Escitalopram Flas Stada 15 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Escitalopram Flas Stada 15 mg orodispersible tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Escitalopram Flas Stada is and what it is used for

Escitalopram Flas Stada 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 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).

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

You should consult a doctor if you get worse or do not improve.

2. What you need to know before taking Escitalopram Flas Stada

Do not take Escitalopram Flas Stada:

• 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 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 have a congenital condition 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 that may affect heart rhythm (see section 2 “Use of Escitalopram Flas Stada with other medicines”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Escitalopram Flas Stada. 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 Flas Stada 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 problems with liver or kidney function. Your doctor may need to adjust your dose,
• if you have diabetes. Treatment with Escitalopram Flas Stada may alter blood glucose control. Adjustment of insulin and/or oral hypoglycemic agent dosage may be necessary,
• if you have low levels of sodium in your blood,
• if you are prone to bleeding or bruising easily,
• if you have a history of bleeding disorders, 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 previously had heart problems or recently suffered 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 diarrhea and vomiting (when ill) 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).

Some medicines in the same group as Escitalopram Flas Stada (called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Be aware

Some patients with bipolar disorder may enter a manic phase. This is characterized by unusual and rapid thought changes, disproportionate 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 weeks of treatment. Inform your doctor immediately if you experience these symptoms.

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 yourself or of suicide. These may increase when starting antidepressants, as all such medicines require time to begin working—usually about two weeks, although in some cases it may take longer.

You may be more likely to have such thoughts:

• if you have previously had suicidal thoughts or self-harm,
• if you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders treated with an antidepressant.

If at any time you have thoughts of self-harm or suicide, contact your doctor or go directly to a hospital. It may help to tell 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 behavior.

Children and adolescents

Escitalopram Flas Stada is not normally 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 (predominantly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Escitalopram Flas Stada orodispersible tablets to patients under 18 years of age if they decide it is in the patient’s best interest. If your doctor has prescribed Escitalopram Flas Stada orodispersible tablets 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 Escitalopram Flas Stada. In addition, the long-term effects on safety, growth, maturity, and cognitive and behavioral development of Escitalopram Flas Stada orodispersible tablets in this age group have not yet been established.

Use of Escitalopram Flas Stada with other medicines

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

Inform 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 Escitalopram Flas Stada. After stopping Escitalopram Flas Stada, 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 to treat depression).
• Sumatriptan and similar medicines (used to treat 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 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 thin the blood, also called anticoagulants). Your doctor will likely monitor your blood clotting time at the beginning and end of treatment with Escitalopram Flas Stada to ensure the anticoagulant dose remains appropriate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain), due to a possible risk of lowering the seizure threshold.
• Neuroleptics (medicines used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs), due to a possible risk of lowering the seizure threshold.
• Flecainide, propafenone, and metoprolol (used for cardiovascular conditions), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of Escitalopram Flas Stada may need to be adjusted.
• Medicines that reduce blood levels of potassium or magnesium, as this increases the risk of life-threatening heart rhythm disturbances.

Do not take Escitalopram Flas Stada 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, intravenous erythromycin, pentamidine, antimalarials such as halofantrine), and certain antihistamines (astemizole, mizolastine). Contact your doctor for any further questions.

Taking Escitalopram Flas Stada with food, drinks, and alcohol

Escitalopram Flas Stada orodispersible tablets can be taken with or without food (see section 3 “How to take Escitalopram Flas Stada”).

As with many medicines, combining Escitalopram Flas Stada with alcohol is not recommended, although no interaction between Escitalopram Flas Stada and alcohol is expected.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Do not take Escitalopram Flas Stada if you are pregnant or breastfeeding unless you and your doctor have discussed the risks and benefits involved.

If you take Escitalopram Flas Stada during the last 3 months of pregnancy, be aware that 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 difficulty sleeping. If your newborn baby shows any of these symptoms, contact your doctor immediately.

Ensure your midwife and/or doctor know that you are being treated with Escitalopram Flas Stada.

During pregnancy, particularly in the last 3 months, medicines such as escitalopram 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 escitalopram 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 be aware that you are taking escitalopram so they can advise you appropriately.

If Escitalopram Flas Stada is used during pregnancy, it should never be stopped abruptly. Escitalopram Flas Stada 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 use of machines

Do not drive or operate tools or machinery until you know how Escitalopram Flas Stada affects you.

This medicine contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains sodium

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

3. How to take Escitalopram Flas Stada

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

Escitalopram orodispersible tablets are taken daily as a single daily dose. You may take escitalopram with or without food.

Escitalopram orodispersible tablets break easily, so they must be handled with care. Do not handle the tablets with wet hands, as they may break.

1. Hold the blister strip by the edges and separate one blister from the rest of the strip by gently tearing along the perforated line.

2. Carefully peel back the backing foil from the blister.

3. Place the tablet on your tongue. The tablet will disintegrate rapidly and can be swallowed without water.

Escitalopram Flas Stada is not suitable for all doses described below. For these doses, you will need to take another medicine available on the market. Please consult your doctor or pharmacist.

Adults

Depression

The recommended dose of escitalopram 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 escitalopram 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 recommended dose of escitalopram 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 your response to the medicine.

Generalized anxiety disorder

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

Use in children and adolescents

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

Duration of treatment

It may take a few weeks before you start to feel better. Continue taking escitalopram even if you start to feel better sooner than expected.

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

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

If you take more Escitalopram Flas Stada than you should

If you take more than the prescribed dose of escitalopram, contact your doctor immediately, go to the nearest hospital emergency department, or contact the Toxicology 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, low blood pressure, and disturbances in the body's water/salt balance. Take the escitalopram packaging with you if you go to the doctor or hospital.

If you forget to take Escitalopram Flas Stada

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 Flas Stada

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

When you stop taking escitalopram, especially if stopped abruptly, you may experience withdrawal symptoms. These are common when stopping treatment with escitalopram. The risk is greater when escitalopram 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, symptoms may be severe or prolonged (2 to 3 months or longer). If you experience severe withdrawal symptoms when stopping escitalopram, contact your doctor. Your doctor may ask you to resume taking your tablets 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 anxiety or agitation; tremor (shakiness); feelings of confusion or disorientation; emotional or irritable feelings; diarrhoea (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. 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 or face, or difficulty breathing or swallowing (allergic reaction),
• high fever, agitation, confusion, tremors, and sudden muscle contractions, which may be signs of a rare condition called serotonin syndrome.

Frequency not known (cannot be estimated from available data):

• difficulty urinating,
• seizures (fits); see also subsection “Warnings and precautions”,
• yellowing of the skin and whites of the eyes, signs of liver dysfunction/hepatitis,
• if you experience fast or irregular heartbeats or fainting, symptoms which may indicate a life-threatening condition known as Torsade de Pointes,
• thoughts of harming yourself (self-harm) or suicidal thoughts; see also subsection “Warnings and precautions”.

In addition to the 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 mucus (sinusitis),
• decreased or increased appetite,
• anxiety, restlessness, strange dreams, difficulty falling asleep, feeling sleepy, dizziness, yawning, tremors, skin itching,
• diarrhoea, constipation, vomiting, dry mouth,
• increased sweating,
• muscle and joint pain (arthralgia and myalgia),
• sexual disturbances (delayed ejaculation, erection problems, decreased sexual drive; 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),
• dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus),
• hair loss,
• excessive menstrual bleeding,
• irregular menstrual periods,
• weight loss,
• rapid heart rate,
• swelling of arms and legs,
• nosebleeds.

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

• aggression, depersonalisation, hallucinations,
• slow heart rate.

Frequency not known (cannot be estimated from available data):

• decrease in blood sodium levels (symptoms include dizziness and malaise with muscle weakness or confusion),
• dizziness upon standing due to low blood pressure (orthostatic hypotension),
• abnormal liver function tests (increased liver enzymes in blood),
• movement disorders (involuntary muscle movements),
• painful erections (priapism),
• signs of increased bleeding, e.g. of the skin or mucous membranes (bruising),
• sudden swelling of skin or mucous membranes (angioedema),
• increased urine output (inappropriate secretion of ADH hormone),
• milk production in men and in women 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, the heart's electrical activity),
• heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for more information.

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

• 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 national reporting system: Spanish Pharmacovigilance System for Human Medicines Website: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Escitalopram Flas Stada

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

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

This medicine does not require any special storage temperature; store in the original packaging to protect it from light and moisture.

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

6. Package contents and other information

Composition of Escitalopram Flas Stada

• The active substance is escitalopram.

Each orodispersible tablet contains 15 mg of escitalopram, equivalent to 19,1625 mg of escitalopram oxalate.

• The other components are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, polacrilin potassium, acesulfame potassium, neohesperidin dihydrochalcone, magnesium stearate, mint flavour [contains: maltodextrin (from maize), modified starch E1450 (waxy maize starch) and peppermint oil (Mentha arvensis)], concentrated hydrochloric acid (for pH adjustment).

Appearance of the product and contents of the package

Escitalopram Flas Stada 15 mg: white or almost white, round, flat tablets, 11 mm in diameter, with bevelled edges, engraved with "15" on one side.

Escitalopram Flas Stada 15 mg is available in packages containing:

28, 30, 56, 98 orodispersible tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Genepharm S.A.

18 km Marathon Avenue,

15351 Pallini, Athens

Greece

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA 3000

Malta

or

Stada Arzneimittel AG

Stadastrasse 2 – 18,

61118 Bad Vilbel

Germany

or

Rontis Hellas S.A.

Medical and Pharmaceutical Products

Industrial Area of Larissa,

P.O. Box 3012, GR41004 Larissa

Greece

or

PharmaPath, S.A.

28is Oktovriou 1

123 51 Agia Varvara

Greece

or

Laboratori Fundació Dau

c/ C 12-14,

Polígono Industrial de la Zona Franca,

08040 Barcelona

Spain

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

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