Escitalopram Normon 15 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Escitalopram Normon 15 mg film-coated tablets EFG

Escitalopram oxalate

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 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. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, including any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Escitalopram Normon is and what it is used for

Escitalopram Normon contains the active substance escitalopram. Escitalopram belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain by increasing the level of serotonin. Disturbances in the serotonin system are considered an important factor in the development of depression and related disorders.

Escitalopram Normon 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 Escitalopram Normon even if it takes some time before you notice any improvement.

Consult a doctor if you worsen or do not improve.

2. What you need to know before taking Escitalopram Normon

Do not take Escitalopram Normon

• If you are allergic (hypersensitive) to escitalopram or to any of the other components of Escitalopram Normon (listed in section 6).
• If you are taking other medicines belonging to the group known as MAO inhibitors, 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 experienced an episode of heart rhythm disorder (detected on an ECG, a test that evaluates heart function).
• If you are taking medicines for heart rhythm disorders or medicines that may affect heart rhythm (see section 2 “Use of Escitalopram Normon with other medicines”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Escitalopram Normon

Please inform your doctor if you have any other disorders or illnesses, as your doctor may need to take them into account. Specifically, tell your doctor:

• If you have epilepsy. Treatment with Escitalopram Normon 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 Escitalopram Normon may alter glycaemic control. Adjustment of insulin and/or oral hypoglycaemic agent dosage may be necessary.
• If you have low sodium levels in your blood.
• If you are prone to bleeding or bruising easily, 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 salt levels due to severe and prolonged diarrhoea and vomiting (while ill) or use of diuretics.
• If you experience rapid or irregular heartbeats, fainting, collapse, or dizziness upon standing, as these 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 characterized by unusually rapid and frequent changes in 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 Escitalopram Normon (also known as SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of 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 such medicines require time to take effect—usually about two weeks, although in some cases 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 help to inform a close family member or 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

Escitalopram Normon should not normally be used in the treatment of children and adolescents under 18 years of age. Also, be aware 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, confrontational behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Escitalopram Normon to patients under 18 years of age if they decide it is most appropriate for the patient. If your doctor has prescribed Escitalopram Normon to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms described above worsen or complications arise while patients under 18 years of age are taking Escitalopram Normon. In addition, the long-term effects on safety, growth, maturation, and cognitive and behavioural development of Escitalopram Normon in this age group have not yet been established.

Other medicines and Escitalopram Normon

Inform 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 Escitalopram Normon. After stopping Escitalopram Normon, 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 (used for severe pain). These increase the risk of side effects.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may increase escitalopram blood levels.
• 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 treatment with Escitalopram Normon 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, 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 Escitalopram Normon may need to be adjusted.
• Medicines that reduce potassium or magnesium levels in blood, as this increases the risk of life-threatening heart rhythm disturbances.

Do not take Escitalopram Normon if you are taking medicines for heart rhythm disorders or medicines that may affect heart rhythm, such as 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, mizolastine). Contact your doctor for any further questions.

Taking Escitalopram Normon with food, drinks, and alcohol

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

As with many medicines, combining Escitalopram Normon with alcohol is not recommended, although no interaction between Escitalopram Normon and alcohol is 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 Escitalopram Normon if you are pregnant or breastfeeding unless you and your doctor have discussed the risks and benefits involved.

If you take Escitalopram Normon in late 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 be aware that you are taking Escitalopram Normon so they can advise you.

If you take Escitalopram Normon 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 your midwife and/or doctor know you are being treated with Escitalopram Normon. During pregnancy, particularly in the last 3 months, medicines like Escitalopram Normon may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes faster and turns blue. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

If Escitalopram Normon 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 effect on human fertility has been observed.

Driving and using machines

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

3. How to take Escitalopram Normon

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

Adults

Depression

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

Panic disorder

The initial dose of Escitalopram Normon 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 it up to a maximum of 20 mg per day.

Social anxiety disorder

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

Generalized anxiety disorder

The normally recommended dose of Escitalopram Normon 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 Escitalopram Normon 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 (over 65 years of age)

The recommended initial dose of Escitalopram Normon is 5 mg taken as a single daily dose. The dose may be increased by your doctor up to 10 mg per day.

Children and adolescents (under 18 years of age)

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

How to take the tablets

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

If necessary, you may split the tablets by placing the tablet on a flat surface with the score facing upwards. The tablets can be broken by pressing down on each end of the tablet with the two index fingers.

Duration of treatment

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

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

Continue taking Escitalopram Normon 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 have recovered.

If you take more Escitalopram Normon than you should

If you take more Escitalopram Normon than prescribed, contact your doctor immediately, go to the nearest hospital emergency department, or contact the Poison Information Service at telephone number 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 Escitalopram Normon packaging with you if you go to the doctor or hospital.

If you forget to take Escitalopram Normon

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 Escitalopram Normon

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

When you stop taking Escitalopram Normon, especially if abruptly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram Normon is discontinued. The risk is greater when Escitalopram Normon 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 Escitalopram Normon, please contact your doctor. He or she may ask you to resume taking your tablets and then taper off more slowly.

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 uneasiness or agitation; tremor (shakiness); feelings of confusion or disorientation; feelings of emotion or irritability; 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 will experience 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, you must 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.

Unknown frequency (cannot be estimated 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 suicide; see also section “Warnings and precautions”.

• Sudden swelling of the skin or mucous membranes (angioedema).

• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2 “Pregnancy, breastfeeding and fertility” for more information.

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

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

• Feeling sick (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, dizziness, yawning, tremors, skin itching.
• Diarrhoea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual disturbances (delayed ejaculation, problems with erection, reduced sexual behaviour; women may experience difficulty achieving 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.
• Fast heartbeat.
• Swelling of arms and legs.
• Nosebleeds.

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

• Aggression, depersonalisation, hallucinations.
• Slow heartbeat.

Unknown frequency (cannot be estimated from available data):

• Decreased sodium levels in the blood (symptoms include dizziness, feeling unwell, muscle weakness, or confusion).
• Dizziness upon standing due to low blood pressure (orthostatic hypotension).
• Abnormal liver function tests (increased liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Signs of abnormal bleeding, e.g. under the skin or mucous membranes (bruising, or ecchymosis).
• Increased secretion of the hormone called ADH, causing water retention in the body and blood dilution, leading to reduced sodium levels (inappropriate antidiuretic hormone secretion, or SIADH).
• 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 electrocardiogram).

Other adverse effects are known to occur with medicines that act similarly to escitalopram (the active substance in Escitalopram Normon). 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 Escitalopram Normon

Keep out of sight and reach of children.

Store below 30 ºC.

Do not use Escitalopram Normon after the expiry date shown on the packaging after EXP. The expiry date is the last day of the month indicated.

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

6. Additional Information

Composition of Escitalopram Normon

The active substance is escitalopram.

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

The other components are:

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

Coating: hypromellose, macrogol 6000, titanium dioxide (E-171) and talc.

Appearance of the product and contents of the pack

Escitalopram Normon 15 mg is presented as film-coated tablets.

Escitalopram Normon 15 mg film-coated tablets are white or almost white, round, biconvex, scored tablets with imprinting, available in packs of 28 and 56 tablets.

Marketing Authorisation Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Spain

OTHER PRESENTATIONS

Escitalopram Normon 10 mg film-coated tablets EFG

Escitalopram Normon 20 mg film-coated tablets EFG

Date of the most recent review of this leaflet: January 2021

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/71421/P_71421.html