VENLAFAXINE SANDOZ 37.5 mg TABLETS

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

Do not take Venlafaxine Sandoz

• if you are allergic to venlafaxineor any of the other ingredients of this medicine (listed in section 6),
• if you are taking or have taken in the last 14 days irreversible monoamine oxidase inhibitors(MAOIs), used to treat depression or Parkinson's disease. Taking MAOIs with venlafaxine can cause serious side effects, even fatal ones. Also, you should wait at least 7 days after stopping venlafaxine before taking any MAOI (see also section “Other medicines and Venlafaxine Sandoz” and the information in this section on “Serotonin syndrome”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take venlafaxine.

• if you are using other medicines taken together with venlafaxine, it could 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 informed that you have abnormal heart rhythms,
• if you have a history of seizures (convulsions),
• if you have a history of low sodium levels in the blood (hyponatremia),
• if you have a tendency to develop bruises or tend to bleed easily (history of bleeding disorders), or if you are using 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 history of or if someone in your family has had mania or bipolar disorder (feeling overexcited or euphoric),
• if you have a history of aggressive behavior.

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

Some medicines in the group that Venlafaxine Sandoz belongs to (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (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 fatigue 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 your depression or anxiety disorder:

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or suicide. These thoughts may increase when you 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 treatment with venlafaxine.

You maybe more likely to think this way:

• if you have previously had thoughts of suicide or self-harm,
• if you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in young adults (less than 25 years of age) with psychiatric conditions who were treated with antidepressants.

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

You may find it helpful to tell a relative or close friendthat you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

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 be careful with your oral hygiene.

Diabetes

Your blood sugar levels may be altered by venlafaxine. Therefore, you may need to adjust the dose of your diabetes medicines.

Children and adolescents

Venlafaxine should not be used for children and adolescents under 18 years of age. Also, you should know that patients under 18 years of age have an increased risk of side effects such as suicide attempts and suicidal thoughts, and there was an increase in reports of hostility (mainly aggression, oppositional behavior, and anger) when taking this group of medicines.

Despite this, the doctor who treats you may prescribe this medicine to patients under 18 years of age when he decides what is best for the patient. If your doctor has prescribed this medicine to a patient under 18 years of age and you want to discuss this decision, tell your doctor. You should inform your doctor if any of the above symptoms appear or worsen when these patients under 18 years of age are taking this medicine.

Additionally, the long-term safety effects of this medicine on growth, maturation, 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 take any other medicines.

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

Do not start or stop taking any other medicines, including those that can be bought without a prescription, natural remedies, and herbal products, before consulting your doctor or pharmacist.

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

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

Examples of these medicines include:

• triptans (used for migraine),
• other medicines for treating depression, for example, SSRIs, SNRIs, tricyclic antidepressants, or medicines containing lithium,
• medicines containing amphetamines (used for treating 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 addiction to opioid drugs or severe pain),
• medicines containing methylene blue (used to treat high levels of methemoglobin in the blood),
• products containing St. John's Wort (also known as “Hypericum perforatum”, a natural remedy or herbal product used to treat mild depression),
• products containing tryptophan (used for problems such as sleep and depression),
• antipsychotics (used to treat a disease with symptoms such as hearing, seeing, or feeling things that do not exist, mistaken beliefs, unusual suspicion, unclear reasoning, and tendency to withdraw).

The 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, overactive reflexes, diarrhea, coma, nausea, vomiting.

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

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

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

Examples of these 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 moxifloxacino (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 (for treating psychiatric conditions),
• metoprolol (a beta-blocker for treating 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 together with alcohol may cause extreme fatigue and unconsciousness, and 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 have a baby, ask your doctor or pharmacist for advice before taking 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 knows you are taking venlafaxine. When taking similar medicines (SSRIs) during pregnancy, it may increase the risk of a serious condition in babies called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and appear blue. These symptoms usually start during the first 24 hours after the baby is born. If this happens to your baby, you should contact your doctor and/or midwife immediately.

If you take this medicine during pregnancy, in addition to breathing problems, other symptoms your baby may have at birth may include inadequate feeding. If your baby has these symptoms when born and you are concerned, contact your doctor and/or midwife, who can advise you.

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

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

Driving and using machines

Do not drive or use tools or machines until you know how the treatment with this medicine affects you.

Venlafaxine Sandoz contains lactose and sodium

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

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

3. How to take Venlafaxine Sandoz

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The usual recommended starting dose is 75 mg per day in divided doses, two or three times a day. Your doctor may gradually increase the dose if necessary, even 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 evening.

Venlafaxine should be taken with food.

Venlafaxine Sandoz 50 mg and 75 mg:

The tablet can be divided into equal doses.

If you have liver or kidney problems, talk to your doctor, as you may need to take a different dose of this medicine.

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 your doctor has prescribed.

Overdose can put your life in danger, especially when taken together with certain medicines and/or alcohol (see section “Other medicines and Venlafaxine Sandoz”).

The symptoms of a possible overdose may include palpitations, changes in the level of consciousness (ranging from drowsiness to coma), blurred vision, seizures or convulsions, and vomiting.

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

If you forget to take Venlafaxine Sandoz

If you miss a dose, take it as soon as you remember. However, if it is already time for your next dose, skip the missed dose and take only one dose as usual. Do not take a double dose to make up for missed doses. Do not take more than the daily dose of venlafaxine that has been prescribed for you in one day.

If you stop taking Venlafaxine Sandoz

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

Your doctor will advise you on how to gradually stop treatment with venlafaxine. This may take a few weeks or months. In some patients, it may be necessary for the discontinuation of treatment to take place very gradually over a period of months or even longer. If you experience any of these or other symptoms that bother you, consult your doctor for further advice.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If any of the following reactions occur, do not take more Venlafaxina Sandoz. Tell your doctor immediately, or go to the emergency department of the nearest hospital:

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

• swelling of the face, mouth, tongue, throat, hands or feet and/or rash with itching (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, itching or urticaria (elevated areas of red or pale skin that often itch) severe,
• signs and symptoms of serotonin syndrome that may include agitation, hallucinations, loss of coordination, rapid heart rate, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, vomiting.
  • In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). The signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test),
  • signs of infection, such as high temperature, chills, tremors, headache, sweating, flu-like symptoms. This may be the result of a blood disorder that can lead to an increased risk of infection,
  • severe skin rash, which can lead to severe blisters and skin peeling,
  • unexplained muscle pain, discomfort or weakness. This may be a sign of rhabdomyolysis.

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

• Signs and symptoms of a condition called "stress cardiomyopathy" that may include chest pain, difficulty breathing, dizziness, fainting and irregular heartbeats.

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

• cough, wheezing and shortness of breath that may be accompanied by elevated temperature,
• black stools (deposits) or blood in stools,
• itching, yellow 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 disorder (muscle spasms or stiffness), seizures or attacks,
• psychiatric problems, such as hyperactivity and unusual feeling of overexcitement,
• withdrawal effects (see section "How to take Venlafaxina Sandoz", "If you stop treatment with Venlafaxina Sandoz"),
• prolonged bleeding, if you cut yourself or get injured, it may take a little 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 (or disconnected) from oneself, lack of orgasm, decreased libido, agitation,
• nervousness, abnormal dreams,
• tremor, a feeling of restlessness or inability to sit still or stay quiet, tingling, altered taste perception, increased muscle tone,
• visual 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,
• difficulty breathing, yawning,
• vomiting, diarrhea,
• mild rash, itching,
• increased frequency of urination, inability to urinate, difficulty urinating,
• menstrual irregularities, such as increased bleeding or irregular bleeding,
• abnormal ejaculation/orgasm (men), erectile dysfunction (impotence),
• weakness (asthenia), fatigue, chills,
• weight gain, weight loss,
• increased cholesterol.

Uncommon (may affect up to 1 in 100 patients)

• hyperactivity, accelerated thoughts and decreased need for sleep (mania),
• hallucinations, feeling detached (or disconnected) from reality, abnormal orgasm (women), lack of feelings or emotions, feeling overexcited, teeth grinding,
• fainting, involuntary muscle movements, altered coordination and balance,
• feeling dizzy (especially when getting up too quickly), decreased blood pressure,
• vomiting blood, black stools (deposits) or blood in stools, which may be a sign of internal bleeding,
• sensitivity to sunlight, bruising, abnormal hair loss,
• inability to control urination,
• stiffness, spasms and involuntary muscle movements,
• mild changes in blood levels of liver enzymes.

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

• seizures or attacks,
• cough, wheezing, and difficulty breathing that may be accompanied by elevated temperature,
• disorientation and confusion, often accompanied by hallucinations (delirium),
• excessive water intake (known as SIADH),
• decreased sodium levels in the blood,
• severe eye pain and reduced or blurred vision,
• rapid, abnormal or irregular heartbeat that may lead to fainting,
• severe back or abdominal pain (which may indicate a serious problem in the intestine, liver or pancreas),
• itching, yellow 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 the blood, which may lead to an increased risk of bruising or bleeding,
• abnormal milk production,
• unexpected bleeding, e.g., bleeding gums, blood in stools 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 suicidal behavior; cases of suicidal thoughts and behavior have been reported during treatment with venlafaxine or shortly after stopping treatment (see section 2. "What you need to know before taking Venlafaxina Sandoz"),
• aggression,
• vertigo,
• excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

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

Reporting of adverse effects

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

5. Conservation of Venlafaxina Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging, after CAD/EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that you no longer need in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

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

• The active ingredient 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 carboxymethyl starch (type A) potato, magnesium stearate, anhydrous colloidal silica, iron oxide brown (E 172).

Appearance of the product and package contents

Venlafaxina Sandoz 37.5 mg tablets:

Oblong tablets, brown-red or pale brown in color, with a score line and marked with 3, with an approximate size of 10.3 x 4.5 mm.

Venlafaxina Sandoz 50 mg tablets:

Oblong tablets, brown-red or pale brown in color, scored and marked with 5 on each half, with an approximate size of 11.5 x 5.0 mm.

Venlafaxina Sandoz 75 mg tablets:

Oblong tablets, brown-red or pale brown in color, scored and marked with 7 on each half, with an approximate size of 13.8 x 5.6 mm.

The tablets are packaged in Alu/PVC blisters or in an HDPE bottle with a child-resistant closure and inserted in a cardboard box, or packaged in an HDPE bottle with a child-resistant closure.

Package 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.

Not all package 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 Varsovia

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 medicine is authorized in the Member States of the European Economic Area under the following names:

Sweden: Venlafaxin Sandoz 37.5 mg tablet

Venlafaxin Sandoz 50 mg tablet

Venlafaxin Sandoz 75 mg tablet

Germany: Venlafaxin HEXAL 37.5 mg Tabletten

Venlafaxin HEXAL 75 mg Tabletten

Date of the last revision of this prospectus:February 2024.

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