Cipralex 5, 10, 15, and 20 mg Film-Coated Tablets

Cipralex 5 mg film-coated tablets

Cipralex 10 mg film-coated tablets

Cipralex 15 mg film-coated tablets

Cipralex 20 mg film-coated tablets

Escitalopram

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 Cipralex is and what it is used for


• 2. Before you take Cipralex


• 3. How to take Cipralex


• 4. Possible side effects


• 5. How to store Cipralex


• 6. Further information

What Cipralex Is And What It Is Used For

Cipralex contains escitalopram and is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalised anxiety disorder and obsessive-compulsive disorder).

Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin-system in the brain by increasing the serotonin level. Disturbances in the serotonin-system are considered an important factor in the development of depression and related diseases.

Before You Take Cipralex

Do not take Cipralex

• if you are allergic (hypersensitive) to escitalopram or any of the other ingredients of Cipralex (see section 6 “Further information”).


• If you take other medicines which belongs to a group called MAO inhibitors, including selegiline (used in the treatment of Parkinson´s disease), moclobemide (used in the treatment of depression) and linezolid (an antibiotic).

Take special care with Cipralex

Please tell your doctor if you have any other condition or illness, as your doctor may need to take this into consideration. In particular, tell your doctor:

• if you have epilepsy. Treatment with Cipralex should be stopped if seizures occur or if there is an increase in the seizure frequency (see also section 4 “Possible side effects").


• if you suffer from impaired liver or kidney function. Your doctor may need to adjust your dosage.


• if you have diabetes. Treatment with Cipralex may alter glycaemic control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted.


• If you have a decreased level of sodium in the blood.


• if you have a tendency to easily develop bleedings or bruises.


• if you are receiving electroconvulsive treatment.


• If you have coronary heart disease.

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 to in sitting or standing still can also occur during the first weeks of the treatment. Tell your doctor immediately if you experience these symptoms.

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

Cipralex 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 attempts, suicidal thoughts and hostility (predominately aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe Cipralex for patients under 18 because he/she decides that this is in their best interest. If your doctor has prescribed Cipralex for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any symptoms listed above develop or worsen when patients under 18 are taking Cipralex. Also, the long term safety effects concerning growth, maturation and cognitive and behavioural development of Cipralex in this age group have not yet been demonstrated.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

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

• ”Non-selective monoamine oxidase inhibitors (MAOIs)”, containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active ingredients. If you have taken any of these medicines you will need to wait 14 days before you start taking Cipralex. After stopping Cipralex you must allow 7 days before taking any of these medicines.


• “Reversible, selective MAO-A inhibitors”, containing moclobemide (used to treat depression).


• “Irreversible MAO-B inhibitors”, containing selegiline (used to treat Parkinson’s disease). These increase the risk of side effects.


• The antibiotic linezolid.


• Lithium (used in the treatment of manic-depressive disorder) and tryptophan.


• Imipramine and desipramine (both used to treat depression).


• Sumatriptan and similar medicines (used to treat migraine) and tramadol (used against severe pain). These increase the risk of side effects.


• Cimetidine and omeprazole (used to treat stomach ulcers), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke). These may cause increased blood levels of Cipralex.


• St. John's Wort (Hypericum perforatum) - a herbal remedy used for depression.


• Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (medicines used for pain relief or to thin the blood, so called anticoagulants).


• Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so called anticoagulants). Your doctor will probably check the coagulation time of your blood when starting and discontinuing Cipralex in order to verify that your dose of anticoagulant is still adequate.


• Mefloquin (used to treat Malaria), bupropion (used to treat depression) and tramadol (used to treat severe pain) due to a possible risk of a lowered threshold for seizures.


• Neuroleptics (medicines to treat schizophrenia, psychosis) due to a possible risk of a lowered threshold for seizures, and antidepressants.


• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases) clomipramine, and nortriptyline (antidepressants) and risperidone, thioridazine, and haloperidol (antipsychotics). The dosage of Cipralex may need to be adjusted.

Taking Cipralex with food and drink

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

As with many medicines, combining Cipralex with alcohol is not advisable, although Cipralex is not expected to interact with alcohol.

Pregnancy and breast-feeding

Inform your doctor if you are pregnant or planning to become pregnant. Do not take Cipralex if you are pregnant unless you and your doctor have discussed the risks and benefits involved.

If you take Cipralex during the last 3 months of your pregnancy you should be aware that the following effects may be seen in your newborn baby: trouble with breathing, bluish skin, fits, body temperature changes, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, vivid reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness and sleeping difficulties. If your newborn baby has any of these symptoms, please contact your doctor immediately.

If used during pregnancy Cipralex should never be stopped abruptly.

Do not take Cipralex if you are breast-feeding unless you and your doctor have discussed the risks and benefits involved.

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

Driving and using machines

You are advised not to drive a car or operate machinery until you know how Cipralex affects you.

How To Take Cipralex

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

Adults

Depression

The normally recommended dose of Cipralex is 10 mg taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg per day.

Panic disorder

The starting dose of Cipralex is 5 mg as one daily dose for the first week before increasing the dose to 10 mg per day. The dose may be further increased by your doctor to a maximum of 20 mg per day.

Social anxiety disorder

The normally recommended dose of Cipralex is 10 mg taken as one daily dose. Your doctor can either decrease your dose to 5 mg per day or increase the dose to a maximum of 20 mg per day, depending on how you respond to the medicine.

Generalised anxiety disorder

The normally recommended dose of Cipralex is 10 mg taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg per day.

Obsessive-compulsive disorder

The normally recommended dose of Cipralex is 10 mg taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg per day.

Elderly patients (above 65 years of age)

The normally recommended starting dose of Cipralex is 5 mg taken as one daily dose.

Children and adolescents (below 18 years of age)

Cipralex should not normally be given to children and adolescents. For further information please see section 2 “Before you take Cipralex”.

You can take Cipralex with or without food. Swallow the tablet with some water. Do not chew them, as the taste is bitter.

If necessary, you can divide the tablets by firstly placing the tablet on a flat surface with the score facing upwards. The tablets may then be broken by pressing down on each end of the tablet, using both forefingers as shown in the drawing.

Duration of treatment

It may take a couple of weeks before you start to feel better. Continue to take Cipralex even if it takes some time before you feel any improvement in your condition.

Do not change the dose of your medicine without talking to your doctor first.

Continue to take Cipralex for as long as your doctor recommends. If you stop your treatment too soon, your symptoms may return. It is recommended that treatment should be continued for at least 6 months after you feel well again.

If you take more Cipralex than you should

If you take more than the prescribed dose of Cipralex, contact your doctor or nearest hospital emergency department immediately. Do this even if there are no signs of discomfort. Some of the signs of an overdose could be dizziness, tremor, agitation, convulsion, coma, nausea, vomiting, change in heart rhythm, decreased blood pressure and change in body fluid/salt balance. Take the Cipralex box/container with you when you go to the doctor or hospital.

If you forget to take Cipralex

Do not take a double dose to make up for forgotten doses. If you do forget to take a dose, and you remember before you go to bed, take it straight away. Carry on as usual the next day. If you only remember during the night, or the next day, leave out the missed dose and carry on as usual.

If you stop taking Cipralex

Do not stop taking Cipralex until your doctor tells you to do so. When you have completed your course of treatment, it is generally advised that the dose of Cipralex is gradually reduced over a number of weeks.

When you stop taking Cipralex, especially if it is abruptly, you may feel discontinuation symptoms. These are common when treatment with Cipralex is stopped. The risk is higher, when Cipralex has been used for a long time or in high doses or when the dose is reduced too quickly. Most people find that the symptoms are mild and go away on their own within two weeks. However, in some patients they may be severe in intensity or they may be prolonged (2-3 months or more). If you get severe discontinuation symptoms when you stop taking Cipralex, please contact your doctor. He or she may ask you to start taking your tablets again and come off them more slowly.

Discontinuation symptoms include: Feeling dizzy (unsteady or off-balance), feelings like pins and needles, burning sensations and (less commonly) electric shock sensations, including in the head, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headaches, feeling sick (nausea), sweating (including night sweats), feeling restless or agitated, tremor (shakiness), feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations).

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

Possible Side Effects

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

The side effects usually disappear after a few weeks of treatment. Please be aware that many of the effects may also be symptoms of your illness and therefore will improve when you start to get better.

See your doctor if you get any of the following side effects during treatment:

Uncommon (more than 1 out of 1000 persons and less than 1 out of 100 persons):

• Unusual bleeds, including gastrointestinal bleeds

Rare (more than 1 out of 10000 and less than 1 out of 1000 persons):

• If you experience swelling of skin, tongue, lips, or face, or have difficulties breathing or swallowing (allergic reaction), contact your doctor or go to a hospital straight away.


• If you have a high fever, agitation, confusion, trembling and abrupt contractions of muscles these may be signs of a rare condition called serotonin syndrome. If you feel like this contact your doctor.

If you experience the following adverse events you should contact your doctor or go to the hospital straight away:

• Difficulties urinating


• Seizures (fits), see also section Take special care with Cipralex


• Yellowing of the skin and the white in the eyes are signs of liver function impairment/hepatitis

In addition to above the following side effects have been reported:

Very common (more than 1 out of 10 persons):

• Feeling sick (nausea)

Common (more than 1 out of 100 persons and less than 1 out of 10 persons):

• Blocked or runny nose (sinusitis)


• Decreased or increased appetite


• Anxiety, restlessness, abnormal dreams, difficulties falling asleep, feeling sleepy, dizziness, yawning, tremors, prickling of the skin


• Diarrhoea, constipation, vomiting, dry mouth


• Increased sweating


• Pain in muscle and joints (arthralgia and myalgia)


• Sexual disturbances (delayed ejaculation, problems with erection, decreased sexual drive and women may experience difficulties achieving orgasm)


• Fatigue, fever


• Increased weight

Uncommon (more than 1 out of 1000 persons and less than 1 out of 100 persons):

• Nettle rash (urticaria), rash, itching (pruritus)


• Grinding one’s teeth, agitation, nervousness, panic attack, confusion state


• Disturbed sleep, taste disturbance, fainting (syncope)


• Enlarged pupils (mydriasis), visual disturbance, ringing in the ears (tinnitus)


• Loss of hair


• Vaginal bleeding


• Decreased weight


• Fast heart beat


• Swelling of the arms or legs


• Nosebleeds

Rare (more than 1 out of 10000 and less than 1 out of 1000 persons):

• Aggression, depersonalisation, hallucination


• Slow heart beat

Some patients have reported (frequency not known):

• Thoughts of harming yourself or thoughts of killing yourself, see also section “Take special care with Cipralex”


• Decreased levels of sodium in the blood (the symptoms are feeling sick and unwell with weak muscles or confused)


• Dizziness when you stand up due to low blood pressure (orthostatic hypotension)


• Abnormal liver function test (increased amounts of liver enzymes in the blood)


• Movement disorders (involuntary movements of the muscles)


• Painful erections (priapism)


• Bleeding disorders including skin and mucous bleeding (ecchymosis) and low level of blood platelets (thrombycytopenia)


• Sudden swelling of skin or mucosa (angioedemas)


• Increase in the amount of urine excreted (inappropriate ADH secretion)


• Flow of milk in women that are not nursing


• Mania

In addition, a number of side effects are known to occur with drugs that work in a similar way to escitalopram (the active ingredient of Cipralex). These are:

• Motor restlessness (akathisia)


• Anorexia

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.

How To Store Cipralex

Keep out of the reach and sight of children.

Do not use Cipralex after the expiry date, which is stated on the label or carton after EXP. The expiry date refers to the last day of the month.

This medicinal product does not require any special storage conditions.

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 Cipralex contains

The active substance is escitalopram. Each Cipralex tablet contains 5 mg, 10 mg, 15 mg or 20 mg escitalopram (as oxalate).

The other ingredients are:

Core: microcrystalline cellulose, colloidal anhydrous silica, talc, croscarmellose sodium and magnesium stearate.

Coating: hypromellose, macrogol 400 and titanium dioxide (E 171).

What Cipralex looks like and contents of the pack

Cipralex is presented as 5 mg, 10 mg, 15 mg and 20 mg film-coated tablets. The tablets are described below.

5 mg: Round, white biconvex film-coated tablets marked with “EK” on one side.

10 mg: Oval, white film-coated tablets. The tablets are scored and marked with “E” and “L” on each side of the score on one side of the tablet.

15 mg: Oval, white film-coated tablets. The tablets are scored and marked with “E” and “M” on each side of the score on one side of the tablet.

20 mg: Oval, white film-coated tablets. The tablets are scored and marked with “E” and “N” on each side of the score on one side of the tablet.

Cipralex is available in the following pack sizes:

Blister (transparent) in cardboard box

5, 10, 15 and 20 mg : 14, 28, 56 and 98 tablets

Blisters (white) in cardboard box

5, 10, 15 and 20 mg: 14, 20, 28, 50, 100 and 200 tablets

Polypropylene container

15 and 20 mg: 100 tablets

5 and 10 mg: 100 and 200 tablets

Unit dose:

5, 10, 15 and 20 mg: 49x1, 56x1, 98x1, 100x1 and 500x1 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

H Lundbeck A/S

Ottiliavej 9

DK-2500 Copenhagen

Denmark

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

Austria: Cipralex

Belgium: Sipralexa

Bulgaria: Cipralex

Cyprus: Cipralex

Czech Republic: Cipralex

Denmark: Cipralex

Estonia: Cipralex

Finland: Cipralex

France: Seroplex

Germany: Cipralex

Greece: Cipralex

Hungary: Cipralex

Iceland: Cipralex

Ireland: Lexapro

Italy: Cipralex

Latvia: Cipralex

Lithuania: Cipralex

Luxembourg: Sipralexa

Malta: Cipralex

The Netherlands: Cipralex

Norway: Cipralex

Poland: Cipralex

Portugal: Cipralex

Romania: Cipralex

Slovakia: Cipralex

Slovenia: Cipralex

Spain: Cipralex

Sweden: Cipralex

United Kingdom: Cipralex

This leaflet was approved: 09/04/2008