IXILANIA 75 mg Extended-Release Hard Capsule

Зміст інструкції

1. Ixilania 75 mg prolonged-release hard capsules, 150 mg prolonged-release hard capsules
   1. What is Ixilania and what is it used for
   2. What you need to know before taking Ixilania
   3. How to take Ixilania
   4. Possible side effects
   5. How to store Ixilania
   6. Contents of the pack and other information

Ixilania 75 mg prolonged-release hard capsules, 150 mg prolonged-release hard capsules

Venlafaxine
Generic medicine

Read this leaflet carefully before you start 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 to them.
• 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 Ixilania is and what it is used for
• 2. What you need to know before you take Ixilania
• 3. How to take Ixilania
• 4. Possible side effects
• 5. How to store Ixilania
• 6. Contents of the pack and other information

1. What is Ixilania and what is it used for

Ixilania contains the active ingredient venlafaxine.
Ixilania is an antidepressant belonging to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRI). This group of medicines is
used for the treatment of depression and other conditions, such as anxiety disorders. It is
believed that people who are depressed and/or anxious have lower levels of serotonin and
noradrenaline in the brain. The way antidepressants work is not fully understood, however they
can be helpful by raising the levels of serotonin and noradrenaline
in the brain.
Ixilania is a treatment for adults suffering from depression. It is also a treatment for adults
with the following anxiety disorders: generalized anxiety disorder, social anxiety disorder (fear of
or tendency to avoid social situations) and panic disorder (panic attacks). Appropriate
treatment of depression or anxiety disorders is important to help you
feel better. If left untreated, your condition may not resolve and may become more serious and
more difficult to treat.

2. What you need to know before taking Ixilania

Do not take Ixilania

• if you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
• if you are taking or have taken within the last 14 days, any of the medicines known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with Ixilania, may lead to serious or even life-threatening side effects. You must also wait at least 7 days after stopping treatment with Ixilania before taking any MAOI (see also the section entitled “Other medicines and Ixilania” and the information in the same section relating to “Serotonin syndrome”).

Warnings and precautions
Talk to your doctor or pharmacist beforetaking Ixilania:

• If you are using other medicines that, when taken together with Ixilania, may increase the risk of developing serotonin syndrome (see the section “Other medicines and Ixilania”).
• If you have eye problems, such as certain types of glaucoma (increased pressure inside the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have been told you have an abnormal heart rhythm.
• If you have a history of seizures.
• If you have a history of low sodium levels in your blood (hyponatremia).
• If you have a tendency to bruise easily or a tendency to bleed easily (history of bleeding disorders), or if you are using other medicines that may increase the risk of bleeding, such as warfarin (used to prevent blood clots) or if you are pregnant (see Pregnancy and breastfeeding).
• If you have a history of mania or bipolar disorder (feeling of excessive excitement or euphoria).
• If you have a history of aggressive behavior.

During the first few weeks of treatment, Ixilania may cause a feeling of restlessness
or inability to sit still or remain quiet. If you experience these symptoms, you should tell your doctor.
Suicidal thoughts and worsening of your depression or anxiety disorder
If you are depressed and/or suffer from anxiety disorders, you may sometimes have thoughts of harming yourself or
committing suicide. These may increase when you first start taking antidepressants,
as it takes time for all medicines like these to start working,
usually about two weeks but sometimes longer.
You are more likely to have these thoughts:

• If you have had previous thoughts of suicide or self-harm.
• If you are young. Information obtained from clinical studies has shown an increased risk of suicidal behavior in young people (under 25 years of age) with psychiatric disorders, who had been treated with an antidepressant.

If you have thoughts of harming yourself or committing suicide at any time, contact your doctor or go
immediately to the hospital.
It may help to tell a relative or close friend that you are depressed or suffering
tell them if they think your depression or anxiety is getting worse, or if you are
concerned about changes in your behavior.
Dry mouth
Dry mouth is reported in 10% of patients treated with venlafaxine. This may increase the
risk of tooth decay. Therefore, you should pay particular attention to your oral hygiene.
Diabetes
Blood glucose levels may be altered by Ixilania. Therefore, it may be necessary to
adjust the dose of your diabetes therapy.
Sexual problems
Medicines such as Ixilania (so-called serotonin-norepinephrine 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.

Children and adolescents
Normally Ixilania should not be used for children and adolescents under the age of 18
years. Also, you should know that patients under the age of 18 have an increased risk of
side effects, such as suicide attempts, suicidal thoughts and hostility (mainly
aggression, oppositional behavior and anger) when taking this class of
medicines. Despite this, the doctor may prescribe this medicine for patients under the age of 18
because they believe that this is in their best interest. If the doctor has
prescribed this medicine for a patient under 18 years of age, and you want to discuss it, talk
to your doctor. You should inform your doctor if any of the
symptoms listed occur or worsen when a patient under 18 years of age is taking Ixilania. In addition,
the effects of long-term safety on growth, maturation and cognitive and behavioral development in this age group have not been demonstrated.

Other medicines and Ixilania
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
The doctor will decide whether you can use Ixilania with other medicines.
Do not start or stop taking other medicines, including over-the-counter medicines, herbal remedies, before asking your
doctor or pharmacist.

• Monoamine oxidase inhibitors that are used to treat depression or Parkinson's disease must not be taken with Ixilania. Tell your doctor if you have taken these

medicines within the last 14 days (MAOIs: see the section “What you need to know before
taking Ixilania”)

• Serotonin syndrome:

A potentially life-threatening condition or reactions such as Neuroleptic Malignant Syndrome (NMS) (see the section “Possible side effects”) may occur with a
treatment with venlafaxine, especially when taken with other medicines.
Examples of these medicines include:
o Triptans (used for migraine)
o Other medicines for the treatment of depression, for example SNRIs, SSRIs, tricyclics, or medicines containing lithium
o Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy and obesity)
o Medicines containing linezolid, an antibiotic (used to treat infections)
o Medicines containing moclobemide, an MAOI (used to treat
depression)
o Medicines containing sibutramine (used for weight loss)
o Medicines containing tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used for
the treatment of severe pain)
o Medicines containing dextromethorphan (used to treat cough)
o Medicines containing methadone (used to treat opioid substance dependence or severe pain)
o Medicines containing methylene blue (used to treat high levels of methemoglobin in
the blood)
o Herbal preparations of St. John's Wort (also called Hypericum Perforatum, a natural remedy based on a medicinal plant used to treat mild depression)
o Products containing tryptophan (used for disorders such as sleep disorders and depression)
o Antipsychotics (used to treat an illness with symptoms such as hearing, seeing or perceiving
things that are not real, false beliefs, strange suspicions, confused reasoning and
detachment)
Signs and symptoms of serotonin syndrome may include a combination of:
restlessness, hallucinations, loss of coordination, rapid heartbeat, increased
body temperature, rapid fluctuations in blood pressure, hyperactive reflexes, diarrhea, coma,
nausea, vomiting.
In its most severe form, serotonin syndrome can resemble Neuroleptic
Malignant Syndrome (NMS). Signs and symptoms of NMS may include a
combination of fever, rapid heartbeat, sweating, severe muscle rigidity,
confusion, increased muscle enzymes (determined by a blood test).

If you think you have serotonin syndrome, tell your doctor immediately or go to the
nearest hospital emergency room.
You should inform your doctor if you are taking medicines that can affect your heart rate.
Examples of these medicines include:

• Antiarrhythmics such as quinidine, amiodarone, sotalol or dofetilide (used to treat abnormal heart rhythm)
• Antipsychotics such as thioridazine (See also above: Serotonin Syndrome)
• Antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections)
• Antihistamines (used to treat allergies)

The following medicines may also interfere with Ixilania and should be used
with caution. It is particularly important that you tell your doctor or pharmacist if you are
using medicines that contain:

• Ketoconazole (an antifungal medicine)
• Haloperidol or risperidone (for the treatment of psychiatric disorders)
• Metoprolol (a beta-blocker for the treatment of high blood pressure and heart problems)

Ixilania with food, drinks and alcohol
You should take Ixilania with food (see the section “How to take Ixilania”).
You should not drink alcohol while taking Ixilania.

Pregnancy and breastfeeding
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 taking this
medicine. You should only use Ixilania after discussing the potential benefits and
potential risks to the fetus with your doctor.
Make sure your midwife and/or doctor know that you are taking Ixilania. When taken
during pregnancy, similar drugs (so-called SSRIs) may increase the risk of a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN). This
condition causes a newborn to breathe rapidly and turn bluish. These symptoms
usually start within the first 24 hours of the baby's life. If this happens, you should
contact your midwife and/or doctor immediately.
If you are taking IXILANIA 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 IXILANIA, so they can advise you on what to do.
If you are taking this medicine during pregnancy, in addition to having difficulty breathing, a
another symptom that your baby may present at birth is difficulty
adequate feeding. If you are concerned that your baby is showing these
symptoms at birth, contact your doctor and/or midwife who will be able to assist you.
Ixilania is excreted in breast milk. There is a risk of an effect on the baby. Therefore,
you should discuss this with your doctor, who will decide whether to stop breastfeeding or therapy
with this medicine.

Driving and using machines
Do not drive and do not use tools or machinery until you understand what effects this medicine
has on you.

3. How to take Ixilania

Take this medicine exactly as described in this leaflet or as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The usual starting recommended dose for the treatment of depression, generalized anxiety disorder and social anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose and, if necessary, up to a maximum dose of 375 mg per day for depression. If you are being treated for panic disorder, your doctor will start with a lower dose (37.5 mg) and subsequently increase the dose gradually. The maximum dose for generalized anxiety disorder, social anxiety disorder and panic disorder is 225 mg per day.
Take Ixilania at approximately the same time each day, in the morning or evening. The capsules must be swallowed whole with liquid and must not be opened, broken, chewed or dissolved.
You must take Ixilania with food.
If you have liver or kidney problems, talk to your doctor, as a dose

adjustment of this medicine may be necessary.
Do not stop treatment with this medicine without consulting your doctor (see the paragraph “If you stop taking Ixilania”).

If you take more Ixilania than you should
Contact your doctor or pharmacist immediately if you take more medicine than the amount prescribed by your doctor.
Symptoms of a possible overdose may include rapid heartbeat, changes in consciousness (ranging from drowsiness to coma), blurred vision, seizures and vomiting.

If you forget to take Ixilania
If you forget to take a dose, take it as soon as you remember. However, if you are due to take your next dose when you remember the forgotten dose, skip the forgotten dose and take only one dose as usual. Do not take a double dose to make up for a forgotten dose. Do not take more than your prescribed daily amount of Ixilania in one day.

If you stop taking Ixilania
Do not stop treatment or reduce the dose without your doctor's advice, even if you feel better. If your doctor believes you no longer need Ixilania, they may ask you to reduce the dose gradually before stopping treatment completely. It is known that undesirable effects occur when patients stop treatment with this medicine, especially when it is stopped abruptly or when the dose is reduced too quickly. Some patients may experience symptoms such as fatigue, dizziness, feeling lightheaded, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation, confusion, ringing in the ears, tingling or rarely sensations of electric shock, weakness, sweating, seizures or flu-like symptoms.
Your doctor will explain how you should gradually stop treatment with Ixilania. If you experience any of these or other symptoms that bother you, consult your doctor for further advice.
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 everyone will experience them.
If you experience any of the following effects, do not take any more Ixilania.

Seek immediate medical attention, or go to the nearest hospital emergency room.
Uncommon (may affect up to 1 in 100 people)

• Swelling of the face, mouth, tongue, throat, hands or feet and/or a raised rash with itching (urticaria), difficulty swallowing or breathing

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

• Chest tightness, wheezing, difficulty swallowing or breathing.
• Severe rash, itching, or urticaria (raised, red or pale patches of skin that often itch).
• Signs and symptoms of serotonin syndrome may include agitation, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a
combination of fever, rapid heartbeat, sweating, severe muscle rigidity,
confusion, increased muscle enzymes (determined by a blood test).

• Signs of infection, such as high temperature, chills, tremors, headache, sweating, flu-like symptoms. This may be due to a blood disorder that causes an increased risk of infection.
• Severe rash that can cause severe blistering and peeling of the skin.
• Unexplained muscle pain, tenderness, or weakness. This may be a sign of rhabdomyolysis.

Other side effects that you should report to your doctorare (the frequencies of these side
effects are included in the “Other side effects” list):

• Cough, wheezing and shortness of breath that may be accompanied by a high temperature.
• Black stools (tarry stools) or blood in the stools.
• Itching, yellowing of the eyes or skin, or dark urine, which may be symptoms of liver inflammation (hepatitis).
• Heart problems, such as rapid or irregular heartbeat, increased blood pressure.
• Eye problems, such as blurred vision, dilated pupils.
• Nervous system problems, such as dizziness, tingling, movement disorders (muscle spasms or stiffness), seizures.
• Psychiatric problems, such as hyperactivity and feeling overly excited.
• Withdrawal syndrome (see the paragraph “How to take Ixilania, If you stop taking Ixilania”).
• Prolonged bleeding - it may take longer than usual to stop bleeding in case of cuts or wounds.

Do not worry if you notice small granules or white spheres in your stools after taking
this medicine. Inside the Ixilania capsules are spheroids (small
white spheres) that contain the active ingredient venlafaxine. These spheroids are released from
the capsule into the stomach. Because the spheroids pass through the entire length of your
gastrointestinal tract, venlafaxine is released slowly. The spheroid coating does not
dissolve and ends up in the stool. Therefore, even if you notice spheroids in your stool, the dose
of medicine has been absorbed.
Other side effects
Very common (may affect more than 1 in 10 people)

• Dizziness; headache; drowsiness
• Insomnia
• Nausea; dry mouth; constipation
• Sweating (including night sweats)

Common (may affect up to 1 in 10 people)

• Decreased appetite
• Confusion; feeling detached from oneself; absence of orgasm; decreased libido; agitation; nervousness; abnormal dreams
• Tremor; feeling restless or inability to sit still or remain still; tingling; altered sense of taste; increased muscle tone
• Visual disturbances including blurred vision; dilated pupils; inability of the eye to automatically refocus from distant to near objects
• Ringing in the ears (tinnitus)
• Rapid heartbeat; palpitations
• Increased blood pressure; hot flushes
• Shortness of breath; yawning
• Vomiting; diarrhea
• Mild rash; itching
• Increased frequency of urination; inability to urinate; difficulty emitting urine
• Menstrual irregularities such as increased bleeding or increased irregularity of bleeding; abnormal orgasm/ejaculation (males); erectile dysfunction (impotence)
• Weakness (asthenia); fatigue; chills
• Weight gain; weight loss
• Increased cholesterol

Uncommon (may affect up to 1 in 100 people)

• Hyperactivity, racing thoughts and decreased need for sleep (mania)
• Hallucinations; feeling detached from reality; abnormal orgasm; absence of sensations or emotions; feeling of overexcitement; teeth grinding
• Fainting; involuntary muscle movements; impaired coordination and balance
• Feeling dizzy (especially when getting up too quickly); low blood pressure
• Vomiting blood; tarry black stools or blood in the stools; which may be a sign of internal bleeding
• Sensitivity to sunlight; bruising; abnormal hair loss
• Urinary incontinence
• Stiffness, spasms and involuntary movements of the muscles
• Mild changes in blood levels of liver enzymes

Rare (may affect up to 1 in 1000 people)

• Seizures
• Cough, wheezing and shortness of breath that may be accompanied by a high temperature.
• Disorientation and confusion often accompanied by hallucinations (delirium)
• Excessive water intake (known as SIADH)
• Decreased blood levels of sodium
• Severe eye pain and decreased or blurred vision
• Abnormal, rapid or irregular heartbeat, which may lead to fainting
• Severe abdominal or back pain (which may indicate a serious problem with the intestine, liver or pancreas)
• Itching, yellowing of the skin or eyes, dark urine, or flu-like symptoms, which are signs of liver inflammation (hepatitis)

Very rare (occurs in less than 1 in 10,000 patients)

• Prolonged bleeding, which may indicate a decrease in the number of platelets in the blood, leading to an increased risk of bruising or bleeding
• Abnormal production of breast milk
• Unexpected bleeding, such as bleeding gums, blood in the urine or vomit, or the appearance of unexpected bruises or burst blood vessels

Frequency not known (cannot be estimated from the available data)

• Suicidal ideation and suicidal behaviour: cases of suicidal ideation and suicidal behaviour have been reported during treatment with venlafaxine or immediately after stopping treatment with venlafaxine (see section 2, What you need to know before taking Ixilania)
• Aggression
• Vertigo
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see Pregnancy and breastfeeding in section 2 for more information.

Sometimes Ixilania causes side effects that you may not be aware of, such as increases
in blood pressure or abnormal heartbeat; mild changes in blood levels of
liver enzymes, sodium or cholesterol. Less frequently, Ixilania may reduce the function of
platelets in your blood, leading to an increased risk of bruising and bleeding.
Therefore, your doctor may want to do occasional blood tests, especially if
you have been taking Ixilania for a long time.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse. By reporting
side effects you can help provide more information on the safety of this
medicine.

5. How to store Ixilania

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 packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ixilania contains
The active ingredient is venlafaxine.
Ixilania 75 mg:
Each hard capsule contains:
active ingredient: venlafaxine hydrochloride 84.9 mg equivalent to venlafaxine base 75 mg
Excipients: microcrystalline cellulose, povidone, talc, anhydrous colloidal silica, magnesium stearate,
ethylcellulose, copovidone, black iron oxide (E172), red iron oxide (E172), titanium
dioxide (E171), gelatin.
Ixilania 150 mg:
Each hard capsule contains:
active ingredient: venlafaxine hydrochloride 169.8 mg equivalent to venlafaxine base 150 mg.
Excipients: microcrystalline cellulose, povidone, talc, anhydrous colloidal silica, magnesium stearate,
ethylcellulose, copovidone, brilliant blue (E133), allura red (E129), sunset yellow (E110) and
titanium dioxide (E171), gelatin

Description of the appearance of Ixilania and contents of the pack
Ixilania 75 mg is a hard gelatin capsule, peach / opaque peach in colour, size '1' with
a thick and thin radial circular band on the body in red ink and a thick and thin circular
radial band on the cap in red ink. The capsule is filled with 6 mini
film-coated tablets of white to off-white colour, round, biconvex, each containing 12.5 mg
each.
Ixilania 75 mg is available in packs containing 14 capsules.
Ixilania 150 mg is a hard gelatin capsule, dark orange / opaque dark orange in colour,
size "0", with a thick and thin radial circular band on the body in white ink and
a thick and thin radial circular band on the cap in white ink. The capsule is
filled with 12 mini film-coated tablets of white to off-white colour, round,
biconvex, each containing 12.5 mg.
Ixilania 150 mg is available in packs containing 10 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Neuraxpharm Italy S.p.A.
Via Piceno Aprutina, 47
63100 Ascoli Piceno (AP)

Manufacturer
PHARMADOX HEALTHCARE LTD
KW20A Kordin Industrial Park Paola PLA 3000, Malta