Alventa

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Alventa
150 mg, prolonged-release capsules, hard
Venlafaxine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please 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 effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Alventa is and what it is used for
2. What you need to know 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 to treat 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 exact mechanism of action of antidepressants is not fully understood, but they may help by increasing the levels of serotonin and noradrenaline in the brain.
Alventa is used to treat 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 may 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 from 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 MAOI medicine, 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 Alventa, discuss this with your doctor or pharmacist:

• If the patient is taking other medicines that, when used together with Alventa, may increase the risk of serotonin syndrome (see section "Alventa and other medicines").
• If the patient has 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 bleeding (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, e.g. warfarin (used as an anticoagulant).
• If the patient has increased cholesterol levels.
• If the patient or any family member has previously had mania or bipolar disorder (feelings of excessive excitement or euphoria).
• If the patient has previously had aggressive behaviour.

Alventa may cause feelings of restlessness or inability to sit still during the first few weeks of treatment. If such symptoms occur, inform your doctor immediately.
Suicidal thoughts and worsening of depression or anxiety disorders
Patients with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually start working only after about 2 weeks, sometimes later. Such thoughts may also occur when the dose is reduced or during discontinuation of Alventa.
Suicidal thoughts or thoughts of self-harm are more likely in:

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

If the patient experiences thoughts of 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 worsening depression or anxiety, or concerning changes in behaviour.
Sexual dysfunction
Medicines such as Alventa (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after stopping treatment.
Dry mouth
Dry mouth is reported in 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 noted 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. If the doctor has prescribed this medicine to a patient under 18 years of age, consult the doctor again if in doubt. Inform the doctor if any of the above symptoms occur or worsen in patients under 18 years of age taking Alventa. The long-term safety of the effects 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 in the treatment of depression or Parkinson’s disease must not be taken with Alventa. Inform your doctor if you have taken these medicines within the last 14 days (MAOIs: see section "Important information before taking Alventa").
• Serotonin syndrome: During treatment with venlafaxine, a life-threatening condition or reactions resembling neuroleptic malignant syndrome (see section "Possible side effects") may occur, especially when taken together 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 (a substance used to treat infections);
• medicines containing the reversible MAOI moclobemide (a substance used to treat depression);
• medicines containing sibutramine (a substance used for weight loss);
• medicines containing tramadol, fentanyl, buprenorphine, tapentadol, pethidine or pentazocine (substances used to treat severe pain) (analgesics);
• medicines containing dextromethorphan (used to treat cough);
• medicines containing methadone (used to treat opioid addiction or severe pain);
• medicines containing methylene blue (a substance 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);
• antipsychotic medicines (used to treat illnesses with symptoms such as hearing, seeing and feeling things that do not exist, delusions, abnormal suspiciousness, abnormal perceptions and judgements, 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 changes in blood pressure, hyperreflexia, diarrhoea, drowsiness, nausea, vomiting.
The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome.
Symptoms include: fever, rapid heartbeat, sweating, muscle rigidity, confusion, increased muscle enzyme levels (detected in blood tests).
If serotonin syndrome is suspected, inform 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 should therefore be used with caution. It is especially 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").
During treatment with Alventa, alcohol should be avoided.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, thinks 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 serious vaginal bleeding 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 the 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 is characterised by rapid breathing and cyanosis. These symptoms usually appear within the first 24 hours after birth. If such symptoms occur in the newborn, contact a doctor and (or) midwife immediately.
If the patient takes this medicine during pregnancy, her newborn may experience other symptoms besides breathing difficulties, such as problems with sucking. If the patient is concerned about such symptoms in the newborn, she should contact the 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 using machines
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 strengths of 37.5 mg, 75 mg, and 150 mg.
The usual recommended starting dose for the treatment of depression, generalized anxiety disorders, 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 with 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 daily 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 divide, 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 Alventa than prescribed, contact your doctor immediately.
Symptoms of possible overdose may include increased heart rate, disturbances in consciousness (ranging from drowsiness to coma), visual disturbances, seizures or convulsions, and vomiting.

Missing 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 in one 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 you can discontinue Alventa, 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, diarrhoea, restlessness, agitation, disorientation, ringing in the ears, tingling or numbness, weakness, sweating, convulsions, flu-like symptoms, vision problems, and elevated 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 may be necessary, lasting months or longer. If any of the listed symptoms or other bothersome symptoms occur, 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 all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, discontinue Alventa and contact a 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 (a red or pale raised rash, often accompanied by itching),
• symptoms of serotonin syndrome may include: restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, hyperreflexia (overactive reflexes), diarrhea, drowsiness, 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, and increased levels of muscle enzymes (detected in blood tests).
• signs of infection such as high fever, chills, shivering, headache, sweating, flu-like symptoms. This may result from a blood disorder leading to increased risk of infection.
• severe skin rash, which may lead to the formation of serious blisters and skin peeling,
• 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 be symptoms of liver inflammation,
• heart problems such as rapid or irregular heartbeat, elevated blood pressure,
• eye problems such as blurred vision, dilated pupils,
• nervous system disorders such as dizziness, tingling sensation, movement coordination problems (muscle spasms or stiffness), seizures or convulsions,
• psychiatric disorders such as excessive activity 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 affect more than 1 in 10 patients)

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

Common (may affect up to 1 in 10 patients)

• decreased appetite,
• confusion, depersonalization (feeling of self-estrangement), anorgasmia, reduced sexual drive, restlessness, nervousness, unusual dreams,
• tremor, anxiety or inability to sit or stand still, tingling, taste disturbances, increased muscle tension,
• visual disturbances, including blurred vision, dilated pupils, inability of the eye to accommodate (automatic adjustment of focus 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 (in men), erectile dysfunction (impotence),
• weakness (asthenia), fatigue, chills,
• weight gain, weight loss,
• increased blood cholesterol levels.

Uncommon (may affect 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, uncontrolled muscle movements, coordination and balance disturbances,
• dizziness (especially upon standing up too quickly), decreased blood pressure,
• vomiting blood, black tarry stools (feces) or blood in the stool, which may indicate internal bleeding,
• light sensitivity, bruising, excessive hair loss,
• urinary incontinence,
• stiffness, cramps and involuntary muscle movements,
• slight 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 problems with the intestines, liver or pancreas),
• 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 from gums, blood in urine or vomit, appearance of unexpected bruises or broken 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; slight changes in blood levels of sodium, cholesterol or liver enzymes. 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 symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. 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 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 conditions are required.
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 150 mg of venlafaxine as venlafaxine hydrochloride.
• The other ingredients are sucrose, pellets (sucrose and corn starch), hydroxypropylcellulose, povidone K 30, ethylcellulose, dibutyl sebacate, talc. The capsule shell contains: 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
Orange-brown capsules filled with white to almost white pellets.
Pack sizes:
10, 14, 20, 28, 30, 50, 60, 98 or 100 extended-release hard capsules in blister packs, contained in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation numbers in Romania, country of export:
4317/2012/01
4317/2012/02
4317/2012/03
4317/2012/04
4317/2012/05
4317/2012/06
4317/2012/07
4317/2012/08
Parallel import licence number: 278/18
This medicinal product is authorised for sale in the European Economic Area member states under the following names: