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CIPRAMIL ORAL DROPS 40MG/ML

Active substance(s): CITALOPRAM HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Cipramil® Oral Drops 40mg/ml / Citalopram Oral Drops 40mg/ml
(citalopram hydrochloride)
This product is available as any of the above names but will be referred to as Cipramil
Drops throughout the remainder of this leaflet.
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 Drops are and what they are 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 Drops are and what they are used for
How does Cipramil Drops work?
Cipramil Drops 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 Drops used for?
Cipramil Drops contain citalopram and is used for the treatment of depression and, when
you feel better, to help prevent these symptoms recurring. Cipramil Drops is also used for
long-term treatment to prevent the occurrence of new episodes of depression or if you have
recurrent depression.
Cipramil Drops is also beneficial in relieving symptoms if you tend to suffer from panic attacks.
2. What you need to know before you take Cipramil Drops
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 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 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.
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.
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 longterm safety effects concerning growth, maturation and cognitive and behavioural development
of Cipramil Drops in this age group have not yet been demonstrated.

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 Drops.
■ Monoamine oxidase inhibitors (MAOIs). These should not be taken at the same time as
Cipramil Drops (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 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.
■ 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.
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.
Taking Cipramil Drops with food, drink and alcohol
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 has 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,
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 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 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.
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.
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 Drops 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.
Adults
Depression
The usual dose is 16 mg (8 drops) per day. This may be increased by your doctor to a
maximum of 32mg (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 16–24mg (8 to 12 drops) per day. The dose may be increased by your doctor to a
maximum of 32mg (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 (less than 18 years of age)
Cipramil Drops 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.
The doses of tablets correspond to doses of drops as follows:
Tablets
Drops
10 mg
8 mg (4 drops)
20 mg
16 mg (8 drops)
30 mg
24 mg (12 drops)
40 mg
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 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 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 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 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 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 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 (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 Drops, 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 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 at
or below 25°C.
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.
If the drops become discoloured, or show any other signs of deterioration you should
seek the advice of your pharmacist who will tell you what to do.

6. Contents of the pack and other information
What Cipramil Drops contains
The active substance in Cipramil Drops is citalopram (as hydrochloride). Each ml of drops
contains 40 mg citalopram (as hydrochloride). The other ingredients are purified water,
ethanol,
hydroxyethylcellulose,
methyl
parahydroxybenzoate
and
propyl
parahydroxybenzoate.
What Cipramil Drops look like and contents of the pack
Cipramil Drops is available in an amber glass bottle with a dropper containing 15 ml clear
colourless oral solution.
POM
PL: 15814/0715
Cipramil® Oral Drops 40mg/ml / Citalopram Oral Drops 40mg/ml
These drops are manufactured by: H. Lundbeck A/S, Ottiliavej 7-9 DK-2500 CopenhagenValby, Denmark and is procured from within the EU and repackaged by the Product
Licence holder: OPD Laboratories Ltd, Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 22.09.2015.
Cipramil is a registered Trade mark of H. Lundbeck A/S, Denmark.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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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