Leaflet:Information for the Patient

Venlafaxina Sandoz 37.5 mg Tablets EFG

Venlafaxina Sandoz 50 mg Tablets EFG

Venlafaxina Sandoz 75 mg Tablets EFG

venlafaxina

Read this leaflet carefully before you start taking this medicine, becauseitcontainsimportant information foryou.

• 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, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents oftheleaflet

1. What is Venlafaxina Sandoz and what it is used for
2. What you need to know before you start taking Venlafaxina Sandoz
3. How to take Venlafaxina Sandoz
4. Possible side effects
5. Storage of Venlafaxina Sandoz
6. Contents of the pack and additional information

Venlafaxina Sandoz contains the active ingredient 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 anxious have lower levels of serotonin and noradrenaline in the brain.

Venlafaxine is a treatment for adults with depression. Treating depressive disorders properly is important to help you feel better. If not treated, your depressive state may not disappear or may worsen and become more difficult to treat.

Do not take Venlafaxina Sandoz

• if you are allergic to venlafaxine or any of the other ingredients in this medicine (listed in section 6),
• if you take or have taken in the last 14 days irreversible monoamine oxidase inhibitors (IMAOs), used to treat depression or Parkinson's disease. Taking IMAOs with venlafaxine may cause serious and even life-threatening side effects. Also, wait at least 7 days after stopping venlafaxine before taking any IMAO (see also the section “Other medicines and Venlafaxina 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 take other medicines that are taken with venlafaxine, it may increase the risk of developing serotonin syndrome (see section “Other medicines and Venlafaxina 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 bleeding or bruising easily (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding, for example, warfarin (used to prevent blood clots), or if you are pregnant (see “Pregnancy and breastfeeding”),
• if you have a history of mania or bipolar disorder (feeling overexcited or euphoric),
• if you have a history of aggressive behavior.

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

Some medicines in the group to which Venlafaxina Sandoz belongs (called ISRS/IRSN) may cause sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

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

Thoughts of suicide and worsening of depression or anxiety disorder:

If you are depressed and/or have anxiety disorders, you may have thought about harming yourself or committing suicide. These thoughts may increase when you start taking antidepressants, as these medicines take time to work, usually two weeks, but sometimes longer. These thoughts may also occur when your dose is reduced or when you stop taking venlafaxine.

You may be more likely to have these thoughts:

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

If you have thoughts of harming yourself or committing suicide at any time, contact your doctor or go to the emergency room of the nearest hospital immediately.

You may find it 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. They may ask you if they think your depression or anxiety is getting worse, or if they are concerned 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). You should take good care of your oral hygiene.

Diabetes

Your blood glucose levels may be affected by venlafaxine. You may need to adjust the dose of your diabetes medicines.

Children and adolescents

Venlafaxine should not be used in children and adolescents under 18 years old. You should also know that young patients under 18 years old have an increased risk of side effects such as suicidal thoughts and attempts and there was an increase in reports of hostility (mainly aggression, oppositional behavior, and irritability) when they take this group of medicines.

Despite this, the doctor who prescribes your medicine may prescribe this medicine to patients under 18 years old when they decide what is best for the patient. If your doctor has prescribed this medicine to a patient under 18 years old and you want to discuss this decision, talk to your doctor. You should inform your doctor if any of the symptoms listed above appear or worsen in these patients under 18 years old who are taking this medicine.

Also, the long-term safety effects of this medicine on growth, maturation, and development in this age group have not been demonstrated.

Other medicines and Venlafaxina Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

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

Do not start or stop taking another medicine, including those available over the counter, natural remedies, and herbal supplements, before consulting with your doctor or pharmacist.

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

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

Examples of these medicines include:

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, hyperactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome may 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).

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

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

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 moxifloxacine (used to treat bacterial infections),
• antihistamines (used to treat allergies).

The following medicines may interact with venlafaxine and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines that contain:

• 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 Venlafaxina Sandoz with food, drinks, and alcohol

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

Do not drink alcohol during treatment with Venlafaxina Sandoz. Taking it with alcohol may cause extreme drowsiness and unconsciousness, and worsen the symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

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

Make sure your midwife and/or doctor know that you are taking venlafaxine. When you take similar medicines (ISRSs) 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 within 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 respiratory problems, other symptoms that your baby may have when born would be 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, there may be a higher risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know what you are taking venlafaxine so they can advise you.

Venlafaxine passes into breast milk. There is a risk of an effect on the baby. You should discuss this with your doctor, and they will decide if you should stop breastfeeding or stop taking this medicine.

Driving and using machines

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

Venlafaxina Sandoz contains lactose and sodium

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

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The usual recommended initial 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 daily dose of 375 mg for depression treatment.

Take venlafaxine approximately at the same time every day, in the morning and at night.

Venlafaxine should be taken with food.

Venlafaxina Sandoz 50 mg and 75 mg:

The tablet can be split into equal doses.

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

Do not stop taking this medication without consulting your doctor (see section “If you interrupt treatment with Venlafaxina Sandoz”).

If you take more Venlafaxina Sandoz than you should

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

Overdose can be life-threatening, especially with the simultaneous use of certain medications and/or alcohol (see section “Other medications and Venlafaxina Sandoz”).

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

If you have taken more venlafaxine than you should, consult your doctor, pharmacist, or call the Toxicological Information Service immediately. Phone: 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Venlafaxina Sandoz

If you have not taken 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 compensate for the missed doses.Do not take more than the daily dose of venlafaxine prescribed in a day.

If you interrupt treatment with Venlafaxina 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, they may ask you to reduce the dose gradually before stopping treatment completely. It is known that adverse effects occur when people stop using this medication, essentially 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, tinnitus, tingling or occasional sensations of electric discharge, weakness, sweating, seizures, or symptoms similar to the flu, vision problems, increased blood pressure (which can cause headaches, fatigue, ringing in the ears, 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, it may be necessary to discontinue treatment 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 other doubts about the use of this medication, consult your doctor or pharmacist.

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

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

Rare (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.

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

-chest tightness, wheezing, difficulty swallowing or breathing,

-severe skin rash, itching, or urticaria (areas of raised 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 Malignant Neuroleptic Syndrome (MNS). The signs and symptoms of MNS may include a combination of fever, rapid heart rate, sweating, severe muscle rigidity, confusion, increased muscle enzymes (determined by blood test),
• signs of infection, such as high temperature, chills, tremors, headache, sweating, symptoms similar to the flu. This can be a 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 can be a sign of rhabdomyolysis.

Unknown frequency (cannot be estimated from available data)

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

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

• cough, wheezing, and shortness of breath that may be accompanied by high temperature,
• black stools or blood in stools,
• itching, yellow eyes or skin, dark urine, which are symptoms of liver inflammation (hepatitis),
• cardiac problems, such as rapid or irregular heart rate, increased blood pressure,
• eye problems, such as blurred vision, dilated pupils,
• nervous system problems, such as dizziness, numbness, movement disorder (muscle spasms or rigidity), seizures, or convulsions,
• psychiatric problems, such as hyperactivity and unusual feelings of overexcitement,
• withdrawal effects (see section "How to take Venlafaxina Sandoz", "If you stop taking Venlafaxina Sandoz"),
• prolonged bleeding, if you cut or injure yourself, it may take a little longer than usual for the bleeding to stop.

Other side effects that may occur

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

• dizziness, headache, somnolence,
• insomnia,
• nausea, dry mouth, constipation,
• sweating (including night sweats).

Common (may affect up to 1 in 10 patients)

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

Rare (may affect up to 1 in 100 patients)

• hyperactivity, rapid thoughts, and decreased need for sleep (mania),
• hallucinations, feeling disconnected (or detached) from reality, abnormal orgasm (women), lack of feelings or emotions, feeling overexcited, grinding of teeth,
• fainting, involuntary muscle movements, alteration of coordination and balance,
• feeling dizzy (especially when standing up too quickly), decreased blood pressure,
• vomiting blood, black stools or blood in stools, which can be a sign of internal bleeding,
• sensitivity to sunlight, bruises, abnormal hair loss,
• inability to control urination,
• rigidity, spasms, and involuntary muscle movements,
• slight changes in liver enzyme levels in the blood.

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

• seizures or convulsions,
• 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 sodium levels in the blood,
• severe eye pain and reduced or blurred vision,
• rapid, abnormal, or irregular heart rate 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, symptoms similar to the flu, which are symptoms of liver inflammation (hepatitis),

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

• prolonged bleeding, which can be a sign of a reduced number of platelets in the blood, which can 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 (veins).

Unknown frequency (cannot be estimated from available data)

• suicidal thoughts and 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 starting to take Venlafaxina Sandoz"),
• aggression,
• dizziness,
• substantial vaginal bleeding after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

Venlafaxine can sometimes cause unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heart rhythm; slight changes in liver enzyme levels, sodium, or cholesterol in the blood. Less frequently, venlafaxine can reduce the function of platelets in the blood, 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 side effects

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

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

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

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

• The active ingredient is venlafaxine.

Each tablet contains37.5 mgof venlafaxine (as hydrochloride).

Each tablet contains50 mgof venlafaxine (as hydrochloride).

Each tablet contains75 mgof venlafaxine (as hydrochloride).

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

Appearance of the product and contents of the package

Venlafaxina Sandoz 37.5 mg tablets:

Oval-shaped tablets with a brown-red or pale brown color with an imprint of 3, with an approximate size of 10.3 x 4.5 mm.

Venlafaxina Sandoz 50 mg tablets:

Oval-shaped tablets with a brown-red or pale brown color with a score and an imprint of 5 on each half, with an approximate size of 11.5 x 5.0 mm.

Venlafaxina Sandoz 75 mg tablets:

Oval-shaped tablets with a brown-red or pale brown color with a score and an imprint of 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 a HDPE bottle with a child-resistant closure and inserted into a cardboard box, or they are packaged in a 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.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible 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 - 9220Lendava,

Slovenia

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Sweden:Venlafaxin Sandoz 37.5 mg tablets

Venlafaxin Sandoz 50 mg tablets

Venlafaxin Sandoz 75 mg tablets

Germany:Venlafaxin HEXAL 37.5 mg Tablets

Venlafaxin HEXAL 75 mg Tablets

Last review date of this leaflet:February 2024.

Further informationabout this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/