Venlafaxine Sandoz 50 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Venlafaxine Sandoz 37.5 mg tablets EFG

Venlafaxine Sandoz 50 mg tablets EFG

Venlafaxine Sandoz 75 mg tablets EFG

venlafaxine

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents

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

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

Venlafaxine Sandoz contains the active substance venlafaxine.

Venlafaxine 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. It is believed that people who are depressed and/or suffer from anxiety have lower levels of serotonin and noradrenaline in the brain.

Venlafaxine is a treatment for depression in adults. Properly treating depressive disorders is important to help you feel better. If left untreated, your depressive condition may not resolve or may worsen and become more difficult to treat.

2. What you need to know before taking Venlafaxine Sandoz

Do not take Venlafaxine Sandoz

• if you are allergic to venlafaxine or to any of the other ingredients of this medicine (listed in section 6),
• if you are taking or have taken irreversible monoamine oxidase inhibitors (MAOIs) within the last 14 days, used to treat depression or Parkinson’s disease. Taking MAOIs together with venlafaxine may cause serious adverse effects, even potentially fatal reactions. In addition, at least 7 days must elapse after stopping venlafaxine before starting any MAOI (see also section “Other medicines and Venlafaxine Sandoz” and the information in this section on “Serotonin syndrome”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take venlafaxine.

• if you are taking other medicines together with venlafaxine, as this may increase the risk of developing serotonin syndrome (see section “Other medicines and Venlafaxine Sandoz”),
• 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 a history of heart problems,
• if you have been diagnosed with abnormal heart rhythms (arrhythmias),
• if you have a history of seizures (fits),
• if you have a history of low sodium levels in the blood (hyponatraemia),
• if you tend to bruise easily or have a tendency to bleed (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding, e.g., warfarin (used to prevent blood clots), or if you are pregnant (see “Pregnancy and breastfeeding”),
• if you have a personal or family history of mania or bipolar disorder (feeling overly excited or euphoric),
• if you have a history of aggressive behaviour.

Venlafaxine may cause a feeling of restlessness or an inability to sit or stand still during the first weeks of treatment. You should consult your doctor if this occurs.

Some medicines in the same class as Venlafaxine Sandoz (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Do not drink alcohol during treatment with Venlafaxine Sandoz, as it may cause extreme drowsiness and unconsciousness. Taking it together with certain medicines and/or alcohol may worsen symptoms of depression and other conditions such as anxiety disorders.

Suicidal thoughts and worsening of depression or anxiety disorder:

If you are depressed and/or suffer from anxiety disorders, you may occasionally have thought about self-harm or suicide. These thoughts may increase when you first start taking antidepressants, as these medicines take time to work—usually about two weeks, but sometimes longer. These thoughts may also occur when your dose is reduced or during discontinuation of venlafaxine treatment.

You may be more likely to have such thoughts:

• if you have previously had suicidal thoughts or thoughts of self-harm,
• if you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults (under 25 years of age) with psychiatric conditions treated with antidepressants.

If you have thoughts of self-harm or suicide at any time, contact your doctor or go to a hospital immediately.

It may be helpful to tell a close family member or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may want to ask them whether they notice your depression or anxiety getting worse, or if they are concerned about changes in your behaviour.

Dry mouth

Dry mouth has been reported in 10% of patients treated with venlafaxine. This may increase the risk of tooth decay (caries). Therefore, you should take care with your oral hygiene.

Diabetes

Your blood glucose levels may be altered by venlafaxine. Therefore, you may need an adjustment in the dose of your diabetes medication.

Children and adolescents

Venlafaxine must not be used in children and adolescents under 18 years of age. In addition, you should know that patients under 18 years of age have an increased risk of adverse effects such as suicide attempts and suicidal thoughts, and there have been more reports of hostility (mainly aggression, oppositional behaviour, and anger) when taking this group of medicines.

Despite this, your doctor may prescribe this medicine to patients under 18 years of age if they consider it to be in the patient’s best interest. If your doctor has prescribed this medicine to a patient under 18 years of age and you wish to discuss this decision, please speak to your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen while these patients under 18 years of age are taking this medicine.

Furthermore, the long-term effects on growth, puberty, and development in this age group have not been established.

Other medicines and Venlafaxine Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Your doctor must decide whether you can take venlafaxine with other medicines.

Do not start or stop taking any other medicine, including those available without a prescription, natural remedies, or herbal products, without first consulting your doctor or pharmacist.

• Monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson’s disease must not be taken with venlafaxine. Inform your doctor if you have taken these medicines within the last 14 days (MAOIs: see section “What you need to know before taking Venlafaxine Sandoz”).
• Serotonin syndrome:

A potentially life-threatening condition, or reactions similar to Neuroleptic Malignant Syndrome (NMS) (see section “Possible side effects”), may occur during treatment with venlafaxine, particularly when taken with other medicines.

Examples of such medicines include:

• triptans (used for migraine),
• other medicines for treating depression, for example, SNRIs, SSRIs, tricyclic antidepressants, or medicines containing lithium,
• medicines containing amphetamines (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, meperidine, 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 elevated methaemoglobin levels in blood),
• products containing St. John’s wort (also known as “Hypericum perforatum”, a natural or herbal remedy used to treat mild depression),
• products containing tryptophan (used for problems such as sleep and depression),
• antipsychotics (used to treat illnesses with symptoms such as hearing, seeing, or feeling things that are not there, false beliefs, unusual suspicion, unclear thinking, and tendency to withdraw).

Signs and symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhoea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome may resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (detected by a blood test).

Contact your doctor immediately or go to the nearest hospital emergency department if you think you are experiencing serotonin syndrome.

You should inform your doctor if you are taking medicines that may affect your heart rhythm.

Examples of such medicines include:

• antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat abnormal heart rhythms),
• antipsychotics 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 and should be used with caution. It is especially important to tell your doctor or pharmacist if you are taking medicines containing:

• ketoconazole (an antifungal medicine),
• haloperidol or risperidone (used to treat psychiatric conditions),
• metoprolol (a beta-blocker used to treat high blood pressure and heart problems).

Taking Venlafaxine Sandoz with food, drinks, and alcohol

Venlafaxine should be taken with food (see section 3 “How to take Venlafaxine Sandoz”).

Do not drink alcohol during treatment with Venlafaxine Sandoz. Taking it with alcohol may cause extreme drowsiness and unconsciousness, and may 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You should only take venlafaxine after discussing the possible benefits and risks to the unborn child with your doctor.

Make sure your midwife and/or doctor know that you are taking venlafaxine. When similar medicines (SSRIs) are taken during pregnancy, there may be an increased risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your doctor and/or midwife immediately.

If you take this medicine during pregnancy, in addition to breathing problems, your baby may also have feeding difficulties at birth. If your baby shows these symptoms at birth and you are concerned, contact your doctor and/or midwife, who can advise you.

If you take venlafaxine in the late stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking venlafaxine so they can advise you appropriately.

Venlafaxine passes into breast milk. There is a risk of effects on the baby. Therefore, you should discuss this with your doctor, who will decide whether to stop breastfeeding or stop treatment with this medicine.

Driving and using machines

Do not drive or operate tools or machinery until you know how this medicine affects you.

Venlafaxine Sandoz contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially “sodium-free”.

3. How to take Venlafaxine Sandoz

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual recommended starting dose is 75 mg per day in divided doses, taken two or three times daily. Your doctor may gradually increase the dose if necessary, up to a maximum dose of 375 mg per day for the treatment of depression.

Take venlafaxine at approximately the same time each day, in the morning and in the evening.

Venlafaxine should be taken with food.

Venlafaxine Sandoz 50 mg and 75 mg:

The tablet may be divided into equal doses.

If you have liver or kidney problems, speak with your doctor, as your dose of this medicine may need to be different.

Do not stop taking this medicine without consulting your doctor (see section “If you stop taking Venlafaxine Sandoz”).

If you take more Venlafaxine Sandoz than you should

Contact your doctor or pharmacist immediately if you take more medicine than prescribed by your doctor.

Overdose can be life-threatening, especially when taken simultaneously with certain medicines and/or alcohol (see section “Other medicines and Venlafaxine Sandoz”).

Symptoms of possible overdose may include palpitations, changes in level of consciousness (ranging from drowsiness to coma), blurred vision, seizures or fits, and vomiting.

If you have taken more venlafaxine than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately. Telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Venlafaxine Sandoz

If you have missed a dose, take it as soon as you remember. 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 forgotten doses. Do not take more than the daily amount of venlafaxine prescribed for you in one day.

If you stop taking Venlafaxine Sandoz

Do not stop or reduce your treatment without consulting your doctor, even if you feel better. If your doctor considers that you no longer need venlafaxine, he or she may instruct you to gradually reduce the dose before stopping treatment completely. Adverse effects are known to occur when people stop using this medicine, particularly when it is stopped suddenly or when the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, lack of coordination, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, tinnitus, tingling or electric shock-like sensations (rarely), weakness, sweating, seizures, flu-like symptoms, vision problems, or increased blood pressure (which may cause headache, fatigue, tinnitus, sweating, etc.).

Your doctor will advise you on how to gradually discontinue treatment with venlafaxine. This may take several weeks or months. In some patients, discontinuation may need to be very gradual over several months or even longer. If you experience any of these or other bothersome symptoms, consult your doctor for further advice.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any of the following reactions, stop taking Venlafaxine Sandoz immediately. Contact your doctor immediately or go to the nearest hospital emergency department:

Uncommon (may affect up to 1 in 100 patients):

• swelling of the face, mouth, tongue, throat, hands or feet and/or itchy rash (urticaria), difficulty swallowing or breathing.

Rare (may affect up to 1 in 1,000 patients):

• chest tightness, wheezing, difficulty swallowing or breathing,
• severe skin rash, severe itching or hives (raised areas of pale or red skin that often itch),
• signs and symptoms of serotonin syndrome, which may include agitation, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, vomiting.
  • In its most severe form, serotonin syndrome may resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, increased muscle enzymes (detected by a blood test),
  • signs of infection, such as high temperature, chills, shivering, headache, sweating, flu-like symptoms. This may result from a blood disorder that can lead to an increased risk of infection,
  • severe skin rash, which may lead to severe blistering and peeling of the skin,
  • unexplained muscle pain, tenderness or weakness. This may be a sign of rhabdomyolysis.

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

• signs and symptoms of a condition called “stress cardiomyopathy” (also known as Takotsubo cardiomyopathy), which may include chest pain, difficulty breathing, dizziness, fainting, and irregular heartbeats.

Other adverse effects about which you should inform your doctor (the frequency of these adverse effects are included in the following list “Other adverse effects that may occur”):

• cough, wheezing, and shortness of breath that may be accompanied by fever,
• tarry stools (faeces) or blood in stools,
• itching, yellowing of the eyes or skin, dark urine, which are symptoms of liver inflammation (hepatitis),
• heart problems, such as rapid or irregular heartbeat, increased blood pressure,
• eye problems, such as blurred vision, dilated pupils,
• nervous system problems, such as dizziness, tingling, movement disorders (muscle spasms or rigidity), seizures or fits,
• psychiatric problems, such as hyperactivity and unusual feelings of over-excitement,
• withdrawal effects (see section “How to take Venlafaxine Sandoz”, “If you stop taking Venlafaxine Sandoz”),
• prolonged bleeding: if you cut yourself or sustain an injury, it may take longer than usual for the bleeding to stop.

Other adverse effects that may occur

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, feeling detached from oneself, inability to achieve orgasm, decreased libido, restlessness,
• nervousness, abnormal dreams,
• tremor, a feeling of restlessness or inability to sit still or remain motionless (akathisia), tingling, altered taste perception, increased muscle tone,
• visual disturbances including blurred vision, dilated pupils, inability of the eye to automatically adjust focus from distant to near objects,
• ringing in the ears (tinnitus),
• rapid heartbeat, palpitations,
• increased blood pressure, hot flushes,
• difficulty breathing, yawning,
• vomiting, diarrhoea,
• mild rash, itching,
• increased frequency of urination, inability to urinate, difficulty urinating,
• menstrual irregularities, such as increased bleeding or increased irregular bleeding,
• abnormal ejaculation/orgasm (in men), erectile dysfunction (impotence),
• weakness (asthenia), fatigue, chills,
• weight gain, weight loss,
• increased cholesterol.

Uncommon (may affect up to 1 in 100 patients):

• hyperactivity, racing thoughts and reduced need for sleep (mania),
• hallucinations, feeling detached from reality, abnormal orgasm (in women), lack of feelings or emotions, feeling over-excited, teeth grinding,
• fainting, involuntary muscle movements, disturbance in coordination and balance,
• feeling dizzy (especially when standing up too quickly), decreased blood pressure,
• vomiting blood, tarry stools (faeces) or blood in stools, which may be a sign of internal bleeding,
• sensitivity to sunlight, bruising, abnormal hair loss,
• inability to control urination,
• muscle rigidity, spasms and involuntary muscle movements,
• slight changes in blood levels of liver enzymes.

Rare (may affect up to 1 in 1,000 patients):

• seizures or fits,
• cough, wheezing, and difficulty breathing that may be accompanied by high temperature,
• disorientation and confusion, often accompanied by hallucinations (delirium),
• excessive water intake (known as SIADH),
• decreased levels of sodium in the blood,
• severe eye pain and reduced or blurred vision,
• rapid, abnormal or irregular heartbeat that may lead to fainting,
• severe abdominal or back pain (which may indicate a serious problem in the intestine, liver or pancreas),
• itching, yellowing of eyes or skin, dark urine, flu-like symptoms, which are symptoms of liver inflammation (hepatitis).

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

• prolonged bleeding, which may be a sign of a reduced number of platelets in your blood, leading to an increased risk of bruising or bleeding,
• abnormal production of breast milk,
• unexpected bleeding, e.g., bleeding from gums, blood in stools or vomit, or appearance of unexpected bruises or broken blood vessels (broken veins).

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

• suicidal thoughts and suicidal behaviour; cases of suicidal thoughts and behaviour have been reported during treatment with venlafaxine or shortly after stopping treatment (see section 2 “What you need to know before you start taking Venlafaxine Sandoz”),
• aggression,
• vertigo,
• heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy” in section 2 for more information.

Venlafaxine may sometimes cause unwanted effects that you may not be aware of, such as increases in blood pressure or abnormal heartbeat; slight changes in blood levels of liver enzymes, sodium or cholesterol. Less frequently, venlafaxine may reduce the function of blood platelets, leading to an increased risk of bruising or bleeding. Therefore, your doctor may require occasional blood tests, particularly if you have been taking venlafaxine for a long time.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Venlafaxine Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container, after EXP/CAD. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Venlafaxine Sandoz 37.5 mg, 50 mg and 75 mg tablets

• The active substance is venlafaxine.

Each tablet contains 37.5 mg of venlafaxine (as hydrochloride).

Each tablet contains 50 mg of venlafaxine (as hydrochloride).

Each tablet contains 75 mg of venlafaxine (as hydrochloride).

• The other components are: microcrystalline cellulose, lactose monohydrate, sodium carboxymethylstarch (potato type A), magnesium stearate, colloidal anhydrous silica, iron oxide brown (E 172).

Appearance of the product and contents of the pack

Venlafaxine Sandoz 37.5 mg tablets:

Oblong, reddish-brown or pale brown tablets with an imprint "3", approximately 10.3 x 4.5 mm in size.

Venlafaxine Sandoz 50 mg tablets:

Oblong, reddish-brown or pale brown, scored tablets with an imprint "5" on each half, approximately 11.5 x 5.0 mm in size.

Venlafaxine Sandoz 75 mg tablets:

Oblong, reddish-brown or pale brown, scored tablets with an imprint "7" on each half, approximately 13.8 x 5.6 mm in size.

The tablets are packed in alu/PVC blisters or in HDPE bottles with a tamper-evident closure, all contained in a cardboard outer, or packaged in HDPE bottles with a tamper-evident closure.

Pack sizes

Blister: 10, 14, 15, 20, 28, 30, 42, 45, 50, 56, 60, 90, 98, 98x1, 100, 100x1, 250 tablets.

Bottle: 28, 30, 42, 50, 56, 60, 90, 98, 100, 250 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova 57,

SI - 1526 Ljubljana

Slovenia

or

Lek S.A.

50 C, Domaniewska Str.

PL - 02-672 Warsaw

Poland

or

ROWA Pharmaceuticals Ltd.

Newtown, Bantry

Co. Cork

Ireland

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

D - 39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Trimlini 2d

SI - 9220 Lendava,

Slovenia

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

Sweden: Venlafaxin Sandoz 37.5 mg tablett

Venlafaxin Sandoz 50 mg tablett

Venlafaxin Sandoz 75 mg tablett

Germany: Venlafaxin HEXAL 37.5 mg Tabletten

Venlafaxin HEXAL 75 mg Tabletten

Date of the most recent revision of this leaflet: February 2024.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/