Leaflet: information for the user

Venlafaxine Retard Stada 75 mg prolonged-release hard capsules EFG

Venlafaxine Retard Stada 150 mg prolonged-release hard capsules EFG

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to take Venlafaxine Retard Stada

3.How to take Venlafaxine Retard Stada

4.Possible side effects

5.Storage of Venlafaxine Retard Stada

6.Contents of the pack and additional information.

Venlafaxina Retard Stada is an antidepressant that belongs to a group of medications called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medications is used to treat depression and other conditions such as anxiety disorders. The exact mechanism of action of antidepressants is not fully understood, but they may help increase the 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), panic disorder (panic attacks). Treating depressive and anxiety disorders properly is important to help you feel better. If left untreated, your condition may not go away or may worsen and become more difficult to treat.

Do not take Venlafaxina Retard Stada

•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 in the last 14 days, any medicine known as an irreversible monoamine oxidase inhibitor (IMAO), used to treat depression or Parkinson's disease. Taking an IMAO irreversible with other medicines, such as Venlafaxina Retard Stada, may produce severe or potentially fatal side effects.

Also, you must wait at least 7 days after stopping Venlafaxina Retard Stada before taking any IMAO (see also the sections “Serotonin syndrome” and “Use of Venlafaxina Retard Stada with other medicines”).

Warnings and precautions

Consult your doctor or pharmacistbeforestarting to take Venlafaxina Retard Stada.

If any of the following conditions affect you, tell your doctor,beforetaking Venlafaxina Retard Stada:

•If you are taking other medicines that, taken with Venlafaxina Retard Stada, may increase the risk of developing serotonin syndrome (see the section “Use of Venlafaxina 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 informed that your heart rhythm is altered.

•If you have a history of seizures (convulsions).

•If you have a history of low sodium levels in the blood (hyponatremia).

•If you have a tendency to develop cardenalias or bleed easily (history of haemorrhagic 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, lactation and fertility”).

•If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling overexcited or euphoric).

•If you have a history of aggressive behavior.

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

Do not drink alcohol during treatment with venlafaxine, as it may cause extreme fatigue and unconsciousness. Taking it with certain medicines and/or alcohol may worsen the symptoms of depression and other conditions, such as anxiety disorders.

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or suicide. This may be more likely to happen:

•If you have had thoughts of suicide or self-harm before.

•If you are a young adult. Clinical trial information has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric illnesses treated with antidepressants.

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

You may find it helpful to tell a close relative or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may also ask them to tell you if they think your depression or anxiety is getting worse, 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. Therefore, you should take good care of your teeth.

Diabetes

Your blood glucose levels may be affected by Venlafaxina Retard Stada. Therefore, your doses of diabetes medicines may need to be adjusted.

Sexual problems

Some medicines in the group to which venlafaxine belongs (called IRSN) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents

Venlafaxina Retard Stada should not normally be used in the treatment of children and adolescents under 18 years old. Also, you should know that in patients under 18 years old, there is a higher risk of side effects such as suicidal thoughts, suicidal behaviour, and hostility (mainly aggression, confrontational behaviour, and irritability) when taking this type of medicine. However, your doctor may prescribe this medicine to patients under 18 years old when they decide it is the best option for the patient. If your doctor has prescribed this medicine to a patient under 18 years old and you want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen in these patients under 18 years old who are taking Venlafaxina Retard Stada. Also, the long-term safety in relation to growth, maturation, and cognitive and behavioural development has not been demonstrated.

Other medicines and Venlafaxina Retard Stada

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

Your doctor must decide if you can take Venlafaxina Retard Stada with other medicines.

Do not start or stop taking any medicine, including those available over the counter, natural remedies, and herbal remedies, without checking with your doctor or pharmacist.

•Irreversible monoamine oxidase inhibitors used to treat depression or Parkinson's diseaseshould not be taken withVenlafaxina Retard Stada. Tell your doctor if you have taken any of these medicines in the last 14 days. (IMAO: see section “What you need to know before starting to take Venlafaxina Retard Stada”)

•Serotonin syndrome: a potentially fatal state or reactions similar to Neuroleptic Malignant Syndrome (NMS) (see section “Possible side effects”), may occur with treatment with venlafaxine, particularly when taken with other medicines.

Examples of these medicines include:

•Triptans (used for migraines)

•Other medicines for treating depression, e.g. ISRN, ISRS, 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 IMAO (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 to treat opioid addiction or severe pain)

•Medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)

•Products containing St. John's Wort (also known as “Hypericum perforatum”, a natural remedy 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 do not exist, false beliefs, unusual suspicion, unclear thinking, 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, hyperactive reflexes, diarrhoea, coma, nausea, and vomiting.

In its most severe form, serotonin syndrome may resemble Neuroleptic Malignant Syndrome (NMS). The 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).

Inform your doctor immediately or go to the 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 allergies)

The following medicines may interact with Venlafaxina Retard Stada and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines that contain:

•Ketoconazole (an antifungal medicine)

•Haloperidol or risperidone (for treating psychiatric conditions)

•Metoprolol (a beta-blocker used to treat high blood pressure and heart problems)

Taking Venlafaxina Retard Stada with food, drinks, and alcohol

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

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

Pregnancy, lactation, and fertility

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

Make sure your midwife and/or doctor know that you are taking Venlafaxina Retard Stada. When taken during pregnancy, similar medicines (ISRS) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and turn blue. These symptoms usually start within 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, in addition to breathing problems, another symptom that your baby may have when born is feeding problems. If your baby has these symptoms when born and you are concerned, contact your doctor and/or midwife who can advise you.

If you take venlafaxine in the final stages of pregnancy, there may be a higher risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking venlafaxine so they can advise you.

Venlafaxina Retard Stada passes into breast milk. There is a risk of an effect on the baby. Therefore, you should discuss the case with your doctor and they will decide if you should stop breastfeeding or stop taking this medicine.

Driving and operating machinery

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

Venlafaxina Retard Stada contains saccharose

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The usual initial recommended 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 Venlafaxina Retard Stada approximately at the same time every day, either in the morning or at night. The capsules should be swallowed whole with liquids and should not be opened, crushed, chewed, or dissolved.

Venlafaxina Retard Stada should be taken with food.

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

Do not stop taking this medication without consulting your doctor (see section “If you interrupt treatment with Venlafaxina Retard Stada”).

If you take more Venlafaxina Retard Stada than you should

Immediately contact your doctor or pharmacist if you take more medication than prescribed by your doctor. You can also contact the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

Overdose can be life-threatening, especially with the simultaneous use of certain medications and/or alcohol (see “Taking Venlafaxina Retard Stada with other medications”).

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

If you forgot to take Venlafaxina Retard Stada

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 one dose as usual. Do not take a double dose to compensate for the missed doses. Do not take more than the daily dose of Venlafaxina Retard Stada prescribed to you in a day.

If you interrupt treatment with Venlafaxina Retard Stada

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

Your doctor will advise you on how to gradually stop treatment with Venlafaxina Retard Stada. This may take several weeks or months. In some patients, the interruption may need to be produced very gradually over months or more. If you experience any of these or other symptoms that bother you, consult your doctor for advice.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If any of the following effects occur, do not take more Venlafaxina Retard Stada.Inform your doctor immediately, or go to the nearest hospital emergency department:

Rare (may affect up to 1 in 100 people)

•Swelling of the face, mouth, tongue, throat, hands, or feet, and/or itchy, swollen, and inflamed skin, difficulty swallowing or breathing.

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

•Chest tightness, breathing sounds, difficulty swallowing or breathing.

•Severe skin rash, itching, or urticaria (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 Malignant Neuroleptic Syndrome (MNS). MNS symptoms may include a combination of fever, rapid heart rate, sweating, severe muscle rigidity, confusion, increased muscle enzymes (determined by blood tests).

•Signs of infection, such as fever, chills, shivering, headache, sweating, or flu-like symptoms. This may be due to a blood disorder that may increase the risk of infection.

•Severe rash, which may lead to the formation of severe blisters and skin peeling.

•Muscle pain, discomfort, or weakness. This may be a sign of rhabdomyolysis.

Unknown frequency (cannot be estimated from available data)

•Signs and symptoms of a condition called "stress cardiomyopathy" that may include chest pain, difficulty breathing, dizziness, fainting, irregular heartbeats.

Other side effects thatyou should inform your doctorare(the frequency of these side effects are included in the list below "other side effects that may occur"):

• Shortness of breath, wheezing, and difficulty breathing that may be accompanied by a high temperature.
• Stool (deposits) that are tar-like or blood in stool.
• Itching, yellow eyes or skin, dark urine, which are symptoms of liver inflammation (hepatitis).

•Heart problems, such as rapid or irregular heart rate, increased blood pressure.

•Eye problems, such as blurred vision, dilated pupils.

•Nerve problems, such as dizziness, numbness, movement disorder (muscle spasms and rigidity), convulsions, or seizures.

•Psychiatric problems, such as hyperactivity (unusual feeling of overexcitement).

•Withdrawal effects (see section "How to take Venlafaxina Retard Stada; If you interrupt treatment with Venlafaxina Retard Stada").

•Prolonged bleeding, if you cut or make a wound, it may take a little longer than usual for bleeding to stop.

Do not worry if you see small white granules or balls in your stool after taking this medicine. Inside the capsules of Venlafaxina Retard Stada, there are spheroids (small white balls) that contain the active ingredient (venlafaxine). These spheroids are released from the capsule in the stomach. As they circulate through the stomach and intestines, venlafaxine is slowly released. The "shell" of the spheroid does not dissolve and is eliminated in the stool. Therefore, although you see spheroids in the stool, the dose of the medicine has been absorbed.

Other side 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)

• Loss of appetite.

• Confusion, feeling strange, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams.
• Tremor,a feeling of restlessness or inability to sit or stay 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.
• Tinnitus (ringing in the ears).
• Rapid heart rate, palpitations.
• Increased blood pressure, hot flushes.
• Difficulty breathing, yawning.
• Vomiting, diarrhea.
• Mild skin rash, itching.
• Increased frequency of urination, inability to urinate, difficulty urinating.
• Irregular menstrual periods, such as increased bleeding or irregular bleeding, abnormal ejaculation/orgasm (men), erectile dysfunction (impotence).
• Weakness (asthenia), fatigue, chills.
• Weight gain or loss.
• Increased cholesterol.

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

• Hyperactivity, rapid 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, alteration of coordination and balance.
• Feeling dizzy (especially when standing up too quickly), decreased blood pressure.
• Vomiting blood, tar-like stools (deposits) or blood in stools, which may be a sign of internal bleeding.
• Sensitivity to sunlight, petechiae, abnormal hair loss.
• Inability to control urination.
• Rigidity, spasms, and involuntary muscle movements.
• Mild changes in liver enzyme levels.

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

• Convulsions or seizures.
• Shortness of breath, wheezing, and lack 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 blood.
• Severe eye pain and reduced or blurred vision.
• Abnormal heart rhythm, rapid or irregular heart rate, 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, symptoms similar to the flu, which are symptoms of liver inflammation (hepatitis).

Very rare (may affect up to 1 in 10,000 people)

• Prolonged bleeding, which may be due to a reduced number of platelets in the blood, leading to an increased risk of petechiae or bleeding.
• Abnormal milk production.
• Unexpected bleeding, such as bleeding gums, blood in urine or vomit, or unexpected petechiae or vascular rupture (broken veins).

Unknown frequency (cannot be estimated from available data)

• Suicidal thoughts and behavior, cases of suicidal thoughts 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 Venlafaxina Retard Stada").
• Aggression.
• Dizziness.
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

Venlafaxina Retard STADA may sometimes cause unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heart rhythm; mild changes in liver enzyme levels, sodium, or cholesterol. Less frequently, Venlafaxina Retard Stada may reduce the function of platelets in the blood, leading to an increased risk of petechiae or bleeding. Therefore, your doctor may wish to perform occasional blood tests, particularly if you have been taking Venlafaxina Retard Stada for a long time.

Reporting of side effects

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

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

Do not use Venlafaxina Retard Stada after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Venlafaxine Retard Stada

The active ingredient is venlafaxine (hydrochloride).

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

Each prolonged-release capsule contains75 mg of the active ingredient venlafaxine (hydrochloride).

The other components are:

Capule content:sugar sphere 20 (sucrose and cornstarch), stearic acid, ethylcellulose, and talc.

Capule 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 ingredient venlafaxine (hydrochloride).

The other components are:

Capule content:sugar sphere 20 (sucrose and cornstarch), stearic acid, ethylcellulose, and talc.

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

Appearance of the product and contents of the package

Venlafaxine Retard Stada is presented in the form of prolonged-release hard capsules.

The capsules are hard gelatin and contain white or off-white spherical particles of approximately1 mmin diameter.

The capsules of Venlafaxine Retard Stada 75 mg have a white opaque cap and body, and the capsules of Venlafaxine Retard Stada 150 mg have a transparent cap and body.

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

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Stada Laboratorios, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing:

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

Last review date of this leaflet: February 2024

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