DIPREX 20 mg/ml ORAL DROPS IN SOLUTION

Introduction

Package Leaflet: Information for the Patient

Diprex 20 mg/ml Oral Drops in EFG Solution

Escitalopram

Read this entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What Diprex is and what it is used for

Diprex belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). SSRIs act on the serotonin system in the brain, increasing the level of serotonin. Alterations in the serotonin system are considered an important factor in the development of depression and related disorders.

Diprex contains escitalopram, which is used to treat:

• depression (major depressive episodes)
• anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder).

2. What you need to know before taking Diprex

Do not take Diprex:

• if you are allergic to escitalopram or any of the other ingredients of this medication (listed in section 6 "Contents of the pack and further information")
• if you are taking other medications that belong to the group called monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic)
• if you have been born with or have had an episode of cardiac rhythm disturbance (detected on an ECG; a test that evaluates heart function)
• if you are taking medications for heart rhythm problems or that may affect heart rhythm (see section 2 "Using Diprex with other medications").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Diprex.

Please inform your doctor if you have any of the following conditions or diseases, as your doctor may need to take them into account. In particular, inform your doctor:

• If you have epilepsy. Treatment with Diprex should be discontinued if you experience seizures for the first time or observe an increase in the frequency of seizures (see also section 4 "Possible side effects").
• If you have suicidal thoughts or think about self-harm. Please see below the point: 'Suicidal thoughts and worsening of your depression or anxiety disorder'
• If you have liver or kidney problems. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Diprex may alter blood sugar control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic medication.
• If you have a low sodium level in your blood.
• If you are under 18 years old
• If you have a history of mania or manic-depressive psychosis
• If you have a tendency to develop bleeding or bruising or if you are pregnant (see "Pregnancy, breastfeeding, and fertility").
• If you are taking any other medication, including herbal remedies. Please see below the point: 'Other medications and Diprex'
• If you are receiving electroconvulsive therapy.
• If you have glaucoma or a history of glaucoma
• If you have coronary heart disease.
• If you are pregnant or breastfeeding
• If you 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 a decrease in 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 a manic-depressive illness, you may enter a manic phase. This is characterized by a change in unusual and rapid ideas, disproportionate joy, and excessive physical activity. If you experience this, contact your doctor.

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

If you have a panic disorder, you may experience increased anxiety symptoms at the start of your treatment. Consult your doctor immediately if you experience these symptoms.

Some medications in the same group as escitalopram (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 occasionally have thoughts of harming or killing yourself. These may increase when taking antidepressants for the first time, as all these medications require time to start working, usually around two weeks, although in some cases it may take longer. You are more likely to have these thoughts:

• If you have previously had thoughts of killing 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 old 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 family member 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 has worsened or if they are concerned about changes in your attitude.

Use in pediatric population (under 18 years old)

Diprex should not normally be used in the treatment of pediatric population (under 18 years old). You should also know that in patients under 18 years old, there is a higher risk of side effects such as suicidal attempts, suicidal ideas, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this class of medications. Nevertheless, the doctor may prescribe escitalopram to patients under 18 years old when they decide it is convenient for the patient. If the doctor has prescribed Diprex to a patient under 18 years old and you want to discuss this decision, please go back 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 old are taking Diprex. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Diprex in this age group have not yet been demonstrated.

Taking Diprex with other medications

Tell your doctor or pharmacist that you are using, have recently used, or may need to use any other medication.

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

• Non-selective monoamine oxidase inhibitors (IMAOs) that contain phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active ingredients. If you are taking any of these medications, you will have to wait 14 days before starting to take Diprex. After finishing treatment with Diprex, 7 days must pass before taking any of these medications.

• Selective and 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 (amino acid)
• Other medications used in the treatment of depression, such as tricyclic antidepressants or other selective serotonin reuptake inhibitors (SSRIs), such as imipramine, desipramine, fluvoxamine, and buprenorphine/opioids.

• Sumatriptan and similar medications (used to treat migraines) and tramadol (used to treat severe pain). These increase the risk of side effects.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers or dyspepsia), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of a stroke). These may cause increases in blood levels of escitalopram.
• St. John's Wort (Hypericum perforatum), a herbal remedy used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medications used for pain relief or to reduce the risk of thrombosis, also called anticoagulants).
• Warfarin, dipyridamole, and fenprocoumon (medications used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably monitor your blood coagulation time at the start and end of treatment with Diprex to verify that the anticoagulant dose is still adequate.
• Mefloquine (used to treat malaria), tricyclic antidepressants, or selective serotonin reuptake inhibitors (SSRIs), bupropion (used to treat depression), tramadol (used to treat severe pain), and neuroleptics (medications for treating schizophrenia, psychosis) due to the possible risk of decreased seizure threshold.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dosage of Diprex may need to be adjusted.
• Medications that decrease blood potassium or magnesium levels, as these conditions increase the risk of life-threatening heart rhythm disorders.

Do not take Diprex

If you are taking medications for heart rhythm problems or medications that may affect heart rhythm, such as antiarrhythmics of Classes IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (e.g., sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, malaria treatment, especially with halofantrine), certain antihistamines (astemizole, mizolastine). If you have any doubts, consult your doctor.

Taking Diprex with food, drinks, and alcohol

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

As with many medications, it is not advisable to combine Diprex with alcohol, although it is expected that Diprex 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 medication.

Do not take Diprex if you are pregnant or breastfeeding, unless you and your doctor have analyzed the risks and benefits involved.

If you take Diprex 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, intense reflexes, tremors, 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 Diprex. During pregnancy, particularly in the last 3 months, medications like Diprex may increase the risk of a serious disease in newborns called persistent pulmonary hypertension (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 Diprex is used during pregnancy, it should never be stopped abruptly.

If you take Diprex in the final stage of pregnancy, there may be a higher 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 Diprex to advise you accordingly.

Citalopram, a medication similar to escitalopram, reduces sperm quality in animal studies. Theoretically, this could affect fertility, but no impact on human fertility has been observed yet.

Driving and using machines

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

Diprex 20 mg/ml Oral Drops in EFG Solution contains ethanol

This medication contains small amounts of ethanol (alcohol), less than 100 mg per 20 drops. Each drop contains 4.8 mg of ethanol (alcohol)

3. How to take Diprex

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Diprex oral drops in solution should not be mixed with other liquids different from water or orange or apple juice, nor with other medications.

Adults

Depression

The recommended dose of Diprex is 10 mg (10 drops) taken in a single daily dose. The dose may be increased by your doctor up to a maximum of 20 mg (20 drops) daily.

Panic Disorder

The initial dose of Diprex is 5 mg (5 drops) daily during the first week, before increasing the dose to 10 mg (10 drops) daily. Your doctor may increase the dose to a maximum of 20 mg (20 drops) per day.

Social Anxiety Disorder

The recommended dose of Diprex is 10 mg (10 drops) taken in a single daily dose. Your doctor may decrease your dose to 5 mg (5 drops) daily or increase the dose to a maximum of 20 mg (20 drops) daily, depending on how you respond to the medication.

Generalized Anxiety Disorder

The recommended dose of Diprex is 10 mg (10 drops) taken in a single daily dose. The dose may be increased by your doctor up to a maximum of 20 mg (20 drops) daily.

Obsessive-Compulsive Disorder

The recommended dose of Diprex is 10 mg (10 drops) taken in a single daily dose. The dose may be increased by your doctor up to a maximum of 20 mg (20 drops) daily.

Elderly patients (over 65 years of age)

The recommended initial dose of Diprex is 5 mg (5 drops), taken in a single daily dose. The dose may be increased by your doctor up to 10 mg (10 drops) daily.

Pediatric population (under 18 years of age)

Diprex should not normally be administered to children and adolescents. For additional information, please see section 2 "What you need to know before taking Diprex"

Duration of treatment

It may take a couple of weeks before you start to feel better. Continue taking Diprex 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 Diprex for the time recommended by your doctor. If you interrupt treatment too early, symptoms may recur. It is recommended that treatment continue for at least 6 months after you feel better.

If you take more Diprex than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. 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 rate, decrease in blood pressure, and changes in body hydro-saline balance. Bring the Diprex package if you go to the doctor or hospital.

If you forget to take Diprex

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 usual routine. If you remember during the night or the next day, skip the forgotten dose and follow your usual routine.

If you stop treatment with Diprex

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

When you stop taking Diprex, especially if it is sudden, you may feel the following symptoms:

Dizziness (unstable or without balance), tingling sensation, itching sensation, and (less frequently) electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of dizziness (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), vision disturbances, palpitations.

These are common when treatment with Diprex is suspended. The risk is greater when Diprex 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 Diprex, please contact your doctor. He or she may ask you to start taking your drops again and taper them off more slowly.

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

4. Possible side effects

Like all medications, Diprex can produce side effects, although not all people experience them.

Side effects usually disappear after a few weeks of treatment. Please be aware that many of the effects could be symptoms of your illness and that, therefore, they will improve when you start to feel better.

If you experience the following side effects, you should contact your doctor or go to the hospital immediately:

• Difficulty urinating.
• Seizures (attacks), see also the section "Warnings and precautions”
• A yellowish tint to the skin and whitening of the eyes are signs of liver function alteration/hepatitis.
• Irregular and rapid heart rate, fainting, which could be symptoms of a potentially fatal condition known as Torsades de Pointes.

Uncommon (may affect up to 1 in 100 patients):

• Unusual bleeding, including gastrointestinal and rectal bleeding.

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

• If you experience skin inflammation, tongue, lip, or face swelling, or have difficulty breathing or swallowing (allergic reaction).
• If you have a high fever, agitation, confusion, tremors, and sudden muscle contractions, these may be signs of a very rare condition called serotonin syndrome.

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

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

• Feeling dizzy (nausea).
• Headache.

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

• Stuffy nose or nasal discharge (sinusitis)
• Appetite alteration, weight gain
• Anxiety, agitation, abnormal dreams, difficulty falling asleep, somnolence, dizziness, yawning, tremors, skin tingling
• Diarrhea, constipation, vomiting, dry mouth
• Increased sweating
• Muscle and joint pain (arthralgia and myalgia)
• Sexual problems (delayed ejaculation, erection problems, reduced sexual desire, and in women, difficulty achieving orgasm)
• Feeling of fatigue (fatigue), fever

Uncommon (may affect up to 1 in 100 patients):

• Hives (urticaria), rash, itching (pruritus)
• Teeth grinding, agitation, nervousness, panic attacks, confusion
• Sleep disturbances, or taste disturbances, fainting (syncope)
• Dilated pupils (mydriasis), vision disturbances, ringing in the ears (tinnitus)
• Hair loss
• Alteration of vaginal bleeding
• Weight loss
• Fast heart rate (tachycardia)
• Swelling in arms and legs
• Nosebleeds.

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

• Aggression, depersonalization, seeing or hearing things that are not real (hallucinations)
• Slow heart rate (bradycardia).

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

• Thoughts of self-harm or suicidal ideas, see also the section "Warnings and precautions”
• Decreased sodium levels in the blood (symptoms are: feeling dizzy, unwell, with muscle weakness, or confused)
• Dizziness when standing up due to low blood pressure (orthostatic hypotension)
• Abnormal liver function tests (increased liver enzyme levels in blood) and abnormal ECG (electrocardiogram) readings
• Movement disorders (involuntary muscle movements)
• Painful erection (priapism)
• Bleeding disorders, including skin and mucous membrane bleeding (ecchymosis) and low platelet count (thrombocytopenia)
• Sudden inflammation of the skin or mucous membranes (angioedema)
• Increased urine production (inadequate ADH secretion)
• Milk flow in non-breastfeeding women
• Mania
• An increased risk of bone fractures has been observed in patients taking this type of medication
• Alteration of heart rhythm (called "prolongation of the QT interval", seen on the ECG, heart electrical activity)
• Severe vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

Additionally, it is known that a certain number of side effects occur with drugs that work similarly to escitalopram (the active ingredient in Diprex). These are:

• Motor restlessness, urge or need to move to stop an unpleasant sensation (akathisia)
• Lack of appetite (anorexia)

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet.

Reporting side effects:

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

5. Conservation of Diprex

Keep this medication out of sight and reach of children.

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

Once the package is opened, the drops can be used for 8 weeks and should be stored at a temperature below 25°C.

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

6. Package contents and additional information

Composition of Diprex

• The active ingredient is escitalopram. Each ml of Diprex contains 20 mg escitalopram (as 25.55 mg escitalopram oxalate).
• Each drop contains 1 mg escitalopram.
• The other components are:

• Propyl gallate
• Anhydrous citric acid
• 96% ethanol
• Sodium hydroxide
• Purified water.

Appearance of Diprex and package contents

Diprex oral drops in solution is a clear, almost colorless to yellow solution.

It is presented in an amber glass bottle, containing 15 ml, with a dropper

Marketing authorization holder and manufacturer

Marketing authorization holder:

Industria Química y Farmacéutica VIR, S.A.

C/Laguna 66-70. Polígono Industrial URTINSA II 28923 Alcorcón (Madrid) Spain

Manufacturer:

Doppel Farmaceutici S.r.l.

Via Martiri delle Foibe, 1

29016 Cortemaggiore (PC)

Italy

or

Neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Str. 23

40764 Langenfeld

Germany

This medication is authorized in the Member States of the European Economic Area with the following names:

Germany: Escitalopram Neuraxpharm

Spain: Diprex 20 mg/ml Oral Drops Solution EFG

Italy: Escitalopram Alter

Date of the last revision of this leaflet:March 2021

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/