CITALOPRAM 40 mg/ml ORAL DROPS

BEFORE YOU TAKE CITALOPRAM ORAL DROPS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Citalopram Oral Drops are not recommended for use in children or adolescents under 18 years of age. See section 2 'Do not take Citalopram Oral Drops:'.

You are at risk of having suicidal thoughts while taking this medicine. Take special care with Citalopram Oral Drops if you have previously had thoughts about killing or harming yourself or you are a young adult. See section 2 'Take special care with Citalopram Oral Drops:'.

When you stop taking this medication you may experience withdrawal symptoms. This is most likely if you stop taking your medicine suddenly. See section 4 'Withdrawal symptoms'.

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 any further questions, 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

IN THIS LEAFLET:

1.    What Citalopram Oral Drops are and what they are used for

2.    Before you take Citalopram Oral Drops

3.    How to take Citalopram Oral Drops

4.    Possible side effects

5.    How to store Citalopram Oral Drops

6.    Further information

OWHAT CITALOPRAM ORAL DROPS ARE AND WHAT THEY ARE USED FOR

Citalopram is one of a type of antidepressants known as Selective Serotonin Re-uptake Inhibitors (SSRls). It increases the effects of the body's naturally occurring hormone, serotonin, by inhibiting its re-uptake in the nerve cells. Citalopram Oral Drops are used:

• To treat depression

• To prevent depression from coming back • To treat panic attacks, which may or may not be associated with a severe fear of leaving the house (agoraphobia).

Do NOT take Citalopram Oral Drops:

•    If you are allergic (hypersensitive) to citalopram or any of the other ingredients of this medicine. Consult your doctor if you think you might be.

•    If you are also taking a medicine containing pimozide. Talk to your doctor.

•    If you are taking or have taken within the last two weeks, any 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 Citalopram Oral Drops. One day must elapse after you have finished taking moclobemide. After stopping Citalopram Oral Drops you must allow 1 week before taking any MAOI

•    If you are under 18 years of age

•    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. Also refer to the section "Taking other medicines" below.

Use in children and adolescents under 18 years of age

Citalopram Oral Drops are not recommended for use in children or adolescents under 18 years of age. 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 this medicine for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed this product 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 citalopram. Also, the long-term safety effects of this medication in this age group, concerning growth and development, have not yet been demonstrated.

Take special care with Citalopram Oral Drops:

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.

If any of the following apply to you discuss it with your doctor or pharmacist BEFORE taking Citalopram Oral Drops:

•    If you have a history of suicide attempts or suicidal thoughts or feelings

•    If you are diabetic (you may need an adjustment of your antidiabetic therapy)

•    If you suffer from epilepsy or a history of seizures or fits

•    If you have a history of bleeding disorders or have ever suffered from bleeding in the stomach or intestine

•    If you suffer from liver problems

•    If you suffer from manic phases

•    If you have panic disorder

•    If you are having electric shock treatment

•    If you have severe kidney problems

•    If you have problems with your eyes, such as certain kinds of glaucoma

•    If you have low sodium levels in your blood, since this can occur as a result of treatment with Citalopram

•    If you are an elderly female, as you may be at risk of having low sodium levels in your blood (see above)

•    If you suffer or have suffered from heart problems or have recently had a heart attack

•    If you have 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)

•    If you experience a fast or irregular heartbeat, fainting, collapse or dizziness on standing up which may indicate abnormal functioning of the heart rate.

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.

BLACK

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 Citalopram 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 your doctor's orders exactly and do not stop the treatment or change the dose without consulting your doctor.

Taking other medicines

Do not take Citalopram Oral Drops in combination with:

•    Any monoamine oxidase inhibitors (MAO-inhibitors) or if you have taken these in the last two weeks. See Section 2 'Do not take Citalopram Oral 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-malarian treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions about this you should speak to your doctor.

•    Herbal remedy St John's Wort (Hypericum perforatum). This should not be taken at the same time as Citalopram Oral drops.

Tell your doctor or pharmacist if you are taking any of the following:

•    Antipsychotics (drugs used to treat mental disorders) e.g. fluphenazine, quetiapine, risperidone or phenothiazines (a type of antipsychotic e.g. chlorpromazine)

•    Antidepressants (zotepine)

•    Aspirin or non-steroidal anti-inflammatory drugs (NSAIDS) e.g. ibuprofen, ketoprofen

•    Medicines which increase the level of serotonin (a brain neurotransmitter) e.g. tramadol (a painkiller) or sumatriptan (for migraine)

•    Medicine for manic depression (lithium)

•    Tryptophan (a dietary supplement)

•    Medicines for indigestion, ulcers e.g. Cimetidine, lansoprazole and omeprazole

Colours:

(PANTONE® is a registered trademark of Pantone, Inc.)

Pantone® GREEN

•    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).

It is important that you consult your doctor or pharmacist if you are taking any other medicine as he/she may need to monitor you or adjust your dose. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Citalopram Oral Drops with food and drink Citalopram Oral Drops may be taken with or without food. As with all antidepressants, it is sensible to avoid drinking alcohol whilst receiving treatment although Citalopram Oral Drops has not been shown to increase the effects of alcohol.

Pregnancy and breast-feeding

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.

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 Citalopram Oral 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 Citalopram Oral Drops. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Citalopram Oral 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 Citalopram Oral 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 Citalopram Oral Drops because small amounts of the medicine can pass into the breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Citalopram Oral 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 Citalopram 40 mg/ml Oral Drops

This medicine contains methyl hydroxybenzoate and propyl hydroxybenzoate which may cause allergic reactions (possibly delayed).

This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per 20 drops.

3 HOW TO TAKE CITALOPRAM ORAL DROPS

Always take your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

To obtain the drops the vial should be held vertically as shown in the diagram.

•    The drops should be added to a glass of either water, apple juice or orange juice, which is taken as a single drink

•    Count the required number of drops into the drink and then stir briefly

•    All the drink should be drunk immediately following mixing

•    You may take your medicine in the morning or the evening, with or without food

•    You may need to take Citalopram Oral Drops for more than 6 months to treat depression or for more than 3 months to treat panic attacks.

It is very important that you follow your doctor's instructions as to the dosage of Citalopram Oral Drops and for how long you should continue to take them. You may not start feeling better straight away but you should keep taking them for as long as your doctor tells you.

Adults

Treating Depression

The usual dose is 16 mg (8 drops)/(0.4 ml) per day. This may be increased by your doctor to a maximum of 32 mg (16 drops)/(0.8 ml) per day.

Treating Panic disorder

The starting dose is 8 mg (4 drops)/(0.2 ml) per day for the first week before increasing the dose to 16-24 mg (8-12 drops) /(0.4-0.6 ml) per day. The dose may be increased by your doctor to a maximum of 32 mg (16 drops)/(0.8 ml) 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)/(0.4 ml) per day.

Children (< 18 years)

Citalopram Oral Drops should not be given to children or adolescents under 18 years of age. For further information, please see section 2, Before you take Citalopram Oral Drops.

Patients with special risks Reduced liver function

Patients with liver complaints should not receive more than 16 mg (8 drops)/(0.4 ml) per day.

Reduced kidney function

The usual adult doses may be used.

Citalopram is also available in tablet form. Citalopram Oral Drops are absorbed into the body differently to Citalopram Tablets. Therefore if you have taken Citalopram Tablets before you will not require exactly the same dose when you are taking the liquid form to get the same effect. The tablet dosage corresponds to the number 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)

60 mg    48    mg    (24 drops)

Depending on your dose this bottle will last you between 12 and 75 days.

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 Citalopram Oral 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 medicine than you should

If you have taken too large a dose of this medicine, contact your doctor or hospital immediately. Do this even if there are no signs of discomfort or poisoning. Always take the labelled medicine package with you whether there is any medication left or not.

Symptoms of overdose may include irregular heartbeat, 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, high fever or heat stroke, abnormal muscle tone, coma.

If you forget to take your medicine If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, miss the forgotten dose altogether and continue with the rest of the medication as normal. Do not take a double dose to make up for a forgotten dose.

If you stop taking Citalopram Oral Drops Even when you start to feel better it is important for you to keep on taking your medicine for as long as your doctor tells you. Never change the dose of your medicine without talking to your doctor first.

Your doctor will want to gradually reduce your dose of Citalopram over several weeks, before you finally stop taking this medicine. If you suddenly stop taking this medicine you may experience side effects such as dizziness, nausea and/or vomiting, numbness or tingling in hands or feet, sleep disturbances (lack of sleep, nightmare, intense dreams), agitation or anxiety, headaches, feeling or being sick, sweating, feeling restless, confused or disorientated, feeling emotional or irritable, loose stools, shaking, irritability, visual disturbances, fluttering or pounding heartbeat (palpitations). These are usually non-serious and disappear within a few days.

Please speak to your doctor, if you experience any of these side effects or any other side effects whilst stopping taking Citalopram.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, this product can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking your medicine and either tell your doctor immediately or go to your nearest hospital. You may be experiencing an allergic reaction to the oral drops:

•    Swelling of the hands, feet, ankles, face, lips, mouth or throat

•    Severe itching of the skin (with raised lumps)

•    Problems with swallowing or breathing

Tell your doctor immediately if you experience:

•    Thoughts of suicide and self harm. This may occur or increase in the first few weeks of treatment for depression, until the antidepressant effect becomes apparent. Tell your doctor immediately if you have any distressing thoughts or experiences.

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 get any of the following symptoms you should stop taking Citalopram Oral Drops and see your doctor immediately

•    Fast, irregular heart beat, fainting which could be symptoms of a life-threatening condition known as Torsades de Pointes.

You may experience some of the following side effects. Speak to your doctor or pharmacist if you are concerned about any of these side effects:

Very common side effects: (more than 1 in 10 patients):

•    Feeling sick

•    Dry mouth

•    Increased sweating

•    Sleepiness

•    Sleeplessness

•    Headache

•    General weakness

•    Sleep disorder.

Common side effects: (more than 5 in 100 but less than 20 in 100 patients):

•    Decreased appetite

•    Decreased weight

•    Agitation

•    Decreased sex drive

•    Anxiety

•    Nervousness

•    Confusion

•    Inability to reach orgasm in females

•    Strange dreams

•    Shaking (tremor)

•    Tingling of the skin

•    Dizziness

•    Inability to concentrate

•    Ringing in the ears

•    Yawning

•    Diarrhoea

•    Feeling sick

•    Constipation

•    Itching

•    Muscle and joint pain

•    Impotence

•    Failure to ejaculate in men

•    Physical and mental exhaustion

•    Migraine

•    Palpitation

•    Taste perversion

•    Forgetfulness

•    Loss of appetite

•    Lack of interest

•    Upset stomach or indigestion

•    Abdominal pain

•    Wind

•    Increased salivation

•    Runny nose

•    Incontinence (involuntary urination)

•    Excessive passage of urine.

Uncommon side effects: (more than 5 in 100 but less than 20 in 100 patients):

•    Increased appetite

•    Increased weight

•    Aggression

•    Feeling detached from one's body and thoughts

•    Hallucination

•    Mania

•    Confusion

•    Fainting

•    Changes to the size of your pupils

•    Fast heart rate

•    Slow heart rate

•    Hair loss

•    Rash

•    Itching

•    Sensitivity to sunlight (Photosensitivity reaction)

•    Difficulty in passing urine or increased need to pass urine

•    Heavy menstrual periods

•    Swelling of the body

•    Extreme happiness (euphoria)

•    Coughing.

Rare side effects (less than 1 in 100 patients):

•    Sudden generalized convulsion (Grand mal convulsion)

•    Movement disturbances

•    Taste disturbances

•    Bleeding

•    Hepatitis (inflammation of the liver)

•    Fever

•    Increased sex drive

•    Generally feeling unwell

•    Restlessness

Other side effects which have been reported include:

•    Reduction in blood platelets, which increase risk of bleeding or bruising

•    Inappropriate ADH secretion

•    Low potassium levels in the blood

•    Panic attack

•    Grinding of teeth (bruxism)

•    Fits

•    Serotonin syndrome (fever, stiffness, muscle spasms, difficulty carrying out normal tasks, rapid changes in breathing and heart rate, changes in mental status including confusion, irritability and extreme agitation which may lead to delirium and coma)

•    Extra-pyramidal disorder (lack of movement, stiffness, shaking or abnormal movements of the mouth and tongue)

•    Involuntary movements (akathisia)

•    Visual disturbance

•    Dizziness or light-headedness when standing up or getting out of bed

•    Nosebleeds

•    Gastro-intestinal bleeding

•    Abnormal liver function test results

•    Blue-black spots (bruising) on the skin

•    Menstrual bleeding at irregular intervals

•    Persistent and painful erection of the penis

•    Involuntary production of milk

•    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.

An increased risk of bone fractures has been observed in patients taking this type of medicine.

Also let your doctor know if you continue to have other symptoms associated with your depression. This might include hallucinations, anxiety, mania or confusion.

Withdrawal Symptoms

When you stop taking this medication you may experience withdrawal symptoms. This is most likely if you stop taking this medicine suddenly. Withdrawal symptoms include dizziness, tingling of the skin, headache, anxiety and feeling sick.

You should not stop taking your oral drops abruptly, and should discuss stopping taking this medication with your doctor.

If you suffer from any of the side effects listed above and they are severe or prolonged or if you experience any other side effects not mentioned in this leaflet, please inform your doctor or pharmacist immediately.

HOW TO STORE CITALOPRAM ORAL DROPS

Keep out of the reach and sight of children. Once the drops have been opened they should not be stored above 25°C and any remaining solution should be discarded after 16 weeks.

Do not use Citalopram Oral Drops after the expiry date which is stated on the carton after EXP The expiry date refers to the last day of that month.

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.

FURTHER INFORMATION

What Citalopram Oral Drops contain

The active ingredient is citalopram. One ml contains 40 mg of the active ingredient.

The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), hydroxyethyl cellulose, ethanol 96%v/v and purified water.

What Citalopram Oral Drops look like and the contents of the pack

It is a clear liquid.

Citalopram Oral Drops comes in packs of 15 ml.

The vial contains 300 drops.

Marketing Authorisation Holder

Teva UK Limited, Eastbourne, BN22 9AG.

Manufacturer

HELP SA Pharmaceuticals Pedini, loannina, Greece

This leaflet was last revised: July 2012

PL 00289/1460

^tir^J=l^l/il    ⁴⁵⁷⁰¹-^F

TEVA UK LIMITED    170 x 480

Reason for revision: V1: Safety variation text update to leaflet to 480mm x 170mm.

Colours:

(PANTONE® is a registered trademark of Pantone, Inc.)

BLACK

Pantone® GREEN

Artwork Originator; Sign & Date:

Artwork Checker; Sign & Date:

Approved for Regulatory submission into MHRA/IMB; Sign & Date:

Packing Site Approval (where not TEVA UK Limited) Sign & Date:

Final approval by MA Holder confirming receipt of MHRA/1MB approval, Sign & Date:

drzafcav I

Digitally signed by Elizabeth Morgan DN: cn=Elizabeth Morgan, o=Teva UK Ltd, ou=Origination Dept,

email=elizabeth.morg an@tevaulccom, c=GB Date: 2012.09.24 14:1.6:38 Z_

Dimensions: L:    480 mm

W:    170 mm

Fonts: Univers Base Font Size: 7.5 Pt

Pharma Code (top to bottom on the front face when reading the text design right way up):

UNKNOWN

3rd Party Code: UNKNOWN

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier. We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

Colours:

(PANTONE® is a registered trademark of Pantone, Inc.)

BLACK

Pantone® GREEN