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Oxactin 20mg Capsules
Fluoxetine (as hydrochloride)

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
• This medicine has been prescribed for you 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.
• If you are a carer or are helping someone else to take their
capsules, please read this leaflet before you give the first
What is in this leaflet:
1. What Oxactin Capsules are and what they are used for
2. What you need to know before you take Oxactin Capsules
3. How to take Oxactin Capsules
4. Possible side effects
5. How to store Oxactin Capsules
6. Contents of the pack and other information
1. What Oxactin Capsules are and what they are used for
• Oxactin Capsules contain fluoxetine which is one of a group
of medicines called selective serotonin reuptake inhibitor
(SSRI) antidepressants.
Oxactin Capsules are used in the treatment of:
• Severe depression
• Anxiety disorders with compulsive thoughts or actions, which
means that you may have uncontrollable thoughts or carry
out repetitive actions. This condition is known as obsessive
compulsive disorder.
• Binge-eating (bulimia nervosa), alongside psychotherapy, in
order to avoid binge-eating and vomiting
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. Oxactin should be offered to a child or young
person with moderate to severe major depressive disorder
only in combination with psychological therapy.
2. What you need to know before you take Oxactin Capsules
Do not take Oxactin Capsules:
• If you are allergic to fluoxetine or any of the other ingredients
of this medicine (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.
• If you are taking other medicines used to treat depression,
known as irreversible non-selective monoamine oxidase
inhibitors (non-selective MAOI, for example: iproniazid) since
serious or even fatal reactions can occur. Treatment with
Oxactin should only be started 2 weeks after discontinuation
of irreversible non-selective MAOIs. Do not take these MAOIs
for at least 5 weeks after you stop taking Oxactin. If Oxactin
has 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, a medicine used for the treatment
of heart failure.
Warnings and precautions
Talk to your doctor or pharmacist before taking Oxactin Capsules
if any of the following applies to you:
- have epilepsy or fits (seizures) or experience an increase in
seizure frequency, contact your doctor immediately; Oxactin
might need to be discontinued.
- mania now or in the past; if you have a manic episode,
contact your doctor immediately, Oxactin might need to be
- 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).
- heart problems.
- weight loss.
- are taking diuretics (water tablets), especially if you are
- are having ECT (electro-convulsive therapy) treatment.
- have a history of bleeding disorders or you develop bruises
or unusual bleeding.
- are taking medicines that thin the blood (see taking other
- have glaucoma (increased pressure in the eye).
- are taking treatment with tamoxifen (used to treat breast
- start to feel restless and cannot sit or stand still (akathisia).
- start to experience 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,
Oxactin might need to be discontinued.
- have 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 this:
• if you have previously had thoughts of killing or harming
• 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 about harming or killing yourself at any
time, contact your doctor or go to a hospital straight away.
You may find it useful 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 that
your depression or anxiety disorder is getting worse, or if they
are worried about changes in your behaviour.
Children and adolescents aged 8 to 18 years
Patients younger than 18 have an increased risk of suicide
attempts, suicidal thoughts and hostility (mainly aggression,
oppositional behaviour and rage) if they are treated with
medicines from this therapeutic class (known as selective
serotonin reuptake inhibitors).Oxactin 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 fluoxetine on growth,
puberty, mental, emotional and behavioural development in this
age group is available. Despite this your doctor may prescribe
Oxactin Capsules to patients younger than 18 years for
moderate to severe major depressive episodes in combination
with psychological therapy because it is in the patients interest.
If your doctor has prescribed Oxactin Capsules to a patient who
is younger than 18 years, and you want to discuss this, you are

requested to contact your doctor. If one of the symptoms listed
above develops or worsens in patients younger than 18 years
while they are taking Oxactin Capsules, you are requested to
inform your doctor of this.
Oxactin should not be used in the treatment of children under
the age of 8 years.
Other medicines and Oxactin Capsules
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines (up to 5 weeks ago).
This includes medicines obtained without a prescription.
The effects of this medicine may change especially if you are
• Certain MAO-inhibitors (some used to treat depression). Nonselective MAO-inhibitors and MAO-inhibitors type A must not
be used with fluoxetine as serious or even fatal reactions
(serotonin syndrome) can occur (see section ‘Do not take
Oxactin Capsules). Treatment with Oxactin Capsules should
only be started at least 2 weeks after discontinuation of an
Irreversible MAOI (for instance tranylcypromine). However,
treatment with fluoxetine can be started the following
day after discontinuation of certain reversible MAOIs (for
instance moclobemide, linezolid, methylthioninium chloride
(methylene blue)). Some MAO-inhibitors type B (selegeline)
can be used with fluoxetine provided that your doctor
monitors you closely.
• Metoprolol (for the treatment of heart failure). Oxactin
Capsules increases the chances of side effects when taken
with metoprolol.
• Tamoxifen (used to treat breast cancer), because Oxactin
Capsules may change the blood levels of this drug and
a reduction of the effect of tamoxifen cannot be excluded,
your doctor may need to consider different antidepressant
• Mequitazine (used to treat allergies), increases the chances
of side effects (such as changes in heart beat) when taken
Oxactin Capsules.
• Phenytoin (for epilepsy). When taken with Oxactin, the
amount of phenytoin in the blood can change, which may
cause side effects. If necessary, the doctor will adjust the
dosage and check you regularly.
• Medicines that can increase the possibility of serotonin
syndrome, such as tramadol (a pain-killer), lithium (for
manic depressive disorders), tryptophan (for depression),
tryptans (medicines for migraine) and St. John’s wort
(Hypericum perforatum). Tryptans also increase the chance
of side effects. If you are taking any of these medicines your
doctor will keep a close eye on you.
• Certain drugs that are broken down by the same enzyme as
fluoxetine such as flecainide or encainide (for disturbance
of heart rhythm), carbamazepine (for epilepsy) and some
drugs for depression (the tricyclic antidepressants). The
doctor will begin with a low dosage of these drugs, or lower
the dosage of fluoxetine. This also applies if you have taken
Oxactin in the last 5 weeks.
• Medicines that may affect the heart’s rhythm, e.g. Class
IA and III antiarrhythmics, antipsychotics (e.g. fentiazine
derviatives, pimozide, haloperidol), tricyclic antidepressants,
certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin,
erythromycin IV, pentamidine), anti-malaria treatment
particularly halofantrine, certain antihistamines (astemizole,
• Warfarin, NSAID (pain killers) or other medicines which can
thin the blood (including clozapine, used to treat certain
mental disorders, and aspirin); Oxactin Capsules may
alter the effect of these medicines on the blood. If Oxactin
Capsules treatment is started or stopped when you are taking
warfarin, your doctor will need to perform certain tests.
• Cyproheptadine (used to treat allergies), reduces the
antidepressant effect of Oxactin Capsules.
• Diuretics (water tablets), carbamazepine and oxcarbazepine
(used to treat epilepsy) may decrease blood sodium levels
• Certain antidepressant medications (TCAs, other SSRIs,
phenothiazines, butyrophenones, mefloquine, chloroquine,
bupropion, tramadol) may increase risk of seizures.
• Flecainide or encainide (for heart problems), carbamazepine
(for epilepsy), tricyclic antidepressants (for example
imipramine, desipramine and amitriptyline); because
Oxactin Capsules may possibly change the blood levels of
these medicines, your doctor may need to lower their dose
when administered with Oxactin Capsules.
If you are having electro-convulsive therapy (electroshock
treatment), which can be used for the treatment of seizures
(fits), any seizure that you have may go on for longer than
normal. The doctor will monitor you more closely.
Oxactin Capsules with food, drink and alcohol
• You can take Oxactin with or without food, whatever you
• Oxactin does not increase the effect of alcohol. However, the
use of alcohol is not recommended during treatment with
Pregnancy, breast-feeding and fertility
Talk to your doctor as soon as possible if you’re pregnant, if you
might be pregnant, or if you are planning to become pregnant.
In babies whose mothers took fluoxetine 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 mothers who
took fluoxetine. You and your doctor may decide that it is better
for you to gradually stop taking Oxactin while you are pregnant.
However, depending on your circumstances, your doctor may
suggest that it is better for you to keep taking Oxactin.
Make sure your midwife and/or doctor know you are on Oxactin
20mg Capsules . When taken during pregnancy, particularly
in the last 3 months of pregnancy, medicines like Oxactin
20mg 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.
Fluoxetine passes into the breast-milk and can cause adverse
effects in babies. If you are breast-feeding your baby, you must
consider stopping breast-feeding. If you continue to breast-feed
your doctor will prescribe the lowest possible effective dose of
Oxactin. Ask your doctor or pharmacist for advice before taking
any medicine.
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
Oxactin 20mg Capsules can cause side effects which may
affect concentration and/or co-ordination. Do not drive or
operate machines until you are sure that Oxactin has no effect
on your ability to drive or use machines.
Oxactin Capsules contain lactose
If your doctor has told you that you do not tolerate certain
sugars, contact your doctor before you take this medicine.

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3. How to take Oxactin Capsules
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
The information below is only a guideline: Your doctor will tell
you what the correct dose for you is. Do not take more capsules
than your doctor tells you.
Swallow the capsules with a drink of water. Do not chew the
Adults and older people
The recommended dose is 1 capsule (20 mg) per day. After 3
to 4 weeks the doctor may increase the dosage if the effect is
not adequate. If required the dosage can be gradually increased
up to a maximum of 3 capsules (60mg) 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 medicines for depression. This is usual
because an improvement in depressive symptoms may not
occur after the first few weeks. Patients with depression should
be treated for at least 6 months.
Obsessive compulsive disorders
The recommended dose is 1 capsule (20 mg) per day. After
2 weeks the doctor may review and adjust your dosage.
If required, the dosage can be gradually increased up to a
maximum of 3 capsules (60mg) daily.
If the treatment has not had any effect after 10 weeks, the doctor
will reconsider your treatment.
Binge-eating (bulimia nervosa)
The recommended dosage is 60 mg (3 capsules per day).
Use in children and adolescents aged 8 to 18 years with
Treatment should be started and be supervised by a specialist.
The starting dose is 10mg/day. After 1 to 2 weeks, your doctor
may increase the dose to 20mg/day. The dose should be
increased carefully to ensure that you receive the lowest effective
dose. Lower weight children may need lower doses. Your doctor
will review the need for continuing treatment beyond 6 months,
and treatment will be reassessed if no improvement is seen.
Older people
For older people the recommended maximum dosage is 40
mg, and in exceptional cases 60 mg per day.
If you notice that Oxactin Capsules are too strong or not strong
enough, ask your doctor or pharmacist for advice
Liver impairment
If you have a liver problem or are using other medication that
might affect Oxactin, your doctor may decide to prescribe a
lower dose or tell you to use Oxactin every other day.
How long should/must you take Oxactin Capsules
Oxactin, and most other medicines for depression, do not work
immediately. You will only notice an effect after about 3 to 4
weeks. Your doctor will tell you how long you must take Oxactin
Capsules for.
If you take more Oxactin Capsules than you should
If you have taken too many capsules, you should tell your
doctor or go to your local hospital immediately. Take the pack
of Oxactin with you if you can.
The following symptoms may occur: nausea, vomiting, fits,
disturbances of the heart and blood vessels (ranging from an
irregular heart beat to cardiac arrest), disturbances in the action
of the lungs and changes in the central nervous system, varying
from agitation to coma.
If you forget to take Oxactin Capsules
If you have forgotten a dose, the effectiveness will usually be
maintained. Take the next capsule at the usual time. Do not
take a double dose to make up for a forgotten capsule. If you
are not sure, ask your doctor or pharmacist.
If you stop using Oxactin Capsules
Do not stop taking Oxactin 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.
Withdrawal symptoms often occur, especially if you stop
suddenly. These symptoms also depend on how much and
how long you have used Oxactin. The following symptoms
can occur: dizziness; sensory disturbances such as pins and
needles for no reason; insomnia, vivid dreams or other sleep
disturbances; weakness, irritability or anxiety; nausea and/
or vomiting; tremors and headache. These symptoms mostly
occur in the first few days after discontinuation of the treatment,
and are mild to moderate.
When stopping Oxactin, 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
• If you develop a rash/itching or allergic reaction such as
swollen lips/tongue/eyelids or difficulty breathing, stop taking
the capsules immediately and contact your doctor straight
• If you experience restlessness and cannot sit or stand still,
you may have something called ‘akathisia’; increasing your
dose of Oxactin may make these feelings worse. If you feel
like this, contact your doctor.
• If your skin starts to peel or blister or you develop a varied
skin reaction or redness, you should contact your doctor
immediately, although 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
• 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 Oxactin Capsules
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 weak, feeling hot or cold
• abnormal liver function 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 cells or neutrophils in the blood
• imbalance of the fluid and chemicals in the body
• untypical wild behaviour
• hallucinations
• agitation
• panic attacks
• confusion
• stuttering
• aggression
• fits
• interruptions to the heart rhythm
• 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
In children and adolescents (8-18 years) – In addition to
the possible side effects listed above, Oxactin Capsules 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
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 the Yellow Card
Scheme website By reporting
side effects you can help provide more information on the safety
of this medicine.
5. How to store Oxactin Capsules
Keep out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated
on the carton and on the blister strip after EXP. The expiry date
refers to the last day of the month.
Do not store above 30°C.
If you have any other questions please talk to your doctor or
If your doctor decides to stop treatment, return any left-over
capsules to a pharmacist. Only keep them if your doctor tells
you to.
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
6. Contents of the pack and other information
What Oxactin Capsules contain
- The active substance is fluoxetine (as hydrochloride). Each
hard capsule contains 20mg fluoxetine (as hydrochloride).
The other ingredients are:
Lactose monohydrate, microcrystalline cellulose (E460(i)),
magnesium stearate (E572) and crospovidone.
Each capsule shell contains gelatine, yellow and black iron
oxide (E172), indigo carmine (E132) and titanium dioxide
The printing ink contains shellac, black iron oxide (E172)
propylene glycol (E1520) and ammonium hydroxide (E527)
What Oxactin Capsules look like and contents of the pack
Oxactin 20mg Capsules are olive-coloured/green capsules
marked FLE 20.
The capsules are packed in blister packs.
A carton contains 10, 14, 20, 28, 30, 50, 60, 100, 200, 250,
500 or 1000 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Niche Generics Limited, 1 The Cam Centre, Wilbury Way,
Hitchin, Hertfordshire SG4 OTW, United Kingdom.
The Manufacturer is:
Niche Generics Limited, 151 Baldoyle Industrial Estate,
Baldoyle, Dublin 13, Ireland.
Distributed by:
Discovery Pharmaceuticals, The Old Vicarage, Market Place,
Castle Donington, Derbyshire DE 74 2JB UK
This leaflet was last revised in January 2017.


Irina 6.02.17

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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.