Sastium

Leaflet accompanying the packaging: patient information

Sastium, 50 mg, coated tablets

Sastium, 100 mg, coated tablets

Sertraline

Before taking the medicine, carefully read the contents of this leaflet, as it contains important information for the patient.

• This leaflet should be kept, so that it can be re-read if necessary.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• This medicine has been prescribed specifically for the patient. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. See section 4.

Table of contents of the leaflet

• 1. What is Sastium and what is it used for
• 2. Important information before taking Sastium
• 3. How to take Sastium
• 4. Possible side effects
• 5. How to store Sastium
• 6. Contents of the packaging and other information

1. What is Sastium and what is it used for

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

Sastium can 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 children and adolescents aged 6-17 years).

Depression is a condition whose symptoms are: sadness, difficulty sleeping or lack of joy in life.
Obsessive-compulsive disorder and panic disorder are anxiety disorders with accompanying constant anxiety due to persistent thoughts (obsessions) that cause repetitive rituals (compulsive actions).
Post-traumatic stress disorder is a condition that can occur after a traumatic experience and is characterized by symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety disorder. It is characterized by intense anxiety or stress in social situations (such as talking to strangers, speaking in front of a group of people, eating or drinking in the presence of others, or fear of potentially embarrassing behavior).
The doctor has decided that this medicine is suitable for treating the patient's disorder.
The patient should consult a doctor if they are unsure why they are taking Sastium.
The patient should tell the doctor if they do not feel better or if they feel worse.

2. Important information before taking Sastium

When not to take Sastium

• if the patient is allergic to sertraline or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking or has taken monoamine oxidase inhibitors (MAOIs, e.g., selegiline, moclobemide) or medicines similar to MAOIs (e.g., linezolid). In the case of stopping sertraline treatment, it is necessary to wait at least one week before starting MAOI treatment. After stopping MAOI treatment, it is necessary to wait at least 2 weeks before starting sertraline treatment;
• if the patient is taking pimozide (a medicine used to treat mental disorders, such as psychoses).

Warnings and precautions

Before starting Sastium treatment, the doctor or pharmacist should be consulted.
Not all medicines are suitable for everyone. The doctor should be informed if the patient currently has or has had any of the following conditions:

• Seizures (fits) or a history of seizures. In case of a seizure, the doctor should be contacted immediately.
• A history of manic-depressive disorder (bipolar) or schizophrenia. In case of a manic episode, the doctor should be contacted immediately.
• A history of thoughts of self-harm or suicide (see below - Suicidal thoughts, worsening depression or anxiety disorders).
• Serotonin syndrome. In rare cases, this syndrome can occur in patients who have taken certain medicines with sertraline. (Symptoms, see section 4. Possible side effects). The doctor should inform the patient if they have had serotonin syndrome in the past.
• Low sodium levels in the blood, as this may occur as a result of taking Sastium. The doctor should also be informed about taking medicines used to treat high blood pressure, as they may also change sodium levels in the blood.
• Older adults: the risk of low sodium levels in the blood (see above) is higher in these patients.
• Liver disease: the doctor may decide to reduce the dose of Sastium.
• Diabetes: Sastium may affect blood sugar levels, so it may be necessary to change the dosage of antidiabetic medicines.
• A history of bleeding disorders (tendency to bruise) or if the patient is pregnant (see - Pregnancy, breastfeeding, and fertility) or has taken medicines that prevent blood clotting [e.g., acetylsalicylic acid (aspirin) or warfarin] or may increase the risk of bleeding.
• Children or adolescents under 18 years of age. Sastium can be used in children and adolescents aged 6-17 years only for the treatment of obsessive-compulsive disorder (OCD). Patients treated for this condition should be closely monitored by the doctor (see below - Children and adolescents).
• Electroconvulsive therapy.
• Eyelid problems, such as certain types of glaucoma (increased eye pressure).
• ECG abnormalities, known as prolonged QT interval.
• Heart disease, low potassium or magnesium levels, a family history of prolonged QT interval, slow heart rate, and concurrent use of medicines that prolong the QT interval.

Sexual dysfunction

Medicines like Sastium (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.

Psychomotor restlessness/akathisia

Sertraline treatment has been associated with the occurrence of a state characterized by psychomotor restlessness and a compulsion to perform movements - often with an inability to sit or stand still (akathisia). This condition usually occurs within the first few weeks of treatment. The doctor should be contacted in case of increased dosage, as it may be harmful to patients with such symptoms.

Withdrawal symptoms

After stopping treatment, side effects (withdrawal symptoms) often occur, especially if treatment is stopped abruptly (see section 3. Stopping Sastium treatment and section 4. Possible side effects). The risk of withdrawal symptoms depends on the duration of treatment, dosage, and rate of dose reduction. These symptoms are usually mild or moderate, but in some patients, they can be severe. They usually occur in the first few days after stopping treatment. They usually resolve on their own within 2 weeks, but in some patients, they may persist for longer (2-3 months or longer). If the decision is made to stop sertraline treatment, it is recommended to gradually reduce the dose over several weeks or months and consult the doctor on the best way to stop treatment.

Suicidal thoughts, worsening depression or anxiety disorders

Patients with depression and/or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of antidepressant treatment, as these medicines usually start working after 2 weeks, and sometimes later.

The occurrence of suicidal thoughts, self-harm, or suicidal behavior is more likely if:

• the patient has had suicidal thoughts or self-harm in the past;
• the patient is a young adult; clinical trial data indicate an increased risk of suicidal behavior in patients under 25 years of age with mental disorders who were treated with antidepressants.

If the patient experiences suicidal thoughts or self-harm, they should immediately contact their doctor or go to the hospital.
It may be helpful to inform relatives or friends about depression or anxiety disorders and ask them to read this leaflet. The patient may ask relatives or friends for help and ask them to inform them if they notice that depression or anxiety has worsened or if there are worrying changes in behavior.

Children and adolescents

Sertraline should not be used in children and adolescents under 18 years of age, with the exception of patients with obsessive-compulsive disorder (OCD). In patients under 18 years of age taking medicines from this group, there is an increased risk of side effects such as suicidal attempts, self-harm, or suicidal thoughts (suicidal thoughts) and hostility (mainly aggressive, defiant, and angry behavior).
However, the doctor may decide to prescribe Sastium to a patient under 18 years of age if it is in the patient's interest. If the doctor prescribes Sastium to a patient under 18 years of age and the child's caregiver wants to discuss this, they should contact the doctor.
Moreover, if any of the above symptoms occur or worsen while taking Sastium, the doctor should be informed.
The safety of long-term use of Sastium in terms of its impact on growth, maturation, learning (cognitive functions), and behavior was assessed in a long-term study involving over 900 children aged 6-16 years who were monitored for 3 years. The study results showed that children treated with sertraline developed normally, except for mild weight gain in children treated with a higher dose.

Sastium and other medicines

The doctor or pharmacist should be informed about all medicines currently being taken or recently taken, as well as any medicines that the patient plans to take.
Some medicines may affect the way Sastium works or Sastium may reduce the effectiveness of other medicines taken at the same time.

Taking Sastium with the following medicines may cause serious side effects:

• Medicines that are monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression) and selegiline (used to treat Parkinson's disease), the antibiotic linezolid, and methylene blue (a substance used to treat high methemoglobin levels in the blood). Sastium should not be taken with these medicines.
• Medicines used to treat mental disorders, such as psychoses (pimozide). Sastium should not be taken with pimozide.

The patient should inform the doctor if they 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 effect of St. John's Wort may persist for 1-2 weeks.
• Preparations containing the amino acid tryptophan.
• Medicines used to treat severe or chronic pain (opioids, e.g., tramadol, fentanyl).
• Medicines used for anesthesia (e.g., fentanyl, mivacurium, and suxamethonium).
• Medicines used to treat migraines (e.g., sumatriptan).
• Medicines that prevent blood clotting (warfarin).
• Medicines used to treat pain/joint inflammation [e.g., metamizole, nonsteroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen, acetylsalicylic acid (aspirin)].
• Sedatives (diazepam).
• Diuretics.
• Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines used to treat diabetes (tolbutamide).
• Medicines used to treat excessive stomach acid production, stomach ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazol).
• Medicines used to treat mania and depression (lithium).
• Other medicines used to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medicines used to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medicines used to treat high blood pressure, chest pain, or heart rate regulation (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 infections (protease inhibitors, such as ritonavir, telaprevir).
• Medicines used to prevent nausea and vomiting after chemotherapy (aprepitant).
• Medicines that increase the risk of changes in heart electrical activity (e.g., antipsychotic and antibiotic medicines).

Taking Sastium with food, drink, and alcohol

Sastium tablets can be taken with or without food.
Alcohol should not be consumed while taking Sastium.
Sastium should not be taken with grapefruit juice, as it may increase the level of sertraline in the body.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a baby, they should consult their doctor before taking this medicine.
The safety of sertraline use in pregnant women has not been fully established. The medicine can be used in pregnant women only if the doctor considers that the benefits to the mother outweigh the potential risks to the fetus.
Taking Sastium at the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Sastium, they should inform their doctor or midwife so that they can provide appropriate advice.
Taking medicines like Sastium during pregnancy, especially in the last trimester, may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), characterized by rapid breathing and blue skin color. These symptoms usually appear in the first day of life.
If the baby experiences any of these symptoms, the midwife or doctor should be contacted immediately.
Newborns may also experience other complications, which usually appear within the first 24 hours after birth. These symptoms include:

• breathing difficulties,
• bluish skin, too hot or cold skin,
• bluish lips,
• vomiting or problems with sucking,
• excessive tiredness, problems with falling asleep or constant crying,
• increased or decreased muscle tone,
• tremors, muscle spasms, or seizures,
• increased reflexes,
• restlessness,
• low blood sugar.

If the baby experiences any of these symptoms or if their condition is worrying, the doctor or midwife should be contacted.
There is evidence that sertraline passes into breast milk. The medicine can be used in breastfeeding women if the doctor considers that the benefits of the medicine outweigh the potential risks to the baby.
In animal studies, some medicines similar to sertraline have been shown to reduce sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans.

Driving and using machines

Psychotropic medicines, such as sertraline, may affect the ability to drive or operate machinery. The patient should wait until it is known how Sastium affects their ability to perform these activities.

Sastium contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Sastium

This medicine should always be taken as directed by the doctor or pharmacist.
In case of doubts, the doctor or pharmacist should be consulted.

Recommended dose of Sastium:

Adults:

Depression and obsessive-compulsive disorder

The usual effective dose for treating depression and OCD is 50 mg/day.
The daily dose can be increased gradually by 50 mg at intervals of at least one week over several weeks. The maximum recommended dose is 200 mg/day.

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

Treatment of panic disorder, social anxiety disorder, and post-traumatic stress disorder should be started with a dose of 25 mg/day, which can be increased to 50 mg/day after one week.
The daily dose can then be increased gradually by 50 mg over several weeks. The maximum recommended dose is 200 mg/day.

Use in children and adolescents

Sastium can be used in children and adolescents aged 6-17 years only for the treatment of obsessive-compulsive disorder (OCD).

Obsessive-compulsive disorder

Children aged 6-12 years:The recommended initial dose is 25 mg/day.
After one week, the doctor may increase the dose to 50 mg/day.
The maximum dose is 200 mg/day.
Adolescents aged 13-17 years:The recommended initial dose is 50 mg/day.
The maximum dose is 200 mg/day.
Patients with liver or kidney disease should inform their doctor and follow their instructions.
Method of administration:
Sastium tablets can be taken with or without food.
The medicine should be taken once a day, in the morning or evening.
The doctor will inform the patient how long they should take the medicine. The treatment period depends on the type of disease and the patient's response to treatment. Improvement may occur only after several weeks of treatment. Depression treatment should usually last for 6 months from the time of improvement.

Taking a higher dose of Sastium than recommended

If the patient accidentally takes too much Sastium, they should immediately contact their doctor or go to the emergency department of the nearest hospital. The patient should take the medicine packaging with them, regardless of whether there is any medicine left in it or not.
Symptoms of overdose may include drowsiness, nausea, and vomiting, rapid heart rate, muscle tremors, agitation, dizziness, and in rare cases, loss of consciousness.

Missing a dose of Sastium

A double dose of the medicine should not be taken to make up for a missed dose.
If the patient forgets to take a tablet, they should not take the missed tablet.
They should simply take the next tablet at the right time.

Stopping Sastium treatment

The patient should not stop taking Sastium on their own. The doctor should gradually reduce the dose of Sastium over several weeks, until the patient finally stops taking it. If the patient suddenly stops taking the medicine, they may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and muscle tremors. If the patient experiences any of these side effects or any other side effects after stopping Sastium treatment, they should contact their doctor.
In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Sastium can cause side effects, although not everybody gets them.
The most common side effect is nausea. Side effects depend on the dose and often disappear or decrease as treatment continues.

The doctor should be contacted immediately

If the patient experiences any of the following symptoms after taking this medicine, as they may be serious.

• If the patient develops a severe skin rash that causes blisters (erythema multiforme; blisters may appear in the mouth and on the tongue). These may be symptoms of a condition called Stevens-Johnson syndrome or toxic epidermal necrolysis. In such cases, the doctor will stop treatment.
• An allergic reaction or allergy, with symptoms such as: itchy skin rash, breathing difficulties, wheezing, swelling of the eyelids, face, or lips.
• If the patient experiences: agitation, confusion, diarrhea, high temperature and blood pressure, excessive sweating, and rapid heart rate. These are symptoms of serotonin syndrome. In rare cases, this syndrome can occur when the patient takes certain medicines at the same time as sertraline. The doctor may then stop the treatment.
• If the patient experiences yellowing of the skin and eyes, which may indicate liver damage.
• If the patient experiences symptoms of depression with thoughts of self-harm or suicide (suicidal thoughts).
• If the patient experiences restlessness and cannot sit or stand still. If the patient experiences restlessness, they should inform their doctor.
• If the patient has a seizure (fit).
• If the patient experiences manic episodes (see section 2. Warnings and precautions).

The following side effects have been reported in clinical trials in adult patients and after the product was placed on the market.

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

insomnia, dizziness, drowsiness, headaches, diarrhea, nausea, dry mouth, ejaculation disorders, fatigue.
Common (may affect up to 1 in 10 people):

• cold, throat infection, runny nose
• decreased appetite, increased appetite
• anxiety, depression, agitation, decreased interest in sex, nervousness, strange feelings, nightmares, teeth grinding
• muscle tremors, movement disorders (such as increased muscle activity, increased muscle tone, difficulty walking, and stiffness, spasms, and involuntary muscle movements)*, numbness and tingling, muscle tension, lack of concentration, taste disorders
• vision disturbances,
• ringing in the ears,
• palpitations,
• hot flashes,
• yawning,
• gastrointestinal disorders, constipation, abdominal pain, vomiting, gas,
• increased sweating, rash,
• back pain, joint pain, muscle pain,
• irregular menstrual periods, erectile dysfunction,
• general malaise, chest pain, weakness, fever
• weight gain
• injuries

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

• gastritis, ear infection,
• tumor,
• hypersensitivity, seasonal allergy,
• decreased thyroid hormone levels in the blood,
• suicidal thoughts and behaviors*, psychotic disorders, thought disorders, apathy, hallucinations, aggression, euphoria, paranoia,
• amnesia, decreased sensation, involuntary muscle contractions, fainting, increased muscle activity, migraine, dizziness when standing up, speech disorders,
• pupil dilation,
• ear pain,
• rapid heart rate, heart problems,
• bleeding disorders (including gastrointestinal bleeding)*, high blood pressure, flushing,
• shortness of breath, nosebleeds, breathing difficulties, wheezing,
• black stools, dental problems, esophagitis, tongue problems, hemorrhoids, increased salivation, swallowing difficulties, hiccup,
• eye swelling, hives, hair loss, itching, skin disorders with blistering, dry skin, facial swelling, cold sweats,
• joint disease, muscle spasms*, muscle weakness,
• increased urination, urinary problems, inability to urinate, urinary incontinence, increased urine production, nocturia,
• sexual dysfunction, heavy menstrual bleeding, menstrual bleeding, sexual dysfunction in women,
• swelling of the legs, chills, difficulty moving, increased thirst
• increased liver enzymes, weight loss.

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

• appendicitis, lymph node enlargement, decreased platelet count*, decreased white blood cell count*,
• severe allergic reactions,
• endocrine disorders,
• high cholesterol, problems with maintaining normal blood sugar levels (diabetes), low blood sugar, high blood sugar, low sodium levels in the blood,
• physical symptoms caused by stress or emotions, nightmares*, drug dependence, sleepwalking, premature ejaculation,
• coma, abnormal movements, difficulty moving, increased sensitivity, sudden severe headache (which may be a symptom of a serious condition called reversible cerebral vasoconstriction syndrome), sensory disturbances,
• blind spots, glaucoma, double vision, photophobia, blood in the eye, uneven pupil size, vision disturbances, tear disorders,
• heart attack, feeling of emptiness in the head, fainting or discomfort in the chest, which may be symptoms of changes in heart electrical activity (visible on an electrocardiogram) or abnormal heart rhythm*, slow heart rate,
• worsening of blood circulation in the arms and legs,
• rapid breathing, pulmonary fibrosis (interstitial lung disease), laryngospasm, speech difficulties, slow breathing, hiccups,
• pulmonary eosinophilia (a disease in which eosinophils, a type of white blood cell, accumulate in the lungs in increased numbers),
• mouth ulcers, pancreatitis*, bloody stools, tongue ulcers, oral pain,
• liver disorders, severe liver dysfunction*, yellowing of the skin and eyes (jaundice)*,
• sunburn*, skin swelling*, abnormal hair structure, abnormal skin odor, hairy skin rash,
• muscle breakdown*, bone disorders,
• decreased urination, delayed urination,
• nipple discharge, vaginal dryness, discharge, painful red penis and foreskin, breast enlargement*, prolonged erection,
• hernia, decreased drug tolerance,
• increased cholesterol levels in the blood, abnormal laboratory test results, abnormal semen test results, bleeding problems*,
• vascular collapse,

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

• jaw spasms*,
• nocturnal enuresis*,
• partial loss of vision,
• colitis (causing diarrhea)*,
• severe vaginal bleeding shortly after delivery (postpartum hemorrhage), see additional information in the subsection Pregnancy, breastfeeding, and fertility in section 2*.
• muscle weakness and severe muscle pain, which may be symptoms of a disorder similar to glutaric aciduria type II.

*Side effects reported after the product was placed on the market.

Additional side effects in children and adolescents:

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

Withdrawal symptoms:

After stopping treatment, side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and muscle tremors may occur (see section 3. Stopping Sastium treatment).
Patient groups taking this type of medicine have been observed to have an increased risk of bone fractures.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Sastium

The medicine should be stored out of sight and reach of children.
This medicine should not be taken after the expiry date stated on the carton after "EXP" and on the blister after "EXP". The expiry date refers to the last day of the month stated.
There are no special precautions for storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Sastium contains

Each 50 mg coated tablet contains sertraline hydrochloride equivalent to 50 mg of sertraline.
Each 100 mg coated tablet contains sertraline hydrochloride equivalent to 100 mg of sertraline.
The other ingredients are:
Tablet core: calcium phosphate dihydrate, microcrystalline cellulose, hydroxypropyl cellulose, sodium carboxymethyl cellulose (type A), magnesium stearate
Tablet coating: Hypromellose 2910, macrogol 400, polysorbate 80, titanium dioxide (E 171)

What Sastium looks like and contents of the pack

Sastium 50 mg is a white, biconvex oval coated tablet with a length of 10.5 mm, width of 4.2 mm, with the marking "I" on one side and "C" on the other side of the score line on one side and smooth on the other. The tablet can be divided into two equal doses.
Sastium 100 mg is a white, biconvex oval coated tablet with a length of 13.3 mm, width of 5.2 mm, with the marking "IJ" on one side and smooth on the other.
Sastium 50 mg/100 mg coated tablets are packaged in PVC/Aluminum blisters or HDPE bottles.
Packaging:
Blisters: 10, 14, 28, 30, 42, 50, 56, 84, 90, or 100 coated tablets in a cardboard box.
HDPE bottles: 50 mg - 250 coated tablets; 100 mg - 250; 500 coated tablets (packaging intended for hospital use).
Not all pack sizes may be marketed.

Marketing authorization holder:

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer/Importer:

Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex HA1 4HF
United Kingdom
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
Netherlands
Accord Healthcare Polska Sp. z o.o.
Lutomierska 50
95-200 Pabianice
Accord Healthcare Single Member
S.A. 64th Km National Road Athens, Schimatari
32009 Lamia
Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: July 2025