VENLAFAXINE SUN 150 mg PROLONGED-RELEASE TABLETS

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

Do not take Venlafaxine Sun

• if you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
• if you are also taking or have taken within the last 14 days, any medicines known as irreversible monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease. Taking an irreversible MAOI with Venlafaxine Sun can cause serious or potentially life-threatening side effects. Additionally, you must wait at least 7 days after stopping Venlafaxine Sun before taking any MAOI (see also section “Using Venlafaxine 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 Venlafaxine Sun

• if you are using other medicines that, when taken with Venlafaxine Sun, may increase the risk of developing serotonin syndrome (see section “Using Venlafaxine 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 (fits)
• 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”)
• if you have a history of or if someone in your family has had mania (feeling overexcited or euphoric) or bipolar disorder
• if you have a history of aggressive behavior

Venlafaxine Sun may cause a feeling of restlessness or difficulty sitting or standing still during the first few weeks of treatment. You should consult your doctor if this happens to you.

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

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming or killing yourself. These thoughts may increase when you first start taking antidepressants, because all 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 the interruption of treatment with Venlafaxine Sun.

You may be 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 a 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 can also 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 can increase the risk of tooth decay (caries). Therefore, you should be careful with your oral hygiene.

Diabetes

Your blood glucose levels may be altered by Venlafaxine Sun. Therefore, the doses of your diabetes medicines may need to be adjusted.

Sexual problems

Some medicines in the same group as Venlafaxine Sun (called SNRIs) 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

Venlafaxine Sun should not normally be used in the treatment of children and adolescents under 18 years of age. The long-term safety effects on growth, maturation, and behavioral development in this age group have not yet been demonstrated. Additionally, you should know that patients under 18 years of age have a higher risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this class of medicines. Despite this, the doctor may prescribe this medicine to patients under 18 years of age when they decide it is the most suitable for 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 tell your doctor. You should inform your doctor if any of the above symptoms develop or worsen when these patients under 18 years of age are taking venlafaxine. Additionally, the long-term safety effects regarding growth, maturity, and cognitive and behavioral development have not yet been demonstrated.

Using Venlafaxine Sun with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Your doctor must decide if you can take Venlafaxine Sun with other medicines.

Do not start or stop taking any medicines, including those that can be bought without a prescription, herbal remedies, and supplements, before checking with your doctor or pharmacist.

• Irreversible monoamine oxidase inhibitors used to treat depression or Parkinson's disease must not be taken with Venlafaxine Sun. Tell your doctor if you have taken any of these medicines in the last 14 days. (MAOI: see section “What you need to know before you take Venlafaxine Sun”).
• 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:

• triptans (used for migraine)
• other medicines for treating depression, e.g., SNRIs, SSRIs, 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 for treating infections)
• medicines containing moclobemide, a reversible MAOI (used for treating depression)
• medicines containing sibutramine (used for weight loss)
• medicines containing tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used for treating severe pain)
• medicines containing dextromethorphan (used for treating cough)
• products containing methadone (used for treating opioid addiction or severe pain)
• medicines containing methylthioninium chloride (methylene blue) (used for treating high levels of methemoglobin in the blood)
• products containing St. John's Wort (also known as “Hypericum perforatum”, a herbal remedy or supplement used for treating mild depression)
• products containing tryptophan (used for problems such as sleep and depression)
• antipsychotics (used for treating a condition with symptoms such as hearing, seeing, or feeling things that do not exist, mistaken beliefs, unusual suspiciousness, unclear reasoning, and a 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 can 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 your nearest hospital if you think you are experiencing serotonin syndrome.

Tell your doctor if you are taking medicines that may affect your heart rhythm.

Some examples of these medicines include:

• antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used for treating irregular heartbeat)
• antipsychotics such as thioridazine (see also "Serotonin syndrome" above)
• antibiotics such as erythromycin or moxifloxacin (used for treating bacterial infections)
• antihistamines (used for treating allergies)

The following medicines may also interact with Venlafaxine Sun and should be used with caution. It is especially important to tell 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 Venlafaxine Sun with food, drinks, and alcohol

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

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Tell your doctor if you become pregnant or are planning to become pregnant. You should only use Venlafaxine Sun after discussing the potential benefits and risks to the unborn child with your doctor.

Make sure your midwife and/or doctor knows you are taking Venlafaxine Sun. When taken during pregnancy, medicines similar to Venlafaxine Sun (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 during 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 your baby may have when born are feeding problems and breathing problems. If your baby has these symptoms when born and you are concerned, contact your doctor and/or midwife who will be able to advise you.

If you take Venlafaxine Sun in the final stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after giving birth, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Venlafaxine Sun so they can advise you.

Breast-feeding

Venlafaxine passes into breast milk. There is a risk of an effect on the baby. Therefore, you should discuss this with your doctor and they will decide whether you should stop breast-feeding or stop Venlafaxine Sun.

Driving and using machines

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

Venlafaxine Sun contains lactose

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

Venlafaxine Sun contains sodium

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

3. How to take Venlafaxina SUN

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 recommended initial 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.

Method of administration

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

Venlafaxina must be taken with food.

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

Do not stop taking this medication without consulting your doctor (see section "If you stop 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 intake 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 the level of alertness, (ranging from drowsiness to coma) blurred vision, convulsions or seizures, and vomiting.

If you forget to take Venlafaxina

Do not take a double dose to make up for forgotten 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 amount of venlafaxine that has been prescribed to you in one day.

If you stop treatment with Venlafaxina

Do not stop taking your treatment or reduce the dose without your doctor's advice, even if you feel better. If your doctor believes you no longer need venlafaxina, they may ask you to gradually reduce the dose before stopping treatment completely. It is known that adverse effects occur when people stop taking venlafaxina 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 rarely, sensations of electric shock, weakness, sweating, convulsions, or flu-like symptoms, vision problems, and increased blood pressure (which can cause headache, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you on how to gradually stop treatment with venlafaxina. This may take several weeks or months. In some patients, the interruption may need to occur 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 questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

Uncommon:may affect up to 1 in 100 people

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

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

• chest tightness, wheezing, difficulty swallowing or breathing.
• severe skin rash, itching, or hives (elevated areas of red or pale 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, 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).

• signs of infection, such as high temperature, chills, tremors, headaches, sweating, flu-like symptoms. This may be the result of a blood disorder that leads to an increased risk of infection.
• severe skin rash, which can lead to severe blistering and peeling of the skin
• unexplained muscle pain, sensitivity, 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" which may include chest pain, difficulty breathing, dizziness, fainting, irregular heartbeats.

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

Other side effectsthat you should inform your doctor aboutare (the frequency of these side effects is included in "Other side effects" below):

• cough, wheezing, shortness of breath that may be accompanied by an increased temperature.

• black stools (bowel movements) or blood in stools.

• yellow eyes or skin, itching, or 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, 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 stop treatment with Venlafaxina Sun").
• prolonged bleeding – if you cut yourself or get injured, it may take a little longer than usual for the bleeding to stop.

The tablet coating does not dissolve completely and comes out in the stools. Do not worry if you see small fragments in your stools after taking this medication. Although you see fragments in the stools, the dose of the medication has been absorbed.

Other side effects

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

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

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

• decreased appetite
• 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 or stand still, 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 skin rash, itching
• increased frequency of urination, inability to urinate, difficulty urinating
• menstrual irregularities, 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, accelerated thoughts, and decreased need for sleep (mania)
• hallucinations, feeling detached (or disconnected) from reality, abnormal orgasm, 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 (bowel movements) or blood in stools, which may be a sign of internal bleeding
• sensitivity to sunlight, bruising, skin rash, abnormal hair loss
• inability to control urination
• stiffness, spasms, and involuntary muscle movements
• mild changes in blood levels of liver enzymes, sodium, or cholesterol.

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

• seizures or convulsions
• cough, wheezing, shortness of breath that may be accompanied by a 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
• abnormal heartbeat, rapid or irregular, which can lead to fainting
• severe abdominal or back 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 people)

• prolonged bleeding, which may be due to a reduced number of platelets in the blood that leads to an increased risk of bruising or bleeding
• abnormal production of breast milk
• unexpected bleeding, for example, bleeding from the gums, blood in urine or vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins).

Frequency not known: cannot be estimated from the available data

• suicidal ideation and behavior; cases of suicidal ideation 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 Sun")
• aggression
• vertigo.
• abundant 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 Sun may reduce blood function or platelets, leading to an increased risk of bruising or bleeding. Therefore, your doctor may want to perform occasional blood tests, especially if you have been taking Venlafaxina Sun for a long time.

Reporting of side effects

If you experience any type of side effect, consult your doctor, 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Venlafaxina SUN

Keep this medication out of 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 pack: Store in the original packaging to protect it from moisture.

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

Medications should not be thrown away through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

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 ingredients are:

For 75 mg:

Core of the tablet

Prolonged-release coating:

Hydroxypropylmethylcellulose,

Povidone (K-30),

Lactose monohydrate,

Methacrylic acid ethyl acrylate copolymer (1:1),

Talc,

Magnesium stearate (E572)

Score line:

Silicified microcrystalline cellulose,

Crospovidone Type A,

Anhydrous colloidal silica,

Sodium lauryl sulfate,

Red aluminum lake (E129),

Talc,

Magnesium stearate (E572)

Coating

Aqueous dispersion of ethylcellulose,

Mannitol,

Povidone (K-30),

Dibutyl sebacate,

Triethyl citrate,

Polysorbate 20,

Opadry II 85F 19250 transparent composed of:

Talc,

Macrogol 3350,

Polysorbate 80,

Polyvinyl alcohol.

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

Shellac,

Black iron oxide (E172),

Propylene glycol.

For 150 mg:

Core of the tablet

Prolonged-release coating:

Hydroxypropylmethylcellulose,

Povidone (K-30),

Lactose monohydrate,

Methacrylic acid ethyl acrylate copolymer (1:1), Talc,

Magnesium stearate (E572)

Score line:

Silicified microcrystalline cellulose,

Crospovidone Type A,

Anhydrous colloidal silica,

Sodium lauryl sulfate,

Red aluminum lake (E129),

Talc,

Magnesium stearate (E572)

Coating

Aqueous dispersion of ethylcellulose,

Mannitol,

Povidone (K-30), Dibutyl sebacate,

Triethyl citrate, Polysorbate 20,

Talc

Opadry II 85F 19250 transparent composed of:

Talc,

Macrogol 3350,

Polysorbate 80,

Polyvinyl alcohol.

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

Shellac,

Black iron oxide (E172),

Propylene glycol.

Appearance of the product and package contents

Venlafaxina Sun 75 mg:

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

Venlafaxina Sun 150 mg:

This medication 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 in color, with a "758" printed in black ink on one side and flat on the other.

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

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

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

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 medication 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 with prolonged release

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

Date of the last revision of this leaflet:January 2024

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