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OLENA 20MG DISPERSIBLE TABLETS

Active substance(s): FLUOXETINE HYDROCHLORIDE / FLUOXETINE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET
®

Olena 20 mg Dispersible Tablets
Fluoxetine
Eight important things you need to know about Olena tablets
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.
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, pharmacist or
nurse.
- 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, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. See
section 4.
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 contain the active substance fluoxetine which is one of a
group of medicines called selective serotonin re-uptake inhibitors (SSRI)
antidepressants.
This medicine is used to treat the following conditions:
Adults:
• Major depressive episodes
• Obsessive-compulsive disorder
• Bulimia nervosa: Olena tablets 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
tablets should be offered to a child or young person with moderate to
severe major depressive disorder only in combination with
psychological therapy.
How Olena tablets works
Everyone has a substance called serotonin in their brain. People who
are depressed or have obsessive-compulsive disorder or bulimia
nervosa have lower levels of serotonin than others. It is not fully
understood how Olena tablets and other SSRIs work but they may help
by increasing the level of serotonin in the brain.
Treating these conditions is important to help you get better. If it’s not
treated, your condition may not go away and may become more
serious and more difficult to treat.
You may need to be treated for a few weeks or months to ensure that
you are free from symptoms.
2. What you need to know before you take Olena tablets
Do not take Olena tablets
• if you are allergic to fluoxetine or any of the other ingredients of
this medicine (listed in section 6)
• if you are taking monoamine oxidase inhibitors (MAOIs) like
iproniazid since serious or even fatal reactions can occur.
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.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Olena tablets:
• if you have a, liver or kidney disorder. Your doctor may decide you
need a lower dose
• if you are pregnant or planning to become pregnant (see
Pregnancy, breast-feeding and fertility section below)
• 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
• if you have a history of mental illness known as mania or
hypomania
• 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
• if you are having Electroconvulsive Therapy (ECT)
• if you are taking tamoxifen used for treatment of breast cancer
• if you are taking aspirin or warfarin, there is a high risk of sudden
bleeding or bruising of skin
• 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
o weight loss
o 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

o 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
o a mixture of all above signs especially if you have taken iproniazid
o 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)
o 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.
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.
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
Tell your doctor or pharmacist if you are taking or have recently taken
or might take any other medicines.
Do not take Olena tablets with:
• 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). 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 than 5 weeks may need to
be considered by your doctor
• 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):
- 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 check-ups 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
- 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 ibruprofen,
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.

102020/LF/164/03

Revision No.:
Revision Date:
Revised by:
CRF:

Olena 20mg
Dispersible Tabletss
28 Tablets
Leaflet
102020
UK
LABORATORIES BTT
(Substipharm)
2
23/08/2016
PAT
AMCo.CRF.352.2015

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Olena tablets with food, drink and alcohol
• You can take Olena tablets with or without food, whatever you prefer
• You should avoid alcohol while you are taking this medicine.
Pregnancy, breast-feeding and fertility
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. You and your doctor
may decide that it is better for you 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.
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.
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.
Olena tablets contain sucrose and sulphur dioxide
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

420mm

3. How to take Olena tablets
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure. Do not
take more tablets than your doctor tells you.
Swallow the tablet(s) with a half a glass of water or disperse the tablet(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.
The recommended dose isAdults:
• 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.
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 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.
Take the pack of Olena tablets with you if you can.
Signs 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.
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 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.
If you stop taking Olena tablets
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.
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 any further questions on the use of this medicine, ask your
doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects although not
everybody gets them.

Stop taking this medicine and talk to your doctor or go to a
hospital immediately if you experience any of the following:
• 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.
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
• flushing
• weight loss
• yawning
• nervousness, anxiety
• indigestion, vomiting
• restlessness, poor concentration • dry mouth
• feeling tense
• rash, urticaria, itching
• decreased sex drive or sexual • excessive sweating
problems (including difficulty
• joint pain
maintaining an erection for
• impotence
sexual activity)
• feeling shaky or chills
• sleep problems, unusual
• unexplained vaginal bleeding
dreams, tiredness or
• passing urine more frequently
sleepiness
• uncontrollable shaking
• dizziness
movements
• changes in taste
• rapid and irregular
• blurred vision
heart beat sensations.
Uncommon (may affect up to 1 in 100 people)
• feeling detached from yourself • nose bleeds
• strange thinking
• hair loss
• abnormally high mood
• ringing in the ears
• orgasm problems
• black coloured or tarry stools
• teeth grinding
indicating bleeding from stomach
• muscle twitching, involuntary • increased tendency to bruising
movements or problems with • unexplained bleeding or bruising,
balance or co-ordination
- due reduction in blood platelets
• memory loss, difficulty in
• difficulty swallowing
remembering
• cold sweat
• enlarged (dilated) pupils
• difficulty passing urine
• low blood pressure
• feeling hot or cold
• shortness of breath
• abnormal liver test results.
Rare (may affect up to 1 in 1000 people)
• reduction in the number of white• muscle pain
blood cells like neutrophils and • raised liver enzymes
leukocytes – report any signs of • lung problems
fever, tiredness as you may
• low levels of salt in the blood
have an infection
• untypical wild behaviour
• reduction in blood platelets,
• hallucinations
which increases risk of bleeding • panic attacks
or bruising
• vasculitis (inflammation
• pain in abdomen indicating
of a blood vessel)
inflammation of liver (hepatitis) • pain in the tube that takes
as well as nausea, vomiting,
food or water to your stomach
production of dark urine,
• sensitivity to sunlight
yellowing of skin and whites
• producing breast milk
of the eyes (jaundice)
• sore throat
• fits
• symptoms of tiredness,
• confusion
weakness, muscle pain,
• aggressive behaviour
diarrhoea, loss of appetite,
• agitation
nausea or vomiting, trouble
• rapid swelling of the tissues
thinking clearly and seeing
around the neck, face,
and hearing things that are
mouth and/or throat
not there. These could be signs
• problems urinating
of Syndrome of Inappropriate
• stammering or slurring
Antidiuretic Hormone Secretion.
while speaking
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. Suicide-related behaviours (suicide
attempt and suicidal thoughts), hostility, mania and 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 this medicine 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 this medicine after the expiry date stated on the carton. The
expiry date refers to the last day of that 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 tablets contain:
• 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).
What Olena tablets look like and the contents of the pack:
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.
Marketing Authorisation Holder:
Mercury Pharmaceuticals Ltd.,
Capital House, 85 King William Street, London EC4N 7BL, UK
Manufacturer:
Laboratoires BTT
ZI de Krafft, 67150 Erstein, France
This leaflet was last revised in August 2016.
Olena is a registered trademark of Mercury Pharma Group Limited.
102020/LF/164/03

Version No:
Product Name:

102020/LF/164/03

Revision No.:
Revision Date:
Revised by:
CRF:

Olena 20mg
Dispersible Tabletss
28 Tablets
Leaflet
102020
UK
LABORATORIES BTT
(Substipharm)
2
23/08/2016
PAT
AMCo.CRF.352.2015

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref:
DCMF:
Print Colours:

180 x 420 mm
N/A
N/A
N/A
N/A
Black

Pack Size:
Component:
SKU:
Market:
Production Site:

Non-Print Colours: Cutter
Tech App. Date:
Min. Font Size:

31/08/2016
8 pt

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, HPRA, etc ) and that Mercury Pharma have
license approval to distribute this component for
sale in the relevant market.

Accept Artwork / Reject Artwork
(Please strike off whichever NOT applicable)

Signature .......................................................................
Name .............................................................................
Date ...............................................................................

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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.

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