Escitalopram Tecnigen Italia: detailed information

Package leaflet: Information for the user

Escitalopram Tecnigen Italia

20 mg/ml oral drops, solution
Escitalopram
Generic medicine
Read this leaflet carefully before taking this medicine because 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 other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

What Escitalopram Tecnigen Italia is and what it is used for
What you need to know before taking Escitalopram Tecnigen Italia
How to take Escitalopram Tecnigen Italia
Possible side effects
How to store Escitalopram Tecnigen Italia
Contents of the pack and other information

1. What Escitalopram Tecnigen Italia is and what it is used for

Escitalopram Tecnigen Italia belongs to a group of antidepressant medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain, increasing the level of serotonin. Imbalances in the serotonin system are considered an important factor in the development of depression and related disorders.
Escitalopram Tecnigen Italia contains escitalopram, which is used for the treatment of:

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

2. What you should know before taking Escitalopram Tecnigen Italia

Do not take Escitalopram Tecnigen Italia

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 called monoamine oxidase inhibitors (MAO inhibitors), including selegiline (used to treat Parkinson’s disease), moclobemide (used to treat depression), or linezolid (an antibiotic);
if you were born with or have experienced an episode of abnormal heart rhythm (visible on an electrocardiogram (ECG), a test to assess how the heart is functioning);
if you are taking medicines for heart rhythm problems or medicines that may affect your heart rhythm (see section 2 “Other medicines and Escitalopram Tecnigen Italia”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Escitalopram Tecnigen Italia. Inform your doctor if you have ever had any of the following conditions or illnesses, as your doctor may need to take them into account:

if you suffer from epilepsy. Treatment with Escitalopram Tecnigen Italia must be discontinued if you experience seizures for the first time or if the frequency of epileptic seizures increases (see also section 4 “Possible side effects”);
if you have thoughts of suicide or of harming yourself. See the subsection “Suicidal thoughts and worsening of depression or anxiety disorder”;
if you have impaired liver or kidney function. Your doctor may need to adjust your dose;
if you have diabetes. Treatment with Escitalopram Tecnigen Italia may alter glycaemic control. It may be necessary to adjust the dose of insulin and/or oral hypoglycaemic agents;
if your blood sodium level is low;
if you are under 18 years of age;
if you have previously experienced mania or manic depression;
if you have a tendency to bleeding or easy bruising, or if you are pregnant (see “Pregnancy, breastfeeding and fertility”);
if you are taking any other medicine, including herbal remedies. See the subsection “Other medicines and Escitalopram Tecnigen Italia”;
if you are undergoing electroconvulsive therapy (ECT);
if you suffer from closed-angle glaucoma or have previously had glaucoma;
if you suffer from coronary heart disease;
if you are pregnant or breastfeeding;
if you suffer or have suffered from heart problems or have recently had a heart attack;
if you have a slow resting heart rate and/or if you think your body may have undergone a significant loss of salt due to prolonged and severe diarrhoea and vomiting (feeling unwell) or due to the use of diuretics (water tablets);
if you experience a fast or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate an irregular heart rhythm.
the use of medicines containing buprenorphine together with Escitalopram Tecnigen Italia may lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Escitalopram Tecnigen Italia”). If you suffer from bipolar disorder, you may enter a manic phase, characterised by unusual and rapid changes in thinking, unjustified happiness, and excessive physical activity. If you experience such symptoms, contact your doctor. Symptoms such as restlessness or difficulty remaining seated or still (akathisia) may also occur during the first few weeks of treatment. Inform your doctor immediately if you experience these symptoms. If you suffer from panic disorder, you may experience an increase in anxiety symptoms at the beginning of treatment. Inform your doctor immediately if you experience these symptoms. Medicines such as Escitalopram Tecnigen Italia (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.

Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or suffer from anxiety disorders, you may sometimes have thoughts of harming yourself or of suicide.
These thoughts may increase at the beginning of treatment with antidepressants, as these medicines all require time to take effect, usually about two weeks but sometimes longer. You may be more likely to have these thoughts if:

you have previously experienced thoughts of suicide or self-harm;
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 have thoughts of harming yourself or of suicide, contact your doctor immediately or go to hospital straight away.
You may find it helpful to inform a close family member or friend about your depression or anxiety disorder and ask them to read this leaflet. You may wish to ask them to alert you if they think your depression or anxiety is worsening, or if they are concerned about any changes in your behaviour.

Children and adolescents
Escitalopram Tecnigen Italia should normally not be used in children and adolescents under 18 years of age. In addition, you should know that patients under 18 years of age have a higher risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger) when taking this class of medicines. However, your doctor may still prescribe Escitalopram Tecnigen Italia to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Escitalopram Tecnigen Italia for a patient under 18 years of age and you wish to discuss this, please speak to your doctor again. Inform your doctor if any of the symptoms described above appear or worsen while the patient under 18 years of age is taking Escitalopram Tecnigen Italia. Furthermore, the long-term safety of Escitalopram Tecnigen Italia with regard to growth, maturation, and cognitive and behavioural development in this age group has not yet been established.

Other medicines and Escitalopram Tecnigen Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. 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 Escitalopram Tecnigen Italia. After stopping Escitalopram Tecnigen Italia, you must wait 7 days 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 medicines 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.
Medicines containing buprenorphine. These medicines may interact with Escitalopram Tecnigen Italia and may cause symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremor, hyperreflexia, increased muscle contraction, fever above 38°C. Contact your doctor if you experience these symptoms;
Sumatriptan and similar medicines (used to treat migraine) and tramadol (used for severe pain). These medicines 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 medicines may cause an increase in blood levels of escitalopram.
St John’s wort (Hypericum perforatum), a herbal preparation used for depression.
Aspirin and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or to thin the blood, so-called anticoagulants). Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so-called anticoagulants). Your doctor will likely monitor your blood clotting time at the beginning and end of treatment with Escitalopram Tecnigen Italia to ensure your anticoagulant dose remains appropriate.
Mefloquine (used to treat malaria), tricyclic antidepressants or selective serotonin reuptake inhibitors (SSRIs), bupropion (used to treat depression), tramadol (used for severe pain), and antipsychotics (medicines 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). A dose adjustment of Escitalopram Tecnigen Italia may be necessary.
Medicines that reduce blood potassium or magnesium levels, as these conditions increase the risk of life-threatening cardiac rhythm disturbances.

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

Escitalopram Tecnigen Italia with food, drinks and alcohol
Escitalopram Tecnigen Italia can be taken regardless of meals (see section 3 “How to take Escitalopram Tecnigen Italia”).
As with many medicines, it is not recommended to combine Escitalopram Tecnigen Italia with alcohol, although no interactions between Escitalopram Tecnigen Italia and alcohol are expected.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Escitalopram Tecnigen Italia if you are pregnant or breastfeeding unless you have already discussed the associated risks and benefits with your doctor.
If you take Escitalopram Tecnigen Italia during the last three months of pregnancy, you should be aware that the newborn may experience the following effects: breathing difficulties, bluish skin colour, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar levels, rigid or floppy muscles, overactive reflexes, tremors, restlessness, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. If your baby shows any of these symptoms, contact your doctor immediately.
Ensure that your midwife and/or doctor know that you are being treated with Escitalopram Tecnigen Italia.
When taken during pregnancy, particularly in the last trimester, medicines such as Escitalopram Tecnigen Italia may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster than normal and have a bluish skin colour. 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 you take Escitalopram Tecnigen Italia near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (tendency to bleed). Inform your doctor or midwife that you are taking Escitalopram Tecnigen Italia so they can advise you on what to do.
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces sperm quality. Theoretically, this could affect fertility, but no impact on human fertility has been observed to date.
If used during pregnancy, Escitalopram Tecnigen Italia must never be stopped abruptly.
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.

Driving and using machines
You are advised not to drive or operate machinery until you know how Escitalopram Tecnigen Italia affects you.

Escitalopram Tecnigen Italia contains ethanol and sodium
This medicine contains 96 mg of alcohol (ethanol) in each ml (20 drops). The amount in 20 drops (1 ml) of this medicine is equivalent to less than 3 ml of beer or 1 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 1 ml (20 drops), i.e. it is essentially “sodium-free”.

3. How to take Escitalopram Tecnigen Italia

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Count the required number of drops into a drink (water, orange juice or apple juice), stir briefly, and then drink it all.
Instructions for use: Invert the bottle completely. If no drops come out, tap the bottle gently to start the flow.
Do not mix Escitalopram Tecnigen Italia with liquids other than water, orange juice or apple juice, and do not mix it with other medicines.

Adults
Depression
The recommended dose of Escitalopram Tecnigen Italia is 10 mg (10 drops) 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 Tecnigen Italia is 5 mg (5 drops) per day for the first week, before increasing to 10 mg (10 drops) per day. The dose may be further increased by your doctor up to a maximum of 20 mg (20 drops) per day.

Social anxiety disorder
The usual recommended dose of Escitalopram Tecnigen Italia is 10 mg (10 drops) 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 response to the medicine.

Generalised anxiety disorder
The recommended dose of Escitalopram Tecnigen Italia is 10 mg (10 drops) as 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 Escitalopram Tecnigen Italia is 10 mg (10 drops) as a single daily dose. The dose may be increased by your doctor up to a maximum of 20 mg (20 drops) per day.

Elderly patients (over 65 years of age)
The recommended initial dose of Escitalopram Tecnigen Italia is 5 mg (5 drops) as a single daily dose. The dose may be increased by your doctor to 10 mg (10 drops) per day.

Use in children and adolescents
Escitalopram Tecnigen Italia must not be used in children and adolescents. For further information, see section 2 “What you need to know before taking Escitalopram Tecnigen Italia”.

Duration of treatment
It may take a couple of weeks before you start to feel better. Continue taking Escitalopram Tecnigen Italia even if you need to wait some time before noticing an improvement in your condition. Do not change the dose of your medicine without first discussing it with your doctor.
Continue taking Escitalopram Tecnigen Italia 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 recovery.

If you take more Escitalopram Tecnigen Italia than you should
If you have taken more Escitalopram Tecnigen Italia than prescribed, contact your doctor or the nearest hospital emergency department immediately, even if you do not feel any symptoms or discomfort. Some signs of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rate, low blood pressure, and disturbances in the body's fluid and electrolyte balance. Take the box/container of Escitalopram Tecnigen Italia with you when going to the doctor or hospital.

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

If you stop taking Escitalopram Tecnigen Italia
Do not stop taking Escitalopram Tecnigen Italia unless your doctor tells you it is safe to do so. Once treatment is completed, it is generally recommended to gradually reduce the dose of Escitalopram Tecnigen Italia over several weeks.
When stopping Escitalopram Tecnigen Italia, especially if abruptly, you may experience the following symptoms:

dizziness (unsteady, lightheaded feeling), tingling sensations, burning sensations, and (less commonly) electric shock-like sensations (also in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headache, malaise (nausea), sweating (including night sweats), feeling restless or agitated, tremor (shakiness), feeling confused or disoriented, emotional lability or irritability, diarrhoea (loose stools), visual disturbances, pounding or racing heartbeat (palpitations). These symptoms are common when stopping treatment with Escitalopram Tecnigen Italia. The risk is higher if Escitalopram Tecnigen Italia has been taken for a long time or at high doses, or if the dose is reduced too quickly. Most people find these symptoms mild and they resolve on their own within two weeks. However, in some patients, symptoms may be severe or prolonged (2–3 months or longer). If you experience severe withdrawal symptoms when stopping Escitalopram Tecnigen Italia, consult your doctor. Your doctor may advise you to restart the drops and then discontinue treatment more gradually.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects generally disappear after a few weeks of treatment. However, consider that many of these side effects may also be symptoms of your illness, which will therefore improve as you start feeling better.
If you experience any of the following side effects, you must contact your doctor immediately or go to hospital:

Difficulty in urinating
Epileptic seizures (convulsions), see also section “Warnings and precautions”
Yellowing of the skin and whites of the eyes, which may be signs of impaired liver function/hepatitis
Rapid or irregular heartbeat, feeling faint – these may be symptoms of a life-threatening condition known as torsade de pointes.

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

Unusual bleeding, including gastrointestinal and rectal bleeding.

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

If you notice swelling of the skin, tongue, lips or face, or have difficulty breathing or swallowing (allergic reaction).
If you experience high fever, agitation, confusion, tremor, and sudden muscle contractions, these could be signs of a condition called serotonin syndrome.

The following side effects have also been reported in addition to those mentioned above:

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

Feeling unwell (nausea)
Headache

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

Stuffy or runny nose (sinusitis)
Altered appetite, weight gain
Anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, tingling sensations on the skin
Diarrhoea, constipation, vomiting, dry mouth
Increased sweating
Muscle and joint pain (arthralgia and myalgia)
Sexual disorders (delayed ejaculation, problems with erection, decreased sexual desire; women may have difficulty achieving orgasm)
Tiredness, fever

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

Hives, skin rash, itching
Teeth grinding, agitation, nervousness, panic attacks, confusional state
Disturbed sleep, altered taste, fainting (syncope)
Enlarged pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus)
Hair loss
Vaginal bleeding
Weight loss
Fast heartbeat (tachycardia)
Swelling of arms or legs
Nosebleeds

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

Aggression, depersonalisation/derealisation, seeing or hearing things that are not real (hallucinations)
Slow heartbeat (bradycardia)

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

Thoughts of harming yourself or of suicide – see also section “Warnings and precautions”
Reduced levels of sodium in the blood (symptoms include feeling unwell, muscle weakness or confusion)
Dizziness when standing up due to low blood pressure (orthostatic hypotension)
Abnormalities in liver function tests (increased liver enzyme levels in blood) and in ECG (electrocardiogram)
Movement disorders (involuntary muscle movements)
Painful erection (priapism)
Bleeding disorders, including bleeding into the skin and mucous membranes (bruising, ecchymosis) and low platelet count (thrombocytopenia)
Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage) – see section 2, “Pregnancy, breastfeeding and fertility”, for further information
Sudden swelling of the skin and mucous membranes (angioedema)
Increased urine production (inappropriate ADH secretion)
Milk flow 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 “prolongation of the QT interval”, visible on ECG, the electrical activity of the heart) have also been reported.

In addition, there are side effects associated with medicines that act similarly to escitalopram (the active substance in Escitalopram Tecnigen Italia), such as:

Psychomotor hyperactivity, urge or need to move to relieve an unpleasant sensation (akathisia)
Loss of appetite (anorexia)

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

5. How to store Escitalopram Tecnigen Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
After first opening, the drops must be used within 8 weeks and should not be stored at temperatures above 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Escitalopram Tecnigen Italia contains
The active substance is escitalopram. Each ml of Escitalopram Tecnigen Italia contains 20 mg of escitalopram
(as 25.55 mg of escitalopram oxalate). 1 drop contains 1 mg of escitalopram.
The other components are: propyl gallate; citric acid; 96% ethanol; sodium hydroxide; purified water.
Description of the appearance of Escitalopram Tecnigen Italia and package contents
Escitalopram Tecnigen Italia oral drops, solution is a clear, almost colourless to yellowish solution supplied in a dark glass bottle containing 15 ml, with a dropper.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare S.r.l.,
Via Marghera, 29
20149 Milan
Italy
Manufacturer
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (PC)
Italy
This medicinal product is authorized in the European Economic Area Member States under the following
names:
Italy: Escitalopram Tecnigen Italia