CIPRAMIL 40 MG/ML ORAL DROPS SOLUTION

Active substance: CITALOPRAM

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• For females, failing to reach an orgasm
• Tiredness
• Prickling of the skin
• Loss of weight
Uncommon (likely to affect up to 1 in every
100 people)
• Bruising easily
• Increased appetite
• Aggression
• Reduced emotions, indifference
• Hallucinations
• Mania
• Fainting
• Large pupils (the dark centre of the
eye)
• Fast heart beat
• Slow heart beat
• Nettle rash
• Loss of hair
• Rash
• Sensitivity to sunlight
• Difficulties urinating
• Vaginal bleeding
• Swelling of the arms or legs
• Increased weight
Rare (likely to affect up to 1 in every 1000
people)
• Convulsions
• Involuntary movements
• Taste disturbances
• Bleeding
• Hepatitis
Some patient have reported (frequency not
known)
• Thoughts of harming or killing
themselves
• An increase in bleeding or bruising
caused by a decrease in blood platelets
• Rash (hypersensitivity)
• Low potassium levels in the blood
(hypokalaemia), which can cause
muscle
weakness,
twitching
or
abnormal heart rhythms
• Panic attack
• Grinding teeth
• Restlessness
• Unusual muscle movements or stiffness
• Involuntary movements of the muscles
(akathisia)
• Low blood pressure
• Nosebleed
• Bleeding disorders including skin and
mucosal bleeding (ecchymosis)
• Sudden swelling of skin or mucosa
• In men, painful erections
• Flow of breast milk in men or in women
who
are
not
breast-feeding
(galactorrhoea)
• Abnormal liver function tests
• An increased risk of bone fractures has
been observed in patients taking this
type of medicines

6. Further information

CIPRAMIL®

What Cipramil Drops contain
The active substance in Cipramil drops is
citalopram.
Each ml contains 40 mg citalopram (as
hydrochloride). The other ingredients are
purified
water,
ethanol,
hydroxyethylcellulose 300, E218 (methyl
parahydroxybenzoate) and E216 (propyl
parahydroxybenzoate).

40 MG/ML ORAL DROPS, SOLUTION

T03310

citalopram (as hydrochloride)
Patient Information Leaflet

The name of the medicine is Cipramil
40mg/ml oral drops, solution but will be
referred to as Cipramil throughout the
following.

What Cipramil Drops look like and
contents of the pack
Cipramil drops are a colourless solution and
are supplied in glass bottles containing
15 ml

Read all of this leaflet carefully before
you start taking this medicine
• Keep this leaflet. You may need to read
it again.
• If you have further questions, please
ask your 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.
• If any of the side effects are troubling, or
if you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.

Manufacturer and Product Licence
Holder
Cipramil is manufactured by H. Lundbeck
A/S, Copenhagen, Valby, Denmark. It is
procured from within the EU by the Product
Licence Holder: Swinghope Limited,
Brandon House, Marlowe Way, Croydon
CR0 4XS and repackaged by Interport
Limited, Brandon House, Marlowe Way,
Croydon CR0 4XS.

In this leaflet:
1. What Cipramil is and what it is used
for
2. Before you take Cipramil Drops
3. How to take Cipramil Drops
4. Possible side effects
5. How to store Cipramil Drops
6. Further information

POM
PL No: 10380/1434
Leaflet revision date: 10/07/12

1. What Cipramil is and what it is used
for
How does Cipramil work?
Cipramil is a Selective Serotonin Reuptake
Inhibitor (SSRI) and belongs to a group of
medicines known as antidepressants.
These medicines help to correct certain
chemical imbalances in the brain that are
causing the symptoms of your illness.
What is Cipramil used for?
Cipramil contains citalopram and is used for
the treatment of depression and, when you
feel better, to help prevent these symptoms
recurring.
Cipramil is also used for long-term treatment
to prevent the occurrence of new episodes
of depression or if you have recurrent
depression.
Cipramil is also beneficial in relieving
symptoms if you tend to suffer from panic
attacks.

2. Before you take Cipramil drops
Do not take Cipramil Drops
• If you are allergic (hypersensitive) to
citalopram, or any of the other
ingredients of Cipramil Drops (see
What Cipramil Drops contain, section
6). Consult your doctor if you think you
might be.
• If you are also taking a medicine
containing pimozide. Talk to your
doctor.
• At the same time as taking medication
known
as
monoamine
oxidase
inhibitors (MAOIs). MAOIs include
medicines
such
as
phenelzine,
iproniazid, isocarboxazid, nialamide,
tranylcypromine and moclobemide
(used for the treatment of depression),
selegiline (used in the treatment of
Parkinson’s disease) and linezolid (an
antibiotic). Even if you have finished
taking one of the following MAOIs:
phenelzine, iproniazid, isocarboxazid,
nialamide or tranylcypromine you will
need to wait 2 weeks before you start
taking Cipramil. One day must elapse
after you have finished taking
moclobemide. After stopping Cipramil
you must allow 1 week before taking
any MAOI.
• If you are born with or have had an
episode of abnormal heart rhythm (seen
at ECG; an examination to evaluate
how the heart is functioning)
• If you take medicines for heart rhythm
problems or that may affect the heart’s
rhythm. (see Taking other medicines,
below).

SSRIs can, very rarely, increase the risk of
bleeding, including stomach or intestinal
bleeding. Let your doctor know if you vomit
blood or develop black or blood stained
stools.
Also let your doctor know if you continue to
have other symptoms associated with your
depression.
This
might
include
hallucinations, anxiety, mania or confusion.
Any side effects that do occur will usually
disappear after a few days. If they are
troublesome or persistent, or if you develop
any other unusual side effects while taking
Cipramil, please tell your doctor.
If you notice any other side effects not
mentioned in this leaflet please tell your
doctor or pharmacist.

5. How to store Cipramil drops

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• Always keep medicines out of the sight
and reach of children.
• After breaking the seal for the first time,
the drops can be used for 16 weeks if
stored below 25°C.
• There is an expiry date on the label. Do
not use the medicine after this date.
• 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.

Take special care with Cipramil
Please tell your doctor if you have any
medical problems, especially if you have:
• Liver disease
• Kidney disease
• Diabetes (you may need an adjustment
of your antidiabetic therapy)
• Epilepsy or a history of seizures or fits
• A bleeding disorder or have ever
suffered from bleeding in the stomach
or intestine
• Mania or panic disorder
• Low blood levels of sodium
• ECT (electroconvulsive therapy)
• Problems with your eyes, such as
certain kinds of glaucoma
• Suffered or suffer from heart problems
or have recently had a heart attack.
• A low resting heart-rate and/or 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).
• Experienced a fast or irregular
heartbeat,
fainting,
collapse
or
dizziness on standing up which may
indicate abnormal functioning of the
heart rate.
Please consult your doctor, even if these
statements were applicable to you at any
time in the past.
Some patients with manic-depressive illness
may enter into a manic phase. This is
characterized by unusual and rapidly
changing ideas, inappropriate happiness
and excessive physical activity. If you
experience this, contact your doctor.
Symptoms such as restlessness or difficulty
in sitting or standing still can also occur
during the first weeks of the treatment. Tell
your doctor immediately if you experience
these symptoms.
Special information relating to your
disease
As with other medicines used to treat
depression or related diseases, the
improvement is not achieved immediately.
After the start of Cipramil treatment it may
take several weeks before you experience
any improvement. In the beginning of the
treatment certain patients may experience
increased anxiety, which will disappear
during continued treatment. Therefore, it is
very important that you follow exactly your
doctor’s orders and do not stop the
treatment or change the dose without
consulting your doctor.
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.

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Taking other medicines
Medicines may affect the action of other
medicines and this can sometimes cause
serious adverse reactions.
Please tell your doctor if you are taking or
have taken any other medicines (including
those purchased without prescription)
during the last 14 days. This includes other
medicines for depression (see Do not take
Cipramil Drops above).
• The herbal remedy St John's Wort
(Hypericum perforatum). This should
not be taken at the same time as
Cipramil.
• Monoamine oxidase inhibitors (MAOIs).
These should not be taken at the same
time as Cipramil (see Do not take
Cipramil Drops above).
Tell your doctor if you are taking any of the
following medicines:
• Linezolid (an antibiotic).
• Sumatriptan (used to treat migraine) or
tramadol (a pain killer). If you feel
unwell when using these medicines
with Cipramil you should see your
doctor.
• Lithium (used to prevent and treat
mania)
and
tryptophan
(an
anti-depressant)
• Pimozide (a neuroleptic). This should
not be taken at the same time as
Cipramil (see Do not take Cipramil
Drops above).
• Imipramine and desipramine (used to
treat depression).
• Medicines containing selegiline (used to
treat Parkinson’s disease)
• Cimetidine (used to treat stomach
ulcers).
• Mefloquine (used to treat malaria).
• Bupropion (used to treat depression).
• Medicines known to affect the blood
platelets (e.g. anticoagulant drugs used
to treat or prevent blood clots; aspirin
and non-steroidal anti-inflammatory
drugs (NSAIDs) such as ibuprofen and
diclofenac used as painkillers and some
antipsychotic drugs and tricyclic
antidepressants).
• Metoprolol, a beta blocker used to treat
migraine, some heart conditions and
high blood pressure. The effects of
either drug could be increased,
decreased or altered.
• Neuroleptics (used in the treatment of
schizophrenia).
Do not take Cipramil if you take medicines
for heart rhythm problems or medicines that
may affect the heart’s rhythm, e.g. such as
Class
IA
and
III
antiarrhythmics,
antipsychotics (e.g. fentiazine derivatives,
pimozide,
haloperidol),
tricyclic
antidepressants,
certain
antimicrobial
agents (e.g. sparfloxacin, moxifloxacin,
erythromycin IV, pentamidine, anti-malarial
treatment particularly halofantrine), certain
antihistamines (astemizole, mizolastine). If
you have any further questions about this
you should speak to your doctor.
Taking Cipramil with food and drink
Cipramil can be taken with or without food
(see section 3 “How to take Cipramil
Drops”).

Children and adolescents (< 18 years)
Cipramil should not be given to children or
adolescents under 18 years of age.

As with all antidepressants, it is sensible to
avoid drinking alcohol whilst receiving
treatment although Cipramil has not been
shown to increase the effects of alcohol.

For further information, please see section
2, Before you take Cipramil Drops.

Pregnancy
Ask your doctor or pharmacist for advice
before taking any medicine. If you are
pregnant, think you might be pregnant, or
are trying to become pregnant, tell your
doctor. Do not take Cipramil if you are
pregnant unless you and your doctor have
discussed the risks and benefits involved.

Patients with special risks
Patients with liver complaints should not
receive more than 16 mg (8 drops) per day.
If you have previously taken Cipramil
tablets, you will find that the dose of your
medicine in mg given as drops is a bit lower
than that of tablets. This is because your
body more easily absorbs the drops than the
tablets, so you do not need as many mg to
have the same effect.

Make sure your midwife and/or doctor know
you are on Cipramil. When taken during
pregnancy, particularly in the last 3 months
of pregnancy, medicines like Cipramil 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. Also, if you take Cipramil
during the last 3 months of your pregnancy
and until the date of birth you should be
aware that the following effects may be seen
in your newborn: fits, being too hot or cold,
feeding difficulties, vomiting, low blood
sugar, stiff or floppy muscles, overactive
reflexes, tremor, jitteriness, irritability,
lethargy, constant crying, sleepiness or
sleeping difficulties. If your newborn baby
gets any of these symptoms please contact
your midwife and/or doctor immediately.

The doses of tablets correspond to doses of
drops as follows:
Tablets
10 mg
20 mg
30 mg
40 mg

Drops
8 mg (4 drops)
16 mg (8 drops)
24 mg (12 drops)
32 mg (16 drops)

How and when to take Cipramil
The drops are for oral use and can be taken
in a drink of water, or orange or apple juice.
Cipramil is taken every day as one dose at
any time of the day.
Duration of treatment
Like other medicines for depression and
panic disorder these drops may take a few
weeks before you feel any improvement.
Continue to take Cipramil even if it takes
some time before you feel any improvement
in your condition.

Breast-feeding
Ask your doctor or pharmacist for advice
before taking any medicine.
If you are breast-feeding, ask your doctor for
advice. You should not breast-feed your
baby when taking Cipramil because small
amounts of the medicine can pass into the
breast milk.

The duration of treatment is individual,
usually at least 6 months. Continue to take
the drops for as long as your doctor
recommends. Do not stop taking them even
if you begin to feel better, unless you are told
to do so by your doctor. The underlying
illness may persist for a long time and if you
stop your treatment too soon your
symptoms may return.

Citalopram, 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.

Patients who have recurrent depression
benefit
from
continued
treatment,
sometimes for several years, to prevent the
occurrence of new depressive episodes.

Driving and using machines
Cipramil does not usually affect the ability to
carry out normal daily activities. However, if
you feel dizzy or sleepy when you start to
take this medicine, you should be careful
when driving, operating machinery or
performing jobs that need you to be alert
until these effects wear off.

Never change the dose of the medicine
without talking to your doctor first.
If you take more Cipramil than you
should
If you think that you or anyone else may
have taken too many Cipramil drops,
contact your doctor or nearest hospital
emergency department immediately. Do this
even if there are no signs of discomfort or
poisoning. Take the Cipramil box/container
with you if you go to a doctor or hospital.
Some of the signs of an overdosage could
be life-threatening.

Important information about some of the
ingredients of Cipramil Drops
This medicinal product contains small
amounts of ethanol (alcohol), less than
100 mg in all doses. These drops also
contain the preservatives E216 and E218,
which may cause allergic reactions (possibly
delayed).

3. How to take Cipramil drops

Symptoms of overdosage may include:
• Irregular heart beat
• Seizures
• Changes in heart rhythm
• Feeling sick (nausea)
• Vomiting
• Sweating
• Drowsiness
• Unconsciousness
• Fast heart beats
• Tremor
• Changes in blood pressure
• Serotonin syndrome (see Section 4)
• Agitation
• Dizziness
• Enlarged eye pupils
• Bluish skin
• Breathing too quickly

How much to take
It is important to take your drops as
instructed by your doctor. The label will tell
you how many to take and how often. If it
does not, or you are not sure, ask your
doctor or pharmacist.
Adults
Depression
The usual dose is 16 mg (8 drops) per day.
This may be increased by your doctor to a
maximum of 32 mg (16 drops) per day.
Panic disorder
The starting dose is 8 mg (4 drops) per day
for the first week before increasing the dose
to between 16 –24 mg (8 to 12 drops) per
day. The dose may be increased by your
doctor to a maximum of 32 mg (16 drops)
per day.

If you forget to take Cipramil
If you forget to take a dose, take the next
dose at the usual time. Do not take a double
dose.

Elderly patients (above 65 years of age)
The starting dose should be decreased to
half of the recommended dose, e.g. 8-16 mg
per day. Elderly patients should not usually
receive more than 16 mg (8 drops) per day.

Effects when treatment with Cipramil is
stopped
Stopping this medicine quickly may cause
symptoms such as dizziness, nausea and
numbness or tingling in hands or feet, sleep
disturbances (vivid dreams, nightmares,
inability to sleep), feeling anxious,
headaches, feeling or being sick, sweating,
feeling restless or agitated, tremor, feeling
confused or disorientated, feeling emotional
or irritable, diarrhoea (loose stools), visual
disturbances,
fluttering
or
pounding
heartbeat (palpitations). These are usually
non-serious and disappear within a few
days.
When you have completed your course of
treatment, the dose of Cipramil is usually
reduced gradually over a couple of weeks.
If you have any further questions on the use
of this product, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, Cipramil can have side
effects and some people may experience
unwanted effects (side effects) whilst taking
Cipramil. Several of the effects listed below
can also be symptoms of your illness and
may disappear as you start to get better.
Serious side effects
Stop taking Cipramil and seek medical
advice immediately if you have any of the
following symptoms:
• Difficulty in breathing.
• Swelling of the face, lips, tongue or
throat that causes difficulty in
swallowing or breathing.
• Severe itching of the skin (with raised
lumps).
• Fast, irregular heart beat, fainting which
could be symptoms of a life-threatening
condition known as torsades de
pointes.
If you notice any of the following you should
contact your doctor immediately as your
dose may need to be reduced or stopped:
• You start having fits for the first time or
fits that you have suffered from in the
past before become more frequent.
• Your behaviour changes because you
feel elated or over excited.
• You experience high fever, agitation,
confusion, and trembling or abrupt
contractions of muscles. These may be
signs of a rare condition called
serotonin syndrome.
• Tiredness, confusion and twitching of
your muscles. These may be signs of a
low blood level of sodium.
If you have thoughts of harming or killing
yourself at any time, contact your doctor
or go to a hospital straight away.
The following side effects are often mild and
usually disappear after a few days’
treatment.
Very common side effects (likely to affect
more than 1 in 10 people)
• Sleepiness
• Difficulty in sleeping
• Increased sweating
• Dry mouth (a dry mouth increases the
risk of tooth decay, so be sure to clean
your teeth more often than usual)
• Feeling sick (nausea)
Common side effects (likely to affect up to 1
in 10 people)
• Lack of appetite
• Agitation
• Decreased sex drive
• Anxiety
• Nervousness
• Confusion
• Abnormal dreams
• Tremor
• Tingling or numbness in the hands or
feet
• Ringing in the ears (tinnitus)
• Yawning
• Diarrhoea
• Vomiting
• Constipation
• Itching
• Pain in muscles and joints
• For men, problems with ejaculation and
erection
T03310

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Use in children and adolescents under 18
years of age
Cipramil should normally not be used for
children and adolescents under 18 years.
Also, you should know that 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. Despite
this, your doctor may prescribe citalopram
for patients under 18 because he/she
decides that this is in their best interests. If
your doctor has prescribed Cipramil 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 Cipramil.
Also, the long-term safety effects
concerning growth, maturation and cognitive
and behavioural development of Cipramil in
this age group have not yet been
demonstrated.

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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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