VENLAFAXINE SUN 75 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Venlafaxina Sun 75 mg prolonged-release tablets

Venlafaxina Sun 150 mg prolonged-release tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Venlafaxina Sun and what is it used for
2. What you need to know before you take Venlafaxina Sun
3. How to take Venlafaxina Sun
4. Possible side effects
5. Storing Venlafaxina Sun
6. Contents of the pack and further information

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

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

Venlafaxine is a treatment for adults with depression. Venlafaxine is also a treatment for adults with the following anxiety disorders: generalised anxiety disorder, social anxiety disorder (fear or avoidance of social situations), panic disorder (panic attacks). Treating your depression or anxiety disorder properly is important to help you feel better. If it is not treated, your condition may not get better or it may get worse and become more difficult to treat.

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

Do not take Venlafaxina 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 Venlafaxina Sun can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after stopping Venlafaxina Sun before you can take any MAOI (see also section “Using Venlafaxina Sun with other medicines” and the information in that section about “Serotonin Syndrome”).

Warnings and precautions

Consult your doctor or pharmacist before taking Venlafaxina Sun

• if you are taking any other medicines that may increase the risk of developing serotonin syndrome when taken with Venlafaxina Sun (see section “Using 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 you have an irregular heart rhythm
• if you have a history of fits (seizures)
• if you have a history of low sodium levels in your blood (hyponatraemia)
• if you have a tendency to develop bruises or have a tendency to bleed easily (a 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 elated) or bipolar disorder
• if you have a history of aggressive behaviour

Venlafaxina Sun may cause a sensation 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.

Do not drink alcohol while you are taking Venlafaxina Sun, as it may increase the risk of side effects. Taking Venlafaxina Sun in combination with alcohol, as well as with certain medicines, may increase the risk of side effects, such as drowsiness.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you can sometimes have thoughts of harming or killing yourself. These thoughts may be increased when you first start taking antidepressants, since these medicines all take time to work, usually about 2 weeks, but sometimes longer. These thoughts can also occur when your dose is reduced or when you stop taking Venlafaxina Sun.

You are more likely to think this way if:

• You have previously had thoughts about killing or harming yourself.
• You are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to hospital straight away.

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 behaviour.

Dry mouth

Dry mouth has been reported in approximately 10% of patients treated with venlafaxine. This may increase the risk of tooth decay. Therefore, you should pay attention to your dental hygiene.

Diabetes

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

Sexual problems

Some medicines of the same group as Venlafaxina Sun (so-called SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Use in children and adolescents under 18 years of age

Venlafaxina Sun should not normally be used for the treatment of children and adolescents under 18 years of age. The long-term safety effects concerning growth, maturation, and cognitive and behavioural development of venlafaxine in this age group have not yet been demonstrated. In addition, you should know that patients under 18 have an increased risk of side effects such as suicide attempt, suicidal thoughts, and hostility (predominantly aggression, oppositional behaviour, and anger) when they take this class of medicines. Nevertheless, your doctor may prescribe this medicine for patients under 18 in certain situations. If your doctor has prescribed this medicine for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above occur or worsen when patients under 18 are taking venlafaxine. Furthermore, the long-term safety effects in terms of growth, maturation, and cognitive and behavioural development of this medicine have not yet been demonstrated.

Using Venlafaxina Sun with other medicines

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

Your doctor will decide whether you can take Venlafaxina Sun with other medicines.

Do not start or stop taking any medicines, including those bought without a prescription, natural remedies, or herbal products, before checking with your doctor or pharmacist.

• Irreversible MAOIs used to treat depression or Parkinson’s disease must not be taken with Venlafaxina Sun. Tell your doctor if you have taken any of these medicines within the last 14 days. (MAOI: see section “What you need to know before you take Venlafaxina Sun”).
• Serotonin Syndrome: A potentially life-threatening or a condition resembling 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 to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity)
• medicines containing the antibiotic linezolid (used to treat infections)
• medicines containing moclobemide, a reversible MAOI (used to treat depression)
• medicines containing sibutramine (used for weight loss)
• medicines containing tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used to treat severe pain)
• medicines containing dextromethorphan (used to treat cough)
• products containing methadone (used for the treatment of opioid addiction or for the treatment of severe pain)
• medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)
• products containing St John’s Wort (also known as “Hypericum perforatum”, a herbal remedy 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 are not there, mistaken beliefs, unusual suspiciousness, unclear reasoning, and a tendency to withdraw from social contact).

The signs and symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhoea, 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, fast heart beat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).

Tell your doctor immediately or go to the casualty department of the 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:

• anti-arrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat irregular heart rhythm)
• 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 also 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 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 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 while you are taking Venlafaxina Sun. Drinking alcohol while taking Venlafaxina Sun may cause drowsiness or increase the risk of side effects, such as drowsiness, and may worsen the symptoms of depression or other mental health conditions.

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 if you are planning to become pregnant. You should not take Venlafaxina Sun during pregnancy unless your doctor considers it essential. You should inform your doctor if you are planning to become pregnant or if you suspect you are pregnant.

Make sure your midwife and/or doctor knows you are taking Venlafaxina Sun. When taken during pregnancy, medicines similar to Venlafaxina Sun (SSRIs) 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 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 after birth are problems with feeding and breathing. 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 Venlafaxina Sun during the last month of your pregnancy, you should be aware that the risk of heavy bleeding after delivery may be increased. Your doctor or midwife should be informed that you are taking Venlafaxina Sun so that they can provide appropriate care.

Breast-feeding

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

Driving and using machines

Do not drive or use tools or machines until you know how Venlafaxina Sun affects you.

Venlafaxina 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.

Venlafaxina Sun contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it 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 normal 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 for 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 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 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 discharge, 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 venlafaxine. This may take several weeks or months. In some patients, the interruption may need to be very gradual 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.

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people suffer from 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.

including 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 a high 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 coating of the tablet does not dissolve completely and comes out in the stool. Do not worry if you see small fragments in your stool after taking this medication. Although you see fragments in the stool, 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 stay seated or 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, or 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 standing 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, leading to an increased risk of bruising or bleeding
• abnormal milk production
• unexpected bleeding, for example, bleeding from the gums, blood in urine or vomit, or the appearance of unexpected bruising 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 you start taking Venlafaxina Sun")
• aggression
• vertigo.
• heavy 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 or 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: 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 at the SIGRE collection point in 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 and 150 mg:

Core of the tablet

Prolonged-release coating:

Hydroxypropyl methylcellulose,

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 with 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 with black ink on one side and flat on the other.

Blister: 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 met verlengde afgifte

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/