Sertraline Teva-Ratio 50 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Sertralina Teva-ratio 50 mg film-coated tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Sertralina Teva-ratio is and what it is used for
2. What you need to know before taking Sertralina Teva-ratio
3. How to take Sertralina Teva-ratio
4. Possible side effects
5. How to store Sertralina Teva-ratio
6. Contents of the pack and other information

1. What Sertralina Teva-ratio is and what it is used for

Sertralina Teva-ratio contains sertraline as the active substance. Sertraline belongs to a group of medicines known as Selective Serotonin Reuptake Inhibitors (SSRIs); these medicines are used to treat depression and/or anxiety disorders.

Sertralina Teva-ratio can be used to treat:

• Depression and prevention of recurrence of depression (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 6–17 years).

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

OCD and panic disorders are anxiety-related illnesses, with symptoms such as persistent worry about recurring thoughts (obsessions) that lead to repetitive rituals (compulsions).

PTSD is a disorder that may occur following an emotionally traumatic experience and has some symptoms similar to those of depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterized by intense anxiety or distress in social situations (for example: speaking with strangers, speaking in public, eating or drinking in front of others, or worrying about possibly behaving in an embarrassing way).

Your doctor has determined that this medicine is suitable for treating your condition.

If you are unsure why you have been prescribed sertraline, you should consult your doctor.

2. What you need to know before taking Sertraline Teva-ratio

Do not take Sertraline Teva-ratio

• If you are allergic to sertraline or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking or have recently taken medicines called monoamine oxidase inhibitors (MAOIs), such as selegiline or moclobemide, or other medicines similar to MAOIs (such as linezolid). If you stop taking 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

Talk to your doctor or pharmacist before taking Sertraline Teva-ratio.

Medicines are not always suitable for everyone. Before starting treatment with Sertraline Teva-ratio, inform your doctor if you have or have previously had any of the following conditions:

• If you have epilepsy (seizures) or a history of seizures. If you have a seizure, contact your doctor immediately.
• If you have bipolar disorder (manic-depressive illness) or schizophrenia. If you experience a manic episode, contact your doctor immediately.
• If you have or have previously had thoughts of harming yourself or of suicide (see below: Suicidal thoughts and worsening of depression or anxiety disorder).
• If you have Serotonin Syndrome. This syndrome rarely occurs when taking certain medicines together with sertraline (for symptoms, see section 4. Possible side effects). Your doctor will advise you if you have previously experienced this syndrome.
• If you have low sodium levels in the blood, as this condition may occur as a result of sertraline treatment. You should also inform your doctor if you are taking any medicines for high blood pressure, as these may also affect blood sodium levels.
• If you are elderly, as you may be at increased risk of low blood sodium levels (see previous point).
• If you have liver disease; your doctor may decide 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 medication.
• If you have a history of bleeding disorders (tendency to bruise easily), or if you are pregnant (see section Pregnancy, breastfeeding and fertility) or have been taking medicines that reduce blood clotting [e.g., acetylsalicylic acid (aspirin), warfarin] or that may increase the risk of bleeding.
• If you are a child or adolescent under 18 years of age. Sertraline Teva-ratio should only be used to treat children and adolescents aged 6 to 17 years with obsessive-compulsive disorder (OCD). If you are to be treated for this condition, your doctor will want to monitor you closely (see below: Children and adolescents).
• If you are receiving electroconvulsive therapy (ECT).
• If you have an eye disorder, such as certain types of glaucoma (increased intraocular pressure).
• If you have been told you have an abnormality on the heart tracing obtained from an electrocardiogram (ECG), known as QT interval prolongation.
• If you have heart disease, low potassium or magnesium levels, a family history of QTc prolongation, slow heart rate, or are taking concomitantly medicines that prolong the QTc interval.

Restlessness/Akathisia:

The use of sertraline has been associated with unpleasant restlessness and an urge to move, often accompanied by an inability to sit or stand still (akathisia). This occurs most frequently during the first few weeks of treatment. Increasing the dose may be harmful; therefore, 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 Teva-ratio and section 4. Possible side effects). The risk of experiencing withdrawal symptoms depends on the duration of treatment, the dose, and the rate at which the dose is reduced. Generally, these symptoms are mild or moderate. However, in some patients they may be severe. These symptoms usually appear during the first few days after stopping treatment. They usually resolve on their own and typically disappear within two weeks. In some patients, they may last longer (2–3 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 discuss the best way to discontinue treatment with your doctor.

Suicidal thoughts 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 of suicide. This risk may increase at the beginning of treatment with antidepressants, because all these medicines take time to work—usually about two weeks, but sometimes longer.

This is more likely to happen if:

• You have previously had thoughts of suicide or self-harm.
• You are a young adult. Clinical trial data show an increased risk of suicidal behavior in psychiatric patients under 25 years of age treated with an antidepressant.

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

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

Sexual problems:

Some medicines in the same class as Sertraline Teva-ratio (called SSRIs/SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents:

Sertraline should normally not be used in the treatment of children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorder (OCD). Patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, thoughts of self-harm or suicide (suicidal ideation), and hostility (mainly aggression, confrontational behavior, and anger reactions) when treated with this class of medicines. Nevertheless, your doctor may decide to prescribe Sertraline Teva-ratio 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 Teva-ratio to you and you are under 18 years of age and wish to discuss this decision, please speak to your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen while you are taking sertraline. The long-term effects on safety, growth, maturation, and cognitive and behavioral development of sertraline in this age group have not yet been fully established.

Other medicines and Sertraline Teva-ratio:

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

Some medicines may affect how Sertraline Teva-ratio works, or Sertraline Teva-ratio itself may reduce the effectiveness of other medicines taken at the same time.

The use of Sertraline Teva-ratio together with the following medicines may cause serious adverse effects:

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

• Medicines used to treat 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 may last 1–2 weeks.

• Products containing the amino acid tryptophan.

• Medicines for severe or chronic pain (opioids, e.g., tramadol, fentanyl).

• Medicines used in anesthesia (e.g., fentanyl, mivacurium, and suxamethonium).

• Medicines for treating migraines (e.g., sumatriptan).

• Medicines that reduce blood clotting (warfarin).

• Medicines for treating pain/arthritis [e.g., metamizole, non-steroidal anti-inflammatory drugs (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, pantoprazol, 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 to regulate 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 the heart's electrical activity (e.g., certain antipsychotics and antibiotics).

Taking Sertraline Teva-ratio with food, drinks, and alcohol:

Sertraline can be taken with or without food.

Alcohol intake should be avoided while you are being treated with sertraline.

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

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

If you take sertraline in the late stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife must know that you are taking Sertraline Teva-ratio so they can advise you accordingly.

When taken during pregnancy, especially during the last three months, medicines like Sertraline Teva-ratio may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this occurs in 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. Symptoms include:

• difficulty breathing,
• bluish or unusually hot or cold skin,
• blue lips,
• vomiting or feeding problems,
• excessive tiredness, inability to sleep, or excessive crying,
• muscle stiffness or reduced muscle tone,
• tremors, restlessness, or seizures,
• increased reflex responses,
• irritability,
• low blood sugar.

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

Evidence indicates that sertraline passes into breast milk. Therefore, sertraline may only be used in women who are breastfeeding if your doctor considers that the benefit outweighs any possible risk to the infant.

Animal studies have shown that some medicines like sertraline may reduce sperm quality. This could theoretically affect fertility; however, the impact on human fertility has not yet been determined.

Driving and using machines:

Psychotropic medicines such as sertraline may affect your ability to drive or operate machinery. Therefore, do not drive or operate heavy machinery until you know how this medicine affects your ability to perform these activities.

Sertraline Teva-ratio contains lactose:

If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Sertraline Teva-ratio contains sodium:

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially "sodium-free".

3. How to take Sertralina Teva-ratio

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

Adults:

Depression and Obsessive-Compulsive Disorder (OCD):

For depression and OCD, the usually effective dose is 50 mg daily. The daily dose may be increased in 50 mg increments at intervals of at least one week, over several weeks. The maximum recommended dose is 200 mg daily.

Panic disorder, social anxiety disorder, and post-traumatic stress disorder:

For panic disorder, social anxiety disorder, and post-traumatic stress disorder, treatment should be initiated at a dose of 25 mg daily, increasing to 50 mg daily after one week.

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

Use in children and adolescents:

Sertraline should only be used to treat children and adolescents aged 6 to 17 years with OCD.

Obsessive-compulsive disorder (OCD):

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

Adolescents aged 13 to 17 years: The recommended starting dose is 50 mg daily. The maximum dose is 200 mg daily.

If you have liver or kidney problems, inform your doctor and follow the instructions he or she gives you.

Method of administration:

Sertraline tablets may be taken with or without food.

Take your medicine once daily, either in the morning or at night.

Your doctor will determine how long you should continue treatment with this medicine. The duration will depend on the nature of your illness and your response to treatment. It may take several weeks before your symptoms begin to improve. Treatment for depression should usually continue for 6 months after symptoms have improved.

If you take more Sertralina Teva-ratio than you should

If you accidentally take too much sertraline, contact your doctor or go to the nearest hospital emergency department. Always bring the medicine packaging with you, whether or not there is any medicine left.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, tremors, agitation, dizziness, and rarely, loss of consciousness.

If you forget to take Sertralina Teva-ratio

Do not take a double dose to make up for forgotten doses. If you miss a dose, do not take it when you remember. Take the next dose at the scheduled time.

If you stop taking Sertralina Teva-ratio

Do not stop treatment with sertraline unless your doctor tells you to. Your doctor will want to gradually reduce your dose of sertraline over several weeks before you stop taking this medicine completely. If you stop treatment abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and tremor. If you experience any of these adverse effects, or any other symptoms, during discontinuation of sertraline treatment, please inform your doctor.

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

4. Possible adverse effects

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

The most common adverse effect is nausea. Adverse effects depend on the dose and often disappear or decrease with continued treatment.

Tell your doctor immediately:

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

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

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

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

Insomnia, dizziness, drowsiness, headache, diarrhea, malaise, dry mouth, ejaculation disorders, and fatigue.

Common (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,
• Tremor, muscle movement problems (such as constant movements, muscle tension, difficulty walking and stiffness, spasms and involuntary muscle movements)*, numbness and tingling, increased muscle tone, difficulty concentrating, abnormal taste,
• Visual disturbances,
• Ringing in the ears,
• Palpitations,
• Hot flushes,
• Yawning,
• Stomach discomfort, 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.

Uncommon (may affect up to 1 in 100 patients):

• Gastroenteritis, ear infection,
• Tumour,
• Hypersensitivity, seasonal allergy,
• Low levels of thyroid hormones,
• Suicidal thoughts, suicidal behaviour*, psychotic disorders, abnormal thinking, lack of self-care, hallucinations, aggression, excessive happiness, paranoia,
• Amnesia, decreased sensitivity, involuntary muscle contractions, fainting, continuous movements, migraine, seizures, dizziness upon standing, abnormal coordination, speech disorders,
• Dilated pupils,
• Ear pain,
• Fast pulse, heart problems,
• Bleeding problems (such as stomach bleeding)*, high blood pressure, hot flushes, blood in urine,
• Shortness of breath, nosebleeds, difficulty breathing possibly noisy,
• Black stools, dental disorders, inflammation of the oesophagus, tongue disorders, haemorrhoids, increased salivation, difficulty swallowing, burping, tongue disorders,
• Swelling of eyes, hives, hair loss, itching, purple spots on the skin, blistering skin problems, dry skin, facial swelling, cold sweat,
• Osteoarthritis, muscle jerks, muscle cramps*, muscle weakness,
• Increased frequency of urination, urinary disorders, urinary retention, urinary incontinence, increased volume of urine, need to urinate at night,
• Sexual dysfunction, excessive vaginal bleeding, vaginal bleeding, female sexual dysfunction,
• Swollen legs, chills, difficulty walking, thirst,
• Increased liver enzyme levels, weight loss,
• Cases of suicidal thoughts and behaviour have been reported during treatment with sertraline or shortly after discontinuation (see section 2).

Rare (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 disorders*,
• High cholesterol, problems controlling blood sugar levels (diabetes), low blood sugar, increased blood sugar levels*, low blood sodium levels*,
• Physical symptoms due to stress or emotions, abnormal nightmares*, drug dependence, sleepwalking, premature ejaculation,
• Coma, abnormal movements, difficulty moving, increased sensitivity, sudden severe headache (which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS))*, sensory disturbances,
• Seeing spots in front of the eyes, glaucoma, double vision, photophobia (eye sensitivity to light), eye bleeding, irregular pupils*, visual disturbances*, tear problems,
• Heart attack, dizziness, fainting or chest discomfort which could be signs of changes in electrical activity (seen on electrocardiogram) or abnormal heart rhythm*, decreased heart rate,
• Circulation problems in arms and legs,
• Rapid breathing, progressive scarring in lung tissue (interstitial lung disease)*, throat spasm, difficulty speaking, slower breathing, hiccups,
• A form of lung disease in which eosinophils (a type of white blood cell) appear in the lungs in high numbers (eosinophilic pneumonia),
• Mouth ulceration, pancreatitis*, blood in stools, tongue ulceration, mouth ulcers,
• Liver function problems, serious liver function problems*, yellowing of skin and eyes (jaundice)*,
• Skin reaction to sunlight*, skin swelling*, abnormal hair texture, abnormal skin odour, capillary rash,
• Muscle tissue rupture*, bone disorder,
• Interrupted urination, decreased urine volume,
• Breast milk secretion, vaginal dryness, genital discharge, pain and redness of the penis and foreskin, breast enlargement*, prolonged erection,
• Hernia, decreased tolerance to the medicine,
• Increased cholesterol levels, abnormal laboratory tests*, abnormal semen, coagulation problems*,
• Relaxation of blood vessel procedures.

Frequency not known: cannot be estimated from available data:

• Jaw locking*,
• Bedwetting (nocturnal urinary incontinence)*,
• Partial loss of vision,
• Inflammation of the colon (causing diarrhea)*,
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for more information.
• Muscle weakness and severe muscle pain, which may be a sign of multiple acyl-coenzyme A dehydrogenase deficiency (MADD)*

*Adverse effects reported after marketing

Other adverse effects in children and adolescents

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

Symptoms that may occur when stopping treatment

If you stop treatment with this medicine abruptly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremor (see section 3. If you stop taking sertraline).

An increased risk of bone fracture has been observed in patients taking this type of medicine.

Reporting of adverse effects

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

5. Storage of Sertraline Teva-ratio

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

Do not use this medicine after the expiry date which is stated on the packaging and on the blister, after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to your local pharmacy’s SIGRE collection point. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sertraline Teva-ratio

• The active substance in Sertraline Teva-ratio is sertraline (hydrochloride). Each tablet contains 50 mg of sertraline.
• The other components are:
  • Tablet core: colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose, copovidone, lactose monohydrate, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide (E-171), and macrogol 400.
  • Film coating: Opadry White Y-5-7068.

Appearance of the product and contents of the pack

Sertraline Teva-ratio 50 mg is presented as film-coated tablets, whitish in color, with the mark “50” on one side.

Sertraline Teva-ratio is available in two pack sizes: 30 and 60 tablets.

The tablets are supplied in aluminum-PVC blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1 Planta

28108 Alcobendas-Madrid

Spain

Manufacturer:

Teva Pharma S.L.U

Polígono Malpica, c/C nº 4

50016 Zaragoza

Spain

Date of the most recent review of the package leaflet: June 2025

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

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: