Miravil

Package leaflet: Information for the user

Miravil, 50 mg, film-coated tablets
Miravil, 100 mg, film-coated tablets
Sertralinum
Please read 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Miravil is and what it is used for

Miravil contains the active substance sertraline. Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines are used to treat depressive and/or anxiety disorders.
Miravil may be used to treat:

• Major depressive episodes and prevention of recurrence of major depression (in adults)
• Social phobia (in adults)
• Post-traumatic stress disorder (PTSD) (in adults)
• Panic disorder with or without agoraphobia (in adults)
• Obsessive-compulsive disorder (OCD) (in adults and in children and adolescents aged 6–17 years)

Depression is an illness characterised by symptoms such as feelings of sadness, difficulty sleeping, or inability to feel joy in life.
OCD and panic disorder are anxiety-related conditions involving persistent worry due to intrusive thoughts (obsessions), leading to repetitive behaviours (compulsions).
Post-traumatic stress disorder (PTSD) is a condition that may occur after a traumatic event and is characterised by symptoms similar to depression and anxiety.
Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterised by intense fear or anxiety 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 worrying about potentially embarrassing behaviour).

Your doctor has decided that this medicine is suitable for treating your condition.
You should consult your doctor if you are unsure why you are taking Miravil.

2. Important information before using Miravil

When not to use Miravil:

• if the patient is allergic to sertraline or any of the other ingredients of this medicine (listed in section 6).
• if the patient is currently taking or has recently taken monoamine oxidase inhibitors (MAO inhibitors, e.g. selegiline, moclobemide) or medicines similar to MAO inhibitors (e.g. linezolid). At least one week must pass after stopping treatment with sertraline before starting treatment with an MAO inhibitor. After stopping treatment with an MAO inhibitor, at least two weeks must pass before starting treatment with sertraline.
• if the patient is taking pimozide (a medicine used to treat psychiatric disorders such as psychosis).

Warnings and precautions
Before starting treatment with Miravil, discuss this with your doctor or pharmacist.
Medicines are not always suitable for everyone. You should tell your doctor before taking Miravil if the patient currently has or has previously had any of the following conditions:

• epilepsy (seizures) or a history of convulsive seizures. If a seizure occurs, contact your doctor immediately.
• a previous history of bipolar disorder (manic-depressive illness) or schizophrenia. If a manic episode occurs, contact your doctor immediately.
• current or past thoughts of self-harm or suicide (see below – Suicidal thoughts, worsening of depression or anxiety disorders).
• serotonin syndrome. In rare cases, this syndrome may occur in patients taking certain medicines at the same time as sertraline. (Symptoms, see section 4. "Possible side effects"). Your doctor should ask whether you have previously experienced serotonin syndrome.
• low sodium levels in the blood, which may occur during treatment with Miravil. You should also inform your doctor if you are taking medicines for high blood pressure, as these may also affect blood sodium levels.
• advanced age – such patients may be more susceptible to reduced sodium levels in the blood (see above).
• liver disease – your doctor may decide to reduce the dose of Miravil.
• diabetes – Miravil may affect blood glucose levels, so a change in dosage of antidiabetic medicines may be necessary.
• a history of bleeding disorders (tendency to bruise easily), or if the patient is pregnant (see "Pregnancy, breastfeeding and effect on fertility") or has previously taken anticoagulant medicines [e.g. acetylsalicylic acid (aspirin) or warfarin] or medicines that may increase the risk of bleeding.
• age under 18 years. Miravil may be used only in the treatment of children and adolescents aged 6 to 17 years with obsessive-compulsive disorder. Patients being treated for this condition should be closely monitored by a doctor (see below – Children and adolescents).
• electroconvulsive therapy (ECT).
• eye disorders, such as certain types of glaucoma (increased pressure in the eye).
• if the patient has been diagnosed with a heart condition on electrocardiogram (ECG) known as prolonged QT interval.
• heart disease, low potassium or magnesium levels, family history of prolonged QT interval, slow heart rate, and concomitant use of medicines that may prolong the QT interval.

Psychomotor agitation/Akathisia:
Sertraline has been associated with a condition characterised by motor restlessness and an urge to move, often with inability to sit still or remain motionless (akathisia). This condition usually occurs during the first weeks of treatment. Increasing the dose of the medicine may be harmful; therefore, if the patient experiences such symptoms, they should inform their doctor.

Withdrawal symptoms:
Adverse effects (withdrawal symptoms) often occur after stopping treatment, especially if treatment is stopped abruptly (see section 3 "Stopping Miravil" and section 4 "Possible side effects"). The risk of withdrawal symptoms depends on the duration of treatment, dose, and speed of dose reduction. These symptoms are generally mild or moderate in intensity, but in some patients they may be severe. They usually occur within the first few weeks after stopping treatment and typically resolve spontaneously within 2 weeks, although in some patients they may persist longer (more than 2–3 months). When deciding to discontinue sertraline treatment, it is recommended to gradually reduce the dose over several weeks or months. The patient should always discuss the best way to stop treatment with their doctor.

Suicidal thoughts, worsening of depression or anxiety disorders:
Patients with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually take about 2 weeks, sometimes longer, to start working.

The likelihood of experiencing suicidal thoughts, thoughts of self-harm or suicide is higher if:

• the patient has previously had suicidal thoughts or self-harm tendencies;
• the patient is a young adult; clinical data indicate an increased risk of suicidal behaviour in individuals under 25 years of age with psychiatric disorders who are being treated with antidepressant medicines.

If the patient experiences suicidal thoughts or thoughts of self-harm, they should immediately contact their doctor or go to hospital.
It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask for help from family or friends and request that they inform them if they notice worsening depression or anxiety, or concerning changes in behaviour.

Sexual dysfunction:
Medicines such as Miravil (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.

Children and adolescents:
Sertraline should generally not be used in children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorder. In patients of this age group, an increased risk of adverse effects such as suicide attempts, thoughts of self-harm or suicide (suicidal thoughts), and hostility (mainly aggressive behaviour, defiance, and anger) has been observed during treatment with medicines of this class. However, a doctor may decide to prescribe Miravil to a patient under 18 years of age if it is in the patient's best interest. If the doctor prescribes Miravil to a patient under 18 years of age and the caregiver wishes to discuss this, they should contact the doctor. Furthermore, if any of the symptoms listed above appear or worsen during treatment with Miravil, the doctor should be informed. In a long-term observational study lasting 3 years involving over 900 children aged 6 to 16 years, the long-term safety of sertraline was evaluated with regard to its effects on growth, maturation, learning (cognitive functions), and behaviour. Overall, study results showed that children treated with sertraline developed normally, except for a small effect on weight gain in children treated with higher doses.

Miravil and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Some medicines may affect the way Miravil works, or Miravil may reduce the effectiveness of other medicines taken at the same time.

Taking Miravil together with the following medicines may cause serious side effects:

• monoamine oxidase inhibitors (MAO inhibitors), e.g. moclobemide (used to treat depression), selegiline (used to treat Parkinson's disease), the antibiotic linezolid, and methylene blue (used to treat high levels of methemoglobin in the blood). Miravil must not be taken together with these medicines.
• medicines used to treat psychiatric disorders such as psychosis (pimozide). Miravil must not be taken together with pimozide.

The patient should inform their doctor if they are taking any of the following medicines:

• medicines containing amphetamine derivatives (used to treat attention deficit hyperactivity disorder (ADHD), excessive sleepiness, and obesity)
• herbal remedies 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 (e.g. opioids, tramadol, fentanyl)
• medicines used in anaesthesia (e.g. fentanyl, mivacurium, and suxamethonium)
• medicines used to treat migraines (e.g. sumatriptan)
• anticoagulant medicines (warfarin)
• medicines used to treat pain/inflammation of joints (e.g. metamizole, non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen, salicylic 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, peptic ulcer disease, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole)
• medicines used to treat mania and depression (lithium)
• other medicines used to treat depression (e.g. amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine)
• medicines used to treat schizophrenia and other psychiatric 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, 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 electrical activity of the heart (e.g. certain antipsychotics and antibiotics).

Miravil with food, drink and alcohol
Miravil tablets may be taken with or without food.
During treatment with Miravil, alcohol should not be consumed.
Sertraline should not be taken together with grapefruit juice, as it may increase the concentration of sertraline in the body.

Pregnancy, breastfeeding and effect on fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The safety of sertraline use in pregnant women has not been fully established. Sertraline may be used in pregnant women only if, according to the doctor's assessment, the benefits of treatment outweigh the potential risks to the developing baby.
Taking Miravil towards the end of pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Miravil, she should inform her doctor or midwife so they can provide appropriate advice. Similar medicines taken by women during pregnancy, especially during the last three months, may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and skin blueness in the baby. These symptoms usually appear within the first day of the baby's life. If such symptoms occur, contact the midwife and (or) doctor immediately.
Other symptoms may also occur in the newborn, usually within the first 24 hours after birth. These symptoms include:

• breathing difficulties,
• skin blueness or skin that is too hot or too cold,
• blue lips,
• vomiting or feeding problems,
• excessive tiredness, difficulty sleeping, or constant crying,
• increased or decreased muscle tone,
• tremors, muscle twitches, or seizures,
• increased reflexes,
• irritability,
• low blood sugar levels.

If any of these symptoms occur in the baby after birth or if the baby's health is concerning, contact the doctor or midwife for advice.

There is evidence that sertraline is excreted into breast milk. The medicine may be used in breastfeeding women if, according to the doctor's assessment, the benefits to the mother outweigh the potential risks to the baby.

Animal studies have shown that some medicines similar to sertraline may reduce semen quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans to date.

Driving and operating machinery
Psychotropic medicines such as sertraline may affect the ability to drive or operate machinery. Patients should wait until they know how Miravil affects them before performing these activities.

Excipients
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Miravil

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
The usual dose of Miravil is:
Adults:
Depression and obsessive-compulsive disorder (OCD)
The usual effective dose for treating depression and OCD is 50 mg per day. The daily dose may be
gradually increased by 50 mg, at intervals of at least one week, over several weeks. The maximum
recommended dose is 200 mg per day.
Anxiety disorders with panic attacks (panic disorder), social phobia, and post-traumatic stress disorder
Treatment of anxiety disorders with panic attacks (panic disorder), social phobia, and post-traumatic
stress disorder should be initiated at a dose of 25 mg per day, increasing after one week to 50 mg per day.
The daily dose may then be gradually increased by 50 mg at a time, over several weeks. The maximum
recommended dose is 200 mg per day.
Use in children and adolescents:
Miravil may be used in the treatment of children and adolescents aged 6–17 years with
obsessive-compulsive disorder (OCD) only.
Obsessive-compulsive disorder:
Children aged 6 to 12 years: The recommended initial dose is 25 mg per day.
After one week, the doctor may increase the dose to 50 mg per day. The maximum dose is
200 mg per day.
Adolescents aged 13 to 17 years: The recommended initial dose is 50 mg per day.
The maximum dose is 200 mg per day.
Patients with liver or kidney disease should inform their doctor and follow medical advice.
Method of administration
Miravil tablets may be taken with or without food.
The medicine should be taken once daily, in the morning or evening.
Your doctor will inform you how long you should continue taking the medicine. The duration of
treatment depends on the type of illness and your individual response to treatment. Improvement
in symptoms may not occur until after several weeks of treatment. Typically, treatment of
depression should continue for 6 months after symptoms have improved.
If you take more Miravil than you should
If you accidentally take too much Miravil, contact your doctor immediately or go to the emergency
department of your nearest hospital. Always take the medicine packaging and label with you,
regardless of whether any medicine remains.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, muscle tremors,
agitation, dizziness, and in rare cases, loss of consciousness.
If you miss a dose of Miravil
Do not take a double dose to make up for a missed dose. If you forget to take a tablet, do not take the
missed tablet. Simply take the next tablet at the usual time.
Stopping Miravil treatment
You must not stop taking Miravil on your own. Your doctor should gradually reduce the dose of Miravil
over several weeks until you stop taking it completely. If you stop taking Miravil suddenly, you may
experience withdrawal symptoms such as dizziness, numbness, sleep disturbances, agitation or anxiety,
headache, nausea, vomiting, and muscle tremors. If you experience any of these or other adverse
effects after stopping Miravil, consult your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The most commonly occurring adverse effect is nausea. Adverse effects depend on
dose and often diminish or weaken with continued treatment.
You should inform your doctor immediately
if any of the following symptoms occur in the patient, as they may
be serious.

• if the patient develops a severe skin rash causing blistering (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 (TEN). In such cases, the doctor will discontinue treatment with this medicine.
• allergic reaction or allergy, which may include symptoms such as: itchy rash, breathing difficulties, wheezing, swelling of the eyelids, face or lips
• if the patient experiences: agitation, confusion, diarrhoea, high temperature and blood pressure, excessive sweating and rapid heartbeat. These are symptoms of serotonin syndrome, which may rarely occur when the patient is taking certain medicines at the same time as sertraline. The doctor may then discontinue the patient's treatment.
• if the patient develops 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 after taking Miravil the patient begins to feel inner restlessness and is unable to sit or stand still. If the patient experiences such restlessness, they should inform their doctor.
• if the patient experiences seizures (fits)
• if the patient experiences manic episodes (see section 2 "Warnings and precautions").

The following adverse effects have been observed in clinical studies in adult patients and after
marketing of the medicine:
Very common ( may affect more than 1 in 10 patients ):
Insomnia, dizziness, drowsiness, headache*, diarrhoea, nausea, dry mouth,
ejaculation disorders, fatigue*.
Common ( may affect up to 1 in 10 patients ):

• cold, sore throat, runny nose
• decreased appetite, increased appetite*
• anxiety*, depression*, agitation*, reduced interest in sex*, nervousness, strange feelings, nightmares, teeth grinding*
• muscle tremors, movement disorders (such as increased motor activity, increased muscle tension, difficulty walking, and muscle stiffness, cramps and involuntary muscle movements)*, numbness and tingling*, increased muscle tension*, lack of concentration, taste disturbances
• visual disturbances*
• tinnitus*
• palpitations*
• hot flushes*
• yawning*
• gastrointestinal discomfort, constipation*, abdominal pain*, vomiting*, flatulence
• increased sweating, rash*
• back pain, joint pain*, muscle pain
• irregular menstruation*, erectile dysfunction
• malaise*, chest pain*, weakness*, fever*
• weight gain*
• injuries.

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

• gastrointestinal disorders, ear infection

• tumour

• hypersensitivity*, seasonal allergy*

• decreased thyroid hormone levels*

• suicidal thoughts, suicidal behaviour*, psychotic disorders*, thinking disorders, emotional blunting, hallucinations*, aggression*, feeling of euphoria*, paranoia

• memory impairment, decreased sensation*, involuntary muscle contractions*, loss of consciousness*, increased motor activity*, migraine*, seizures*, dizziness upon standing, coordination disorders, speech disorders

• pupil dilation*

• ear pain

• increased heart rate*, heart problems

• haemorrhagic disorders (including stomach bleeding)*, high blood pressure*, sudden skin reddening, blood in urine*

• shortness of breath, nosebleeds*, breathing difficulties (wheezing possible)*

• tarry stools, dental disorders, oesophagitis, tongue problems, haemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders

• eye swelling*, urticaria*, hair loss*, itching*, purpuric skin spots*, skin disorders with blister formation, dry skin, facial swelling, cold sweats

• degenerative joint disease, muscle tics, painful muscle cramps*, decreased muscle strength

• increased frequency of urination, difficulty urinating, inability to urinate, urinary incontinence*, increased urine volume, nocturia, sexual dysfunction, excessive vaginal bleeding, vaginal haemorrhage,
  sexual dysfunction in women

• leg swelling*, chills, difficulty walking*, increased thirst

• increased liver enzyme activity*, weight loss*.

During treatment with sertraline or shortly after discontinuation, cases of suicidal thoughts
and behaviour have been reported (see section 2).
Rare ( may affect up to 1 in 1,000 patients ):

• diverticulitis, lymph node swelling, decreased platelet count*, decreased white blood cell count*
• severe allergic reactions*
• endocrine disorders*
• high cholesterol levels, problems maintaining normal blood sugar levels (diabetes)*, low blood glucose*, increased blood sugar*, low blood sodium levels*
• physical symptoms caused by stress or emotions*, terrifying nightmares*, drug dependence, sleepwalking, premature ejaculation
• coma*, abnormal movements, difficulty moving, increased sensory sensitivity, sudden severe headache (which may be a symptom of a serious condition called reversible cerebral vasoconstriction syndrome)*, sensory disturbances
• visual scotoma, glaucoma, double vision, sensation of harmful light effects on the eye, blood in the eye*, unequal pupil size*, visual disturbances*, tearing problems
• myocardial infarction*, feeling of emptiness in the head, fainting or chest discomfort, which may be symptoms of changes in the heart's electrical activity (visible on electrocardiogram) or irregular heartbeat*, slowed heart rate
• worsening of blood circulation in the upper and lower limbs
• increased breathing rate, progressive pulmonary fibrosis (interstitial lung disease)*, laryngospasm, difficulty speaking, slowed breathing, hiccups
• a form of lung disease in which eosinophils (a type of white blood cell) appear in increased numbers in the lungs (eosinophilic pneumonia)
• oral ulceration, pancreatitis*, presence of blood in stool, tongue ulceration, oral pain
• liver function disorders, severe liver function disorders*, yellowing of the skin and eyes (jaundice)*
• skin reaction to sunlight*, skin swelling*, abnormal hair structure, abnormal skin odour, scalp rash
• rhabdomyolysis*, bone disorders
• delayed urination*, decreased urination
• nipple discharge*, vaginal dryness, genital discharge, painful red penis and foreskin*, breast enlargement*, prolonged penile erection*
• hernia, decreased drug tolerance
• increased blood cholesterol levels*, abnormal laboratory test results*, abnormal semen analysis, blood clotting problems*
• vasodilation.

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

• bruxism*
• nocturnal enuresis*
• partial loss of vision
• inflammation of the large intestine (causing diarrhoea)*
• severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage)*, see additional information in subsection "Pregnancy, breastfeeding and fertility" in section 2
• muscle weakness and severe muscle pain, which may be symptoms of a disorder resembling glutaric aciduria type II.

* Adverse effects reported after marketing of the medicine
Additional adverse effects in children and adolescents
In clinical studies involving children and adolescents, adverse effects were generally similar
to those occurring in adults (see above). The most common adverse effects in children
and adolescents were: headache, insomnia, diarrhoea and nausea.
Symptoms occurring after discontinuation
After abrupt discontinuation of the medicine, adverse effects such as dizziness,
numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting and muscle tremors
may occur (see section 3 "Discontinuing Miravil").
An increased risk of bone fractures has been observed in patients taking medicines in this class.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, patients should inform their doctor or pharmacist. Adverse effects can
be reported directly to the Department of Monitoring Adverse Effects of Medicinal Products, 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the
safety of the medicine.

5. How to store Miravil

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and outer packaging. The expiry date refers to the last day of the specified month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Miravil contains

• The active substance in this medicine is sertraline.

Miravil 50 mg coated tablet:
One coated tablet contains sertraline hydrochloride equivalent to 50 mg of sertraline.
Miravil 100 mg coated tablet:
One coated tablet contains sertraline hydrochloride equivalent to 100 mg of sertraline.

Other ingredients are:
Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, hydroxypropylcellulose, sodium carboxymethyl starch (type A), magnesium stearate.
Tablet coating: Opadry White OY-S-7355 [titanium dioxide (E 171), hypromellose 5 cP, polyethylene glycol 400, polysorbate 80].

What Miravil looks like and contents of the pack

Miravil 50 mg tablets are white, biconvex, capsule-shaped, film-coated tablets, marked with the letter "A" on one side and the digits "8" and "1" separated by a hyphen on the other side. The tablets can be divided into two equal parts.

Miravil 100 mg coated tablets are white, biconvex, capsule-shaped, film-coated tablets, marked with the letter "A" on one side and the number "82" on the other side.

Pack sizes:

• Blister packs: 30 and 100 coated tablets.
• HDPE bottle: 100 coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer
Orion Corporation, Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland

For further information, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Finland and Lithuania: Sertralin Orion
Poland: Miravil