CIPRAMIL ORAL DROPS 40MG/ML

Active substance: CITALOPRAM HYDROCHLORIDE

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Pg 4

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Cipramil oral drops

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/2682G

DATE OF PROOF:

01/08/12

DATE:

PROOF HISTORY:
v.4 - waymade - 01/08/12

DATE:

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED JANUARY 2012
INCLUDING BOTH SAFETY WARNINGS

Pg 1

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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.
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.
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.
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 Drops, 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






Always keep medicines out of the sight and reach of children.
After breaking the seal for the first time, do not store above 25°C and use within 16 weeks.
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.
If the medicine become discoloured or show any other signs of deterioration, you should ask your
pharmacist who will advise you what to do.

6. Further information
What Cipramil Drops contain
The active substance in Cipramil Drops is citalopram (as hydrochloride). One ml of solution contains 40 mg of
citalopram (44.48mg citalopram hydrochloride).
1 drop contains 2mg citalopram.
The other ingredients are purified water, methylparahydroxybenzoate, propylparahydroxybenzoate, ethanol
and hydroxyethylcellulose.
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
POM

PL No: 06464/2682

This product is manufactured by H Lundbeck A/S, Ottiliavej 7-9, Valby, DK-2500 Denmark and is procured
from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 1.8.2012
Cipramil is a registered trademark of H Lundbeck A/S

CIPRAMIL®

ORAL DROPS 40mg/ml /
CITALOPRAM HYDROCHLORIDE ORAL DROPS 40mg/ml
(Citalopram hydrochloride)
Patient Information Leaflet

Your medicine is called Cipramil Oral Drops 40mg/ml /Citalopram Hydrochloride Oral Drops 40mg/ml, but will
usually be referred to throughout this leaflet as Cipramil Drops.
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.
In this leaflet:
1. What Cipramil Drops are and what they are 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

1. What Cipramil Drops are and what they are used for
How do Cipramil Drops work?
Cipramil Drops are 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 are Cipramil Drops used for?
Cipramil Drops contain citalopram and are used for the treatment of depression and, when you feel better, to
help prevent these symptoms recurring. Cipramil Drops are also used for long-term treatment to prevent the
occurrence of new episodes of depression or if you have recurrent depression.
Cipramil Drops are 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 Drops. One day must elapse after you have finished taking
moclobemide. After stopping Cipramil Drops 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” overleaf).
Take special care with Cipramil Drops
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 Drops 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.

Pg 2

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Cipramil oral drops

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/2682G

DATE OF PROOF:

01/08/12

DATE:

PROOF HISTORY:
v.4 - waymade - 01/08/12

DATE:

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED JANUARY 2012
INCLUDING BOTH SAFETY WARNINGS

Pg 2

Use in children and adolescents under 18 years of age
Cipramil Drops 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 Drops 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 Drops. Also, the long-term safety
effects concerning growth, maturation and cognitive and behavioural development of Cipramil Drops in this
age group have not yet been demonstrated.
Taking other medicines
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 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 overleaf).



The herbal remedy St John's Wort (Hypericum perforatum). This should not be taken at the same time
as Cipramil Drops.
Monoamine oxidase inhibitors (MAOIs). These should not be taken at the same time as Cipramil
Drops (see Do not take Cipramil Drops overleaf).

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 Drops 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 Drops (see Do not
take Cipramil Drops overleaf).
• 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 Drops 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 Drops with food and drink
Cipramil Drops can be taken with or without food (see section 3 “How to take Cipramil Drops”).
As with all antidepressants, it is sensible to avoid drinking alcohol whilst receiving treatment although Cipramil
Drops have not been shown to increase the effects of alcohol.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or think you might be pregnant, or are trying to become pregnant, tell your doctor. Do not
take Cipramil Drops 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 Drops. When taken during pregnancy,
particularly in the last 3 months of pregnancy, medicines like Cipramil Drops 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. Also, if you take
Cipramil drops 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.
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.
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 Drops because small amounts of the medicine can pass into the breast milk.
Driving and using machines
Cipramil Drops do 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 methylparahydroxybenzoate and propylparahydroxybenzoate,
which may cause allergic reactions (possibly delayed).

3. How to take Cipramil Drops

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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 Drops
The drops are for oral use and can be taken in a drink of water, or orange or apple juice.
Cipramil Drops are 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 Drops 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 Drops 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 Drops 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 Drops
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 Drops are 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 Drops 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 Drops can have side effects and some people may experience unwanted effects
(side effects) whilst taking Cipramil Drops. 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 Drops 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.

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
(8-12 drops) per day. The dose may be increased by your doctor to a maximum of 32 mg (16 drops) per day.
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.
Children and adolescents (< 18 years)
Cipramil Drops should not be given to children or adolescents under 18 years of age. For further information,
please see section 2, 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.
Pg 3

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
that 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
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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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