PROZAC 20MG HARD CAPSULES

Active substance: FLUOXETINE HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

therapy after 4-6 sessions. Prozac should be
offered to a child or young person with moderate
to severe major depressive disorder only in
combination with psychological therapy.
2. 
BEFORE YOU TAKE PROZAC HARD
CAPSULES
Do not take Prozac if you are:
•  llergic (hypersensitive) to fluoxetine or any of
a
the other ingredients of Prozac (see 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.
• aking other medicines known as nont
selective monoamine oxidase inhibitors or
reversible monoamine oxidase inhibitors
type A (MAOIs), since serious or even fatal
reactions can occur. Examples of such MAOIs
include medicines used to treat depression
such as nialamide, iproniazide, moclobemide,
phenelzine, tranylcypromine, isocarboxazid,
toloxatone and also linezolid (an antibiotic)
and methylthioninium chloride also called
methylene blue (used to treat high levels of
methaemoglobin in the blood).
Treatment with Prozac 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)).
Do not take any MAOIs for at least 5 weeks after you
stop taking Prozac. If Prozac has been prescribed for
a long period and/or at a high dose, a longer interval
needs to be considered by your doctor.
Take special care with Prozac
Tell your doctor if any of the following applies to you:
•  pilepsy or fits. If you have a fit (seizures) or
e
experience an increase in seizure frequency,
contact your doctor immediately; Prozac might
need to be discontinued;
•  ania now or in the past; if you have a manic
m
episode, contact your doctor immediately because
Prozac might need to be discontinued;
•  iabetes (your doctor may need to adjust your
d
dose of insulin or other antidiabetic treatment);
• iver problems (your doctor may need to adjust
l
your dosage);
• heart problems;
• ow resting heart-rate and/or if you know that
l
you may have salt depletion as a result of
prolonged severe diarrhoea and vomiting (being
sick) or usage of diuretics (water tablets);
• glaucoma (increased pressure in the eye);
•  ngoing treatment with diuretics (water tablets),
o
especially if you are elderly;
• ongoing ECT (electro-convulsive therapy);
•  istory of bleeding disorders or appearance of
h
bruises or unusual bleeding;
•  ngoing treatment with medicines that thin the
o
blood (see “Taking other medicines”);
•  ngoing treatment with tamoxifen (used to treat
o
breast cancer) (see “Taking other medicines”);
•  tarting to feel restless and cannot sit or stand
s
still (akathisia). Increasing your dose of Prozac
may make this worse;
•  ppearance of fever, muscle stiffness or tremor,
a
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 Prozac might
need to be discontinued.

PROZAC® 20 mg hard capsules

CODE LEATUS : —

RECTO / VERSO
EN ROULEAU / P. 1

DIMENSIONS
250 x 157,5 mm

Responsable: Mr FRANC Pascal
PATHEON France
40, boulevard de Champaret
CS 11006 – 38307 Bourgoin-Jallieu Cedex
tél.: 04 74 93  87 00 fax.: 04 74 93 87 81

Taille du texte mini : 8 pt

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Recto

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485

LAIZE
157,5 mm
RECTO

CODE ARTICLE
MU 2549

DESCRIPTIF TECHNIQUE DE L’ARTICLE
(Remplace 7058468)
NOTICE DOUBLE
(L05)
PROZAC 20 mg / gélules / Angleterre - Irlande
V1_09 MAR 2013

couleur(s) pantone
trames:
dans l’ordre prévu linéature: 150 lpi
inclinaison :
d’impression:

fluoxetine
EIGHT IMPORTANT THINGS YOU NEED TO KNOW
ABOUT PROZAC
Prozac 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.
Prozac is not for use In children and adolescents
under 18. See section 2, Use in children and
adolescents aged 8 to 18 years.
Prozac 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 Prozac hard 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 Prozac without talking to your
doctor. If you stop taking Prozac 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 Prozac may make these feelings worse. See
section 4, Possible side-effects.
Taking some other medicines with Prozac 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.
- Keep this leaflet. You may need to read it again.
-  you have any further questions, ask your
If
doctor or pharmacist.
- 
This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
-  any of the side effects gets serious, or if you
If
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. 
What Prozac hard capsules are and what they
are used for
2. Before you take Prozac hard capsules
3. How to take Prozac hard capsules
4. Possible side effects
5. How to store Prozac hard capsules
6. Further information
1. 
WHAT PROZAC HARD CAPSULES ARE IS
AND WHAT THEY ARE USED FOR
Prozac contains fluoxetine which is one of a group
of medicines called selective serotonin re-uptake
inhibitor (SSRI) antidepressants.
This medicine is used to treat the following conditions:
Adults:
• Major depressive episodes
• Obsessive-compulsive disorder
•  ulimia nervosa: Prozac is used alongside
B
psychotherapy for the reduction of binge-eating
and purging
Children and adolescents aged 8 years and above:
•  oderate to severe major depressive disorder, if
M
the depression does not respond to psychological

1

1

3

DÉFILEMENT

CODE ARTICLE
MU 2549

LAIZE
157,5 mm

DIMENSIONS
250 x 157,5 mm

RECTO / VERSO
EN ROULEAU / P. 2

DESCRIPTIF TECHNIQUE DE L’ARTICLE
(Remplace 7058468)
NOTICE DOUBLE
(L05)
PROZAC 20 mg / gélules / Angleterre - Irlande
V2_10 JAN 2013

Responsable: Mr FRANC Pascal
PATHEON France
40, boulevard de Champaret
CS 11006 – 38307 Bourgoin-Jallieu Cedex
tél.: 04 74 93  87 00 fax.: 04 74 93 87 81

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dans l’ordre prévu linéature: 150 lpi
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DÉFILEMENT

Verso

2

PLI / COLLE

• phenytoin (for epilepsy); because Prozac 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 Prozac.
• tramadol (a painkiller) or triptans (for
migraine); there is an increased risk of
hypertension (raised blood pressure).
•  edicines that may affect the heart’s rhythm,
m
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, mizolastine).
• flecainide or encainide (for heart problems),
carbamazepine (for epilepsy), tricyclic
antidepressants (for example imipramine,
desipramine and amitriptyline); because
Prozac may possibly change the blood levels of
these medicines, your doctor may need to lower
their dose when administered with Prozac.
• tamoxifen (used to treat breast cancer),
because Prozac 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
treatments.
•  arfarin, NSAID or other medicines which can
w
thin the blood (including clozapine, used to treat
certain mental disorders, and aspirin); Prozac
may alter the effect of these medicines on the
blood. If Prozac treatment is started or stopped
when you are taking warfarin, your doctor will
need to perform certain tests.
•  ou should not start to take the herbal remedy
Y
St John’s wort while you are being treated with
Prozac since this may result in an increase in side
effects. If you are already taking St John’s wort
when you start on Prozac, stop taking St John’s
wort and tell your doctor at your next visit.
Taking Prozac with food and drink
•  ou can take Prozac with or without food,
Y
whatever you prefer.
•  ou should avoid alcohol while you are taking
Y
this medicine.
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before
taking any 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.
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 Prozac while
you are pregnant. However, depending on your
circumstances, your doctor may suggest that it is
better for you to keep taking Prozac.
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

Thoughts of suicide and worsening of your
depression or anxiety disorder.
 you are depressed and/or have anxiety
If
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:
- f you have previously had thoughts about
I
killing or harming yourself.
- f you are a young adult. Information from
I
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.
 you have thoughts of harming or killing
If
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 sideeffects such as suicide attempt, suicidal thoughts
and hostility (predominantly aggression, oppositional
behaviour and anger) when they take this class of
medicines. Prozac 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 Prozac 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
Prozac 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 Prozac
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 Prozac.
Prozac should not be used in the treatment of
children under the age of 8 years.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines
(up to 5 weeks ago) including medicines obtained
without prescription.
Prozac may affect the way some other medicines
work (interaction), especially the following:
•  ertain monoamine oxidase inhibitors (MAOIs),
C
some used to treat depression. Non-selective
MAOIs and MAOIs type A must not be used with
Prozac as serious or even fatal reactions (serotonin
syndrome) can occur (see section “Do not take
Prozac”). Treatment with Prozac 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 MAOIs type B (selegeline) can
be used with Prozac provided that your doctor
monitors you closely.
• ithium, tryptophan; there is an increased risk
l
of serotonin syndrome when these drugs are
taken with Prozac. Your doctor will carry out
more frequent check-ups.

CODE LEATUS : —

DU NOIR

Recto

RECTO / VERSO
EN ROULEAU / P. 3

PLI / COLLE

Responsable: Mr FRANC Pascal
PATHEON France
40, boulevard de Champaret
CS 11006 – 38307 Bourgoin-Jallieu Cedex
tél.: 04 74 93  87 00 fax.: 04 74 93 87 81

LAIZE
157,5 mm

DIMENSIONS
250 x 157,5 mm

Noir

couleur(s) pantone
trames:
dans l’ordre prévu linéature: 150 lpi
inclinaison :
d’impression:

DESCRIPTIF TECHNIQUE DE L’ARTICLE
(Remplace 7058468)
NOTICE DOUBLE
(L05)
PROZAC 20 mg / gélules / Angleterre - Irlande
V1_09 MAR 2013
CODE ARTICLE
MU 2549

If you take more Prozac than you should
• f you take too many capsules, go to your nearest
I
hospital emergency department (or casualty) or
tell your doctor straight away.
• Take the pack of Prozac 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 Prozac
• f you miss a dose, do not worry. Take your next
I
dose the next day at the usual time. Do not take
a double dose to make up for a forgotten dose.
•  aking your medicine at the same time each day
T
may help you to remember to take it regularly.
If you stop taking Prozac
•  o not stop taking Prozac without asking your
D
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 Prozac: 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
Prozac are mild and disappear within a few weeks.
If you experience symptoms when you stop treatment,
contact your doctor.
When stopping Prozac, 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
Prozac, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Prozac can cause side effects,
although not everybody gets them.
• f you have thoughts of harming or killing yourself
I
at any time, contact your doctor or go to a
hospital straight away (see Section 2).
• f you get a rash or allergic reaction such as
I
itching, swollen lips/tongue or wheezing/shortness
of breath, stop taking the capsules straight
away and tell your doctor immediately.
• f you feel restless and cannot sit or stand still,
I
you may have akathisia; increasing your dose of
Prozac may make you feel worse. If you feel like
this, contact your doctor.
•  ell your doctor immediately if your skin starts
T
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:
•  combination of symptoms (known as “serotonin
a
syndrome”) including unexplained fever with
faster breathing or heart rate, sweating, muscle
stiffness or tremor, confusion, extreme agitation
or sleepiness (only rarely);
• eelings of weakness, drowsiness or confusion
f
mostly in elderly people and in (elderly) people
taking diuretics (water tablets);
• prolonged and painful erection;
• irritability and extreme agitation.
•  eart problems, such as fast or irregular
h
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 Prozac:
Very common (seen in more than 1 in every 10
patients)

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
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
Prozac may affect your judgment or co-ordination.
Do not drive or use machinery without advice from
your doctor or pharmacist.
3. HOW TO TAKE PROZAC HARD CAPSULES
Always take Prozac exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure. The instructions will
also be on the label on the pack. 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 usual dose is:
•  epression: The recommended dose is 1
D
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.
•  ulimia nervosa: The recommended dose is 3
B
capsules (60 mg) daily.
•  bsessive-compulsive disorder: The
O
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.
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 Prozac oral liquid). 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 Prozac, your doctor may
decide to prescribe a lower dose or tell you to use
Prozac every other day.

3

DÉFILEMENT

sens lecture
code laetus

CODE ARTICLE
MU 2549

LAIZE
157,5 mm

DIMENSIONS
250 x 157,5 mm

DESCRIPTIF TECHNIQUE DE L’ARTICLE
(Remplace 7058468)
NOTICE DOUBLE
(L05)
PROZAC 20 mg / gélules / Angleterre - Irlande
V1_09 MAR 2013

Responsable: Mr FRANC Pascal
PATHEON France
40, boulevard de Champaret
CS 11006 – 38307 Bourgoin-Jallieu Cedex
tél.: 04 74 93  87 00 fax.: 04 74 93 87 81

DU NOIR

couleur(s) pantone
trames:
dans l’ordre prévu linéature: 150 lpi
inclinaison :
d’impression:

Noir

CODE LEATUS : —

DÉFILEMENT

RECTO / VERSO
EN ROULEAU / P. 4

4

Verso

Bone fractures – an increased risk of bone
fractures has been observed in patients taking this
type of medicines.
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 (8-18 years) – In
addition to the possible side effects listed above,
Prozac may slow growth or possibly delay sexual
maturity. Nose bleeds were also commonly reported
in children.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5. HOW TO STORE PROZAC HARD CAPSULES
Keep out of the reach and sight of children.
Do not take Prozac after the expiry date (EXP)
which is stated on the pack. The expiry date refers
to the last day of that month.
Do not store your capsules above 30°C.
If you have any other questions please talk to your
doctor or pharmacist.
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. FURTHER INFORMATION
What Prozac hard capsules contains
The active substance is fluoxetine hydrochloride.
Each capsule contains fluoxetine hydrochloride
equivalent to 20 milligram (mg) of fluoxetine.
Other ingredients are: maize starch flowable and
dimeticone.
The capsule shell is made of gelatin, patent
blue V (E131), yellow iron oxide (E172), titanium
dioxide (E171) and black edible printing ink, which
contains shellac, black iron oxide (E172), propylene
glycol and may contain ammonium hydroxide and
potassium hydroxide.
What Prozac hard capsules looks like and
contents of the pack
Prozac is a hard capsule.
The capsules are yellow and green, and marked
‘Lilly 3105’ The capsules are available in PVC/
.
aluminium blister packs of 2, 7, 12, 14, 20, 28, 30,
50, 56, 70, 98, 100 and 500. Not all pack sizes may
be marketed.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is Eli Lilly and
Company Limited, Lilly House, Priestley Road,
Basingstoke, Hampshire, RG24 9NL, U.K.
The manufacturer is Patheon France, 40, boulevard
de Champaret, 38300 Bourgoin-Jallieu, France.
The leaflet was last approved in March 2013.
Detailed information on this medicine is available on
the Medicine and Healthcare products Regulatory
Agency (MHRA) web site: http://www.mhra.gov.uk/
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Austria: Fluctine
Belgium: Prozac, Fontex
Czech Republic: Prozac
France: Prozac
Greece: Ladose
Ireland: Prozac
Italy: Prozac
Luxembourg: Prozac, Fontex
Malta: Prozac
Portugal: Prozac
Spain: Prozac
Slovenia: Prozac
United Kingdom: Prozac

- 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
- 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 (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
- memory impairment
- lung problems
- hepatitis, abnormal liver function test results
- muscle pain
- problems urinating
- confusion
- stuttering
- nose bleeds
- ringing in the ears
- unexplained bruising or bleeding

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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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