Package leaflet: Information for the patient

Sertraline Accord 50 mg film-coated tablets, 100 mg film-coated tablets

Equivalent medicine
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.

Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Sertraline Accord is and what it is used for
What you need to know before taking Sertraline Accord
How to take Sertraline Accord
Possible side effects
How to store Sertraline Accord
Contents of the pack and other information

1. What Sertralina Accord is and what it is used for

Sertralina Accord contains the active substance sertraline. Sertraline belongs to a group of medicines known as Selective Serotonin Re-uptake Inhibitors (SSRIs); these medicines are used to treat depression and/or anxiety disorders.
Sertralina Accord may 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 to 17 years).

Depression is a clinical illness with symptoms such as feeling sad, inability to sleep properly or to enjoy life as you used to.
OCD and panic disorder are anxiety-related conditions with symptoms such as persistent, intrusive worries (obsessions) that lead you to perform ritualistic actions (compulsions).
PTSD is a condition that may occur after a strongly traumatic experience, and some symptoms of this condition are similar to those of depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterised by feelings of intense anxiety or distress in social situations (e.g. speaking to strangers, speaking in public, eating or drinking in front of others, or fear of behaving in an embarrassing way).
Your doctor has determined that this medicine is suitable for treating your condition.
Ask your doctor if you are unsure why Sertralina Accord has been prescribed for you.
Contact your doctor if you do not feel better or if you feel worse.

2. What you should know before taking Sertraline Accord

Do not take Sertraline Accord:

If you are allergic to sertraline or to any of the other ingredients of this medicine (listed in section 6).
If you are currently taking, or have recently taken, medicines called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide), or medicines with MAOI-like activity (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 for mental disorders such as psychosis).

Warnings and precautions
Talk to your doctor or pharmacist before taking Sertraline Accord.
Medicines are not always suitable for everyone. Inform your doctor before taking Sertraline Accord if you suffer, or have previously suffered, from any of the following conditions:

If you have epilepsy (epileptic seizures) or a history of seizures. In case of a seizure, contact your doctor immediately.
If you have suffered from bipolar disorder (manic-depressive illness) or schizophrenia. In case of a manic episode, contact your doctor immediately.
If you are having or have ever had thoughts of harming or killing yourself (see below – Suicidal thoughts and worsening of depression or anxiety disorder).
If you suffer from serotonin syndrome. In rare cases, this syndrome may occur when taking certain medicines together with sertraline (for symptoms, see section 4. Possible side effects). Your doctor will determine whether you have previously experienced this condition.
If you have low sodium levels in the blood, as this condition may occur during treatment with Sertraline Accord. You should also inform your doctor if you are taking certain medicines for high blood pressure, as these may also affect sodium levels in the blood.
If you are elderly, as you may be at increased risk of low sodium levels in the blood (see above).
If you have liver disease: your doctor may decide to prescribe a lower dose of Sertraline Accord.
If you have diabetes: blood glucose levels may be affected by treatment with Sertraline Accord, and the dose of your diabetes medicines may need to be adjusted. Also inform your doctor if you have a history of bleeding disorders (tendency to bruise easily), if you are pregnant (see Pregnancy, breastfeeding and fertility), or if you are taking medicines that thin the blood (e.g. acetylsalicylic acid (aspirin) or warfarin) or medicines that may increase the risk of bleeding.
If you are a child or adolescent under 18 years of age. Sertraline Accord should only be used to treat children and adolescents aged 6 to 17 years who suffer from obsessive-compulsive disorder (OCD). If a child or adolescent is being treated for this disorder, the doctor will want to monitor them closely (see below Use in children and adolescents).
If you are undergoing electroconvulsive therapy (ECT).
If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
If you have been diagnosed with an abnormal heart rhythm on electrocardiogram (ECG), known as QT interval prolongation.
If you have heart disease, low potassium or magnesium levels, a family history of QT interval prolongation, slow heart rate, or are taking concomitant medicines that prolong the QT interval.

Sexual problems:
Medicines such as sertraline tablets (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.
Restlessness/Akathisia
The use of sertraline has been associated with distressing restlessness and a need to move, often accompanied by an inability to sit still or remain motionless (akathisia). This condition is more likely to occur during the first few weeks of treatment. Increasing the dose may be harmful for patients who develop these symptoms; therefore, discuss this with your doctor.
Withdrawal reaction
Undesirable effects related to stopping treatment (withdrawal reactions) are common, especially if treatment is stopped suddenly (see section 3 “If you stop taking Sertraline Accord” and section 4 “Possible side effects”). The risk of withdrawal reactions depends on the duration of treatment, the dose, and the extent of dose reduction. These symptoms are usually mild to moderate in intensity. However, in some patients, they may be severe. They typically occur within the first few days after stopping treatment. Generally, these symptoms resolve on their own within 2 weeks. In some patients, they may last longer (2–3 months or more). When stopping treatment with sertraline, it is recommended to gradually reduce the dose over a period of several weeks or months. Always talk to your doctor to determine the best way to stop treatment.
Suicidal thoughts and worsening of depression or anxiety disorder:
If you are depressed and/or have anxiety disorders, you may sometimes have thoughts about harming or killing yourself. These thoughts may worsen when starting antidepressants, as all these medicines require time before they become effective, usually about 2 weeks but sometimes longer.
You are more likely to have such thoughts if:

You have previously had thoughts of killing yourself or harming yourself.
You are a young adult. Available data from clinical trials have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric conditions treated with an antidepressant.

If at any time you have thoughts about harming or killing yourself, contact your doctor or go immediately to the nearest hospital.
It may be helpful to inform a close family member or friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them to observe whether your depression or anxiety disorder is worsening, or whether they are concerned about changes in your behaviour.
Children and adolescents:
Sertraline should not routinely be used in children and adolescents under 18 years of age, except for 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 thoughts), and hostile behaviour (mainly aggression, oppositional behaviour and anger) when treated with this class of medicines. However, your doctor may decide to prescribe Sertraline Accord to a patient under 18 years of age if it is in the patient’s best interest. If your doctor has prescribed Sertraline Accord to you and you are under 18 years of age and wish to discuss this decision, please contact your doctor. Additionally, if any of the symptoms listed above appear or worsen during treatment with Sertraline tablets, you must inform your doctor. The long-term safety of Sertraline tablets with regard to growth, maturation and cognitive development, and behavioural development has been evaluated in a long-term study involving over 900 children aged 6 to 16 years, monitored for a period of 3 years. Overall, the study results showed that children treated with sertraline had normal development, apart from a slight increase in weight in those treated with higher doses.
Other medicines and Sertraline Accord
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect the activity of Sertraline Accord, or Sertraline Accord may reduce the effectiveness of other medicines taken at the same time.
Taking Sertraline Accord with the following medicines may cause serious side effects:

Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression), selegiline (used to treat Parkinson’s disease), the antibiotic linezolid, and methylene blue (used to treat high levels of methaemoglobin in the blood). Do not use Sertraline Accord together with these medicines.
Medicines used to treat mental disorders such as psychosis (pimozide). Do not use Sertraline Accord together with pimozide.

Inform your doctor if you are taking any of 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 for 1–2 weeks.
Products containing the amino acid tryptophan.
Medicines used to treat severe or chronic pain (opioids, e.g. tramadol, fentanyl).
Medicines used in anaesthesia (e.g. fentanyl, mivacurium, and suxamethonium).
Medicines used to treat migraine (e.g. sumatriptan).
Medicines used to thin the blood (warfarin).
Medicines used to treat pain/arthritis (non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)).
Sedatives (diazepam).
Diuretics (also known as "water tablets").
Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
Medicines used to treat diabetes (tolbutamide).
Medicines used to treat excess stomach acid, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
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 to regulate heart rate and rhythm (such as verapamil, diltiazem, flecainide, and 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).

Sertraline Accord with food, drinks and alcohol:
Sertraline Accord may be taken with or without food.
Alcohol consumption should be avoided during treatment with Sertraline Accord.
Sertraline must not be taken with grapefruit juice, as this may increase sertraline levels in the body.
Pregnancy, breastfeeding and fertility:
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of sertraline in pregnant women has not been fully established. Sertraline should be given to pregnant women only if the doctor considers that the benefit to the mother outweighs any possible risk to the developing baby.
If you take Sertraline Accord near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (a tendency to bleed easily). Inform your doctor or midwife that you are taking Sertraline Accord so they can advise you accordingly. When taken during pregnancy, particularly during the last three months, medicines such as Sertraline Accord may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN). This condition causes the newborn to breathe rapidly and have a bluish skin colour. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact the midwife and/or doctor immediately.
The baby may also experience other conditions, which usually begin within the first 24 hours after birth. Symptoms include:

Breathing difficulties,
Bluish skin colour or being too hot or too cold,
Bluish lips,
Vomiting or feeding difficulties,
Being very tired, unable to sleep, or crying excessively,
Stiff or floppy muscles,
Tremors, nervousness, jerks,
Increased reflex responses,
Irritability,
Low blood sugar levels.

If your baby shows any of the above symptoms at birth, or if you have any concerns about your baby’s health, contact your doctor or midwife, who will be able to advise you.
There is evidence that sertraline is excreted in human breast milk. Sertraline should only be used during breastfeeding if the doctor considers that the benefit to the mother outweighs any possible risk to the baby.
In animal studies, some medicines like sertraline may reduce sperm quality. In theory, this could affect fertility, but no impact on human fertility has been observed.
Driving and using machines:
Psychotropic medicines such as sertraline may affect your ability to drive or operate machinery. Therefore, you should not drive or operate machinery until you know whether this medicine affects your ability to perform these activities.
Sodium content in Sertraline tablets:
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Sertraline Accord

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults:
Depression and Obsessive-Compulsive Disorder (OCD):
For depression and OCD, the usual effective dose is 50 mg/day. The daily dose may be increased 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 (PTSD):
For panic disorder, social anxiety disorder, and PTSD, treatment should start at a dose of 25 mg/day, which should then be increased to 50 mg/day after one week.
The daily dose may then be increased by 50 mg increments over several weeks. The maximum recommended dose is 200 mg/day.
Use in children and adolescents:
Sertraline Accord should only be used for the treatment of children and adolescents aged 6 to 17 years with Obsessive-Compulsive Disorder (OCD).
Obsessive-Compulsive Disorder (OCD):
Children aged 6-12 years: The recommended starting dose is 25 mg/day.
After one week, your doctor may increase the dose by 50 mg/day. The maximum dose is 200 mg/day.
Adolescents aged 13-17 years: The recommended starting dose is 50 mg/day. The maximum dose is 200 mg/day.
If you have liver or kidney problems, inform your doctor and follow the instructions they provide.
Method of administration:
Sertraline Accord may be taken with or without food.
Take the medicine once daily, either in the morning or in the evening.
Your doctor will tell you how long you should take this medicine. This depends on the duration of the illness and your response to treatment. It may take several weeks before symptoms begin to improve. Treatment for depression should usually continue for 6 months after improvement is observed.
If you take more Sertraline Accord than you should:
If you accidentally take too much Sertraline Accord, contact your doctor immediately or go to the nearest emergency room. Always take the medicine pack with you, whether or not it still contains any medicine.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, tremors, agitation, dizziness, and in rare cases, loss of consciousness.
If you forget to take Sertraline Accord:
Do not take a double dose to make up for forgotten doses. If you forget to take a dose, do not take the missed dose. Take the next dose at the usual time.
If you stop taking Sertraline Accord:
Do not stop treatment with Sertraline Accord unless instructed by your doctor. Your doctor may wish to gradually reduce the dose of Sertraline Accord over several weeks before stopping the medicine completely. If you stop taking this medicine suddenly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and tremors. If you experience any of these adverse effects, or any other adverse effects during treatment with Sertraline Accord, speak to your doctor.
If you have any questions about the use of Sertraline Accord, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sertralina Accord can cause side effects, although not everybody gets them.
Nausea is the most common side effect. Side 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 they may be serious:

If you develop a severe skin reaction causing blistering (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. In such cases, your doctor will stop treatment.
Allergic reactions or allergies, which may include symptoms such as itchy rash, breathing difficulties, wheezing, swelling of the eyelids, face or lips.
If you experience agitation, confusion, diarrhoea, high fever and high blood pressure, excessive sweating and rapid heartbeat. These are symptoms of Serotonin Syndrome. In rare cases, this syndrome may occur when certain medicines are taken together with sertraline. Your doctor may decide to stop treatment.
If you develop yellowing of the skin and eyes, which may indicate liver damage.
If you develop depressive symptoms with thoughts of harming yourself or of suicide (suicidal thoughts).
If you begin to feel restless and are unable to sit still or remain motionless after starting treatment with Sertralina Accord. You must inform your doctor if you start feeling restless.
If you have seizures.
If a manic episode occurs (see section 2 “Warnings and precautions”).

The following side effects have been observed in clinical studies conducted in adult patients and after marketing authorisation:

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

Insomnia, dizziness, drowsiness, headache, diarrhoea, nausea, dry mouth, absence of ejaculation,
fatigue.

Common (may affect up to 1 in 10 people):

Cold sweats, sore throat, runny nose,
Decreased appetite, increased appetite,
Anxiety, depression, agitation, decreased interest in sex, nervousness, strange feeling, nightmares, teeth grinding,
Tremors, movement disorders (such as excessive movement, muscle tension, difficulty walking and stiffness, spasms (involuntary muscle movements)*, numbness and tingling, increased muscle tension, lack of attention, abnormal taste,
Visual disturbances,
Ringing in the ears,
Palpitations,
Hot flushes,
Yawning,
Stomach disturbances, constipation, abdominal pain, vomiting, gas,
Increased sweating, rash,
Back pain, joint pain, muscle pain,
Menstrual irregularities, erectile dysfunction,
Malaise, chest pain, weakness, fever,
Weight gain,
Injuries.
Gastroenteritis, ear infection,
Tumour,
Hypersensitivity, seasonal allergy,
Low blood levels of thyroid hormones,
Suicidal thoughts, suicidal behaviour*, psychotic disorder, abnormal thinking, lack of care, hallucinations, aggression, euphoric mood, paranoia,
Amnesia, decreased sensation, involuntary muscle contractions, fainting, excessive movements, migraine, seizures, dizziness upon standing, abnormal coordination, speech disorders,
Dilated pupils,
Earache,
Rapid heartbeat, heart problems,
Bleeding problems (such as stomach bleeding)*, high blood pressure, blood rushes, blood in urine,
Shortness of breath, nosebleeds, breathing difficulties, possible wheezing,
Dark stools, dental problems, oesophagitis, tongue problems, haemorrhoids, increased salivation, difficulty swallowing, burping, tongue disorders,
Eye swelling, hives, hair loss, itching, purple spots on the skin, blistering skin problems, dry skin, facial oedema, cold sweats,
Osteoarthritis, muscle contractions, muscle cramps*, muscle weakness,
Increased frequency of urination, inability to urinate, urinary incontinence, increased urine volume, nocturia,
Sexual dysfunction, excessive vaginal bleeding, vaginal haemorrhage, female sexual dysfunction,
Swelling of legs, chills, difficulty walking, thirst,
Increased liver enzyme levels, weight loss.

Cases of suicidal ideation and suicidal behaviour have been reported during treatment with sertraline or immediately after discontinuation of treatment (see section 2).

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

Diverticulitis, swollen lymph glands, decreased platelets*, decreased white blood cells*,
Severe allergic reaction,
Endocrine disorders*,
High cholesterol, problems controlling blood sugar levels (diabetes), low blood sugar, increased blood sugar levels*, low levels of salts in the blood*,
Physical symptoms due to stress or emotions, terrifying abnormal dreams*, drug dependence, sleepwalking, premature ejaculation,
Coma, abnormal movements, movement difficulties, increased senses (hearing, vision, taste, smell and touch), sudden severe headache (which may be a sign of a serious condition known as Reversible Cerebral Vasoconstriction Syndrome (RCVS), in which blood vessels in the brain suddenly narrow, causing headache and other symptoms)*, sensory disturbances,
Spots in front of the eyes, glaucoma, double vision, light blinding the eyes, blood in the eyes, unequal pupil size*, abnormal vision*, tear problems,
Heart attack, dizziness, fainting or chest discomfort which could be signs of altered electrical activity (seen on electrocardiogram) or abnormal heart rhythm*, slow heartbeat,
Poor circulation in arms and legs,
Rapid breathing, progressive scarring of lung tissue (interstitial lung disease)*, throat closure, difficulty speaking, slow breathing, hiccups,
A form of lung disease in which eosinophils (a type of white blood cell) appear in greater numbers in the lung (eosinophilic pneumonia).
Mouth ulcers, pancreatitis*, blood in stools, tongue ulceration, inflamed mouth,
Liver function problems, severe liver function problems*, yellowing of skin and eyes (jaundice)*,
Skin reaction to sunlight*, skin oedema*, abnormal hair texture, abnormal skin odour, rash,
Rhabdomyolysis (muscle tissue breakdown)*, bone disorder,
Urinary hesitation, decreased urination,
Breast milk secretion, dry vaginal area, genital discharge, red painful penis and foreskin, breast enlargement*, prolonged erection,
Hernia, decreased tolerance to the drug,
Increased blood cholesterol levels, abnormal laboratory tests*, abnormal sperm, coagulation problems*,
Procedure for relaxing blood vessels.

Not known: frequency cannot be estimated from the available data:

Trismus*,
Incontinence*,
Partial loss of vision,
Inflammation of the colon (causing diarrhoea).
Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage). See section 2, “Pregnancy, breastfeeding and fertility”, for further information.

* Adverse effect reported after marketing authorisation

Additional side effects in children and adolescents:
In clinical studies in children and adolescents, side effects were generally similar to those observed in adults (see above). The most common side effects in children and adolescents were headache, insomnia, diarrhoea and nausea.

Symptoms that may occur when treatment is stopped:
If you stop treatment with this medicine suddenly, you may experience side effects such as dizziness, tingling, sleep disturbances, agitation or anxiety, headache, nausea, vomiting and tremor (see section 3 “If you stop taking Sertralina Accord”).

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency website: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sertraline Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sertralina Accord contains
Sertralina Accord 50 mg film-coated tablets contain sertraline hydrochloride equivalent to 50 mg of
sertraline.
Sertralina Accord 100 mg film-coated tablets contain sertraline hydrochloride equivalent to 100 mg of
sertraline.
The other components are:
Tablet core:
Calcium hydrogen phosphate dihydrate (E341)
Microcrystalline cellulose (E460)
Hydroxypropylcellulose (E463)
Sodium starch glycolate (type A)
Magnesium stearate (E470b)
Film coating:
Opadry White containing:
Hypromellose 2910 (5mPa.s) (E464)
Macrogol 400 (E1521)
Polysorbate 80 (E433)
Titanium dioxide (E171)

Description of the appearance of Sertralina Accord and package contents
Sertralina Accord 50 mg film-coated tablets are white, capsule-shaped, biconvex, film-coated tablets, marked with “I” and “C” on both sides of the score line and plain on the other side.
The tablets can be divided into equal parts. The 50 mg tablet is approximately 10.5 mm long and 4.2 mm thick.
Sertralina Accord 100 mg film-coated tablets are white, capsule-shaped, biconvex, film-coated tablets, marked with “IJ” on one side and plain on the other side. The 100 mg tablet is approximately 13.3 mm long and 5.2 mm thick.
Sertralina tablets are available in opaque white PVC – aluminium blisters and plastic bottles made of polyethylene (HDPE).
Pack sizes:
Blister packs: 10, 14, 28, 30, 42, 50, 56, 84, 90 or 100 tablets.
Plastic bottles in polyethylene (HDPE): 50 mg – 250 tablets, 100 mg – 250 and 500 tablets (for hospital use only).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Healthcare Single Member
S.A. 64th Km National Road Athens,
Lamia, Schimatari, 32009, Greece

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

| Country | Medicinal Product Name | |-------------|----------------------------| | Netherlands | Sertraline Accord 50 mg/100 mg filmomhulde tabletten | | Austria | Sertralin Accord 50 mg/100 mg Filmtabletten | | Bulgaria | Sertraline Accord 50 mg/100 mg film-coated tablets | | Cyprus | Sertraline Accord 50 mg/100 mg film-coated tablets | | Denmark | Sertralin Accord 50 mg/100 mg filmovertrukne tabletter | | Estonia | Sertraline Accord | | Finland | Sertraline Accord 50 mg/100 mg tabletti, kalvopäällysteinen | | Hungary | Sertraline Accord 50 mg/100 mg filmtabletta | | Ireland | Sertraline 50 mg/100 mg film-coated tablets | | Italy | Sertralina Accord | | Latvia | Sertraline Accord 50 mg/100 mg apvalkotās tabletes | | Poland | Pramidin | | Sweden | Sertraline Accord 50 mg/100 mg filmdragerad tablet | | Slovak Republic | Sertraline Accord 50 mg/100 mg filmomobalené tablety |