Venlapiine Retard 75 mg prolonged-release hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Venlapine Retard 75 mg prolonged-release hard capsules EFG

venlafaxine

Read the entire leaflet carefully before starting to take 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Package leaflet contents:

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

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

Venlapine Retard contains the active substance venlafaxine.

Venlapine Retard is an antidepressant which 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. The exact way antidepressants work is not fully understood, but they may help 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). Properly treating depressive and anxiety disorders 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 starting to take Venlapine Retard

Do not take Venlapine Retard

• 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, a medicine known as an irreversible monoamine oxidase inhibitor (MAOI), used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with Venlapine Retard may cause serious, and potentially even life-threatening, adverse effects. In addition, you must wait at least 7 days after stopping Venlapine Retard before starting any irreversible MAOI (see also section “Taking Venlapine Retard with other medicines” and the information in that section regarding “Serotonin syndrome”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Venlapine Retard.

• If you are taking other medicines that, when taken together 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 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 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 and breastfeeding”).
• If you have a history of, or if a family member has had, mania or bipolar disorder (feeling over-excited or euphoric).
• If you have a history of aggressive behavior.

Venlapine Retard may cause a feeling of restlessness or difficulty sitting or staying still during the first weeks of treatment. You should consult your doctor if this occurs.

Do not drink alcohol while being treated with Venlapine Retard, as it may cause extreme tiredness 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 experience thoughts of harming yourself or committing suicide. These thoughts may increase when you first start taking antidepressants, because all of these medicines take time to take effect—usually about two weeks, but sometimes longer. These thoughts may also occur when your dose is reduced or when treatment with Venlapine Retard is discontinued.

This is more likely to happen if:

• You have previously had thoughts of harming yourself or of suicide.
• 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 disorders treated with antidepressants.

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

You may find it helpful to inform 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 dental caries. Therefore, you should take care with your dental hygiene.

Diabetes

Your blood glucose levels may be affected by Venlapine Retard. Consequently, an adjustment of the dose of your diabetes medication may be necessary.

Sexual problems

Medicines such as Venlapine Retard (the so-called SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.

Children and adolescents

Venlapine Retard should normally not be used in the treatment of children and adolescents under 18 years of age. In addition, you should be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (predominantly aggression, confrontation behavior, and irritability) when taking this type of medication. Nevertheless, the treating physician may prescribe this medicine to patients under 18 years of age when deciding it is in the patient's best interest. If your doctor has prescribed this medication to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You must inform your doctor if any of the symptoms listed above develop or worsen while these patients under 18 years of age are taking Venlapine Retard. In addition, the long-term safety of this medication with regard to growth, maturation, and cognitive and behavioral development in this age group has not been established.

Other Medicines and Venlapine Retard

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

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

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

• Monoamine oxidase inhibitors (MAOIs), which are used to treat depression or Parkinson’s disease, must not be taken with Venlapine Retard. Inform 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 Venlapine Retard”).

• Serotonin syndrome:

Serotonin syndrome, a potentially life-threatening condition, or reactions resembling Neuroleptic Malignant Syndrome (NMS) (see section “Possible Side Effects”), may occur during treatment with venlafaxine, particularly when taken with other medicines.

Examples of such medicines include:

• Triptans (used for migraine).
• Other medicines used 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, an MAOI (used to treat depression).
• Medicines containing sibutramine (used for weight loss).
• Medicines containing opioids (e.g., buprenorphine, tramadol, fentanyl, tapentadol, petidine, or pentazocine) (used to treat severe pain).
• Medicines containing dextromethorphan (used to treat cough).
• Medicines containing methadone (used for opioid addiction treatment or for treatment of severe pain).
• Medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood).
• Herbal 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 conditions such as sleep problems and depression).
• Antipsychotics (used to treat illnesses with symptoms such as hearing, seeing, and 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, 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, tachycardia, 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 irregular heart rhythms).
• 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 inform your doctor or pharmacist if you are taking medicines containing:

• Ketoconazole (an antifungal medicine).
• Haloperidol or risperidone (used to treat psychiatric conditions).
• Metoprolol (a beta-blocker used to treat high blood pressure and heart problems).

Taking Venlapine Retard with food, beverages, and alcohol

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

Do not drink alcohol while being treated with 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 lactation

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. You should only take Venlapine Retard after discussing with your doctor the potential benefits and possible risks to the unborn child.

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

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

If you take Venlapine Retard 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 Venlapine Retard so they can advise you appropriately.

Venlapine Retard passes into breast milk. There is a risk of effects on the breastfed infant. Therefore, you must discuss this with your doctor, who will decide whether you should discontinue breastfeeding or discontinue treatment with this medicine.

Driving and operating machinery

Do not drive or operate 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 tablet and is therefore considered essentially "sodium-free".

3. How to take Venlapine Retard

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

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 increase it 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 must be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.

Venlapine Retard should be taken with food.

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

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

If you take more Venlapine Retard than you should

Contact your doctor or pharmacist immediately if you take more Venlapine Retard than prescribed. You may also contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.

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

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 Venlapine Retard

If you have missed 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 forgotten doses. Do not take more than the daily amount of Venlapine Retard prescribed for you in one day.

If you stop treatment with Venlapine Retard

Do not stop taking this medication or reduce the dose without consulting your doctor, even if you feel better. If your doctor considers that you no longer need Venlapine Retard, they may instruct you to gradually reduce the dose before stopping treatment completely. Adverse effects are known to occur when patients discontinue this medicine, especially if it is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, lack of coordination, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, tinnitus, tingling sensations, or, rarely, 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 Venlapine Retard. This may take several weeks or months. In some patients, discontinuation may need to be carried out very gradually over several months or longer. If you experience any of these or other bothersome symptoms, consult your doctor for further 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 Venlapine Retard immediately and contact 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 swollen, itchy rash, 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 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, hyperactive 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 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 may progress to serious 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, shortness of breath, dizziness, fainting, or irregular heartbeats.

Other adverse effects you should report to your doctor (the frequency of these adverse effects is listed in the section below “Other adverse effects that may occur”) include:

• Cough, noisy breathing, and shortness of breath, which may be accompanied by increased temperature.
• Tar-like stools or blood in the stool.
• Itching, yellowing of the 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 disorders (muscle spasms and stiffness), seizures or fits.
• Psychiatric problems, such as hyperactivity (unusual feeling of being overexcited).
• Withdrawal effects (see section “How to take Venlapine Retard, if you stop taking Venlapine Retard”).
• Prolonged bleeding—if you are cut or injured, it may take longer than normal 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 detached, lack of 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), reduced erectile function (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, impaired coordination and balance.
• Dizziness (especially when standing up too quickly); decreased blood pressure.
• Vomiting blood, tar-like stools (faeces) or blood in the stools, which may indicate internal bleeding.
• Sensitivity to sunlight, bruising, abnormal hair loss.
• Inability to control urination.
• Muscle stiffness, spasms and involuntary muscle movements.
• Slight changes in blood levels of liver enzymes.

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

• Seizures.
• 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 sodium levels in 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 increased 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 bruises or broken blood vessels (ruptured veins).

Frequency not known (cannot be estimated from available data)

• Suicidal thoughts and suicidal behaviour—cases of suicidal thoughts 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 Venlapine Retard”).
• Aggression.
• Vertigo.
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage). See “Pregnancy and breastfeeding” in section 2 for more information.

Venlapine Retard sometimes causes unwanted effects that you may not be aware of, such as increases in blood pressure or abnormal heartbeat; slight 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 wish to carry out occasional blood tests, especially if you have been taking Venlapine Retard 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 Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Venlapine Retard

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister pack, after CAD. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the Sigre Collection Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the container and additional information

Composition of Venlapine Retard 75 mg prolonged-release hard capsules

The active substance is venlafaxine.

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

The other components are:

Capsule contents: hypromellose, methacrylic acid copolymer (type B), sodium lauryl sulfate (E487), magnesium stearate

Coating: butylated basic methacrylate copolymer 12.5%, Capsule shell: gelatin, titanium dioxide (E171), iron oxide red (E172)

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

Appearance of the product and contents of the pack

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

Packs 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 Responsible

Pharmathen, S.A.

6, Dervenakion Str. – GR – 15351

(Pallini, Attikis) Greece

Or

Pharmathen International, S.A.

Sapes Industrial Park

Block 5, 69300 Rodopi

Greece

Or

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona

69 08970

Sant Joan Despí

Barcelona - Spain

Date of the most recent review of this leaflet: June 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.