HEIPRAM 15 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Heipram15 mg film-coated tablets EFG

(Escitalopram)

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Heipram and what is it used for

Heipram contains the active substance escitalopram. Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain, increasing the level of serotonin.

Escitalopram 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 to take Heipram even if it takes time to notice any improvement.

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

2. What you need to know before you take Heipram

Do not takeHeipram

• 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 that belong to the group of 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 been born with or have had an episode of abnormal 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 "Using Heipram with other medicines").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Heipram.

Please inform your doctor if you have any other disorder or disease, as your doctor may need to take it into account. In particular, inform your doctor:

• If you have epilepsy. Treatment with escitalopram should be discontinued if seizures occur for the first time or if there is an increase in the frequency of seizures. (See also section 4 "Possible side effects").
• If you have liver or kidney failure. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with escitalopram may alter glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic.
• If you have low sodium levels in your blood.
• If you have a history of bleeding disorders or if you 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 salt levels as a result of severe and prolonged diarrhea and vomiting (being sick) or use of diuretics.
• If you experience rapid or irregular heartbeats, fainting, collapse, or dizziness when standing up, which may indicate abnormal heart rhythm.
• If you have or have had eye problems, such as certain types of glaucoma (increased pressure in the eye).

Please note:

Some patients with manic-depressive illness may enter a manic phase. This is characterized by a change in ideas that is uncommon and rapid, disproportionate joy, and excessive physical activity. If you experience this, contact your doctor.

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

Medicines like Heipram (also called 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 your depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may sometimes have thoughts of harming or killing yourself. These may increase when you first start taking antidepressants, as all these medicines take time to start working, usually around two weeks, although in some cases it may take longer.

Youwould be more likely to have these thoughts:

• If you have previously had thoughts of killing yourself or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who were 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 friendthat you are depressed or have an anxiety disorder and ask them to read this leaflet. You can ask them if they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your attitude.

Children and adolescents

Escitalopram 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 a greater risk of adverse effects, such as suicidal attempts, suicidal ideas, and hostility (predominantly aggression, confrontational behavior, and irritation) when taking this class of medicines. Nevertheless, your doctor may prescribe escitalopram to patients under 18 years of age when they decide it is most convenient for the patient. If the doctor who corresponds to you has prescribed escitalopram 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 progress or if you experience complications when patients under 18 years of age are taking escitalopram. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of escitalopram in this age group have not yet been demonstrated.

UsingHeipramwith other medicines:

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• Non-selective monoamine oxidase inhibitors (MAOIs) that contain phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active ingredients. If you have taken any of these medicines, you will need to wait 14 days before starting to take escitalopram. After finishing escitalopram, 7 days must pass before taking any of these medicines.
• Reversible MAO-A inhibitors that contain moclobemide (used in the treatment of depression).
• Irreversible MAO-B inhibitors that contain 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 manic-depressive 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 (antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause an increase in blood levels of escitalopram.
• St. John's Wort (Hypericum perforatum) - a medicinal herb 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 bleeding.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably check the blood coagulation time at the start and end of treatment with escitalopram to ensure that the dose of anticoagulant is still adequate.
• 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). It may be necessary to adjust the dose of escitalopram.
• Medicines that decrease potassium or magnesium levels in the blood, as this increases the risk of heart rhythm disorders, which can be life-threatening.

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

TakingHeipramwith food, drinks, and alcohol

Escitalopram can be taken with or without food (see section 3 "How to take Heipram").

As with many medicines, it is not recommended to combine escitalopram and alcohol, although it is not expected that Heipram will interact with alcohol.

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 Heipram if you are pregnant or breastfeeding unless you and your doctor have analyzed the risks and benefits involved.

If you take escitalopram during the last 3 months of your pregnancy, be aware that the following effects may be observed in the newborn baby: difficulty breathing, blue skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, muscle stiffness or floppiness, exaggerated reflexes, tremors, restlessness, irritability, lethargy, constant crying, and difficulty sleeping. If your newborn baby has any of these symptoms, please contact your doctor immediately.

Make sure your midwife and/or doctor know that you are being treated with Heipram.

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

If you take Heipram in the final stage of pregnancy, there may be a greater risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking escitalopram to be able to advise you.

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

It is expected that escitalopram will be excreted in breast milk.

Citalopram, a medicine similar to escitalopram, has been shown to reduce sperm quality in animal models. This effect could theoretically affect fertility, but to date, its impact on human fertility has not been observed.

Driving and using machines

It is advised that you should not drive or use machinery until you know how escitalopram can affect you.

Heipram contains sodium

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

3. How to take Heipram

Follow the administration instructions of this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Adults

Depression

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

Anxiety Disorder

The initial dose of escitalopram is 5 mg as a single dose per day for the first week before increasing the dose to 10 mg per day.

Your doctor may increase it later up to a maximum of 20 mg per day.

Social Anxiety Disorder

The normally recommended dose of escitalopram is 10 mg taken as a single dose per day.

Your doctor may decrease 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 medication.

Generalized Anxiety Disorder

The normally recommended dose of escitalopram is 10 mg taken as a single dose per day. 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 is 10 mg taken as a single dose per day.

The dose may be increased by your doctor up to a maximum of 20 mg per day.

Elderly patients (over 65 years old)

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

Use in children and adolescents

Escitalopram should not normally be administered to children and adolescents. For additional information, please see section 2 "Warnings and precautions".

Renal impairment

Caution is advised in patients with severely decreased renal 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 can take escitalopram with or without food. Swallow the tablets with water. Do not chew them, as they have a bitter taste. If necessary, you can split the tablets by placing the tablet on a flat surface with the score line facing up. The tablets can be broken by pressing down on each end of the tablet with your index fingers.

Duration of treatment

It may take a couple of weeks before you start to feel better. Continue taking escitalopram even if you start to feel better before the expected time.

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

Continue taking escitalopram for the time recommended by your doctor. If you interrupt the treatment too early, the symptoms may reappear. It is recommended that the treatment continues for at least 6 months after you feel better.

If you take more Escitalopram than you should:

If you take more doses of escitalopram than prescribed, contact your doctor immediately, go to the emergency department of the nearest hospital, or consult the Toxicology Information Service, phone 915 620 420. Do this even if you do not observe discomfort or signs of intoxication. Some signs of overdose may be dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rhythm, decrease in blood pressure, and changes in body water balance. Bring the escitalopram package if you go to the doctor or hospital.

If you forget to take Escitalopram:

Do not take a double dose to make up for forgotten doses. If you forgot to take a dose and remember before going to bed, take it immediately. The next day, follow your normal routine: If you remember during the night or the next day, skip the forgotten dose and follow your normal routine.

If you interrupt treatment with Escitalopram:

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

When you stop taking escitalopram, especially if it is sudden, you may feel withdrawal symptoms. These are common when treatment with escitalopram is suspended. The risk is greater when escitalopram has been used for a long time, in 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 can be intense or prolonged (2-3 months or more). If you have severe withdrawal symptoms when you stop taking escitalopram, please contact your doctor. He or she may ask you to start taking your tablets again and stop them more slowly.

Withdrawal symptoms include: feeling of dizziness (unstable or without balance), feeling of tingling, feeling of itching, and (less frequently) electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of nausea (nausea), sweating (including night sweats), feeling of unease or agitation, tremors (instability), feeling of confusion or disorientation, feelings of emotion or irritation, diarrhea (loose stools), visual disturbances, rapid or irregular heartbeat.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can have adverse effects, although not all people experience them.

Adverse effects usually disappear after a few weeks of treatment. Please be aware that many of the effects can be symptoms of your disease and will improve when you start to feel better.

If you have any of the following symptoms, contact your doctor or go to the 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):

• Skin swelling, tongue, lips, pharynx, or face, hives, or difficulty breathing or swallowing (severe allergic reaction)
• High fever, agitation, confusion, tremors, and sudden muscle contractions can be signs of a rare condition called serotonin syndrome.

Unknown (frequency cannot be determined from available data):

• Difficulty urinating.
• Seizures (attacks), see also section "Warnings and precautions".
• Yellowing of the skin and whites of the eyes, signs of liver function alteration/hepatitis.
• If you experience rapid or irregular heartbeats or fainting, symptoms that 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 mucous (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty sleeping, feeling sleepy, dizziness, yawning, tremors, itching of the skin.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual disturbances (delayed ejaculation, erection problems, decreased sexual behavior, 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, agitation, nervousness, anxiety attacks, confusion.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbance, ringing in the ears (tinnitus).
• Hair loss.
• Excessive menstrual bleeding.
• Irregular menstrual period
• Weight loss.
• Rapid heartbeat.
• Swelling of arms and legs.
• Nosebleeds.

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

• Aggression, depersonalization, hallucinations.
• Slow heartbeat.

Unknown (frequency cannot be determined from available data):

• Decrease in sodium levels in the blood (symptoms are feeling dizzy and unwell with muscle weakness or confusion).
• Dizziness when standing up due to low blood pressure (orthostatic hypotension).
• Altered liver function tests (increased liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Signs of abnormal bleeding, e.g., from the skin or mucous membranes (ecchymosis).
• Increased secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, reducing the amount of sodium (inadequate ADH secretion).
• Milk flow 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 medication.
• Alteration of heart rhythm (called QT interval prolongation, observed in the ECG, heart electrical activity).
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

Other adverse effects are known to occur with drugs that work similarly to escitalopram (the active ingredient of Heipram). These are:

• Motor restlessness (akathisia).
• Lack of appetite

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Heipram

Keep this medication out of sight and reach of children.

Do not store above 30 ºC.

Do not use this medication after the expiration date that appears on the packaging after "EXP". The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Heipram

• The active ingredient is escitalopram. Each film-coated tablet contains 15 mg of escitalopram (as escitalopram oxalate).
• Other ingredients are:

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

Coating: hypromellose, titanium dioxide (E171), and macrogol.

Appearance of the product and package contents

Heipram 15 mg film-coated tablets are white, elliptical, convex, scored on one side, with lateral notches and the inscription "E-" engraved on the other side. The tablets can be divided into two equal halves.

Heipram 15 mg film-coated tablets are available in blister packs of 28 and 56 tablets.

Marketing authorization holder and manufacturerMarketing authorization holder

Laboratorios Alter, S.A.

C/Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036, Madrid

Spain

or

Laboratorios Alter, S.A.

C/ Zeus, 6

Polígono Industrial R2

28880, Meco (Madrid)

Spain

Date of the last revision of this leaflet

December 2024

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