Document: Citalopram Jubilant film-coated tablet ENG PL change

• Citalopram Jubilant film-coated tablet PL
• Citalopram Jubilant film-coated tablet ENG PL

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Package leaflet: Information for the user

Citalopram Jubilant 10 mg film-coated tablets

Citalopram Jubilant 20 mg film-coated tablets

Citalopram Jubilant 30 mg film-coated tablets

Citalopram Jubilant 40 mg film-coated tablets

Citalopram (as hydrobromide)

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 any further questions, 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.

What is in this leaflet

How does Citalopram Jubilant work?

Citalopram Jubilant 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 Citalopram Jubilant used for?

Citalopram Jubilant contains citalopram and is used for the treatment of episodes of major depression.

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

Do not take Citalopram Jubilant

• if you are allergic to citalopram or any of the other ingredients of this medicine (listed in section 6).

• if you are taking, or have taken in the last 2 weeks an antidepressant medicine of the type called monoamine oxidase inhibitors (MAOIs) e.g. selegiline or moclobemide.

• if you are treated with linezolid (an antibiotic medicine) unless you are under close observation and monitoring of blood pressure.

• 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 section ‘Other medicines and Citalopram Jubilant’ below).

Warnings and precautions

Talk to your doctor or pharmacist before taking Citalopram Jubilant if you:

• Suffer from diabetes, treatment with Citalopram Jubilant may alter control of your sugar levels.

• Suffer from epilepsy or seizures, as seizures are a potential risk with antidepressant drugs.

• Receive electro-convulsive therapy.

• Have a history of mania/hypomania, Citalopram Jubilant should be used with caution and should be discontinued when you enter a manic phase.

• Have kidney or liver problems. Citalopram Jubilant is not recommended for use in patients with severe kidney problems.

• Have a bleeding disorder, Citalopram Jubilant may cause bleeding.

• Are using medicinal products that effect the clotting of blood (see section ‘Other medicines and Citalopram Jubilant’).

• Have a stomach ulcer or have had any bleeding in the stomach or intestine in the past.

• Suffer from low blood potassium or magnesium levels.

• Suffer from psychosis with depressive episodes.

• Experience ‘serotonin syndrome’. A combination of symptoms, such as agitation, tremor, muscle contractions and hyperthermia may indicate the development of this condition. Treatment with Citalopram Jubilant should be discontinued immediately.

• 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.

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

• During the first few weeks of treatment symptoms such as restlessness, and an inability to sit or stand still may develop in patients taking anti-depressants. In patients who develop these symptoms, increasing the dose could be harmful.

• Citalopram Jubilant should be discontinued in any patients who develop fits (epilepsy) or if their frequency of fits increase. Citalopram Jubilant should be avoided in patients with unstable (uncontrolled) epilepsy. Patients with controlled epilepsy should be carefully monitored.

• Citalopram Jubilant should not be used at the same time as medicines which have a serotonergic effect including pain killers and medicines used to treat migraines (see ‘Other medicines and Citalopram Jubilant’).

• Citalopram Jubilant should be used with caution in patients with low sodium levels

You should not discontinue treatment with Citalopram Jubilant abruptly due to the withdrawal effects that might occur (see section 3 ‘How to take Citalopram Jubilant’).

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.

Children and adolescents

Citalopram Jubilant 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 Citalopram Jubilant 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 Jubilant. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of citalopram in this age group have not yet been demonstrated.

Other medicines and Citalopram Jubilant

DO NOT TAKE Citalopram Jubilant

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines’.

• 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.

• If you take monoamine oxidase inhibitors (MAOIs), e.g. phenelzine, isocarboxazid or tranylcypromine do not take Citalopram Jubilant for 14 days after discontinuation of treatment with a so called irreversible MAOI. Do not take Citalopram Jubilant for the time specified after discontinuation of treatment with a reversible MAOI (e.g. moclobemide), as stated in the patient information leaflet of the reversible MAOI. Do not take MAOIs for 7 days after discontinuation of treatment with Citalopram Jubilant. Do not use Citalopram Jubilant if you are taking more than 10 mg/day of the MAO selegiline.

• If you take pimozide (an antipsychotic medicine). Citalopram Jubilant must not be taken together with pimozide due to the influence of this combination to the heart function.

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

Talk to your doctor or pharmacist if you are taking, or have previously taken any of the following:

• Other medicinal products with serotonergic effects such as sumatriptan, other triptans or tryptophan (see ‘Warnings and precautions’).

• An anticoagulant (to prevent blood clotting), e.g. warfarin, aspirin (acetylsalicylic acid), dipyridamole or ticlopidine.

• Medicines that lower the seizure threshold i.e. neuroleptics, mefloquine or bupropion.

• Herbal preparations containing St John’s wort (Hypericum perforatum).

• Pain-relief and inflammation medicines called non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, ketoprofen or diclofenac.

• Medicines used to treat pain, such as tramadol (see ‘Warnings and precautions’).

• Medicines used to treat depression, e.g. fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine.

• Medicines used to treat migraine, e.g. sumatriptan and other triptans (see ‘Warnings and precautions’).

• Medicines used to treat heart failure, e.g. metoprolol.

• Medicines for psychiatric illness, e.g. lithium, risperidone or chlorpromazine.

• Medicines for stomach ulcers, e.g. omeprazole, esomeprazole, lansoprazole or cimetidine.

• Medicines that decrease blood levels of potassium or magnesium as these conditions increase the risk of life-threatening heart rhythm disorder (QT prolongation, Torsades de Pointes).

• Linezolid (an antibiotic medicine).

Citalopram Jubilant with food, drink and alcohol

Citalopram Jubilant can be taken with or without food (see section 3).

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, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There is only limited experience concerning the use of Citalopram during pregnancy. Do not take Citalopram Jubilant if you are pregnant or planning to become 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 Jubilant. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Citalopram Jubilant 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.

You should not discontinue treatment with Citalopram Jubilant abruptly. If you are taking Citalopram Jubilant in the last 3 months of pregnancy, let your doctor know as your baby might have some symptoms when it is born. These symptoms usually begin during the first 24 hours after the baby is born. They include not being able to sleep or feed properly, trouble with breathing, a blue-ish skin or being too hot or cold, being sick, crying a lot, stiff or floppy muscles, lethargy, tremors, jitters or fits. If your baby has any of these symptoms when it is born, contact your doctor who will be able to advise you.

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

Breast-feeding

Citalopram Jubilant passes into breast milk in small amounts. There is a risk of an effect on the baby. If you are taking Citalopram Jubilant, talk to your doctor before you start breast-feeding.

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

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 Jubilant may affect your ability to drive a car or use machines. Do not drive or use machines until you know how Citalopram Jubilant affects you. Please ask your doctor or pharmacist if you are unsure about anything.

Citalopram Jubilant contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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.

Citalopram Jubilant should be taken as a single dose, either in the morning or the evening. The tablets can be taken with or without food. The tablets should be swallowed with a drink of water or other fluid. Citalopram Jubilant does not work immediately. An antidepressant effect should not be expected for at least 2 weeks. Treatment should continue until you are free of symptoms for 4-6 months. Citalopram Jubilant should be withdrawn slowly. It is advised that the dose is gradually reduced over a 1-2 week period. Do not stop taking Citalopram Jubilant even if you begin to feel better, unless you are told to do so by the doctor. Never change the dose of your medicine without talking to your doctor first.

The usual dose is:

Adults

Depression

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

Panic disorder

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

Elderly patients (> 65 years of age)

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

Use in Children and adolescents

Citalopram Jubilant should not be used in the treatment of children and adolescents under 18 years of age. (see ‘Warnings and precautions’).

Liver problems

Patients with mild to moderate liver problems should receive a starting dose of 10 mg per day. Patients with liver complaints should not receive more than 20 mg per day. Such patients should be clinically monitored. Caution and extra careful dosing is advised in patients with severe liver problems.

Kidney problems

In patients with mild to moderate kidney problems no dosage adjustment is required. The use of Citalopram Jubilant in patients with severe kidney problem is not recommended as no information is available in these patients.

Withdrawal symptoms seen on discontinuation

Abrupt discontinuation should be avoided. When stopping treatment with Citalopram Jubilant the dose should be gradually reduced over a 1-2 week period in order to reduce the risk of withdrawal reactions (see section ‘If you stop taking Citalopram Jubilant’ and ‘Possible side effects’).

If intolerable symptoms occur following a decrease in the dose upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, your doctor may continue decreasing the dose, but at a more gradual rate.

If you take more Citalopram Jubilant than you should

If you have taken more Citalopram Jubilant than you should, talk to a doctor or pharmacist immediately.

Symptoms of an overdose include: sleepiness, a condition of near unconsciousness with apparent mental inactivity, reduced ability to respond to stimulation or coma, seizures, ECG changes (e.g. prolonged QT interval), irregular heartbeat, feeling sick, vomiting, discolouration of the skin, sweating, hyperventilation. Features of serotonin syndrome may occur (see ‘Possible side effects’), particularly when other substances are co-ingested.

If you forget to take Citalopram Jubilant

If you miss a dose, do not take a double dose to make up for a forgotten dose.

If you stop taking Citalopram Jubilant

Do not stop taking Citalopram Jubilant unless you are told to do so by your doctor.

Since withdrawal reactions may occur when the treatment is stopped, it is advised to reduce the dose gradually at intervals of 1-2 weeks.

Withdrawal reactions include: dizziness, pins and needles, electric shock sensations, numbness, sleeplessness, intense dreams, agitation, anxiety, feeling sick or being sick, shaking, confusion, sweating, headache, diarrhoea, faster heartbeat (palpitations), emotional instability, irritability and visual disturbances. Most of the withdrawal reactions are mild and self-limiting in nature but may be severe in some patients.

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

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

A few people may develop a severe allergic reaction. This is a very rare but serious side effect. If you experience any of the following symptoms stop taking Citalopram Jubilant and tell your doctor immediately or go to your nearest casualty department:

• Swelling of the lips, face and neck (allergic reaction) leading to severe difficulty in swallowing or breathing.

• Shock (strong decrease of blood pressure, paleness, agitation, weak and fast pulse, clammy skin, decreased consciousness) caused by a sudden strong vascular dilatation as a result of severe allergy to certain substances (anaphylactic reactions).

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

Serotonin syndrome has been reported in patients treated with this type of antidepressant (SSRI). Tell your doctor if you experience high fever, trembling, muscle twitches and anxiety because these symptoms may indicate the development of this condition. Treatment with Citalopram Jubilant should be discontinued immediately.

Cases of thoughts/behaviours of harming or killing yourself have been reported during Citalopram Jubilant therapy or early after treatment has been stopped (see section 2 ‘Warnings and precautions’). If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

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

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

• Headache

• Feeling your heart beat

• 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)

• Feeling of weakness (asthenia)

Common side effects (likely to affect up to 1 in 10 people)

• Loss of appetite

• Agitation

• Decreased sex drive

• Anxiety

• Nervousness

• Confusion

• Abnormal dreams (unusual and intense dreams)

• Tremor

• Tingling or numbness in the hands or feet

• Ringing in the ears (tinnitus)

• Yawning

• Diarrhoea

• Constipation

• Itching

• Pain in muscles and joints

• For men, problems with ejaculation and erection

• For females, failing to reach an orgasm

• Tiredness

• Loss of weight

• Problems with concentration

• Memory loss

• Absence of emotion or enthusiasm

• Dizziness

• Runny and itchy nose

• Inflammation of the sinuses (pain and pressure in your face, which is worse when you lean forwards, blocked nose, sore throat and cough, headache, fever, earache, toothache or pain in your upper jaw)

• Indigestion/heart burn

• Being sick

• Stomach pain

• Wind

• Increased saliva

• Problems with urination (e.g. controlling urination)

Uncommon (likely to affect up to 1 in every 100 people)

• Bruising easily

• Increased appetite

• Absence op appetite

• Aggression

• A state of optimism

• Cheerfulness and well-being (euphoria)

• General feeling of discomfort or uneasiness

• 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

• Coughing

• Rash

• Sensitivity to sunlight

• Difficulties urinating

• Abnormally heavy and prolonged menstrual period

• 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, e.g. from the vagina, stomach, skin and mucous membranes (the lubricated inner lining of the mouth, nasal passages, vagina and urethra)

• Unintentional and purposeless motions

• Inflammation of the liver (hepatitis)

• Lower amount of blood sodium, predominantly in the elderly (which causes hallucinations, confusion, fits, lack of energy and muscle cramps or weakness)

• Fever

Some patient have reported (frequency not known)

• An increase in bleeding or bruising caused by a decrease in blood platelets

• Low potassium levels in the blood

• Panic attack

• Grinding teeth

• Restlessness

• Unusual muscle movements or stiffness

• Involuntary movements of the muscles (akathisia)

• 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

• Inappropriate ADH secretion (characterised by an excessive production of urine)

• Fits

• Impairment of voluntary movement, i.e. tremor, tics, changes in muscle tone, slowness of movement, involuntary and/or irregular muscle movements that occur in the facial area, restlessness of the arms and legs (akathisia)

• Visual disturbance

• Dizziness when suddenly standing up

• Changes in electric recording heart (ECG QT interval prolonged)

• Bleeding in your stomach or intestine

• Irregular menstrual bleeding

Since withdrawal reactions may occur when the treatment is stopped, it is advised to reduce the dose gradually at intervals of 1-2 weeks.

Withdrawal reactions include: dizziness, pins and needles, electric shock sensations, numbness, sleeplessness, intense dreams, agitation, anxiety, feeling sick or being sick, shaking, confusion, sweating, headache, diarrhoea, faster heartbeat (palpitations), emotional instability, irritability and visual disturbances. Most of the withdrawal reactions are mild and self limiting in nature.

Any side effects that do occur will usually disappear after a few days.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. 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 protect the environment.

What Citalopram Jubilant contains

• The active substances is citalopram. Each Citalopram Jubilant tablet contains 10 mg, 20 mg, 30 mg or 40 mg citalopram (as hydrobromide).

• The other ingredients are:

Tablet core: microcrystalline cellulose (E460), lactose monohydrate, copovidone (E1201), croscarmellose sodium (E468), maize starch, magnesium stearate (E470b), hypromellose (E464), glycerol (E422).

Tablet coating: hypromellose, titanium dioxide (E171), macrogol (E1521).

What Citalopram Jubilant looks like and contents of the pack

Citalopram Jubilant is presented as 10mg, 20mg, 30mg and 40mg film-coated tablets. The tablets are described below.

Citalopram Jubilant 10mg: White, round, film-coated tablets of approximately 5,60 mm diameter, debossed with ‘F7’ on one side and plain on the other side.

Citalopram Jubilant 20 mg: White oval shaped, biconvex, film-coated tablets of approximately 8,15 mm length and 5,65 mm width, with scoreline on one side, debossed with ‘F’ on the left side and ‘8’ on the right side of the scoreline and plain on the other side.

Citalopram Jubilant 30 mg: White, modified capsule shaped, biconvex, film-coated tablets of approximately 11,15 mm length and 5,65 mm width, with scoreline on both sides, debossed with ‘F’ and ‘9’ on either side of the scoreline on one side of the tablets.

Citalopram Jubilant 40 mg: White oval shaped, biconvex, film-coated tablets of approximately 11,65 mm length and 7,15 mm width, with scoreline on one side, debossed with ‘G’ on the left side and ‘1’ on the right side of the scoreline and plain on the other side.

Citalopram Jubilant is available in the following pack sizes:

Alu/PVC/PVDC blister in cardboard box

20, 28, 30, 50, 56, 84, 90, 98 and 100 tablets

Alu/Alu blisters in cardboard box

20, 28, 30, 50, 56, 84, 90, 98 and 100 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer

PSI supply nv

Axxes Business Park

Guldensporenpark 22 – Block C

9820 Merelbeke

Belgium

This medicinal product is authorised in the Member States of the EEA under the following names:

Cyprus : Citalopram Jubilant 20 mg Επικαλυμμένο με λεπτό υμένιο δισκίο

Denmark : Citalopram Jubilant 10 – 20 – 30 – 40 mg Filmovertrukket tablet

Germany : Citalopram Jubilant 10 – 20 – 30 – 40 mg Filmtabletten

The Netherlands : Citalopram Jubilant 10 – 20 – 30 – 40 mg filmomhulde tabletten

Sweden : Citalopram Jubilant 10 – 20 – 30 – 40 mg Filmdragerad tablett

United Kingdom : Citalopram 10 – 20 – 40 mg film-coated tablets

This leaflet was last revised in 2015-01-20, SE takes over as RMS