Olena tablets treats 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.

Olena tablets are not for use in children and adolescents under 8. (See section 2, Children and adolescents aged 8 to 18 years).

Olena tablets 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 Olena tablets.

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 Olena tablets without talking to your doctor. If you stop taking Olena tablets 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 Olena tablets may make these feelings worse. See section 4, Possible side-effects.

Taking some other medicines with Olena tablets can cause problems. You may need to talk to your doctor. See section 2, Other medicines and Olena tablets.

If you are pregnant or planning to get pregnant, talk to your doctor. See section 2, Pregnancy, breast-feeding 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 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 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

• if you are 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 tablets straight away and contact your doctor immediately.
• if you are taking irreversible, non-selective monoamine oxidase inhibitors (MAOIs) like iproniazid since serious or even fatal reactions can occur (e.g. iproniazid used to treat depression)

Treatment with Olena tablets 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 Olena tablets. If Olena tablets have 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 used in treatment of heart failure since there is an increased risk of your heart beat becoming too slow.

Talk to your doctor or pharmacist before taking Olena tablets:

• if you have a, liver or kidney disorder. Your doctor may decide you need a lower dose
• 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 Olena tablets might need to be discontinued
• The use of buprenorphine/opioids together with Olena tablets can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and 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 immediately; Olena tablets might need to be discontinued;
• if you have a history of mental illness known as mania or hypomania ; if you have a manic episode, contact your doctor immediately because Olena tablets might need to be discontinued
• if you suffer from or have a family history of heart problems or a condition which can increase the likelihood of you having heart problems (e.g. if you have low potassium or magnesium in your blood, conditions known as hypokalemia or hypomagnesemia)
• if you 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
• if you have a history of bleeding disorders or develop unexpected bruising, reddening under the skin or bleeding from any other part of the body, or if you are pregnant (see ‘Pregnancy’)
• if you are having Electroconvulsive Therapy (ECT)
• if you are taking tamoxifen used for treatment of breast cancer. (See “Other medicines and Olena tablets”)
• ongoing treatment with medicines that thin the blood (see ‘Other medicines and Olena’);
• if you have glaucoma (increased pressure in the eye); it may increase the risk of mydriasis (dilation of pupil of the eye)
  if you have an ongoing treatment with diuretics (water tablets), especially if you are elderly.

Talk to your doctor if you experience the following after taking Olena tablets

• weight loss
• constant restlessness. A need to move constantly and not being able to stand or sit still for long periods. Increasing your dose of Olena tablets may make this worse
• raised body temperature, muscle stiffness, confusion, irritation, extreme aggressiveness becoming worse especially if you are simultaneously taking tryptophan or other medicines to treat mental disorders; 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 Olena tablets might need to be discontinued
• a mixture of all above signs especially if you have taken iproniazid
• 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)
• rash, fever, redness, breathing difficulty, swelling of limbs. These could be signs of an allergic reaction. Stop taking Olena tablets and tell your doctor if you experience any of these symptoms.

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 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.

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.

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

• Any irreversible, non-selective MAOIs for at least 5 weeks after you stop taking Olena tablets. If Olena tablets have 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
• Certain irreversible, non-selective monoamine oxidase inhibitors (MAOIs), some used to treat depression. Irreversible, non-selective MAOIs must not be used with Olena tablets as serious or even fatal reactions (serotonin syndrome) can occur (see section “Do not take Olena tablets”). Treatment with Olena tablets should only be started at least 2 weeks after discontinuation of an irreversible, non-selective MAOI (for instance tranylcypromine).
• metoprolol when used for heart failure; there is an increased risk of your heart beat becoming too slow.

Olena tablets may affect the way the following medicines work (interaction):

• Treatment with Olena tablets can be started the following day after discontinuation of certain reversible MAOIs (for instance moclobemide, linezolid, methylthioninium chloride (methylene blue)). Some MAOIs type B (selegeline) can be used with Olena tablets provided that your doctor monitors you closely;
• tamoxifen; used to treat breast cancer; because Olena tablets 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; used to treat allergies ; because taking this drug with Olena tablets may increase the risk of changes in the electrical activity of the heart
• phenytoin (for epilepsy); because Olena tablets may influence the blood levels of this drug, your doctor may need to introduce phenytoin more carefully and carry out checkups when given with Olena tablets
• 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 Olena tablets. Your doctor will carry out more frequent check-ups
• buprenorphine/opioids: These medicines may interact with Olena tablets 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.
• 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), anti-malaria treatment particularly halofantrine or certain antihistamines (astemizole, mizolastine), because taking one or more of these drugs with Olena tablets 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). Olena tablets may alter the effect of these medicines on the blood. If Olena tablets 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 Olena tablets
• 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 Olena tablets
• 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 Olena tablets 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 Olena tablets may possibly change the blood levels of these medicines, your doctor may need to lower their dose when administered with Olena tablets.

• you can take Olena tablets 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.

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 Olena tablets 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 Olena tablets.

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.

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.

If you take Olena tablets 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 Olena tablets so they can advise you.

Breast feeding:

Breast-feeding is not recommended whilst taking this medicine. 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.

Psychotropic drugs such as Olena Tablet can affect your judgement or co-ordination. Do not drive or use machinery unless you are sure that you are not affected.

This medicine contains 0.04 mg sorbitol in each 1 tablet which is equivalent to 0.04 mg/ tablet.

This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.

This medicine also contains sulfur dioxide (E220) which may rarely cause severe undesirable reactions including allergies and tightening of the muscles that line the airways in the lungs (bronchospasm).

Adults:

• depression:
  The recommended dose is 1 tablet (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 tablets (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 tablets (60 mg) daily
• obsessive compulsive disorder: The recommended dose is 1 tablet (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 3 tablets (60 mg) daily. If no improvement is noted within 10 weeks, your doctor will reconsider your treatment.

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.

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 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.

Elderly:

Your doctor will increase the dose with more caution and the daily dose should generally not exceed 2 tablets (40 mg). The maximum dose is 3 tablets (60 mg) daily.

Liver impairment:

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

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.

Take the pack of Olena tablets with you if you can.

Symptoms of an overdose include feeling sick, being sick, seizures, heart problems (like irregular heart beat and cardiac arrest), lung problems and change in mental condition ranging from excitation to coma.

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose then take the next dose at the usual time.

Taking your medicine at the same time each day may help you to remember to take it regularly.

Do not stop taking Olena tablets 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 tablets.

If you stop taking the tablets abruptly you may rarely develop dizziness, nausea/vomiting (feeling sick or being sick), tingling feelings like pins and needles, sleep disturbances (vivid dreams, nightmares, inability to sleep); feeling restless or agitated; unusual tiredness or weakness, tremor (shakiness), headache, and anxiety. In most cases, these symptoms are mild and short-lived. Talk to your doctor before you stop taking the tablets and follow their advice. Your doctor may reduce your dose gradually over one or two weeks- this should help reduce the chance of withdrawal effects.

• 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.

The most frequent side effects (very common: may affect more than 1 in 10 people) are insomnia, headache, diarrhoea, feeling sick (nausea) and fatigue.

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.
• bleeding from stomach
• excessively happy but may become angry or irritable

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 Olena tablets:

Common (may affect up to 1 in 10 people)

• 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
• disturbance in attention
• dizziness
• changes in taste
• blurred vision
• flushing
• yawning
• indigestion, vomiting
• dry mouth
• rash, urticaria, itching
• excessive sweating
• joint pain
• feeling shaky or chills
• unexplained vaginal bleeding
• passing urine more frequently
• uncontrollable shaking movements
• rapid and irregular heart beat sensations .

Uncommon (may affect up to 1 in 100 people)

• feeling detached from yourself
• strange thinking abnormally high mood
• sexual problems, including orgasm problems, occasionally persisting after treatment discontinuation
• thoughts of suicide or harming yourself
• teeth grinding
• muscle twitching, involuntary movements or problems with balance or co-ordination
• memory impairment
• enlarged (dilated) pupils
• low blood pressure
• shortness of breath
• nose bleeds
• gastrointestinal bleeding
• hair loss
• ringing in the ears
• increased tendency to bruising
• unexplained bruising or bleeding
• difficulty swallowing
• cold sweat
• difficulty passing urine
• feeling hot or cold
• abnormal liver function test results
• symptoms of tiredness, weakness, muscle pain, diarrhoea, loss of appetite, nausea or vomiting, trouble thinking clearly and seeing and hearing things that are not there. These could be signs of Syndrome of Inappropriate Antidiuretic Hormone Secretion.

Rare (may affect up to 1 in 1000 people)

• low levels of salt in the blood
• reduction in the number of white blood cells like neutrophils and leukocytes – report any signs of fever, tiredness as you may have an infection
• reduction in blood platelets, which increases risk of bleeding or bruising
• pain in abdomen indicating inflammation of liver (hepatitis) as well as nausea, vomiting, production of dark urine, yellowing of skin and whites of the eyes (jaundice)
• confusion
• stuttering
• aggressive behaviour
• fits
• agitation
• 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
• muscle pain
• problems urinating
• lung problems
• untypical wild behaviour
• hallucinations
• panic attacks
• vasculitis (inflammation of a blood vessel)
• sensitivity to sunlight
• producing breast milk

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

• Heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see Pregnancy 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 (aged 8 to 18 years) - in addition to the possible side effects listed above, this medicine 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 the Yellow Card Scheme 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.

• the active substance is fluoxetine 20mg. 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).

Olena tablets are white, oblong, convex tablets with a score-line on one side.

Olena tablets are available in the following pack sizes:

7, 10, 14, 20, 28, 30, 60, 70 and 100 dispersible tablets.

Not all pack sizes may be marketed.

Manufacturer: