Escitalopram Tecnigen

PACKAGE LEAFLET: INFORMATION FOR THE USER

ESCITALOPRAM TECNIGEN 10 mg film-coated tablets, 20 mg film-coated tablets

Generic medicine
Please read all of 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 they have the same symptoms as yours, because it may 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:

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

1. WHAT ESCITALOPRAM TECNIGEN IS AND WHAT IT IS USED FOR

Escitalopram TecniGen contains the active substance escitalopram. Escitalopram TecniGen belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain, increasing levels of serotonin. Disturbances in the serotonin system are considered an important factor in the development of depression and related disorders.
Escitalopram TecniGen contains escitalopram and is used to treat 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).
It may take a few weeks before you start to feel better. Continue taking Escitalopram TecniGen even if it takes some 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 TECNIGEN

Do not take Escitalopram TecniGen:

• 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 for the treatment of Parkinson’s disease), moclobemide (used for the treatment of depression), or linezolid (an antibiotic).
• if you were born with or have had an episode of abnormal heart rhythm (detectable via electrocardiogram (ECG), a test used to assess heart function).
• 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”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Escitalopram TecniGen.
Inform your doctor if you have any other condition or illness, as this may influence your treatment. In particular, inform your doctor:

• if you suffer from epilepsy. Treatment with Escitalopram TecniGen should 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 impaired liver or kidney function. Your doctor may need to adjust your dosage.
• if you have diabetes. Treatment with Escitalopram TecniGen may alter blood glucose control. The dosage of insulin and/or oral antidiabetic medicines may need to be adjusted.
• if your blood sodium level is low.
• if you have a tendency to bleed easily or to develop bruises.
• if you are undergoing electroconvulsive therapy.
• if you have coronary heart disease.
• if you have or have previously had 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 experienced a significant loss of salt due to prolonged and severe diarrhoea or vomiting, 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.
• if you have or have previously had eye problems, such as certain types of glaucoma (increased pressure in the eye).

Medicines such as Escitalopram TecniGen (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 persisted after discontinuation of treatment.
Warning
Some patients with bipolar disorder 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 sitting still or standing still may also occur during the first weeks of treatment. Inform your doctor immediately if you experience such symptoms.
Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or suffer from anxiety disorders, you may sometimes feel an urge to harm yourself or to commit suicide.
These thoughts may increase at the beginning of treatment with antidepressants, as these medicines take time to work, usually about two weeks but sometimes longer.
You may be more likely to have these thoughts if:

• you have previously had thoughts of suicide or self-harm.

• you are a young adult. Data from clinical studies 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 self-harm or suicide, contact your doctor immediately or go to the nearest 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 ask them to inform you if they believe your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.
  Children and adolescents
  Escitalopram TecniGen should generally not be used in children and adolescents under 18 years of age. Furthermore, you should know that patients under 18 years of age have a higher risk of experiencing 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 prescribe Escitalopram TecniGen to patients under 18 years of age if they decide it is in their best interest. If your doctor has prescribed Escitalopram TecniGen to a patient under 18 years of age and you wish to discuss this, speak to your doctor again. You must 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. In addition, the long-term effects on safety regarding growth, maturation, and cognitive and behavioural development in this age group have not yet been established.
  Other medicines and Escitalopram TecniGen
  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, iproniazide, isocarboxazide, nialamide, or tranilcypramine as active ingredients. If you have taken any of these medicines, you must wait 14 days before starting Escitalopram TecniGen. After stopping Escitalopram TecniGen, you must wait 7 days before taking any of these medicines.

• "Reversible selective MAO-A inhibitors", containing moclobemide (used for the treatment of depression).

• "Irreversible MAO-B inhibitors", containing selegiline (used for the treatment of Parkinson’s disease). These medicines increase the risk of adverse effects.

• The antibiotic linezolid.

• Lithium (used for the treatment of bipolar disorder) and tryptophan.

• Imipramine and desipramine (both used for the treatment of depression).

• Sumatriptan and similar medicines (used for the treatment of migraine) and tramadol (used for severe pain). These medicines increase the risk of adverse effects.

• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may cause an increase in escitalopram levels in the blood.

• St. John’s wort (Hypericum perforatum) – a herbal preparation used for depression.

• Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or to thin the blood, so-called anticoagulants). These medicines may increase the tendency to bleed.

• Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so-called anticoagulants). Your doctor will likely monitor your blood clotting time at the start and upon discontinuation of Escitalopram TecniGen to ensure the anticoagulant dose remains appropriate.

• Mefloquine (used for the treatment of malaria), bupropion (used to treat depression), and tramadol (used for the treatment of severe pain) due to the possible risk of lowering the seizure threshold.

• Neuroleptics (medicines for the treatment of schizophrenia and psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the seizure threshold.

• Flecainide, propafenone, and metoprolol (used for cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Adjustment of the Escitalopram TecniGen dosage may be necessary.

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

• Cimetidine, lansoprazole, and omeprazole (used for the treatment of gastric ulcers), fluconazole (used for the treatment of fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause an increase in blood levels of escitalopram.

Do not take Escitalopram TecniGen if you are taking medicines for heart rhythm problems or medicines that may affect your heart rhythm, such as class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. 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 with food, drinks and alcohol
Escitalopram TecniGen can be taken with or without food (see section 3 “How to take Escitalopram TecniGen”).
As with many medicines, it is not recommended to combine Escitalopram TecniGen with alcohol, although no interactions between Escitalopram TecniGen and alcohol are expected.
Pregnancy, breastfeeding and fertility
If you are pregnant or planning to become pregnant, consult your doctor before taking this medicine. Do not take Escitalopram TecniGen if you are pregnant or breastfeeding unless you have discussed the associated risks and benefits with your doctor.
If you take Escitalopram TecniGen during the last three months of pregnancy, 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, muscle stiffness or floppiness, heightened reflexes, tremors, restlessness, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. If your newborn shows any of these symptoms, contact your doctor immediately.
Ensure that your midwife and/or doctor are aware that you are being treated with Escitalopram TecniGen.
When taken during pregnancy, particularly in the last trimester, medicines such as Escitalopram TecniGen 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 used during pregnancy, Escitalopram TecniGen must never be stopped abruptly.
Escitalopram TecniGen 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 the impact on human fertility has not been observed.
Driving and using machines
It is recommended not to drive or operate machinery until you know how Escitalopram TecniGen affects you.

3. HOW TO TAKE ESCITALOPRAM TECNIGEN

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Adults
Depression
The usual recommended dose of Escitalopram TecniGen is 10 mg taken as a single daily dose. Your doctor may
increase the dose up to a maximum of 20 mg per day.
Panic disorder
The initial dose of Escitalopram TecniGen is 5 mg as a single daily dose for the first week, before increasing the
dose to 10 mg per day. Your doctor may further increase the dose up to a maximum of 20 mg per day.
Social anxiety disorder
The usual recommended dose of Escitalopram TecniGen is 10 mg taken as a single daily dose. Your doctor may
either reduce the dose to 5 mg per day or increase it up to a maximum of 20 mg per day, depending on your
response to the medicine.
Generalized anxiety disorder
The usual recommended dose of Escitalopram TecniGen is 10 mg taken as a single daily dose. Your doctor may
increase the dose up to a maximum of 20 mg per day.
Obsessive-compulsive disorder
The usual recommended dose of Escitalopram TecniGen is 10 mg taken as a single daily dose. Your doctor may
increase the dose up to a maximum of 20 mg per day.
Elderly patients (over 65 years of age)
The recommended initial dose of Escitalopram TecniGen is 5 mg taken as a single daily dose. Your doctor may
increase the dose to 10 mg per day.
Use in children and adolescents
Escitalopram TecniGen should normally not be used in children and adolescents. For further information, see
section 2 “What you need to know before taking Escitalopram TecniGen”.
Escitalopram TecniGen may be taken with or without food. Swallow the tablet with some water. Do not chew the
tablets as they are bitter.
If necessary, you may split the tablet by first placing it on a flat surface with the score line facing upwards. The
tablet can then be broken by pressing downwards on both sides of the tablet using your index fingers, as shown
in the illustration below.

Duration of treatment
It may take a few weeks before you start to feel better. Continue taking Escitalopram TecniGen even if you need
to wait some time before noticing an improvement in your condition.
Do not change the dose of the medicine without first discussing it with your doctor.
Continue taking Escitalopram TecniGen for the entire duration recommended by your doctor. If you stop the
treatment too early, symptoms may return. It is recommended to continue treatment for at least 6 additional
months after recovery.
If you take more Escitalopram TecniGen than you should
If you take a dose of Escitalopram TecniGen higher than prescribed, contact your doctor or the emergency
department of the nearest hospital immediately, even if you do not feel unwell. Some signs of overdose may
include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rate, low blood pressure,
and disturbances in fluid and electrolyte balance in the body. Take the box/container of Escitalopram TecniGen
with you when you go to the doctor or hospital.
If you forget to take Escitalopram TecniGen
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 as usual the next day. If you only remember during the night or the
following day, skip the missed dose and continue as usual.
If you stop taking Escitalopram TecniGen
Do not stop taking Escitalopram TecniGen unless your doctor tells you to. Once the treatment course is completed,
it is generally recommended to gradually reduce the dose of Escitalopram TecniGen over several weeks.
When stopping Escitalopram TecniGen, especially abruptly, you may experience withdrawal symptoms. These
symptoms are common when stopping treatment with Escitalopram TecniGen. The risk is higher if Escitalopram
TecniGen has been used for a long time, at high doses, or if the dose is reduced too quickly. Most people find that
these symptoms are mild and usually disappear spontaneously 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, consult your doctor. Your doctor may advise you to restart treatment and
then gradually reduce the dose more slowly.
Withdrawal symptoms include: dizziness (unstable, wobbly balance), tingling sensations, burning sensations, and
(less commonly) electric shock-like sensations, even 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, feeling confused or disoriented, feeling overly emotional or irritable, diarrhoea (loose
stools), visual disturbances, pounding or racing heartbeat (palpitations).
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

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

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

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

• Unusual bleeding, including gastrointestinal bleeding

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

• Swelling of the skin, tongue, lips or face, or difficulty breathing or swallowing (allergic reaction)
• High fever, agitation, confusion, tremor and sudden muscle contractions may be signs of a rare condition called serotonin syndrome.

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

• Difficulty urinating
• Seizures (convulsions); see also section “Warnings and precautions”
• Yellowing of the skin and whites of the eyes, which may indicate impaired liver function/hepatitis
• Fast and irregular heartbeat and fainting, which may be symptoms of a life-threatening condition known as Torsades de Pointes
• Thoughts of self-harm or suicidal thoughts; see section “Warnings and precautions”

In addition to the above, the following adverse reactions have been reported:

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

• Headache
• Nausea

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

• Stuffy or runny nose (sinusitis)
• Decreased or increased appetite
• Anxiety, restlessness, abnormal dreams, difficulty sleeping, 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, erection problems, decreased sexual desire; women may experience 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 attack, confusion
• Disturbed sleep, taste disturbances, fainting (syncope)
• Enlarged pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus)
• Hair loss
• Heavy menstrual bleeding
• Irregular menstrual cycle
• Weight loss
• Rapid heartbeat
• Swelling of the arms or legs
• Nosebleeds

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

• Aggression, depersonalization, hallucinations
• Slow heartbeat

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

• Reduced sodium levels in the blood (symptoms include nausea, muscle weakness or confusion)
• Dizziness upon standing due to low blood pressure (orthostatic hypotension)
• Abnormal liver function tests (increased liver enzyme levels in the blood)
• Movement disorders (involuntary muscle movements)
• Painful erection (priapism)
• Signs of increased bleeding, for example of the skin and mucous membranes (bruising)
• Sudden swelling of the skin and mucous membranes (angioedema)
• Increased urine output (inappropriate ADH secretion)
• Milk discharge in men and 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 (referred to as “QT interval prolongation”, detectable on ECG, the recording of the heart's electrical activity)

In addition, it is known that certain adverse reactions occur with medicines that act similarly to escitalopram (the active substance in Escitalopram TecniGen). These include:

• Motor restlessness (akathisia)
• Loss of appetite

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

5. HOW TO STORE ESCITALOPRAM TECNIGEN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of the month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION
What Escitalopram TecniGen contains
Escitalopram TecniGen 10 mg:

• The active substance is escitalopram. Each tablet contains 10 mg of escitalopram (as escitalopram oxalate).
• The other components are:
• Tablet core: microcrystalline cellulose, sodium croscarmellose, talc, anhydrous colloidal silica and magnesium stearate
• Tablet coating: hypromellose, titanium dioxide (E171) and macrogol.

Escitalopram TecniGen 20 mg:

• The active substance is escitalopram. Each tablet contains 20 mg of escitalopram (as escitalopram oxalate).
• The other components are:
• Tablet core: microcrystalline cellulose, sodium croscarmellose, talc, anhydrous colloidal silica and magnesium stearate
• Tablet coating: hypromellose, titanium dioxide (E171) and macrogol.

Description of the appearance of Escitalopram TecniGen and pack contents
Escitalopram TecniGen 10 mg
Escitalopram TecniGen 10 mg tablets are elliptical, white, biconvex, with a score line on both sides.
Escitalopram TecniGen 10 mg tablets are supplied in blisters of 28 tablets.
Escitalopram TecniGen 20 mg
Escitalopram TecniGen 20 mg tablets are oblong, white, biconvex, with a score line on one side and a "+" mark imprinted on the other side.
Escitalopram TecniGen 20 mg tablets are supplied in blisters of 28 tablets.
Marketing Authorization Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)
Manufacturer responsible for batch release
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, n.º 11, Venda Nova, 2700 – 486 Amadora, Portugal
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal
This medicine is authorized in the European Economic Area countries under the following names:
Portugal: Escitalopram Biofarmoz
Italy: Escitalopram TecniGen