Package leaflet: Information for the patient

Sertraline Mylan Generics 50 mg film-coated tablets, 100 mg film-coated tablets

sertraline hydrochloride
Generic medicine
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Sertralina Mylan Generics is and what it is used for

Sertralina Mylan Generics contains the active substance sertraline. 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 Mylan Generics can be used to treat the following conditions:

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 one used to.

OCD and panic disorder are anxiety-related conditions with symptoms such as persistent, intrusive thoughts (obsessions) that lead to repetitive ritualistic behaviours (compulsions).
PTSD is a condition that may occur following a severe emotional trauma, 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 intense feelings of anxiety or stress 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.
You should ask your doctor if you are unsure why you have been prescribed Sertralina Mylan Generics.
Consult your doctor if you do not feel well or feel worse after taking Sertralina Mylan Generics.

2. What you need to know before taking Sertraline Mylan Generics

Do not take Sertraline Mylan Generics

if you are allergic to sertraline or to any of the excipients of this medicine (listed in section 6).
if you are taking or have recently taken medicines called monoamine oxidase inhibitors (MAOIs, e.g. selegiline, moclobemide) or medicines with a similar action to MAOIs (such as linezolid). If you stop treatment with sertraline, you must wait one week before starting treatment with an MAOI. After stopping treatment with an MAOI, you must wait at least 2 weeks before starting treatment with sertraline. If you are taking another medicine called pimozide (an antipsychotic medicine).

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

Serotonin syndrome or Neuroleptic Malignant Syndrome (a potentially fatal condition). In rare cases, these syndromes may occur when certain medicines are taken together with sertraline (see “Other medicines and Sertraline Mylan Generics” below). (For symptoms, see section 4 “Possible side effects”). Your doctor will advise you if you have previously experienced this condition.
If you have low levels of sodium in your blood, as this condition may occur as a result of treatment with Sertraline Mylan Generics. You should also inform your doctor if you are taking certain medicines for high blood pressure (hypertension), as these medicines may also alter sodium levels in the blood.
Be cautious if you are elderly, as you may be at higher risk of low sodium levels in the blood (see above).
Liver disease: your doctor may decide to prescribe you a lower dose of Sertraline Mylan Generics.
Diabetes: blood glucose levels may be affected by treatment with Sertraline Mylan Generics, and it may be necessary to adjust the dose of your diabetes medication.
Epilepsy or a history of seizures. If you experience a seizure, contact your doctor immediately.
If you have suffered from bipolar disorder (manic-depressive illness) or schizophrenia. If you experience a manic episode, contact your doctor immediately.
If you have had or currently have thoughts of harming yourself or of suicide (see below “Suicidal thoughts and worsening of depression or anxiety disorder”).
If you have experienced bleeding problems or if you are taking medicines that thin the blood (e.g. acetylsalicylic acid (aspirin) or warfarin) or that may increase the risk of bleeding.
Children or adolescents under 18 years of age. Sertraline Mylan Generics should only be used to treat children and adolescents aged 6 to 17 years suffering from obsessive-compulsive disorder. If a child or adolescent is being treated for this disorder, the doctor must monitor them closely (see “Children and adolescents” below). If you are undergoing electroconvulsive therapy (ECT). If you have a history of glaucoma (increased pressure in the eye).
If you have low potassium levels in your blood, a family history of sudden death or heart problems, suffer from other heart conditions, or are taking medicines known to affect heart rhythm. In these cases, you are at higher risk of developing heart rhythm problems (QT interval prolongation, Torsades de Pointes). If you are taking Sertraline Mylan Generics, it may affect urine screening tests.

Medicines such as Sertraline Mylan Generics (so-called selective serotonin reuptake inhibitors / SSRIs and serotonin-noradrenaline reuptake inhibitors / SNRIs) 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 akathisia (distressing restlessness and an urge to move, often accompanied by an inability to sit still). This condition is more likely to occur during the first weeks of treatment. Increasing the dose may be harmful for patients who develop these symptoms.
Withdrawal reaction
Withdrawal reactions that occur when stopping the medicine are common, especially if treatment is stopped suddenly (see section 3 “If you stop taking Sertraline Mylan Generics” 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. Generally, these symptoms are mild to moderate in intensity; however, in some patients they may be severe. They usually occur in the first few days after stopping treatment. These symptoms normally resolve on their own within 2 weeks. In some patients, they may last longer (2-3 months or more).
When stopping treatment with Sertraline Mylan Generics, it is recommended to gradually reduce the dose over a period of several weeks or months, and you should always discuss the best way to discontinue treatment with your doctor.
Suicidal thoughts and worsening of depression or anxiety disorders
If you are depressed and/or have anxiety disorders, you may sometimes think about harming yourself or about suicide.
These thoughts may worsen when you first start taking antidepressants, as all these medicines take time to become effective, usually about 2 weeks but sometimes longer.
You are more likely to have such thoughts if:

You have previously thought about suicide or self-harm.
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 think about harming yourself or about suicide, contact your doctor or go immediately to the nearest hospital. It may be helpful to inform a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them if they think your depression or anxiety disorder is worsening, or if they are concerned about changes in your behaviour.

Children and adolescents:
Sertraline Mylan Generics should not normally be used in children and adolescents under 18 years of age, except for patients with Obsessive-Compulsive Disorder. Patients under 18 years of age have a higher risk of adverse effects, such as suicide attempts, 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 Mylan Generics to a patient under 18 years of age if it is in the patient’s best interest. If your doctor has prescribed Sertraline Mylan Generics to a patient under 18 years of age and you wish to discuss this decision, please contact your doctor. Furthermore, if any of the symptoms listed above develop or worsen while a patient under 18 years of age is being treated with Sertraline Mylan Generics, you must inform the doctor.
Finally, the long-term safety of Sertraline Mylan Generics on growth, maturation, and cognitive and behavioural development in this age group has not been established.
Other medicines and Sertraline Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Some medicines may affect the activity of Sertraline Mylan Generics or Sertraline Mylan Generics may reduce the effectiveness of other medicines taken simultaneously.
Taking Sertraline Mylan Generics with the following medicines may cause serious adverse events:

Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (for treating depression) and selegiline (for treating Parkinson’s disease), the antibiotic linezolid, and methylene blue (for treating high levels of methaemoglobin in the blood). Do not use Sertraline Mylan Generics together with MAOIs.
Medicines for the treatment of mental disorders (e.g. pimozide). Do not use Sertraline Mylan Generics together with pimozide. Opioid medicines for the treatment of acute or chronic pain (e.g. buprenorphine). Do not use Sertraline Mylan Generics together with opioids without first consulting your doctor. These medicines may interact with Sertraline Mylan Generics and may cause symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, fever above 38°C. Contact your doctor if you experience such symptoms.

Inform your doctor or pharmacist 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. Discuss this with your doctor.
Products containing the amino acid tryptophan.
Medicines for the treatment of migraine (e.g. sumatriptan).
Medicines to thin the blood (e.g. warfarin, ticlopidine).
Medicines for the treatment of pain/arthritis (non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)).
Diuretics.
Medicines for the treatment of epilepsy (phenytoin, phenobarbital, carbamazepine).
Medicines for the treatment of excess stomach acid, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
Medicines for the treatment of mania and depression (lithium).
Other medicines for the treatment of depression (such as amitriptyline, nortriptyline, desipramine, nefazodone, fluoxetine, fluvoxamine).
Medicines for the treatment of schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
Medicines used for anaesthesia or for the treatment of chronic and severe pain (mivacurium, suxamethonium, and opioid medicines such as fentanyl).
Medicines used to treat high blood pressure, chest pain, or to regulate heart rate and rhythm (such as flecainide, propafenone, verapamil, and diltiazem).
Medicines for the treatment of HIV infections (such as ritonavir).
Medicines for the treatment of fungal infections (such as fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole).
Antibiotics (such as clarithromycin, erythromycin, telithromycin).
Medicines for the treatment of nausea and vomiting (such as aprepitant).
Medicines for the treatment of tuberculosis (rifampicin).
Medicines known to affect heart rhythm (such as levofloxacin, haloperidol, imipramine).

Sertraline Mylan Generics with beverages and alcohol
Alcohol consumption should be avoided during treatment with Sertraline Mylan Generics.
Sertraline Mylan Generics should not be taken with grapefruit juice, as this may increase the level of sertraline in the blood.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking any medicine.
The safety of sertraline in pregnant women has not been fully established. Sertraline should be given to pregnant women only if your doctor considers that the benefit to the mother outweighs any possible risk to the fetus. Women of childbearing age should use an adequate method of contraception if they are being treated with sertraline.
Ensure that your midwife and/or doctor are aware that you are being treated with Sertraline Mylan Generics. When taken during pregnancy, particularly during the last 3 months of pregnancy, medicines such as Sertraline Mylan Generics may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing in the newborn and a bluish skin colour. These symptoms usually appear within the first 24 hours after birth. Inform your midwife and/or doctor immediately if your baby shows these symptoms.
Your baby may also experience other conditions, which usually begin within the first 24 hours after birth.
Symptoms include:

breathing difficulties,
bluish skin or being too hot or too cold,
blue lips,
vomiting or feeding difficulties,
being very tired, unable to sleep or crying a lot,
stiff or floppy muscles,
tremors, nervousness, jerks,
increased reflex responses,
irritability,
low blood sugar.

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 breast milk. Sertraline should be used in breastfeeding women only if your 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 count. 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.
This product contains less than 1 mmol of sodium (23 mg) per tablet, meaning it is essentially “sodium-free”.

3. How to take Sertraline Mylan Generics

Always take this medicine exactly as instructed by your doctor or pharmacist.
Sertraline Mylan Generics tablets can be taken with or without food.
Take the medicine once daily, in the morning or in the evening.
The tablets may be divided into two equal doses.
You may notice that this medicine has an unusual odour and/or taste. This is normal, and you can
minimise this by taking the medicine with a glass of water, immediately after placing the tablet in your mouth.
If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults:
Depression and Obsessive-Compulsive Disorder (OCD):
For depression and OCD, the recommended 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:
For panic disorder, social anxiety disorder, and post-traumatic stress disorder, treatment should begin at a dose of 25 mg/day, then increased to 50 mg/day after one week.
The daily dose may then be increased by 50 mg at intervals over several weeks. The maximum recommended dose is 200 mg/day.
Use in children and adolescents
Sertraline Mylan Generics should only be used for the treatment of children and adolescents aged 6–17 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 to 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 problems with your liver or kidneys, inform your doctor and follow the instructions given by your doctor.
Your doctor will tell you how long you should take this medicine. This will depend on the duration of your illness and your response to treatment. It may take several weeks before symptoms begin to improve.
If you take more Sertraline Mylan Generics than you should
If you accidentally take too much Sertraline Mylan Generics, contact your doctor immediately or go to the nearest emergency department. 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 Mylan Generics
If you forget to take a dose, do not take the missed dose. Take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.
If you stop taking Sertraline Mylan Generics
Do not stop taking Sertraline Mylan Generics unless your doctor tells you to. Your doctor may gradually reduce your dose of Sertraline Mylan Generics over several weeks before stopping completely. If you stop taking this medicine suddenly, you may experience unwanted effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and tremors.
If you experience any of these unwanted effects, or any other unwanted effects during treatment with Sertraline Mylan Generics, speak to your doctor.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Tell your doctor immediately
If you experience any of the following symptoms after taking this medicine, these symptoms may be serious.

If you have an epileptic seizure (convulsions)
Allergic reaction or allergy, which may include symptoms such as itchy raised rash (urticaria), breathing difficulties, wheezing, or sudden swelling of the eyelids, face or lips
Inability to urinate
If you experience symptoms of depression with suicidal thoughts and suicidal behaviour. These symptoms have been reported during treatment with sertraline or immediately after stopping treatment (see section 2)
If you have a heart attack
If you become unconscious (in a coma)
If you experience severe stomach or abdominal pain, feel very bloated, and have a high body temperature. These may be signs of diverticulitis, where a pouch in the lining of the intestine becomes inflamed or infected
Blood in the faeces (stools) – the blood may be fresh or the faeces may appear black or tarry
Unexpected or unusual vaginal bleeding (e.g. very heavy)
Problems controlling blood sugar levels (diabetes)
Glaucoma (increased pressure in the eyes), which may cause severe eye pain, redness of the eyes, or you may notice halos or blurred vision
Very slow breathing
If you develop a severe skin reaction causing blistering (which may affect the mouth, tongue and genitals). 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
If you experience agitation, confusion, diarrhoea, high fever and high blood pressure, excessive muscle stiffness or sweating, and rapid heartbeat. These are symptoms of Serotonin Syndrome or Neuroleptic Malignant Syndrome. In rare cases, these syndromes may occur when certain medicines are taken together with sertraline. Your doctor may stop treatment
If you experience severe muscle pain, weakness or swelling of the muscles (due to muscle breakdown – rhabdomyolysis)
If you have a sudden, severe headache (which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome (RCVS) or Call-Fleming syndrome)
If you develop serious lung problems. You may develop a persistent cough without phlegm, or feel progressively short of breath
If you develop yellowing of the skin and eyes, which may be a sign of liver damage
If you experience inflammation of the pancreas causing severe pain in the upper stomach, often with nausea or vomiting
If you begin to feel restless and unable to sit or stand still after starting treatment with Sertralina Mylan Generics. You must inform your doctor if you start feeling restless
If you experience manic episodes (see section 2 “Warnings and precautions”)
If there is a decrease in white blood cells, which help fight infections (you may get more infections, e.g. sore throat, mouth ulcers and fever)
If you have bleeding problems (such as stomach bleeding – if you vomit, the vomit may look like coffee grounds)
Changes in heart rhythm, which may be seen on an electrocardiogram (ECG) (with signs of a serious disorder called QT interval prolongation or Torsades de Pointes)

The following additional side effects have been observed in clinical studies and after marketing in adult patients.
Very common (may affect more than 1 in 10 people):

Insomnia (difficulty sleeping), dizziness, drowsiness, headache, diarrhoea, nausea, dry mouth, ejaculation failure, fatigue

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

Cold, sore throat, runny nose
Decreased or increased appetite
Depression, feeling strange, nightmares, anxiety, agitation, nervousness, reduced sexual interest, teeth grinding
Numbness and tingling, tremors, movement disorders (such as tense muscles and difficulty walking), abnormal twisting of the neck, arms and trunk, muscle tension, altered taste, lack of attention
Vision disturbances, ringing in the ears
Palpitations, hot flushes, yawning
Abdominal pain, vomiting, constipation, stomach discomfort, gas in the stomach
Skin rash, increased sweating
Back pain, muscle or joint pain
Erectile dysfunction, irregular menstruation
Chest pain, malaise (general feeling of being unwell), fever, weakness
Weight gain
Wounds

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

Gastroenteritis, ear infections, tumour
Hypersensitivity, seasonal allergy
Hallucinations (seeing, hearing or sensing things that are not there), excessive feeling of happiness, lack of personal care, altered thinking, aggression, psychotic disorders, paranoia
Involuntary muscle contractions, coordination disturbances, excessive movements, amnesia (loss of memory), reduced sensation, speech disorders, dizziness when standing up, fainting, migraine
Ear pain
Rapid heartbeat, heart problems, high blood pressure, facial flushing, blood in urine
Shortness of breath, nosebleeds, breathing difficulties, possible wheezing
Oesophageal problems, difficulty swallowing, haemorrhoids, increased salivation, tongue disorders, problems with tongue, dental problems, belching
Dilated pupils
Swelling of the eyes, development of red spots on the skin, facial swelling, hair loss, cold sweats, dry skin, dermatitis, urticaria, itching
Osteoarthritis, muscle weakness, muscle cramps, muscle contractions
Nocturnal urination, increased urine volume, increased frequency of urination, difficulty urinating, urinary incontinence
Increased and prolonged menstrual bleeding (menorrhagia), sexual dysfunction
Swelling of arms and legs, chills, difficulty walking, thirst
Increased liver enzyme levels, weight loss
Low levels of thyroid hormone

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

Swelling of lymph glands
High cholesterol levels, low blood sugar levels, decreased salts in the blood (sodium), increased blood sugar levels (hyperglycaemia)
Decreased platelets (you may develop bruises or bleed more easily), severe allergic reaction
Physical symptoms due to stress or emotions, abnormal frightening dreams, drug dependence, sleepwalking, premature ejaculation
Abnormal movements, difficulty moving, increased sensations, sensory disturbances
Development of spots on the eye, glaucoma, double vision (diplopia), discomfort caused by light (photophobia), blood collection in the anterior chamber of the eye (hyphaema), abnormal vision, pupils of different sizes, altered tear production
Slowed heartbeat
Poor blood circulation to arms and legs
Throat tightness, rapid breathing, difficulty speaking, hiccups
Mouth pain, ulceration of the tongue, mouth ulceration, liver function problems
Skin problems with blister formation, rash around hair follicles, changes in hair structure, altered skin odour, skin oedema, photosensitivity reaction
An increased risk of bone fractures has been observed in patients taking this type of medicine, bone disorders
Reduced urination, urinary hesitation
Endocrine problems
Increased cholesterol levels in the blood, abnormal laboratory test results, altered seminal fluid, problems with blood clotting
Dryness of the vaginal area, red and painful penis and foreskin, genital discharge, prolonged erection, breast discharge, breast enlargement
Hernia, reduced drug tolerance, blood vessel dilation

Not known (frequency cannot be estimated from the available data)

Trismus (also known as locked jaw, is a reduced ability to open the jaw)
Partial loss of vision
Inflammation of the colon (causing diarrhoea)

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). After the marketing of sertraline, nocturnal enuresis has also been reported. The most common side effects in children and adolescents were headache, insomnia, diarrhoea and nausea.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Sertraline Mylan Generics

Keep in the original packaging.
Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging following Exp.. The expiry date refers to the last day of the month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Sertralina Mylan Generics contains

The active substance is sertraline hydrochloride. One tablet contains 50 mg or 100 mg of sertraline.
The other excipients are calcium hydrogen phosphate, microcrystalline cellulose, magnesium stearate, sodium starch glycolate (type A), hypromellose (E464), titanium dioxide (E171), polydextrose (E1200), triacetin and macrogol.

Description of the appearance of Sertralina Mylan Generics and pack sizes
Sertralina Mylan Generics 50 mg film-coated tablets
White to almost white, capsule-shaped, film-coated tablets marked with “ST/50” on one side and the letter “G” on the other.
Sertralina Mylan Generics 100 mg film-coated tablets
White to almost white, capsule-shaped, film-coated tablets marked with “ST/100” on one side and the letter “G” on the other.
Sertralina Mylan Generics 50 mg and 100 mg is available in HDPE bottles (with an optional desiccant) and blisters in pack sizes of 14, 15, 20, 28, 30, 50, 60, 98, 100, 250, 300, 500 tablets*.
*Not all pack sizes may be marketed.

MARKETING AUTHORISATION HOLDER
Mylan S.p.A. – Via Vittor Pisani, 20 – 20124 Milano, Italy

RESPONSIBLE BATCH RELEASE MANUFACTURER
McDermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road - Dublin 13 - Ireland
Generics [UK] Ltd.
Station Close, Potters Bar, Hertfordshire, EN6 1TL – United Kingdom
Mylan Hungary Kft.
H-2900
Komárom, Mylan utca 1
Hungary

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Sertralina Mylan Generics 50 mg and 100 mg film-coated tablets
Ireland: Depreger 50 mg & 100 mg film-coated tablet