Venlafaxine Sun 75 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Venlafaxine Sun 75 mg prolonged-release tablets

Venlafaxine Sun 150 mg prolonged-release tablets

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Venlafaxine is an antidepressant that belongs to a group of medicines known as serotonin and norepinephrine 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 suffer from anxiety have lower levels of serotonin and noradrenaline in the brain. How antidepressants work is not fully understood, but they may help increase the levels of serotonin and noradrenaline in the brain.

Venlafaxine is a treatment for depression in adults. Venlafaxine is also a treatment for the following anxiety disorders in adults: generalized anxiety disorder, social anxiety disorder (fear of or avoidance of social situations), panic disorder (panic attacks). Properly treating depressive and anxiety disorders is important to help you feel better. If left untreated, your condition may not resolve or may worsen and become more difficult to treat.

2. What you need to know before taking Venlafaxine Sun

Do not take Venlafaxine Sun

• if you are allergic to venlafaxine or to 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 medicine known as an irreversible monoamine oxidase inhibitor (MAOI) used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with Venlafaxine Sun may cause serious or even potentially fatal side effects. In addition, you must wait at least 7 days after stopping Venlafaxine Sun before starting any MAOI (see also section “Use of Venlafaxine Sun with other medicines” and the information in that section about “Serotonin Syndrome”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Venlafaxine Sun

• if you are using other medicines that, when taken together with Venlafaxine Sun, could increase the risk of developing serotonin syndrome (see section “Use of 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 tend to develop bruises or have a tendency to bleed easily (history of bleeding disorders), or if you are taking 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 or a family member has had mania (feeling overexcited or euphoric) or bipolar disorder
• if you have a history of aggressive behaviour

Venlafaxine Sun may cause a feeling of restlessness or an inability to sit or stay still during the first 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 together with certain medicines and/or alcohol may worsen symptoms of depression and other conditions such as anxiety disorders.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or of suicide. These may increase when you first start taking antidepressants, because all these medicines take time to work—usually about two weeks, although sometimes longer. These thoughts may also occur when your dose is reduced or during discontinuation of treatment with Venlafaxine Sun.

You may be more likely to have such thoughts:

• If you have previously had suicidal thoughts or thoughts of self-harm.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults (under 25 years of age) with psychiatric conditions treated with antidepressants.

If you have thoughts of harming yourself or of suicide at any time, contact your doctor or go to a hospital immediately.

It may be 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. You may also ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.

Dry mouth

Dry mouth has been reported in 10% of patients treated with venlafaxine. This may increase the risk of tooth decay (caries). Therefore, you should take care 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 group to which Venlafaxine Sun belongs (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 effects on growth, maturation, and behavioural development of venlafaxine in this age group have not yet been established. In addition, you should know that patients under 18 years of age have a higher risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe this medicine to patients under 18 years of age if they decide it is best 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 speak to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen while these patients under 18 years of age are taking venlafaxine. In addition, the long-term effects on safety, growth, maturity, and cognitive and behavioural development of this medicine have not yet been established.

Use of Venlafaxine Sun with other medicines

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

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

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

• 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 within the last 14 days. (MAOIs: see section “What you need to know before taking 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 such medicines include:

• triptans (used for migraine)

• other medicines to treat depression, for example, 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, meperidine, or pentazocine (used to treat severe pain)

• medicines containing dextromethorphan (used to treat cough)

• products containing methadone (used for opioid addiction treatment or for treatment of severe pain)

• medicines containing methylene blue (used to treat elevated methemoglobin levels in blood)

• products containing St. John’s wort (also known as “Hypericum perforatum”, a natural or herbal remedy used to treat mild depression)

• products containing tryptophan (used for problems such as sleep and depression)

• antipsychotics (used to treat a condition with symptoms such as hearing, seeing, or feeling things that are not there, false beliefs, unusual suspicion, unclear thinking, and tendency to withdraw).

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, diarrhoea, coma, nausea, vomiting.

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

Contact 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.

Some 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 allergy).

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 containing:

• ketoconazole (an antifungal medicine)
• haloperidol or risperidone (to treat psychiatric conditions)
• metoprolol (a beta-blocker used to treat 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 together with alcohol may cause extreme tiredness and unconsciousness, and may worsen symptoms of depression and other conditions such as anxiety disorders.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become 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 Venlafaxine Sun after discussing the potential benefits and potential risks to the unborn child with your doctor.

Make sure your midwife and/or doctor knows that you are taking Venlafaxine Sun. When taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

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

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

Breastfeeding

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

Driving and using machines

Do not drive or operate tools or machinery 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 certain sugars, consult with them before taking this medicine.

Venlafaxine Sun contains sodium

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

3. How to take Venlafaxine Sun

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

The usual recommended starting 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, further 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 medicine at approximately the same time each day, either in the morning or in the evening. The tablets must be swallowed whole with liquid and must not be crushed, chewed, or dissolved.

Venlafaxine should be taken with food.

If you have liver or kidney problems, speak with your doctor, as your dose of this medicine may need to be adjusted.

Do not stop taking this medicine without consulting your doctor (see section “If you stop taking Venlafaxine Sun”).

If you take more Venlafaxine than you should

Call your doctor or pharmacist immediately if you take more of this medicine than prescribed. Overdose can be life-threatening, especially when taken simultaneously with certain medicines and/or alcohol (see “Taking Venlafaxine Sun with other medicines”). You may also contact the toxicology information service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

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

If you forget to take Venlafaxine

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

If you stop taking Venlafaxine

Do not stop your treatment or reduce the dose without your doctor’s advice, even if you feel better. If your doctor considers that you no longer need venlafaxine, they may instruct you to gradually reduce the dose before stopping treatment completely. Adverse effects are known to 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, unsteadiness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, tinnitus, tingling sensations, or in rare cases, electric shock-like sensations, weakness, sweating, seizures, flu-like symptoms, visual disturbances, and increased blood pressure (which may cause headache, dizziness, tinnitus, sweating, etc.).

Your doctor will advise you on how to gradually discontinue treatment with venlafaxine. This process may take several weeks or months. In some patients, discontinuation may need to be very gradual over months or longer. If you experience any of these or other bothersome symptoms, consult your doctor for advice.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If any of the following effects occur, stop taking Venlafaxine Sun immediately and inform your doctor or go to the nearest hospital emergency department:

Uncommon: may affect up to 1 in 100 people

• Swelling of the face, mouth, tongue, throat, hands or feet, and/or skin rash (urticaria), 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 (raised, red or pale areas of skin that are often itchy).
• 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 may resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (detected by a blood test).

• Signs of infection, such as high fever, chills, shivering, headache, sweating, flu-like symptoms. This may result from a blood disorder leading to an increased risk of infection.
• Severe skin rash, which may lead to severe blistering and peeling of the skin.
• Unexplained muscle pain, tenderness or weakness. This may be a sign of rhabdomyolysis.

Frequency not known: cannot be estimated from available data

• Signs and symptoms of a condition called "stress cardiomyopathy" (also known as Takotsubo cardiomyopathy), which may include chest pain, difficulty breathing, dizziness, fainting, or irregular heartbeats.

Other adverse effects that you should report to your doctor are (the frequency of these side effects is included in "Other adverse effects" below):

• Cough, wheezing, shortness of breath, which may be accompanied by an increase in body temperature.
• Tar-like stools or blood in the stools.
• Yellowing of the 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 disorders, seizures or fits.
• Psychiatric problems, such as hyperactivity and unusual feelings of overexcitement.
• Withdrawal effects (see section “How to take Venlafaxine Sun, if you stop taking Venlafaxine Sun”).
• Prolonged bleeding – if you cut yourself or sustain an injury, it may take slightly longer than normal for the bleeding to stop.

The tablet coating does not dissolve completely and may pass into the stool. Do not be alarmed if you notice small fragments in your stool after taking this medicine. Even if you see fragments in your stool, the medicine dose has been absorbed.

Other adverse 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 from oneself, inability to achieve orgasm, decreased libido, agitation, restlessness, abnormal dreams
• Tremor, a feeling of restlessness or inability to sit still or remain motionless, tingling, altered taste perception, increased muscle tone
• Visual disturbances including blurred vision, dilated pupils, inability of the eye to automatically adjust focus from distant to near objects
• Ringing in the ears (tinnitus)
• Rapid heartbeat, palpitations
• Increased blood pressure, hot flushes
• Difficulty breathing, yawning
• Vomiting, diarrhoea
• Mild skin rash, itching
• Increased frequency of urination, inability to urinate, difficulty urinating
• Menstrual irregularities, such as increased bleeding or increased irregular bleeding, abnormal ejaculation/orgasm (in men), erectile dysfunction (impotence)
• Weakness (asthenia), fatigue, chills
• Weight gain or weight loss
• Increased cholesterol

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

• Hyperactivity, racing thoughts and reduced need for sleep (mania)
• Hallucinations, feeling detached from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, teeth grinding
• Fainting, involuntary muscle movements, disturbance in coordination and balance
• Feeling dizzy (especially when standing up too quickly), decreased blood pressure
• Vomiting blood, tar-like stools (faeces) or blood in the stools, which may be a sign of internal bleeding
• Sensitivity to sunlight, bruising, skin rash, abnormal hair loss
• Inability to control urination
• Muscle stiffness, spasms and involuntary movements
• Slight changes in blood levels of liver enzymes

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

• Seizures or fits
• Cough, noisy breathing and shortness of breath which may be accompanied by high temperature
• Disorientation and confusion, often accompanied by hallucinations (delirium)
• Excessive water intake (known as SIADH)
• Decreased levels of sodium in the blood
• Severe eye pain and reduced or blurred vision
• Abnormal, rapid or irregular heartbeat, 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 signs 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 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 available data

• Suicidal thoughts and suicidal behaviour; cases of suicidal ideation and behaviour have been reported during treatment with venlafaxine or shortly after discontinuation of treatment (see section 2 “What you need to know before taking Venlafaxine Sun”)
• Aggression
• Vertigo
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy” in section 2 for more information

Venlafaxine may sometimes cause unwanted effects that you may not be aware of, such as increases in blood pressure or abnormal heartbeat; slight changes in blood levels or liver enzymes, sodium or cholesterol. Less frequently, Venlafaxine Sun may reduce blood cell function or platelet count, leading to an increased risk of bruising or bleeding. Therefore, your doctor may wish to carry out occasional blood tests, particularly if you have been taking Venlafaxine Sun for a long time.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Venlafaxine Sun

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Blister pack: Store in the original packaging to protect from moisture.

Tablet container: Keep the container tightly closed to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Venlafaxine Sun

The active substance is venlafaxine.

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

The other components are:

For 75 mg and 150 mg:

Tablet core

Prolonged-release film coating:

Hydroxypropylmethylcellulose,

Povidone (K-30),

Lactose monohydrate,

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

Magnesium stearate (E572)

Removable layer:

Silicified microcrystalline cellulose,

Crospovidone Type A,

Anhydrous colloidal silica,

Sodium lauryl sulfate,

Aluminium red 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.

Nature of the product and pack contents

Venlafaxine Sun 75 mg:

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

Venlafaxine Sun 150 mg:

This medicine is presented as prolonged-release tablets with two coating layers, oval, biconvex, measuring 16.35 mm x 7.85 mm, pink and white in colour, with "758" printed in black ink on one side and plain on the other.

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

Bottle packs: pack sizes of 30 and 1000 (clinical pack) prolonged-release tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

Local representative:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona

Spain

Tel: +34 93 342 78 90

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

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

The 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 most recent revision of this leaflet: January 2024

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