VENLAPINE RETARD 75 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Venlapine Retard 75 mg prolonged-release hard capsulesEFG

venlafaxine

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

1. What is Venlapine Retard and what is it used for

Venlapine Retard contains the active substance venlafaxine.

Venlapine Retard 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 not fully understood how antidepressants work, but they may help to increase the levels of serotonin and norepinephrine in the brain.

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

2. What you need to know before you take Venlapine Retard

Do not take Venlapine Retard

• 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 Venlapine Retard can cause serious or even life-threatening side effects. Additionally, you must wait at least 7 days after stopping Venlapine Retard before taking any irreversible MAOI (see also section “Taking Venlapine Retard with other medicines” and the information in that section on “Serotonin syndrome”).

Warnings and precautions

Consult your doctor or pharmacist beforeyou start taking Venlapine Retard.

• If you are taking other medicines that, when taken with Venlapine Retard, could increase the risk of developing serotonin syndrome (see section “Taking Venlapine Retard 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 you have an abnormal heart rhythm.
• If you have a history of seizures (fits).
• If you have a history of low sodium levels in your 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 and breastfeeding”).
• If you have a history of, or if a family member has had, mania or bipolar disorder (feeling overexcited or elated).
• If you have a history of aggressive behavior.

Venlapine Retard 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 while you are taking Venlapine Retard, as it may cause extreme drowsiness and unconsciousness. Concomitant use with alcohol and/or certain medicines may worsen your 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 an anxiety disorder, you may sometimes have thoughts of harming yourself or suicide. 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 you reduce your dose or during the discontinuation of treatment with Venlapine Retard.

This is more likely to happen:

• 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 adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming yourself 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 friend that 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 behavior.

Dry mouth

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

Diabetes

Your blood glucose levels may be altered due to Venlapine Retard. Consequently, it may be necessary to adjust the dose of your diabetes medication.

Sexual problems

Medicines like Venlapine Retard (so-called SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.

Children and adolescents

Venlapine Retard should not normally be used in the treatment of children and adolescents under 18 years. In addition, you should know that in patients under 18 years, there is an increased risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontation, and irritability) when they take this type of medicine. Nevertheless, your doctor may prescribe this medicine to patients under 18 years when he decides it is the best for the patient. If your doctor has prescribed this medicine to a patient under 18 years and you want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the above symptoms develop or worsen when these patients under 18 years take Venlapine Retard. Additionally, the long-term safety of this medicine in this age group concerning growth, maturation, and cognitive and behavioral development has not been demonstrated.

Other medicines and Venlapine Retard

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

Your doctor will decide whether you can take Venlapine Retard with other medicines.

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

• Monoamine oxidase inhibitors, which are used to treat depression or Parkinson's disease, must not be taken with Venlapine Retard. Tell your doctor if you have taken these medicines in the last 14 days. (MAOIs: see section “What you need to know before you take Venlapine Retard”).
• Serotonin syndrome:

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, 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, an MAOI (used to treat depression).
• Medicines containing sibutramine (used for weight loss).
• Medicines containing opioids (e.g., buprenorphine, tramadol, fentanyl, tapentadol, pethidine, or pentazocine) (used to treat severe pain).
• Medicines containing dextromethorphan (used to treat cough).
• Medicines containing methadone (used for opioid addiction treatment or for severe pain treatment).
• Medicines containing methylene blue (used to treat high levels of methemoglobin in the blood).
• Products containing St. John's Wort (also known as “Hypericum perforatum”, a herbal or plant-based 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, and feeling things that do not exist, mistaken beliefs, unusual suspicion, 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, 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, tachycardia, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).

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

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

Some examples of these medicines include:

• Antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat irregular heartbeat).
• 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 also interact with Venlapine Retard 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 Venlapine Retard with food, drinks, and alcohol

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

Do not drink alcohol while you are taking Venlapine Retard. Concomitant use with alcohol may cause extreme drowsiness and unconsciousness and may worsen your 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 plan to become pregnant, consult your doctor before using this medicine. You should only take Venlapine Retard after discussing with your doctor the possible benefits and the possible risks to the unborn child.

Make sure your midwife and/or doctor know you are taking Venlapine Retard. When similar medicines (SSRIs) are taken during pregnancy, they may increase the risk of a serious condition in babies, called persistent pulmonary hypertension in newborns (PPHN), making the baby breathe faster and have a bluish appearance. These symptoms usually appear during the first 24 hours after the baby's birth. 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 at birth include poor feeding, as well as 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 Venlapine Retard in the final stage 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 know you are taking Venlapine Retard so they can advise you.

Venlapine Retard 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 breastfeeding or stop the treatment with this medicine.

Driving and using machines

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

Venlapine Retard contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, so it is essentially “sodium-free”.

3. How to take Venlapine Retard

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. Ask your doctor or pharmacist if you have any doubts.

The usual 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, 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.

Take Venlapine Retard at approximately the same time each day, either in the morning or in the evening. The capsules should be swallowed whole with liquids and should not be opened, crushed, chewed, or dissolved.

Venlapine Retard should be taken with food.

If you have liver or kidney problems, talk to your doctor, as you may need a different dose of Venlapine Retard.

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

If you take more Venlapine Retard than you should

Call your doctor or pharmacist immediately if you take more Venlapine Retard than your doctor prescribed. You can also contact the Toxicology Information Service, phone 91 562 04 20, stating the medicine and the amount taken.

Overdose can be life-threatening, especially when taken with alcohol and/or certain medicines (see “Other medicines and Venlapine Retard”).

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

If you forget to take Venlapine Retard

If you miss 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 a single dose as usual. Do not take a double dose to make up for the forgotten doses. Do not take more than the daily dose of Venlapine Retard that your doctor has prescribed in one day.

If you stop taking Venlapine Retard

Do not stop taking your treatment or reduce the dose without your doctor's advice, even if you feel better. If your doctor thinks you no longer need Venlapine Retard, he may ask you to reduce the dose gradually before stopping treatment completely. It is known that side effects occur when people stop using this medicine, especially when it is stopped abruptly or the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, tiredness, dizziness, instability, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling, or, in rare cases, sensations of electric shock, weakness, sweating, seizures, or symptoms similar to the flu, vision problems, and increased blood pressure (which can cause headache, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you how to gradually stop taking Venlapine Retard. This may take several weeks or months. In some patients, it may be necessary to stop treatment very gradually over months or more. If you experience any of these or other symptoms that bother you, consult your doctor for further advice.

If you have any other 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 all people suffer from them.

If any of the following effects occur, do not take more Venlapine Retard. Tell your doctor immediately, or go to the emergency department 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 swollen rash with itching, 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 reddened or pale skin that often itch).
• Signs and symptoms of serotonin syndrome, which may include agitation, hallucinations, loss of coordination, tachycardia, increased body temperature, rapid changes in blood pressure, hyperactive 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 increased temperature, chills, shivering, headache, sweating, or flu-like symptoms. This may be due to a blood disorder that can lead to an increased risk of infection.
• Severe rash, which can lead to the formation of severe blisters and skin peeling. Unexplained muscle pain, discomfort, 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" that may include chest pain, difficulty breathing, dizziness, fainting, irregular heartbeats.

Other adverse effects that you should report to your doctorare (the frequency of these adverse effects is included in the list below "other adverse effects that may occur"):

• Cough, breathing noise, and difficulty breathing that may be accompanied by an increased temperature.
• Black stools (deposits) or blood in stools.
• Itching, yellow eyes or skin, 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.
• Nerve problems, such as dizziness, tingling, movement disorder (muscle spasms and stiffness), convulsions, or seizures.
• Psychiatric problems, such as hyperactivity (unusual feeling of overexcitement).
• Withdrawal effects (see section "How to take Venlapine Retard, if you interrupt treatment with Venlapine Retard").
• Prolonged bleeding, if you cut or injure yourself, it may take a little longer than usual for the bleeding to stop.

Other adverse effects that may occur

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

• Dizziness, headache, drowsiness.
• Insomnia
• Nausea, dry mouth, constipation
• Excessive sweating (including night sweats).

Common (may affect up to 1 in 10 people)

• Decreased appetite.
• Confusion, feeling strange, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams.
• Tremors, a feeling of restlessness or inability to remain 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 urination frequency, 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 from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, teeth grinding.
• Fainting, involuntary muscle movements, altered coordination and balance
• Feeling of dizziness (especially when getting up too quickly); decreased blood pressure.
• Vomiting blood, black stools (deposits) or blood in stools, which may be a sign of internal bleeding.
• Sensitivity to sunlight, bruising, abnormal hair loss.
• Inability to control urination.
• Stiffness, spasms, and involuntary muscle movements.
• Mild changes in blood levels of liver enzymes.

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

• Seizures
• Cough, breathing noise, and 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, 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, 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 milk production.
• Unexpected bleeding, for example, bleeding from the gums, blood in urine or vomit, or the appearance of bruising or broken blood vessels (broken veins).

Frequency not known (cannot be estimated from the available data)

• Suicidal ideation and suicidal behavior, cases of suicidal ideation and behavior have been reported during treatment with venlafaxine or shortly after discontinuation of treatment (see section 2. "What you need to know before taking Venlapine Retard")
• Aggression
• Dizziness
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy and breastfeeding" in section 2 for more information.

Venlapine Retard sometimes produces unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heartbeat; mild changes in blood levels of liver enzymes, sodium, or cholesterol. Less frequently, Venlapine Retard may reduce the function of blood 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 Venlapine Retard for a long time.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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5. Storage of Venlapine Retard

Keep out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and blister, after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of through wastewater or household waste. Deposit the containers and medicines you no longer need in the Sigre Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Venlapine Retard 75 mgprolonged-release hard capsules

The active ingredient is venlafaxine.

Each prolonged-release capsule contains 75 mg of venlafaxine as venlafaxine hydrochloride.

The other ingredients are:

Capsule content:hypromellose, ammonio methacrylate copolymer (type B), sodium lauryl sulfate (E487), magnesium stearate

Coating:butylated methacrylic acid copolymer 12.5%, Capsule:gelatin, titanium dioxide (E171), iron oxide red (E 172),

Printing ink:Shellac, iron oxide black (E172), propylene glycol (E1520).

Appearance of the product and package contents

Venlapine Retard 75 mg prolonged-release hard capsules EFG: hard gelatin capsules of opaque flesh color (size 0) containing two film-coated round and biconvex tablets, serigraphed VEN on the cap and 75 on the body.

Packages containing 28, 30, or 98 capsules.

Only some pack sizes may be marketed.

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer

Pharmathen, S.A.

6, Dervenakion Str. – GR – 15351

(Pallini. Attikis) Greece

O

Pharmathen International, S.A.

Sapes Industrial Park

Block 5, 69300 Rodopi

Greece

O

Neuraxpharm Pharmaceuticals, S.L.

Avda Barcelona

69 08970

Sant Joan Despí

Barcelona - Spain

Date of the last revision of this leaflet: June 2023

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