Escitalopram Krka

Package leaflet: Information for the patient

Escitalopram Krka 5 mg film-coated tablets, 10 mg film-coated tablets, 15 mg film-coated tablets, 20 mg film-coated tablets

Generic medicine
Please 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 could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist (see section 4).

Contents of this leaflet:

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

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

Escitalopram Krka 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).
Escitalopram 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. Imbalances in the serotonin system are considered an important factor in the development of depression and related conditions.
It may take a couple of weeks before you start to feel better. Continue taking Escitalopram Krka, even though it may take some time before you notice an improvement in your condition.
You should speak with a doctor if you do not feel better or if you feel worse.

2. What you should know before taking Escitalopram Krka

Do not take Escitalopram Krka

• if you are allergic to escitalopram or to any of the excipients 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), and linezolid (an antibiotic),
• if you suffer from congenital arrhythmia or have previously experienced an episode of arrhythmia (detected on ECG, a test to assess your heart function),
• if you are taking medicines to treat heart rhythm disorders or that may affect heart rhythm (see section 2 "Other medicines and Escitalopram Krka").

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

• If you suffer from epilepsy. Your doctor will discontinue treatment with Escitalopram Krka if seizures occur or if there is an increase in seizure frequency (see also section 4 "Possible side effects").
• If you suffer from hepatic or renal impairment. Your doctor may need to adjust your dosage.
• If you have diabetes. Treatment with Escitalopram Krka may alter glycaemic control (blood sugar levels). Adjustment of insulin and/or oral hypoglycaemic agents may be necessary.
• If your blood sodium levels are low.
• If you tend to bruise easily or bleed.
• If you are undergoing electroconvulsive therapy (electroshock treatment).
• If you suffer from coronary heart disease.
• If you suffer or have suffered from heart problems or have recently had a heart attack.
• If you have a low resting heart rate and/or if you think your body may have undergone significant loss of salts due to prolonged and severe diarrhoea and vomiting (feeling unwell) or due to the use of diuretics (tablets that increase urine production).
• If your heartbeat is fast or irregular, or if you experience symptoms such as fainting, collapse, or dizziness when standing up, which may indicate an abnormal heart rhythm.
• If you suffer from closed-angle glaucoma or have a history of glaucoma (increased pressure inside the eye).

Warning
Some patients with bipolar disorder may enter a manic phase. This is characterized by unusual and rapidly changing thoughts, inappropriate and excessive physical activity. If you feel this way, contact your doctor.
Symptoms such as restlessness or difficulty sitting still may also occur during the first weeks of treatment. If these symptoms appear, inform your doctor immediately.
Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or suffer from anxiety disorders, you may sometimes have self-harming or suicidal thoughts.
These effects may worsen when starting antidepressants, as all such medicines require time to take effect.
You are more likely to have such thoughts:

• if you have previously had episodes of suicidal or self-harming thoughts.
• if you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults under 25 years of age with psychiatric disorders previously treated with an antidepressant. If at any time you experience self-harming or suicidal thoughts, contact your doctor immediately or go to the nearest medical facility. It may be helpful to inform a friend or relative that you are depressed or suffer from anxiety disorders and ask them to read this leaflet. You may ask them whether they notice your depression or anxiety worsening or if they observe any concerning changes in your behaviour.

Use in children and adolescents under 18 years of age
Escitalopram Krka should not normally be used to treat children and adolescents under 18 years of age. You should be aware that, when taking this class of medicines, patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, oppositional behaviour, and anger). Despite the above, your doctor may prescribe Escitalopram Krka to patients under 18 years of age if they consider it strictly necessary. If your doctor has prescribed Escitalopram Krka to a patient under 18 years of age and you wish to obtain further information, please consult your doctor again. You should inform your doctor if any of the symptoms listed above appear or worsen during treatment with Escitalopram Krka in a patient under 18 years of age. Furthermore, the long-term safety effects of Escitalopram Krka on growth, maturation, and cognitive and behavioural development in this patient group have not yet been established.

Other medicines and Escitalopram Krka
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
DO NOT TAKE Escitalopram Krka if you are taking medicines to treat heart rhythm disorders or that may affect heart rhythm, such as:

• Class IA and III antiarrhythmics
• Antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol)
• Tricyclic antidepressants
• Some antimicrobial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine)
• Antimalarial treatment (particularly with halofantrine)
• Some antihistamines (astemizole, mizolastine).

If you have any doubts, consult your doctor.
Inform your doctor if you are taking any of the following medicines:

• "Non-selective monoamine oxidase inhibitors (MAO inhibitors)" (used to treat depression), containing the active substances phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If you have taken any of these medicines, you must wait 14 days before starting Escitalopram Krka. After stopping treatment with Escitalopram Krka, 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 increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used in the treatment of bipolar disorder) and tryptophan (used to treat depression).
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medicines (used to treat migraine) and tramadol (used for severe pain). These 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 may cause an increase in blood levels of escitalopram.
• St. John's wort (Hypericum perforatum) – a herbal remedy used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or to thin the blood, so-called anticoagulants). These 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 when starting and stopping treatment with Escitalopram Krka to ensure that the anticoagulant dose remains appropriate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used for severe pain) due to a possible risk of lowering the seizure threshold.
• Neuroleptics (medicines for treating schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to a 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). Adjustment of the Escitalopram Krka dosage may be necessary.
• Medicines that reduce blood levels of potassium or magnesium, as these conditions increase the risk of potentially fatal heart rhythm disturbances.

Escitalopram Krka with food and alcohol
Escitalopram Krka can be taken with or without food (see section 3 "How to take Escitalopram Krka").
As with many medicines, it is not recommended to take Escitalopram Krka together with alcohol, although escitalopram has not been shown to interact with alcohol.

Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Do not take Escitalopram Krka during pregnancy unless you and your doctor have discussed the risks and benefits.
If you take Escitalopram Krka during the last 3 months of pregnancy, you should be aware that your baby may experience the following effects: breathing difficulties, bluish skin, seizures, changes in body temperature, feeding difficulties, vomiting, hypoglycaemia, hypertonia or hypotonia, exaggerated reflexes, tremor, restlessness, irritability, lethargy, persistent crying, drowsiness, and difficulty sleeping. If you notice any of these symptoms in your baby, contact your doctor immediately.
Ensure that your midwife and/or doctor are aware that you are taking Escitalopram Krka. If taken during pregnancy, especially during the last 3 months, medicines like Escitalopram Krka may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the newborn to breathe rapidly and appear bluish. These symptoms usually occur within the first 24 hours after birth. If your baby shows these symptoms, contact your midwife and/or doctor immediately.
Escitalopram Krka must never be stopped abruptly if used during pregnancy.
Escitalopram is expected to be excreted in breast milk.
Do not take Escitalopram Krka while breastfeeding unless you and your doctor have discussed the risks and benefits.
Citalopram, a medicine similar to escitalopram, has been shown to reduce sperm quality in animal studies. In theory, this could affect fertility, but no impact on male fertility has been observed so far.

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

Escitalopram Krka contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Escitalopram Krka

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 Krka 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 Krka is 5 mg once daily for the first week, before increasing the dose to 10 mg per day. The dose may then be further increased by your doctor up to a maximum of 20 mg per day.

Social anxiety disorder
The usual recommended dose of Escitalopram Krka 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.

Generalised anxiety disorder
The usual recommended dose of Escitalopram Krka is 10 mg taken as a single daily dose. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Obsessive-compulsive disorder
The usual recommended dose of Escitalopram Krka is 10 mg taken as a single daily dose. 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 Krka is 5 mg taken as a single daily dose. The dose may be increased by your doctor to 10 mg per day.

Use in children and adolescents (under 18 years of age)
Escitalopram Krka should normally not be given to children and adolescents. For further information, please refer to section 2 "What you need to know before taking Escitalopram Krka".

Dosage schedule and method of administration
You may take Escitalopram Krka with or without food. Swallow the tablet with some water. Do not chew it, as the taste is bitter.
10 mg and 20 mg tablets: the tablet may be divided into equal doses.

Duration of treatment
You should take this medicine for a few weeks before you start to feel better. Continue taking Escitalopram Krka even if it takes time before you notice an improvement in your condition.
Do not change the dose of your medicine without consulting your doctor.
Continue taking Escitalopram Krka for as long as your doctor recommends. If you stop treatment too early, your symptoms may return. It is advisable to continue treatment for at least 6 months after you start feeling better.

If you take more Escitalopram Krka than you should
If you take more than the prescribed dose of Escitalopram Krka, contact your doctor or the nearest hospital emergency department immediately. Do this even if you do not have any signs of discomfort. Some signs of overdose may include dizziness, tremors, agitation, seizures, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and fluid/electroly imbalances.
Take the pack of Escitalopram Krka with you when you go to the doctor or hospital.

If you forget to take Escitalopram Krka
Do not take a double dose to make up for a forgotten dose. If you remember the missed dose on the same day, take it as soon as you remember. Then continue as usual the next day. Do not take the missed dose during the night or the following day—skip the missed dose and continue with your regular dosing schedule.

If you stop taking Escitalopram Krka
Do not stop taking Escitalopram Krka unless your doctor tells you to. After completing the course of treatment, it is generally recommended that the dose of Escitalopram Krka be gradually reduced over several weeks.
When stopping Escitalopram Krka, especially if stopped abruptly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram Krka is discontinued. The risk is higher if Escitalopram Krka has been used for a long time or at high doses, or if the dose is reduced too quickly. Most patients find that symptoms are mild and 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 after stopping Escitalopram Krka, contact your doctor. They may advise you to restart taking the tablets and to discontinue them more slowly.

Withdrawal symptoms include: dizziness (a sensation of unsteadiness or loss of balance), feelings of tingling, burning sensations, and (less commonly) electric shock-like sensations, even in the head; sleep disturbances (intense dreams, nightmares, inability to sleep); feelings of anxiety; headache; feeling unwell (nausea); sweating (including night sweats); restlessness or agitation; tremor (shakiness); confusion or disorientation; emotional lability or irritability; diarrhoea (loose stools); visual disturbances; palpitations (fibrillation or rapid heartbeat).

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 gets them.
Side effects usually disappear within a few weeks of starting treatment.
You should be aware that many of these side effects may also be symptoms of the underlying illness and will therefore improve 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):

• 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, motor agitation (agitation), confusion, tremors, and sudden muscle contractions – these may be signs of a rare condition called serotonin syndrome.

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

• Difficulty passing urine.

• Seizures (convulsive fits) – also see section "Warnings and precautions".
• Yellowing of the skin and whites of the eyes, which are signs of impaired liver function/hepatitis.
• Fast or irregular heartbeat, fainting – these could be symptoms of a life-threatening condition known as torsades de pointes.
• Thoughts of harming yourself or of suicide – see also the section "Warnings and precautions".

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

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

• Feeling unwell
• 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, tremors, skin tingling
• Diarrhoea, constipation, vomiting, dry mouth
• Increased sweating
• Muscle and joint pain (arthralgia and myalgia)
• Sexual disorders (delayed ejaculation, erection problems, 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, tingling sensation (pruritus)
• Teeth grinding, motor disorder (agitation), nervousness, panic attacks, confusion
• Sleep disorders, taste disturbances, fainting (syncope)
• Dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus)
• Hair loss
• Excessive menstrual bleeding
• Irregular menstrual periods
• Weight loss

• Fast heartbeat

• Swollen 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):

• Decreased sodium levels in the blood (symptoms include feeling unwell, weakness, muscle weakness, or confusion)
• Dizziness upon standing due to low blood pressure (orthostatic hypotension)
• Abnormal liver function tests (increased levels of 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) and low platelet count (thrombocytopenia)
• Sudden swelling of the skin or mucous membranes (angioedema)
• Increased urine output (inappropriate antidiuretic hormone secretion – SIADH)
• Milk production in men and women who are not breastfeeding
• Mania
• Changes in heart rhythm (called "QT interval prolongation", detected on ECG, the heart's electrical activity)

In addition, a number of side effects are commonly observed with medicines that work in a similar way to escitalopram. These include:

• Motor restlessness (inability to sit still – akathisia)
• Loss of appetite

An increased risk of bone fractures has been observed in patients taking this type of medicine.

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 www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Escitalopram Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after
Exp. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
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 Krka contains

• The active substance is escitalopram. Each film-coated tablet contains 5 mg of escitalopram, equivalent to 6.390 mg of escitalopram oxalate. Each film-coated tablet contains 10 mg of escitalopram, equivalent to 12.780 mg of escitalopram oxalate. Each film-coated tablet contains 15 mg of escitalopram, equivalent to 19.170 mg of escitalopram oxalate. Each film-coated tablet contains 20 mg of escitalopram, equivalent to 25.560 mg of escitalopram oxalate.
• The excipients are monohydrate lactose, crospovidone, povidone K30, microcrystalline cellulose, pregelatinized corn starch and magnesium stearate in the tablet core; and hypromellose 6cP (E464), titanium dioxide (E171), monohydrate lactose, macrogol 3000, triacetin and black ink (shellac (E904), black iron oxide (E172), propylene glycol (E1520)) in the film coating (see section 2).

Description of the appearance of Escitalopram Krka and package contents
5 mg film-coated tablets: white, round, biconvex film-coated tablets with bevelled edges and a diameter of 5.5 millimetres, printed with "5" in black on one side of the tablet.
10 mg film-coated tablets: white, oval, biconvex film-coated tablets, scored on one side, size 9 x 6 mm, printed with "10" in black on each side of the tablet. The tablet can be divided into equal doses.
15 mg film-coated tablets: white, round, biconvex film-coated tablets with bevelled edges and a diameter of 8.5 millimetres, printed with "15" in black on one side of the tablet.
20 mg film-coated tablets: white, oval, biconvex film-coated tablets, scored on one side, size 12 x 7.5 mm, printed with "20" in black on each side of the tablet. The tablet can be divided into equal doses.
Escitalopram Krka film-coated tablets are available in packs of 14, 20, 28, 30, 50, 56, 60, 90 and 100 tablets in blisters (OPA/aluminium/PVC-aluminium).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer responsible for batch release:
KRKA, d.d., Novo mesto, Krka Ločna, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA – FARMA d.o.o., DPC Jastrebarsko, Cvetković bb, 10450 Jastrebarsko, Croatia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicinal product is authorised in the European Economic Area Member States under the following names: