Escitalopram Accord

Package leaflet: Information for the user

Escitalopram Accord 10 mg film-coated tablets, 20 mg film-coated tablets

escitalopram
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, as 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:

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

1. What escitalopram Accord is and what it is used for

Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain by increasing serotonin levels.
Escitalopram Accord 10/20 mg film-coated tablets contain escitalopram and are 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 film-coated tablets, even if it may take some time before you notice an improvement in your condition.
Contact a doctor if you do not feel better or if you get worse.

2. What you need to know before taking Escitalopram Accord

Do not take Escitalopram Accord

• 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 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 (visible on electrocardiogram (ECG), a test to assess heart function).
• If you are taking medicines for heart rhythm problems or that may affect heart rhythm (see section 2 “Other medicines and Escitalopram Accord”).

Warnings and precautions
Tell your doctor if you have any other condition or illness, as your doctor may need to take this into account. In particular, inform your doctor:

• If you have epilepsy. Treatment with Escitalopram Accord 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 your liver or kidney function is impaired. Your doctor may adjust the dose of the medicine.
• If you have diabetes. Treatment with Escitalopram Accord may alter blood glucose 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 have a tendency to bleed or bruise easily, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”).
• If you are undergoing electroconvulsive therapy.
• If you have coronary heart disease.
• If you have or have had heart problems or recently suffered 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 or 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 eye problems, such as certain types of glaucoma (increased eye pressure).

Warning
Some patients with bipolar disorder may enter a manic phase, characterized 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 notice such symptoms.
Medicines like Escitalopram (so-called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted even 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 occasionally feel the urge to harm yourself or even 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 expressed intentions to commit suicide or harm yourself.
• You are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with an antidepressant.

If you have thoughts of self-harm or suicide at any time, contact your doctor immediately
or go straight to the nearest hospital.
It may be helpful to inform a relative or a close friend about your depression or anxiety disorder and ask them to read this leaflet. You may ask them to alert you if they believe your depression or anxiety is worsening, or if they are concerned about any changes in your behaviour.

Use in children and adolescents
Escitalopram Accord should not normally 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 experiencing side 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 Accord to patients under 18 years of age if they consider it the best option in that particular case. If your doctor has prescribed Escitalopram Accord to a patient under 18 years of age and you wish to discuss this, please 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 Accord. Furthermore, the long-term safety of Escitalopram Accord with regard to growth, maturation, and cognitive and behavioural development in this age group has not yet been established.

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

• “Non-selective monoamine oxidase inhibitors (MAOIs)” containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine as active ingredients. If you have taken any of these medicines, you must wait 14 days before starting Escitalopram Accord. After stopping Escitalopram Accord, 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 side effects.
• Buprenorphine (an opioid medicine). Concomitant use increases the risk of serotonin syndrome, a potentially life-threatening condition. Symptoms may include involuntary and rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, and fever above 38°C. Contact your doctor if you experience these symptoms.
• The antibiotic linezolid.
• Lithium (used in the treatment of bipolar disorder) and tryptophan.
• Imipramine and desipramine (both used for the treatment of depression).
• Sumatriptan and similar medicines (used to treat migraine) and tramadol and similar medicines (opioids, used for severe pain). These medicines increase the risk of side effects.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach 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 Escitalopram Accord levels.
• St. John’s wort (Hypericum perforatum) – a herbal preparation 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 medicines may increase the tendency to bleed.
• Warfarin, dipyridamole, acenocoumarol, 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 Accord to ensure your anticoagulant dose remains appropriate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used for severe pain), due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines for the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) 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). Dose adjustment of Escitalopram Accord may be necessary.

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

Escitalopram Accord with food, drinks and alcohol
Escitalopram Accord can be taken regardless of meals (see section 3 “How to take Escitalopram Accord”).
As with many medicines, it is not recommended to combine Escitalopram Accord with alcohol, although no interactions between escitalopram 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 Accord if you are pregnant or breastfeeding unless you have already discussed the risks and benefits with your doctor. If you take Escitalopram Accord 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, rigid or floppy muscle tone, exaggerated reflexes, tremor, nervousness, 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 taking Escitalopram Accord. When taken during pregnancy, particularly in the third trimester, medicines like Escitalopram Accord 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 Accord close to 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 Accord so they can advise you on what to do.
If used during pregnancy, Escitalopram Accord must never be stopped abruptly.

Escitalopram Accord is expected to be excreted in breast milk.
Animal studies have shown that citalopram, a medicine similar to Escitalopram Accord, reduces sperm quality. This could theoretically affect fertility, but no impact on human fertility has been observed to date.

Driving and using machines
It is recommended not to drive or operate machinery until you know how Escitalopram Accord affects you.

Escitalopram Accord 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 Accord

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Adults

Depression
The usual recommended dose of Escitalopram Accord is 10 mg once daily. Your doctor may increase the dose up to a maximum of 20 mg per day.

Panic disorder
The initial dose of Escitalopram Accord is 5 mg once daily for the first week, then increased to 10 mg daily. 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 Accord is 10 mg once daily. Your doctor may reduce the dose to 5 mg daily 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 Accord is 10 mg once daily. Your doctor may increase the dose up to a maximum of 20 mg per day.

Obsessive-compulsive disorder
The recommended dose of Escitalopram Accord is 10 mg once daily. Your doctor may increase the dose up to a maximum of 20 mg per day.

Elderly patients (over 65 years of age)
The recommended starting dose of Escitalopram Accord is 5 mg once daily. Your doctor may increase the dose to 10 mg per day.

Use in children and adolescents
Escitalopram Accord should not normally be used in children and adolescents. For further information, see section 2 “Warnings and precautions”.

Reduced kidney function
Caution is advised in patients with severely reduced kidney function. Take as prescribed by your doctor.

Reduced liver function
Patients with liver impairment should not receive more than 10 mg per day. Take as prescribed by your doctor.

Patients known to be poor metabolizers of the CYP2C19 enzyme
Patients with this known genotype should not receive more than 10 mg per day. Take as prescribed by your doctor.

How to take the tablets
Escitalopram Accord may be taken with or without food. Swallow the tablet with a little water. Do not chew the tablets as they have a bitter taste.
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.
Only the 10 mg and 20 mg tablets can be divided into equal doses.

Duration of treatment
It may take a few weeks before you start to feel better. Continue taking Escitalopram Accord 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 Accord for the entire duration recommended by your doctor. 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 Accord than you should
If you have taken more Escitalopram Accord 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 fluid and electrolyte balance. Take the Escitalopram Accord packaging/container with you when going to the doctor or hospital.

If you forget to take Escitalopram Accord
Do not take a double dose to make up for the forgotten dose. If you forget to take a dose and remember before going to bed, take the missed dose 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 with your regular dosing schedule.

If you stop taking Escitalopram Accord
Do not stop taking Escitalopram Accord unless your doctor tells you to. Once the treatment course is completed, it is generally recommended to gradually reduce the dose of Escitalopram Accord over several weeks.

When stopping Escitalopram Accord, especially abruptly, you may experience withdrawal symptoms. These symptoms are common when discontinuing treatment with Escitalopram Accord. The risk is greater if Escitalopram Accord has been used for a long time or at high doses, or if the dose is reduced too quickly. Most people find these symptoms mild and self-limiting 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 Accord, consult your doctor. Your doctor may advise you to restart the tablets and then discontinue treatment more gradually.

Withdrawal symptoms include: dizziness (unsteady, unstable 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, emotional lability or irritability, diarrhoea (loose stools), visual disturbances, and pounding or racing heartbeat (palpitations).

If you have any questions about the use of this medicine, ask 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, please bear in mind that many of these side effects may also be symptoms of your illness, and therefore will improve once treatment starts working and you start feeling better.
If you experience any of the following symptoms, 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, throat or face, hives or difficulty breathing or swallowing (severe allergic reaction). High fever, agitation, confusion, tremor and sudden muscle contractions may be signs of a rare condition known as serotonin syndrome.

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

• Difficulty urinating
• Fast or irregular heartbeat and fainting, which could be symptoms of a life-threatening condition known as Torsades de Pointes.
• Seizures (convulsions); see also section 2 “Warnings and precautions”
• Yellowing of the skin and whites of the eyes, which may be signs of impaired liver function/hepatitis.
• Self-harming or suicidal thoughts; see also section 2 “Warnings and precautions”
• Sudden swelling of the skin or mucous membranes (angioedema)

The following side effects have also been reported in addition to those listed 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)
• Decreased or increased appetite
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, tingling of the skin
• Diarrhoea, constipation, vomiting, dry mouth
• Increased sweating
• Muscle and joint pain (arthralgia and myalgia)
• Sexual problems (delayed ejaculation, erection problems, decreased sexual desire; women may experience difficulty achieving orgasm)
• Fatigue, fever
• Increase in body weight

Uncommon (may affect up to 1 in 100 people)

• Hives, skin rash, itching
• Teeth grinding, agitation, nervousness, panic attack, confusion
• Disturbed sleep, altered taste, fatigue (syncope)
• Enlarged pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus)
• Hair loss
• Excessive menstrual bleeding
• Irregular menstrual cycle
• Vaginal bleeding
• Decrease in body weight
• Fast heartbeat
• Swelling of arms or legs
• Nosebleeds

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

• Aggression, depersonalisation, hallucinations
• Slow heartbeat

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

• Reduced levels of sodium in the blood (symptoms include feeling unwell, muscle weakness or confusion)
• Changes in heart rhythm (known as “prolongation of the QT interval”, visible on ECG, the heart's electrical activity)
• Dizziness upon standing due to low blood pressure (orthostatic hypotension)
• Abnormalities in liver function tests (increased levels of liver enzymes in the blood)
• Movement disorders (involuntary muscle movements)
• Painful erection (priapism)
• Signs of abnormal bleeding, for example from the skin and mucous membranes (bruising)
• Increased secretion of a hormone called ADH, causing the body to retain water and dilute the blood, thereby reducing sodium levels (inappropriate ADH secretion)
• Milk production 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.
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2, “Pregnancy, breastfeeding and fertility”, for further information

In addition, there are side effects that occur with medicines acting similarly to escitalopram (the active substance in Escitalopram Accord film-coated tablets), such as:

• 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
adverse-reactions.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Escitalopram Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, label or
packaging after EXP.
The expiry date refers to the last day of that 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Escitalopram Accord contains
The active substance is escitalopram.
Each film-coated tablet of Escitalopram Accord 10 mg / 20 mg contains 10 mg / 20 mg of
escitalopram (as oxalate).
The excipients are:
Core: microcrystalline cellulose (PH 101) (E460), sodium croscarmellose (E468), hypromellose
E5 (E464), talc (E553b), anhydrous colloidal silica (E551), magnesium stearate (E470b)
Coating: hypromellose E-15 (E464), titanium dioxide (E171), macrogol 400

Description of the appearance of Escitalopram Accord and package contents
Escitalopram Accord is available as 10 mg and 20 mg film-coated tablets. The tablets are described below.
10 mg: Film-coated tablets, white to off-white, oval-shaped, approximately 8.10 mm long and 5.60 mm wide, biconvex, with the inscription '1' and '0' on both sides of the break line on one side of the tablet and smooth on the other side.
20 mg: Film-coated tablets, white to off-white, oval-shaped, approximately 11.60 mm long and 7.10 mm wide, biconvex, with a break line on one side of the tablet and smooth on the other side.
The 10 mg and 20 mg tablets can be divided into equal doses.

Escitalopram Accord 10 / 20 mg is available in the following pack sizes:
Blister packs in the outer carton:
10 mg and 20 mg: 14, 28, 56 and 98 tablets
Bottle packs made of HDPE containing 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta
08039-Barcelona,
Spain.

Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009, Greece

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

| Country | Medicinal Product Name | |-------------|----------------------------| | Austria | Escitalopram Accord 5 mg/10 mg/20 mg film tablets | | Czech Republic | Escitalopram Accord 5 mg /10 mg/20 mg potahované tablety | | Denmark | Escitalopram Accord Healthcare | | Estonia | Escitalopram Accord 10 mg/20 mg | | Ireland | Escitalopram 5 mg/10 mg/20 mg film-coated tablets | | Latvia | Escitalopram Accord 10 mg/20 mg apvalkotas tabletes | | Portugal | Escitalopram Accord | | Spain | Escitalopram Accord 5 mg /10 mg/20 mg comprimidos recubiertos con película | | Bulgaria | Escitalopram Accord 10 mg филмирани таблетки | | Finland | Escitalopram Accord 10/20 mg Tabletti, kalvopäällysteinen | | Italy | Escitalopram Accord | | The Netherlands | Escitalopram Accord 5 mg/10 mg /20 mg Filmomhulde tabletten | | Sweden | Escitalopram Accord 5 mg /10 mg /20 mg Filmdragerade tabletter | | Slovakia | Escitalopram Accord 10 mg /20 mg filmom obalené tablety | | United Kingdom | Escitalopram 5 mg/10 mg /20 mg Film-coated tablets |