Xipram

Patient Information Leaflet: Information for the User

XIPRAM 5 mg film-coated tablets, 10 mg film-coated tablets, 15 mg film-coated tablets, 20 mg film-coated tablets

Equivalent medicine
Please read this entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What XIPRAM is and what it is used for

XIPRAM contains the active substance escitalopram. XIPRAM belongs to a group of medicines known as Selective Serotonin Reuptake Inhibitors (SSRIs).
Escitalopram 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 XIPRAM 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 XIPRAM

Do not take XIPRAM:

• 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 known as MAO inhibitors, including selegiline (used in the treatment of Parkinson’s disease), moclobemide (used in the treatment of depression), or linezolid (an antibiotic).
• If you were born with or have had an episode of abnormal heart rhythm (identified by an ECG, a test performed to assess heart function).
• If you are taking medicines for heart rhythm problems or that may affect your heart rhythm (see section 2 “Other medicines and XIPRAM”).

Warnings and precautions
Talk to your doctor or pharmacist before taking XIPRAM.
Inform your doctor if you have other conditions or diseases, as they may need to be considered. In particular, inform your doctor:

• if you suffer from epilepsy. Treatment with XIPRAM must be discontinued if 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 XIPRAM may alter blood glucose control. It may be necessary to adjust your dose of insulin and/or oral hypoglycaemic agents.
• if you have low sodium levels in your blood.
• if you have a tendency to develop bleeding or bruising, 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 know you have salt deficiencies due to prolonged severe diarrhoea and vomiting (feeling unwell) or if you are taking diuretics (medicines to increase urination).
• if, when standing up, you experience a 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 characterized by rapidly changing unusual thoughts, 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 (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 may 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 have thoughts of 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 longer 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 have thoughts of harming yourself or committing suicide, contact your doctor or go to hospital immediately. It may be helpful to inform a family member or close friend that you suffer from depression or an anxiety disorder, and ask them to read this leaflet. You may ask them to inform you if they think your depression or anxiety is worsening or if they are concerned about any changes in your behaviour.

Children and adolescents
XIPRAM is generally not intended for use in children and adolescents under 18 years of age.
Furthermore, 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 ideation, and hostility (mainly aggression, oppositional behaviour, and anger). Despite this, your doctor may prescribe XIPRAM to patients under 18 years of age if they consider it the best treatment option. If your doctor has prescribed XIPRAM 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 above symptoms appear or worsen during treatment with XIPRAM in a patient under 18 years of age. In addition, the long-term safety effects of escitalopram on growth, maturation, and cognitive and behavioural development have not yet been established in this age group.

Other medicines and XIPRAM
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 treatment with XIPRAM. After stopping treatment with XIPRAM, 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 or similar medicines (opioids, used to treat severe pain). These increase the risk of adverse 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 may cause an increase in escitalopram levels in the blood;
• St. John’s wort (Hypericum perforatum), a herbal remedy used for depression;
• acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used for pain relief or to reduce blood thickness, also called antiplatelet agents). These may increase the tendency to bleed;
• warfarin, dipyridamole, and phenprocoumon (medicines used to reduce blood thickness, also called anticoagulants). Your doctor will likely monitor your clotting time at the beginning and end of treatment with XIPRAM 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 reduced 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 XIPRAM 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 XIPRAM if you are taking medicines for heart rhythm problems or that may affect your heart rhythm, such as, for example, class IA and III antiarrhythmics, antipsychotics (such as phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (such as sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial treatments, particularly halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine). If you have any further doubts, contact your doctor.

XIPRAM with food, drinks, and alcohol
XIPRAM may be taken with or without food (see section 3 “How to take XIPRAM”).
An interaction between XIPRAM and alcohol is not expected. However, as with many medicines, the combination of XIPRAM and alcohol is not recommended.

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 using this medicine. Do not take XIPRAM if you are pregnant or breastfeeding unless your doctor has discussed the risks and benefits of treatment with you.
If you take XIPRAM during the third trimester of pregnancy, you should be aware that the following effects may occur in the newborn: breathing difficulties, bluish skin colour, seizures, unstable body temperature, feeding difficulties, vomiting, hypoglycaemia (low blood glucose levels), hypertonia or hypotonia, hyperreflexia, tremor, restlessness, irritability, lethargy, persistent 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 XIPRAM. Medicines such as XIPRAM, when taken during pregnancy, particularly during the last three months, 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 occurs in your baby, contact your midwife and/or doctor immediately.
If you take XIPRAM near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (a tendency to bleed easily). Inform your doctor or midwife that you are taking XIPRAM so they can advise you on what to do.
Abrupt discontinuation of XIPRAM treatment should be avoided during pregnancy.
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 effects on human fertility have not been observed.

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

XIPRAM contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially ‘sodium-free’.

3. How to take XIPRAM

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Adults
Depression
The usual recommended dose of XIPRAM 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 XIPRAM for the first week of treatment is 5 mg once daily, then increased to 10 mg
once daily. Your doctor may increase this dose up to a maximum of 20 mg per day.
Social anxiety disorder
The normally recommended dose of XIPRAM 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 normally recommended dose of XIPRAM 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 XIPRAM is 10 mg once daily. This 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 starting dose of XIPRAM is 5 mg once daily. This dose may be increased by your
doctor up to 10 mg per day.
Use in children and adolescents
XIPRAM should normally not be taken by 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 the medicine as prescribed
by your doctor.
Reduced liver function
Patients with liver disorders 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
XIPRAM may be taken independently of food. Swallow the tablets with a glass of water. Do not chew
them, as they have a bitter taste.
If necessary, the 10 mg, 15 mg, and 20 mg tablets can be split by placing them on a flat surface with the
score line facing upwards. The tablets can be divided by pressing downwards on each end of the tablet,
using both index fingers as shown in the illustration.

The 10 mg, 15 mg, and 20 mg tablets can be divided into equal doses.
Duration of treatment
It may take a few weeks before you notice any improvement. Continue taking XIPRAM even if you do
not immediately feel better.
The dosage must never be changed without first consulting your doctor.
Continue taking XIPRAM 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 six months after
symptoms have resolved.
If you take more XIPRAM than you should
If you have taken more XIPRAM than prescribed, contact your doctor or go immediately to the
emergency department of the nearest hospital. Do this 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 XIPRAM packaging with
you when you go to the doctor or hospital.
If you forget to take XIPRAM
Do not take a double dose to make up for a missed dose. If you forget to take a dose and remember
before going to bed, take it immediately. Continue with your usual dosing schedule 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 XIPRAM
Do not stop taking XIPRAM unless your doctor tells you to. When completing treatment, it is generally
advised that the dose of XIPRAM be gradually reduced over several weeks.
When stopping XIPRAM, especially if stopped abruptly, you may experience withdrawal symptoms.
These are common when discontinuing treatment with XIPRAM. The risk is greater if you have taken
XIPRAM 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 couple of weeks. However, in some
patients, withdrawal symptoms may be severe or may persist for a longer period (2–3 months or more).
If you experience severe withdrawal symptoms when stopping treatment with XIPRAM, 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), sensations of pins and
needles, burning sensations, and (less frequently) electric shock-like sensations, even 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, emotional lability or irritability, diarrhoea (loose stools), visual disturbances, and heart
rhythm disturbances (palpitations).
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects usually disappear after a few weeks of treatment. Please bear in mind that many of the
side effects may also be symptoms of your illness, and therefore decrease as you start to feel better.
If any of the following symptoms occur, 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 a choking sensation (severe allergic reaction).
• High fever, agitation, confusion, tremor and sudden muscle contractions may be symptoms of a rare condition called serotonin syndrome.

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

• Difficulty passing urine.
• Seizures (fits); see also section “Warnings and precautions”.
• Yellowing of the skin and whites of the eyes, which are signs of liver dysfunction/hepatitis.
• Rapid or irregular heartbeat, fainting sensation, which may be symptoms of a life-threatening condition known as torsades de pointes.
• Thoughts of self-harm (hurting yourself) 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, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, skin changes.
• Diarrhoea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual disorders (delayed ejaculation, erection problems, reduced sexual drive, and women may have difficulty achieving orgasm).
• Tiredness, fever.
• Weight gain.

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

• Hives, skin rash, itching.
• Teeth grinding, agitation, nervousness, panic attacks, confusion state.
• Disturbed sleep, taste disturbances, fainting (syncope).
• Pupil dilation (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, depersonalisation, hallucinations.
• Slowing of the heartbeat.

Not known (frequency cannot be estimated from the 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 tests (increased levels of liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Signs of abnormal bleeding, for example under the skin and mucous membranes (bruising) and low platelet count in the blood (thrombocytopenia).
• Increased production of a hormone called ADH, causing water retention and blood dilution, resulting in reduced sodium levels (inappropriate ADH secretion).
• Increased levels of the hormone prolactin in the blood.
• Milk secretion in men and in women who are not breastfeeding.
• Mania.
• An increased risk of bone fractures has been observed in patients taking this type of medicine.
• Changes in heart rhythm (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 for medicines that act like escitalopram (the active
substance in XIPRAM). These are:

• Motor restlessness (akathisia).
• Loss of appetite.

Reporting of side effects
If you get any side effects, including ones 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.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 XIPRAM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry
date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 XIPRAM contains
Each film-coated tablet contains 5 mg of escitalopram (as oxalate).
Each film-coated tablet contains 10 mg of escitalopram (as oxalate).
Each film-coated tablet contains 15 mg of escitalopram (as oxalate).
Each film-coated tablet contains 20 mg of escitalopram (as oxalate).
The other components are:
Tablet core: Silicified microcrystalline cellulose, butylhydroxytoluene, butylhydroxyanisole,
sodium croscarmellose, microcrystalline cellulose (PH-102), anhydrous colloidal silica, talc, magnesium stearate.
Tablet coating: Hypromellose (5 cps), macrogol 400, titanium dioxide.

Description of the appearance of XIPRAM and package contents
Film-coated tablet.
XIPRAM 5 mg film-coated tablets
Film-coated tablets, white to off-white, round in shape [diameter 5.6 mm], biconvex, with ‘F’ engraved on one side and ‘53’ on the other side.

XIPRAM 10 mg film-coated tablets
Film-coated tablets, white to off-white, oval-shaped, biconvex, with ‘F’ engraved on one side and ‘54’ on the other side, with a score line between ‘5’ and ‘4’. Dimensions are 8.1 mm x 5.6 mm. The tablets can be divided into equal doses.

XIPRAM 15 mg film-coated tablets
Film-coated tablets, white to off-white, oval-shaped, biconvex, with ‘F’ engraved on one side and ‘55’ on the other side, with a score line between ‘5’ and ‘5’. Dimensions are 9.8 mm x 6.3 mm. The tablets can be divided into equal doses.

XIPRAM 20 mg film-coated tablets
Film-coated tablets, white to off-white, oval-shaped, biconvex, with ‘F’ engraved on one side and ‘56’ on the other side, with a score line between ‘5’ and ‘6’. Dimensions are 11.6 mm x 7.1 mm. The tablets can be divided into equal doses.

XIPRAM is available in blister packs containing 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 - Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
Generis Farmacêutica S.A.
Rua João de Deus, 19, Venda Nova,
2700-487 Amadora
Portugal

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: XIPRAM
Portugal: Escitalopram Limeg