Alventa

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Alventa, 75 mg, prolonged-release capsules, hard
Venlafaxine
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Alventa is and what it is used for

Alventa contains the active substance - venlafaxine.
Alventa is an antidepressant medicine belonging to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). Medicines in this group are used in the treatment of depression and other conditions such as anxiety disorders. It is believed that people experiencing depression and/or anxiety have lower levels of serotonin and noradrenaline in the brain. The mechanism of action of antidepressant medicines is not fully understood, but they may help by increasing the levels of serotonin and noradrenaline in the brain.
Alventa is used in the treatment of depression in adults. Alventa is also indicated for the treatment of the following anxiety disorders in adults: generalized anxiety disorder, social phobia (fear or avoidance of social situations), and panic disorder (panic attacks). For the patient to feel better, it is important that treatment for depression and anxiety disorders is properly managed. If treatment is not initiated, the patient's condition may not improve, may worsen, and will become significantly more difficult to treat.

2. Important information before taking Alventa

When not to take Alventa

• If the patient is allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
• If the patient is currently taking or has taken within the last 14 days any medicine belonging to the group of irreversible monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease. Taking irreversible MAOIs together with Alventa may cause severe or even life-threatening adverse reactions. Also, before starting any medicine from the MAOI group, the patient should wait at least 7 days after stopping Alventa (see also section "Alventa and other medicines" and information in this section regarding serotonin syndrome).

Warnings and precautions
Before starting treatment with Alventa, discuss this with your doctor or pharmacist:

• If the patient is taking other medicines which, when taken together with Alventa, may increase the risk of serotonin syndrome (see section "Alventa and other medicines").
• If the patient suffers from eye disorders, such as certain types of glaucoma (increased pressure in the eyeball).
• If the patient has previously had high blood pressure.
• If the patient has previously had heart diseases.
• If the patient has previously had heart rhythm disorders.
• If the patient has previously had seizures (epilepsy).
• If the patient has previously had low sodium levels in the blood (hyponatraemia).
• If the patient has a tendency to bruise easily or to bleed (bleeding disorders in the past), or if the patient is pregnant (see section "Pregnancy, breastfeeding and fertility") or if the patient is taking other medicines that may increase the risk of bleeding, such as warfarin (used as an anticoagulant).
• If the patient's cholesterol levels have increased.
• If the patient or anyone in their family has previously had mania or bipolar disorder (feelings of excessive excitement or euphoria).
• If the patient has previously exhibited aggressive behaviour.

Alventa may cause feelings of restlessness or an inability to sit still during the first few weeks of treatment. If such symptoms occur, inform your doctor immediately.
Do not consume alcohol while being treated with Alventa, as this may cause extreme fatigue and loss of consciousness. Concurrent use with alcohol and (or) certain medicines may worsen symptoms of depression and other medical conditions, such as anxiety disorders.

Suicidal thoughts and worsening of depression or anxiety disorders
Patients with depression or anxiety disorders may sometimes experience thoughts about self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually take about 2 weeks, sometimes longer, to start working. Such thoughts may also occur when the dose is reduced or when Alventa is discontinued.
The following suicidal thoughts or thoughts of self-harm are more likely in:

• Patients who previously had thoughts about self-harm or suicide;
• Young adult patients. Clinical trial data show an increased risk of suicidal behaviour in individuals under 25 years of age with psychiatric disorders who were treated with antidepressant medicines.

If the patient develops thoughts about self-harm or suicide, contact a doctor immediately or go to the nearest hospital.
It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to inform him/her if they notice that depression or anxiety worsens or if there are worrying changes in the patient's behaviour.

Sexual dysfunction
Medicines such as Alventa (so-called SSRIs or SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.

Dry mouth
Dry mouth is reported by 10% of patients treated with venlafaxine. This may increase the risk of dental caries. Therefore, special attention should be paid to oral hygiene.

Diabetes
Alventa may alter blood glucose levels and therefore may require adjustment of the dose of antidiabetic medicines.

Children and adolescents
Alventa should not be used in children and adolescents under 18 years of age.
It should also be emphasized that patients under 18 years of age who take medicines from this group are at increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and anger).
Nevertheless, a doctor may prescribe this medicine to patients under 18 years of age if he/she considers it beneficial for them. If a doctor has prescribed this medicine to a patient under 18 years of age, any doubts should be discussed again with the doctor. Inform the doctor if any of the above-mentioned symptoms occur or worsen in patients under 18 years of age taking Alventa. Long-term safety regarding the impact on growth, maturation, and cognitive and behavioural development in this age group has not yet been established.

Alventa and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The treating doctor will decide whether Alventa can be taken together with other medicines.
Do not start or stop taking other medicines, including over-the-counter medicines, natural or herbal remedies, without first consulting your doctor or pharmacist.

• Monoamine oxidase inhibitors used to treat depression or Parkinson's disease must not be taken with Alventa. Inform your doctor if the patient has taken these medicines within the last 14 days (MAOIs; see section "Important information before taking Alventa").
• Serotonin syndrome: During treatment with venlafaxine, a potentially life-threatening condition or reactions resembling neuroleptic malignant syndrome (see section "Possible side effects") may occur, especially when used concomitantly with medicines such as:
• Triptans (substances used for migraine headaches);
• Other medicines used to treat depression, e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, or medicines containing lithium;
• Medicines containing amphetamine derivatives (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity);
• Medicines containing the antibiotic linezolid (used to treat infections);
• Medicines containing the reversible MAOI moclobemide (used to treat depression);
• Medicines containing sibutramine (used for weight loss);
• Medicines containing opioids (e.g., buprenorphine, tramadol, fentanyl, tapentadol, pethidine, or pentazocine) used to treat severe pain;
• Medicines containing dextromethorphan (used to treat cough);
• Medicines containing methadone (used to treat opioid addiction or severe pain);
• Medicines containing methylene blue (used to treat high methemoglobin levels in the blood);
• Medicines containing St. John's wort (Hypericum perforatum), natural or herbal remedies used to treat mild depression;
• Medicines containing tryptophan (used for sleep problems and depression);
• Antipsychotics (used to treat diseases with symptoms such as hearing, seeing, or feeling things that do not exist, delusions, abnormal suspiciousness, abnormal perceptions and judgments, social withdrawal).

Subjective and objective symptoms of serotonin syndrome may include a combination of the following:
agitation, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid fluctuations in blood pressure, hyperreflexia, diarrhoea, lethargy, nausea, vomiting.
The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome.
Its symptoms include: fever, rapid heartbeat, sweating, muscle rigidity, confusion, increased muscle enzyme levels (detected in blood tests).
If serotonin syndrome is suspected, contact your doctor immediately or go to the nearest hospital emergency department.

If the patient is taking medicines that may affect heart rhythm, inform the doctor. Examples of such medicines:

• Antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat heart rhythm disorders),
• Antipsychotics such as thioridazine (see above - serotonin syndrome),
• Antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections),
• Antihistamines (used to treat allergies).

The following medicines may also interact with Alventa and therefore should be used with caution. It is particularly important to inform the doctor if the patient is taking medicines containing:

• Ketoconazole (an antifungal medicine);
• Haloperidol or risperidone (medicines used to treat psychiatric disorders);
• Metoprolol (a beta-blocker used to treat high blood pressure and heart diseases).

Alventa with food, drink and alcohol
Alventa should be taken with food (see section 3 "How to take Alventa").
Do not consume alcohol while being treated with Alventa. Concurrent use with alcohol may cause extreme fatigue and loss of consciousness and may worsen symptoms of depression and other medical conditions, such as anxiety disorders.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.
Alventa should only be used after discussing with the doctor the potential benefits and potential risks to the unborn child.
Taking Alventa late in pregnancy may increase the risk of severe vaginal bleeding occurring shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Alventa, she should inform her doctor or midwife so they can provide appropriate advice.
Inform your doctor and (or) midwife about taking Alventa. Taking similar medicines during pregnancy [such as serotonin reuptake inhibitors (SSRIs)] may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN), which manifests as rapid breathing and cyanosis. These symptoms usually appear within the first 24 hours after birth. If such symptoms occur in the newborn, contact your doctor and (or) midwife immediately.
If the patient takes this medicine during pregnancy, her newborn may experience, in addition to breathing difficulties, other symptoms such as feeding problems. If the patient is concerned about such symptoms in the newborn, she should contact her doctor and (or) midwife, who will be able to provide appropriate advice.
Alventa passes into breast milk. There is a risk that the medicine may affect the infant. Therefore, this issue should be discussed with the doctor, and the doctor will decide whether breastfeeding should be discontinued or treatment with this medicine stopped.

Driving and operating machinery
Do not drive or operate machinery until you know how this medicine affects you.

Alventa contains sucrose
If the patient has been told by a doctor that he or she has an intolerance to certain sugars, he or she should consult the doctor before taking this medicine.

3. How to use Alventa

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Alventa is available in the following strengths: 37.5 mg, 75 mg, 150 mg.
The usual recommended starting dose for the treatment of depression, generalized anxiety disorders,
and social phobia is 75 mg once daily. This dose may be gradually increased by the doctor if necessary,
up to a maximum dose of 375 mg per day in the case of depression. For panic disorder, treatment should
be initiated at a lower dose (37.5 mg), which may then be gradually increased. The maximum dose for
the treatment of generalized anxiety disorders, social phobia, and panic disorder is 225 mg per day.
Alventa should be taken every day at approximately the same time, regardless of whether it is taken
in the morning or evening. The capsules must be swallowed whole with liquid.
Do not split, crush, chew, or dissolve the capsules.
Alventa should be taken with food.
Inform your doctor if you have any liver or kidney problems, as your dose may need to be adjusted.
Do not stop taking this medicine without consulting your doctor (see section "Stopping Alventa").
Taking more Alventa than prescribed
If you take more than the prescribed dose of this medicine, contact your doctor immediately.
Overdose can be life-threatening, especially when taken with alcohol and/or certain other medicines
(see section "Alventa with other medicines").
Symptoms of possible overdose may include rapid heartbeat, disturbances in consciousness (from
drowsiness to coma), visual disturbances, seizures or convulsions, and vomiting.
If you miss a dose of Alventa
If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose,
skip the missed dose and take only your next scheduled dose at the usual time. Do not take a double
dose to make up for a missed dose. Do not take more than the daily dose of Alventa prescribed by
your doctor within a single day.
Stopping Alventa
Do not stop treatment or reduce the dose of Alventa without consulting your doctor, even if you
feel better. If your doctor decides that Alventa can be discontinued, they will advise you on how
to gradually reduce the dose before stopping treatment completely. Patients discontinuing Alventa,
especially those who stop abruptly or reduce the dose too quickly, may experience adverse effects
such as suicidal thoughts, aggression, fatigue, dizziness, a feeling of emptiness in the head, headache,
insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, restlessness, agitation,
disorientation, ringing in the ears, tingling or numbness, weakness, sweating, seizures, flu-like
symptoms, vision problems, and increased blood pressure (which may cause headaches, dizziness,
ringing in the ears, sweating, etc.).
Your doctor will advise you on how to gradually discontinue Alventa. This process may take several
weeks or months. In some patients, a very gradual discontinuation lasting months or longer may be
necessary. If any of the listed symptoms occur, or any other symptoms that are bothersome, consult
your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, discontinue Alventa and contact your doctor immediately or go to the nearest hospital
Emergency Department:
Uncommon (may occur in fewer than 1 in 100 people)

• swelling of the face, lips, tongue, throat, hands or feet, and (or) raised, itchy rash (urticaria), difficulty swallowing or breathing.

Rare (may occur in fewer than 1 in 1000 people)

• chest tightness, wheezing, difficulty swallowing or breathing,
• severe skin rash, itching or urticaria (raised red or pale rash, often accompanied by itching),
• symptoms of serotonin syndrome may include: psychomotor agitation, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, hyperreflexia (overreaction), diarrhea, lethargy, nausea, vomiting. The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome. Symptoms of neuroleptic malignant syndrome may include fever, rapid heartbeat, sweating, muscle rigidity, confusion, increased muscle enzyme levels (detected in blood tests).
• signs of infection such as high fever, chills, shivering, headache, sweating, flu-like symptoms. This may be due to a blood disorder leading to increased risk of infection.
• severe skin rash which may lead to formation of serious blisters and peeling of the skin,
• muscle pain of unknown origin, tenderness or weakness. These may be symptoms of rhabdomyolysis.

Frequency unknown (cannot be estimated from available data)

• symptoms of a condition known as "stress cardiomyopathy", which may include: chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.

If any of the following adverse reactions occur, contact your doctor.
(The frequency of these adverse reactions is listed below under the section “Other adverse reactions”):

• cough, wheezing and shortness of breath, possibly accompanied by high fever,
• black (tarry) stools or blood in the stool,
• itching, yellowing of the skin or eyes, or dark urine, which may indicate liver inflammation,
• heart problems such as rapid or irregular heartbeat, elevated blood pressure,
• eye problems such as blurred vision, dilated pupils,
• nervous system problems such as dizziness, tingling sensation, movement coordination disorders (muscle spasms or stiffness), seizures or convulsions,
• psychiatric problems such as excessive restlessness and feelings of unnatural excitement,
• withdrawal symptoms (see sections “How to take Alventa” and “Stopping Alventa”),
• prolonged bleeding time – if injured, the time required to stop bleeding may be slightly longer than usual.

Other adverse reactions
Very common (may occur in more than 1 in 10 patients)

• dizziness, headache, drowsiness,
• insomnia,
• nausea, dry mouth, constipation,
• sweating (including night sweats).

Common (may occur in up to 1 in 10 patients)

• decreased appetite,
• confusion, depersonalization (feeling of self-alienation), anorgasmia, reduced sexual drive, restlessness, nervousness, unusual dreams,
• tremor, anxiety or inability to sit still or remain motionless, tingling, taste disturbances, increased muscle tension,
• visual disturbances, including blurred vision, dilated pupils, inability of the eye to accommodate (automatic focusing change from distant to near objects),
• ringing in the ears (tinnitus),
• rapid heartbeat, palpitations,
• increased blood pressure, sudden flushing, especially of the face,
• shortness of breath, yawning,
• vomiting, diarrhea,
• mild rash, itching,
• increased frequency of urination, inability to urinate, difficulty urinating,
• menstrual irregularities such as heavy bleeding or more frequent irregular bleeding, ejaculation/orgasm disorders (men), erectile dysfunction (impotence),
• weakness (asthenia), fatigue, chills,
• weight gain, weight loss,
• increased blood cholesterol levels.

Uncommon (may occur in up to 1 in 100 patients)

• excessive excitement, racing thoughts and reduced need for sleep (mania),
• hallucinations, derealization (feeling of detachment or separation from reality), orgasm disorders, apathy, feeling of excessive stimulation, teeth grinding,
• fainting, involuntary muscle movements, coordination and balance disorders,
• dizziness (especially upon standing too quickly), decreased blood pressure,
• vomiting blood, black tarry stools (faeces) or blood in the stool, which may indicate internal bleeding,
• light sensitivity, bruising, excessive hair loss,
• urinary incontinence,
• stiffness, spasms and involuntary muscle movements,
• minor changes in liver enzyme activity in blood.

Rare (may occur in fewer than 1 in 1000 people)

• seizures,
• cough, wheezing and shortness of breath, possibly accompanied by high fever,
• disorientation and confusion, often with accompanying hallucinations (delirium),
• excessive water retention in the body (SIADH),
• decreased sodium levels in blood,
• severe eye pain and vision loss or blurred vision,
• abnormal, rapid or irregular heartbeat which may lead to fainting,
• severe abdominal or back pain (which may indicate serious intestinal, liver or pancreatic problems),
• itching, yellowing of the skin or whites of the eyes, dark urine or flu-like symptoms, which are signs of liver inflammation.

Very rare (may occur in fewer than 1 in 10,000 people)

• prolonged bleeding, which may be a sign of reduced platelet count, indicating increased risk of bruising or bleeding,
• abnormal milk production in women,
• unexpected bleeding, e.g. bleeding gums, blood in urine or vomit, appearance of unexpected bruises or ruptured blood vessels (broken veins).

Frequency unknown (cannot be estimated from available data)

• suicidal thoughts and behaviors – during treatment with venlafaxine or shortly after treatment discontinuation, cases of suicidal thoughts and behaviors have been reported (see section 2. “Important information before taking Alventa”),
• aggressive behavior,
• dizziness,
• severe vaginal bleeding occurring shortly after childbirth (postpartum hemorrhage); for additional information see section 2 “Pregnancy, breastfeeding and fertility”.

Alventa may sometimes cause adverse reactions that the patient may not be aware of, such as increased blood pressure or abnormal heart function; minor changes in blood sodium, cholesterol or liver enzyme levels. In even rarer cases, Alventa may impair platelet function, leading to an increased risk of petechiae or bleeding. Therefore, your doctor may recommend periodic blood tests, especially during long-term treatment with Alventa.
Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Alventa medicine

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Alventa contains

• The active substance is venlafaxine. Each extended-release hard capsule contains 75 mg of venlafaxine in the form of venlafaxine hydrochloride.
• Other ingredients are: sucrose, pellets (sucrose, corn starch), hydroxypropylcellulose, povidone K 30, ethylcellulose, dibutyl sebacate, talc.
• The capsule shell ingredients are: gelatin, iron oxide red (E 172), titanium dioxide (E 171), iron oxide yellow (E 172). See section 2 "Alventa contains sucrose".

What Alventa looks like and contents of the pack
Light pink capsules filled with white to almost white pellets.
Pack sizes:
30 or 60 extended-release hard capsules in PVC-PVDC/Aluminium blister packs,
in a cardboard carton.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing Authorization Holder in Romania, country of export:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged by:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw, Poland
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorization Number in Romania, country of export: 4316/2012/05
Parallel Import License Number: 53/19
This medicinal product is authorized for sale in the European Economic Area countries under the following names: