Cipralex 20 mg/ml oral solution drops

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Cipralex 20 mg/ml Oral drops solution

escitalopram

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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 contains escitalopram and 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) in adults over 18 years of age.

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 you worsen or do not improve.

2. What you need to know before taking Cipralex

Do not take Cipralex

• If you are allergic to escitalopram or 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 were born with or have had an episode of heart rhythm disorder (detected on an ECG, a test that evaluates heart function).

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

Warnings and precautions

Talk to your doctor or pharmacist before you start 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. Adjustment of insulin and/or oral hypoglycaemic agent dosage 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 recently suffered a heart attack.
• If your resting heart rate is slow and/or you know you may have low levels of salts 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 racing thoughts, 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 of harming or killing yourself. These may increase when starting 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 killing or harming yourself.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in antidepressant-treated psychiatric patients under 25 years of age.

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 in the treatment of 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 (predominantly 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 most appropriate for the patient. If your doctor has prescribed Cipralex to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. 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 effects on safety and on growth, maturation, and cognitive and behavioural development of Cipralex 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, isocarboxazid, 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, 7 days must pass before starting 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 the 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 in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of Cipralex may need to be adjusted.

• Medicines that reduce potassium or magnesium levels in the blood, 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 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, antimalarials 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 interaction between Cipralex and alcohol is not expected.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 be observed 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 that 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 must 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

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

Cipralex 20 mg/ml oral drops solution contains alcohol.

This medicine contains 100 mg of alcohol (96% ethanol) per ml, equivalent to 11.8% v/v. The amount in 1 ml of this medicine is equivalent to less than 3 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have any notable effect.

Cipralex 20 mg/ml oral drops solution contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per ml; hence, it is essentially “sodium-free”.

3. How to take Cipralex

Follow exactly the instructions for using this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Turn the bottle completely upside down. If drops do not come out, gently tap the base of the bottle to start the flow.

Put the required number of drops into your drink (water, orange juice or apple juice), gently shake and then drink it all.

Cipralex Oral Drops must not be mixed with other liquids or with other medicines.

Adults

Depression

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

Panic disorder

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

Social anxiety disorder

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

Generalised anxiety disorder

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

Obsessive-compulsive disorder

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

Elderly patients (over 65 years of age)

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

Children and adolescents

Cipralex should not normally be given to children and adolescents. For further information, please see section 2 “What you need to know before taking Cipralex”.

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 to be slow metabolisers of CYP2C19

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

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 the length of time recommended by your doctor. 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, telephone 915.620.420. Do this even if you do not notice any discomfort or signs of poisoning. Some of the signs of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rate, decreased blood pressure, and disturbances in the body's fluid and electrolyte balance. Take the Cipralex container with you if 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 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 treatment with 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 Cipralex treatment 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 resolve on their own within two weeks. However, in some patients they may be severe or prolonged (2–3 months or more). If you have severe withdrawal symptoms when stopping Cipralex, please contact your doctor. He or she may ask you to restart your drops and taper off more slowly.

Withdrawal symptoms include: dizziness (feeling unsteady or off balance), tingling sensations, burning sensations, and (less commonly) electric shock-like sensations, even in the head; sleep disturbances (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; feelings of emotional lability or irritability; diarrhoea (loose stools); visual disturbances; 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 have 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, or face, 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 and whites of the eyes, signs of liver dysfunction/hepatitis.
• If you experience rapid or irregular heartbeat 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 those listed above, the following adverse effects have been reported:

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

• Feeling dizzy (nausea).
• Headache.

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

• Nasal congestion or runny nose (sinusitis).

• Decreased or increased appetite.

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

  • Diarrhea, constipation, vomiting, dry mouth.

• Increased sweating.

• Muscle and joint pain (arthralgia and myalgia).

• Sexual disturbances (delayed ejaculation, erection problems, reduced sexual activity; 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 increased bleeding, e.g., bruising of the skin or mucous membranes (ecchymosis) and low platelet count in the blood (thrombocytopenia).
• Sudden swelling of the skin or mucous membranes (angioedema).
• Increased secretion of a hormone called ADH, causing the body to retain water and dilute the blood, reducing sodium levels (inappropriate antidiuretic hormone 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,” observed on ECG, the heart's electrical activity).
• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for more information.

In addition, other adverse effects are known to occur with drugs that act similarly to escitalopram (the active ingredient 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 is the last day of the month indicated.

After opening the container, the drops may be used for 8 weeks and should be stored below 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cipralex

The active substance is escitalopram. Each ml of Cipralex oral drops contains 20 mg of the active substance escitalopram (as escitalopram oxalate).

1 drop contains 1 mg of escitalopram.

The other components are:

Propyl gallate

Anhydrous citric acid

Ethanol 96%

Sodium hydroxide

Purified water

Appearance of the product and contents of the container

Cipralex Oral Drops solution is supplied in a 15 ml amber glass bottle with a dropper.

Cipralex Oral Drops solution is a clear, almost colourless to yellowish solution.

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 was authorized in the EEA Member States under the following names:

Czech Republic: Cipralex 20mg/ml

Denmark: Cipralex

Finland: Cipralex

France: Seroplex

Germany: Cipralex 20mg/ml Tropfen zum Einnehmen, Losung

Greece: Cipralex

Italy: Cipralex

Norway: Cipralex

Portugal: Cipralex

Spain: Cipralex

Sweden: Cipralex

United Kingdom: Cipralex

Date of the most recent review of this leaflet: December 2023

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/