Zarelis Retard 37.5 mg prolonged-release tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

ZARELIS Retard 37.5 mg prolonged-release tablets

venlafaxine

Read the entire leaflet carefully before you start taking 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, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Zarelis Retard

3. How to take Zarelis Retard

4. Possible side effects

5. How to store Zarelis Retard

6. Contents of the pack and other information

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

Zarelis Retard contains the active substance venlafaxine.

Venlafaxine is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. The way antidepressants work is not fully understood, but they may help increase levels of serotonin and norepinephrine in the brain.

Venlafaxine is a treatment for adults with depression. Venlafaxine 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 improve or may worsen and become more difficult to treat.

2. What you need to know before starting to take Zarelis Retard

Do not take Zarelis Retard

• If you are allergic to venlafaxine or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking or have taken irreversible monoamine oxidase inhibitors (MAOIs) within the last 14 days, used to treat depression or Parkinson's disease. Taking MAOIs together with venlafaxine may cause serious adverse reactions, even potentially fatal ones. Additionally, at least 7 days must pass after stopping venlafaxine before starting any MAOI (see also section “Other medicines and Zarelis Retard” and the information in this section on “Serotonin syndrome”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• If you are taking other medicines that, when taken together with venlafaxine, could increase the risk of developing serotonin syndrome (see section “Other medicines and Zarelis Retard”).
• If you have a swallowing disorder, or stomach or intestinal condition that reduces your ability to swallow or move food through the intestines by normal movements.
• 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 diagnosed with abnormal heart rhythms (arrhythmias).
• 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 history of bleeding disorders (tendency to develop bruises or tendency to bleed easily), 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 section “Pregnancy and breastfeeding”).
• If you have a history of, or if a member of your family has had, mania or bipolar disorder (feeling overly excited or euphoric).
• If you have a history of aggressive behavior.

Venlafaxine may cause a feeling of restlessness or an inability to sit or stand still during the first 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 and 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 suffer from anxiety disorders, you may sometimes experience thoughts of self-harm or suicide. These thoughts may increase when you first start taking antidepressants, because all of these medicines take time to become effective—usually about two weeks, but sometimes longer. These thoughts may also occur when your dose has been reduced or during discontinuation of venlafaxine treatment.

You may be more likely to have such thoughts:

• If you have previously had thoughts of suicide or self-harm.
• If 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 you have any thoughts of self-harm or suicide at any time, contact your doctor immediately or go to a hospital.

You may find it helpful to inform a close friend or family member that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may also ask them to let you know 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 dental deterioration (caries). Therefore, you should take care with your dental hygiene.

Diabetes

Your blood glucose levels may be affected by venlafaxine. Therefore, a dose adjustment of the medication used for diabetes may be necessary.

Sexual problems

Some medicines such as venlafaxine (called SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents

Venlafaxine should normally not be used in the treatment of children and adolescents under 18 years of age. In addition, you should be aware that patients under 18 years of age have a higher risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and anger) when taking this type of medication.

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 appear or worsen while these patients under 18 years of age are taking venlafaxine. In addition, the long-term effects on growth, maturation, and cognitive development have not been established for this medicine in this age group.

Other medicines and Zarelis 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 venlafaxine with other medicines.

Do not start or stop taking any other medicine, including those available without a prescription, natural remedies, or herbal medicines, without first consulting your doctor or pharmacist.

• Monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson’s disease, must not be used with venlafaxine. 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 Zarelis Retard”).
• Serotonin syndrome:

A potentially life-threatening condition, or 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, meperidine, 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 or herbal remedy used to treat mild depression)
• products containing tryptophan (used for conditions such as sleep problems and depression)
• antipsychotics (used to treat conditions with symptoms such as hearing, seeing, or feeling things that are not real, false beliefs, unusual suspicion, unclear thinking, and social withdrawal)

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). Symptoms and signs of NMS may include a combination of fever, rapid heart rate, sweating, severe muscle rigidity, confusion, and increased levels of muscle enzymes (detected in blood tests).

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

You should inform your doctor if you are taking medicines that may affect your heart rhythm.

Examples of such medicines include:

• antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat abnormal heart rhythms)
• antipsychotics such as thioridazine (see also above section “Serotonin syndrome”)
• antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections)
• antihistamines (used to treat allergies)

The following medicines may also interact with venlafaxine and should be used with caution. It is especially important to inform your doctor or pharmacist if you are taking medicines containing:

• ketoconazole (antifungal medicines)
• haloperidol or risperidone (used to treat psychiatric conditions)
• metoprolol (a beta-blocker used to treat high blood pressure and heart problems)

Use of Zarelis Retard with food, beverages, and alcohol

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

Do not drink alcohol during treatment with venlafaxine. Taking it with alcohol may cause extreme tired游戏副本

Pregnancy and breastfeeding

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

Make sure your midwife and/or doctor knows that you are taking venlafaxine. When taking similar medicines during pregnancy (SSRIs), there may be an increased risk of the baby developing a serious condition called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, you must contact a doctor and/or midwife immediately.

If you take venlafaxine in the later 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 provide appropriate advice.

If you take this medicine during pregnancy, other symptoms your baby may have at birth include feeding difficulties and breathing problems. If your baby has these symptoms at birth and you are concerned, contact your doctor and/or midwife, who will be able to advise you.

Venlafaxine passes into breast milk. There is a risk of adverse effects on the baby; therefore, you should consult your doctor, who will decide whether to discontinue breastfeeding or discontinue treatment with this medicine.

Driving and use of machines

Do not drive or operate tools or machinery until you know how venlafaxine affects you.

Zarelis Retard contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Zarelis Retard

Follow exactly the instructions given by your doctor for taking this medicine. 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, raise 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 venlafaxine at approximately the same time each day, either in the morning or in the evening. The tablets must be swallowed whole with liquid and must not be divided, crushed, chewed, or dissolved.

Venlafaxine should be taken with food.

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

Do not stop taking venlafaxine without consulting your doctor (see section “If you stop taking Zarelis Retard”).

If you take more Zarelis Retard than you should

Contact your doctor or pharmacist immediately if you take more medicine than prescribed by your doctor.

An overdose may be life-threatening, especially when taken simultaneously with certain medications and/or alcohol (see "Other medicines and Zarelis Retard").

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Zarelis 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 your next 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 venlafaxine prescribed for you in one day.

If you stop treatment with Zarelis Retard

Do not stop taking your medication or reduce the dose without consulting your doctor, even if you feel better. If your doctor considers that you no longer need venlafaxine, they may advise you to gradually reduce the dose before stopping treatment completely. Adverse effects are known to occur when people stop taking this medicine, especially if it is stopped suddenly or if the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, lack of balance, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation, confusion, tinnitus (ringing in the ears), tingling sensations, or, less commonly, electric shock-like sensations, weakness, sweating, seizures, or flu-like symptoms, as well as vision problems and increased blood pressure (which may cause headache, dizziness, tinnitus, sweating, etc.).

Your doctor will advise you on how to gradually discontinue treatment with venlafaxine. This process may take several weeks or months. In some patients, discontinuation may need to be very gradual over periods of 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 will experience them.

If any of the following effects occur, stop taking venlafaxine. Contact your doctor immediately, 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 itchy raised 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 urticaria (raised areas of red or pale skin that often itch).
• Signs and symptoms of serotonin syndrome may include restlessness, hallucinations, lack of coordination, rapid heart rate, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting.

Serotonin syndrome, in its most severe form, may resemble Neuroleptic Malignant Syndrome (NMS). Symptoms and signs of NMS may include a combination of fever, rapid heart rate, sweating, severe muscle rigidity, confusion, and increased levels of muscle enzymes (detected by a blood test).

• Signs of infection, such as increased temperature, chills, shaking, 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 lead 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" which may include chest pain, shortness of breath, dizziness, fainting, or irregular heartbeat.

Other adverse effects about which you should inform your doctor include (the frequency of these adverse effects are included in the following list “Other adverse effects that may occur”):

• Cough, noisy breathing and difficulty breathing, which may be accompanied by increased temperature.
• Tar-like stools (faeces) or blood in the stools.
• Itching, yellowing of the 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.
• Nervous system problems, such as dizziness, tingling, movement disorders (muscle spasms or stiffness), seizures or fits.
• Psychiatric problems, such as restlessness and unusual over-excitement.
• Withdrawal effects (see section “How to take Zarelis Retard, If you stop taking Zarelis Retard”).
• Prolonged bleeding – If you are cut or injured, the bleeding may take longer than usual to stop.

Do not be concerned if you see a tablet in your feces after taking this medication. As the tablets pass through your gastrointestinal tract, venlafaxine is slowly released. The tablet's shell does not dissolve and is eliminated in the feces. Therefore, even if you see the tablet in your feces, the medication dose has been absorbed.

Other possible adverse effects

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

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

Common (may affect up to 1 in 10 people)

• Decreased appetite.
• Confusion; feeling detached (or separated) from oneself, anorgasmia, decreased libido, agitation, restlessness, abnormal dreams.
• Tremor, a sensation of restlessness or inability to sit or remain still; tingling; altered sense of taste; increased muscle tone.
• Eye disorders including blurred vision, dilated pupils, difficulty in adjusting focus from far to near.
• 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, difficulties in urination.
• Menstrual irregularities, such as increased bleeding or increased irregular bleeding, abnormal ejaculation/orgasm (in males), erectile dysfunction (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; overexcitement or euphoria; teeth grinding.
• Fainting; involuntary muscle movements; disturbance in coordination and balance.
• Feeling dizzy (especially when standing up too quickly); increased blood pressure.
• Vomiting blood, tarry stools (faeces), or blood in stools which may be signs of internal bleeding.
• Sensitivity to sunlight, bruising, abnormal hair loss.
• Inability to control urination.
• Muscle stiffness, spasms and involuntary movements.
• Slight changes in blood levels of liver enzymes.

Rare (may affect up to 1 in 1,000 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 symptoms of liver inflammation (hepatitis).

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

• Prolonged bleeding, which may be due to a low 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 bruises or broken blood vessels (broken veins).

Frequency not known (cannot be estimated from available data)

• Suicidal thoughts and behaviour. Cases of suicidal thoughts and behaviour have been reported during treatment with venlafaxine or immediately after discontinuation of treatment (see section 2, "What you should know before taking Zarelis Retard").
• Aggression.
• Dizziness.
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2, "Pregnancy and breastfeeding" for more information.

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

Reporting of adverse effects

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

5. Storage of Zarelis Retard

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

Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Blister pack: Store in the original packaging to protect it from moisture.

Bottle: Keep the bottle tightly closed to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zarelis Retard

The active substance is venlafaxine.

Each prolonged-release tablet contains 37.5 mg of venlafaxine (as hydrochloride).

The other components (excipients) are:

• Core: mannitol (E421), povidone K-90, polyethylene glycol 400, microcrystalline cellulose (E 460(i)), colloidal anhydrous silica, and magnesium stearate (E 470b).
• Coating material: cellulose acetate, polyethylene glycol 400, hypromellose, lactose monohydrate, titanium dioxide (E171), and triacetin.

Appearance of the product and contents of the pack

The 37.5 mg prolonged-release tablets are 7 mm, round, biconvex and white.

Zarelis Retard 37.5 mg is available in blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 100 and 500 tablets; and in plastic bottles containing 10, 14, 20, 28, 30, 50, 56, 60, 100 and 500 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

ITALFARMACO, S.A.

San Rafael, 3 – 28108 Alcobendas (Madrid),

Spain

Manufacturer:

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara),

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: February 2025

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

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu