Leaflet: information for the user

Venlafaxine Sun 75 mg prolonged-release tablets

Venlafaxine Sun 150 mg prolonged-release tablets

Read this 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given 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.

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

2. What you need to know before starting to take Venlafaxine Sun

3. How to take Venlafaxine Sun

4. Possible side effects

5. Storage of Venlafaxine Sun

6. Contents of the pack and additional information

Venlafaxina is an antidepressant that belongs to a group of medications called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medications is used to treat depression and other conditions such as anxiety disorders. It is believed that people who are depressed and/or experience anxiety have lower levels of serotonin and norepinephrine in the brain. The exact mechanism of how antidepressants work is not fully understood, but they may help increase levels of serotonin and norepinephrine in the brain.

Venlafaxina is a treatment for adults with depression. Venlafaxina is also a treatment for adults with the following anxiety disorders: generalized anxiety disorder, social anxiety disorder (fear or avoidance of social situations), panic disorder (panic attacks). Treating depressive and anxiety disorders properly is important to help you feel better. If left untreated, your disorder may not go away or may worsen and become more difficult to treat.

Do not take Venlafaxina Sun

• if you are allergic to venlafaxine or any of the other ingredients in this medicine (listed in section 6).
• if you are also taking or have taken in the last 14 days, any medicine known as an irreversible monoamine oxidase inhibitor (IMAO) used to treat depression or Parkinson's disease. Taking an IMAO irreversible with Venlafaxina Sun may cause serious or potentially life-threatening side effects. Also, you should wait at least 7 days after stopping Venlafaxina Sun before taking any IMAO (see also the section "Taking Venlafaxina Sun with other medicines" and the information in that section on "Serotonin Syndrome").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Venlafaxina Sun

• if you are taking other medicines that, taken with Venlafaxina Sun, may increase the risk of developing serotonin syndrome (see section "Taking Venlafaxina Sun with other medicines")
• 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 told that your heart rhythm is abnormal
• 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 (a 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")
• if you have a history of mania (feeling overexcited or euphoric) or bipolar disorder
• if you have a history of aggressive behavior

Venlafaxina Sun may cause restlessness or difficulty sitting or staying still during the first few weeks of treatment. You should consult your doctor if this happens.

Do not drink alcohol during treatment with Venlafaxina Sun, as it may cause extreme drowsiness and unconsciousness. Taking Venlafaxina Sun 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 sometimes have thoughts of harming yourself or committing suicide. These thoughts may increase when you start taking antidepressants, as all 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 Venlafaxina Sun.

You may be more likely to have these thoughts:

• if you have had thoughts of suicide or self-harm before
• if you are ayoung adult. Clinical trial information 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 hospital directly.

You may find it helpful to tell a close relative or friend who is depressed or has an anxiety disorder, and ask them to read this leaflet. You may also ask them to tell 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 Venlafaxina Sun. Therefore, your doses of diabetes medicines may need to be adjusted.

Sexual problems

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

Use in children and adolescents under 18 years of age

Venlafaxina Sun should not normally be used in the treatment of children and adolescents under 18 years of age.Long-term safety effects on growth, maturation, and behavioral development of venlafaxine in this age group have not been demonstrated. In addition, patients under 18 years of age have a higher risk of adverse effects such as suicidal behavior, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this class of medicines. However, your doctor may prescribe this medicine to patients under 18 years of age when they decide it is in the best interest of the patient. If your doctor has prescribed this medicine to a patient under 18 years of age, and you wish to discuss this decision, please talk to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen in these patients under 18 years of age while they are taking venlafaxine. In addition, the long-term safety effects and those related to growth, maturation, and cognitive and behavioral development of this medicine have not been demonstrated.

Use of Venlafaxina Sun with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

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

Do not start or stop taking any medicine, including those available over the counter, natural remedies, and herbal products, without checking with your doctor or pharmacist.

• Irreversible monoamine oxidase inhibitors used to treat depression or Parkinson's disease should not be taken with Venlafaxina Sun. Tell your doctor if you have taken any of these medicines in the last 14 days. (IMAO: see section "What you need to know before taking Venlafaxina Sun").
• Serotonin syndrome: A potentially life-threatening state, 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 migraines)
• other medicines for treating depression, for example, SSRIs, SNRIs, tricyclic antidepressants, or medicines containing lithium
• medicines containing amphetamines (used for attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity)
• medicines containing the antibiotic linezolid (used for infections)
• medicines containing moclobemide, an irreversible MAO-A inhibitor (used for depression)
• medicines containing sibutramine (used for weight loss)
• medicines containing tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used for severe pain)
• medicines containing dextromethorphan (used for cough)
• products containing methadone (used for opioid addiction or for severe pain)
• medicines containing methylene blue (used for high levels of methaemoglobin in the blood)
• products containing St. John's Wort (also known as "Hypericum perforatum", a natural remedy or herbal product used for mild depression)
• products containing tryptophan (used for problems such as sleep and depression)
• antipsychotics (used for conditions with symptoms such as hearing, seeing, or feeling things that do not exist, false beliefs, unusual suspicion, unclear thinking, 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, 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 nearest hospital emergency department if you think you are experiencing serotonin syndrome.

Inform 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 rhythm)
• 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 interact with Venlafaxina Sun 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 (for treating psychiatric conditions)
• metoprolol (a beta-blocker for treating high blood pressure and heart problems)

Taking Venlafaxina Sun with food, drinks, and alcohol

Venlafaxina SUN should be taken with food (see section 3 "How to take Venlafaxina Sun").

Do not drink alcohol during treatment with Venlafaxina Sun. Taking Venlafaxina Sun 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.

Pregnancy

Inform your doctor if you become pregnant or are trying to become pregnant. You should only use Venlafaxina Sun 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 Venlafaxina Sun. When taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and turn 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 midwife and/or doctor immediately.

If you are taking this medicine during pregnancy, other symptoms that your baby may have when born are feeding problems and breathing difficulties. If your baby has these symptoms when born and you are concerned, contact your doctor and/or midwife for advice.

If you take Venlafaxina Sun 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 that you are taking Venlafaxina Sun so they can advise you.

Breastfeeding

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 whether you should stop breastfeeding or stop taking this medicine.

Driving and using machines

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

Venlafaxina Sun contains lactose

This medicine contains lactose. If your doctor has told you that you are intolerant to certain sugars, consult them before taking this medicine.

Venlafaxina Sun contains sodium

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.

Dose

The usual initial recommended dose for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose and if necessary, even more up to a maximum of 375 mg per day for depression. If you are being treated for panic disorder, your doctor will start with a lower dose (37.5 mg) and then gradually increase the dose. The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg/day.

Administration Form

Take this medication approximately at the same time every day, either in the morning or at night. The tablets must be swallowed whole with liquids and not crushed, chewed, or dissolved.

Venlafaxine should be taken with food.

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 Sun”).

If you take more Venlafaxina than you should

Call your doctor or pharmacist immediately if you take more of this medication than prescribed by your doctor. Overdose can put your life in danger, especially with the simultaneous use of certain medications and/or alcohol (see “Taking Venlafaxina Sun with other medications”). You can also contact the toxicology information service, phone 91 562 04 20 indicating the medication and the amount taken.

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 forgot to take Venlafaxina

Do not take a double dose to compensate for the missed doses. 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 more than the daily dose of venlafaxine prescribed in a day.

If you interrupt treatment with Venlafaxina

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 gradually reduce the dose before stopping treatment completely. It is known that adverse effects occur when people stop taking venlafaxine suddenly or if the dose is reduced very quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, instability, headaches, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, tinnitus, tingling, or in rare cases, sensations of electric discharge, weakness, sweating, seizures, or symptoms similar to the flu, vision problems, and increased blood pressure (which can cause headaches, dizziness, 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, the interruption may need to be produced very gradually over months or more. If you experience any of these or other symptoms that bother you, consult your doctor for advice.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

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

Rare: may affect up to 1 in 1,000 people

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

Uncommon: may affect up to 1 in 100 people

• chest tightness, wheezing, difficulty swallowing or breathing.
• severe skin rash, itching, or urticaria (raised, red, or pale areas of skin that often itch).
• signs and symptoms of serotonin syndrome, which 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 may 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, headaches, sweating, 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 skin peeling.
• unexplained muscle pain, sensitivity, or weakness. This may be a sign of rhabdomyolysis.

Frequency unknown: cannot be estimated from available data

-signs and symptoms of a condition called "stress cardiomyopathy" that may

include chest pain, difficulty breathing, dizziness, fainting, irregular heartbeats.

Other side effectsthatyou should inform your doctorare (the frequency of these side effects are included in "Other side effects" below):

• cough, wheezing, shortness of breath that may be accompanied by a fever.

• black, tarry stools or blood in stools.
• yellowing of the eyes or skin, itching, dark urine, which are symptoms of liver inflammation (hepatitis).

• heart problems, such as rapid or irregular heart rate, high blood pressure.
• eye problems, such as blurred vision, dilated pupils.
• nervous system problems, such as dizziness, numbness, movement disorder, convulsions, or seizures.
• psychiatric problems, such as hyperactivity and unusual feelings of overexcitement.
• withdrawal effects (see the section "How to take Venlafaxina Sun, if you interrupt treatment with Venlafaxina Sun").
• prolonged bleeding – if you cut or injure yourself, it may take a little longer than usual for the bleeding to stop.

The coating of the tablet does not dissolve completely and is excreted in the stool.Do not worry if you see small fragments in your stool after taking this medicine. Although you see fragments in the stool, the dose of the medicine has been absorbed.

Other side effects

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

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

Common: (may affect up to 1 in 10 people)

• decreased appetite
• 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 sense of taste, increased muscle tone
• visual disturbances, including blurred vision, dilated pupils, inability of the eye to automatically change focus from distant to near objects
• tinnitus (ringing in the ears)
• rapid heart rate, palpitations
• increased blood pressure, hot flushes,
• difficulty breathing, yawning.
• vomiting,diarrhea
• mild skin rash, itching
• increased frequency of urination, inability to urinate, difficulties with urination
• irregular menstrual periods, such as increased bleeding or irregular bleeding, abnormal ejaculation/orgasm (males), erectile dysfunction (impotence)
• weakness (asthenia), fatigue, chills.
• weight gain or loss
• increased cholesterol.

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

• hyperactivity, rapid thoughts, and decreased need for sleep (mania)
• hallucinations, feeling disconnected (or detached) from reality, abnormal orgasm, 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, tarry stools or blood in stools, which may be a sign of internal bleeding
• sensitivity to sunlight, bruises, skin rash, abnormal hair loss
• inability to control urination
• rigidity, spasms, and involuntary muscle movements
• slight changes in liver enzyme levels.

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

• convulsions or seizures
• cough, wheezing, and shortness of breath that may be accompanied by a fever
• 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
• abnormal heart rhythm, rapid or irregular heart rate, which may lead to fainting
• severe abdominal or back pain (which may indicate a serious problem in the intestine, liver, or pancreas)
• itching, yellowing of the 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 people)

• prolonged bleeding, which may be due to a reduced number of platelets in the blood, leading to an increased risk of bleeding or bruising
• abnormal milk production
• unexpected bleeding, such as bleeding gums, blood in urine or vomit, or unexpected bruising or bleeding (hemorrhages).

Frequency unknown: 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 Sun")
• aggression
• dizziness.
• excessive bleeding after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

Venlafaxina sometimes causes unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heart rhythm; slight changes in blood levels or liver enzymes, sodium, or cholesterol. Less frequently, Venlafaxina Sun may reduce blood function or platelets, leading to an increased risk of bleeding or bruising. Therefore, your doctor may wish to perform occasional blood tests, particularly if you have been taking Venlafaxina Sun for a long time.

Reporting side effects

If you experience any type of side effect, consult your pharmacist or nurse, 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 on the safety 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. The expiration date is the last day of the month indicated.

Blister: Store in the original packagingto protect it from moisture.

Tablet packaging: Keep the packaging perfectly closed to protect it from moisture.

Medications should not be disposed of through drains or trash. Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Venlafaxina Sun

The active ingredient is venlafaxine.

Each prolonged-release tablet contains 75 mg or 150 mg of venlafaxine (as venlafaxine hydrochloride).

The other components are:

For 75 mg:

Tablet core

Prolonged-release coating:

Hydroxypropylmethylcellulose,

Povidone (K-30),

Lactose monohydrate,

Ethyl acrylate-methacrylic acid copolymer (1:1),

Talc,

Magnesium stearate (E572)

Peelable layer:

Microcrystalline cellulose silicified,

Crospovidone Type A,

Anhydrous colloidal silica,

Sodium lauryl sulfate,

Red aluminum lake (E129),

Talc,

Magnesium stearate (E572)

Coating

Water dispersion of ethylcellulose,

Manitol,

Povidone (K-30),

Dibutyl sebacate,

Triethyl citrate,

Polysorbate 20,

Opadry II 85F 19250 transparent compound of:

Talc,

Macrogol 3350,

Polysorbate 80,

Polvinyl alcohol.

Printing ink (opacode-s-1-17823 black)

Shellac,

Iron oxide black (E172),

Propylene glycol.

For 150 mg:

Tablet core

Prolonged-release coating:

Hydroxypropylmethylcellulose,

Povidone (K-30),

Lactose monohydrate,

Ethyl acrylate-methacrylic acid copolymer (1:1), Talc,

Magnesium stearate (E572)

Peelable layer:

Microcrystalline cellulose silicified,

Crospovidone Type A,

Anhydrous colloidal silica,

Sodium lauryl sulfate,

Red aluminum lake (E129),

Talc,

Magnesium stearate (E572)

Coating

Water dispersion of ethylcellulose,

Manitol,

Povidone (K-30), Dibutyl sebacate,

Triethyl citrate, Polysorbate 20,

Talc

Opadry II 85F 19250 transparent compound of:

Talc,

Macrogol 3350,

Polysorbate 80,

Polvinyl alcohol.

Printing ink (opacode-s-1-17823 black)

Shellac,

Iron oxide black (E172),

Propylene glycol.

Appearance of the product and contents of the package

Venlafaxina Sun 75 mg:

This medicine is presented as prolonged-release tablets with two layers of coating, round, biconvex, with a diameter of 8.4 mm, pink and white, with a "759" printed in black ink on one face and flat on the other.

Venlafaxina Sun 150 mg:

This medicine is presented as prolonged-release tablets with two layers of coating, oval, biconvex, with dimensions of 16.35 mm x 7.85 mm, pink and white, with a "758" printed in black ink on one face and flat on the other.

Blister: package sizes 14, 15, 20, 28, 30, 50 or 100 prolonged-release tablets

Tablet package: package sizes: 30 and 1000 (clinical package) prolonged-release tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Local representative:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona

Spain

Tel: +34 93 342 78 90

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

Spain:Venlafaxina Sun 75 mg / 150 mg prolonged-release tablet

Netherlands:Venlafaxine Sun 37.5 mg / 75 mg / 150 mg, tablet met verlengde afgifte

United Kingdom:Sunveniz XL 37.5 mg / 75 mg / 150 mg, prolonged-release tablets

Last review date of this leaflet:January 2024

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