Cipralex 15 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cipralex 15 mg film-coated tablets

escitalopram

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

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

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Cipralex is and what it is used for
2. What you need to know before taking Cipralex
3. How to take Cipralex
4. Possible side effects
5. How to store Cipralex
6. Contents of the pack and other information

1. What Cipralex is and what it is used for

Cipralex contains the active substance escitalopram. Cipralex belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).

Cipralex is indicated for the treatment of depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder).

It may take a couple of weeks before you start to feel better. Continue taking Cipralex even if it takes some time to notice improvement.

You should consult a doctor if your condition worsens or if you do not improve.

2. What you need to know before taking Cipralex

Do not take Cipralex

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

• If you are taking other medicines belonging to the group called monoamine oxidase inhibitors (MAOIs), including selegiline (used for the treatment of Parkinson's disease), moclobemide (used for the treatment of depression), and linezolid (an antibiotic).

• If you have been born with or have experienced an episode of irregular heart rhythm (detected on an ECG, a test that evaluates heart function).

• If you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm (see section 2 “Taking Cipralex with other medicines”).

Warnings and precautions

Talk to your doctor or pharmacist before taking Cipralex.

Please inform your doctor if you have any other disorder or illness, as your doctor may need to take this into account. Specifically, tell your doctor:

• If you have epilepsy. Treatment with Cipralex should be discontinued if you experience seizures for the first time or notice an increase in seizure frequency (see also section 4 “Possible side effects”).
• If you have hepatic or renal impairment. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Cipralex may alter glycaemic control. A dose adjustment of insulin and/or oral hypoglycaemic agents may be necessary.
• If you have low sodium levels in the blood.
• If you have a history of bleeding disorders or develop unusual bruising, or if you are pregnant (see “Pregnancy, breastfeeding and fertility”).
• If you are receiving electroconvulsive therapy.
• If you have coronary artery disease.
• If you have or have had heart problems or have recently had a heart attack.
• If your resting heart rate is slow and/or you know you may have low levels of salt due to severe and prolonged diarrhoea and vomiting (being unwell) or use of diuretics.
• If you experience rapid or irregular heartbeats, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm.
• If you have or have previously had eye problems, such as certain types of glaucoma (increased pressure in the eye).

Please note:

Some patients with bipolar disorder may enter a manic phase. This is characterised by unusually rapid and frequent changes of thought, excessive happiness, and excessive physical activity. If you experience this, contact your doctor.

Symptoms such as restlessness or difficulty sitting or standing still may also occur during the first few weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Medicines like Cipralex (also known as SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may occasionally have thoughts about harming yourself or committing suicide. These thoughts may increase when you first start taking antidepressants, as all these medicines require time to begin working—usually about two weeks, although in some cases it may take longer. You are more likely to have such thoughts:

• If you have previously had thoughts of harming or killing yourself.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age treated with an antidepressant.

If at any time you have thoughts of harming or killing yourself, contact your doctor or go directly to a hospital.

It may be helpful for you to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them whether they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your behaviour.

Children and adolescents

Cipralex should not normally be used to treat children and adolescents under 18 years of age. Also, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, confrontation behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Cipralex to patients under 18 years of age if they decide it is the most appropriate treatment. If your doctor has prescribed Cipralex to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You must inform your doctor if any of the symptoms described above worsen or complications arise while patients under 18 years of age are taking Cipralex. In addition, the long-term safety effects of Cipralex on growth, maturation, and cognitive and behavioural development in this age group have not yet been established.

Taking Cipralex with other medicines

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

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

• “Non-selective monoamine oxidase inhibitors (MAOIs)” containing phenelzine, iproniazid, isocarboxazide, nialamide, or tranylcypromine as active ingredients. If you have taken any of these medicines, you must wait 14 days before starting Cipralex. After stopping Cipralex, you must wait 7 days before taking any of these medicines.

• “Reversible selective MAO-A inhibitors” containing moclobemide (used in the treatment of depression).

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

• The antibiotic linezolid.

  • Lithium (used in the treatment of bipolar disorder) and tryptophan.
  • Imipramine and desipramine (both used for the treatment of depression).
  • Sumatriptan and similar medicines (used for the treatment of migraine) and tramadol and similar medicines (opioids, used for severe pain). These increase the risk of side effects.
  • Cimetidine, lansoprazole, and omeprazole (used for the treatment of stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause increased blood levels of escitalopram.
  • St. John’s wort (Hypericum perforatum) – a herbal remedy used for depression.
  • Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or reduce the risk of thrombosis, also called anticoagulants). These may increase the tendency to bleed.

• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will likely monitor your blood clotting time at the beginning and end of Cipralex treatment to ensure your anticoagulant dose remains appropriate.

• Mefloquine (used for the treatment of malaria), bupropion (used for the treatment of depression), and tramadol (used for the treatment of severe pain) due to the possible risk of lowering the seizure threshold.

• Neuroleptics (medicines used for the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the seizure threshold.

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

• Medicines that reduce blood potassium or magnesium levels, as this increases the risk of life-threatening heart rhythm disturbances.

Do not take Cipralex if you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm, e.g. Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarial treatments particularly halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine). Contact your doctor for any further questions.

Taking Cipralex with food, drinks and alcohol

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 recommended, although an interaction between Cipralex and alcohol is not expected.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

If you take Cipralex during the last 3 months of pregnancy, the following effects may occur in the newborn baby: breathing difficulties, bluish skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, exaggerated reflexes, tremors, restlessness, irritability, lethargy, constant crying, drowsiness, and sleep difficulties. If your newborn baby shows any of these symptoms, please contact your doctor immediately.

Ensure that your midwife and/or doctor know you are being treated with Cipralex.

During pregnancy, particularly in the last 3 months, medicines like Cipralex may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually begin within the first 24 hours after birth. If they occur in your baby, contact your midwife and/or doctor immediately.

If you take Cipralex late in pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know you are taking Cipralex so they can advise you.

If Cipralex is used during pregnancy, it should never be stopped abruptly.

Escitalopram is expected to be excreted in breast milk.

Citalopram, a medicine similar to escitalopram, has been shown to reduce sperm quality in animal models. Theoretically, this effect could affect fertility, but to date, no impact on human fertility has been observed.

Driving and using machines

It is advised not to drive or operate machinery until you know how Cipralex affects you.

Cipralex contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Cipralex

Follow exactly the instructions for using this medicine as given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Adults

Depression

The normally recommended dose of Cipralex is 10 mg taken as a single daily dose. Your doctor may increase this up to a maximum of 20 mg per day.

Panic disorder

The initial dose of Cipralex is 5 mg as a single daily dose for the first week before increasing the dose to 10 mg per day. Your doctor may subsequently increase the dose up to a maximum of 20 mg per day.

Social anxiety disorder

The normally recommended dose of Cipralex is 10 mg taken as a single daily dose. Your doctor may reduce your dose to 5 mg per day or increase it up to a maximum of 20 mg per day, depending on how you respond to the medication.

Generalized anxiety disorder

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

Obsessive-compulsive disorder

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

Elderly patients (over 65 years of age)

The recommended starting dose of Cipralex is 5 mg taken as a single daily dose. The dose may be increased by your doctor to 10 mg per day.

Use in children and adolescents

Cipralex should not normally be given to children and adolescents. For further information, please see section 2 “Warnings and precautions”.

Renal impairment

Caution is advised in patients with severely reduced kidney function. Take as prescribed by your doctor.

Hepatic impairment

Patients with liver problems should not receive more than 10 mg per day. Take as prescribed by your doctor.

Patients considered as slow metabolizers of CYP2C19

Patients with this known genotype should not receive more than 10 mg per day. Take as prescribed by your doctor.

How to take the tablets

You may take Cipralex with or without food. Swallow the tablets with water. Do not chew them, as they have a bitter taste.

If necessary, the 15 mg tablets can be divided by placing the tablet on a flat surface with the score side facing upwards. The tablets can be split by pressing down on each end of the tablet with the two index fingers, as shown in the figure.

The 15 mg tablets can be divided into equal doses.

Duration of treatment

It may take a few weeks before you start to feel better. Continue taking Cipralex even if you start to feel better before the expected time.

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

Continue taking Cipralex for as long as your doctor recommends. If you stop treatment too early, symptoms may return. It is recommended that treatment continues for at least 6 months after you feel well again.

If you take more Cipralex than you should

If you take more Cipralex than prescribed, contact your doctor immediately, go to the nearest hospital emergency department, or contact the Toxicology Information Service at telephone 915.620.420. Do this even if you do not notice any discomfort or signs of poisoning. Some signs of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and disturbances in the body's fluid and electrolyte balance. Take the Cipralex packaging with you if you go to see a doctor or to the hospital.

If you forget to take Cipralex

Do not take a double dose to make up for missed doses. If you forget to take a dose and remember before going to bed, take it immediately. The next day, continue as usual. If you remember during the night or the following day, skip the missed dose and continue as usual.

If you stop taking Cipralex

Do not stop taking Cipralex until your doctor tells you to. When you have completed your course of treatment, it is generally recommended that the dose of Cipralex be gradually reduced over several weeks.

When you stop taking Cipralex, especially if abruptly, you may experience withdrawal symptoms. These are common when treatment with Cipralex is stopped. The risk is greater when Cipralex has been used for a long time, at high doses, or when the dose is reduced too quickly. Most people find that these symptoms are mild and disappear on their own within two weeks. However, in some patients, they may be severe or prolonged (2–3 months or more). If you experience severe withdrawal symptoms when stopping Cipralex, please contact your doctor. He or she may advise you to restart taking your tablets and then stop more gradually.

Withdrawal symptoms include: dizziness (feeling unsteady or off balance), tingling sensations, burning sensations, and (less frequently) electric shock-like sensations, even in the head; sleep disturbances (overly vivid dreams, nightmares, inability to sleep); restlessness, headache, dizziness (nausea), sweating (including night sweats), feelings of unease or agitation, tremor (shakiness), feelings of confusion or disorientation, emotional or irritable feelings, diarrhea (loose stools), visual disturbances, rapid pulse, or palpitations.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects usually disappear after a few weeks of treatment. Please be aware that many of these effects may be symptoms of your illness and will therefore improve as you start to feel better.

If you experience any of the following symptoms, contact your doctor or go to hospital immediately:

Uncommon (may affect up to 1 in 100 people):

• Unusual bleeding, including gastrointestinal bleeding.

Rare (may affect up to 1 in 1,000 people):

• Swelling of the skin, tongue, lips, throat, or face, hives, or difficulty breathing or swallowing (severe allergic reaction).
• High fever, agitation, confusion, tremors, and sudden muscle contractions, which may be signs of a rare condition called serotonin syndrome.

Not known (frequency cannot be determined from available data):

• Difficulty urinating.
• Seizures (fits); see also section “Warnings and precautions”.
• Yellowing of the skin or whites of the eyes, signs of liver dysfunction/hepatitis.
• If you experience rapid or irregular heartbeats or fainting, symptoms which may indicate a life-threatening condition known as Torsade de Pointes.
• Thoughts of harming yourself or thoughts of killing yourself; see also section “Warnings and precautions”.
• Sudden swelling of the skin or mucous membranes (angioedema).

In addition to the above, the following adverse effects have been reported:

Very common (may affect more than 1 in 10 people):

• Feeling nauseous (nausea).
• Headache.

Common (may affect up to 1 in 10 people):

• Nasal congestion or mucus (sinusitis).

• Decreased or increased appetite.

• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, feeling drowsy, yawning, tremors, skin itching.

  • Diarrhea, constipation, vomiting, dry mouth.

• Increased sweating.

• Muscle and joint pain (arthralgia and myalgia).

• Sexual disturbances (delayed ejaculation, erectile problems, reduced sexual drive, and women may experience difficulty reaching orgasm).

• Fatigue, fever.

• Weight gain.

Uncommon (may affect up to 1 in 100 people):

• Hives, skin rash, itching (pruritus).

• Teeth grinding, restlessness, nervousness, panic attacks, confusion.

• Sleep disturbances, taste disturbances, fainting (syncope).

• Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus).

• Hair loss.

• Excessive menstrual bleeding.

• Irregular menstrual periods.

• Weight loss.

• Rapid heartbeat.

• Swelling of arms and legs.

• Nosebleeds.

Rare (may affect up to 1 in 1,000 people):

• Aggression, depersonalization, hallucinations.
• Slow heart rate.

Not known (frequency cannot be determined from available data):

• Decreased sodium levels in the blood (symptoms include dizziness and malaise with muscle weakness or confusion).
• Dizziness upon standing due to low blood pressure (orthostatic hypotension).
• Abnormal liver function tests (elevated liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Signs of abnormal bleeding, e.g., of the skin or mucous membranes (bruising) and low platelet count in the blood (thrombocytopenia).
• Increased secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, reducing sodium levels (inappropriate ADH secretion).
• Increased levels of prolactin hormone in the blood.
• Milk production in men and in women who are not breastfeeding.
• Mania.
• An increased risk of bone fractures has been observed in patients treated with this type of medicine.
• Changes in heart rhythm (known as “prolongation of the QT interval”, seen on ECG, electrical activity of the heart).
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for more information.

Other adverse effects are known to occur with drugs that act similarly to escitalopram (the active substance in Cipralex). These include:

• Motor restlessness (akathisia).
• Loss of appetite.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cipralex

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cipralex

The active substance is escitalopram.

Each Cipralex tablet contains 15 mg of escitalopram (as oxalate).

The other components are:

Core: silicified microcrystalline cellulose, talc, sodium croscarmellose, and magnesium stearate.

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

Appearance of the product and contents of the pack

Cipralex 15 mg is presented as film-coated tablets.

The tablets are white, oval, biconvex, scored, film-coated, measuring 9.8 x 6.3 mm, and marked with "E" and "M" on either side of the score line on one side of the tablet.

The 15 mg tablets can be divided into equal doses.

Cipralex 15 mg is available in the following pack sizes:

Blister packs, included in a carton: 14, 28, 56, and 98 tablets.

Unit dose packs: 49x1, 56x1, 98x1, 100x1, and 500x1 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Lundbeck España, S.A.
Av. Diagonal, 605, 7º 2ª
08028 Barcelona
Spain

Manufacturer

• Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark

This medicinal product has been authorized 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
Netherlands: Lexapro
Hungary: Cipralex
Iceland: Cipralex
Ireland: Lexapro
Italy: Cipralex
Lithuania: Cipralex
Luxembourg: Sipralexa
Malta: Cipralex
Norway: Cipralex
Poland: Cipralex
Portugal: Cipralex
Romania: Cipralex
Slovakia: Cipralex
Slovenia: Cipralex
Spain: Cipralex
Sweden: Cipralex
United Kingdom: Cipralex

Date of the most recent review of this summary: November 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/