Escitalopram Pensapharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Escitalopram pensa pharma 20 mg/ml oral drops, solution

Escitalopram
Equivalent medicine
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT ESCITALOPRAM PENSA PHARMA IS AND WHAT IT IS USED FOR

Escitalopram belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonergic system in the brain by increasing levels of serotonin. Alterations in the serotonergic system are considered important factors in the development of depression and related disorders.
Escitalopram pensa pharma 20 mg/ml oral drops solution contains escitalopram and is used 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) in adults over 18 years of age.
It may take a couple of weeks before you start to feel better. Continue taking Escitalopram pensa pharma, even if it takes time before you notice an improvement in your condition.
Contact your doctor if you do not feel better or if you feel worse.

2. WHAT YOU SHOULD KNOW BEFORE TAKING ESCITALOPRAM PENSA PHARMA

PHARMA
Do not take Escitalopram pensa pharma:

• If you are allergic to escitalopram or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking other medicines belonging to a group known as MAO inhibitors, including selegiline (used to treat Parkinson’s disease), moclobemide (used to treat depression), or linezolid (an antibiotic).
• If you have been born with or have experienced an episode of heart rhythm disorder (identified by an ECG, a test performed to assess heart function).
• If you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm (see section 2 “Other medicines and Escitalopram pensa pharma”).

Warnings and precautions:
Talk to your doctor or pharmacist before taking Escitalopram pensa pharma.
Inform your doctor if you have any other condition or illness, as this may need to be taken into account. In particular, inform your doctor:

• If you suffer from epilepsy. Treatment with Escitalopram pensa pharma must be discontinued if you experience seizures for the first time or if the frequency of seizures increases (see also section 4 “Possible side effects”).
• If you have impaired liver or kidney function. Your doctor may need to adjust your dosage.
• If you have diabetes. Treatment with Escitalopram pensa pharma may alter blood glucose control. In such cases, it may be necessary to adjust the dose of insulin and/or oral hypoglycemic agents.
• If you have low levels of sodium in your blood.
• If you have a tendency to bleed or bruise easily (e.g., gastrointestinal bleeding or bruising) or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”).
• If you are receiving electroconvulsive therapy.
• If you suffer from coronary heart disease.
• If you have or have had heart problems or have recently had a heart attack.
• If you have a slow resting heart rate and/or if you know you have electrolyte imbalances due to prolonged severe diarrhea and vomiting (feeling unwell) or if you are using diuretics (medicines to increase urination).
• If, when standing up, you experience a rapid or irregular heartbeat, fainting, collapse, or dizziness, which may indicate a heart rhythm disorder.
• If you have or have previously had eye problems, such as certain types of glaucoma (increased pressure inside the eye).

Medicines such as Escitalopram pensa pharma (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have been observed to persist after discontinuation of treatment.

Please note:
Some patients with bipolar disorder may enter a manic phase. This is characterized by unusual thoughts that change rapidly, inappropriate happiness, and excessive physical activity. If you experience these feelings, contact your doctor.
Symptoms such as restlessness or difficulty sitting still or standing still may occur during the first weeks of treatment. If you experience these symptoms, inform your doctor immediately.

Thoughts of suicide and worsening of depression or anxiety disorder:
If you suffer from depression and/or anxiety disorders, you may sometimes think about harming yourself or committing suicide.
These thoughts may be more common at the beginning of treatment with antidepressants, as these medicines usually take about two weeks or more to show their effect. You are more likely to have these thoughts:

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. Data from clinical trials have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with an antidepressant. If at any time you think about harming yourself or committing suicide, contact your doctor or go immediately to the hospital. It may be helpful to inform a family member or close friend that you suffer from depression or an anxiety disorder, and ask them to read this leaflet. You may ask them to tell you if they think your depression or anxiety is worsening or if they are concerned about any changes in your behaviour.

Children and adolescents under 18 years of age:
Normally, Escitalopram pensa pharma should not be taken by children and adolescents under 18 years of age. It is also important to know that, when taking this class of medicines, patients under 18 years of age have a higher risk of side effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, oppositional behaviour, and anger). Nevertheless, your doctor may prescribe Escitalopram pensa pharma to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Escitalopram pensa pharma to a patient under 18 years of age and you would like more information, please contact your doctor again.
You must inform your doctor if any of the symptoms listed above appear or worsen during treatment with Escitalopram pensa pharma in patients under 18 years of age. In addition, the long-term safety effects of Escitalopram pensa pharma on growth, maturation, and cognitive and behavioural development have not yet been established in this age group.

Other medicines and Escitalopram pensa pharma:
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking any of the following medicines:

• "Non-selective monoamine oxidase inhibitors (MAOIs)" containing phenelzine, iproniazid, isocarboxazide, nialamide, or tranylcypromine as active ingredients. If you have taken any of these medicines, you must wait 14 days before starting treatment with Escitalopram pensa pharma. After stopping treatment with Escitalopram pensa pharma, 7 days must pass before taking any of these medicines.
• "Reversible selective 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.
• Imipramine and desipramine (both used to treat depression).
• 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 gastric ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause an increase in escitalopram levels in the blood.
• St. John’s Wort (Hypericum perforatum) – a herbal medicine used for depression.
• Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (medicines used for pain relief or to reduce blood thickness, known as anticoagulants). These may increase the tendency to bleed.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce blood thickness, known as anticoagulants). Your doctor will likely monitor your blood clotting time at the beginning and end of treatment with Escitalopram pensa pharma to ensure your anticoagulant dose remains appropriate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain), due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines used to treat 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 disorders), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). A dosage adjustment of Escitalopram pensa pharma may be necessary.
• Medicines that reduce blood levels of potassium or magnesium, as these conditions increase the risk of life-threatening heart rhythm disorders.

DO NOT TAKE ESCITALOPRAM PENSA PHARMA if you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm, such as Class IA and III antiarrhythmics, antipsychotics (such as phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (such as sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarial treatments, particularly halofantrine), or certain antihistamines (astemizole, mizolastine). If you have any further doubts, contact your doctor.

Escitalopram pensa pharma with food, drinks, and alcohol:
Escitalopram pensa pharma can be taken with or without food (see section 3 “How to take Escitalopram pensa pharma”). As with many medicines, it is not recommended to combine Escitalopram pensa pharma with alcohol, although no significant interaction between Escitalopram pensa pharma and alcohol is expected.

Pregnancy, breastfeeding and fertility:
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Do not take Escitalopram pensa pharma if you are pregnant or breastfeeding unless your doctor has discussed the risks and benefits with you.
If you take Escitalopram pensa pharma near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after childbirth, especially if you have bleeding disorders (tendency to bleed). Inform your doctor or midwife that you are taking Escitalopram pensa pharma so they can advise you accordingly.
If you take Escitalopram pensa pharma during the third trimester of pregnancy, you should be aware that the following effects may occur in the newborn: breathing difficulties, bluish skin colour, seizures, unstable body temperature, feeding difficulties, vomiting, low blood glucose levels, stiff or floppy muscles, increased reflexes, tremors, restlessness, irritability, lethargy, persistent crying, drowsiness, and sleep difficulties. If the newborn shows any of these symptoms, contact your doctor immediately.
Ensure that your midwife and/or doctor know that you are taking Escitalopram pensa pharma. Medicines such as Escitalopram pensa pharma, when taken during pregnancy, particularly during the last three months, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually appear within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.
If used during pregnancy, Escitalopram pensa pharma should not be stopped abruptly.
Escitalopram pensa pharma is expected to be excreted in breast milk.
Citalopram, a medicine similar to escitalopram, has been shown to reduce sperm quality in animal studies. In theory, this could affect fertility, but effects on human fertility have not been observed.

Driving and using machines:
It is advisable not to drive or operate machinery until you know how Escitalopram pensa pharma affects you.

Important information about certain excipients:
This medicine contains 94 mg of alcohol (ethanol) in each ml, equivalent to 12% v/v. The amount in 1 ml of this medicine is equivalent to less than 2.4 ml of beer or 0.96 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e., essentially ‘sodium-free’.

3. HOW TO TAKE ESCITALOPRAM PENSA PHARMA

Take Escitalopram Pensa Pharma exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Turn the bottle completely upside down. If no drops come out, gently tap the bottle to start the flow.

Pour the required number of drops into a drink (water, orange juice, or apple juice), mix briefly, and then drink the entire mixture.
Do not mix Escitalopram Pensa Pharma with other liquids and do not mix it with other medicines.

Adults:
Depression
The usual dose of Escitalopram Pensa Pharma 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) per day.

Panic disorder
The initial dose of Escitalopram Pensa Pharma is 5 mg (5 drops) per day for the first week, before increasing 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 normally recommended dose of Escitalopram Pensa Pharma is 10 mg (10 drops) taken as a single daily dose. Your doctor may reduce the dose to 5 mg (5 drops) per day or increase it up to a maximum of 20 mg (20 drops) per day, depending on your individual response to treatment.

Generalized anxiety disorder
The normally recommended dose of Escitalopram Pensa Pharma 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) per day.

Obsessive-compulsive disorder
The normally recommended dose of Escitalopram Pensa Pharma 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) per day.

Elderly (aged over 65 years):
The recommended initial dose of Escitalopram Pensa Pharma is 5 mg (5 drops) taken as a single daily dose. Your doctor may increase the dose up to 10 mg (10 drops) per day.

Use in children and adolescents (under 18 years of age):
Escitalopram Pensa Pharma is generally not recommended for use in children and adolescents. For further information, see section 2 "What you need to know before taking Escitalopram Pensa Pharma".

Duration of treatment:
It may take a few weeks before you notice any improvement. Continue taking Escitalopram Pensa Pharma even if it takes time for your condition to improve. Do not change the dosage without first consulting your doctor.
Continue taking Escitalopram Pensa Pharma for as long as your doctor has recommended. If you stop treatment too early, your symptoms may return. It is recommended to continue treatment for at least 6 months after symptoms have resolved.

If you take more Escitalopram Pensa Pharma than you should:
If you have taken more Escitalopram Pensa Pharma than prescribed, contact your doctor or go immediately to the nearest hospital emergency department. Do this even if you do not feel unwell. Some symptoms of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rhythm, low blood pressure, and disturbances in electrolyte balance. Take the Escitalopram Pensa Pharma container/box with you when going to the doctor or hospital.

If you forget to take Escitalopram Pensa Pharma:
Do not take a double dose to make up for the missed dose. If you forget to take a dose and remember before going to bed, take it immediately and continue your treatment as usual the next day. If you remember during the night or the following day, skip the missed dose and continue with your regular dosing schedule.

If you stop taking Escitalopram Pensa Pharma:
Do not stop taking Escitalopram Pensa Pharma unless your doctor tells you to. When completing treatment, it is generally recommended that the dose of Escitalopram Pensa Pharma be gradually reduced over several weeks.
When stopping Escitalopram Pensa Pharma, especially if stopped abruptly, you may experience withdrawal symptoms. These are common when discontinuing treatment with Escitalopram Pensa Pharma. The risk is higher if you have taken Escitalopram Pensa Pharma for a long time or at high doses, or if the dose is reduced too quickly. Most patients find that such symptoms are mild and usually resolve spontaneously within a couple of weeks. However, in some patients, withdrawal symptoms may be severe or may persist for a longer time (2–3 months or more). If you experience severe withdrawal symptoms when stopping treatment with Escitalopram Pensa Pharma, inform your doctor. Your doctor may restart your treatment and continue reducing the dose more gradually.

Withdrawal symptoms include: dizziness (feeling unsteady or off-balance), tingling sensations, burning sensations, and (less commonly) electric shock-like sensations (also in the head), sleep disturbances (vivid dreams, nightmares, difficulty sleeping), anxiety, headache, malaise (nausea), sweating (including night sweats), restlessness or agitation, tremor (shaking), confusion or disorientation, excessive emotionality or irritability, diarrhoea (loose stools), visual disturbances, and disturbances in heart rhythm (palpitations).

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

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects usually disappear after a few weeks of treatment. Please note that many of these adverse effects may also be symptoms of your underlying illness and will therefore improve as you start to feel better.

If any of the following symptoms occur, you must contact your doctor or go to hospital immediately:
Uncommon (may affect up to 1 in 100 people):

• Abnormal bleeding, including gastrointestinal haemorrhage
  Rare (may affect up to 1 in 1,000 people):
• If you experience swelling of the skin, tongue, lips, throat or face, hives, or have difficulty breathing or swallowing (severe allergic reaction), contact your doctor or go to hospital immediately.
• If you develop high fever, agitation, confusion, tremor and sudden muscle contractions, these may be symptoms of a rare condition called serotonin syndrome. If you experience these, contact your doctor.
  Not known (frequency cannot be estimated from available data):
• Difficulty urinating
• Seizures (fits); see also section "Warnings and precautions"
• Yellowing of the skin or whites of the eyes, which are signs of liver dysfunction/hepatitis
• Rapid or irregular heartbeat, feeling faint—these could be symptoms of a life-threatening condition known as Torsades de Pointes
• Thoughts of self-harm or suicide; see also section 2 "Pregnancy, breastfeeding and fertility"
• Sudden swelling of the skin or mucous membranes (angioedema)
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage). See section 2 “Pregnancy, breastfeeding and fertility” for further information

In addition to those listed above, the following side effects have been reported:
Very common (may affect more than 1 in 10 people):

• Nausea
• Headache

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

• Stuffy or runny nose (sinusitis)
• Decreased or increased appetite
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, skin irritation
• Diarrhoea, constipation, vomiting, dry mouth
• Increased sweating
• Muscle and joint pain (arthralgia and myalgia)
• Sexual disorders (delayed ejaculation, erectile dysfunction, decreased sexual desire, and women may have difficulty achieving orgasm)
• Fatigue, fever
• Weight gain

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

• Hives, skin rash, itching
• Teeth grinding, agitation, nervousness, panic attacks, confusion
• Disturbed sleep, taste disturbances, fainting (syncope)
• Dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus)
• Hair loss
• Excessive vaginal bleeding
• Irregular menstrual periods
• Weight loss
• Increased heart rate
• Swelling of arms and legs
• Nosebleeds
  Rare (may affect up to 1 in 1,000 people):
• Aggression, depersonalization, hallucinations
• Slowed heart rate

Not known (frequency cannot be estimated from available data):

• Decreased sodium levels in the blood (symptoms include nausea, malaise, muscle weakness or confusion)
• Dizziness upon standing due to a drop in blood pressure (orthostatic hypotension)
• Changes in liver function tests (increased liver enzymes in the blood)
• Movement disorders (involuntary muscle movements)
• Painful erections (priapism)
• Signs of increased bleeding, for example from the skin and mucous membranes (bruising)
• Increased secretion of a hormone called ADH, causing the body to retain water and dilute the blood, thereby reducing sodium levels (inappropriate antidiuretic hormone 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 medicine
• Changes in heart rhythm (known as “QT interval prolongation”, detected by ECG,
  which records the electrical activity of the heart).

Additionally, a number of adverse effects are known to occur with medicines that act similarly to escitalopram. These include:

• Motor restlessness (akathisia)
• Loss of appetite

Reporting of adverse effects
If you experience any adverse effects, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ESCITALOPRAM PENSA PHARMA

• Keep this medicine out of the sight and reach of children.
• Do not use Escitalopram Pensa Pharma after the expiry date stated on the label or packaging following "Exp". The expiry date refers to the last day of that month.
• The drops must be used within 8 weeks of opening and stored at a temperature not exceeding 25°C.
• Keep the bottle tightly closed and in an upright position.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Escitalopram pensa pharma contains
The active substance is escitalopram. Each ml of Escitalopram pensa pharma oral drops contains 20 mg of
escitalopram (as escitalopram oxalate). 1 drop contains 1 mg of escitalopram.
The other components are propyl gallate; anhydrous citric acid; 96% ethanol; sodium hydroxide and purified water.

Description of the appearance of Escitalopram pensa pharma and package contents
Escitalopram pensa pharma oral drops solution is available in 15 ml or 15 ml x 5 packs in amber glass bottles with dropper. It is a clear solution. Not all pack sizes may be marketed.

Marketing Authorization Holder
Pensa Pharma S.p.A., Via Ippolito Rosellini 12, 20124 Milano, Italy

Manufacturer
Chanelle Medical, Loughrea, Co. Galway, Ireland
JSC Grindeks, 53 Krustpils street, Riga, LV-1057, Latvia

This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy Escitalopram pensa pharma