Heipram 15 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Heipram 15 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 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 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 side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Heipram is and what it is used for

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

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 taking Heipram 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 Heipram

Do not take Heipram

• If you are allergic to escitalopram or to any of the other components 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 “Use of Heipram with other medicines”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Heipram.

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

• If you have epilepsy. Treatment with escitalopram 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 liver or kidney impairment. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with escitalopram may alter glucose control. A dose adjustment of insulin and/or oral hypoglycemic agents may be necessary.
• If you have low sodium levels in your 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 salt levels due to severe and prolonged diarrhea and vomiting (while 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).

Please note:

Some patients with bipolar disorder may enter a manic phase. This is characterized by unusually rapid and racing thoughts, excessive happiness, and increased 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 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 depression or anxiety disorder

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

You are more likely to have these types of thoughts:

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

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

It may be helpful for you 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 should not normally be used to treat children and adolescents under 18 years of age.

Also, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe escitalopram to patients under 18 years of age if they decide it is the most appropriate treatment. If your doctor 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 worsen or become complicated while a patient under 18 years of age is taking escitalopram. In addition, the long-term effects on safety, growth, maturation, and cognitive and behavioral development of escitalopram in this age group have not yet been fully established.

Use of Heipram with other medicines:

Inform your doctor or pharmacist if you are using, have recently used, or might need to use 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 tranilcypramine as active ingredients. If you have taken any of these medicines, you must wait 14 days before starting escitalopram. After stopping escitalopram, you must wait 7 days before taking any of these medicines.
• “Reversible selective MAO-A inhibitors” containing moclobemide (used for the treatment of depression).
• “Irreversible MAO-B inhibitors” containing selegiline (used for the treatment of Parkinson’s disease). These increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used for 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 treatment with escitalopram 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 for cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of escitalopram 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 Heipram 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, antimalarial treatments, particularly halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine). Contact your doctor for any further questions.

Taking Heipram with food, drinks, and alcohol

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

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

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

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

During pregnancy, particularly in the last 3 months, medicines like Heipram 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 appears 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 Heipram 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 is used during pregnancy, it should never be stopped abruptly.

Escitalopram is expected to be excreted in breast milk.

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

Driving and using machines

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

Heipram contains sodium

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

3. How to take Heipram

Follow exactly the instructions for taking this medicine as given 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 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 normally 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 how you respond to the medication.

Generalized anxiety disorder

The normally 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 normally 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)

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

Use in children and adolescents

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

Renal impairment

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

Hepatic impairment

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

Patients considered as slow metabolizers of CYP2C19

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

How to take the tablets

You may take escitalopram with or without food. Swallow the tablets with water. Do not chew them, as they have a bitter taste. If necessary, the tablets may be divided by placing the tablet on a flat surface with the score side facing up. The tablets can be split by pressing down on each end with the 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 alter the dose of the medicine without first speaking to your doctor.

Continue taking escitalopram 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 escitalopram than you should:

If you take more escitalopram than prescribed, contact your doctor immediately, go to the nearest hospital emergency department, or contact the Toxicology Information Service at telephone number 915 620 420. Do so 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 rhythm, decreased blood pressure, and disturbances in the body's fluid and electrolyte balance. Bring the escitalopram packaging with you 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 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:

Do not stop treatment with escitalopram unless 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 abruptly, you may experience withdrawal symptoms. These are common when treatment with escitalopram is stopped. 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 disappear 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 escitalopram, please contact your doctor. He or she 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 frequently) 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 emotion or irritability; diarrhea (loose stools); visual disturbances; rapid pulse or palpitations.

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

4. Possible adverse effects

Like all medicines, this medicine can have 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 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 sick (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, drowsiness, 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, reduced sexual activity, and 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 levels of sodium 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 (increased liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Signs of abnormal bleeding, e.g. of the skin or mucous membranes (bruising) and low platelet count in the blood (thrombocytopenia).
• Increased secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, reducing sodium levels (inappropriate ADH secretion).
• Increased levels of prolactin hormone in the blood.
• Milk production in men and 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 QT interval prolongation, observed 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 are known to occur with medicines that act similarly to escitalopram (the active substance in Heipram). 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 website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Heipram

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

Do not store above 30 ºC.

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

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 you are unsure, 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 Heipram

• The active substance is escitalopram. Each film-coated tablet contains 15 mg of escitalopram (as escitalopram oxalate).
• The other components are:

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

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

Appearance of the product and contents of the pack

Heipram 15 mg tablets are white, elliptical, biconvex, with a score line on one side, lateral notches and the imprint “E-” engraved on the other side. The tablets can be divided into equal doses.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of this leaflet: October 2025

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