Diprex 20 mg/ml oral solution EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Diprex 20 mg/ml oral drops solution EFG

Escitalopram

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Leaflet contents:

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. How to store Diprex
6. Contents of the pack and other information

1. What Diprex is and what it is used for

Diprex belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). SSRIs act on the serotonergic system in the brain, increasing the level of serotonin. Dysfunction of the serotonergic system is 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 (fear of crowds/bridges/outdoor spaces), 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 components of this medicine (listed in section 6 “Contents of the pack and further information”)
• if you are taking other medicines belonging to the group known as monoamine oxidase inhibitors (MAO inhibitors), including selegiline (used for the treatment of Parkinson's disease), moclobemide (used for the treatment of depression), and linezolid (an antibiotic)
• if you have a congenital or have experienced 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 medicines that may affect heart rhythm (see section 2 “Taking Diprex with other medicines”).

Warnings and precautions

Talk to your doctor or pharmacist or nurse before starting to take Diprex.

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

• If you have epilepsy. Treatment with Diprex 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 suicidal thoughts or thoughts of self-harm. Please see below under: ‘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 glucose control. Adjustment of insulin and/or oral hypoglycemic agent dosage may be necessary.
• If you have low levels of sodium in the blood.
• If you are under 18 years of age
• If you have a history of mania or bipolar disorder
• If you are prone to 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 under: ‘Other medicines and Diprex’
• If you are receiving electroconvulsive therapy.
• If you have narrow-angle glaucoma or a history of glaucoma
• If you have coronary heart disease.
• If you are pregnant or breastfeeding
• If you have 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 due to severe and prolonged diarrhea and vomiting (being unwell) 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 bipolar disorder, you may enter a manic phase. This is characterized by unusually rapid and racing thoughts, excessive happiness, and excessive physical activity. If you experience this, contact your doctor.

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

Some medicines in the same group as escitalopram (called SSRIs/SNRIs) 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 suffer from an anxiety disorder, you may occasionally have thoughts of harming or killing yourself. These may increase when starting 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 such thoughts:

• If you have previously had thoughts of killing yourself or self-harm.
• 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 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 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 has worsened, or if they are concerned about changes in your behavior.

Use in pediatric population (under 18 years of age)

Diprex should not normally be used in the treatment of pediatric patients (under 18 years of age). You should also be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontation 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 most appropriate for the patient. If your doctor has prescribed Diprex to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You must inform your doctor if any of the symptoms described above worsen or develop complications while patients under 18 years of age are taking Diprex. In addition, the long-term effects on safety with regard to growth, maturation, and cognitive and behavioral development of Diprex in this age group have not yet been established.

Taking Diprex with other medicines

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

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

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

• 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 bipolar disorder) and tryptophan (an amino acid)

• Other medicines 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 medicines (used to treat migraine) and tramadol (used to treat severe pain). These increase the risk of adverse effects.

• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcer or dyspepsia (indigestion)), 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 for pain relief or to reduce the risk of thrombosis, also called anticoagulants).

• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor may monitor your blood clotting time at the beginning and end of treatment with Diprex to ensure the anticoagulant dose remains appropriate.

• 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 (medicines used to treat schizophrenia, psychosis) due to the possible risk of lowered seizure threshold.

• Flecainide, propafenone, and metoprolol (used for cardiovascular conditions), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dosage of Diprex may need to be adjusted.

• Medicines that reduce blood levels of potassium or magnesium, as these conditions increase the risk of life-threatening heart rhythm disorders.

Do not take Diprex

If you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm, such as antiarrhythmics of Classes IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g., sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarial treatment, especially with halofantrine), or 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 medicines, it is not advisable to combine Diprex with alcohol, even though significant interaction with alcohol is not 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 Diprex if you are pregnant or breastfeeding unless you and your doctor have evaluated the risks and benefits involved.

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

Ensure that your midwife and/or doctor know you are being treated with Diprex. During pregnancy, particularly in the last 3 months, medicines 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 begin within the first 24 hours after birth. If they occur in your baby, contact your midwife and/or doctor immediately.

If Diprex is used during pregnancy, it must never be stopped abruptly.

If you take Diprex in late 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 Diprex so they can advise you.

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

Driving and use of machines

It is advised not to drive or operate machinery until you know how Diprex affects you.

Diprex 20 mg/ml oral drops solution contains ethanol

This medicine 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 for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Diprex oral drops solution must not be mixed with liquids other than water or orange or apple juice, nor with other medicines.

Adults

Depression

The recommended dose of Diprex is 10 mg (10 drops) taken as a single daily dose. Your doctor may increase the dose up to a maximum of 20 mg (20 drops) daily.

Panic disorder

The initial dose of Diprex is 5 mg (5 drops) daily for the first week, before increasing the dose to 10 mg (10 drops) daily. 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 as a single daily dose. Your doctor may reduce your dose to 5 mg (5 drops) daily or increase it up to a maximum of 20 mg (20 drops) daily, depending on your response to the medicine.

Generalized anxiety disorder

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

Paediatric population (under 18 years of age)

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

Duration of treatment

It may take a few 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 medicine without first speaking to your doctor.

Continue taking Diprex 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 Diprex than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested. Do this even if you do not notice discomfort or signs of poisoning. Some signs of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rate, decreased blood pressure, and disturbances in the body's fluid and electrolyte balance. Take the Diprex packaging with you if you go to the doctor or hospital.

If you forget to take Diprex

Do not take a double dose to make up for missed doses.

If you forget to take a dose and remember before going to bed, take it immediately. The next day, continue as usual. If you remember during the night or the following day, skip the missed dose and continue as usual.

If you stop taking Diprex

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

When you stop taking Diprex, especially if abruptly, you may experience the following symptoms:

Dizziness (feeling unsteady or off balance), tingling sensation, burning sensation, and (less frequently) electric shock-like sensations, even in the head; sleep disturbances (overly 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 anxiety or irritability; diarrhoea (loose stools); visual disturbances; palpitations.

These symptoms are common when treatment with Diprex is stopped. The risk is greater 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 resolve on their own within two weeks. However, in some patients they may be severe or prolonged (2–3 months or longer). If you experience severe withdrawal symptoms when stopping Diprex, please contact your doctor. They may ask you to restart your drops and taper them more slowly.

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

4. Possible adverse effects

Like all medicines, Diprex can produce adverse effects, although not everyone experiences them.

Adverse effects usually disappear after a few weeks of treatment. Please be aware that many of these effects could be symptoms of your illness and therefore will improve as you start to feel better.

If you experience any of the following adverse effects, you must contact your doctor or go to hospital immediately:

• Difficulty urinating.
• Seizures (fits), see also section "Warnings and precautions"
• Yellowing of the skin and whitening of the eyes, signs of liver dysfunction/hepatitis.
• Irregular and rapid heartbeat, fainting, which could be symptoms of a life-threatening 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 swelling of the skin, tongue, lips, or face, or have difficulty breathing or swallowing (allergic reaction).
• If you have high fever, restlessness, confusion, tremors, and sudden muscle contractions, these may be signs of a very rare condition called serotonin syndrome.

In addition to the adverse effects listed above, the following adverse 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 disturbance, weight gain
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, skin tingling
• Diarrhea, constipation, vomiting, dry mouth
• Increased sweating
• Pain in muscles and joints (arthralgia and myalgia)
• Sexual problems (delayed ejaculation, erection problems, reduced sexual desire, and in women, difficulty achieving orgasm)
• Feeling tired (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, taste disturbances, fainting (syncope)
• Dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus)
• Hair loss
• Vaginal bleeding disorders
• Weight loss
• Fast heartbeat (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 heartbeat (bradycardia)

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

• Thoughts of self-harm or suicidal ideation, see also section "Warnings and precautions"
• Low levels of sodium in the blood (symptoms include dizziness, malaise, muscle weakness, or confusion)
• Dizziness upon standing due to low blood pressure (orthostatic hypotension)
• Abnormal liver function tests (elevated liver enzymes in blood) and abnormal ECG (electrocardiogram) readings
• Movement disorders (involuntary muscle movements)
• Painful erection (priapism)
• Bleeding disorders including bleeding into the skin and mucous membranes (ecchymosis) and low platelet count (thrombocytopenia)
• Sudden swelling of the skin or mucous membranes (angioedema)
• Increased urine output (inappropriate ADH secretion)
• Milk production in women who are not breastfeeding
• Mania
• An increased risk of bone fractures has been observed in patients taking this type of medication
• Changes in heart rhythm (known as "QT interval prolongation", seen on ECG, electrical activity of the heart)
• Severe vaginal bleeding shortly after childbirth (postpartum haemorrhage), see "Pregnancy and lactation and fertility" in section 2 for more information.

In addition, a number of adverse effects are known to occur with drugs that work in a similar way to escitalopram (the active substance in Diprex). These include:

• Motor restlessness, urgency or need to move to relieve an unpleasant sensation (akathisia)
• Loss of appetite (anorexia)

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects:

If you experience any type of 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Diprex

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

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

After opening the container, the drops may be used for 8 weeks and should be stored below 25°C.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diprex

• The active substance 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 contents of the container

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

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area member states under the following names:

Germany: Escitalopram Neuraxpharm
Spain: Diprex 20 mg/ml Oral Solution Drops EFG
Italy: Escitalopram Alter

Date of the latest revision of this leaflet: March 2021

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/