Zarelis Retard 300 mg prolonged-release tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

ZARELIS Retard 300 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 must not be given to other people, even if they have the same symptoms as you, as it may 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 adverse effects

5. Storage of 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.

Zarelis Retard 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.

Zarelis Retard is a treatment for depression in adults. 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 starting 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 also taking, or have taken within the last 14 days, any medicine known as an irreversible monoamine oxidase inhibitor (MAOI), used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with venlafaxine may cause serious, and potentially life-threatening, adverse effects. In addition, you must wait at least 7 days after stopping venlafaxine before taking any irreversible MAOI (see also the section entitled “Other medicines and Zarelis Retard” and the information in that section regarding “Serotonin syndrome”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take venlafaxine.

• 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 via normal peristaltic 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 an abnormal heart rhythm.
• 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 or a family member has had a history of mania or bipolar disorder (feeling overexcited or euphoric).
• If you have a history of aggressive behavior.

Venlafaxine may cause a feeling of restlessness or an inability to sit or stay still during the first weeks of treatment. You should consult your doctor if this occurs.

Do not drink alcohol during treatment with Zarelis Retard, as it may cause extreme drowsiness and loss of consciousness. 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 an anxiety disorder, you may sometimes have thoughts of harming yourself or of suicide. These suicidal thoughts may increase when starting antidepressant therapy, as all these medicines take time to become effective, usually about two weeks, but sometimes longer. These thoughts may also occur when your dose is reduced or during discontinuation of venlafaxine treatment.

You are more likely to experience this if:

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

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

It may be 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 wish to ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.

Dry mouth

Dry mouth has been reported in 10% of patients treated with venlafaxine. This may increase the risk of dental problems (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 in the group to which venlafaxine belongs (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 in patients under 18 years of age, there is an increased risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (predominantly aggression, confrontation behavior, and irritability) when taking this type of medication. Nevertheless, the physician in charge may prescribe this medicine to patients under 18 years of age if they decide it is the most appropriate option for the patient. If your physician 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. Furthermore, the long-term effects on safety, as well as on growth, maturation, and cognitive and behavioral development, of this medicine have not yet been established.

Other medicines and Zarelis Retard

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

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

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

• Monoamine oxidase inhibitors (MAOIs), which are used to treat depression or Parkinson’s disease, must not be used with venlafaxine. Inform your doctor if you have taken these medicines within the last 14 days (MAOIs: see section “What you need to know before taking Zarelis Retard”).

• Serotonin syndrome:

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 these 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, 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 elevated levels of methemoglobin 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 auditory, visual, or perceptual hallucinations, false beliefs, unusual distrust, confused 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.

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 in blood).

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

You should inform your doctor if you are taking medicines that affect heart rhythm. Examples of these medicines include:

• antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat heart rhythm disorders)
• 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 (to treat psychiatric conditions)
• metoprolol (a beta-blocker used to treat high blood pressure and heart problems)

Use of Zarelis Retard with food, drinks, and alcohol

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, if you think you may be pregnant, or if you are planning to have a baby, 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 similar medicines (known as serotonin reuptake inhibitor antidepressants: SSRIs) are taken during pregnancy, 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 bluish. These symptoms usually begin within the first 24 hours after birth. If this occurs in your case, 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 Zarelis Retard so they can advise you appropriately.

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 effects on the breastfed infant; therefore, you must discuss this with your doctor, who will decide whether you should discontinue breastfeeding or discontinue treatment with this medicine.

Driving and operating machinery

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

Zarelis Retard contains lactose

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

3. How to take Zarelis Retard

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

The usual starting dose recommended 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.

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 opened, crushed, chewed, or dissolved.

Zarelis Retard 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 venlafaxine without consulting your doctor (see section “If you stop treatment with 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. You may also contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

Overdose may be life-threatening, especially when taken simultaneously with certain medicines and/or alcohol (see section "Taking Zarelis Retard 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 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 a forgotten dose. 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 instruct 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 the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, lack of coordination, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation, confusion, tinnitus, tingling sensations, or, in rare cases, electric shock-like sensations, weakness, sweating, seizures, flu-like symptoms, vision problems, and increased blood pressure (which may cause headache, dizziness, tinnitus, sweating, etc.).

Your doctor will advise you on how to gradually discontinue venlafaxine treatment. 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 experiences them.

If any of the following effects occur, stop taking venlafaxine immediately. Inform 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, swollen 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 hyperactivity, hallucinations, lack of coordination, rapid heart rate, increased body temperature, rapid changes in blood pressure, hyperactive 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 in blood tests).

• 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 progress to the formation of severe blisters and skin peeling.
• Unexplained muscle pain, tenderness, or weakness. This may be a sign of rhabdomyolysis.

Frequency unknown (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, and irregular heartbeats.

Other side effects that you should report to your doctor include (the frequency of these adverse effects are included in the list below “Other adverse effects that may occur”):

• Cough, noisy breathing, and difficulty breathing, which may be accompanied by increased temperature.
• Tarry 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 and stiffness), seizures or fits.
• Psychiatric problems, such as hyperactivity and euphoria (unusual excitement).
• Effects due to discontinuation of treatment (see section “How to take Zarelis Retard, If you stop taking Zarelis Retard”).
• Prolonged bleeding – If you are cut or injured, bleeding from the wound 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 structure 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 adverse effects that may occur

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 from oneself, anorgasmia, decreased libido, agitation.
• Nervousness, abnormal dreams.
• Tremors, a feeling of restlessness or inability to sit still or remain motionless, altered taste perception, increased muscle tone.
• Eye disorders including blurred vision; dilated pupils, difficulty focusing the eyes when shifting from far to near vision.
• Ringing in the ears (tinnitus).
• Fast 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 (men); 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), decreased coordination and balance.
• Vomiting blood, tarry stools (faeces) or blood in the stools, which may be signs of internal bleeding.
• Sensitivity to sunlight, bruising, rash.
• Inability to control urine.
• Muscle stiffness, spasms and involuntary muscle movements. Mild changes in blood levels of liver enzymes.

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

• 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 low number of platelets in the blood leading to increased bruising or bleeding.
• Abnormal production of breast milk.
• Unexpected bleeding, for example bleeding from the gums, blood in urine or vomit, or the appearance of bruises or broken blood vessels (ruptured veins).

Frequency not known (cannot be estimated from the available data)

• Suicidal thoughts and behaviour. Cases of suicidal thoughts and behaviour have been reported during venlafaxine therapy or immediately after discontinuation of treatment (see section 2, What you need to know before taking Zarelis Retard).
• Aggression.
• Dizziness.
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage). See “Pregnancy and breastfeeding” in section 2 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; mild changes in blood levels of liver enzymes, sodium or cholesterol. Less frequently, Zarelis Retard may reduce the function of blood platelets, leading to an increased risk of bruising or bleeding. Therefore, your doctor may wish to carry out occasional blood tests, particularly if you have been taking Zarelis Retard for a long time.

If you experience any of these adverse effects, inform your doctor or pharmacist. This includes any adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not mentioned in this leaflet. You can also report them directly via the Spanish System for Pharmacovigilance of 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 packaging, after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature. Store in the original packaging to protect it from moisture.

Do not dispose of any medicine via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Zarelis Retard

The active substance is venlafaxine.

Each tablet contains 300 mg of venlafaxine (as hydrochloride).

The other components are: mannitol (E421), povidone, macrogol, anhydrous colloidal silica, microcrystalline cellulose (E 460(i)), magnesium stearate (E 470b), cellulose acetate, hypromellose, lactose monohydrate, titanium dioxide (E171), and triacetin.

Appearance of the product and contents of the pack

Extended-release tablets 300 mg, round, biconvex, white or almost white.

Zarelis Retard 300 mg is available in blisters of 10, 14, 20, 28, 30, 42, 50, 56, 60, 98, 100 and 500 tablets. Only certain pack sizes may be marketed.

Marketing Authorization Holder:

ITALFARMACO, S.A.

San Rafael, 3 – 28108 Alcobendas (Madrid), SPAIN

Manufacturer responsible:

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara), SPAIN

or

Sandoz A/S

Edvard Thomsens Vej 142300 København S,

Denmark

or

Genericon Pharma

Gesellschaft m.b.H.,

Hafnerstrasse 211, 8054 Graz,

Austria

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

Member State	Medicinal Product Name
Sweden	Venlafaxin Liconsa 75mg prolonged-release tablets
Austria	Venlafaxin +pharma 75mg Retard tablets
Spain	Zarelis Retard 75mg prolonged-release tablets
Hungary	Faxiprol 75mg retard tablet
Germany	Venlafaxin AAA-Pharma 75mg Retard tablets
Finland	Venlafaxin Sandoz 75 mg prolonged-release tablets

Date of most recent review of this leaflet: February 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines 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