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Package Leaflet: Information for the patient

Olena 10, 30, 40 and 60 mg capsules
Fluoxetine hydrochloride
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
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
- 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
Fluoxetine belongs to a group of medicines called selective
serotonin reuptake inhibitor (SSRI) antidepressants. This
medicine is used to treat the following conditions:
- 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.
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
• 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
• 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
• 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
• 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
• you should avoid alcohol while you are taking this
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any
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
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.
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
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.
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
• 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:
By reporting side effects you can help provide more
information on the safety of this medicine.
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.
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.
Olena is a registered trademark of Mercury Pharma Group

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.