Olena 30 Mg Capsules
e
MercuryPharma
Package Leaflet: Information for the patient
Olena® 10, 30, 40 and 60 mg capsules
Fluoxetine hydrochloride
EIGHT IMPORTANT THINGS YOU NEED TO KNOW ABOUT OLENA
Olena 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 is not for use In children and adolescents under 18.
See section 2, Use in children and adolescents aged 8 to 18 years.
Olena 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 hard capsules.
Some people who are depressed or anxious think of harming or killing themselves. If you start to feel worse, or think of harming or killing yourself, see your doctor or go to a hospital straight away. See section 2.
Don’t stop taking Olena without talking to your doctor. If you stop taking Olena 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 may make these feelings worse. See section 4, Possible side-effects.
Taking some other medicines with Olena can cause problems. You may need to talk to your doctor. See section 2, Taking other medicines.
If you are pregnant or planning to get pregnant, talk to your doctor. See section 2, Pregnancy and breastfeeding. Read all of this leaflet carefully before you start taking 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 or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Olena capsules are and what they are used for
2. What you need to know before you take Olena capsules
3. How to take Olena capsules
4. Possible side effects
5. How to store Olena capsules
6. Contents of the pack and other information
1. WHAT OLENA CAPSULES ARE AND WHAT THEY ARE USED FOR
Fluoxetine belongs to a group of medicines called selective
serotonin reuptake inhibitor (SSRI) antidepressants. This
medicine is used to treat the following conditions:
Adults:
- major depressive episodes
- obsessive-compulsive disorder (OCD)
- the eating disorder bulimia nervosa: Olena are 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. Olena 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 OLENA CAPSULES
Do not take Olena 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 other medicines used to treat depression, known as non-selective monoamino oxidase inhibitor or reversible monoamine oxidase inhibitors type A (MAOIs), since serious or even fatal reactions can occur. Examples of MAOIs include 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 Olena should only be started at least 2 weeks after discontinuation of an irreversible MAOI (for instance tranylcypromine). However, treatment with Olena can be started the following day after discontinuation of certain reversible MAOIs (for instance moclobemide, linezolid, methylthioninium chloride (methylene blue)).
Do not take any MAOIs for at least 5 weeks after you stop taking Olena. If Olena have been prescribed for a long period and/or at a high dose, a longer interval needs to be considered by your doctor.
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 Olena 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 to your doctor or pharmacist, you might want to ask them to give you written instructions based on the sizes and marking of the capsule shells.
Warnings and precautions
Talk to your doctor or pharmacist before taking Olena if any of the following applies to you:
• epilepsy and fits. If you have a fit (seizures) or experience an increase in the seizure frequency, contact your doctor; immediately; Olena might need to be discontinued;
• mania (overactive behaviour or thoughts) now or in the past; if you have a maniac episode, contact your doctor immediately because Olena 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 depletation as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets);
• glaucoma (increase pressure in the eye);
• ongoing treatment with diuretics (water tablets), especially if you are elderly;
• ongoing ECT (electro-convulsive therapy);
• history of bleeding disorders or appearance of bruises or unusual bleeding;
• ongoing treatment with medicines that thin the blood (see “Other medicines and Olena capsules”);
• ongoing treatment with tamoxifen (used to treat breast cancer);
• starting to feel restless and cannot sit or stand still (akathisia). Increasing your dose of Olena 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 Olena might need to be discontinued.
Thoughts of suicide and worsening of you 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 behaviours in adults aged less than 25 year 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. Olena 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 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 Olena 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 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 worse when patients under 18 are taking Olena. Olena should not be used in treatment of children under the age of 8 years.
Other medicines and Olena capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Olena may affect the way some other medicines work (interaction), especially the following:
• certain monoamine oxidase inhibitors (MAOIs, some used to treat depression). Non-selective MAOIs and MAOIs type A must not be used with Olena as serious or even fatal reactions (serotonin syndrome) can occur (see section “Do not take Olena”). Treatment with Olena should only be started at least 2 weeks after discontinuation of an irreversible MAOI (for instance tranylcypromine). However, treatment with Olena 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 provided that your doctor monitors you closely.
• lithium, tryptophan; there is an increased of serotonin syndrome when these drugs are taken with Olena. Your doctor will carry out more frequent check-ups.
• phenytoin (for epilepsy); because Olena 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 Olena.
• tramadol (a painkiller) or triptans (for migraine); there is an increased risk of hypertension (raised blood pressure).
• medicines that may affect the heart's rhythm e.g. Class IA and III antiarrhythmics, antipsychotics (e.g. fentiazine derivatives, pimozide, haloperidol), Tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine), anti-malaria treatment particularly halofantrine, certain antihistamines (astemizole, mizolastine).
• flecainide or encainide (for heart problems), carbamazepine (for epilepsy), tricyclic antidepressants (for example imipramine, desipramine and amitriptyline); because Olena may possibly change the blood levels of these medicines, your doctor may need to lower their dose when administered with Olena.
• tamoxifen (used to treat breast cancer), because Olena may change the blood levels of this drug and a reduction of the effects of tamoxifen cannot be excluded, your doctor may need to consider different antidepressant treatments.
• warfarin, NSAID or other medicines which can thin the blood (including clozapine, used to treat certain mental disorders, and aspirin); Olena may alter the effect of these medicines on the blood. If Olena 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 Olena since this may result in an increase in side effects. If you are already taking St John’s wort when you start on Olena, stop taking St John's wort and tell your doctor and your next visit.
Taking Olena with food and drink
• you can take Olena with or without food, whatever you prefer.
• you should avoid alcohol while you are taking this medicine.
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any 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 Olena during the first few months of pregnancy, there have been some reports suggesting an increased risk of birth 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 Olena.
You and your doctor may decide that it is better for you to gradually stop taking Olena while you are pregnant. However, depending on your circumstances, your doctor may suggest that it is better for you to keep taking Olena.
When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Olena 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 effect 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 Olena.
Fertility: Olena have 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
Olena may affect your judgment or co-ordination. Do not drive or use machinery without advice from your doctor or pharmacist.
3. HOW TO TAKE OLENA CAPSULES
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The instruction will also be on the label on the pack. Do not take more capsules than your doctor tells you. Swallow the capsules with a drink of water. Do not chew the capsules.
Adults:
The usual dose is:
• Depression: The recommended dose is 20 mg daily. Your doctor will review and adjust your dosage is 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 a daily.
• Obsessive compulsive disorder: the recommended dose is 20 mg a 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.
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/day. After 1 to 2 weeks your doctor may increase the dose 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 Olena, your doctor may decide to prescribe a lower dose or tell you to use Olena capsules every other day.
If you take more Olena 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 Olena 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 Olena
• 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 Olena
• do not stop taking Olena 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 effect) when you stop taking Olena: dizziness; tingling feeling 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 Olena are mild and disappear within a few weeks. If you experience symptoms when you stop treatment, contact your doctor.
When stopping Olena, 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 Olena capsules, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everyone 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 breathe, 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 Olena may make your 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 patient
taking Olena:
Very common (seen in more than 1in every 10 patients)
• insomnia
• headache
• diarrhea, feeling sick (nausea)
• fatigue
Common (seen in 1 to 10 in every 100 patients)
• not feeling hungry, weight loss
• restlessness, poor concentration
• dizziness
• uncontrollable shaking movements
• yawning
• excessive sweating
• dry mouth
• passing urine more frequently
• feeling shaky or chills
• flushing
• rapid and irregular heartbeat sensations
• nervousness, anxiety
• feeling tense
• change in taste
• blurred vision
• rash, urticaria, itching
• joint pain
• indigestion, vomiting
• unexplained vaginal bleeding
• Sleep problems, unusual dreams, tiredness or sleepiness
• decreased sex drive or sexual problems (including difficulty maintaining an erection for sexual activity)
Uncommon (seen in 1 to 10 in every 1,000 patients)
• feeling detached from yourself
• abnormally high mood
• teeth grinding
• low blood pressure
• difficulty swallowing
• increased tendency to bruising
• difficulty passing urine
• strange thinking
• orgasm problems
• enlarged (dilated) pupils
• shortness of breath
• hair loss
• cold sweat
• feeling hot or cold
• muscle twitching, involuntary movements or problems with balance or co-ordination
Rare (seen in 1 to 10 in every 10,000 patients)
• low levels of salt in the blood
• hallucinations
• panic attacks
• widening of blood vessels
• producing breast milk
• raised prolactin levels in the blood
• unusual bleeding or bruising
• untypical wild behaviour
• agitation
• fits (epileptic)
• sensitivity to sunlight
• difficulty in passing urine
• 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 and water to your stomach
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
• problems urinating
• stuttering
• ringing in the ears
• unexplained bruising or bleeding
• muscle pain
• confusion
• nose bleeds
• gastrointestinal bleeding
• prolonged painful erection
• hepatitis, abnormal liver function test results
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 8-18 years) - In addition to the possible side effects listed above, Olena 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. Website: 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 CAPSULES
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) which is stated on the pack. The expiry date refers to the last day of the 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 Olena capsules contain:
• the active substance is fluoxetine hydrochloride. Each capsule contains fluoxetine hydrochloride equivalent to 10, 30, 40 or 60 mg of fluoxetine
• the other ingredients are pregelatinised starch. The capsule shell is made of gelatin, patent blue V (E131), yellow iron oxide (E172) titanium dioxide (E171); the 10 mg capsules shell also contains sodium lauryl sulfate.
What Olena capsules look like and the contents of the pack:
Olena capsules are hard gelatin capsules.
The 10 mg capsules have an off-white opaque body marked ‘F10’ and a dark green opaque marked ‘F 10’ containing a white to off-white powder.
The 30 mg capsules have an off-white opaque body marked ‘F30’ and a dark green opaque marked ‘F 30’ containing a white to off-white powder.
The 40 mg capsules have an off-white opaque body marked ‘F40’ and a dark green opaque marked ‘F 40’ containing a white to off-white powder.
The 60 mg capsules have an off-white opaque body marked ‘F60’ and a dark green opaque marked ‘F 60’ containing a white to off-white powder.
Olena capsules are available in aluminium/PVC blister packs of 30 capsules
This leaflet was last revised in June 2015.
PL 21880/0153-0156
Marketing Authorisation Holder and Manufacturer:
Medreich PLC, Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK.
E-mail: info@medreich.co.uk
Olena is a registered trademark of Mercury Pharma Group Limited.
200636-38-39-40/LF/274/01