VENLAFAXINE TARBIS 75 mg PROLONGED-RELEASE HARD CAPSULES

2. Before taking Venlafaxine Retard Tarbis

Do not take Venlafaxine Retard Tarbis

• If you are allergic to venlafaxine or any of the other ingredients of Venlafaxine Retard Tarbis.
• 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 other medicines, such as Venlafaxine Retard Tarbis, can cause serious or potentially life-threatening side effects. Additionally, you must wait at least 7 days after you stop taking Venlafaxine Retard Tarbis before taking any irreversible MAOI (see also the sections "Serotonin syndrome" and "Using other medicines").

Be cautious when taking Venlafaxine Retard Tarbis

• If you are taking other medicines that, when taken at the same time as Venlafaxine Retard Tarbis, may increase the risk of developing serotonin syndrome (see the section "Using 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 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 tend to bleed easily (history of bleeding disorders), or if you are using other medicines that may increase the risk of bleeding, or if you are pregnant (see "Pregnancy and breastfeeding").
• If your cholesterol levels increase.
• 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.

Venlafaxine Retard Tarbis may cause a feeling of restlessness or difficulty sitting or standing still. You should consult your doctor if this happens to you.

If any of these situations apply to you, consult your doctor before taking Venlafaxine Retard Tarbis.

Some medicines in the same group as Venlafaxine Retard Tarbis (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Do not drink alcohol during treatment with Venlafaxine Retard Tarbis, as it may cause extreme tiredness and unconsciousness. Taking it 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 an anxiety disorder, you may sometimes have thoughts of harming yourself or committing suicide. These thoughts may increase when you start taking antidepressants, because these medicines take time to work, usually around two weeks, but sometimes longer.

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 young adults (less than 25 years of age) with psychiatric disorders who were treated with antidepressants.

If you have thoughts of self-harm 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 can also 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.

Use in children and adolescents under 18 years of age

Venlafaxine Retard Tarbis should not normally be used in the treatment of children and adolescents under 18 years of age. Additionally, you should know that in patients under 18 years of age, there is a greater risk of side effects such as suicidal attempts, suicidal ideas, and hostility (mainly aggression). The doctor who prescribes you Venlafaxine Retard Tarbis may prescribe it to patients under 18 years of age when they decide it is most convenient for the patient. If the doctor who prescribes you Venlafaxine Retard Tarbis has prescribed it to a patient under 18 years of age, and you want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms mentioned above develop or worsen when these patients under 18 years of age are taking Venlafaxine Retard Tarbis. Additionally, the long-term effects on safety, growth, maturity, and cognitive and behavioral development of Venlafaxine Retard Tarbis have not yet been demonstrated.

Using other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Your doctor must decide if you can take Venlafaxine Retard Tarbis with other medicines.

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

• Monoamine oxidase inhibitors (MAOIs: see section "Before taking Venlafaxine Retard Tarbis")
• Serotonin syndrome:
• Serotonin syndrome, a potentially life-threatening condition (see section "Possible side effects"), may occur with venlafaxine treatment, particularly when taken with other medicines.

Examples of these medicines include:

• Triptans (used for migraines)
• Medicines for treating depression, such as SNRIs, SSRIs, tricyclic antidepressants, or medicines containing lithium
• Medicines containing the antibiotic linezolid (used to treat infections)
• Medicines containing moclobemide, a reversible MAOI (used to treat depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing tramadol (a pain reliever)
• Products containing St. John's Wort (also called "Hypericum perforatum", a natural or herbal remedy used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and depression).

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.

Seek immediate medical attention if you think you are experiencing serotonin syndrome.

The following medicines may also interact with Venlafaxine Retard Tarbis 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 Venlafaxine Retard Tarbis with food and drinks

Venlafaxine Retard Tarbis should be taken with food (see section 3 "How to take Venlafaxine Retard Tarbis 75 MG").

Do not drink alcohol during treatment with Venlafaxine Retard Tarbis. Taking it with alcohol may cause extreme tiredness and unconsciousness, and worsen symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy and breastfeeding

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 know that you are taking venlafaxine to advise you.

Tell your doctor if you become pregnant or are trying to become pregnant. You should only use Venlafaxine Retard Tarbis after discussing with your doctor the possible benefits and risks to the unborn child.

If you are taking Venlafaxine Retard Tarbis during pregnancy, tell your midwife and/or doctor, as your baby may have some symptoms when born. These symptoms usually start during the first 24 hours after the baby is born. They include feeding problems and breathing problems. If your baby has these symptoms when born and you are concerned, contact your doctor and/or midwife, who can advise you.

Venlafaxine Retard Tarbis passes into breast milk. There is a risk of an effect on the baby. Therefore, you should discuss this with your doctor, and they will decide whether you should stop breastfeeding or stop treatment with Venlafaxine Retard Tarbis.

Driving and using machines

Do not drive or operate tools or machines until you know how Venlafaxine Retard Tarbis affects you.

Important information about some of the ingredients of Venlafaxine Retard Tarbis

This medicine contains sucrose. Patients with hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.

3. How to take Venlafaxine Retard Tarbis 75 mg

Follow exactly the administration instructions of Venlafaxine Retard Tarbis indicated by your doctor. Consult your doctor or pharmacist if you have 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 dose 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 Tarbis at approximately the same time each day, either in the morning or in the evening. The capsules should be swallowed whole with liquids and not opened, crushed, chewed, or dissolved.

Venlafaxine Retard Tarbis should be taken with food.

If you have liver or kidney problems, talk to your doctor, as it may be necessary that your dose of Venlafaxine Retard Tarbis is different.

Do not stop taking Venlafaxine Retard Tarbis without consulting your doctor (see section "If you stop taking Venlafaxine Retard Tarbis").

If you take more Venlafaxine Retard Tarbis than you should

Call your doctor or pharmacist immediately if you take more Venlafaxine Retard Tarbis than prescribed by your doctor. You can also contact the Toxicology Information Service, phone 91562 04 20, indicating the medicine and the amount taken.

Overdose can put your life in danger, especially when taken with certain medicines and/or alcohol (see "Taking Venlafaxine Retard Tarbis with other medicines").

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 Venlafaxine Retard Tarbis

If you have not taken 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 more than the daily dose of Venlafaxine Retard Tarbis that has been prescribed for you in one day.

If you stop taking Venlafaxine Retard Tarbis

Do not stop taking your treatment or reduce the dose without your doctor's advice, even if you feel better. If your doctor believes you no longer need Venlafaxine Retard Tarbis, they may ask you to gradually reduce the dose before stopping treatment completely. It is known that side effects occur when people stop using Venlafaxine Retard Tarbis, especially when Venlafaxine Retard Tarbis is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as fatigue, dizziness, instability, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling, or rarely, sensations of electric shock, weakness, sweating, seizures, or flu-like symptoms.

Your doctor will advise you on how to gradually stop taking Venlafaxine Retard Tarbis. 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 product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, VenlafaxinaRetardTarbis can cause adverse effects, although not all people suffer from them.

Do not worry if you notice small granules or white balls in your stool after taking VenlafaxinaRetardTarbis. Inside the VenlafaxinaRetardTarbis capsules, there are spheroids or small white balls that contain the active ingredient venlafaxine. These spheroids are released from the capsule in the gastrointestinal tract. Since the spheroids move along the length of the gastrointestinal tract, venlafaxine is released slowly. The "shell" of the spheroid remains undissolved and is eliminated in the stool. Therefore, although you may see spheroids in your stool, your dose of venlafaxine has been absorbed.

Allergic Reactions

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

• Chest tightness, wheezing, difficulty swallowing or breathing.
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, dizziness, tingling sensations, sudden reddening of the skin and/or a feeling of heat.
• Severe skin rash, itching, or hives (elevated areas of red or pale skin that often itch) severe.

Severe Adverse Effects

If you notice any of the following signs, you may need urgent medical attention:

• Heart problems, such as rapid or irregular heartbeat, increased blood pressure.
• Eye problems, such as blurred vision, dilated pupils.
• Nervous system problems: such as dizziness, tingling, movement disorder, convulsions, or seizures
• Psychiatric problems, such as hyperactivity and euphoria.
• Treatment withdrawal (see section "How to take VenlafaxinaRetardTarbis, If you interrupt treatment with VenlafaxinaRetardTarbis").

Complete List of Adverse Effects

The frequency (possibility of occurrence) of adverse effects is classified as follows:

• Blood Disorders

Uncommon: appearance of bruises, black stools (deposits) or blood in the stool, which can be a sign of internal bleeding.

Unknown: reduced number of platelets in the blood, leading to an increased risk of bruising or bleeding; blood disorders, which can lead to an increased risk of infection

• Metabolic/Nutritional Disorders

Frequent: weight loss, increased cholesterol

Uncommon: weight gain

Unknown: slight changes in blood levels of liver enzymes; reduction of sodium levels in blood; itching, yellow eyes or skin, dark urine, or flu-like symptoms, which are symptoms of liver inflammation (hepatitis); confusion, excessive water intake (known as syndrome of inappropriate antidiuretic hormone secretion - SIADH); abnormal milk production

• Nervous System Disorders

Very Frequent: dry mouth, headache

Frequent: abnormal dreams; decreased libido; dizziness; increased muscle tone; insomnia; nervousness; tingling; sedation; tremors; confusion; feeling separated (or detached) from oneself and reality

Uncommon: lack of feelings or emotions; hallucinations; involuntary muscle movement; agitation; alteration of balance and coordination

Rare: a feeling of restlessness or inability to sit or stay still; convulsions or seizures; overexcitement or euphoria

Unknown: a high temperature with stiff muscles, confusion, or agitation, and sweating, or if you experience jerky muscle movements that you cannot control, can be symptoms of serious conditions known as neuroleptic malignant syndrome; euphoric feelings, drowsiness, rapid eye movement, clumsiness, restlessness, feeling of being drunk, sweating, or stiff muscles, which are symptoms of serotonin syndrome; disorientation and confusion often accompanied by hallucinations (delirium); stiffness, spasms, and involuntary muscle movements; thoughts of self-harm or suicide.

• Eye and Ear Disorders

Frequent: blurred vision

Uncommon: altered taste perception, ringing in the ears (tinnitus)

Unknown: severe eye pain and reduced or blurred vision

• Cardiac/Circulatory Disorders

Frequent: increased blood pressure, hot flashes, palpitations

Uncommon: feeling dizzy (especially when standing up too quickly), fainting, rapid heartbeat

Unknown: decreased blood pressure; abnormal, rapid, or irregular heartbeat, which can lead to fainting

• Respiratory System Disorders

Frequent: yawning

Unknown: cough, difficult breathing, shortness of breath, and high temperature, which are symptoms of lung inflammation associated with an increase in white blood cells (eosinophilic pneumonia)

• Digestive System Disorders

Very Frequent: nausea

Frequent: decreased appetite, constipation, vomiting

Uncommon: teeth grinding, diarrhea

Unknown: severe back or abdominal pain (which may indicate a serious problem in the intestine, liver, or pancreas)

• Skin Disorders

Very Frequent: sweating (including night sweats)

Uncommon: skin rash, abnormal hair loss

Unknown: skin rash that can lead to severe blisters and peeling of the skin; itching; mild skin rash

• Muscle Disorders

Unknown: unexplained muscle pain, discomfort, or weakness (rhabdomyolysis)

• Urinary System Disorders

Frequent: difficulty urinating; increased frequency of urination

Uncommon: inability to urinate

• Sexual and Reproductive Disorders

Frequent: abnormal ejaculation/orgasm (men), lack of orgasm, erectile dysfunction (impotence); menstrual irregularities, such as increased bleeding or irregular bleeding

Uncommon: abnormal orgasm (women)

Unknown Frequency: heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy and Breastfeeding" in section 2 for more information.

• General

Frequent: weakness (asthenia), chills

Uncommon: sensitivity to sunlight

Unknown: swelling of the face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this can be a severe allergic reaction)

VenlafaxinaRetardTarbis sometimes produces unwanted effects that you may not be aware of, such as increased blood pressure or an abnormal heartbeat; slight changes in blood levels of liver enzymes, sodium, or cholesterol. Less frequently, VenlafaxinaRetardTarbis may reduce the function of blood platelets, leading to an increased risk of bruising or bleeding. Therefore, your doctor may want to perform blood tests occasionally, especially if you have been taking VenlafaxinaRetardTarbis for a long time.

Reporting Adverse Reactions

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this leaflet.

You can also report them directly through the Spanish Medicines Agency's website: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine

5. Storage of Venlafaxina Retard Tarbis 75 mg

Keep out of the reach and sight of children.

Do not use VenlafaxinaRetardTarbis after the expiration date that appears on the packaging, after CAD.

The expiration date is the last day of the month indicated.

No special storage conditions are required

Store in a dry place.

Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Additional Information

Composition of VenlafaxinaRetardTarbis 75 mg prolonged-release capsules

The active ingredient is Venlafaxine (hydrochloride). Each capsule contains 75 mg venlafaxine (hydrochloride)

The other components are: sugar spheres (sucrose and cornstarch), hydroxypropyl cellulose (HPC LM), hydroxypropyl methylcellulose (6 CPS), talc, hydroxypropyl methylcellulose (E-15), surelease E-7-7050, isopropyl alcohol, and purified water.

Appearance of the Product and Packaging Contents

VENLAFAXINA RETARD Tarbis 75 mg is presented in the form of hard prolonged-release capsules.

The capsules are hard gelatin that contain white or off-white spheroids approximately 1 mm in diameter, with a yellow cap and transparent body.

Each package contains 30 hard prolonged-release capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer:

PLIVA KRAKOW, S.A.

Mogilska 80 Str.

31-546 Cracovia

Poland

Or

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

Laguna, 66-68-70, Polígono Industrial Urtinsa II

28923 –Alcorcón

Spain

Or

ARAFARMA GROUP

c/Fray Gabriel de San Antonio, 6-10

Pol Ind del Henares (Marchamalo) -19180

Spain

This leaflet was approved in December 2023