Axiven

Package Leaflet: Information for the User

Axyven, 37.5 mg, prolonged-release tablets

Axyven, 75 mg, prolonged-release tablets

Axyven, 150 mg, prolonged-release tablets

Venlafaxine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Axyven and what is it used for

Axyven contains the active substance venlafaxine. Axyven is an antidepressant that belongs to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. The mechanism of action of antidepressants is not fully understood, but they may help by increasing the levels of serotonin and noradrenaline in the brain. Axyven is used to treat adult patients with depression. Axyven is also indicated for the treatment of the following anxiety disorders in adult patients: generalized anxiety disorder, social anxiety disorder (fear or avoidance of social situations), and panic disorder (panic attacks). It is important for the patient's well-being that the treatment of depression and anxiety disorders is carried out properly. If the patient does not undergo treatment, their condition may not improve, may worsen, and may become more difficult to treat.

2. Important information before taking Axyven

When not to take Axyven:

• 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 certain medicines called irreversible monoamine oxidase inhibitors (IMAOs) used to treat depression or Parkinson's disease. Taking irreversible IMAOs with Axyven may cause serious or life-threatening side effects.

Side effects can also occur when you stop taking IMAO medicines and start taking Axyven (see also "Axyven with other medicines" and "Serotonin syndrome").

Warnings and precautions

Before startingtreatment with Axyven, you should discuss it with your doctor or pharmacist:

• If you are taking other medicines that may increase the risk of serotonin syndrome when taken with Axyven (see "Axyven with other medicines").
• If you have problems with swallowing, stomach or intestinal problems that reduce your ability to swallow or pass food through proper bowel movements.
• If you have eye problems, such as certain types of glaucoma (increased pressure in the eyeball).
• If you have a history of high blood pressure.
• If you have had heart problems in the past.
• If you have had irregular heart rhythms.
• If you have had seizures (epilepsy) in the past.
• If you have had low sodium levels in your blood (hyponatremia) in the past.
• If you have had bleeding disorders (tendency to bruise or bleed) or if you are taking other medicines that may increase the risk of bleeding, such as warfarin (used to prevent blood clots), or if you are pregnant (see "Pregnancy, breastfeeding, and fertility").
• If you or anyone in your family has had mania or bipolar disorder (excessive excitement or euphoria) in the past.
• If you have had aggressive behavior in the past.

During the first few weeks of treatment with Axyven, you may experience restlessness or an inability to sit or stand still. If such symptoms occur, you should inform your doctor. Do not drink alcohol during treatment with Axyven, as it may cause extreme fatigue and loss of consciousness. Taking Axyven with alcohol and/or certain other medicines may increase the severity of depression and other conditions, such as anxiety disorders. Suicidal thoughts and worsening of depression or anxiety disorders Patients with depression and/or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such thoughts or behavior may worsen at the beginning of treatment with antidepressants, as these medicines usually start working after two weeks or sometimes later. These thoughts may also occur after reducing the dose or during discontinuation of Axyven. Such thinking may be more likely if:

• You have had suicidal thoughts or self-harm in the past.
• You are a young adult. Data from clinical trials indicate an increased risk of suicidal behavior in young adults (people under 25) with mental health conditions who were treated with antidepressants.

If you experience suicidal thoughts or thoughts of self-harm, you should immediately contact your doctor or go to the emergency department of the nearest hospital. It may be helpful to inform your relatives or friends about your depression or anxiety disorder and ask them to read this leaflet. You can ask your relatives or friends to help you and ask them to inform you if they notice that your depression or anxiety has worsened or if you have made any disturbing changes in your behavior. Dry mouth Dry mouth was reported by 10% of patients treated with venlafaxine. This may increase the risk of tooth decay. Therefore, you should take special care of your oral hygiene. Patients with diabetes The level of glucose in your blood may change when taking Axyven. Therefore, the dosage of your antidiabetic medicines may need to be adjusted. Sexual dysfunction Medicines like Axyven (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.

Children and adolescents

Axyven should not normally be used in children and adolescents under 18 years of age. It should also be known that in the case of taking this class of medicines, patients under 18 years of age are at increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). Despite this, your doctor may prescribe this medicine to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed this medicine to a patient under 18 years of age and you have any doubts, you should consult your doctor. You should inform your doctor if any of the following symptoms occur or worsen in patients under 18 years of age taking Axyven. Additionally, as yet, there are no long-term data on the safety of this medicine in this age group regarding the effects on growth, maturation, and cognitive and behavioral development.

Axyven with other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. Your doctor will decide whether to use Axyven with other medicines. Do not start or stop taking other medicines, including those available without a prescription, herbal, or natural remedies, without consulting your doctor or pharmacist first.

• Do not takemonoamine oxidase inhibitors with Axyven, which are used to treat depression or Parkinson's disease. Inform your doctor if you have taken these medicines in the last 14 days (IMAO; see "Important information before taking Axyven").
• Serotonin syndrome:A potentially life-threatening or neuroleptic malignant-like syndrome (see section "Possible side effects") may occur during treatment with venlafaxine, especially when taken with other medicines.

Examples of such medicines include:

• Triptans (used to treat migraine headaches).
• Other medicines used to treat depression, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and noradrenaline reuptake inhibitors (SNRIs), tricyclic antidepressants, or lithium-containing medicines.
• 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 moclobemide, IMAO (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 methemoglobin in the blood).
• Medicines containing St. John's Wort (Hypericum perforatum, herbal or natural remedies used to treat mild depression).
• Medicines containing tryptophan (used to treat sleep problems and depression).
• Antipsychotic medicines (used to treat symptoms such as hearing, seeing, or feeling things that do not exist, delusional beliefs, unusual suspicion, unclear reasoning, and withdrawal behavior).

Subjective and objective symptoms of serotonin syndrome may include a combination of the following symptoms: restlessness, hallucinations, loss of coordination, accelerated heart rate, elevated body temperature, rapid changes in blood pressure, hyperactivity, diarrhea, coma, nausea, vomiting. In its most severe form, serotonin syndrome can resemble neuroleptic malignant syndrome. Objective and subjective symptoms may include a combination of fever, accelerated heart rate, sweating, severe muscle stiffness, disorientation, and increased levels of muscle enzymes (measured in a blood test).

In case of suspected serotonin syndrome, you should immediately contact your doctor or go to the emergency department of the nearest hospital.

If you are taking medicines that may affect your heart rhythm, you should inform your doctor. Examples of such medicines include:

• 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 Axyven and should be used with caution. It is especially important to inform your doctor or pharmacist if you are taking medicines containing:

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

Axyven with food, drink, and alcohol

Axyven should be taken with food (see section 3, "How to take Axyven"). Do not drink alcohol during treatment with Axyven. Taking Axyven with alcohol may cause extreme fatigue and loss of consciousness, as well as worsen symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine. You should only take Axyven after discussing the potential benefits and risks with your doctor. Make sure your doctor and/or midwife know that you are taking Axyven. Taking similar medicines (SSRIs) during pregnancy may increase the risk of serious complications in the newborn, called persistent pulmonary hypertension of the newborn (PPHN), which is characterized by rapid breathing and bluish discoloration. These symptoms usually occur within the first 24 hours after birth. If such symptoms occur in the newborn, you should immediately contact your doctor and/or midwife. Taking Axyven at the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Axyven, you should inform your doctor or midwife so that they can provide you with appropriate advice. If you are taking this medicine during pregnancy, your baby may experience, in addition to breathing difficulties, other symptoms such as sucking problems after birth. If you are concerned about such symptoms in your newborn after birth, you should contact your doctor and/or midwife, who will be able to provide you with proper advice. Axyven passes into breast milk. There is a risk of an effect on the baby. You should discuss this with your doctor, and your doctor will decide whether to stop breastfeeding or stop treatment with this medicine.

Driving and using machines

Do not drive or operate any tools or machines until you know how Axyven affects you.

Axyven contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Axyven

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The usual recommended starting dose for depression, generalized anxiety disorder, social anxiety disorder is 75 mg once daily. This dose may be gradually increased by your doctor if necessary up to a maximum dose of 375 mg once daily for depression. For panic disorder, treatment should start with a dose of 37.5 mg once daily, which may be gradually increased. The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg once daily. Axyven should be taken once daily at approximately the same time, regardless of whether you take it in the morning or evening. The tablets should be swallowed whole with a drink of water and should not be divided, crushed, chewed, or dissolved. Axyven should be taken with food (see section 2, "Important information before taking Axyven"). If you have liver or kidney problems, you should inform your doctor, as you may need a dose adjustment. Do not stop taking Axyven without consulting your doctor (see section "Stopping treatment with Axyven").

Taking a higher dose of Axyven than recommended

If you have taken more Axyven than you should, you should immediately contact your doctor or pharmacist. Overdose can be life-threatening, especially when taken with alcohol and/or certain other medicines (see "Axyven with other medicines"). Symptoms of possible overdose may include accelerated heart rate, disturbances of consciousness (from drowsiness to coma), visual disturbances, seizures or convulsions, and vomiting.

Missing a dose of Axyven

If you forget to take a dose, you should take it as soon as possible. However, if it is almost time for your next dose, you should skip the missed dose and take only one dose at the usual time. Do not take a double dose to make up for a missed dose. Do not take more than the prescribed daily dose of Axyven.

Stopping treatment with Axyven

Do not stop taking Axyven without consulting your doctor, even if you feel better. If your doctor decides that you can stop taking Axyven, they will tell you how to gradually reduce the dose before completely stopping treatment. When stopping treatment with Axyven, especially when stopping suddenly or reducing the dose too quickly, you may experience side effects. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, disorientation, ringing in the ears, tingling or rarely electric shock sensation, weakness, sweating, seizures, or flu-like symptoms, and increased blood pressure (which can cause headaches, dizziness, ringing in the ears, sweating, etc.). Your doctor will advise you on how to gradually stop taking Axyven. This may take several weeks or months. In some patients, it may be necessary to stop the medicine very gradually over several months or longer. If you experience any of these symptoms or other symptoms that are troublesome to you, you should consult your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Axyven can cause side effects, although not everybody gets them. If you experience any of the following side effects, you should stop taking Axyven and immediately contact your doctor or go to the emergency department of the nearest hospital.

Uncommon (may affect up to 1 in 100 people)

• Swelling of the face, lips, tongue, throat, hands, or feet, and/or a raised, itchy rash (hives), difficulty swallowing or breathing.

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

• Chest pain, wheezing, difficulty swallowing or breathing.
• Severe rash, itching, or hives (red or pale rash, which may be itchy).
• Symptoms of serotonin syndrome may include: restlessness, hallucinations, loss of coordination, accelerated heart rate, elevated body temperature, rapid changes in blood pressure, hyperactivity, diarrhea, coma, nausea, vomiting. In its most severe form, serotonin syndrome can resemble neuroleptic malignant syndrome. Symptoms of neuroleptic malignant syndrome may include a combination of fever, accelerated heart rate, sweating, severe muscle stiffness, disorientation, and increased levels of muscle enzymes (measured in a blood test).
• Symptoms of infection, such as high fever, chills, shivering, headache, flu-like symptoms. This may be the result of a blood disorder that increases the risk of infection.
• Severe rash that may lead to severe blistering and peeling of the skin.
• Muscle pain of unknown cause, tenderness, or weakness. These may be symptoms of rhabdomyolysis.

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

• Symptoms of a condition called stress cardiomyopathy, including: chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.

Other side effects that you should tell your doctor about(the frequency of these side effects is given below in the section "Other side effects") include:

• Cough, wheezing, shortness of breath, which may be accompanied by high fever.
• Black (tarry) stools or blood in stools.
• Itching, yellowing of the skin or eyes, dark urine, which may be symptoms of liver inflammation.
• Heart problems, such as accelerated or irregular heartbeat, high blood pressure.
• Eye problems, such as blurred vision, dilated pupils.
• Nervous system problems, such as dizziness, tingling sensation, coordination problems (muscle spasms or stiffness), seizures or convulsions.
• Psychiatric problems, such as excessive restlessness and feeling of unnatural excitement.
• Withdrawal symptoms (see sections "How to take Axyven" and "Stopping treatment with Axyven").
• Prolonged bleeding - if you cut or injure yourself, it may take a little longer than usual to stop the bleeding.

You should not be concerned if you notice a tablet in your stool.

Venlafaxine is slowly released from the tablet as it passes through the gastrointestinal tract. The tablet shell does not dissolve and is excreted in the stool. Therefore, if you notice a tablet in your stool, you should not be concerned; the venlafaxine dose has been absorbed.

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.
• Disorientation, feeling of detachment (or separation) from oneself, lack of orgasm, decreased libido, agitation, nervousness, unusual dreams.
• Tremors, feeling of restlessness or inability to sit or stand still, tingling sensation, taste disturbances, increased muscle tone.
• Vision problems, including blurred vision, dilated pupils, inability of the eye to automatically change focus from distant to near objects.
• Ringing in the ears (tinnitus).
• Accelerated heart rate, palpitations.
• Increased blood pressure, flushing.
• Shortness of breath, yawning.
• Vomiting, diarrhea.
• Mild rash, itching.
• Increased frequency of urination, urinary retention, difficulty urinating.
• Menstrual irregularities, such as increased or irregular bleeding, or other menstrual disorders.
• Weakness, fatigue, chills.
• Weight gain, weight loss.
• Increased cholesterol levels.

Uncommon (may affect up to 1 in 100 people)

• Excessive excitement, racing thoughts, and decreased need for sleep (mania).
• Hallucinations, feeling of detachment (or separation) from reality, orgasm disorders, lack of feelings or emotions, feeling of excessive excitement, teeth grinding.
• Fainting, uncontrolled muscle movements, coordination and balance problems.
• Dizziness (especially when standing up too quickly), decreased blood pressure.
• Bloody vomiting, black (tarry) stools or blood in stools, which may be signs of internal bleeding.
• Sensitivity to light, bruising, excessive hair loss.
• Loss of bladder control.
• Stiffness, muscle spasms, and uncontrolled muscle movements.
• Mild changes in liver enzyme activity in the blood.

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

• Seizures or convulsions.
• Cough, wheezing, shortness of breath, which may be accompanied by high fever.
• Disorientation and confusion, which may be accompanied by hallucinations (delirium).
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH).
• Decreased sodium levels in the blood.
• Severe eye pain and decreased vision or blurred vision.
• Abnormal, accelerated, 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 eyes, dark urine, or flu-like symptoms, which may be symptoms of liver inflammation.

Very rare (may affect up to 1 in 10,000 people)

• Prolonged bleeding, which may be a sign of decreased platelet count, leading to increased risk of bruising or bleeding.
• Unusual milk production in women.
• Unexpected bleeding, such as bleeding from the gums, blood in the urine or vomit, or unexpected bruising or bleeding.

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

• Suicidal thoughts and behaviors; during treatment with venlafaxine, or shortly after stopping treatment, there have been reports of suicidal thoughts and behaviors (see section 2, "Important information before taking Axyven").
• Aggressive behavior.
• Dizziness.
• Severe vaginal bleeding shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2.

Axyven may sometimes cause side effects that you may not be aware of, such as increased blood pressure or abnormal heart rhythm, mild changes in liver enzyme activity, sodium or cholesterol levels in the blood. More rarely, Axyven may cause bleeding disorders, which increase the risk of bruising or bleeding. Therefore, your doctor may recommend that you have a blood test from time to time, especially if you are taking Axyven for a long time.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Axyven

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 after EXP. The expiry date refers to the last day of that month. There are no special storage instructions for this medicine. Blister packs: store in the original package to protect from moisture. HDPE bottle: store the bottle tightly closed to protect from moisture. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Axyven contains

• The active substance is venlafaxine.

Each prolonged-release tablet contains 37.5 mg, 75 mg, or 150 mg of venlafaxine (as hydrochloride). The other ingredients are: Core: mannitol (E 421), povidone K 90, macrogol 400, microcrystalline cellulose (E 460(i)), silicon dioxide, anhydrous, magnesium stearate (E 470b). Coating: cellulose acetate (320S NF), cellulose acetate (398-10NF), macrogol 400, Opadry White Y-30-18037 (hypromellose, lactose monohydrate, titanium dioxide (E 171), triacetin).

What Axyven looks like and contents of the pack

37.5 mg: round, 7 mm in diameter, biconvex, white prolonged-release tablets. 75 mg: round, 7.5 mm in diameter, biconvex, white prolonged-release tablets. 150 mg: round, 9.5 mm in diameter, biconvex, white prolonged-release tablets. Axyven is available in blister packs of 28 and 30 prolonged-release tablets and in plastic bottles containing 100 prolonged-release tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Exeltis Poland Sp. z o.o. ul. Szamocka 8 01-748 Warsaw

Manufacturer

Laboratorios LICONSA, S.A. Avda. Miralcampo no 7 Poligono Industrial Miralcampo 19200 Azuqueca de Henares Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Sweden Venlafaxin 1A Farma 37.5/75/150/225 mg prolonged-release tablets Estonia Venlafaxine Wörwag Pharma 37.5/75/150/225 mg prolonged-release tablets Greece SEROSMINE 37.5/75/150/225 mg prolonged-release tablets France VENLAFAXINE BIPHAR 150/225 mg prolonged-release tablets Italy Zarelis 37.5/75/150/225 mg prolonged-release tablets Netherlands Venlafaxine Aurobindo 225 mg prolonged-release tablets Poland Axyven, 37.5/75/150 mg, prolonged-release tablets Portugal Zarelix 37.5/75/150/225 mg prolonged-release tablets United Kingdom Venlafaxine XL 37.5/75/150/225 mg prolonged-release tablets Date of last revision of the leaflet:25.02.2025