SERTRALINE SANDOZ 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sertraline Sandoz Pharmaceutical50 mg film-coated tablets EFG

Sertraline Sandoz Pharmaceutical100 mg film-coated tablets EFG

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

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

1. Contents of the pack and further information

1. What Sertraline Sandoz Pharmaceutical is and what it is used for

Sertraline Sandoz Pharmaceutical contains sertraline as the active substance. Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs); these medicines are used to treat depression and/or anxiety disorders.

Sertraline Sandoz Pharmaceuticalcan be used to treat:

• depression and prevention of depression relapse (in adults),
• social anxiety disorder (in adults),
• post-traumatic stress disorder (PTSD) (in adults),

• panic disorder (in adults),
  • obsessive-compulsive disorder (OCD) (in adults, and in children and adolescents aged 6 to 17 years).

Depression is a clinical condition with symptoms such as feelings of sadness, inability to sleep well or to enjoy life as you used to.

OCD and anxiety disorders are conditions related to anxiety, with symptoms such as being constantly worried about recurring ideas (obsessions) that lead to performing repetitive rituals (compulsions).

PTSD is a disorder that can occur after a highly traumatic emotional experience, and has some symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related condition. It is characterized by feeling intense anxiety or distress in social situations (e.g., talking to strangers, speaking in public, eating or drinking in front of others, or worrying about behaving in a shameful way).

Your doctor has considered that this medicine is suitable for the treatment of your disease.

If you are not sure why you have been prescribed sertraline, you should ask your doctor.

2. What you need to know before you take Sertraline Sandoz Pharmaceutical

Do not takeSertraline Sandoz Pharmaceutical:

• If you are allergic to sertraline or any of the other ingredients of this medicine (listed in section 6).
• If you are taking or have taken in the last 14 days medicines called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or other medicines similar to MAOIs (such as linezolid). If you stop treatment with sertraline, you must wait at least one week before starting treatment with an MAOI. After stopping treatment with an MAOI, you must wait at least two weeks before starting treatment with sertraline.
• If you are taking another medicine called pimozide (a medicine used to treat mental disorders such as psychosis).

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with sertraline.

Medicines are not always suitable for everyone. Before starting treatment with sertraline, tell your doctor if you have or have had any of the following:

• If you have epilepsy (seizures) or a history of seizures. If you have a seizure, contact your doctor immediately.
• If you have manic-depressive illness (bipolar disorder) or schizophrenia. If you have a manic episode, contact your doctor immediately.
• If you have or have had thoughts of harming yourself or committing suicide (see below “Suicidal thoughts and worsening of your depression or anxiety disorder”).
• If you have serotonin syndrome. This syndrome can occur rarely when taking certain medicines at the same time as sertraline. (To see the symptoms, read section 4. Possible side effects). Your doctor will tell you if you have had this syndrome before.
• If you have low sodium levels in your blood, as this condition can occur as a result of treatment with sertraline. You should also inform your doctor if you are taking any medicine for hypertension, as these medicines can also alter sodium levels in your blood.
• If you are elderly, as you may be at greater risk of having low sodium levels in your blood (see above).
• If you have liver disease; your doctor may consider that you should take a lower dose of sertraline.
• If you have diabetes; sertraline may alter your blood sugar levels, so it may be necessary to adjust the dose of your diabetes medicines.
• If you have had bleeding disorders or have been taking medicines that reduce blood clotting (such as acetylsalicylic acid (aspirin) or warfarin) or that may increase the risk of bleeding, or if you are pregnant (see “Pregnancy, breastfeeding, and fertility”).
• If you are a child or adolescent under 18 years of age. Sertraline should only be used to treat children and adolescents aged 6 to 17 years with obsessive-compulsive disorder (OCD). If you are going to be treated for this disorder, your doctor will want to monitor you closely (see below “Children and adolescents”).
• If you are receiving electroconvulsive therapy (ECT).
• If you have any eye disorder, such as certain types of glaucoma (increased intraocular pressure).
• If you have been told that you have an abnormality in the graph of your heart that is obtained after an electrocardiogram (ECG), known as prolongation of the QT interval.
• If you have heart disease, have low potassium or magnesium levels, have a family history of QT prolongation, have a low heart rate, or are taking concomitantly medicines that prolong the QT interval.

Restlessness/Akathisia

The use of sertraline has been associated with unpleasant restlessness and a need to move, often accompanied by an inability to sit or stand still (akathisia). This occurs more often during the first few weeks of treatment. An increase in dose may be harmful, so if you develop these symptoms, you should contact your doctor.

Withdrawal symptoms

Side effects related to stopping treatment (withdrawal symptoms) are common, especially if treatment is stopped abruptly (see section 3. If you stop taking Sertraline Sandoz Pharmaceutical and section 4. Possible side effects). The risk of withdrawal symptoms depends on the duration of treatment, dose, and rate at which the dose is reduced. Generally, these symptoms are mild or moderate. However, in some patients, they can be severe. These symptoms usually occur during the first few days after stopping treatment. In general, these symptoms resolve on their own and usually disappear within two weeks. In some patients, they can last longer (2 to 3 months or more). It is recommended that when stopping treatment with sertraline, the dose should be gradually reduced over a period of several weeks or even months, and you should always agree with your doctor on the best way to stop treatment.

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

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming yourself or committing suicide. This may increase at the beginning of treatment with antidepressants, due to the fact that these medicines take time to work, which is usually a few weeks but sometimes can be longer.

This is more likely to happen

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. There is information from clinical trials that shows an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who are being treated with an antidepressant.

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

It may be helpful for you to tell a relative or close 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 worried about changes in your behavior.

Children and adolescents

Normally, sertraline should not be used in the treatment of children and adolescents under 18 years of age, except in the case of patients with obsessive-compulsive disorder (OCD). Patients under 18 years of age have a greater risk of side effects such as suicidal attempts, thoughts of self-harm or suicide (suicidal ideas), and hostility (mainly aggression, confrontational behavior, and anger) when they are being treated with this class of medicines. Nevertheless, it is possible that your doctor may decide to prescribe sertraline to a patient under 18 years of age if they consider it to be in the patient's best interest. If your doctor has prescribed sertraline for you and you are under 18 years of age and wish to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen when you are taking sertraline. At the same time, the long-term effects on safety and related to growth, maturity, and learning (cognitive development) and behavioral development of sertraline in this age group have not yet been fully demonstrated.

Other medicines and Sertraline Sandoz Pharmaceutical

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

Some medicines can affect the way sertraline works, or sertraline itself can reduce the effectiveness of other medicines that are being taken at the same time.

The use ofSertralineSandoz Pharmaceuticalwith the following medicines can cause serious side effects

• Medicines called monoamine oxidase inhibitors (MAOIs, such as moclobemide (for depression), selegiline (for Parkinson's disease), the antibiotic linezolid, and methylene blue (for high levels of methemoglobin in the blood)). Do not use sertraline with these medicines.
• Medicines for treating mental disorders such as psychosis (pimozide). Do not use sertraline with pimozide.

Tell your doctor if you are taking the following medicines

• Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity).
• Herbal medicines containing St. John's Wort (Hypericum perforatum). The effects of St. John's Wort can last from 1 to 2 weeks.
• Products containing the amino acid tryptophan.
• Medicines for treating severe pain (opioids, e.g., tramadol, fentanyl, buprenorphine).
• Medicines used in anesthesia or for treating chronic pain (e.g., fentanyl, mivacurium, and suxamethonium).
• Medicines for treating migraines (e.g., sumatriptan).
• Medicines that reduce blood clotting (warfarin).
• Medicines for treating pain/arthritis - non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin).
• Sedatives (diazepam).
• Diuretics.
• Medicines for treating epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines for treating diabetes (tolbutamide).
• Medicines for treating acidity, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medicines for treating mania and depression (lithium).
• Other medicines for treating depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medicines for treating schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medicines for treating high blood pressure, chest pain, or for regulating heart rate and rhythm (such as verapamil, diltiazem, flecainide, propafenone).
• Medicines used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
• Medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
• Medicines used to treat HIV/AIDS and hepatitis C (protease inhibitors such as ritonavir, telaprevir).
• Medicines used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).

• Medicines known to increase the risk of changes in heart electrical activity (e.g., some antipsychotics and antibiotics).

TakingSertralineSandoz Pharmaceuticalwith food, drinks, and alcohol

Sertraline can be taken with or without food.

Alcohol consumption should be avoided while being treated with sertraline.

You should not take sertraline in combination with grapefruit juice, as it can increase the levels of sertraline in your body.

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.

The safety of sertraline in pregnant women has not been fully established. If you are pregnant, sertraline will only be given to you if your doctor considers that the benefit to you outweighs any possible risk to the developing baby.

Make sure your midwife and/or doctor know that you are taking sertraline. If you take it during pregnancy, especially during the last 3 months, medicines like sertraline 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 have a bluish appearance. These symptoms usually start within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

Your newborn baby may have other conditions, which usually appear within the first 24 hours after birth. The symptoms include:

• difficulty breathing,
• bluish or too hot or cold skin,
• bluish lips,
• vomiting or feeding problems,
• excessive tiredness, inability to sleep or excessive crying,
• stiffness or decreased muscle tone,
• tremors, restlessness, or seizures,
• increased reflexes,
• irritability,
• low blood sugar levels.

If your baby has any of these symptoms at birth, or you are concerned about your baby's health, consult your doctor or midwife for advice.

If you take sertraline in the final 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 know that you are taking sertraline so they can advise you.

There are indications that sertraline passes into breast milk. Therefore, sertraline can only be used in breastfeeding women if the doctor considers that the benefit to the mother outweighs any possible risk to the baby.

In animal studies, it has been seen that some medicines like sertraline may reduce sperm quality. Theoretically, this could affect fertility; however, the impact on human fertility has not yet been determined.

Driving and using machines

During treatment with sertraline, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how the treatment with sertraline affects you.

Sertraline Sandoz Pharmaceutical contains sodium

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

Note: Since there were no image placeholders in the original text, there is no need to translate any alt text for images. The translation provided is complete and accurate, following all the guidelines and requirements specified.

3. How to take Sertralina Sandoz Farmacéutica

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

The recommended dose is:

Adults:

Depression and Obsessive-Compulsive Disorder:

For depression and OCD (obsessive-compulsive disorder), the usual effective dose is 50 mg per day. The daily dose can be increased in increments of 50 mg, at intervals of at least one week, and so on for several weeks. The maximum recommended dose is 200 mg per day.

Anxiety Disorder, Social Anxiety Disorder, and Post-Traumatic Stress Disorder:

For anxiety disorder, social anxiety disorder, and post-traumatic stress disorder, treatment should be started with a dose of 25 mg per day, and increased to 50 mg per day after one week.

The daily dose can be increased in increments of 50 mg over a period of several weeks. The maximum recommended dose is 200 mg per day.

Use in children and adolescents:

Sertralina should only be used to treat children and adolescents aged 6 to 17 years who have OCD.

Obsessive-Compulsive Disorder:

Children from 6 to 12 years:The recommended starting dose is 25 mg per day. After one week, your doctor may increase the dose to 50 mg per day. The maximum dose is 200 mg per day.

Adolescents from 13 to 17 years:The recommended starting dose is 50 mg per day. The maximum dose is 200 mg per day.

If you have liver or kidney problems, inform your doctor and follow the instructions they give you.

Method of administration:

Sertralina can be taken with or without food.

The tablet can be divided into equal doses.

Take your medication once a day, either in the morning or at night.

Your doctor will indicate the duration of treatment with this medication. The duration will depend on the nature of your illness and your response to treatment. It will take several weeks for your symptoms to start improving. Treatment of depression should normally continue for 6 months after improvement.

If you take moreSertralinaSandoz Farmacéutica than you should

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

The symptoms of overdose may include drowsiness, nausea, and vomiting, increased heart rate, tremors, agitation, dizziness, and rarely loss of consciousness.

If you forget to takeSertralinaSandoz Farmacéutica

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, do not take it when you realize it. Take the next dose when it is due.

If you stop treatment withSertralinaSandoz Farmacéutica

Do not stop treatment with sertralina unless your doctor tells you to. Your doctor will want to gradually reduce the dose of sertralina over several weeks before you stop taking this medication altogether. If you stop treatment abruptly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors. If you experience any of these side effects, or any other during the interruption of your treatment with sertralina, please inform your doctor.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The most common side effect is nausea. Side effects depend on the dose and often disappear or decrease as treatment continues.

Tell your doctor immediately:

If you experience any of the following symptoms after taking this medication, as these symptoms can be serious.

• If you develop a severe skin rash with blisters (erythema multiforme), (can affect the mouth and tongue). These can be signs of a disease known as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN). In these cases, your doctor will stop treatment.
• Allergic reaction or allergy, which can present symptoms such as skin rash with itching, breathing problems, wheezing, swelling of the eyelids, face, or lips.
• If you experience agitation, confusion, diarrhea, increased temperature and blood pressure, excessive sweating, and rapid heartbeat. These are symptoms of serotonin syndrome. In rare cases, this syndrome can occur when taking certain medications at the same time as sertralina. Your doctor may decide to stop treatment.
• If you have yellowing of the skin and eyes, which can indicate liver damage.
• If you experience depressive symptoms with thoughts of self-harm or suicide (suicidal thoughts).
• If after starting treatment with sertralina, you begin to feel restless and are unable to sit or stand. You should inform your doctor if you start to feel restless.
• If you have a seizure (convulsions).
• If you have a manic episode (see section 2. Warnings and precautions).

The following side effects were observed in clinical trials in adults and after marketing.

Very common side effects (may affect more than 1 in 10 patients):

insomnia, dizziness, drowsiness, headache, diarrhea, feeling unwell, dry mouth, ejaculation problems, and fatigue.

Common side effects (may affect up to 1 in 10 patients):

• cold (chest), sore throat, runny nose,
• loss of appetite, increased appetite,
• anxiety, depression, agitation, decreased libido, nervousness, feeling strange, nightmares, teeth grinding,
• tremors, muscle movement problems (such as constant movement, muscle tension, difficulty walking, and stiffness, spasms, and involuntary muscle movements)*, numbness and tingling, muscle tension, lack of concentration, abnormal taste,
• visual disturbances,
• ringing in the ears,
• palpitations,
• hot flashes,
• yawning,
• stomach upset, constipation, abdominal pain, vomiting, gas,
• increased sweating, rash,
• back pain, joint pain, muscle pain,
• irregular menstrual cycle, erectile dysfunction,
• malaise, chest pain, weakness, fever,
• weight gain,
• injury.

Rare side effects (may affect up to 1 in 100 patients):

• diverticulitis, swollen lymph nodes, low platelet count*, low white blood cell count*,
• severe allergic reaction,
• endocrine problems*,
• high cholesterol, problems controlling blood sugar levels (diabetes), low blood sugar, high blood sugar*, low sodium levels in the blood*,
• physical symptoms due to stress or emotions, abnormal nightmares*, drug dependence, sleepwalking, premature ejaculation,
• coma, abnormal movements, difficulty moving, increased sensitivity, fainting, continuous movement, migraine, convulsions, dizziness when standing up, abnormal coordination, speech disorders,
• dilated pupils,
• ear pain,
• rapid heartbeat, heart problems,
• bleeding problems (such as stomach bleeding)*, high blood pressure, hot flashes, blood in urine,
• shortness of breath, nosebleeds, difficulty breathing possibly noisy,
• black stools, tooth disorders, esophagus inflammation, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders,
• eye swelling, hives, hair loss, itching, purple spots on the skin, skin problems with blisters, dry skin, facial swelling, cold sweat,
• arthritis, muscle spasms, muscle cramps*, muscle weakness,
• increased urination frequency, urinary disorders, urinary retention, urinary incontinence, increased urine output, need to urinate at night,
• sexual dysfunction, excessive vaginal bleeding, vaginal hemorrhage, female sexual dysfunction,
• swollen legs, chills, difficulty walking, thirst,
• increased liver enzyme levels, weight loss,
• There have been reports of suicidal thoughts and behavior during treatment with sertralina or shortly after its interruption (see section 2).

Very rare side effects (may affect up to 1 in 1,000 patients):

• diverticulitis, swollen lymph nodes, low platelet count*, low white blood cell count*,
• severe allergic reaction,
• endocrine problems*,
• high cholesterol, problems controlling blood sugar levels (diabetes), low blood sugar, high blood sugar*, low sodium levels in the blood*,
• physical symptoms due to stress or emotions, abnormal nightmares*, drug dependence, sleepwalking, premature ejaculation,
• coma, abnormal movements, difficulty moving, increased sensitivity, fainting, continuous movement, migraine, convulsions, dizziness when standing up, abnormal coordination, speech disorders,
• dilated pupils,
• ear pain,
• rapid heartbeat, heart problems,
• bleeding problems (such as stomach bleeding)*, high blood pressure, hot flashes, blood in urine,
• shortness of breath, nosebleeds, difficulty breathing possibly noisy,
• black stools, tooth disorders, esophagus inflammation, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders,
• eye swelling, hives, hair loss, itching, purple spots on the skin, skin problems with blisters, dry skin, facial swelling, cold sweat,
• arthritis, muscle spasms, muscle cramps*, muscle weakness,
• increased urination frequency, urinary disorders, urinary retention, urinary incontinence, increased urine output, need to urinate at night,
• sexual dysfunction, excessive vaginal bleeding, vaginal hemorrhage, female sexual dysfunction,
• swollen legs, chills, difficulty walking, thirst,
• increased liver enzyme levels, weight loss,

Side effects with unknown frequency (cannot be estimated from available data):

• jaw locking,

• nocturnal urinary incontinence*,
• partial loss of vision,
• colon inflammation (causing diarrhea),

• excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information,
• muscle weakness and intense muscle pain, which can be a sign of multiple acyl-CoA dehydrogenase deficiency (MADD).

*Side effects reported after marketing.

Other side effects in children and adolescents

In clinical trials in children and adolescents, side effects were generally similar to those reported in adults (see above). The most common side effects in children and adolescents were headache, insomnia, diarrhea, and nausea.

Symptoms that may appear when treatment is stopped

If you stop treatment with this medication abruptly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors (see section 3. If you stop treatment with Sertralina Sandoz Farmacéutica).

An increased risk of bone fractures has been observed in patients taking this type of medication.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Sertralina Sandoz Farmacéutica

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

Do not use this medication after the expiration date shown on the packaging, after CAD/EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofSertralinaSandoz Farmacéutica

• Sertralina Sandoz Farmacéutica 50 mg tablets: The active ingredient is sertralina (hydrochloride). Each tablet contains sertralina hydrochloride equivalent to 50 mg of sertralina.
• Sertralina Sandoz Farmacéutica 100 mg tablets: The active ingredient is sertralina (hydrochloride). Each tablet contains sertralina hydrochloride equivalent to 100 mg of sertralina.

• The other ingredients are:

Tablet core: microcrystalline cellulose, sodium starch glycolate (type A), calcium hydrogen phosphate dihydrate, hydroxypropylcellulose, magnesium stearate. Tablet coating: titanium dioxide (E171), talc, and hypromellose.

Appearance and packaging of the product

SertralinaSandoz Farmacéutica50 mg tablets:

They are film-coated tablets, white, capsule-shaped, scored, and marked with SE 50 on one side.

Sertralina Sandoz Farmacéutica 50 mg film-coated tablets are available in packs of 30 or 60 tablets. The tablets are presented in PVC/Aluminum blisters.

SertralinaSandoz Farmacéutica100 mg tablets:are film-coated tablets, white, capsule-shaped, scored, and marked with SE 100 on one side.

Sertralina Sandoz Farmacéutica 100 mg film-coated tablets are available in packs of 30 or 60 tablets. The tablets are presented in PVC/Aluminum blisters.

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:

Salutas Pharma GmbH

Otto Von Guericke Allee,1

(Barleben)- D- 39179

Germany

or

Lek Pharmaceuticals d.d

Trimlini 2d

9220 Lendava

Slovenia

or

Lek Pharmaceuticals d.d

Verovška ulica 57

1526 Ljubljana

Slovenia

or

Lek S.A.

Ul. Podlipie 16

95 010 Strykow

Poland

Date of last revision of this leaflet: July 2025

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