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OLENA 20MG DISPERSIBLE TABLETS

Active substance(s): FLUOXETINE HYDROCHLORIDE

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10
mm
10
mm

180mm

PATIENT INFORMATION LEAFLET
®

Olena 20 mg Dispersible Tablets
Fluoxetine
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 only. 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.
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

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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 body.
• 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 IV, 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.

Date of Approval:

PROOF

13

To be implemented by:

10/10/2013
Product Description:

Originated by

Date:

Olena 20mg Dispersible Tablets

ST

30/08/2012 No

Tech Approved

Component:

Revised by

Version:

Leaflet

SMT

102020/LF/1

Manufacturer:

File Name:

Deviation No.:

BTT

102020LF Olena 20mg Tabs v1_13 AMDEV-13-0127

Market:

Software Package:

Barcode:

UK

Quark Xpress 9

N/A

Minimum Font Size & Typeface:

Dimensions:

Pharma Code:

9pt Swiss 721BT

180 x 320mm

N/A

Colours: Black

Key Line:

M

Date:

10
mm

10
mm

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.

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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

Date of Approval:

PROOF

13

To be implemented by:

10/10/2013
Product Description:

Originated by

Date:

Olena 20mg Dispersible Tablets

ST

30/08/2012 No

Tech Approved

Component:

Revised by

Version:

Leaflet

SMT

102020/LF/1

Manufacturer:

File Name:

Deviation No.:

BTT

102020LF Olena 20mg Tabs v1_13 AMDEV-13-0127

Market:

Software Package:

Barcode:

UK

Quark Xpress 9

N/A

Minimum Font Size & Typeface:

Dimensions:

Pharma Code:

9pt Swiss 721BT

180 x 320mm

N/A

Colours: Black

Key Line:

M

Date:

Expand view ⇕

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.

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