraine or cluster headaches

•    class IA and III antiarrhythmics

•    antipsychotics (e.g. fentiazine derviatives, pimozide, haloperidol)

•    antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin I\\ pentamidine)

•    anti-malarials (e,g halofantrine)

•    antihistamines (e,g astemizole, mizolastine).

•    tricyclic antidepressants (e,g. imipramine, desipramine and amitriptyline)

•    medicines to thin the blood (e.g. warfarin)

•    non-steroidal anti-inflammatory drugs (NSAIDs e.g. ibuprofen)

•    aspirin

•    tryptophan

•    tamoxifen (used to treat breast cancer)

•    the herbal remedy St Johns wort (Hypericum perforatum). This should not be taken at the same time as Olena tablets and mention it to your doctor at your next visit.

Pregnancy, breast-feeding and fertility If you are pregnant, planning to become pregnant or are breast-feeding ask your doctor, pharmacist or midwife for advice before taking this medicine.

When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Olena tablets 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.

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 this medicine 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 mother who took this medicine. You and your doctor may decide that it is better for you to gradually stop taking Olena tablets while you are pregnant."However, depending on your circumstances, your doctor may suggest that it is better for you to keep taking Olena tablets.

Breast-feeding is not recommended whilst taking this medicine. Driving and using machines

Antidepressants can affect your judgement or co-ordination.

Do not drive or use machinery unless you are sure that you are not affected.

Important information about some of the ingredients of Olena tablets

This medicine contains sorbitol which is a sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine also contains sulfur dioxide (E220) which may cause allergic reactions.

3. How to take Olena tablets

Always take Olena tablets exactly as your doctor has told you.

If you are not sure, check with your doctor or pharmacist. Swallow the tablet(s) with a half a glass of water or disperse the tablets(s) in half a glass of water and drink. Do not crush or chew the tablets.

You are advised NOT to drink alcohol with this medicine. Doses:

Adults:

•    Depression: 20 mg (one tablet) a day. Maximum dose should not exceed 60 mg (3 tablets a day)

•    Bulimia: 60 mg (3 tablets) a day

•    Obsessive compulsive disorder: 20 mg (one tablet) a day. Maximum daily dose should not exceed 60 mg (3 tablets) a day.

The tablet may be divided in to equal doses.

If you suffer from kidney or liver problems or are elderly, your doctor may prescribe a different dose.

Originated by

ST

Date:

30/08/2012

Tech Approved

No

180mm

Children and adolescents aged 8 to 18 years with depression:

Treatment should be started and be supervised by a specialist. The starting dose is 10 mg (half tablet) a day. After 1 to 2 weeks your doctor may increase the dose 20 mg a 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.

Olena tablets may not make you feel any better for the first two weeks or more. It should be taken for as long as your doctor tells you to.

If you take more Olena tablets than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include feeling sick, being sick, seizures, heart problems, lung problems and signs of altered Central Nervous System status ranging from excitation to coma.

If you forget to take Olena tablets

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

If you stop taking Olena tablets

If you stop taking the tablets abruptly you may rarely develop dizziness, feeling sick, pins and needles, headache, and anxiety. In most cases, these symptoms are mild and shortlived. Talk to your doctor before you stop taking the tablets and follow their advice. Your doctor may reduce your dose gradually at the end of treatment, though this is often not necessary.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Olena tablets 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 tablets 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 Olena tablets 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.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

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

•    changes 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.

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

•    lung problems

•    hepatitis, abnormal liver function test results

•    muscle pain

•    problems urinating

•    confusion

•    nose bleeds

•    ringing in the ears

•    unexplained bruising or bleeding.

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.

In children and adolescents (aged 8 to 18 years) - in addition to the possible side effects listed above, this medicine may slow growth or possibly delay sexual maturity. Nose bleeds were also commonly reported in children.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Olena tablets

Keep out of the sight and reach of children.

Do not store above 30°C. Store in the original package in order to protect from moisture.

Do not use Olena tablets after the expiry date stated on the carton. The expiry date refers to the last day of that month. 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 Olena tablets contain:

•    The active substance is fluoxetine 20 mg. Each dispersible tablet contains fluoxetine hydrochloride equivalent to 20mg of fluoxetine.

•    The other ingredients are mannitol (E421), croscarmellose sodium, magnesium stearate, saccharin sodium and peppermint flavour*.

* Peppermint flavour contains sorbitol (E420) and sulfur dioxide (E220).

What Olena tablets look like and the contents of the pack:

Olena tablets are white, oblong, convex tablets with a scoreline on one side.

Olena tablets are available in the following pack sizes:

1 x 7 dispersible tablets

1 x 10 dispersible tablets

1 x 14 dispersible tablets

1 x 20 dispersible tablets

1 x 28 dispersible tablets

1 x 30 dispersible tablets

1 x 60 dispersible tablets

1 x 70 dispersible tablets

1 x 100 dispersible tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Mercury Pharmaceuticals Ltd.,

No. 1 Croydon, 12-16 Addiscombe Road,

Croydon CR0 0XT, UK

Manufacturer:

Laboratoires BTT ZI de Krafft 67150 Erstein France

This leaflet was last revised in October 2013.

Olena is a registered trademark of Mercury Pharma Group Limited.

102020/LF/1

Originated by

ST

Date:

30/08/2012

Tech Approved

No