VENLAFAXINE RETARD SANDOZ 75 mg PROLONGED-RELEASE HARD CAPSULES

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

1. Package contents and further information

1. What is Venlafaxine Retard Sandoz and what is it used for

Venlafaxine Retard Sandoz contains the active substance venlafaxine.

Venlafaxine Retard Sandoz 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 noradrenaline in the brain.

Venlafaxine Retard Sandoz 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). Properly treating depressive and anxiety disorders is important to help you feel better. If left untreated, your condition may not improve or may worsen and become more difficult to treat.

2. What you need to know before you take Venlafaxine Retard Sandoz

Do not take Venlafaxine 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 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 venlafaxine can cause serious or even life-threatening side effects. Additionally, you must wait at least 7 days after you stop taking venlafaxine before taking any MAOI (see also section “Other medicines and Venlafaxine Retard Sandoz” and the information in that section on “Serotonin Syndrome”).

Warnings and precautions

Consult your doctor or pharmacist beforestarting treatment with Venlafaxine Retard Sandoz:

• if you are taking other medicines that, when taken with venlafaxine, could increase the risk of developing serotonin syndrome (see section “Other medicines and Venlafaxine 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 informed that your heart rhythm is abnormal,
• if you have a history of seizures (fits),
• if you have a history of low sodium levels in your blood (hyponatremia),
• if you have a tendency to develop bruises or tend to bleed easily (history of bleeding disorders), or if you are using other medicines that may increase the risk of bleeding, e.g., warfarin (used to prevent blood clots), or if you are pregnant (see “Pregnancy”),
• if you have a history of or if someone in your family has had mania or bipolar disorder (feeling overexcited or euphoric),
• if you have a history of aggressive behavior.

Venlafaxine 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 during treatment with venlafaxine, as it may cause extreme tiredness and unconsciousness. Taking it 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 or killing yourself. These may increase when you first start taking antidepressants, because all these medicines take time to work, usually around 2 weeks, but sometimes longer. These thoughts may also occur when your dose is reduced or when you stop taking Venlafaxine Retard Sandoz.

This is more likely to happen:

• if you have previously had thoughts of suicide or self-harm,
• if you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself 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 package 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 behavior.

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 be careful with your dental hygiene.

Diabetes

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

Sexual problems

Some medicines of the same group as venlafaxine (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Children and adolescents

Venlafaxine should not normally be used in the treatment of children and adolescents under 18 years. In addition, you should know that in patients under 18 years, there is an increased risk of side effects such as suicide attempt, suicidal thoughts, and hostility (predominantly aggression, confrontation, and irritability) when they take this class of medicines. Despite this, your doctor may prescribe this medicine to patients under 18 years when he/she decides that it is the best option for the patient. If your doctor has prescribed this medicine to a patient under 18 years and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the above symptoms occur or worsen when these patients under 18 years are taking venlafaxine. Additionally, the long-term safety of venlafaxine in relation to growth, maturation, and cognitive and behavioral development has not been demonstrated.

Other medicines and Venlafaxine Retard Sandoz

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

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

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

• Monoamine oxidase inhibitors used to treat depression or Parkinson’s disease must not be taken with Venlafaxine Retard Sandoz. Tell your doctor if you have taken any of these medicines in the last 14 days. (MAOI: see section “What you need to know before you take Venlafaxine Retard Sandoz”).
• 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 (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 for opioid addiction treatment or for severe pain treatment),
• 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 herbal or plant-based 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 do not exist, mistaken beliefs, unusual suspicion, unclear reasoning, 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, overactive 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).

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

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

Examples of these medicines include:

• anti-arrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat irregular heartbeat),
• 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 also interact with Venlafaxine Retard Sandoz 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 Venlafaxine Retard Sandoz with food, drinks, and alcohol

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

Do not drink alcohol during treatment with venlafaxine. Taking it with alcohol may cause extreme tiredness and unconsciousness, and 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should only take Venlafaxine Retard Sandoz after discussing the potential benefits and risks with your doctor.

Make sure your midwife and/or doctor know you are taking Venlafaxine Retard Sandoz. When similar medicines (SSRIs) are taken during pregnancy, they can 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 must 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 problems. If your baby has these symptoms when born and you are concerned, contact your doctor and/or midwife who can advise you.

If you take venlafaxine in the late stage of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after giving birth, 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.

Venlafaxine Retard Sandoz passes into breast milk. There is a risk of an effect on the baby. Therefore, you should discuss this with your doctor, and he/she will decide whether 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.

Venlafaxine Retard Sandoz 150 mg and 225 mg contains sodium and azo colorants

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 orange yellow S (E 110) and allura red AC (E 129).

225 mg prolonged-release hard capsules:

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

3. How to take Venlafaxine Retard Sandoz

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, generalized 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 you on a lower dose (37.5 mg) and then gradually increase the dose. The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg/day.

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

Venlafaxine Retard Sandoz should be taken with food.

If you have liver or kidney problems, 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 section “If you stop taking Venlafaxine Retard Sandoz”).

If you take more Venlafaxine Retard Sandoz than you should

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

Overdose can put your life in danger, especially when taken with certain medicines and/or alcohol (see “Other medicines and Venlafaxine Retard Sandoz”)

The 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 Venlafaxine Retard Sandoz

If you miss 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 dose of Venlafaxine Retard Sandoz that has been prescribed for you in one day.

If you stop treatment withVenlafaxine Retard Sandoz

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

Your doctor will advise you on how to gradually stop treatment with Venlafaxine Retard Sandoz. This may take several weeks or months. In some patients, the discontinuation may need to be very gradual 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 questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following effects occur, do not take more Venlafaxine Retard Sandoz. Tell your doctor immediately, or go to the emergency room 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 tightness, breathing sounds, difficulty swallowing or breathing,
• severe skin rash, itching, or hives (elevated areas of red 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 enzyme levels (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 side effects that you should tell your doctor aboutare (the frequency of these side effects is 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,
• nervous system problems, such as dizziness, tingling, movement disorder (muscle spasms and stiffness), seizures, or attacks,
• psychiatric problems, such as hyperactivity (unusual feeling of overexcitement),
• withdrawal syndrome (see section "How to take Venlafaxine Retard Sandoz, if you stop treatment with Venlafaxine Retard Sandoz"),
• prolonged bleeding, if you cut or injure yourself, it may take a little longer than usual to stop bleeding.

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)

• Decreased 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, 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, 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 liver enzyme levels.

Rare (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, rapid, or irregular heartbeat, which can 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 production of breast milk,
• unexpected bleeding, for example, bleeding gums, blood in urine or vomit, or the appearance of unexpected bruising or broken blood vessels (broken veins).

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

• Suicidal ideation and suicidal behavior, cases of suicidal ideation 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 Venlafaxine Retard Sandoz"),
• aggression,
• vertigo,
• excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

Venlafaxine Retard Sandoz sometimes produces unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heartbeat; mild changes in blood liver enzyme levels, sodium, or cholesterol. Less frequently, Venlafaxine Retard Sandoz 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 Venlafaxine Retard Sandoz for a long time.

Reporting of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Venlafaxine Retard Sandoz

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

Do not use this medicine after the expiration date stated on the packaging and blister after CAD/EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

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 ingredients are:

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

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

Capsule printing ink: shellac, dehydrated alcohol, 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 ingredients are:

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

Capsule shell: brilliant blue FCF (E 133) (contains sodium), Allura red AC (E 129) (contains sodium), sunset yellow FCF (E 110) (contains sodium), titanium dioxide (E 171), gelatin, purified water.

Capsule printing ink: shellac, dehydrated alcohol, 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 ingredients are:

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

Capsule shell: carmoisine (E 122) (contains sodium), titanium dioxide (E 171), gelatin, purified water.

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

Appearance and packaging

Venlafaxine Retard Sandoz 75 mg prolonged-release hard capsules

Hard gelatin capsules, opaque, peach-colored, approximately 19 mm in length, with a thick and thin radial circular band printed in red on the body and cap.

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

Venlafaxine Retard Sandoz 150 mg hard capsulesof prolonged release

Hard gelatin capsules, opaque, dark orange, approximately 21 mm in length, with a thick and thin radial circular band printed in white on the body and cap.

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

Venlafaxine Retard Sandoz 225 mg hard capsulesof prolonged release

Hard gelatin capsules, opaque, pink, approximately 23 mm in length, with a thick and thin radial circular band printed in blue on the body and cap.

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

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

Package sizes

Blisters containing 7, 10, 12, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, and 112 (only for 75 and 150 mg) prolonged-release hard capsules.

Single-dose blisters containing 100x1 prolonged-release hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

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

Date of last revision of this leaflet:August 2023

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