Escitalopram Medreg: detailed information

Package leaflet: Information for the patient

Escitalopram Medreg 10 mg film-coated tablets

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 they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Escitalopram Medreg is and what it is used for

Escitalopram Medreg contains the active substance escitalopram. Escitalopram Medreg belongs to a
group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). These
medicines act on the serotonin system in the brain by increasing serotonin levels.
Escitalopram Medreg 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 couple of weeks before you start to feel better. Continue taking Escitalopram Medreg,
even if it takes some time for your condition to show improvement.
Contact your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Escitalopram Medreg

Do not take Escitalopram Medreg

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 the group of MAO inhibitors, including selegiline (used in the treatment of Parkinson’s disease), moclobemide (for the treatment of depression), or linezolid (an antibiotic).
if you suffer from congenital arrhythmia or have had an episode of arrhythmia (detected on ECG, a test to assess the function of your heart).
if you are taking medicines to treat heart rhythm disorders or that may affect heart rhythm (see section 2 “Other medicines and Escitalopram Medreg”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Escitalopram Medreg.
Inform your doctor if you have any other condition or illness, as your doctor may need to take this into account. In particular, tell your doctor:

if you suffer from epilepsy. Treatment with Escitalopram Medreg should be discontinued if epileptic seizures occur for the first time or if there is an increase in seizure frequency (see also section 4 “Possible side effects”).
if you have impaired liver or kidney function. Your doctor may need to adjust your dose.
if you have diabetes. Treatment with Escitalopram Medreg may alter glycaemic control. It may be necessary to adjust the dose of insulin and/or oral hypoglycaemic agents.
if you have low levels of sodium in your blood.
if you have a tendency to bleed or bruise easily, 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 heart problems or have recently had a heart attack.
if you have a low resting heart rate and/or if you know you have salt deficiencies due to prolonged severe diarrhoea and vomiting (feeling unwell) or are using diuretics (medicines to increase urination).
if, when standing up, you experience rapid or irregular heartbeat, fainting, collapse, or dizziness, which may indicate an abnormality in heart rhythm.
if you have or have previously had eye problems, such as certain types of glaucoma (increased eye pressure).

Please note
Some patients with bipolar disorder may enter a manic phase. This is characterised 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 or standing still may occur during the first weeks of treatment. If these symptoms occur, inform your doctor immediately.
Medicines such as Escitalopram Medreg (so-called SSRIs/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 your 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. Clinical study data 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 to hospital immediately. It may be helpful to inform a close relative or 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
Escitalopram Medreg should generally not be used in children and adolescents under 18 years of age. In addition, you should know that, when taking this class of medicines, patients under 18 years of age have an increased risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger). Despite this, your doctor may prescribe Escitalopram Medreg to patients under 18 years of age if they consider it to be the best treatment option for them. If your doctor has prescribed Escitalopram Medreg 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 Medreg in a patient under 18 years of age. Furthermore, the long-term safety effects of Escitalopram Medreg on growth, maturation, and cognitive and behavioural development have not yet been established in this age group.

Other medicines and Escitalopram Medreg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell 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 ingredient. If you have taken any of these medicines, you must wait 14 days before starting treatment with Escitalopram Medreg. After stopping treatment with Escitalopram Medreg, 7 days must pass before taking any of these medicines.
“Reversible selective MAO-A inhibitors” containing moclobemide (used in the treatment of depression).
“Irreversible MAO-B inhibitors” containing selegiline (used in the treatment of Parkinson’s disease). These increase the risk of adverse effects.
The antibiotic linezolid.
Lithium (used in the treatment of bipolar disorder) and tryptophan.
Imipramine and desipramine (both used to treat depression).
Sumatriptan and similar medicines (used to treat migraine) and tramadol and similar medicines (opioids, used to treat severe pain). These increase the risk of adverse effects.
Cimetidine, lansoprazole, and omeprazole (used to treat gastric ulcer), 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 product used for depression.
Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used for pain relief or to reduce blood clotting, also called antiplatelets). These may increase the tendency to bleed.
Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce blood clotting, also called anticoagulants). Your doctor will likely monitor your clotting time at the beginning and end of treatment with Escitalopram Medreg 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 lowered seizure threshold.
Neuroleptics (medicines used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs), due to the possible risk of lowered seizure threshold.
Flecainide, propafenone, and metoprolol (used in cardiovascular conditions), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). A dose adjustment of Escitalopram Medreg 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.

Do not take Escitalopram Medreg if you are taking medicines for heart rhythm problems or that may affect 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, hydroxyzine, mizolastine). If you have any further doubts, contact your doctor.

Escitalopram Medreg with food, drinks and alcohol
Escitalopram Medreg can be taken with or without food (see section 3 “How to take Escitalopram Medreg”).
As with many medicines, combining Escitalopram Medreg with alcohol is not recommended, although an interaction between Escitalopram Medreg and alcohol is not 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 Medreg if you are pregnant or breastfeeding, unless your doctor has discussed the risks and benefits of treatment with you.
If you take Escitalopram Medreg during the last 3 months of pregnancy, you should be aware that the following effects may occur in the newborn: breathing difficulties, bluish skin, seizures, unstable body temperature, feeding difficulties, vomiting, low blood sugar levels, hypertonia or hypotonia, hyperreflexia, tremor, restlessness, irritability, lethargy, continuous crying, drowsiness, and sleep disturbances. 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 Medreg. When taken during pregnancy, particularly during the last 3 months, medicines like Escitalopram Medreg 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 happens to your baby, contact your midwife and/or doctor immediately.
If you take Escitalopram Medreg near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders. Inform your doctor or midwife that you are taking Escitalopram Medreg so they can advise you on what to do.
If used during pregnancy, Escitalopram Medreg must never be stopped abruptly.
Escitalopram is expected to be excreted in breast milk.
Citalopram, a medicine similar to escitalopram, has been shown in animal studies to reduce sperm quality. In theory, this could affect fertility, but the impact on human fertility has not yet been observed.

Driving and using machines
Do not drive or operate machinery until you know how Escitalopram Medreg affects you.

Escitalopram Medreg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Escitalopram Medreg

Take this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.
Adults
Depression
The usual recommended dose of Escitalopram Medreg is 10 mg once daily. Your doctor may increase this dose up to a maximum of 20 mg per day.
Panic disorder
The initial dose of Escitalopram Medreg is 5 mg per day for the first week before increasing 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 dose of Escitalopram Medreg normally recommended is 10 mg once daily. Your doctor may reduce the dose to 5 mg per day or increase it up to a maximum of 20 mg per day, depending on your individual response to treatment.
Generalized anxiety disorder
The dose of Escitalopram Medreg normally recommended is 10 mg once daily. This dose may be increased by your doctor up to a maximum of 20 mg per day.
Obsessive-compulsive disorder
The normally recommended dose of Escitalopram Medreg is 10 mg once daily. The dose may be increased by your doctor up to a maximum of 20 mg per day.
Elderly patients (over 65 years of age)
The recommended initial dose of Escitalopram Medreg is 5 mg once daily. This dose may be increased by your doctor up to 10 mg per day.
Use in children and adolescents
Escitalopram Medreg should normally not be taken by children and adolescents. For further information, see section 2 "Warnings and precautions".
Patients with reduced renal function
Caution is advised in patients with severely impaired renal function. Take the medicine as prescribed by your doctor.
Patients with reduced liver function
Patients with liver impairment should not receive more than 10 mg per day. Take the medicine as prescribed by your doctor.
Patients known to be slow metabolizers of the CYP2C19 enzyme
Patients with this known genotype should not receive more than 10 mg per day. Take the medicine as prescribed by your doctor.
How to take the tablets
Escitalopram Medreg may be taken with or without food. Swallow the tablet with water. Do not chew it, as it has a bitter taste. The tablet may be divided into equal doses.
Duration of treatment
It may take a few weeks before you notice any improvement. Continue taking Escitalopram Medreg even if you do not experience immediate improvement in your condition.
Dosage should never be changed without first consulting your doctor.
Continue taking Escitalopram Medreg for as long as your doctor has recommended. If treatment is stopped too early, symptoms may return. It is recommended to continue treatment for at least 6 months after symptoms have resolved.
If you take more Escitalopram Medreg than you should
If you have taken more Escitalopram Medreg than prescribed, contact your doctor or go immediately to the nearest hospital emergency department, 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 pack/blister of Escitalopram Medreg with you when going to a doctor or hospital.
If you forget to take Escitalopram Medreg
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose and remember before going to bed, take it immediately. Continue taking your medicine 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 Medreg
Do not stop taking Escitalopram Medreg unless your doctor tells you to. When completing treatment, it is generally recommended that the dose of Escitalopram Medreg be gradually reduced over a period of a few weeks.
When stopping Escitalopram Medreg, especially if stopped suddenly, you may experience withdrawal symptoms. These are common when discontinuing treatment with Escitalopram Medreg. The risk is higher if you have taken Escitalopram Medreg for a long time, at high doses, or if the dose is reduced too quickly. Most patients find that these symptoms are mild and usually resolve spontaneously within a few weeks. However, in some patients, 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 Medreg, inform your doctor. Your doctor may advise you to restart treatment and then gradually reduce the dose more slowly.
Withdrawal symptoms include: dizziness (feeling unsteady or off balance), pins and needles sensations, burning sensations (less frequent), electric shock-like sensations, including 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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The side effects usually disappear after a few weeks of treatment. Please note that many of the side effects may also be symptoms of your illness and therefore decrease as you start to feel better.
If you experience any of the following symptoms, you must contact your doctor or go to hospital immediately:
Uncommon (may affect up to 1 in 100 people):

abnormal bleeding, including gastrointestinal bleeding

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

swelling of the skin, tongue, lips, throat or face, hives or difficulty breathing or swallowing (a life-threatening allergic reaction)
high fever, agitation, confusion, tremor and sudden muscle contractions; these may be symptoms of a rare condition called serotonin syndrome

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

difficulty passing urine
epileptic seizures (fits), see also section “Warnings and precautions”
yellowing of the skin and whites of the eyes, which are signs of impaired liver function/hepatitis
rapid or irregular heartbeat, feeling of fainting, which may be symptoms of a life-threatening condition known as Torsade de Pointes
thoughts of self-harm or suicide, see also section “Warnings and precautions”
sudden swelling of the skin or mucous membranes (angioedema)

In addition to the side effects listed above, the following have also been reported:
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)
decreased or increased appetite
anxiety, restlessness, unusual dreams, difficulty sleeping, drowsiness, dizziness, yawning, tremor, tingling sensation of 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 and, in women, difficulty achieving orgasm)
fatigue, fever
weight gain

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

hives, skin rash, itching sensation (pruritus)
teeth grinding, agitation, nervousness, panic attacks, confusion state
disturbed sleep, taste disturbances, fainting (syncope)
dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus)
hair loss
increased menstrual flow
irregular menstrual cycle
weight loss
increased heart rate
swelling of arms or 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 feeling unwell with muscle weakness or confusion)
dizziness upon standing due to a drop in blood pressure (orthostatic hypotension)
changes in liver function test values (increased levels of liver enzymes in the blood)
movement disorders (involuntary muscle movements)
painful erections (priapism)
signs of abnormal bleeding, for example, of the skin and mucous membranes (bruising) and low platelet count in the blood (thrombocytopenia)
increased secretion of a hormone called ADH, causing fluid retention and dilution of the blood, resulting in reduced sodium levels (inappropriate ADH secretion)
increased blood levels of the hormone prolactin
milk secretion 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 (called “prolongation of the QT interval”, assessed by an ECG that records the heart’s electrical activity)
heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage), see section 2 “Pregnancy, breastfeeding and fertility” for further information

In addition, a number of side effects are known to occur with medicines that act like escitalopram (the active substance in Escitalopram Medreg). These include:

motor restlessness (akathisia)
loss of appetite

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 the website 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 Medreg

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister after "Scad." and "EXP". The expiry date refers to the last day of that month.
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. Package contents and other information

What Escitalopram Medreg contains

The active substance is escitalopram. Each film-coated tablet contains 10 mg of escitalopram (as oxalate).
The other excipients are: tablet core: microcrystalline cellulose, sodium croscarmellose, talc, anhydrous colloidal silica, magnesium stearate; coating: hypromellose (E464), titanium dioxide (E171), talc, macrogol (PEG-400)

Description of the appearance of Escitalopram Medreg and contents of the pack
Film-coated, biconvex tablets, white to almost white, oval-shaped, approximately
7.8 x 5.3 - 8.2 x 5.7 mm, with the imprint “C4” in relief on one side and a break line on the other side.
The tablet can be divided into equal doses.
The film-coated tablets are supplied in transparent PVDC/PVC/Al blisters, packed in cardboard cartons.
Pack sizes: 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

Manufacturer:
Medis International a.s.
Průmyslová 961/16
747 23 Bolatice
Czech Republic

Pharmazet Group s.r.o.
Třtinová 260/1
Čakovice
196 00 Prague 9
Czech Republic

This medicinal product is authorized in the European Economic Area countries under the following names:
Slovakia: Escitalopram Medreg
Czech Republic: Escitalopram Medreg
Poland: Escitalopram Medreg
Italy: Escitalopram Medreg
Romania: Escitalopram Gemax Pharma 10 mg film-coated tablets