Alventa

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Alventa, 150 mg, prolonged-release capsules, hard
Venlafaxinum
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for possible future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the 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 disorders such as anxiety disorders. It is believed that people with depression and (or) anxiety have lower levels of serotonin and noradrenaline in the brain. The exact 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 of depression and anxiety disorders is properly conducted. 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 using Alventa

When not to use 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 the following with your doctor or pharmacist:

• If the patient is taking other medicines that, when taken together with Alventa, may increase the risk of serotonin syndrome (see section "Alventa and other medicines").
• If the patient suffers from eye diseases, 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 or 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, e.g. warfarin (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, during the first few weeks of treatment, cause a feeling of restlessness or
inability to sit still or remain in one place. If such symptoms occur, the patient should
inform their doctor.
Do not consume alcohol during treatment 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 have thoughts of self-harm or
suicide. These symptoms or behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, or sometimes longer, to start working. Such thoughts may also occur when the dose is reduced or when Alventa is discontinued.
The following suicidal or self-harming thoughts 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 patients under 25 years of age with psychiatric disorders who were treated with antidepressants.

If the patient experiences thoughts of self-harm or suicide, they should immediately
contact their doctor 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 or 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 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 necessitate 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 manifestations of anger).
Nevertheless, a doctor may prescribe this medicine to patients under 18 years of age if they consider it beneficial. If the doctor has prescribed this medicine to a patient under 18 years of age, any doubts should be discussed again with the doctor. The doctor should be informed if any of the above-mentioned 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 you are currently taking, have recently taken, or plan to take.
Your doctor will decide whether Alventa can be taken together with other medicines.
Do not start or stop taking any other medicines, including over-the-counter medicines, natural or herbal remedies, without first consulting your doctor or pharmacist.

• Monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease must not be taken with Alventa. Inform your doctor if you have taken any of these medicines within the last 14 days (see MAOIs in section "Important information before using Alventa").
• Serotonin syndrome: During treatment with venlafaxine, a life-threatening condition or a reaction resembling neuroleptic malignant syndrome 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 (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 dependence or severe pain);
• medicines containing methylene blue (used to treat high levels of methaemoglobin 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 diseases with symptoms such as hearing, seeing, or 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 fluctuations in blood pressure, hyperreflexia, diarrhoea, drowsiness, nausea, vomiting.
The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome.
Its symptoms include: fever, rapid heartbeat, sweating, muscle rigidity, confusion,
elevated 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, they should inform their doctor. Examples of such medicines:

• antiarrhythmic medicines such as quinidine, amiodarone, sotalol, or dofetilide (used to treat heart rhythm disorders),
• antipsychotic medicines 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 your 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 during treatment 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, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Alventa should be used only after discussing with the doctor the potential benefits and potential risks to the unborn child.
Taking Alventa towards the end of 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 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 is characterised by rapid breathing and cyanosis. These symptoms usually appear within the first day 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, apart from breathing difficulties, other symptoms such as problems with sucking. 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 of the medicine affecting the infant.
Therefore, this issue should be discussed with the doctor, who will decide whether breastfeeding should be discontinued or treatment with this medicine stopped.
Driving and using machines
Do not drive or operate machinery until the patient knows how this medicine affects them.
Alventa contains sucrose
If the patient has been informed by their doctor that they have an intolerance to certain sugars, they should consult their 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,
you should 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 per day. This dose may be gradually increased by your 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 should then be gradually increased. The maximum
daily 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 divide, crush, chew, or dissolve the capsules.
Alventa should be taken with food.
You should inform your doctor if you have any liver or kidney problems, as this may require an
adjustment of the dose.
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.
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 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 Alventa can be discontinued, they will advise you on how to
gradually reduce the dose before stopping treatment completely. In patients discontinuing Alventa,
especially after abrupt cessation or too rapid dose reduction, adverse effects may occur, such as
suicidal thoughts, aggression, feeling tired, dizziness, a sensation 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, convulsions, flu-like
symptoms, visual disturbances, 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 symptoms listed above, or other symptoms that are troublesome to you,
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 your doctor immediately or go to the nearest hospital Emergency Department:

Not common (may affect 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 affect fewer than 1 in 1,000 people)

• chest tightness, wheezing, difficulty swallowing or breathing,
• severe skin rash, itching or hives (red or pale raised areas, 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, increased reflexes (hyperreactivity), 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 stiffness, confusion, and increased muscle enzyme levels (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 formation of severe blisters and skin peeling,
• unexplained muscle pain, 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 breathlessness, 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, increased 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 restlessness and feelings of unnatural excitement,
• withdrawal symptoms (see sections “How to take Alventa” and “Stopping Alventa”),
• prolonged bleeding time – in case of cuts, 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 desire, agitation, nervousness, unusual dreams,
• tremor, feeling of restlessness 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 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,
• breathlessness, yawning,
• vomiting, diarrhea,
• mild rash, itching,
• increased frequency of urination, inability to urinate, difficulty in urination,
• 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.

Not common (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 excitement, 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 (faeces) or blood in the stool, which may indicate internal bleeding,
• light sensitivity, bruising, excessive hair loss,
• urinary incontinence,
• stiffness, cramps and involuntary muscle movements,
• minor changes in liver enzyme activity in blood.

Rare (may affect fewer than 1 in 1,000 people)

• seizures,
• cough, wheezing and breathlessness, 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 heart function 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 affect fewer than 1 in 10,000 people)

• prolonged bleeding, which may indicate reduced platelet count, meaning 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 broken blood vessels (ruptured veins).

Frequency unknown (cannot be estimated from available data)

• suicidal thoughts and behaviors – during treatment with venlafaxine or shortly after 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 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 reactions 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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 required. This will help protect the environment.

6. Contents of the pack and other information

What Alventa contains

• The active substance is venlafaxine. Each prolonged-release hard capsule contains 150 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 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.
Packaging:
30 or 60 prolonged-release hard capsules in PVC-PVDC/Aluminium blister packs,
in a cardboard box.
For more detailed information, please contact the responsible party or 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
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 Authorisation Number in Romania, country of export: 4317/2012/05
Parallel Import Authorisation Number: 54/19
This medicinal product is authorised for sale in the Member States of the European Economic Area under the following names: