Miravil

Package Leaflet: Information for the User

Miravil, 50 mg, Film-Coated Tablets

Miravil, 100 mg, Film-Coated Tablets

Sertraline

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

• You should 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What Miravil is and what it is used for
• 2. 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 depression and/or anxiety disorders.

Miravil can be used to treat:

• major depressive episodes and prevention of recurrence of major depressive episodes (in adults)
• social anxiety disorder (in adults)
• post-traumatic stress disorder (PTSD) (in adults)
• panic disorder with or without agoraphobia (in adults)
• obsessive-compulsive disorder (OCD) (in adults and children and adolescents aged 6-17 years)
• (aged 6-17 years)

Depression is a condition where you may feel sad, have trouble sleeping or lose interest in things you used to enjoy.
OCD and panic disorder are anxiety-related conditions where you may feel fear, have obsessions (recurring thoughts), and compulsions (repetitive behaviors).
PTSD is a condition that can occur after a traumatic event, with symptoms similar to depression and anxiety.
Social anxiety disorder is an anxiety-related condition where you may feel fear or anxiety in social situations (such as talking to strangers, speaking in front of a group, eating or drinking in public, or worrying about embarrassing yourself).
Your doctor has decided that this medicine is suitable for treating your condition. If you are not sure why you have been prescribed Miravil, you should ask your doctor.

2. Before you take Miravil

Do not take Miravil:

• if you are allergic to sertraline or any of the other ingredients of this medicine (listed in section 6)
• if you are taking or have taken monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or other MAOI-like drugs (such as linezolid) within the last 2 weeks. After stopping sertraline, you must wait at least 1 week before taking an MAOI. After stopping an MAOI, you must wait at least 2 weeks before taking sertraline.
• if you are taking pimozide (a medicine used to treat certain psychiatric conditions, such as psychosis)

Warnings and precautions

Before taking Miravil, you should discuss this with your doctor or pharmacist.
Medicines do not always suit everyone. You should tell your doctor if you have any of the following conditions or have had them in the past:

• seizures (fits) or have had seizures in the past. If you have a fit, you should contact your doctor immediately.
• bipolar disorder (manic-depressive illness) or schizophrenia. If you have a manic episode, you should contact your doctor immediately.
• thoughts of suicide or self-harm (see below - Suicidal thoughts, worsening of depression or anxiety)
• serotonin syndrome. This is a rare condition that can occur when certain medicines, including sertraline, are taken together (see section 4 "Possible side effects"). Your doctor will tell you if you have had serotonin syndrome in the past.
• low sodium levels in the blood, as this can occur when taking Miravil. You should also tell your doctor if you are taking medicines for high blood pressure, as these can also affect sodium levels in the blood.
• elderly - these patients may be more prone to low sodium levels in the blood (see above)
• liver disease - your doctor may decide to reduce the dose of Miravil.
• diabetes - Miravil may affect blood sugar levels, so your diabetes medication may need to be adjusted.
• bleeding disorders (such as a tendency to bruise easily) or if you are pregnant (see "Pregnancy, breastfeeding, and fertility") or have taken medicines that prevent blood clotting (such as aspirin or warfarin) or may increase the risk of bleeding.
• age under 18. Miravil should only be used in children and adolescents aged 6-17 years with obsessive-compulsive disorder. Patients in this age group should be closely monitored by their doctor (see below - Children and adolescents).
• electroconvulsive therapy (ECT)
• eye diseases, such as certain types of glaucoma (increased pressure in the eye)
• if you have been informed that you have a heart condition known as QT prolongation (seen on an electrocardiogram, ECG)
• heart disease, low potassium or magnesium levels, a family history of QT prolongation, slow heart rate, and concomitant use of medicines that prolong QT interval.

Psychomotor restlessness/Akathisia:

Sertraline has been associated with the occurrence of a condition characterized by restlessness, feeling compelled to move, and being unable to sit or stand still (akathisia). This condition usually occurs within the first few weeks of treatment. Increasing the dose may be harmful, so if you experience these symptoms, you should tell your doctor.

Withdrawal effects:

After stopping treatment, withdrawal effects are common, especially if treatment is stopped abruptly (see section 3 "Stopping Miravil" and section 4 "Possible side effects"). The risk of withdrawal effects depends on the duration of treatment, dose, and rate of dose reduction. These effects are usually mild or moderate, but can be severe in some patients. They usually occur within the first few weeks after stopping treatment. They usually resolve on their own within 2 weeks, but in some patients, they can last longer (more than 2-3 months). If you decide to stop taking sertraline, it is recommended to gradually reduce the dose over several weeks or months, and you should discuss the best way to stop treatment with your doctor.

Suicidal thoughts, worsening of depression or anxiety:

Patients with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. These thoughts can worsen at the start of treatment with antidepressants, as these medicines start to work usually after 2 weeks, sometimes later.
Suicidal thoughts are more likely to occur if:

• you have had suicidal thoughts or self-harm in the past
• you are a young adult; clinical trial data suggest an increased risk of suicidal behavior in young adults with psychiatric conditions treated with antidepressants

If you have thoughts of self-harm or suicide, you should contact your doctor or go to the hospital immediately.
It may be helpful to tell a relative or friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You can ask your relative or friend to tell you if they think your depression or anxiety has got worse, or if they are worried about changes in your behavior.

Sexual dysfunction:

Medicines like Miravil (SSRIs) may cause sexual dysfunction (see section 4). In some cases, these effects have continued after stopping treatment.

Children and adolescents:

Sertraline should not be used in children and adolescents under 18 years of age, except for patients with obsessive-compulsive disorder. In this age group, there is an increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggressive, oppositional, and angry behavior) when taking medicines of this type. However, your doctor may decide to prescribe Miravil to a patient under 18 years of age if it is in the patient's best interest. If your doctor prescribes Miravil to a patient under 18 years of age and you wish to discuss this with the doctor, you should contact the doctor. Furthermore, if any of the above symptoms occur while taking Miravil, you should tell your doctor. In a long-term observational study lasting 3 years with over 900 children aged 6-16 years, the safety of long-term sertraline treatment was evaluated in terms of its effect on growth, maturation, cognitive function, and behavior. In general, the results showed that children treated with sertraline developed normally, except for a small increase in body weight in children treated with higher doses.

Miravil with other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, and about any medicines you plan to take.
Some medicines can affect the way Miravil works or Miravil can reduce the effectiveness of other medicines taken at the same time.
Taking Miravil with the following medicines can cause serious side effects:

• 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 methemoglobin in the blood). You should not take Miravil with these medicines.
• medicines used to treat psychiatric conditions, such as psychosis (pimozide). You should not take Miravil with pimozide.

You should tell your doctor if you are taking any of the following medicines:

• medicines containing amphetamine derivatives (used to treat attention deficit hyperactivity disorder, excessive sleepiness, and obesity)
• herbal medicines containing St. John's Wort (Hypericum perforatum)
• preparations containing the amino acid tryptophan
• medicines used to treat severe or chronic pain (such as opioids, tramadol, fentanyl)
• medicines used in anesthesia (such as fentanyl, mivacurium, and suxamethonium)
• medicines used to treat migraines (such as sumatriptan)
• medicines that prevent blood clotting (such as warfarin)
• medicines used to treat pain/inflammation of the joints (such as metamizole, non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, aspirin)
• sedatives (such as diazepam)
• diuretics
• medicines used to treat epilepsy (such as phenytoin, phenobarbital, carbamazepine)
• medicines used to treat diabetes (such as tolbutamide)
• medicines used to treat excessive stomach acid, stomach ulcers, and heartburn (such as cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazol)
• medicines used to treat mania and depression (such as lithium)
• other medicines used to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine)
• medicines used to treat schizophrenia and other psychiatric conditions (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 (such as aprepitant)
• medicines known to increase the risk of changes in heart rhythm (such as certain antipsychotics and antibiotics)

Miravil with food, drink, and alcohol

Miravil film-coated tablets can be taken with or without food.
Do not drink alcohol while taking Miravil.
Sertraline should not be taken with grapefruit juice, as it can increase the levels of sertraline in the body.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The safety of sertraline in pregnancy has not been fully established. Sertraline can only be used during pregnancy if your doctor considers it essential.
Taking Miravil at the end of pregnancy may increase the risk of severe bleeding from the vagina, which can occur shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Miravil, you should tell your doctor or midwife so that they can give you appropriate advice. Similar medicines taken by pregnant women, especially during the last three months, may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and blue discoloration of the skin. These symptoms usually appear in the first day of life. If they occur, you should contact your midwife and/or doctor immediately.
Newborn babies may also experience other symptoms, usually within the first 24 hours after birth. These symptoms include:

• breathing difficulties
• blue discoloration of the skin or being too hot or too cold
• blue lips
• vomiting or feeding problems
• excessive tiredness, difficulty sleeping, or constant crying
• increased or decreased muscle tone
• shivering, muscle contractions, or convulsions
• increased reflexes
• restlessness
• low blood sugar levels

If your baby experiences any of these symptoms or if you are concerned about their health, you should contact your doctor or midwife.
There is evidence that sertraline passes into breast milk. The medicine can be used during breastfeeding if your doctor considers it essential for you. In animal studies, some medicines similar to sertraline have been shown to decrease sperm quality. This could theoretically affect fertility, although this has not been observed in humans.

Driving and using machines

Psychotropic medicines, such as sertraline, can affect your ability to drive or operate machinery. You should wait until you know how Miravil affects you before driving or operating machinery.

Excipients

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Miravil

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The usual dose of Miravil is:

Adults:

Depression and obsessive-compulsive disorder
The recommended effective dose for 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 with or without agoraphobia, social anxiety disorder, and post-traumatic stress disorder (PTSD)
Treatment of panic disorder with or without agoraphobia, social anxiety disorder, and PTSD should start with a dose of 25 mg/day. After one week, the dose can be increased to 50 mg/day. 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:

Miravil can only be used to treat obsessive-compulsive disorder (OCD) in children and adolescents aged 6-17 years.
Obsessive-compulsive disorder:
Children aged 6-12 years:The recommended starting 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 starting dose is 50 mg/day.
The maximum dose is 200 mg/day.
Patients with liver or kidney disease should tell their doctor and follow their advice.

Method of administration

Miravil film-coated tablets can be taken with or without food.
The medicine should be taken once a day, in the morning or evening.
Your doctor will tell you how long you should take the medicine. The treatment period depends on the type of disease and your response to treatment. Improvement of symptoms may only be noticeable after several weeks of treatment. Treatment of depression should usually be continued for 6 months after improvement.

Overdose

If you accidentally take too much Miravil, you should immediately contact your doctor or go to the emergency department of your nearest hospital. You should take the medicine package with you, even if it is empty.
Symptoms of overdose may include drowsiness, nausea, and vomiting, rapid heartbeat, muscle tremors, agitation, dizziness, and in rare cases, loss of consciousness.

Missed dose

You should not take a double dose to make up for a missed dose. If you forget to take a tablet, you should not take the missed tablet. You should simply take the next tablet at the right time.

Stopping Miravil

You should not stop taking Miravil without talking to your doctor. Your doctor should gradually reduce the dose of Miravil over several weeks, until you stop taking it altogether. If you stop taking Miravil abruptly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and muscle tremors. If you experience any of these side effects or any other side effects after stopping Miravil, you should contact your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Miravil can cause side effects, although not everybody gets them.
The most common side effect is nausea. Side effects are dose-dependent and usually decrease or disappear after continued treatment.

See your doctor immediately

If you experience any of the following symptoms, as they can be serious:

• if you develop a severe skin rash that causes blistering (erythema multiforme; blisters may occur in the mouth and on the tongue). These can be symptoms of a condition known as Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN). Your doctor will stop treatment with this medicine.
• allergic reaction or allergy, which can cause symptoms such as itching, difficulty breathing, wheezing, swelling of the eyelids, face, or lips
• if you experience: agitation, confusion, diarrhea, high blood pressure, and rapid heartbeat. These are symptoms of serotonin syndrome, which can occur rarely when certain medicines, including sertraline, are taken together. Your doctor may stop treatment with this medicine.
• if you develop yellowing of the skin and eyes, which can be a sign of liver damage
• if you experience symptoms of depression with thoughts of self-harm or suicide (see above - Suicidal thoughts, worsening of depression or anxiety)
• if you experience restlessness and are unable to sit or stand still. If you experience restlessness, you should tell your doctor.
• if you have seizures (fits)
• if you experience manic episodes (see section 2 "Warnings and precautions").

The following side effects have been reported in clinical trials with adults and after marketing:

Very common ( may affect more than 1 in 10 people):
Insomnia, dizziness, somnolence, headache*, diarrhea, nausea, dry mouth, ejaculation disorder, fatigue*.
Common ( may affect up to 1 in 10 people):

• cold, sore throat, runny nose
• decreased appetite, increased appetite*
• anxiety*, depression*, agitation*, decreased libido*, nervousness, abnormal dreams, bruxism*
• tremors, movement disorders (such as increased muscle activity, increased muscle tone, difficulty walking, and stiffness), muscle contractions, and involuntary movements*
• visual disturbances*
• ringing in the ears*
• palpitations*
• hot flushes*
• yawning*
• gastrointestinal disorders, constipation*, abdominal pain*, vomiting*, flatulence
• increased sweating, rash*
• back pain, joint pain*, muscle pain
• menstrual irregularities*, erectile dysfunction
• malaise*, chest pain*, weakness*, fever*
• weight gain*
• injuries

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

• gastrointestinal disorders, ear infection
• tumor
• hypersensitivity*, seasonal allergy*
• decreased thyroid hormone levels*
• suicidal thoughts, suicidal behavior*, psychotic disorders*, thought disorders, apathy, hallucinations*, aggression*, euphoria*, paranoia
• amnesia, decreased sensitivity*, involuntary muscle contractions*, loss of consciousness*, increased muscle activity*, migraine*, seizures*, dizziness upon standing, coordination disorders, speech disorders
• pupil dilation*
• ear pain
• rapid heartbeat*, heart problems
• bleeding disorders (including gastrointestinal bleeding)*, high blood pressure*, flushing, urticaria
• shortness of breath, nosebleeds*, breathing difficulties (which may include wheezing)*
• black stools, dental disorders, esophagitis, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, glossitis
• eye edema*, urticaria*, hair loss*, pruritus*, purpura*, skin disorders with blistering, dry skin, facial edema, cold sweats
• osteoarthritis, muscle twitches, painful muscle contractions*, muscle weakness
• increased urine production, difficulty urinating, urinary incontinence*, increased urine frequency, nocturia, sexual dysfunction, menstrual irregularities, vaginal hemorrhage, sexual dysfunction in women
• edema of the feet*, chills, difficulty walking*, increased thirst
• increased liver enzyme levels*, decreased weight*

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

• appendicitis, lymphadenopathy, decreased platelet count*, decreased white blood cell count*
• severe allergic reactions*
• endocrine disorders*
• high cholesterol levels, problems with blood sugar control (diabetes)*, low blood sugar levels*, high blood sugar levels*, low sodium levels in the blood*
• physical symptoms caused by stress or emotions*, terrifying nightmares*, drug dependence, sleepwalking, premature ejaculation
• coma*, abnormal movements, difficulty moving, increased sensitivity, sudden severe headache (which may be a sign of a serious condition called reversible cerebral vasoconstriction syndrome)*, sensory disturbances
• floaters, glaucoma, double vision, sensitivity to light, eye pain*, unequal pupil size*, visual disturbances*, eye dryness
• heart attack*, feeling of fainting or discomfort in the chest, which can be symptoms of changes in heart rhythm (visible on an electrocardiogram) or irregular heartbeat*, slow heartbeat
• worsening of blood circulation in the arms and legs
• rapid breathing, progressive scarring of lung tissue (interstitial lung disease)*, bronchospasm, difficulty speaking, slow breathing, hiccups
• a condition in which eosinophils (a type of white blood cell) appear in the lungs in increased numbers (eosinophilic pneumonia)
• mouth ulcers, pancreatitis*, blood in stool, tongue pain, oral discomfort
• liver function disorders, severe liver function disorders*, yellowing of the skin and eyes (jaundice)*
• sunburn*, skin edema*, abnormal hair structure, abnormal skin odor, rash on hairy skin
• muscle breakdown*, bone disorders
• urinary retention*, decreased urine production
• breast discharge, vaginal dryness, genital discharge, painful erection*, breast enlargement*, prolonged erection*
• hernia, decreased tolerance to medicines
• increased cholesterol levels in the blood*, abnormal laboratory test results*, abnormal sperm test results, bleeding disorders*
• vascular collapse

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

• bruxism*
• nocturnal enuresis*
• partial loss of vision
• inflammation of the colon (which can cause diarrhea)*
• severe bleeding from the vagina, which can occur shortly after delivery (postpartum hemorrhage)*, see additional information in section 2 "Pregnancy, breastfeeding, and fertility"
• 2.

* Side effects reported after marketing

Additional side effects in children and adolescents

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

Withdrawal effects

After stopping treatment, withdrawal effects can occur, such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and muscle tremors (see section 3 "Stopping Miravil").
An increased risk of bone fractures has been reported in patients taking medicines of this type.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the national reporting system:
Department for Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Miravil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and outer packaging. The expiry date refers to the last day of that month.
There are no special storage requirements.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Miravil contains

• The active substance is sertraline.

Miravil 50 mg film-coated tablets:
One film-coated tablet contains sertraline hydrochloride, equivalent to 50 mg of sertraline.
Miravil 100 mg film-coated tablets:
One film-coated tablet contains sertraline hydrochloride, equivalent to 100 mg of sertraline.
Other ingredients are: Tablet core: calcium phosphate dihydrate, microcrystalline cellulose, hydroxypropyl cellulose, sodium carboxymethyl cellulose (type A), magnesium stearate.
Coating: Opadry White OY-S-7355 [titanium dioxide (E 171), hypromellose 5 cP, macrogol 400, polysorbate 80].

What Miravil looks like and contents of the pack

Miravil 50 mg tablets are white, biconvex, capsule-shaped, film-coated, marked with the letter "A" on one side and the numbers "8" and "1" separated by a line on the other side. The tablets can be divided into two equal parts.
Miravil 100 mg film-coated tablets are white, biconvex, capsule-shaped, film-coated, marked with the letter "A" on one side and the number "82" on the other side.
Pack sizes:

• Blisters: 30 and 100 film-coated tablets.
• HDPE bottle: 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization 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
To obtain more detailed information, you should contact your local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
kontakt@orionpharma.info.pl

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

Finland and Lithuania: Sertraline Orion
Poland: Miravil
Date of last revision of the leaflet:30.05.2024