Document: leaflet MAH GENERIC_PL 28176-0164 change

• leaflet CO-PHARMA_PL 28176-0164
• leaflet MAH GENERIC_PL 28176-0164

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Citalopram 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 tliis leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    Tliis medicine has been prescribed for you only. Do not pass it on to others.

It may harm them, even if their signs of ilhiess are the same as yours.

-    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in tliis leaflet. See section 4.

What is in this leaflet:

1.    What Citalopram oral drops are and what they are used for

2.    What you need to know 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.    Contents of the pack and other information

1.    WHAT CITALOPRAM ORAL DROPS ARE AND WHAT THEY ARE USED FOR

How does Citalopram work?

Citalopram 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 ilhiess.

What is Citalopram used for?

Citalopram oral drops contains citalopram and is used for the treatment of depression and, when you feel better, to help prevent these symptoms recurring. Citalopram is also used for long-term treatment to prevent the occurrence of new episodes of depression or if you have recurrent depression.

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

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE CITALOPRAM ORALDROPS

Do not take Citalopram oral drops:

•    If you are allergic (hypersensitive) to citalopram, or any of the other ingredients of Citalopram oral drops (see what Citalopram oral drops contain, in 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 file 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 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 bom with or have had an episode of abnormal heart rhythm (seen at ECG; an examination to evaluate how the heart is functioning).

•    If you take medicines for heart rhythm problems or that may affect the heart’s rhythm (see Taking other medicines, below).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Citalopram.

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 Citalopram treatment it may take several weeks before you experience any improvement. In file 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 tliis:

•    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 tliis 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.

Children and adolescents under 18 years of age

Citalopram 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 tliis class of medicines. Despite tliis, your doctor may prescribe citalopram for patients under 18 because he/she decides that tliis is in their best interests. If your doctor has prescribed Citalopram for a patient under 18 and you want to discuss tliis, 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 oral drops. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Citalopram in tliis age group have not yet been demonstrated.

Other medicines and Citalopram

Medicines may affect the action of other medicines and tliis can sometimes cause serious adverse reactions.

Dimension: 450 x 310 mm

Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines (including those purchased without prescription) during the last 14 days. This includes other medicines for depression (see Do not take Citalopram oral drops above).

•    The herbal remedy St John's wort (Hypericum perforatum). This should not be taken at the same time as Citalopram oral drops.

•    Monoamine oxidase inhibitors (MAOIs). These should not be taken at the same time as Citalopram oral drops (see Do not take Citalopram oral drops above).

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

•    Linezolid (an antibiotic).

•    Sumatriptan (used to treat migraine) or tramadol (a pain killer). If you feel unwell when using these medicines with Citalopram oral 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 Citalopram oral drops (see Do not take Citalopram oral drops above).

•    Imipramine and desipramine (used to treat depression).

•    Medicines containing selegiline (used to treat Parkinson’s disease)

•    Cimetidine (used to treat stomach ulcers).

•    Mefloquine (used to treat malaria).

•    Bupropion (used to treat depression).

•    Medicines known to affect the blood platelets (e.g. anticoagulant drugs used to treat or prevent blood clots; aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and diclofenac used as painkillers; and some antipsychotic drugs and tricyclic antidepressants).

•    Metoprolol, a beta blocker used to treat migraine, some heart conditions and high blood pressure. The effects of either drug could be increased, decreased or altered.

•    Neuroleptics (used in the treatment of schizophrenia).

Do not take Citalopram 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.

Citalopram with food and drink

Citalopram oral drops can be taken with or without food (see section 3 “How to take Citalopram oral drops”).

As with all antidepressants, it is sensible to avoid drinking alcohol whilst receiving treatment although Citalopram 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 planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take Citalopram 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. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Citalopram 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 bom. If this happens to your baby you should contact your midwife and/or doctor immediately. Also, if you take Citalopram 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 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

Citalopram 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.

Citalopram oral drops contains ethanol (alcohol), E216 and E218 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 CITALOPRAM ORAL DROPS 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 file 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.

Elderly people (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 (younger than 18 years of age)

Citalopram oral 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 Citalopram oral 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 Citalopram 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 Citalopram oral drops

The drops are for oral use and can be taken in a drink of water, or orange or apple juice.

Citalopram oral 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 Citalopram even if it takes some time before you feel any improvement in your condition.

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