Document: leaflet MAH GENERIC_PL 17780-0037 change

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Rare (may affect up to 1 in 1000 people):

•    Tired, weak, confused and have muscles that ache, are stiff or do not work well. This may be due to low sodium levels in your blood

•    Increased sex drive

•    Changes in the way things taste

•    Fits or seizure

•    Coughing

•    Fever

•    Bleeding under skin or mucous membrane

•    Involuntary movements

•    Hepatitis

•    Feeling generally unwell

Not known (frequency cannot be estimated from the available data):

•    Panic attacks

•    Abnormal production of breast milk in men and women

•    Feeling dizzy when you stand up (postural hypotension)

•    Blurred vision

•    Clenching or grinding the teeth (Bruxism)

•    You may bruise more easily than usual. This could be because of a blood disorder (th rom bocytopen ia)

•    Liver problems shown by blood tests

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

•    Feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could be an illness called ‘syndrome of inappropriate anti-diuretic hormone secretion’ (SIADH). This rare side effect is more likely to happen if you are elderly.

•    Tiredness, confusion, and muscle weakness and muscle cramps. This may be due to low levels of potassium in your body (hypokalaemia)

•    Nose bleed (Epistaxis)

•    Wide spreading of bruising (Ecchymosis)

•    Bleeding between menstrual periods

•    A persistent or painful erection that lasts for several hours (priapism).

•    Rash (hypersensitivity)

•    Restlessness

•    Unusual movements or stiffness

•    Involuntary movements of the muscles (akathisia)

•    Low blood pressure

•    Sudden swelling of skin or mucosa

•    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 Citalopram, 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.aov.uk/vellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

6. Children and adolescents under 18

Use in 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 and suicidal behaviour when they take this type of medicine. 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 citalopram 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 below start or get worse when patients under 18 are taking citalopram.

Among children and teenagers under 18 given citalopram, these side effects are common

•    Increased thoughts about suicide and suicide attempts

•    Being hostile, aggressive or unfriendly

•    Being agitated

7. How to store citalopram

•    Keep out of the sight and reach of children.

•    Store in the original packaging

•    Do not use after the expiry date stated on the pack.

•    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.

8. Contents of the pack and other information

What Citalopram 10mg, 20mg and 40mg film-coated Tablets contains:

The active substance is: citalopram hydrobromide

Citalopram Tablets contain 10 mg, 20 mg or 40 mg of citalopram (as citalopram hydrobromide).

The other ingredients are: mannitol, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate. The film-coating contains hypromellose, titanium dioxide (E171) and macrogol 6000.

What Citalopram 10mg, 20mg and 40mg film-coated Tablets look like and contents of the pack: This medicine comes in blister packs of 28 film-coated tablets.

•    Citalopram 10 mg tablets are round, biconvex, white film coated tablets, diameter 6 mm.

•    Citalopram 20 mg tablets are round biconvex, white film coated tablets, diameter 8 mm, with a score line.

•    Citalopram 40 mg tablets are round biconvex, white film coated tablets, diameter 10 mm, with a score line.

Marketing Authorisation Holder

Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK Manufacturer

Sanofi-Aventis Sp. Z.o.o., Pharmaceutical Production Plant, Ul. Lubelska 52, 35-233, Rzeszow, Poland This leaflet was last revised in October 2014 ‘Zentiva’ is a registered trademark. © 2014 Zentiva

Citalopram 10mg, 20mg and 40mg film-coated Tablets

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine.

•    Citalopram treats depression and panic disorders but it will not work straight away. Like all medicines,

it can have side-effects. It is important that you and your doctor talk about the benefits and the possible unwanted effects of the medicine before you start taking it.

•    Citalopram should not be taken by children or teenagers under 18. (see Section 6 on page 4).

•    Citalopram will not work straight away. You may feel worse before feeling better after starting the medicine. Your doctor should ask to see you again 2 or 3 weeks after you first start taking the medicine. Tell your doctor if you feel no better, (see Section 3 on page 2).

•    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(see section 2 on page 1).

•    If you feel restless or feel like you cannot keep still, go to your doctor. If you keep on taking more citalopram each day, it may make these feelings worse, (see Section 5 on page 3).

•    Talk to your doctor before you stop taking citalopram. If you stop taking it suddenly or miss a dose you may get unwanted effects, (see Section 4, on page 3).

•    Taking some other medicines with citalopram can cause problems. You may need to talk to your doctor first. (See Section 2 on page 1).

•    If you are pregnant or planning to get pregnant, talk to your doctor before taking citalopram.

(See Section 2 on page 1).

Read the rest of this leaflet carefully before 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. See section 5.

What is in this leaflet:

1.    What citalopram is and what it is used for

2.    What you need to know before you take citalopram

3.    How to take citalopram

4.    Stopping citalopram

5.    Possible side effects

6.    Children and adolescents under 18

7.    How to store citalopram

8.    Contents of the pack and other information

1. What citalopram is and what it is used for

Citalopram belongs to a group of antidepressants called SSRIs (selective serotonin reuptake inhibitors). Citalopram is used to treat:

•    Depression

•    Panic disorders including fear of wide open spaces (agoraphobia) or crowds

Other medicines or psychotherapy can also treat these conditions. Treating your condition properly is important to help you get better. Without treatment your condition may get worse and be more difficult to treat.

2. What you need to know before you take citalopram

Do not take citalopram if:

•    You are allergic (hypersensitive) to citalopram or any of the other ingredients in this medicine (see Section 8: Further Information).

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

•    You are taking a MAOI (monoamine oxidase inhibitor) medicine, or have taken them in the last 2 weeks. Examples of MAOIs include: tranylcypromine, phenelzine and isocarboxazid (for depression) or selegiline (for Parkinson’s disease)

•    You are taking a medicine called moclobemide, or have taken it in the last 24 hours

•    You are taking pimozide (an antipsychotic medicine).

•    You are taking linezolid (an antibiotic medicine used to treat pneumonia and infections in skin)

•    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)

•    You take medicines for heart rhythm problems or that may affect the heart’s rhythm. Also refer to the section “Taking other medicines” below.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking citalopram.

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.

Warnings and precautions

Take special care and check with your doctor or pharmacist before taking citalopram if:

•    You have epilepsy or have ever had a fit

•    You have diabetes

•    You have or have ever had a history of overactive behaviour or thoughts (mania)

•    You are having ECT (electro-convulsive treatment).

•    You have bleeding disorders or have ever suffered from bleeding in the stomach or intestine or use anticoagulants (for thinning the blood)

•    You are taking this medicine for a panic disorder. You may need to be started on a lower dose.

•    You have problems with your eyes, such as certain kinds of glaucoma or you have in history of glaucoma.

•    You have liver disease.

•    You have severe kidney disease

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

•    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)

•    You experience a fast or irregular heartbeat, fainting, collapse or dizziness on standing up which may be signs of an abnormal heart rate.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking citalopram.

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.

Pregnancy, breast-feeding and fertility

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 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 born. 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: trouble with breathing, stiff or loose muscles, jitteriness, a bluish skin or being too hot or cold. If your newborn baby gets any of these symptoms please contact your midwife and/or doctor immediately.

Citalopram may get into breast milk in very small amounts and may affect your baby. Talk to your doctor before you start 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.

Taking citalopram with other medicines:

DO NOTTAKE 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. fentiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarian treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions about this you should speak to your doctor.

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines.

This includes medicines you buy without a prescription, including herbal medicines. This is because citalopram can affect the way some other medicines work. Also some medicines can affect the way citalopram works.

Some medicines should not be taken with citalopram (see Do not take citalopram above).

In particular, tell your doctor if you are taking any of the following:

•    Other medicines for depression (SSRIs, tricyclic antidepressants, such as clomipramine, nortriptyline, imipramine and desipramine, and medicines containing buproprion, oxitriptan and tryptophan)

•    Some medicines for mental illness (such as perphenazine, risperidone and lithium)

•    Medicines for epilepsy (such as phenytoin, sodium valproate, phenobarbital or carbamazepine)

•    Painkillers containing acetylsalicylic acid (such as aspirin) or non-steroidal anti-inflammatory medicines (NSAID’s) such as ibuprofen

•    Medicines for migraine such as sumatriptan (triptans)

•    Herbal products containing St John’s Wort

•    Medicines for pain such as tramadol

•    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.

•    Medicines for early-stage Parkinson’s disease such as selegiline

•    Lithium (used to prevent and treat mania) and tryptophan (an antidepressant)

•    Medicines used to heal active stomach and duodenal ulcers such as cimetidine

•    Antibiotics such as Linezolid

•    Mefloquine (used to treat malaria)

•    Neuroleptics (used in the treatment of schizophrenia)

Taking citalopram with food, drink and alcohol:

Citalopram can be taken with or without food. Do not drink alcohol whilst taking citalopram.

Driving and using machines

Citalopram has a minor or moderate influence on the ability to drive and use machines. You should be careful when driving, operating machinery or performing jobs that need you to be alert. Do not drive or use machines if you feel you are affected.

3. How to take citalopram

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

Your doctor will tell you how much to take when you first start taking it. Most people start to feel better after 2 to 3 weeks. If you do not feel any better after this time, talk to your doctor. He or she may tell you to take more of the medicine each day.

Taking citalopram:

•    Take your medicine at the same time every day

•    Swallow the tablets with a glass of water

How much to take:

Depression

•    The usual dose is 20 mg per day. This may be increased by your doctor to a maximum of 40mg per day.

•    The exact dose will depend on how your condition responds to treatment

•    You will normally be asked to keep taking this medicine for at least 6 months Panic disorder (panic attacks):

•    The starting dose is 10mg per day for the first week before increasing the dose to 20-30mg per day. The dose may be increased by your doctor to a maximum of 40mg per day.

•    The exact dose will depend on how your condition responds to treatment.

Older people (above 65 years of age)

The starting dose should be decreased to half of the recommended dose, e.g. 10-20mg per day. Older people should not usually receive more than 20mg per day.

People with liver problems

Patients with liver complaints should not receive more than 20mg per day.

If you take more citalopram than you should:

If you think that you or anyone else may have taken too many citalopram tablets, contact your doctor or go to the nearest hospital straight away. Do this even if there are no signs of discomfort or poisoning. Signs could include: feeling sick (nausea), being sick (vomiting), dizziness, sweating, fits, being veiy sleepy, passing out or going into a coma, tremor, having a blue colour to the skin, fast short breathing, changes in blood pressure, a staring or fixed look on the face, changes in heart rhythm, a fast or irregular heart beat, agitation, enlarged eye pupils or serotonin syndrome (see Section 5)

Take the carton and any tablets left with you. This is so that the doctor knows what you have taken.

If you forget to take citalopram:

•    If you forget a tablet and you remember before you go to bed, take it straight away. Carry on as usual the next day.

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