Prospect: information for the patient

Venlafaxine Retard Sandoz75 mg hard capsulesof prolonged release EFG

Venlafaxine Retard Sandoz150 mg hard capsulesof prolonged release EFG

Venlafaxine Retard Sandoz225 mg hard capsulesof prolonged release EFG

venlafaxine

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the samesymptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Content of the prospect:

1. 1. What is Venlafaxine Retard Sandoz and for what it is used
2. What you need to know before starting to take Venlafaxine Retard Sandoz
3. How to takeVenlafaxineRetardSandoz
4. Possible adverse effects
5. Storage of Venlafaxine RetardSandoz

6.Content of the package and additional information

Venlafaxina Retard Sandoz contains the active ingredient venlafaxine.

Venlafaxina Retard Sandoz 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 exact way in which antidepressants work is not fully understood, but they may help to increase levels of serotonin and noradrenaline in the brain.

Venlafaxina Retard Sandoz 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 depressive and anxiety disorders properly is important to help you feel better. If left untreated, your condition may not go away or may worsen and become harder to treat.

Do not take Venlafaxina Retard Sandoz

• 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 in the last 14 days, any medicine known as an irreversible monoamine oxidase inhibitor (IMAO) used to treat depression or Parkinson's disease. Taking an IMAO irreversible with venlafaxine may cause severe or potentially fatal side effects. Also, you should wait at least 7 days after stopping venlafaxine before taking any IMAO (see also the section “Other medicines and Venlafaxina Retard Sandoz” and the information in that section on “Serotonin Syndrome”).

Warnings and precautions

Consult your doctor or pharmacistbeforestarting to take Venlafaxina Retard Sandoz:

• If you are taking other medicines that, taken together with venlafaxine, may increase the risk of developing serotonin syndrome (see the section “Other medicines and Venlafaxina Retard Sandoz”),
• 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,
• If you have a history of low sodium levels in the blood (hyponatremia),
• If you have a tendency to develop bleeding or bruising easily (a history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding, for example, warfarin (used to prevent blood clots), or if you are pregnant (see “Pregnancy”),
• If you have a history of mania or bipolar disorder (feeling overexcited or euphoric),
• If you have a history of aggressive behavior.

Venlafaxine may cause restlessness or difficulty sitting or staying still during the first few weeks of treatment. You should consult your doctor if this happens.

Do not drink alcohol during treatment with venlafaxine, as it may cause extreme drowsiness and unconsciousness. Taking it with certain medicines and/or alcohol may worsen the symptoms of depression and other conditions, such as anxiety disorders.

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or suicide. This may be more likely to happen:

• If you have had thoughts of suicide or self-harm before,
• If you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in young adults (less than 25 years old) with psychiatric disorders treated with antidepressants.

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

You may find it 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 can also ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Dry mouth

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

Diabetes

Your blood glucose levels may be affected by venlafaxine. Therefore, your doses of diabetes medicines may need to be adjusted.

Sexual problems

Some medicines in the group to which venlafaxine belongs (called ISRS/IRSN) may cause sexual symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents

Venlafaxine should not normally be used in the treatment of children and adolescents under 18 years old. You should also know that in patients under 18 years old, there is a higher risk of side effects such as suicidal thoughts, suicidal behavior, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. However, your doctor may prescribe this medicine for patients under 18 years old if they decide it is the best option for the patient. If your doctor has prescribed this medicine for a patient under 18 years old, and you want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen in these patients under 18 years old who are taking venlafaxine.Additionally, the long-term safety in relation to growth, maturation, and cognitive and behavioral development has not been demonstrated.

Other medicines and Venlafaxina Retard Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Your doctor should decide if you can take Venlafaxina Retard Sandoz with other medicines.

Do not start or stop taking any medicine, including those available over the counter, natural remedies, or herbal remedies, without checking with your doctor or pharmacist.

• Irreversible monoamine oxidase inhibitors used to treat depression or Parkinson's diseaseshould not be taken with Venlafaxina Retard Sandoz. Tell your doctor if you have taken any of these medicines in the last 14 days. (IMAO: see section “What you need to know before starting to take Venlafaxina Retard Sandoz”).
• Serotonin syndrome:

A potentially fatal condition, or reactions similar to Neuroleptic Malignant Syndrome (NMS) (see section “Possible Side Effects”) may occur with treatment with venlafaxine, particularly when taken with other medicines. Examples of these medicines include:

• Triptans (used for migraines),
• Other medicines for treating depression, for example, ISRN, ISRS, 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 IMAO (used to treat depression),
• Medicines containing sibutramine (used for weight loss),
• Medicines containing opioids (e.g., buprenorphine, tramadol, fentanyl, tapentadol, pethidine, or pentazocine) used to treat severe pain,
• Medicines containing dextromethorphan (used to treat cough),
• Medicines containing methadone (used to treat opioid addiction or to treat severe pain),
• Medicines containing methylene blue (used to treat high levels of methemoglobin in the blood),
• Products containing St. John's Wort (also known as “Hypericum perforatum”, a natural remedy 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 hearing, seeing, or feeling things that do not exist, false beliefs, unusual suspicion, unclear thinking, and tendency to withdraw).

The signs and symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome may 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).

Inform 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.

Examples of these medicines include:

• Antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat abnormal 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 allergies).

The following medicines may interact with Venlafaxina Retard Sandoz and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines that contain:

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

Taking Venlafaxina Retard Sandoz with food, drinks, and alcohol

Venlafaxina Retard Sandoz should be taken with food (see section 3 “How to take Venlafaxina Retard Sandoz”).

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

Pregnancy, breastfeeding, and fertility

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

Make sure your midwife and/or doctor know that you are taking Venlafaxina Retard Sandoz. When taken during pregnancy, similar medicines (ISRS) may increase the risk of a severe condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and turn blue. These symptoms usually start within the first 24 hours after the baby's birth. If this happens to your baby, you should contact your midwife and/or doctor immediately.

If you are taking this medicine during pregnancy, in addition to breathing problems, another symptom your baby may have when born is feeding difficulties. If your baby has these symptoms when born and you are concerned, contact your doctor and/or midwife for advice.

Taking venlafaxine in the final stages of pregnancy may increase the risk of heavy vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking venlafaxine so they can advise you.

Venlafaxina Retard Sandoz passes into breast milk. There is a risk of an effect on the baby. You should discuss this with your doctor and they will decide if you should stop breastfeeding or stop taking this medicine.

Driving and using machines

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

Venlafaxina Retard Sandoz 150 mg and 225 mg contain sodium and azo dyes

This medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release hard capsule; this is essentially “sodium-free”.

150 mg prolonged-release hard capsules:

This medicine may cause allergic reactions because it contains Yellow Iron Oxide (E 172) and Red Iron Oxide (E 172).

225 mg prolonged-release hard capsules:

This medicine may cause allergic reactions because it contains Carmoisine (E 122)..

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

The usual initial recommended 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, even more 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 Venlafaxina Retard Sandoz approximately at the same time every day, either in the morning or at night. The capsules must be swallowed whole with liquid and should not be opened, crushed, chewed, or dissolved.

Venlafaxina Retard Sandoz should be taken with food.

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

Do not stop taking this medication without consulting your doctor (see section “If you interrupt treatment with Venlafaxina Retard Sandoz”).

If you take more Venlafaxina Retard Sandoz than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Overdose can put your life in danger, especially with the simultaneous use of certain medications and/or alcohol (see “Other medications and Venlafaxina Retard Sandoz”)

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

If you forgot to take Venlafaxina Retard Sandoz

If you have not taken a dose, take it as soon as you remember. However, if it is already time for your next dose, skip the missed dose and take only one dose as usual. Do not take a double dose to compensate for the missed doses. Do not take more than the daily dose of Venlafaxina Retard Sandoz prescribed in a day.

If you interrupt treatment with Venlafaxina Retard Sandoz

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

Your doctor will advise you on how to gradually stop treatment with Venlafaxina Retard Sandoz. This may take several weeks or months. In some patients, the interruption may need to be produced very gradually over months or more. If you experience any of these or other symptoms that bother you, consult your doctor for advice.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

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

Rare (may affect up to 1 in 100 people)

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

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

• Pressure in the chest, breathing sounds, 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, hyperactive reflexes, diarrhea, coma, nausea, vomiting.

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

• signs of infection, such as fever, chills, shivering, headache, sweating, or symptoms similar to the flu. This may be due to a blood disorder that may increase the risk of infection,
• severe rash, which may lead to the formation of severe blisters and skin peeling,
• unexplained muscle pain, discomfort, or weakness. This may be a sign of rhabdomyolysis.

Unknown frequency (cannot be estimated from available data)

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

Other side effects thatyou should inform your doctorare (the frequency of these side effects are included in the following list "other side effects that may occur"):

• cough, breathing sounds, and difficulty breathing that may be accompanied by an increased temperature,
• black stools 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, numbness, movement disorder (muscle spasms and rigidity), seizures, or attacks,
• psychiatric problems, such as hyperactivity (unusual feeling of overexcitement),
• withdrawal syndrome (see section "How to take Venlafaxina Retard Sandoz, if you interrupt treatment with Venlafaxina Retard Sandoz"),
• prolonged bleeding, if you cut or injure yourself, it may take a little longer than usual for bleeding to stop.

Other side 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)

• Loss of appetite,
• confusion, feeling strange, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams,
• tremor, a feeling of restlessness or inability to sit or stay still, numbness, altered taste perception, increased muscle tone,
• visual disturbances, including blurred vision, dilated pupils, inability of the eye to automatically focus on distant objects to near objects,
• ringing in the ears (tinnitus),
• rapid heartbeat, palpitations,
• increased blood pressure, hot flushes,
• difficulty breathing, yawning,
• vomiting, diarrhea,
• mild skin rash, itching,
• increased frequency of urination, inability to urinate, difficulty urinating,
• irregular menstrual periods, such as increased bleeding or irregular bleeding, abnormal ejaculation/orgasm (males), erectile dysfunction (impotence),
• weakness (asthenia), fatigue, chills,
• weight gain or loss,
• increased cholesterol.

Rare (may affect up to 1 in 100 people)

• Hyperactivity, rapid thoughts, and decreased need for sleep (mania),
• hallucinations, feeling detached from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, grinding of teeth,
• fainting, involuntary muscle movements, alteration of coordination and balance,
• feeling dizzy (especially when standing up too quickly), decreased blood pressure,
• vomiting blood, black stools or blood in stools, which may be a sign of internal bleeding,
• sensitivity to sunlight, petechiae, abnormal hair loss,
• inability to control urination,
• rigidity, spasms, and involuntary muscle movements,
• slight changes in liver enzyme levels in the blood.

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

• Seizures or attacks,
• cough, breathing sounds, 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, symptoms similar to the flu, 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, leading to an increased risk of petechiae or bleeding,
• abnormal milk production,
• unexpected bleeding, for example, bleeding gums, blood in urine or vomit, or the appearance of unexpected petechiae or vascular rupture (broken veins).

Unknown frequency (cannot be estimated with available data)

• Suicidal thoughts and behavior, cases of suicidal thoughts and behavior have been reported during treatment with venlafaxine or shortly after discontinuation of treatment (see section 2. “What you need to know before taking Venlafaxina Retard Sandoz”),
• aggression,
• dizziness,
• abundant vaginal bleeding after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

Venlafaxina Retard Sandoz sometimes causes unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heartbeat; slight changes in liver enzyme levels, sodium, or cholesterol in the blood. Less frequently, Venlafaxina Retard Sandoz may reduce the function of platelets in the blood, leading to an increased risk of petechiae or bleeding. Therefore, your doctor may wish to perform occasional blood tests, particularly if you have been taking Venlafaxina Retard Sandoz for a long time.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and blisterafter CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Venlafaxine Retard Sandoz

The active ingredient is venlafaxine.

Venlafaxine Retard Sandoz 75 mg prolonged-release hard capsules:

• Each prolonged-release hard capsule contains 84.9 mg of venlafaxine hydrochloride, equivalent to 75 mg of venlafaxine.
• The other components are:

Capule content:microcrystalline cellulose, povidone (K90 D), talc, anhydrous colloidal silica, magnesium stearate, ethylcellulose, and copovidone.

Capule coating:iron oxide black (E 172), iron oxide red (E 172), titanium dioxide (E 171), gelatin, purified water.

Capule printing ink:shellac, anhydrous ethanol, isopropyl alcohol, butyl alcohol, propylene glycol, concentrated ammonia solution, iron oxide red (E 172).

Venlafaxine Retard Sandoz 150 mg prolonged-release hard capsules:

• Each prolonged-release hard capsule contains 169.8 mg of venlafaxine hydrochloride, equivalent to 150 mg of venlafaxine.
• The other components are:

Capule content:microcrystalline cellulose, povidone (K90 D), talc, anhydrous colloidal silica, magnesium stearate, ethylcellulose, and copovidone.

Capule coating:brilliant blue FCF (E 133) (contains sodium), red Allura AC (E 129) (contains sodium), yellow-orange S (E 110) (contains sodium), titanium dioxide (E 171), gelatin, purified water.

Capule printing ink:shellac, anhydrous ethanol, isopropyl alcohol, butyl alcohol, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E 171).

Venlafaxine Retard Sandoz 225 mg prolonged-release hard capsules:

• Each prolonged-release hard capsule contains 254.7 mg of venlafaxine hydrochloride, equivalent to 225 mg of venlafaxine.
• The other components are:

Capule content:microcrystalline cellulose, povidone (K90 D), talc, anhydrous colloidal silica, magnesium stearate, ethylcellulose, and copovidone.

Capule coating:carmin (E 122) (contains sodium), titanium dioxide (E 171), gelatin, purified water.

Capule printing ink:shellac, anhydrous ethanol, isopropyl alcohol, butyl alcohol, propylene glycol, concentrated ammonia solution, carmine indigo (E 132).

Appearance of the product and packaging content

Venlafaxine Retard Sandoz 75 mg prolonged-release hard capsules

Hard gelatin capsules, opaque, orange, approximately 19 mm in size, with a thick and thin radial ring in red printing on the body and cap.

The capsule is filled with 6 mini-coated tablets, white to off-white, round, biconvex, 12.5 mg each.

VenlafaxineRetardSandoz150 mg prolonged-release hard capsules

Hard gelatin capsules, opaque, dark orange, approximately 21 mm in size, with a thick and thin radial ring in white printing on the body and cap.

The capsule is filled with 12 mini-coated tablets, white to off-white, round, biconvex, 12.5 mg each.

VenlafaxineRetardSandoz225 mg prolonged-release hard capsules

Hard gelatin capsules, opaque, pink, approximately 23 mm in size, with a thick and thin radial ring in blue printing on the body and cap.

The capsule is filled with 18 mini-coated tablets, white to off-white, round, biconvex, 12.5 mg each.

They are presented in aluminum-PVC/PVDC blisters, aluminum-PVC/ACLAR blisters, and aluminum-OPA/Alu/PVC blisters (only for 225 mg).

Packaging sizes

Blister packs containing7, 10, 12, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, and 112 (only for 75 and 150 mg) prolonged-release hard capsules.

Unit dose blister packs containing100 x 1 prolonged-release hard capsules.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer:

Lek Pharmaceuticals d.d

Verov?kova ulica, 57

1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,Sachsen-Anhalt

39179 Barleben

Germany

Last review date of this leaflet:August 2023

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