VANDRAL RETARD 150 mg PROLONGED-RELEASE HARD CAPSULES

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Vandral Retard and what is it used for
2. What you need to know before you take Vandral Retard
3. How to take Vandral Retard
4. Possible side effects
5. Storing Vandral Retard
6. Contents of the pack and other information

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

Vandral Retard contains the active substance venlafaxine.

Vandral Retard 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. It is not fully understood how antidepressants work, but they may help to increase the levels of serotonin and norepinephrine in the brain.

Vandral Retard is a treatment for adults with depression. It is also a treatment for adults with the following anxiety disorders: generalised anxiety disorder, social anxiety disorder (fear or avoidance of social situations), panic disorder (panic attacks). Treating your depression or anxiety disorder properly is important to help you feel better. If it is not treated, your condition may not improve or may get worse and become more difficult to treat.

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

Do not take Vandral Retard

• If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
• If you are also taking or have taken 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 Vandral Retard can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after stopping Vandral Retard before you can take any MAOI (see also the section “Taking Vandral Retard with other medicines” and the information in that section about “Serotonin Syndrome”).

Warnings and precautions

Consult your doctor or pharmacist before taking Vandral Retard:

• If you are taking other medicines that, when taken with Vandral Retard, could increase the risk of developing serotonin syndrome (see the 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 you have an irregular heart rhythm.
• If you have a history of seizures (fits).
• If you have a history of low sodium levels in your blood (hyponatraemia).
• If you have a history of bleeding disorders, or if you are taking other medicines that may increase the risk of bleeding, e.g. warfarin (used to prevent blood clots), or if you are pregnant (see section Pregnancy, breast-feeding and fertility).
• If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling overexcited or irrationally happy).
• If you have a history of aggressive behaviour.

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

Do not drink alcohol while you are taking Vandral Retard, as it may increase the risk of side effects. Taking Vandral Retard in combination with certain medicines or alcohol may increase the risk of side effects, such as drowsiness, and may worsen your depression or other medical 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 can sometimes have thoughts of harming yourself or suicide. These thoughts may be increased when you first start taking antidepressants, since these medicines all take time to work, usually about 2 weeks, but sometimes longer. These thoughts may also occur when your dose is reduced or when you stop taking Vandral Retard.

This is more likely to happen if:

• You have previously had thoughts about killing yourself or harming yourself.
• You are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

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

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 might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Dry mouth

Dry mouth has been reported in 10% of patients treated with venlafaxine. This may increase the risk of tooth decay. Therefore, you should pay attention to your dental hygiene.

Diabetes

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

Sexual problems

Some medicines of the same group as Vandral Retard (so-called SNRIs) may cause sexual dysfunction (see section 4). In some cases, these sexual problems persist after stopping treatment.

Children and adolescents

Vandral Retard should not normally be used in the treatment of children and adolescents under 18 years of age. In addition, you should know that in patients under 18 years of age, there is an increased risk of side effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe this medicine to patients under 18 years of age when it is in their best interests. If your doctor has prescribed this medicine to a patient under 18 years of age and you want to discuss this, please contact your doctor. You should inform your doctor if any of the above symptoms occur or get worse when patients under 18 years of age are taking Vandral Retard.

Furthermore, the long-term safety of Vandral Retard in relation to growth, maturation, and cognitive and behavioural development in this age group has not been demonstrated.

Taking Vandral Retard with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

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

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

• Irreversible monoamine oxidase inhibitors 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 you take Vandral Retard”).

• Serotonin Syndrome:

A potentially life-threatening condition or reactions similar to Neuroleptic Malignant Syndrome (NMS) (see section “Possible side effects”) may occur with venlafaxine treatment, particularly when taken with other medicines.

Examples of these medicines include:

• Triptans (used for migraine)
• Other medicines for treating 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 (such as buprenorphine, tramadol, fentanyl, tapentadol, pethidine, or pentazocine) used to treat severe pain
• Medicines containing dextromethorphan (used to treat coughs)
• Medicines containing methadone (used for addiction to opioids or for severe pain treatment)
• 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 herbal remedy used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and depression)
• Antipsychotics (used to treat a disease with symptoms such as hearing, seeing, or feeling things that are not there, mistaken beliefs, unusual suspiciousness, unclear reasoning, and a tendency to withdraw)

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

restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). The signs and symptoms of NMS may include a combination of fever, fast heart beat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).

Tell your doctor immediately or go to the casualty department of the nearest hospital if you think you are experiencing serotonin syndrome.

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

Some examples of these medicines include:

• Anti-arrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat irregular heart rhythms)
• Antipsychotics such as thioridazine (see also serotonin syndrome above)
• Antibiotics such as erythromycin or moxifloxacine (used to treat bacterial infections)
• Antihistamines (used to treat allergies)

The following medicines may also interact with Vandral Retard 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 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 while you are taking Vandral Retard. Drinking alcohol while taking Vandral Retard may cause drowsiness and may worsen your depression or other medical conditions, such as anxiety disorders.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should only take Vandral Retard after discussing the potential benefits and risks with your doctor.

Make sure your midwife and/or doctor know you are taking Vandral Retard. When similar medicines (SSRIs) are taken during pregnancy, they may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start during the first 24 hours after the baby is born. If this happens to your baby, you should contact your midwife and/or doctor immediately.

If you take Vandral Retard during the last trimester of your pregnancy, you should be aware that the following effects may be seen in your newborn baby: trouble with breathing, blue discolouration of the skin, fitting, temperature instability, feeding difficulties, irritability, shakiness or stiffness, limpness, and/or weak crying. If your newborn baby has any of these symptoms, you should contact your doctor or midwife.

Vandral Retard passes into breast milk. There is a risk of an effect on the baby. Therefore, you should discuss the matter with your doctor, and he/she will decide whether you should stop breast-feeding or stop the treatment with Vandral Retard.

Driving and using machines

Do not drive or use any tools or machines until you know how Vandral Retard affects you.

Vandral Retard contains sodium

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

3. How to take Vandral Retard

Take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The usual recommended starting dose for the treatment of depression, generalised 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 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 generalised 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 should be swallowed whole with fluid and should not be opened, crushed, chewed, or dissolved.

Vandral Retard should be taken with food.

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

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

If you take more Vandral Retard than you should

In case of overdose or accidental intake, contact your doctor, pharmacist, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

Overdose can put your life at risk, especially when taken with certain medicines and/or alcohol (see Taking Vandral Retard with other medicines).

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 Vandral Retard

If you miss a dose, take it as soon as you remember. However, if it is 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 a forgotten dose. Do not take more than the prescribed daily dose of Vandral Retard in one day.

If you stop taking Vandral Retard

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

Your doctor will advise you how to gradually stop taking Vandral Retard. This may take several weeks or months. In some patients, the withdrawal may need to be very gradual over several months or longer. If you experience any of these or other symptoms that are troublesome for you, contact your doctor for advice.

If you have any further questions on 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 all people suffer from them.

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

Uncommon (may affect up to 1 in 100 people)

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

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

• Chest oppression, breathing noise, difficulty swallowing or breathing.
• Severe skin rash, itching, or hives (elevated areas of reddened or pale skin that often itch).
• Signs and symptoms of serotonin syndrome that may include agitation, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome can resemble neuroleptic malignant syndrome (NMS). The signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined 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 can lead 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 the available data)

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

Other adverse effects that you should inform your doctor aboutare (the frequency of these adverse effects is included in the list below "other adverse effects that may occur"):

• Cough, breathing noise, and difficulty breathing that may be accompanied by a high temperature.
• Black stools (deposits) or blood in stools.
• Itching, yellow 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 disorder (muscle spasms and stiffness), convulsions, or seizures.
• Psychiatric problems, such as hyperactivity (unusual feeling of overexcitement).
• Withdrawal effects (see section "How to take Vandral Retard, if you interrupt treatment with Vandral Retard").
• Prolonged bleeding, if you cut or injure yourself, it may take a little longer than usual for the bleeding to stop.

Do not worry if you notice white balls or small granules in your stools after taking this medicine. Inside the Vandral Retard capsules, there are spheroids (small white balls) that contain the active ingredient (venlafaxine). These spheroids are released from the capsule in the stomach. As they circulate through the stomach and intestines, venlafaxine is slowly released. The "shell" of the spheroid does not dissolve and is eliminated in the stools. Therefore, although you may see spheroids in the 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, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams.
• Tremors, a feeling 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 change focus from distant to near objects.
• Ringing in the ears (tinnitus).
• Rapid heartbeat, palpitations.
• Increased blood pressure, hot flashes.
• Difficulty breathing, yawning.
• Vomiting, diarrhea.
• Mild skin rash, itching.
• Increased urination frequency, inability to urinate, difficulty urinating.
• Menstrual irregularities, such as increased bleeding or irregular bleeding, abnormal ejaculation/orgasm (men), erectile dysfunction (impotence).
• Weakness (asthenia), fatigue, chills.
• Weight gain or loss.
• Increased cholesterol.

Uncommon (may affect up to 1 in 100 people)

• Hyperactivity, accelerated thoughts, and decreased need for sleep (mania).
• Hallucinations, feeling detached from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, teeth grinding.
• Fainting, involuntary muscle movements, altered coordination and balance.
• Feeling dizzy (especially when getting up too quickly), decreased blood pressure.
• Vomiting blood, black stools (deposits) or blood in stools, which may be a sign of internal bleeding.
• Sensitivity to sunlight, bruising, abnormal hair loss.
• Inability to control urination.
• Stiffness, spasms, and involuntary muscle movements.
• Mild changes in blood levels of liver enzymes.

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

• Seizures or convulsions.
• Cough, breathing noise, and shortness of breath that may be accompanied by a high temperature.
• Disorientation and confusion often accompanied by hallucinations (delirium).
• Excessive water intake (known as SIADH).
• Decreased sodium levels in the blood.
• Severe eye pain and reduced or blurred vision.
• Abnormal heartbeat, rapid or irregular, which may lead to fainting.
• Severe abdominal or back pain (which may indicate a serious problem in the intestine, liver, or pancreas).
• Itching, yellow eyes or skin, dark urine, 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 reduced number of platelets in the blood that leads to an increased risk of bruising or bleeding.
• Abnormal milk production.
• Unexpected bleeding, for example, bleeding from the gums, blood in urine or vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins).

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

• Suicidal thoughts and behavior, cases of suicidal thoughts and behavior have been reported during treatment with venlafaxine or shortly after stopping treatment (see section 2. "What you need to know before taking Vandral Retard").
• Aggression.
• Dizziness.
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

Vandral Retard sometimes produces unwanted effects that you may not be aware of, such as increased blood pressure or an abnormal heartbeat; 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 want to perform occasional blood tests, especially if you have been taking Vandral Retard for a long time.

Reporting of Adverse Effects

If you experience any 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 Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Vandral Retard

The active ingredient 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 ingredients are:

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

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

Capsule printing ink:shellac, iron oxide red (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 ingredients are:

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

Capsule shell:gelatin, iron oxide red and yellow (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 ingredients are:

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

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

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

Product Appearance and Package Contents

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

Vandral Retard 75 mg is available in:

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

Unit-dose blister packages of 14, 28, 84, and 100 hard capsules.

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

Vandral Retard 150 mg is available in:

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

Unit-dose blister packages of 14, 28, 84, and 100 hard capsules.

Vandral Retard 225 mg is an opaque capsule with a light gray shell and dark orange body, with "W" and "225" in white print

Vandral Retard 225 mg is available in:

Packages with blisters of 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 98, 100 and clinical packages of 500 (10x50) and 1,000 (10x100).

Unit-dose blister packages of 14, 28, 84, and 100 hard capsules.

Not all package 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

Pfizer Ireland Pharmaceuticals

Little Connell

Newbridge

County Kildare

Ireland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

Calle General Aranaz, 86

28027 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names*:

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

Date of the last revision of this leaflet: July 2023

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