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OLENA 20 MG CAPSULES

Active substance(s): FLUOXETINE HYDROCHLORIDE / FLUOXETINE HYDROCHLORIDE / FLUOXETINE HYDROCHLORIDE

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Package Leaflet: Information for the user

Olena® 20 mg capsules
Fluoxetine Hydrochloride
EIGHT IMPORTANT THINGS YOU NEED TO KNOW ABOUT
OLENA 20mg CAPSULES
Olena 20mg 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 20mg is not for use in children and adolescents under 18.
See section 2, Use in children and adolescents aged 8 to 18 years.
Olena 20mg 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 20mg without talking to your doctor. If
you stop taking Olena 20mg 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 capsules may make
these feelings worse. See section 4, Possible side effects.
Taking some other medicines with Olena 20mg 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 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 or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
What Is In This Leaflet:
1. What Olena 20mg capsules are and what they are used for
2. What you need to know before you take Olena 20mg capsules
3. How to take Olena 20mg Capsules
4. Possible side effects
5. How to store Olena 20mg Capsules
6. Content of the pack and other information
1. WHAT OLENA 20 MG CAPSULES ARE AND
WHAT THEY ARE USED FOR
Olena 20mg is one of a group of medicines called selective
serotonin re-uptake inhibitors (SSRI) antidepressants.
It is used to treat the following conditions:
• Major -depressive episodes
• Obsessive-compulsive disorder (also known as OCD)
• The eating disorder bulimia nervosa. Olena 20mg is 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.
How Olena 20mg Capsule 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 Olenaand 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 20MG CAPSULES
Do not take Olena 20mg capsules if you are:
• Allergic to Olena or any of the other ingredients listed in 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 known as irreversible, non-selective
monoamine oxidase inhibitors (MAOIs), since serious or even fatal
reactions can occur (e.g. iproniazid used to treat depression).
Treatment with Olena 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 20mg.
Olena has been prescribed for a long period and/or at a high
dose, a longer interval needs to be considered by your doctor.
• taking metoprolol (to treat heart failure) since there is an
increased risk of your heart beat becoming too slow.
Warnings and precautions
Talk to your doctor or pharmacist before taking Olena if any of the
following applies to you:
• heart problems
• 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
• mania now or in the past; if you have a manic episode, contact
your doctor immediately because Olena might need to be
discontinued
• history of bleeding disorders or appearance of bruises or
unusual bleeding
• ongoing treatment with medicines that thin the blood (see
‘Other medicines and Fluoxetine’)
• epilepsy or fits. If you have a fit (seizures) or experience an
increase in seizure frequency, contact your doctor immediately;
Olena might need to be discontinued
• ongoing ECT (electro-convulsive therapy)
• ongoing treatment with tamoxifen (used to treat breast cancer)
(see ‘Other medicines and Fluoxetine’)
• starting to feel restless and cannot sit or stand still (akathisia).
Increasing your dose of Olena may make this worse
• 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)
• 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)
• ongoing treatment with diuretics (water tablets), especially if
you are elderly
• glaucoma (increased pressure in the eye).

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 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 behaviour in adults aged
less than 25 years 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 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 worsen when patients
under 18 are taking Fluoxetine.
Olena should not be used in the treatment of children under the
age of 8 years.
Other medicines and Olena 20mg capsules
Tell your doctor or pharmacist if you are taking or have recently
taken any other medication.
Do not take Olena 20mg with:
• Certain irreversible, non-selective monoamine oxidase
inhibitors (MAOIs), some used to treat depression.
Irreversible, non-selective MAOIs must not be used with Olena
as serious or even fatal reactions (serotonin syndrome) can
occur (see section “Do not take Olena 20mg”). Treatment with
Olena should only be started at least 2 weeks after
discontinuation of an irreversible, non-selective MAOI (for
instance tranylcypromine). Do not take any irreversible, nonselective MAOIs for at least 5 weeks after you stop taking Olena
20mg Capsules. If Olena has 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 20mg may affect the way the following medicines work
(interaction):
• tamoxifen (used to treat breast cancer); because Olena 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 Olena 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 (for allergies); because taking this drug with
Olena may increase the risk of changes in the electrical activity
of the heart
• 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 20mg Capsule
• 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
Fluoxetine. 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 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 may alter the effect of these medicines on the
blood. If Olena 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 20mg Capsule
• 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 20mg Capsule
• 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 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 may possibly change the blood
levels of these medicines, your doctor may need to lower their
dose when administered with Olena 20mg Capsule.
Olena 20mg capsules with food and drink and alcohol
• You can take this medicine with or without food, whatever you
prefer
• You should avoid alcohol while you are taking this medicine as
it could make your depression worse.
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.

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200637/LF/274/02

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460 x 185 mm
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Black

Olena 20 mg Capsules
30 Capsules
Leaflet
200637
UK
Medreich
2
01/03/2017
PAT
PR 10130

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8 pt

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PAGE 1 OF 2

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 20mg capsules 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 20mg capsules.
When taken during pregnancy, particularly in the last 3 months of
pregnancy, medicines like Olena 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.
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 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 Fluoxetine.
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.
Breast-feeding
Olena 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
Psychotropic drugs such as Olena 20mg may affect your
judgment or co-ordination. Do not drive or use machinery until
you know how Olena affects you.
3. HOW TO TAKE OLENA 20MG CAPSULES
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure. 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 recommended dose is:
• Depression - The recommended dose is one capsule (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
capsules (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 capsules
(60 mg) daily.
• Obsessive-compulsive disorder: The recommended dose is
1 capsule (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
capsules (60 mg) daily. If no improvement is noted within 10
weeks, your doctor will reconsider your treatment.
Use in 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 (given as 2.5 ml of Fluoxetine oral
solution). After 1 to 2 weeks, your doctor may increase the dose
to 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 2 capsules (40 mg). The
maximum dose is 3 capsules (60 mg) daily.
Liver impairment:
If you have a liver problem or are using other medication that
might affect olena 20mg capsule, your doctor may decide to
prescribe a lower dose or tell you to use Olena every other day.
If you take more Olena Capsules 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 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 20mg Capsules
• 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 20mg capsules
• 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 effects) when
you stop taking Olena 20mg capsule: dizziness; tingling feelings
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 Fluoxetine, 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 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.
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
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 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 sides effects (very common side effects that
may affect more than 1 user in 10) 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:
Common (may affect up to 1 in 10 people)
• 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
• change 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 (may affect up to 1 in 100 people)
• feeling detached from yourself
• strange thinking
• abnormally high mood
• orgasm problems
• thoughts of suicide or harming yourself
• teeth grinding
• muscle twitching, involuntary movements or problems with
balance or co-ordination
• memory impairment
• enlarged (dilated) pupils
• ringing in the ears
• low blood pressure
• shortness of breath
• nose bleeds
• difficulty swallowing
• hair loss
• increased tendency to bruising
• unexplained bruising or bleeding
• cold sweat
• difficulty passing urine
• feeling hot or cold
• abnormal liver test results.
Rare (may affect up to 1 in 1,000 people)
• low levels of salt in the blood
• reduction in blood platelets, which increases risk of bleeding or
bruising
• reduction in white blood cell count
• untypical wild behaviour
• hallucinations
• agitation
• panic attacks
• confusion
• stuttering
• aggression
• 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
• hepatitis
• lung problems
• sensitivity to sunlight
• muscle pain
• problems urinating
• producing breast milk.
Bone fractures-An increased risk of bone fractures has been
observed in patients taking this type of medicines.
Most of these side effects are likely to disappear with continued
treatment.
In children and adolescents (8-18 years) – In addition to the
possible side effects listed above, Olena 20mg capsule 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 or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via Yellow Card Scheme, website:
www.mhra.gov.uk/yellowcard. By reporting side affects you can
help provide more information on the safety of this medicine
5. HOW TO STORE OLENA 20MG CAPSULES
Keep your capsules in the original package. Keep them out of the
sight and reach of children.
Do not take your capsules after the expiry date on the carton and
blister which is stated on the carton after EXP. The expiry date
refers to the last day of that month.
Do not throw away any medicine 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. FURTHER INFORMATION
What Olena 20mg 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
10,14,20,30,50,70,or 100 capsules.
Not all pack sizes may be marketed.
PL No.: 21880/0009, This leaflet was last revised in February 2017
Marketing Authorisation Holder and Manufacturer:
Medreich PLC
Warwick House,
Plane Tree Crescent,
Feltham TW13 7HF,
United Kingdom
Olena is a registered trademark of Mercury Pharma Group
Limited.
200637/LF/274/02

Version No:
Product Name:
Pack Size:
Component:
SKU:
Market:
Production Site:
Revision No.:
Revision Date:
Revised by:
CRF:

200637/LF/274/02

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

460 x 185 mm
N/A
N/A
N/A
N/A
Black

Olena 20 mg Capsules
30 Capsules
Leaflet
200637
UK
Medreich
2
01/03/2017
PAT
PR 10130

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

21/02/2017
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 .............................................................................
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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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