Venlafaxine prolonged-release Stada 150 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Venlafaxine Retard Stada 75 mg prolonged-release hard capsules EFG

Venlafaxine Retard Stada 150 mg prolonged-release hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because 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 effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Venlafaxina Retard Stada is and what it is used for

Venlafaxina Retard Stada 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. The way antidepressants work is not fully understood, but they may help increase levels of serotonin and norepinephrine in the brain.

Venlafaxina Retard Stada is a treatment for adults with depression. It is also a treatment for adults with the following anxiety disorders: generalized anxiety disorder, social anxiety disorder (fear or avoidance of social situations), 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 resolve or may worsen and become more difficult to treat.

2. What you need to know before taking Venlafaxine Retard Stada

Do not take Venlafaxine Retard Stada

• If you are allergic to venlafaxine or to any of the other ingredients of this medicine (listed in section 6).
• If you are currently 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 other medicines such as Venlafaxine Retard Stada may cause serious or even potentially fatal adverse effects.

In addition, you must wait at least 7 days after stopping Venlafaxine Retard Stada before starting any MAOI (see also sections “Serotonin syndrome” and “Use of Venlafaxine Retard Stada with other medicines”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Venlafaxine Retard Stada.

Tell your doctor before taking Venlafaxine Retard Stada if any of the following apply to you:

• If you are taking other medicines that, when taken with Venlafaxine Retard Stada, could increase the risk of developing serotonin syndrome (see section “Use of Venlafaxine Retard Stada 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 bruise easily or a tendency to bleed (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, breastfeeding and fertility”).
• If you have a history of, or if a family member has had, mania or bipolar disorder (feeling overly excited or euphoric).
• If you have a history of aggressive behavior.

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

Do not drink alcohol during treatment with venlafaxine, as it may cause extreme drowsiness or 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 committing suicide. This risk may increase when starting antidepressants, as all these medicines take time to work—usually about two weeks, but sometimes longer. These thoughts may also occur when your dose is reduced or during discontinuation of venlafaxine treatment.

This is more likely to happen if:

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

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

It may be 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 behavior.

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 altered by Venlafaxine Retard Stada. Therefore, the doses of your diabetes medications may need to be adjusted.

Sexual problems

Some medicines in the same class as venlafaxine (called SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents

Venlafaxine Retard Stada should not normally 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 suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, 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 in the patient’s best interest. If your doctor has prescribed this medicine to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. 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 Venlafaxine Retard Stada. Furthermore, the long-term safety regarding growth, maturation, and cognitive and behavioral development has not been established.

Other medicines and Venlafaxine Retard Stada

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

Your doctor must decide whether you can take Venlafaxine Retard Stada 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 (MAOIs) used to treat depression or Parkinson’s disease must not be taken with Venlafaxine Retard Stada. Tell your doctor if you have taken any of these medicines in the last 14 days. (MAOIs: see section “What you need to know before taking Venlafaxine Retard Stada”)

• 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 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, 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 treating 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 real, 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, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (detected 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 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 allergies)

The following medicines may also interact with Venlafaxine Retard Stada 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 (used to treat psychiatric conditions)
• metoprolol (a beta-blocker used to treat high blood pressure and heart problems)

Taking Venlafaxine Retard Stada with food, drinks and alcohol

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

Do not drink alcohol during treatment with venlafaxine. Taking it together with alcohol may cause extreme drowsiness or unconsciousness and may worsen symptoms of depression and other conditions such as anxiety disorders.

Pregnancy, breastfeeding and fertility

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

Make sure your midwife and/or doctor knows that you are taking Venlafaxine Retard Stada. Medicines similar to venlafaxine (SSRIs) taken during pregnancy 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 turn blue. 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, in addition to breathing problems, another symptom your baby may have at birth is feeding difficulties. 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 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 so they can advise you appropriately.

Venlafaxine Retard Stada passes into breast milk. There is a risk of effects on the baby. Therefore, you should discuss the situation 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 Retard Stada contains sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Venlafaxine Retard Stada

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

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.

Take Venlafaxine Retard Stada 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.

Venlafaxine Retard Stada should be taken with food.

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

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

If you take more Venlafaxine Retard Stada than you should

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

Overdose can be life-threatening, especially when taken simultaneously with certain medicines and/or alcohol (see “Taking Venlafaxine Retard Stada with other medicines”).

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

If you forget to take Venlafaxine Retard Stada

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 next dose as usual. Do not take a double dose to make up for a forgotten dose. Do not take more than the daily amount of Venlafaxine Retard Stada prescribed for you in one day.

If you stop taking Venlafaxine Retard Stada

Do not stop taking 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 Retard Stada, they may ask you to gradually reduce the dose before stopping treatment completely. Adverse effects are known to occur when people stop taking this medicine, especially when it is stopped suddenly or when the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, tiredness, dizziness, lack of stability, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling, or, in rare cases, electric shock-like sensations, weakness, sweating, seizures, or flu-like symptoms, vision problems, and increased blood pressure (which may cause headache, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you on how to gradually discontinue treatment with Venlafaxine Retard Stada. This 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 will experience them.

If any of the following effects occur, stop taking Venlafaxine Retard Stada immediately and contact your doctor right away 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, noisy breathing, 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 heart rate, 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 could lead to an increased risk of infection.
• Severe rash, which may progress 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 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 included in the list below “Other adverse effects that may occur”):

• Cough, noisy breathing and difficulty breathing, which may be accompanied by increased temperature.
• Tar-like stools (feces) or blood in stools.
• 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 disorder (muscle spasms and stiffness), seizures or fits.
• Psychiatric problems, such as hyperactivity (unusual feeling of over-excitement).
• Withdrawal effects (see section “How to take Venlafaxine Retard Stada; If you stop taking Venlafaxine Retard Stada”).
• Prolonged bleeding — if you get a cut or wound, it may take slightly longer than normal for the bleeding to stop.

Do not be concerned if you notice small granules or white beads in your stools after taking this medicine. Inside the Venlafaxine Retard Stada capsules are spheroids (small white beads) that contain the active substance (venlafaxine). These spheroids are released from the capsule in the stomach. As they pass through the stomach and intestines, venlafaxine is slowly released. The "shell" of the spheroid does not dissolve and is excreted in the feces. Therefore, even if you see spheroids in your stools, the dose of the medicine has been absorbed.

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 between 1 and 10 in 100 people)

• Decreased appetite.
• Confusion, feeling strange, anorgasmia, decreased libido, agitation, restlessness, abnormal dreams.
• Tremor, a sensation of inner restlessness or inability to sit still or remain motionless (akathisia), 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, diarrhea.
• Mild skin rash, itching.
• Increased frequency of urination, inability to urinate, difficulty urinating.
• Menstrual irregularities such as increased or irregular bleeding, abnormal ejaculation/orgasm (in men), erectile dysfunction (impotence).
• Weakness (asthenia), fatigue, chills.
• Weight gain or weight loss.
• Increased cholesterol.

Uncommon (may affect between 1 and 10 in 1,000 people)

• Hyperactivity, racing thoughts, and reduced need for sleep (mania).
• Hallucinations, feeling detached from reality, abnormal orgasm, lack of feelings or emotions, feeling overstimulated, teeth grinding.
• Fainting, involuntary muscle movements, disturbances in coordination and balance.
• Feeling dizzy (especially when standing up too quickly), decreased blood pressure.
• Vomiting blood, tarry stools (faeces), or blood in stools, which may be signs of internal bleeding.
• Sensitivity to sunlight, bruising easily, abnormal hair loss.
• Inability to control urination.
• Muscle rigidity, spasms, and involuntary muscle movements.
• Slight changes in blood levels of liver enzymes.

Rare (may affect between 1 and 10 in 10,000 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, fast, 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 the 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 Retard Stada”).
• Aggression.
• Vertigo.
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for further information.

Venlafaxine Retard STADA may sometimes cause unwanted effects that you may not be aware of, such as increases in blood pressure or abnormal heart rhythm; slight changes in blood levels of liver enzymes, sodium, or cholesterol. Less frequently, Venlafaxine Retard Stada 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 Venlafaxine Retard Stada for a long time.

Reporting of adverse reactions

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

5. Storage of Venlafaxine Retard Stada

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

Do not use Venlafaxine Retard Stada after the expiry date which is stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

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

6. Contents of the container and additional information

Composition of Venlafaxine Retard Stada

The active substance is venlafaxine (hydrochloride).

Venlafaxine Retard Stada 75 mg prolonged-release hard capsules EFG:

Each prolonged-release capsule contains 75 mg of the active substance venlafaxine (hydrochloride).

The other components are:

Capsule contents: sugar spheres 20 (sucrose and maize starch), stearic acid, ethylcellulose and talc.

Capsule coating: gelatin and titanium dioxide (E-171).

Venlafaxine Retard Stada 150 mg prolonged-release hard capsules EFG:

Each prolonged-release capsule contains 150 mg of the active substance venlafaxine (hydrochloride).

The other components are:

Capsule contents: sugar spheres 20 (sucrose and maize starch), stearic acid, ethylcellulose and talc.

Capsule shell: gelatin and titanium dioxide (E-171).

Appearance of the Product and Contents of the Container

Venlafaxine Retard Stada is available as prolonged-release hard capsules.

The capsules are hard gelatin capsules containing white or almost white spherical pellets approximately 1 mm in diameter.

Venlafaxine Retard Stada 75 mg capsules have an opaque white cap and body, while Venlafaxine Retard Stada 150 mg capsules have a transparent cap and body.

Venlafaxine Retard Stada 75 mg is available in packages containing 30 prolonged-release hard capsules or clinical package of 500 prolonged-release hard capsules.

Venlafaxine Retard Stada 150 mg is available in packages containing 30 prolonged-release hard capsules or clinical package of 500 prolonged-release hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party:

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturing Responsible Party:

Valpharma International S.p.A.

Via G. Morgagni, 2

61016 Pennabilli (Pesaro-Urbino)

Italy

or

Natrix Sciences Ltd.

HF 79, A-B Hal Far Industrial Estate (Birzebbugia)

BBG07 - Malta

or

Farmalider, S.A.

C/Aragoneses, 2

Alcobendas 28108

Madrid

Spain

Date of the most recent review of this leaflet: February 2024

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