Vandral Retard 75 mg prolonged-release hard capsules

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Vandral Retard 75 mg prolonged-release hard capsules

Vandral Retard 150 mg prolonged-release hard capsules

Vandral Retard 225 mg prolonged-release hard capsules

venlafaxine

Read the entire leaflet carefully before starting to take 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 the effects are not listed in this leaflet. See section 4.

Package leaflet contents:

1. What Vandral Retard is and what it is used for
2. What you need to know before taking Vandral Retard
3. How to take Vandral Retard
4. Possible side effects
5. Storage of Vandral Retard
6. Package contents and additional information

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

Vandral Retard contains the active substance venlafaxine.

Vandral Retard is an antidepressant that belongs to a group of medicines called serotonin and noradrenaline 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 noradrenaline in the brain.

Vandral Retard 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 appropriately 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.

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

Do not take Vandral 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 Vandral Retard may cause serious, and potentially life-threatening, adverse effects. In addition, you must wait at least 7 days after stopping Vandral Retard before taking any MAOI (see also section “Taking Vandral Retard with other medicines” and the information in that section on “Serotonin Syndrome”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Vandral Retard:

• If you are taking other medicines that, when taken together with Vandral Retard, could increase the risk of developing serotonin syndrome (see section “Taking Vandral Retard with other medicines”).
• If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have been told that your heart rhythm is abnormal.
• If you have a history of seizures (fits).
• If you have a history of low sodium levels in the blood (hyponatremia).
• If you have a 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, breastfeeding and fertility).
• If you have a history of, or if a member of your family has had, mania or bipolar disorder (feeling overexcited or euphoric).
• If you have a history of aggressive behaviour.

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

Do not drink alcohol during treatment with Vandral Retard, 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 have anxiety disorders, you may sometimes experience thoughts of harming yourself or suicide. These thoughts may increase when you first start taking antidepressants, as all these medicines take time to work, usually about two weeks, although sometimes longer. These thoughts may also occur when your dose is reduced or during discontinuation of treatment with Vandral Retard.

You are more likely to experience this:

• 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 harming yourself or committing suicide at any time, contact your doctor immediately or go directly to a hospital.

It may be helpful to tell a close family member or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may also ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.

Dry mouth

Dry mouth has been reported in 10% of patients treated with venlafaxine. This may increase the risk of tooth decay (caries). Therefore, you should take care with your dental hygiene.

Diabetes

Your blood glucose levels may be altered by Vandral Retard. Therefore, the doses of your diabetes medications may need to be adjusted.

Sexual problems

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

Children and adolescents

Vandral Retard 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 suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) 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 the most appropriate option for the patient. If your doctor has prescribed this medicine to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You must inform your doctor if any of the symptoms listed above develop or worsen while these patients under 18 years of age are taking Vandral Retard.

Furthermore, long-term safety with regard to growth, maturation, and cognitive and behavioral development has not been established.

Taking Vandral Retard with other medicines

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

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

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

• Monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease must not be taken with Vandral Retard. Tell your doctor if you have taken any of these medicines within the last 14 days. (MAOIs: see section “What you need to know before starting to take Vandral Retard”).

• Serotonin syndrome:

A potentially life-threatening condition, or reactions resembling Neuroleptic Malignant Syndrome (NMS) (see section “Possible Side Effects”), may occur during treatment with venlafaxine, particularly when taken with other medicines.

Examples of such medicines include:

• Triptans (used for migraine)
• Other medicines to treat depression, for example, SNRIs, SSRIs, tricyclic antidepressants, or medicines containing lithium
• Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder [ADHD], narcolepsy, and obesity)
• Medicines containing the antibiotic linezolid (used to treat infections)
• Medicines containing moclobemide, an MAOI (used to treat depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing opioids (e.g., buprenorphine, tramadol, fentanyl, tapentadol, meperidine, or pentazocine) used to treat severe pain
• Medicines containing dextromethorphan (used to treat cough)
• Medicines containing methadone (used for opioid addiction treatment or for treating severe pain)
• Medicines containing methylene blue (used to treat elevated blood methemoglobin levels)
• 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 and depression)
• Antipsychotics (used to treat a disorder with symptoms such as hearing, seeing, or feeling things that are not real, false beliefs, unusual suspicion, unclear thinking, and tendency to withdraw)

Signs and symptoms of serotonin syndrome may include a combination of the following:

restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (determined by a blood test).

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

Inform your doctor if you are taking medicines that may affect your heart rhythm.

Some examples of such medicines include:

• Antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat irregular 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 allergy)

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

• Ketoconazole (an antifungal medicine).
• Haloperidol or risperidone (to treat psychiatric conditions).
• Metoprolol (a beta-blocker used to treat high blood pressure and heart problems).

Taking Vandral Retard with food, drinks and alcohol

Vandral Retard should be taken with food (see section 3 "How to take Vandral Retard").

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

Pregnancy, breastfeeding and fertility

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

Ensure that your midwife and/or doctor knows that you are taking Vandral Retard. When taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and turn blue. These symptoms usually begin within the first 24 hours after the baby's birth. If this happens to your baby, contact your midwife and/or doctor immediately.

If you take Vandral Retard in the late stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Vandral Retard so they can advise you appropriately.

If you take this medicine during pregnancy, in addition to breathing problems, another symptom your baby may have at birth is feeding difficulties. If your baby shows these symptoms at birth and you are concerned, contact your doctor and/or midwife, who will be able to advise you.

Vandral Retard passes into breast milk. There is a risk of adverse effects on the breastfed infant. Therefore, you must discuss this with your doctor, who will decide whether to discontinue breastfeeding or to discontinue treatment with this medicine.

Driving and operating machinery

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

Vandral Retard contains sodium

Vandral Retard 150 mg and 225 mg capsules contain less than 23 mg of sodium (1 mmol) per capsule; this is essentially "sodium-free".

3. How to take Vandral Retard

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

The usual recommended starting dose for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose, and if necessary, further up to a maximum of 375 mg per day for depression. If you are being treated for panic disorder, your doctor will start with a lower dose (37.5 mg) and then gradually increase the dose. The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg/day.

Take Vandral Retard at approximately the same time each day, either in the morning or in the evening. The capsules must be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.

Vandral Retard should be taken with food.

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

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

If you take more Vandral Retard than you should

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

Overdose can be life-threatening, especially when taken simultaneously with certain medicines and/or alcohol (see section "Taking Vandral Retard with other medicines").

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

If you forget to take Vandral 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 a 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 Vandral Retard prescribed for you in one day.

If you stop taking Vandral 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 Vandral Retard, 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, aggressiveness, tiredness, dizziness, lack of coordination, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling sensations, or, rarely, electric shock-like sensations, weakness, sweating, seizures, or flu-like symptoms, vision problems, and increased blood pressure (which may cause headache, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you on how to gradually discontinue treatment with Vandral Retard. This process may take several weeks or months. In some patients, discontinuation may need to be very gradual over months or longer. If you experience any of these or other bothersome symptoms, consult your doctor for advice.

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

4. Possible adverse effects

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

If you experience any of the following effects, stop taking Vandral Retard immediately and inform your doctor right away or go to the nearest hospital emergency department:

Uncommon (may affect up to 1 in 100 people)

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

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

• Chest tightness, noisy breathing, difficulty swallowing or breathing.
• Severe skin rash, itching or 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 heartbeat, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (detected by a blood test).

• Signs of infection, such as increased temperature, chills, shivering, 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, discomfort or weakness. This may be a sign of rhabdomyolysis.

Frequency not known (cannot be estimated from available data)

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

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

• Cough, noisy breathing, and difficulty breathing, which may be accompanied by an increase in temperature.
• Tar-like stools or blood in stools.
• Itching, yellowing of the eyes or skin, dark urine, which are symptoms of liver inflammation (hepatitis).
• Heart problems, such as rapid or irregular heartbeat, increased blood pressure.
• Eye problems, such as blurred vision, dilated pupils.
• Nerve problems, such as dizziness, tingling, movement disorders (muscle spasms and stiffness), seizures or fits.
• Psychiatric problems, such as hyperactivity (unusual feeling of over-excitement).
• Withdrawal effects (see section “How to take Vandral Retard, if you stop taking Vandral Retard”).
• Prolonged bleeding: if you cut yourself or sustain a wound, it may take slightly longer than normal for the bleeding to stop.

Do not be concerned if you notice white pellets or small granules in your stools after taking this medicine. Inside the Vandral Retard capsules there are spheroids (small white pellets) containing the active substance (venlafaxine). These spheroids are released from the capsule in the stomach. As they pass through the stomach and intestines, venlafaxine is slowly released. The “shell” of the spheroid does not dissolve and is eliminated in the stool. Therefore, even if you see spheroids in your stools, the dose of the medicine has been absorbed.

Other adverse effects that may occur

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

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

Common (may affect up to 1 in 10 people)

• Decreased appetite.
• Confusion, feeling strange, anorgasmia, decreased libido, agitation, restlessness, abnormal dreams.
• Tremor, a sensation of restlessness or inability to remain seated or still, tingling, altered taste perception, increased muscle tone.
• Visual disturbances including blurred vision, dilated pupils, inability of the eye to automatically adjust focus from distant to near objects.
• Ringing in the ears (tinnitus).
• Rapid heartbeat, palpitations.
• Increased blood pressure, hot flushes.
• Difficulty breathing, yawning.
• Vomiting, 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 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, feeling overexcited, teeth grinding.
• Fainting, involuntary muscle movements, impaired coordination and balance.
• Feeling dizzy (especially when standing up too quickly), decreased blood pressure.
• Vomiting blood, tarry stools (faeces) or blood in stools, which may be a sign 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 signs of liver inflammation (hepatitis).

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

• Prolonged bleeding, which may be due to a reduced number of platelets in the blood leading to an increased risk of bruising or bleeding.
• Abnormal production of breast milk.
• Unexpected bleeding, for example, bleeding from the gums, blood in urine or vomit, or the appearance of unexpected bruises or broken blood vessels (ruptured veins).

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

• Suicidal thoughts and suicidal behaviour; cases of suicidal thoughts and behaviour have been reported during treatment with venlafaxine or shortly after discontinuation of treatment (see section 2, “What you need to know before taking Vandral Retard”).
• Aggression.
• Dizziness.
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for more information.

Vandral Retard may sometimes cause side 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, Vandral 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 Vandral Retard for a long time.

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor, pharmacist or nurse, 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 Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of VANDRAL RETARD

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

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

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Vandral Retard

The active substance is venlafaxine.

Vandral Retard 75 mg:

Each prolonged-release capsule contains 84.85 mg of venlafaxine hydrochloride, equivalent to 75 mg of venlafaxine base.

The other components are:

Capsule contents: microcrystalline cellulose, ethylcellulose, hypromellose, talc.

Capsule shell: gelatin, red and yellow iron oxides (E172), titanium dioxide (E171).

Capsule printing ink: shellac, red iron oxide (E172), ammonium hydroxide, simethicone, propylene glycol.

Vandral Retard 150 mg:

Each prolonged-release capsule contains 169.7 mg of venlafaxine hydrochloride, equivalent to 150 mg of venlafaxine base.

The other components are:

Capsule contents: microcrystalline cellulose, ethylcellulose, hypromellose, talc.

Capsule shell: gelatin, red and yellow iron oxides (E172), titanium dioxide (E171).

Capsule printing ink: shellac, sodium hydroxide (see section 2), povidone, titanium dioxide (E171), propylene glycol.

Vandral Retard 225 mg:

Each prolonged-release capsule contains 254.52 mg of venlafaxine hydrochloride, equivalent to 225 mg of venlafaxine base.

The other components are:

Capsule contents: microcrystalline cellulose, ethylcellulose, hypromellose, talc.

Capsule shell: gelatin, black, red and yellow iron oxides (E172), titanium dioxide (E171).

Capsule printing ink: shellac, sodium hydroxide (see section 2), povidone, titanium dioxide (E171), propylene glycol.

Appearance of the product and contents of the pack

Vandral Retard 75 mg is an opaque, peach-coloured, prolonged-release hard (gelatin) capsule, 19.4 mm x 6.91 mm, with a 'W' and the dose '75' printed in red.

Vandral Retard 75 mg is available in:

Blister packs containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 98, and 100 hard capsules, clinical packs of 500 (10x50) and 1,000 (10x100) hard capsules, or in plastic (HDPE) bottles containing 14, 20, 50, and 100 hard capsules and clinical packs of 500 and 1,000 hard capsules.

Unit-dose blister packs containing 14, 28, 84, and 100 hard capsules.

Vandral Retard 150 mg is an opaque, orange-coloured, prolonged-release hard (gelatin) capsule, 23.5 mm x 7.65 mm, with a 'W' and the dose '150' printed in white.

Vandral Retard 150 mg is available in:

Blister packs containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 98, and 100 hard capsules, clinical packs of 500 (10x50) and 1,000 (10x100) hard capsules, or in plastic (HDPE) bottles containing 14, 20, 50, and 100 hard capsules and clinical packs of 500 and 1,000 hard capsules.

Unit-dose blister packs containing 14, 28, 84, and 100 hard capsules.

Vandral Retard 225 mg is an opaque capsule with a light grey coat and a dark orange body, with "W" and "225" printed in white.

Vandral Retard 225 mg is available in:

Blister packs containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 98, and 100 hard capsules, and clinical packs of 500 (10x50) and 1,000 (10x100).

Unit-dose blister packs containing 14, 28, 84, and 100 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder, Manufacturer, and Local Representative

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

or

FAMAR HEALTH CARE SERVICES MADRID, S.A.U.

Avda. Leganés, 62

Alcorcón

28923 Madrid

Spain

For further information regarding this medicinal product, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

Calle General Aranaz, 86

28027 Madrid

Spain

This medicinal product is authorized in the European Economic Area member states and in the United Kingdom (Northern Ireland) under the following names*:

* The list of brand names follows in subsequent text.

Austria	Efectin ER 37.5 mg Capsules Efectin ER 75 mg Capsules Efectin ER 150 mg Capsules
Belgium, Luxembourg	Efexor-Exel 37.5 Efexor-Exel 75 Efexor-Exel 150 Efexor-Exel 225
Bulgaria	Efectin ER 75 mg Efectin ER 150 mg
Czech Republic	Efectin ER 37.5 mg Efectin ER 75 mg Efectin ER 150 mg
Cyprus, Greece, Estonia, Lithuania, Portugal	Efexor XR
Latvia	Efexor XR Efexor XR 75 Efexor XR 150
Denmark, Finland, Iceland, Norway, Sweden	Efexor Depot
France	Effexor L.P.
Germany	Trevilor retard 37.5 mg Trevilor retard 75 mg Trevilor retard 150 mg
Ireland, Malta, United Kingdom (Northern Ireland)	Efexor XL
Netherlands	Efexor XR 37.5 Efexor XR 75 Efexor XR 150
Italy	Efexor Faxine
Poland	Efectin ER 37.5 Efectin ER 75 Efectin ER 150
Romania	Efectin EP 37.5 mg Efectin EP 75 mg Efectin EP 150 mg
Slovenia	Efectin ER 37.5 mg modified release hard capsules Efectin ER 75 mg modified release hard capsules Efectin ER 150 mg modified release hard capsules
Spain	Vandral Retard 75 mg prolonged release hard capsules Vandral Retard 150 mg prolonged release hard capsules Vandral Retard 225 mg prolonged release hard capsules

*[Please note that not all products and concentrations listed may be commercially available].

Date of the most recent review of this leaflet: July 2023

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