Venlafaxine Teva

Package Leaflet: Information for the User

Venlafaxine Teva, 37.5 mg, prolonged-release hard capsules

Venlafaxine Teva, 75 mg, prolonged-release hard capsules

Venlafaxine Teva, 150 mg, prolonged-release hard capsules

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 Venlafaxine Teva is and what it is used for
• 2. What you need to know before you take Venlafaxine Teva
• 3. How to take Venlafaxine Teva
• 4. Possible side effects
• 5. How to store Venlafaxine Teva
• 6. Contents of the pack and other information

1. What Venlafaxine Teva is and what it is used for

Venlafaxine Teva contains the active substance venlafaxine.
Venlafaxine Teva 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. It is thought that people who are depressed and/or anxious have lower levels of serotonin and norepinephrine in the brain. The exact mechanism of action of antidepressants is not fully understood, but they are thought to help by increasing the levels of serotonin and norepinephrine in the brain.
Venlafaxine Teva is used to treat depression in adults. It is also used to treat generalized anxiety disorder, social anxiety disorder, and panic disorder in adults. For the best effect, it is important that depression and anxiety disorders are treated properly. If left untreated, the condition may not improve, may worsen, and may become more difficult to treat.

2. What you need to know before you take Venlafaxine Teva

When not to take Venlafaxine Teva

• 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 MAOIs with Venlafaxine Teva can cause serious or even life-threatening side effects.

Do not take Venlafaxine Teva if you are taking any of these medicines. Also, before starting to take any MAOI medicine, you should wait at least 7 days after stopping Venlafaxine Teva (see also "Venlafaxine Teva with other medicines" and the information in this section about serotonin syndrome).

Warnings and precautions

Before starting to take Venlafaxine Teva, tell your doctor:

• if you are taking any other medicines that may increase the risk of serotonin syndrome when taken with Venlafaxine Teva (see "Venlafaxine Teva with other medicines").
• if you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
• if you have had high blood pressure in the past.
• 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 the blood (hyponatremia) in the past.
• if you have a tendency to bruise or bleed easily, 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 and breastfeeding").
• if you or anyone in your family has had mania or bipolar disorder (feeling excessively excited or euphoric).
• if you have had aggressive behavior in the past.

Venlafaxine Teva may cause feelings of restlessness or an inability to sit or stand still in the first few weeks of treatment. If you experience these symptoms, tell your doctor.
Do not drink alcohol while taking Venlafaxine Teva, as it may cause extreme drowsiness and loss of consciousness. Taking Venlafaxine Teva with alcohol and/or certain other medicines may increase the risk of worsening 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. These thoughts may worsen when first taking antidepressants, as these medicines may take about 2 weeks to start working, sometimes longer. These thoughts may also occur when reducing the dose or stopping Venlafaxine Teva.
Suicidal thoughts are more likely to occur if:

• you have had suicidal thoughts or self-harm in the past.
• you are a young adult. 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 have thoughts of self-harm or suicide, contact your doctor or go to the emergency department immediately.
It may be helpful to tell your family or friends that you are taking Venlafaxine Teva and ask them to read this leaflet. You may want to ask them to tell you if they notice any worsening of your depression or anxiety, or if they notice any changes in your behavior.

Dry mouth
Dry mouth has been reported in 10% of patients taking venlafaxine. This may increase the risk of tooth decay. Therefore, pay special attention to oral hygiene.

Diabetes
Blood sugar levels may be affected while taking Venlafaxine Teva. Therefore, your diabetes medication may need to be adjusted.

Sexual dysfunction
Medicines like Venlafaxine Teva (SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Pellets in stool
Do not be concerned if you see small, white balls or granules in your stool after taking this medicine. Inside the capsules of Venlafaxine Teva are spheroids (small white balls) that contain the active substance (venlafaxine). These balls are released from the capsule into the stomach. As they pass through the stomach and intestines, venlafaxine is slowly released. The spheroid "coating" does not dissolve and is eliminated in the stool. Therefore, even if the spheroids are visible in the stool, the dose of the medicine has been absorbed.

Children and adolescents

Venlafaxine Teva should not normally be used in children and adolescents under 18 years of age.
It is important to note that in the treatment of 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 expressions of anger). However, your doctor may prescribe Venlafaxine Teva to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Venlafaxine Teva to a patient under 18 years of age and you have any concerns, consult your doctor. You should inform your doctor if a patient under 18 years of age taking Venlafaxine Teva experiences any of the above symptoms or if they worsen. There is also a lack of available data on the long-term safety of this medicine in this age group regarding growth, maturation, and cognitive and behavioral development.

Venlafaxine Teva 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 Venlafaxine Teva 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.

• Monoamine oxidase inhibitors, used to treat depression or Parkinson's disease, must not be taken with Venlafaxine Teva. Tell your doctor if you have taken these medicines in the last 14 days. (MAOIs: see "Important information before taking Venlafaxine Teva").
• Serotonin syndrome:During treatment with venlafaxine, a potentially life-threatening condition or neuroleptic malignant syndrome (NMS) may occur, 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-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 the MAOI inhibitor moclobemide (used to treat depression),
• medicines containing sibutramine (used for weight loss),
• medicines containing opioids (such as buprenorphine, tramadol, fentanyl, tapentadol, pethidine, or pentazocine) used to treat severe pain.
• medicines containing dextromethorphan (used to treat cough),
• medicines containing methadone (used to treat opioid addiction or severe pain),
• medicines containing methylene blue (used to treat high 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 for sleep problems and depression),
• antipsychotic medicines (used to treat mental illnesses with symptoms such as hearing, seeing, or feeling things that are not there, false beliefs, unnatural suspicion, unclear reasoning, and withdrawal).

The subjective and objective symptoms of serotonin syndrome may include the following: restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, overreactivity, diarrhea, coma, nausea, vomiting.

The most severe form of serotonin syndrome can resemble neuroleptic malignant syndrome. Its symptoms include: fever, rapid heartbeat, sweating, muscle stiffness, disorientation, elevated levels of muscle enzymes (detected in a blood test).

If you suspect serotonin syndrome, tell your doctor or go to the emergency department immediately.

Tell your doctor if you are taking any medicines that may affect your heart rhythm. 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 also "Serotonin syndrome" above)
• antibiotics, such as erythromycin or moxifloxacin (used to treat bacterial infections)
• antihistamines (used to treat allergies).

The following medicines may also interact with Venlafaxine Teva and should be used with caution. It is especially important to inform your doctor if you are taking medicines containing:

• ketokonazole (an antifungal medicine)
• haloperidol or risperidone (medicines used to treat mental illnesses)
• metoprolol (a beta-blocker used to treat high blood pressure and heart disease).

Venlafaxine Teva with food, drink, and alcohol

Venlafaxine Teva should be taken with food (see section 3 "How to take Venlafaxine Teva").
Do not drink alcohol while taking Venlafaxine Teva. Taking Venlafaxine Teva with alcohol may cause extreme drowsiness and loss of consciousness, and may worsen 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 or pharmacist for advice before taking this medicine. Venlafaxine Teva should only be used after consulting your doctor about the potential benefits and risks to the unborn child.
Tell your doctor and/or midwife that you are taking Venlafaxine Teva. Taking similar medicines (SSRIs) during pregnancy may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN), which is characterized by rapid breathing and bluish discoloration. These symptoms usually occur within the first day of life. If such symptoms occur in the newborn, contact the midwife and/or doctor immediately.
Taking Venlafaxine Teva late in pregnancy may increase the risk of severe bleeding from the vagina, which can occur shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Venlafaxine Teva, tell your doctor or midwife so that they can give you appropriate advice.
If you are taking this medicine during pregnancy, after the baby is born, in addition to breathing difficulties, the baby may experience other symptoms, such as difficulty sucking. If you are concerned about such symptoms in your newborn, contact your doctor and/or midwife, who will be able to give you appropriate advice.
Venlafaxine Teva passes into breast milk. There is a risk of affecting the baby. Therefore, 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 machinery until you know how this medicine affects you.

Venlafaxine Teva contains sucrose

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

3. How to take Venlafaxine Teva

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Typically, the recommended initial dose for depression, generalized anxiety disorder, and 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 for depression. For panic disorder, treatment should be started with a lower dose (37.5 mg) and then gradually increased. The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg per day.
Venlafaxine Teva should be taken orally.
Venlafaxine Teva should be taken once a day, at approximately the same time, regardless of whether the medicine is taken in the morning or evening. To ensure that the pellets (beads inside the capsules) are swallowed completely, the capsules should be swallowed whole, with a drink of water, and not opened, crushed, chewed, or dissolved.
Venlafaxine Teva should be taken with food.
If you have liver or kidney problems, tell your doctor, as you may need to have your dose adjusted.
Do not stop taking this medicine without consulting your doctor (see "Stopping Venlafaxine Teva").

Taking more Venlafaxine Teva than prescribed

If you have taken more than the prescribed dose of Venlafaxine Teva, contact your doctor or pharmacist immediately.
Overdose can be life-threatening, especially if taken with alcohol and/or certain other medicines (see "Venlafaxine Teva with other medicines").

Symptoms of possible overdose may include rapid heartbeat, changes in consciousness (from drowsiness to coma), changes in vision, seizures, and vomiting.

Missing a dose of Venlafaxine Teva

If you forget to take 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 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 dose of Venlafaxine Teva in a 24-hour period.

Stopping Venlafaxine Teva

Do not stop taking this medicine or reduce the dose without consulting your doctor, even if you feel better. If your doctor decides that you can stop taking Venlafaxine Teva, they will tell you how to gradually reduce the dose before stopping treatment completely. When stopping treatment with this medicine, especially when stopping abruptly or reducing the dose too quickly, side effects may occur. Some patients may experience symptoms such as suicidal thoughts, aggressive behavior, fatigue, dizziness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, disorientation, ringing in the ears, tingling or numbness, weakness, sweating, seizures, or flu-like symptoms. Your doctor will advise you on how to gradually stop taking Venlafaxine Teva. This may take several weeks or months. In some patients, it may be necessary to stop the medicine very gradually over a period of months or longer. If you experience any of these symptoms or other symptoms that are bothersome to you, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking Venlafaxine Teva and contact your doctor or go to the emergency department 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 skin rash, itching, or hives (red or pale rash, which may be itchy)
• symptoms of serotonin syndrome, such as: restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, overreactivity, diarrhea, coma, nausea, vomiting. The most severe form of serotonin syndrome can resemble neuroleptic malignant syndrome. Its symptoms include: fever, rapid heartbeat, sweating, muscle stiffness, disorientation, elevated levels of muscle enzymes (detected in a blood test).
• infection symptoms, such as high fever, chills, shivering, headache, sweating, and flu-like symptoms. This may be due to a blood disorder that increases the risk of infection.
• severe skin rash, which 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 (or "broken heart syndrome"), including: chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.

Tell your doctorif you experience any other side effects, such as (the frequency of these side effects is listed below in the "Other side effects" section):

• cough, wheezing, shortness of breath, which may be accompanied by high fever
• black (tarry) stools or blood in the stool
• yellowing of the skin or eyes, or dark urine, which may be signs of liver inflammation
• heart rhythm disorders, such as rapid or irregular heartbeat, high blood pressure
• eye disorders, such as blurred vision, dilated pupils
• nervous system disorders, such as dizziness, tingling, 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 Venlafaxine Teva" and "Stopping Venlafaxine Teva")
• Prolonged bleeding time - in case of injury, the wound may bleed slightly longer than usual.

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
• feeling confused, feeling detached (or separated) from oneself, lack of orgasm, decreased libido, agitation, nervousness, unusual dreams
• tremors, feeling restless or unable to sit or stand still, tingling, taste disturbances, increased muscle tone
• vision disturbances, 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
• increased blood pressure, hot flashes
• shortness of breath, yawning
• vomiting, diarrhea
• mild rash, itching
• increased frequency of urination, urinary retention, difficulty urinating
• menstrual disturbances, such as heavy bleeding or more frequent irregular bleeding; ejaculation or orgasm disturbances (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 activity, racing thoughts, and reduced need for sleep (mania)
• hallucinations, feeling detached (or separated) from reality, orgasm disturbances, lack of feelings or emotions, feeling overly excited, 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 the stool, which may be a sign of internal bleeding
• photosensitivity, bruising, excessive hair loss
• involuntary urination
• stiffness, muscle spasms, and involuntary movements
• slight changes in liver enzyme activity in the blood

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

• seizures
• cough, wheezing, shortness of breath, which may be accompanied by high fever
• excessive water intake (known as SIADH)
• low sodium levels in the blood
• severe eye pain and vision disturbances or blurred vision
• severe abdominal or back pain (which may indicate severe bowel, liver, or pancreas disorders)
• itching, yellowing of the skin or eyes, or dark urine, which may be signs of liver inflammation
• disorientation and confusion, often with hallucinations (delirium)
• abnormal, rapid, or irregular heartbeat, which may lead to fainting

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 the urine or vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins)

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

• Suicidal thoughts and behaviors: during treatment with venlafaxine or soon after stopping treatment, there have been reports of suicidal thoughts and behaviors (see section 2 "Important information before taking Venlafaxine Teva").
• Aggressive behavior
• Vertigo of labyrinthine origin
• Severe postpartum hemorrhage (postpartum hemorrhage), see additional information in the "Pregnancy and breastfeeding" section in section 2.

Venlafaxine Teva may sometimes cause side effects that you are not aware of, such as increased blood pressure or abnormal heart rhythm; slight changes in sodium, cholesterol, or liver enzyme levels in the blood. More rarely, Venlafaxine Teva may affect platelet function, leading to an increased risk of bruising or bleeding. Therefore, your doctor may recommend a blood test from time to time, especially during long-term treatment with Venlafaxine Teva.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring, 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Venlafaxine Teva

Keep this medicine out of the sight and reach of children.
Do not use Venlafaxine Teva after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Store in a temperature below 30°C.
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 Venlafaxine Teva contains

The active substance is venlafaxine.
Venlafaxine Teva 37.5 mg:
Each prolonged-release hard capsule contains venlafaxine hydrochloride, equivalent to 37.5 mg of venlafaxine.
Venlafaxine Teva 75 mg:
Each prolonged-release hard capsule contains venlafaxine hydrochloride, equivalent to 75 mg of venlafaxine.
Venlafaxine Teva 150 mg:
Each prolonged-release hard capsule contains venlafaxine hydrochloride, equivalent to 150 mg of venlafaxine.
Other ingredients are:
Capsule contents: sucrose, pellets (sucrose + corn starch), hypromellose, type 2910, ethylcellulose, type B, talc.
Capsule shell:
Venlafaxine Teva 37.5 mg:
Iron oxide black (E 172), titanium dioxide (E 171), gelatin, iron oxide red (E 172)
Venlafaxine Teva 75 mg:
Iron oxide red (E 172), titanium dioxide (E 171), gelatin
Venlafaxine Teva 150 mg:
Iron oxide yellow (E 172), titanium dioxide (E 171), gelatin, iron oxide red (E 172)
Ink: shellac, propylene glycol, concentrated ammonia solution, iron oxide black (E172), potassium hydroxide

What Venlafaxine Teva looks like and contents of the pack

Venlafaxine Teva 37.5 mg:
Hard capsules with a non-transparent gray cap and non-transparent pink body, filled with white to beige microgranules. The capsules are marked with black ink on the cap with "VNL" and on the body with "37.5". Dimensions: approximately 16 mm x 6 mm
Venlafaxine Teva 75 mg:
Hard capsules with a non-transparent pink cap and non-transparent pink body, filled with white to beige microgranules. The capsules are marked with black ink on the cap with "VNL" and on the body with "75". Dimensions: approximately 20 mm x 7 mm.
Venlafaxine Teva 150 mg:
Hard capsules with a non-transparent brown cap and non-transparent brown body, filled with white to beige microgranules. The capsules are marked with black ink on the cap with "VNL" and on the body with "150". Dimensions: approximately 24 mm x 8 mm.
Blisters containing: 10, 14, 20, 28, 30, 50, 98, and 100 prolonged-release hard capsules, or single-dose blisters containing 100x1 prolonged-release hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

Manufacturer

Teva Pharma S.L.U.
C/C, n. 4, Poligono Industrial Malpica
50016 Zaragoza,
Spain
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80,
31-546 Kraków

For more information about this medicine, contact the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warszawa, tel. (22) 345 93 00.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria:
Venlafaxin Actavis
Bulgaria:
Лароксин XR
Croatia: Velafax XL
Denmark:
Venlafaxin Teva
Laroxin XR
Finland:
Venlafaxin ratiopharm
France:
VENLAFAXINE TEVA LP
Netherlands:
Venlafaxine retard Teva
Iceland:
Venlafaxin Teva
Luxembourg: Venlafaxin-ratiopharm
Germany:
Venlafaxin-ratiopharm
Norway: Venlafaxin Teva
Poland:
Venlafaxine Teva
Portugal: Venlafaxina ratiopharm
Sweden:
Venlafaxin Teva
Italy:
Venlafaxina Teva

Date of last revision of the leaflet: June 2024