Leaflet: Information for the patient

Diprex 20 mg/ml oral drops in EFG solution

Escitalopram

Read 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 doubts, consult your doctor, or pharmacist
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, or pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What is Diprex and what it is used for

2. What you need to know before starting to take Diprex

3. How to take Diprex

4. Possible side effects

5. Storage of Diprex

6. Contents of the pack and additional information.

Diprexbelongs to a group of antidepressants known as 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 diseases.

Diprex contains escitalopram, which is used to treat:

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

Do not take Diprex:

• If you are allergic to escitalopram or any of the other components of this medication (listed in the section 6 “Contents of the package and additional 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 a history of birth or have experienced an episode of heart rhythm alteration (detected in an ECG; a test that evaluates the heart's function)
• If you are taking medications for heart rhythm problems or that can affect heart rhythm (see section 2 “Use of Diprex with other medications”).

Warnings and precautions

Consult your doctor or pharmacist or nurse 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 interrupted if seizures occur for the first time or if you observe an increase in seizure frequency (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 problems or kidney problems. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Diprex may alter blood sugar control. You may need to adjust your insulin and/or oral hypoglycemic dose.
• If you have low sodium levels 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 medicines. Please see below the point: ‘Other medications and Diprex’
• If you are receiving electroconvulsive therapy.
• If you have angle-closure glaucoma, or have a history of glaucoma
• If you have coronary artery disease.
• If you are pregnant or breastfeeding
• 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 sodium levels due to severe and prolonged diarrhea and vomiting (being sick) or use of diuretics.
• If you experience rapid or irregular heartbeats, dizziness, fainting, 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 unusual and rapid changes in ideas, excessive 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 beginning of your treatment. Consult your doctor immediately if you experience these symptoms.

Some medications in the group to which escitalopram belongs (called SSRIs/SSNRIs) may cause sexual dysfunction symptoms (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 have an anxiety disorder, you may occasionally have thoughts of harming yourself or committing suicide. 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 harming yourself or committing suicide.
• If you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in adults under 25 years old with psychiatric illnesses treated with an antidepressant.

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

It may be helpful to tell a family member or close friend that 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)

Diprex should not be used normally in the treatment of the pediatric population (under 18 years). Also, be aware that in patients under 18 years, there is a higher risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. However, the doctor who prescribes it may prescribe escitalopram to patients under 18 years when they decide it is best for the patient. If the doctor who prescribes it has prescribed Diprex to a patient under 18 years and wants 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 are taking Diprex. At the same time, the long-term effects on safety related to growth, maturity, and cognitive and behavioral development of Diprex in this age group have not yet been demonstrated.

Use of Diprex with other medications

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

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

• Non-selective monoamine oxidase inhibitors (MAOIs); containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active ingredients. If you are taking any of these medications, you will need to wait 14 days before starting to take Diprex.After stopping Diprex, 7 days must pass before taking any of these medications.

• Selective and reversible MAO-A inhibitors containing moclobemide (used to treat depression).
• Irreversible MAO-B inhibitors containing selegiline (used to treat Parkinson's disease). These increase the risk of adverse effects.
• The antibiotic linezolid.
• Lithium (used to treat manic-depressive disorder) and tryptophan (amino acid)
• Other medications used to treat 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 adverse effects.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers or indigestion), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant and ticlopidine (used to reduce the risk of a stroke). These may cause increased blood levels of escitalopram.
• St. John's Wort (Hypericum perforatum), a herbal remedy, used to treat depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medications used to relieve pain or reduce the risk of thrombosis, also called anticoagulants).
• Warfarin, dipiridamol, and phenprocoumon (medications used to reduce the risk of thrombosis, also called anticoagulants). Your doctor may need to monitor your blood clotting time at the beginning and end of treatment with Diprex to ensure 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 used to treat schizophrenia, psychosis) due to the possible risk of lowering the seizure threshold.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine, and nortriptyline (antidepressants) and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of Diprex may need to be adjusted.
• Medications that lower 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 can affect heart rhythm, such as antiarrhythmic drugs of Classes IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (e.g. esparfloxacine, moxifloxacine, erythromycin IV, pentamidine, malaria treatment, especially with halofantrine), certain antihistamines (astemizol, mizolastine). If you have any doubts, consult your doctor.

Use of 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 recommended to combine Diprex with alcohol, although it is expected thatDiprexwill interact with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do nottakeDiprexifyouarepregnantorinlactationuntilyouandyourdoctorhaveanalyzedtherisksandbenefitsinvolved.

If you take Diprex during the last 3 months of yourpregnancybeawarethattheremaybeobservedinthenewbornthefollowingeffects:difficulty breathing,blue skin,seizures,temperature changes,feeding difficulties,vomiting,low blood sugar,muscle stiffness or weakness,intense reflexes,shaking,irritability,lethargy,constant crying,obtundation,anddifficulty falling asleep. If your newborn has any of these symptoms,pleasecontactyourdoctorimmediately.

Make sure your midwife and/or doctor know that you are being treated with Diprex. During pregnancy, especially in the last 3 months, medications like Diprex 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 start within the first 24 hours after birth. If they appear in your baby, contact your midwife and/or doctor immediately.

SiDiprex is used during pregnancy, it should not be stopped abruptly.

If you take Diprex in the final stages of 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 know that you are taking Diprex to be able to advise you.

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

Driving and operating machinery

It is recommended that you do not drive or operate machinery until you know how Diprex affects you.

Diprex 20 mg/ml oral drops in solution contain 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)

Follow exactly the administration instructions of this medication as 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, or 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) per day.

Panic disorder

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

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) per day.

Older adults (65 years of age or older)

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) per day.

Pediatric population (under 18 years)

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

Treatment duration

It may take a couple of weeks before you start feeling better.Continue taking Diprex even if you start feelingbetter before the expected time.

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

Continue taking Diprex for the recommended time by your doctor.If you interrupt the treatment too soon, symptoms may reappear.It is recommended that treatment continue for at least 6 months after feeling well again.

If you take more Diprex than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Do it even if you do not observe discomfort or signs of intoxication. Some signs of overdose may be dizziness, tremor, agitation, convulsion, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and changes in the body's hydro-electrolyte balance. Bring the Diprex packaging if you go to the doctor or hospital.

If you forget to take Diprex

Do not take a double dose to compensate for the missed doses.

If you forget 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, leave the missed dose and follow your usual routine.

If you interrupt the treatment with Diprex

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

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

Sensation of dizziness (unstable or without balance), sensation of tingling, sensation of pricklingand (less frequently) electric shock, even in the head, sleep disturbances (too intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, sensation of nausea (dizziness), sweating (including nocturnal sweating), feeling of anxiety or agitation, tremor (instability), feeling of confusion or disorientation, feelings of emotion or irritability, diarrhea (loose stools), vision disturbances, palpitations.

These are common when Diprex treatment is suspended. The risk is higher when Diprex 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 in two weeks. However, in some patients, they may be intense or prolonged (2-3 months or more). If you have severe withdrawal symptoms when stopping Diprex, please contact your doctor. They may ask you to take your drops again and taper them off more slowly.

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

Like all medicines, Diprex can cause side effects, although not everyone will experience them.

Side effects usually disappear after a few weeks of treatment. Please be aware that many of the side effects could be symptoms of your illness and will improve as 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.
• Convulsions (seizures). See also the section "Warnings and precautions”
• A yellowish discoloration of the skin and whitening of the eyes are signs of liver dysfunction/hepatitis.
• Irregular and rapid heart rhythm, fainting, which could be symptoms of a potentially fatal condition called Torsades de Pointes.

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

In addition to the side effects mentioned above, 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):

• Blocked nose or nasal discharge (sinusitis)
• Changes in appetite, weight gain
• Anxiety, agitation, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, skin tingling
• Diarrhea, constipation, vomiting, dry mouth
• Increased sweating
• Muscle and joint pain (arthritis and myalgia)
• Sexual problems (delayed ejaculation, erectile dysfunction, reduced libido, and in women, difficulty achieving orgasm)
• Feeling tired (fatigue), fever

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

• Hives (urticaria), rash, itching (pruritus)
• Grinding of teeth, agitation, nervousness, panic attacks, confusion
• Changes in sleep or taste, fainting (syncope)
• Dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus)
• Hair loss
• Changes in vaginal bleeding
• Weight loss
• Rapid heart rate (tachycardia)
• Inflammation in arms and legs
• Nasal bleeding.

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).

Unknown frequency (the frequency cannot be estimated from available data):

• Thoughts of self-harm or suicidal ideas. See also the section "Warnings and precautions”
• Low sodium levels in the blood (symptoms are: feeling dizzy, unwell, with muscle weakness, or confused)
• Dizziness when standing due to low blood pressure (orthostatic hypotension)
• Abnormal liver function test results (elevated liver enzymes) and abnormal ECG (electrocardiogram) readings
• Movement disorders (involuntary muscle movements)
• Painful erection (priapism)
• Bleeding disorder, including skin and mucous membrane bleeding (ecchymosis) and low platelet count (thrombocytopenia)
• Sudden inflammation of the skin or mucous membranes (angioedema)
• Inadequate secretion of antidiuretic hormone (ADH), leading to increased urine production
• Milk leakage in women who are not breastfeeding
• Mania
• A higher risk of bone fractures has been observed in patients taking this type of medication
• Abnormal heart rhythm (called "prolongation of the QT interval," seen on the ECG, electrical activity of the heart).
• Severe postpartum hemorrhage (bleeding after childbirth), see "Pregnancy, lactation, and fertility" in section 2 for more information.

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

• Restlessness, urgency, or need to move to stop an unpleasant sensation (akathisia)
• Loss 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 orpharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication

Keep this medication out of the 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 container is opened, the drops can be used for 8 weeks and should be stored at a temperature below 25°C.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Diprex

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

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

Appearance of Diprex and contents of the package

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

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

IndustryChemicalandPharmaceuticalVIR,S.A.

C/Laguna66-70.PolígonoIndustrialURTINSAII
28923Alcorcón(Madrid)
Spain

Responsible for manufacturing:

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 medicine 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 in Solution EFG

Italy:Escitalopram Alter

Last revision date of this leaflet:March 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/