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Package Leaflet: Information for the user

Olena® 20 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 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 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
Read all of this leaflet carefully before you start
taking this medicine.
- 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 any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.What Olena 20 mg capsules are and what they are
used for
2.Before you take Olena 20 mg capsules
3.How to take Olena 20 mg capsules
4.Possible side effects
5.How to store Olena 20 mg capsules
6.Further information
Olena is one of a group of medicines called
selective serotonin re-uptake inhibitors (SSRI)
antidepresants. It is used to treat:
• Depression
• Obsessive-compulsive disorder (aslso known as
• The eating disorder bulimia nervosa.

• suffer from diabetes
• suffer from any other psychiatric disorders
• have a bleeding disorder (e.g haemophilia) or take
medicines than thin your blood or can affect how
your blood clots
• are receiving Electroconvulsive therapy (ECT)
• are taking St. Johns Wort, a herbal medicine for
• have a history of self-harm, suicidal thoughts or
attempted suicide. It can take 3 to 4 weeks before
your illness improves so you may still be at risk. If
you get these feelings when you are taking this
medicine you must contact your doctor
Taking other medicines
Tell your doctor or pharmacist if you are taking or
have recently taken any other medication, including
medicines obtained without a prescription.
Tell your doctor if you are taking:
• any type of Monoamine Oxidase Inhibitors
(MAOIs) used to treat depression.
• phenytoin used to treat epilepsy.
• medicines known as ‘Serotenergic drugs’ such as
tramadol or triptans.
• medicines used to treat depressive disorders such
as lithium and tryptophan.
• any other antidepressants e.g. flecainide, ecainide,
carbamazepine and tricyclic antidepressants.
• blood thinning medicines e.g. warfarin
• St John’s Wort, a herbal remedy used for depression
Taking Olena 20 mg capsules capsules with food
and drink
You should take this medicine with a drink of water
during or after meals. Although Olena does not
increase the effect of alcohol, the combination of this
type of medicine and alcohol is not advisable as it
could make your depression worse.
Pregnancy and breast-feeding
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 showing an increased risk of birth defects, in
particular those 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.
Make sure your midwife and/or doctor know you are on
Olena 20 mg capsules. When taken during pregnancy,
particularly in the last 3 months of pregnancy,
medicines like Olena 20 mg capsules may increase the
risk of a serious condition in babies, called persistent
pulmonary hypertension of the new born (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.
Driving and using machines
Caution should be taken because Olena may affect
your ability to drive or operate machines.



Do not take Olena 20 mg capsules if you:
• are allergic to fluoxetine or any of the other
ingredients listed in section 6. Symptoms of an
allergic reaction include rash, swollen face or lips,
itching or breathing difficulties.
• have taken any of the following medicines:
- irreversible MAOIs (also known as monoamine
oxidase inhibitors) in the last two weeks as
serious and sometimes fatal reactions can occur.
Example of MAOIs includes tranylcypromine,
phenelzine and isocarboxazid (used to treat
depression) or selegiline (used to treat
Parkinson’s disease)
- reversible MAOIs (also known as monoamine
oxidase inhibitors) within the last 24 hours e.g

Always take Olena 20 mg capsules exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure. The capsules are for
adults only and should be swallowed whole with a
glass of water.
• depression - The usual dose for depression is
one capsule (20 mg) per day for at least 6 months
• OCD: the usual dose for Obsessive Compulsive
Disorder is one capsule (20 mg) per day
• bulimia nervosa: the usual dose for bulimia
nervosa is three capsules (60 mg) per day.
For all conditions, your doctor may adjust your dose
depending on your response to the treatment.

Do not take any MAOIs at the same time as Olena.
You must wait at least 5 weeks after you stop taking
Olena before starting to take any MAOI.
If you think any of the above points apply to you, do
not take the capsules. Talk to your doctor first and
follow the advice given.
Take special care and tell your doctor if you:
• are less than 18 years of age
• suffer from or have history of seizures, fits or
• suffer from or have history of mania or hypomania
(very high or low moods)
• suffer from liver problems or heart disease

Dosage in the Elderly
Your doctor may prescribe a lower dose up to a
maximum of 60 mg (3 capsules) a day.
Dosage in patients with liver problems
Your doctor may prescribe a lower or less frequent
dose e.g. one capsule every other day.
Thoughts of harming or killing yourself
If you are depressed 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
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
If you have suicidal feeling or thoughts of harming
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.
Do not stop taking Olena 20 mg capsules until
you doctor tells you to
When stopping treatment your doctor will help you
reduce the dosage gradually over a period of at
least one to two weeks in order to reduce the risk of
withdrawal reactions.
Common withdrawal symptoms include dizziness,
pins and needles, trouble sleeping, intense dreams,
weakness, headache, agitation, anxiety, shaking,
being sick and nausea.
If you take more Olena 20 mg capsules than you
you must contact your doctor or nearest hospital
If you forget to take Olena 20 mg capsules
Do not take a double dose to make up for a
forgotten dose. Take the next dose at the normal
time and continue regular dosing.
Like all medicines, Olena 20 mg capsules can cause
side effects although not everybody gets them.
Serious Allergic Reactions
These reactions can include:
• itching, redness, rash or hives
• swelling of the face, lips, throat, hands or feet
• feeling generally unwell with rash, swollen or
painful joints, fever or swollen lymph gland ( this
could be a serum-sickness like reaction and could
take up to two weeks to appear).
Other Serious Side Effects
• a combination of symptoms such as unexplained
fever, breathing problems, excessive sweating,
muscle and joint pain, confusion, extreme
agitation and uncontrollable movement. These
symptoms could be a sign of serious conditions
such as serotonin syndrome or neuroleptic
malignant syndrome
• a read or raised rash followed by blistering or
peeling of the skin, mouth, eyes and genitals
• fever, feeling sick, being dick and abdominal pain.
This could be a sign of hepatitis
• suicidal feelings or thoughts of harming yourself.
If you get any of the above symptoms stop taking
the capsules and contact your doctor, pharmacist
or nearest hospital IMMEDIATELY.
Other side effects include:
• headache
• dizziness
• tiredness, drowsiness or yawning
• diarrhoea
• feeling sick or being sick
• low blood pressure causing dizziness when you
stand up
• indigestion
• loss of appetite
• hair loss
• difficulty swallowing
• changes in sense of taste
• dry mouth or sore throat
• difficulty breathing
• other lung problems
• euphoria
• very high or very low moods
• changes in your normal thought process e.g.
feeling detached from reality
• movement problems e.g. twitching, difficulty
walking or balancing, shaking or muscle spasms
• fits
• inability to sit still
• agitation or anxiety
• nervousness
• confusion
• hallucinations
• vision problems such as blurred vision or
abnormally large pupils
• problems sleeping or abnormal dreams
• sweating or flushing
• muscle or joint pain
• sensitivity to light
• chills
• difficulty concentrating
• panic attacks
• unusual bleeding or bruising
• low salt levels in the blood
• abnormal liver function test
• problems urinating or increased frequency of

• sexual problems such a delayed or absent
ejaculation, inability to orgasm, painful and
persistent erection, milk production without being
pregnant or breastfeeding.
An increased risk of bone fractures has been
observed in patients taking this type of medicines.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
If you stop taking Olena suddenly you may get
withdrawal symptoms such as dizziness, pins and
needles, problems sleeping, intense dreams,
weakness, agitation or anxiety, feeling sick of being
sick, shaking or headache. These symptoms are not
serious and will disappear.
Keep your capsules in the original package. Keep
them out of the reach and sight of children.
Do not take your capsules after the expiry date on
the carton and blister.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist hot to
dispose of medicines no longer required. These
measures will help protect the environment.
What Olena 20 mg capsules contain:
The active substance is fluoxetine hydrochloride.
The other ingredients is pre-gelatinised maize
starch. The gelatin capsules are coloured with E172,
E133 and E171. The black ink contains shellac and
Black iron Oxide.
What Olena 20 mg capsules look like and
contents of the pack
The capsules are coloured green and off-white and
are marked FLX/MIL. They are available as blister
pack containing 30 capsules.
PL No.: 21880/0009, Package insert leaflet was last
revised in May 2015.
Marketing Authorisation Holder and
Medreich PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK
Olena is a registered trademark of Mercury Pharma
Group Limited.

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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.