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CIPRAMIL DROPS 40MG/ML

Active substance(s): CITALOPRAM HYDROCHLORIDE

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Package leaflet: Information for the user

Cipramil® Drops
40 mg/ml oral drops, solution
citalopram (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 further questions, please 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 you doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Cipramil is and what it is used for
2. What you need to know before you take Cipramil Drops
3. How to take Cipramil Drops
4. Possible side effects
5. How to store Cipramil Drops
6. Contents of the pack and other information
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.

Other medicines and Cipramil Drops
Medicines may affect the action of other medicines and this can sometimes
cause serious adverse reactions.
Please tell your doctor or pharmacist if you are taking,have taken or might
take any other medicines This includes other medicines for depression (see
Do not take Cipramil Drops).
• 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).
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 antidepressant).
• Pimozide (a neuroleptic). This should not be taken at the same time as
Cipramil.
• 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. phenothiazine 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.

Cipramil is also beneficial in relieving symptoms if you tend to suffer from
panic attacks.

Taking Cipramil with food,drink and alcohol
Cipramil can be taken with or without food (see section 3 “How to take
Cipramil Drops”).

2. What you need to know before you take Cipramil Drops

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.

Do not take Cipramil Drops
• If you are allergic to citalopram, or any of the other ingredients of this
medicine (listed in section 6). Consult your doctor if you think you might
be.
• 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 Other medicines and Cipramil Drops).
Warnings and Precautions
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.
Please note:
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.

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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.

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.
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.
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 breastfeed your baby when taking Cipramil because small amounts of the
medicine can pass into the breast milk.
Fertility
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.
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.
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
How much to take
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Turn the bottle completely upside down. If no drops come out, tap the
bottle lightly to start the flow.

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.

If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.

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.

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.

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.

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.

Children and adolescents (less than 18 years of age)
Cipramil should not be given to children or adolescents under 18 years of
age. For further information, please see section 2, What you need to know
before you take Cipramil Drops.
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.

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GB-069-06-40-13418

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.
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.
Patients who have recurrent depression benefit from continued treatment,
sometimes for several years, to prevent the occurrence of new depressive
episodes.
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.
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
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.
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, (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 this medicine can cause side effects, although not
everybody gets them. 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 lifethreatening condition known as torsades de pointes.

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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 (hyponatraemia).
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 (may affect more than 1 in 10 people)
• Sleepiness
• Difficulty in sleeping
• Headache
• Changes in your sleeping pattern
• Loss of body strength, weakness
• 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 (may affect up to 1 in 10 people)
• Lack of appetite
• Agitation
• Decreased sex drive
• Anxiety
• Nervousness
• Confusion
• Abnormal dreams
• Reduced emotions, indifference (apathy)
• Tremor
• Tingling or numbness in the hands or feet
• Dizziness
• Problems concentrating
• Migraine
• Loss of memory (amnesia)
• Ringing in the ears (tinnitus)
• Palpitations
• Yawning
• Blocked or runny nose (rhinitis)
• Diarrhoea
• Vomiting
• Constipation
• Stomach pain
• Flatulence (wind)
• Increase in saliva (drooling)
• Itching
• Pain in muscles and joints







For men, problems with ejaculation and erection
For women, failing to reach an orgasm
Tiredness
Prickling of the skin
Loss of weight

Uncommon (may affect up to 1 in 100 people)
• Bruising easily
• Increased appetite
• Aggression
• 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
• Excessive menstrual bleeding
• Swelling of the arms or legs
• Increased weight
Rare (may affect up to 1 in 1000 people)
• Increased sex drive
• Convulsions
• Involuntary movements
• Taste disturbances
• Bleeding
• Coughing
• Hepatitis
• Feeling unwell (malaise)
Some patient have reported (frequency not known)
• Thoughts of harming or killing themselves, see also section 2. “What
you need to know before you take Cipramil Drops”
• An increase in bleeding or bruising caused by a decrease in blood
platelets (thrombocytopenia)
• 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)
• Irregular menstrual periods
• Abnormal liver function tests
• An increased risk of bone fractures has been observed in patients
taking this type of medicines
• Abnormal heart rhythm
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly Via the Yellow Card Scheme at: www.mhra.gov.
uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Cipramil Drops
• Always keep this medicine 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 (room temperature).
• Do not use this medicine after the expiry date which is stated on the
label or carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help to protect the environment.
6. Contents of the pack and other information
What Cipramil Drops contain
The active substance in Cipramil drops is citalopram (as hydrochloride).
Each ml of drops contains 40 mg citalopram. The other ingredients
are purified water, ethanol, hydroxyethylcellulose, E218 (methyl
parahydroxybenzoate) and E216 (propyl parahydroxybenzoate).
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.
Manufacturer
H. Lundbeck A/S
Ottiliavej 9
2500 Valby
Denmark
Marketing Authorisation Holder
For any information about this medicine, please contact the Marketing
Authorisation holder:
Lundbeck Limited
2nd Floor
Building 3 Abbey View
Everard Close
St Albans
AL1 2PS
UK
01908 638972
This leaflet was last revised in 12/2017
To request a copy of this leaflet in braille, large print or audio please call
free of charge:
0800 198 5000
Please be ready to give the following information:
Product name

Product code number

Cipramil Drops 40 mg/ml

PL 0458/0071

This is a service provided by the Royal National Institute of Blind People.

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GB-069-06-40-13418

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