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 all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• You should 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Axyven is and what it is used for
• 2. Before you take 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 Axyven is and what it is used for

Axyven contains the active substance venlafaxine. Axyven is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine 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 norepinephrine in the brain. Axyven is used to treat adults with depression. Axyven is also used to treat generalized anxiety disorder, social anxiety disorder, and panic disorder in adults. It is essential for the patient's well-being that depression and anxiety disorders are treated properly. If the patient does not receive treatment, their condition may not improve, may worsen, and may become more difficult to treat.

2. Before you take Axyven

Do not 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, any medicines known as irreversible monoamine oxidase inhibitors (MAOIs), which are used to treat depression or Parkinson's disease. Taking irreversible MAOIs with Axyven may cause serious or life-threatening reactions.

Side effects can be serious. If you take MAOIs and Axyven, you may experience serious side effects. Also, before starting to take any MAOI, you should wait at least 7 days after stopping your treatment with Axyven (see also "Axyven with other medicines" and the information in "Serotonin syndrome").

Warnings and precautions

Before startingtreatment with Axyven, you should discuss this 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 eye).
• 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 while taking 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 start of treatment with antidepressants, as these medicines start to work usually after two weeks or sometimes later. These thoughts may also occur when the dose is reduced or when treatment with Axyven is stopped. 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 have shown an increased risk of suicidal behavior in young adults (under 25 years) 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 may want to ask your relatives or friends to tell you if they notice that your depression or anxiety has worsened or if you have 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 pay special attention to oral hygiene. Patients with diabetes The blood sugar level may change when taking Axyven. Therefore, the dosage of antidiabetic medicines may need to be adjusted. Sexual dysfunction Medicines like Axyven (SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Children and adolescents

Axyven should not normally be used in children and adolescents under 18 years. It is also known that in the case of this class of medicines, patients under 18 years are at increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and anger). Despite this, your doctor may prescribe this medicine to patients under 18 years if they consider it to be in their best interests. If your doctor has prescribed this medicine to a patient under 18 years and you have any concerns, you should consult your doctor. You should inform your doctor if any of the following symptoms occur or worsen in patients under 18 years taking Axyven. Additionally, as yet, there is no long-term safety data available on the use of this medicine in this age group regarding 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, and about any medicines you plan to take. Your doctor will decide whether you can take Axyven with other medicines. Do not start or stop taking other medicines, including those available without a prescription, herbal, or natural products, without consulting your doctor or pharmacist first.

• Do not takemonoamine oxidase inhibitors (MAOIs) with Axyven. MAOIs are used to treat depression or Parkinson's disease. Tell your doctor if you have taken these medicines in the last 14 days (see "Important information before taking Axyven").
• Serotonin syndrome:A potentially life-threatening or neuroleptic malignant syndrome-like reaction (see section 4) may occur with venlafaxine treatment, 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 norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, or 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 moclobemide, an MAOI (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 products used to treat mild depression.
• Medicines containing tryptophan (used for sleep problems and depression).
• Antipsychotic medicines (used to treat symptoms such as hearing, seeing, or feeling things that are not there, false beliefs, unusual suspicion, unclear thinking, and withdrawal behavior).

Subjective and objective symptoms of serotonin syndrome may include a combination of the following symptoms: restlessness, hallucinations, loss of coordination, rapid heart rate, elevated body temperature, rapid changes in blood pressure, overreactivity, 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, rapid heart rate, sweating, severe muscle stiffness, confusion, and increased muscle enzyme levels (measured in a blood test).

In case of suspected serotonin syndrome, seek medical help immediately.

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

• Anti-arrhythmic medicines, such as quinidine, amiodarone, sotalol, or dofetilide (used to treat irregular heart rhythms).
• 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 you should use them 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 while taking Axyven. Taking Axyven with alcohol may cause extreme fatigue and loss of consciousness, as well as worsening of depression and other conditions, such as anxiety disorders.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 you are taking Axyven. Taking similar medicines (SSRIs) during pregnancy may increase the risk of the baby having a serious condition called persistent pulmonary hypertension of the newborn (PPHN), which is characterized by rapid breathing and bluish discoloration. These symptoms usually appear within the first 24 hours after birth. If such symptoms occur in the newborn, you should contact your doctor and/or midwife immediately. Taking Axyven at the end of pregnancy may increase the risk of severe bleeding from the vagina, which occurs 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 they can provide you with appropriate advice. If you take this medicine during pregnancy, your baby may experience breathing difficulties, as well as other symptoms such as feeding 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 appropriate 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 you should 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, check with your doctor or pharmacist. The usual recommended starting dose for depression, generalized anxiety disorder, social anxiety disorder 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 start with a lower dose (37.5 mg) and then gradually increase. The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg per day. Axyven should be taken once a day, 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, "Before you take Axyven"). If you have liver or kidney problems, you should tell 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 take more Axyven than you should, you should contact your doctor or pharmacist immediately. 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 rapid heart rate, changes in consciousness (from drowsiness to coma), changes in vision, 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 your regular dose at the usual time. Do not take a double dose to make up for a forgotten dose. Do not take more than the prescribed dose in one day.

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 stopping treatment completely. 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, restlessness, confusion, ringing in the ears, tingling or electric shock-like sensations, weakness, sweating, seizures, or flu-like symptoms. 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 contact your doctor or go to the emergency department of the nearest hospital immediately.

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 raised rash, often itchy).
• Symptoms of serotonin syndrome may include: restlessness, hallucinations, loss of coordination, rapid heart rate, elevated body temperature, rapid changes in blood pressure, overreactivity, 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, rapid heart rate, sweating, severe muscle stiffness, confusion, and increased muscle enzyme levels (measured in a blood test).
• Symptoms of infection, such as high fever, chills, shivering, headache, and flu-like symptoms, which may be signs of a blood disorder.
• Severe rash, which may lead to severe blistering and peeling of the skin.
• Muscle pain, tenderness, or weakness, which may be symptoms of a condition called 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, and 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, and shortness of breath, which may be accompanied by high fever.
• Black (tarry) stools or blood in stools, which may be signs of internal bleeding.
• Itching, yellowing of the skin or eyes, dark urine, which may be signs of liver inflammation.
• Heart problems, such as rapid or irregular heartbeat, high blood pressure.
• Eyes problems, such as blurred vision, dilated pupils.
• Nervous system problems, such as dizziness, tingling, coordination problems (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 Axyven" and "Stopping treatment with Axyven").
• Prolonged bleeding - if you cut or injure yourself, it may take longer than usual to stop the bleeding.

Do not be concerned if you see a tablet in your stool.

Venlafaxine is slowly released from the tablet as it passes through your digestive system. The tablet shell does not dissolve and is passed out in your stool. Therefore, if you see a tablet in your stool, do not be concerned; the venlafaxine has been absorbed.

It has been absorbed.

Other side effects

Very common (may affect more than 1 in 10 people)

• Dizziness, headache, somnolence.
• 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, restlessness, nervousness, unusual dreams.
• Tremor, feeling of restlessness or inability to sit or stand still, tingling, 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).
• Rapid heartbeat, palpitations.
• High blood pressure, flushing.
• Shortness of breath, yawning.
• Vomiting, diarrhea.
• Mild rash, itching.
• Increased frequency of urination, urinary retention, difficulty urinating.
• Menstrual disorders, such as increased bleeding or irregular bleeding, ejaculation disorders/orgasm (in men), erectile dysfunction (impotence).
• Weakness (asthenia), fatigue, chills.
• Weight gain, weight loss.
• Increased cholesterol levels.

Uncommon (may affect up to 1 in 100 people)

• Excessive excitement, racing thoughts, and reduced 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, involuntary muscle movements, coordination problems.
• Dizziness (especially when standing up too quickly), low blood pressure.
• Blood in vomit, black (tarry) stools, or blood in stool, which may be signs of internal bleeding.
• Sensitivity to light, bruising, excessive hair loss.
• Loss of bladder control.
• Stiffness, muscle spasms, and involuntary 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, and 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), which may cause low sodium levels in the blood.
• Low sodium levels in the blood.
• Severe eye pain and decreased vision or blurred vision.
• Abnormal, rapid, or irregular heartbeat, which may lead to fainting.
• Severe abdominal or back pain (which may be signs of serious problems with the intestines, liver, or pancreas).
• Itching, yellowing of the skin or eyes, dark urine, or flu-like symptoms, which may be signs of liver inflammation.

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

• Prolonged bleeding, which may be a sign of low platelet count, increasing the risk of bruising or bleeding.
• Unusual milk production in women.
• Unexpected bleeding, such as bleeding from the gums, blood in urine or vomit, or unexplained bruising or bleeding.

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

• Suicidal thoughts and behaviors; there have been reports of suicidal thoughts and behaviors during venlafaxine treatment or shortly after stopping treatment (see section 2, "Before you take Axyven").
• Aggressive behavior.
• Dizziness.
• Severe bleeding from the vagina, which occurs shortly after delivery (postpartum hemorrhage); see additional information in section 2, "Pregnancy, breastfeeding, and fertility".

Axyven may also 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 or 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 regular blood tests, especially during long-term treatment with Axyven.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects 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, phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. You can also report side effects 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. This 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, 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