XIPRAM 5 mg Film-Coated Tablets

Зміст інструкції

1. XIPRAM 5 mg film-coated tablets, 10 mg film-coated tablets, 15 mg film-coated tablets, 20 mg film-coated tablets
   1. What is XIPRAM and what is it 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. Package Contents and Other Information

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

Generic medicine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is XIPRAM and what is it used for

XIPRAM contains the active ingredient escitalopram. XIPRAM belongs to the group of medicines
called Selective Serotonin Reuptake Inhibitors (SSRIs) antidepressants.
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 to take
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 need to know before taking XIPRAM

Do not take XIPRAM:

• If you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).
• If you are taking other medicines that belong to a group known as MAO inhibitors, including selegiline (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression) and linezolid (an antibiotic).
• If you have been born with or have had an episode of an irregular heartbeat (identified with an ECG, an examination conducted to assess how your heart works).
• If you are taking medicines for heart rhythm problems or that can affect the heart rhythm (see section 2 “Other medicines and XIPRAM”).

Warnings and precautions
Talk to your doctor or pharmacist before taking XIPRAM.
Tell your doctor if you have any other conditions or illnesses, as your doctor may need to take them
into consideration. In particular, tell your doctor:

• if you suffer from epilepsy. Treatment with XIPRAM should be stopped if you experience convulsions for the first time or if the frequency of convulsions increases (see also section 4 “Possible side effects”).
• if you suffer from impaired liver or kidney function. An adjustment of the dosage may be necessary by your doctor.
• if you suffer from diabetes. Treatment with XIPRAM may alter blood glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic agent.
• if you have a low level of sodium 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 receiving electroconvulsive therapy.
• if you suffer from coronary heart disease.
• if you suffer from 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 know you have salt deficiencies as a result of prolonged severe diarrhea and vomiting (feeling unwell) or use diuretics (water tablets).
• if, when standing up, you experience a rapid or irregular heartbeat, fainting, collapsing or dizziness, which may indicate an abnormality in the heart rhythm.
• if you have or have had any eye problems in the past, such as certain types of glaucoma (increased pressure in the eye).

Keep in mind
Some patients with manic-depressive illness may enter a manic phase. This is
characterized by rapidly changing unusual ideas, inappropriate and excessive physical
activity. If you experience these feelings, contact your doctor.
Symptoms such as restlessness or difficulty sitting still or standing up may occur during the
first weeks of treatment. If these symptoms occur, tell your doctor immediately.
Medicines such as escitalopram (so-called selective serotonin reuptake inhibitors (SSRIs)
and serotonin-noradrenaline reuptake inhibitors (SNRIs)) can cause symptoms of sexual dysfunction (see
section 4). In some cases, persistence of these symptoms has been observed after discontinuation of
treatment.

Thoughts of suicide 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 frequent at the beginning of treatment with antidepressants, as
these medicines generally take about two weeks or more to show their effect.
You are more likely to have these thoughts:

• if you have already thought about suicide or self-harm in the past;
• if you are a young adult. Data from clinical studies have shown an increased risk of suicide-related behavior in adults under 25 years of age with psychiatric disorders treated with an antidepressant. If at any time you should think about harming yourself or committing suicide, contact your doctor or go to the hospital immediately. It may help to tell a relative or close friendthat you are suffering from depression or an

think that your depression or anxiety is getting worse or if they are concerned about any
change in your behavior.

Children and adolescents
Normally XIPRAM should not be taken by children and adolescents under 18 years of age.
Also, you should know that, in case of 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 (essentially aggression, oppositional behavior and anger). Despite
the above, your doctor may prescribe XIPRAM to patients under 18 years of age if they believe
that this is the best solution for them. If your doctor has prescribed XIPRAM to a patient of
under 18 years of age and you would like more information, contact your doctor again. You should inform your
doctor if one of the above symptoms appears or worsens during the taking of XIPRAM by a patient of
under 18 years of age. Furthermore, the effects on long-term safety of
escitalopram relating to growth, maturation and cognitive and behavioral development have not
yet been demonstrated in this age group.

Other medicines and XIPRAM
Tell 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, iproniazide, isocarboxazide, nialamide and tranylcypromine as the active ingredient. If you have taken one of these medicines you must wait 14 days before starting treatment with XIPRAM. After stopping treatment with XIPRAM, 7 days must pass before taking one of these medicines;
• “reversible MAO-A selective 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 side effects;
• the antibiotic linezolid;
• lithium (used in the treatment of manic-depressive 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 side effects;
• cimetidine, lansoprazole and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke). These can cause an increase in the levels of escitalopram 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 density, also called antiplatelet agents). These can increase the tendency to bleed;
• warfarin, dipyridamole and phenprocoumone (medicines used to reduce blood density, also called anticoagulants). Your doctor will probably check your blood clotting time at the beginning and end of treatment with XIPRAM to verify whether your anticoagulant dose is still appropriate;
• mefloquine (used to treat malaria), bupropion (used to treat depression) and tramadol (used to treat severe pain) due to the possible risk of a reduced convulsive threshold;
• neuroleptics (medicines used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the convulsive threshold;
• flecainide, propafenone and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants) and risperidone, thioridazine and haloperidol (antipsychotics). An adjustment of the dosage of XIPRAM may be necessary;
• medicines that reduce the levels of potassium or magnesium in the blood, as these conditions increase the risk of life-threatening heart rhythm disorders.

Do not take XIPRAM if you are taking medicines for heart rhythm problems or that can affect
the heart rhythm, such as, for example, Class IA and III antiarrhythmics, antipsychotics (such as phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (such as
sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial treatments, in particular
chloroquine). If you have further doubts, contact your doctor.

XIPRAM with food, drinks and alcohol
XIPRAM can be taken with or without food (see section 3 “How to take XIPRAM”).
No interaction with alcohol is expected with XIPRAM. However, as with many medicines,
the combination of XIPRAM and alcohol is not recommended.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine. Do not take
XIPRAM if you are pregnant or breastfeeding, unless your doctor has discussed with
you the risks and benefits of treatment.
If you take XIPRAM in the third trimester of pregnancy, you should be aware that the following
effects may be observed in the newborn: difficulty breathing, bluish skin color, seizures, instability of body temperature, difficulty feeding, vomiting, hypoglycemia (low
blood glucose levels), hypertonia or hypotonia, hyperreflexia, tremor, nervousness, irritability,
lethargy, crying continuously, difficulty sleeping and difficulty falling asleep. If the newborn shows any of these
symptoms, contact your doctor immediately.
Make sure your midwife and/or doctor know that you are taking XIPRAM. When taken
during pregnancy, especially in the last 3 months of pregnancy, medicines such as XIPRAM
can increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and makes it look bluish.
These symptoms usually appear within the first 24 hours after the baby is born. If this
happens to your baby, you should 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 suffer from bleeding disorders
(easy bleeding). Inform your treating doctor or midwife/obstetrician that you are taking
XIPRAM, so that they can advise you on what to do.
Abrupt discontinuation of treatment with XIPRAM 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 the impact on human fertility
has not yet been observed.

Driving and using machines
It is recommended not to drive vehicles or use machines until you know what influence
XIPRAM has on 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 following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Adults

Depression
The usual recommended dose of XIPRAM is 10 mg per day, in a single dose. This dose may be increased by your doctor 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 per day, then to be increased to 10 mg per day. 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 per day, in a single dose. Your doctor may decrease the dose to 5 mg per day or increase it up to a maximum of 20 mg per day, based on your individual response to treatment.

Generalized anxiety disorder
The normally recommended dose of XIPRAM is 10 mg per day, in a single dose. This dose may be increased by your doctor up to a maximum of 20 mg.

Obsessive-compulsive disorder
The normally recommended dose of XIPRAM is 10 mg per day, in a single dose. This dose may be increased by your doctor up to a maximum of 20 mg.
Elderly patients (over 65 years of age)
The recommended initial dose of XIPRAM is 5 mg per day, in a single dose. This dose may be increased by your doctor up to 10 mg per day.
Use in children and adolescents
Normally XIPRAM should not be taken by children and adolescents. For further information see section 2 ”Warnings and precautions”.
Impaired renal function
Caution is advised in patients with severely impaired renal function. Take the medicine as prescribed by your doctor.
Impaired hepatic 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 poor 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 can be taken independently of food intake. Swallow the tablets with a glass of water. Do not chew them, as they have a bitter taste.
If necessary, the 10, 15 and 20 mg tablets can be broken by placing them on a flat surface with the fracture line facing upwards. The tablets can be broken by pressing down on each edge of the tablet, using both index fingers as shown in the drawing.

The 10, 15 and 20 mg tablets can be divided into equal doses.

Duration of treatment
It may take a couple of weeks before you notice any improvement. Continue to take XIPRAM even if there is no immediate improvement in your condition.
The dosage should never be changed without first consulting your doctor.
Continue to take XIPRAM for the entire time that your doctor has recommended. If the treatment is stopped too early, the symptoms may return. It is recommended to continue the treatment for at least six months after the resolution of the symptoms.

If you take more XIPRAM than you should
If you have taken a dose of XIPRAM higher than that prescribed, you should contact your doctor or go immediately to the emergency room of the nearest hospital. Do this even if you have no signs of discomfort. Some of the symptoms of overdose may be dizziness, tremor, agitation, convulsions, coma, nausea, vomiting, altered heart rhythm, decreased blood pressure and changes in electrolyte balance. Bring the XIPRAM package 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 bedtime, take it immediately. Continue your usual intake the next day. If, however, you remember during the night or the next day, skip the missed dose and continue with the normal dosage.

If you stop taking XIPRAM
Do not stop taking XIPRAM until your doctor tells you to. When you have completed the treatment, it is generally recommended that the dose of XIPRAM be gradually reduced over a few weeks.
When you stop taking XIPRAM, especially if you stop it abruptly, you may experience withdrawal symptoms. These are common when stopping treatment with XIPRAM. The risk is greater if you have taken XIPRAM for a long time or in high doses or if the dose is reduced too quickly. Most patients have found that these symptoms are mild and generally disappear spontaneously within a couple of weeks. However, in some patients the withdrawal symptoms may be severe or may persist over time (2-3 months or more). If you experience severe withdrawal symptoms when stopping treatment with XIPRAM, inform your doctor. They may ask you to restart the treatment and continue reducing the doses more gradually.
Withdrawal symptoms include: dizziness (feeling unstable or off balance), tingling sensations, burning sensations and (less frequently) electric shock 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, excessive emotionality or irritability, diarrhea (loose stools), visual disturbances, heart rhythm disturbances (palpitations).

If you have any further questions on 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 usually disappear after a few weeks of treatment. Keep in mind
that many of the side effects can also be symptoms of your illness and, therefore,
decrease when you start to feel better.

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

• Swelling of the skin, tongue, lips, throat or face, hives or difficulty breathing or feeling of suffocation (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 urinating.
• Convulsions (seizures), see also paragraph “Warnings and precautions”.
• Yellowing of the skin and whites of the eyes are signs of impaired liver function/hepatitis.
• Rapid, irregular heartbeat, feeling faint, which may be symptoms of a life-threatening condition known as torsade de pointes.
• Thoughts of self-harm or suicide. See also paragraph “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):

• Blocked or runny nose (sinusitis).
• Decreased or increased appetite.
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, skin changes.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual dysfunction (delayed ejaculation, problems with erection, decreased sexual drive and women may have difficulty reaching orgasm).
• Fatigue, fever.
• Weight gain.

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

• Hives, skin rash, itching.
• Teeth grinding, agitation, nervousness, panic attacks, confused state.
• Disturbed sleep, altered taste, 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):

• Aggression, depersonalization, hallucinations.
• Slowing of the heartbeat.

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

• Decreased level of sodium in the blood (symptoms are feeling unwell with muscle weakness or confusion).
• Dizziness when assuming an upright position due to a drop in blood pressure (orthostatic hypotension).
• Changes in liver function values (increased amount 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 level of platelets in the blood (thrombocytopenia).
• Increased production of a hormone called ADH, which causes fluid retention and dilution of the blood, resulting in a decrease in sodium levels (inappropriate secretion of ADH).
• Increased levels of the hormone prolactin in the blood.
• Secretion of milk 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.
• Alteration of the heart rhythm (called “prolongation of the QT interval”, assessed by an ECG that records the electrical activity of the heart).
• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), see paragraph 2 “Pregnancy, breastfeeding and fertility” for further information.

In addition, a number of side effects are known for drugs that act like escitalopram (active
ingredient of XIPRAM). They are:

• Restlessness (akathisia).
• Loss of appetite.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 pack 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 any medicine in waste water 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 ingredients are:

Tablet Core: Silicified microcrystalline cellulose, butylhydroxytoluene, butylated hydroxyanisole,
sodium croscarmellose, microcrystalline cellulose (PH-102), anhydrous colloidal silica, talc, magnesium
stearate.

Tablet Coating: Hypromellose (5cps), macrogol 400, titanium dioxide.

Description of the appearance of XIPRAM and contents of the pack
Film-coated tablet.
XIPRAM 5 mg film-coated tablets
Film-coated tablets, white to off-white in color, round in shape [diameter 5.6 mm],
biconvex, with ‘F’ imprinted on one side and ‘53’ on the other side.
XIPRAM 10 mg film-coated tablets
Film-coated tablets, white to off-white in color, oval in shape, biconvex, with ‘F’ imprinted
on one side and ‘54’ on the other side, with a score line between ‘5’ and ‘4’. The 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 in color, oval in shape, biconvex, with ‘F’ imprinted
on one side and ‘55’ on the other side, with a score line between ‘5’ and ‘5’. The 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 in color, oval in shape, biconvex, with ‘F’ imprinted
on one side and ‘56’ on the other side, with a score line between ‘5’ and ‘6’. The dimensions are 11.6
mm x 7.1 mm. The tablets can be divided into equal doses.
XIPRAM is available in blister packs of 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 authorised in the Member States of the European Economic Area with the
following denominations:
Italy: XIPRAM
Portugal: Escitalopram Limeg