MIRAVIL 100 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Miravil, 50 mg, Film-Coated Tablets
3. Miravil, 100 mg, Film-Coated Tablets
   1. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
   2. Contents of the Pack
4. What Miravil is and what it is used for
   1. Miravil can be used to treat:
5. Before you take Miravil
   1. Do not take Miravil:
   2. Warnings and precautions
   3. Akathisia
   4. Withdrawal effects
   5. Suicidal thoughts, worsening of depression or anxiety disorders:
   6. Sexual dysfunction
   7. Children and adolescents
   8. Interactions with other medicines
   9. Miravil with food, drink, and alcohol
   10. Pregnancy, breastfeeding, and fertility
   11. Driving and using machines
   12. Excipients
6. How to take Miravil
   1. The usual dose of Miravil is:
   2. Adults:
   3. Use in children and adolescents:
   4. Method of administration
   5. If you take more Miravil than you should
   6. If you forget to take Miravil
   7. Stopping treatment with Miravil
7. Possible side effects
   1. See a doctor immediately
   2. Additional side effects in children and adolescents
   3. Withdrawal effects
   4. Reporting of side effects
8. How to store Miravil
9. Contents of the pack and other information
   1. What Miravil contains
   2. What Miravil looks like and contents of the pack
   3. Marketing Authorisation Holder
   4. Manufacturer
   5. This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the User

Miravil, 50 mg, Film-Coated Tablets

Miravil, 100 mg, Film-Coated Tablets

Sertraline

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 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 signs of illness 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 Pack

• 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 (SSRI); 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, or feel hopeless, or lose interest in activities that used to bring you pleasure. OCD and panic disorder are conditions related to anxiety, where you may feel fear or anxiety, or have obsessions (recurring thoughts) that make you perform repetitive actions (compulsions). PTSD is a condition that can occur after a person experiences a very traumatic event and is characterised by symptoms similar to depression and anxiety. Social anxiety disorder is a condition related to anxiety, where you may feel fear or anxiety in social situations (such as talking to strangers, speaking in front of a group of people, eating or drinking in front of others, or worrying about embarrassing yourself). Your doctor has decided that this medicine is suitable for you to treat 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 other medicines called monoamine oxidase inhibitors (MAOIs), such as selegiline, moclobemide, or linezolid, or other medicines that are like MAOIs, such as methylene blue (see section "Other medicines and Miravil")
• if you are taking a medicine called pimozide (used to treat mental disorders, such as psychosis)

Warnings and precautions

Before you start taking Miravil, tell your doctor or pharmacist if you have or have had:

• epilepsy or have had seizures (fits) in the past. If you have a fit while taking Miravil, contact your doctor immediately
• bipolar disorder or schizophrenia. If you have a manic episode while taking Miravil, contact your doctor immediately
• thoughts of suicide or have tried to harm yourself. See "My thoughts are more negative than usual" in section 4
• serotonin syndrome. This is a rare condition that can occur when taking certain medicines, including sertraline (see section 4 "Possible side effects"). Your doctor will tell you if you have had serotonin syndrome in the past
• low sodium levels in your blood, as this can occur when taking Miravil. Also, tell your doctor if you are taking medicines for hypertension, as these can also affect sodium levels in your blood
• if you are elderly, as you may be more at risk of getting low sodium levels in your blood (see above)
• liver disease, as your doctor may decide to reduce your dose of Miravil
• diabetes, as Miravil may affect your blood sugar levels, and you may need to adjust your dose of antidiabetic medicines
• a history of bleeding disorders, or if you are taking other medicines that may increase the risk of bleeding, such as aspirin or warfarin, or if you have recently had a stroke
• if you are under 18 years old. Miravil should only be used in children and adolescents aged 6-17 years with obsessive-compulsive disorder. If you are being treated for this condition, you should be closely monitored by your doctor (see section "Children and adolescents")
• if you are receiving 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 called 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 can cause QT prolongation

Akathisia

Sertraline has been associated with the occurrence of a condition called akathisia, characterized by a subjective feeling of restlessness, and an urge to move, often accompanied by an inability to sit or stand still. This condition typically occurs within the first few weeks of treatment. Increasing the dose may be harmful, so if you experience any of these symptoms, you should talk to your doctor.

Withdrawal effects

When you stop taking Miravil, you may experience withdrawal effects, especially if you have been taking it for a long time. The risk of withdrawal effects depends on the duration of treatment, dosage, and rate of dose reduction. These effects are usually mild to moderate and resolve on their own within two weeks, but in some patients, they may be severe and prolonged (beyond 2-3 months). They usually occur within the first few weeks after stopping treatment. If your doctor decides to stop your treatment with sertraline, they will gradually reduce your dose over a period of weeks or months.

Suicidal thoughts, worsening of depression or anxiety disorders:

Patients with depression or anxiety disorders may sometimes have thoughts of harming themselves or committing suicide. These thoughts can worsen when first taking antidepressants, as these medicines can take up to 2 weeks to start working, and sometimes even longer.

• if you have had thoughts of harming yourself or committing suicide in the past
• if you are a young adult. Data from clinical trials have shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions, who were treated with an antidepressant

If you experience any of these symptoms, you should contact your doctor or go to the hospital immediately. It may be helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You should also ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

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 old, except for those with obsessive-compulsive disorder. In children and adolescents under 18 years old, treated with sertraline for major depressive disorder, there was an increased risk of suicidal thoughts and behaviour when compared to placebo. If you are being treated for this condition, you should be closely monitored by your doctor.

Interactions with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

• 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). Do not take Miravil with these medicines
• medicines used to treat mental disorders, such as psychosis (pimozide). Do not take Miravil with pimozide

Tell your doctor if you are taking:

• medicines containing amphetamine (used to treat attention deficit hyperactivity disorder (ADHD), excessive sleepiness, and obesity)
• herbal medicines containing St. John's Wort (Hypericum perforatum). The effects of St. John's Wort may last for 1-2 weeks
• preparations containing the amino acid tryptophan
• medicines used to treat severe or chronic pain (such as opioids, tramadol, fentanyl)
• medicines used in anaesthesia (such as fentanyl, mivacurium, and suxamethonium)
• medicines used to treat migraines (such as sumatriptan)
• medicines that prevent blood clotting (warfarin)
• medicines used to treat pain/inflammation of the joints (such as metamizole, non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, acetylsalicylic acid (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 acid production in the stomach, 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 mental disorders (such as perphenazine, levomepromazine, and olanzapine)
• medicines used to treat high blood pressure, chest pain, or to regulate heart 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 or hepatitis C (such as protease inhibitors, e.g. 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 the electrical activity of the heart (such as certain antipsychotics and antibiotics)

Miravil with food, drink, and alcohol

Miravil 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 your 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 should only be used during pregnancy if your doctor considers it essential.

Taking Miravil at the end of pregnancy may increase the risk of heavy bleeding after delivery, especially if you have a history of bleeding disorders. If you are taking Miravil, tell your doctor or midwife, so they can advise you.

Babies whose mothers took Miravil during the last three months of pregnancy may have a higher risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually occur in the first 24 hours after birth.

Babies born to mothers who took Miravil during pregnancy may also have other symptoms, including:

• difficulty breathing
• bluish skin or too hot or too cold skin
• blue lips
• vomiting or feeding problems
• excessive sleepiness, difficulty sleeping, or constant crying
• increased or decreased muscle tone
• tremors, muscle contractions, or seizures
• increased reflexes
• restlessness
• low blood sugar

If your baby experiences any of these symptoms, you should contact your doctor or midwife, who will be able to advise you.

Sertraline passes into breast milk. Miravil can be used during breastfeeding, but only if your doctor considers it essential for you. In animal studies, some medicines similar to sertraline have been shown to decrease sperm quality, which could affect fertility. However, no effects on fertility have been seen in humans.

Driving and using machines

Psychotropic drugs, such as sertraline, may affect your ability to drive or operate machinery. Wait until you know how Miravil affects you before driving or operating machinery.

Excipients

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

3. How to take Miravil

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose of Miravil is:

Adults:

Depression and obsessive-compulsive disorder: The recommended effective dose is 50 mg per day. The dose can be increased gradually, in increments of 50 mg, over several weeks. The maximum recommended dose is 200 mg per day.

Panic disorder, social anxiety disorder, and post-traumatic stress disorder (PTSD): Treatment should start with a dose of 25 mg per day, which can be increased to 50 mg per day after one week. The dose can then be increased gradually, in increments of 50 mg, over several weeks. The maximum recommended dose is 200 mg per day.

Use in children and adolescents:

Miravil can only be used to treat obsessive-compulsive disorder in children and adolescents aged 6-17 years.

Obsessive-compulsive disorder:

Children aged 6-12 years:The recommended starting dose is 25 mg per day. After one week, your doctor may increase the dose to 50 mg per day. The maximum dose is 200 mg per day.

Adolescents aged 13-17 years:The recommended starting dose is 50 mg per day. The maximum dose is 200 mg per day.

Patients with liver or kidney disease should tell their doctor, who will prescribe the correct dose.

Method of administration

Miravil can be taken with or without food.

Take the medicine once a day, in the morning or evening.

Your doctor will tell you how long you should take Miravil. The duration of treatment 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 continue for 6 months after the symptoms have improved.

If you take more Miravil than you should

If you have taken more Miravil than you should, contact your doctor or go to the hospital immediately. Take the medicine pack with you, even if it is empty.

Symptoms of overdose may include drowsiness, nausea, vomiting, rapid heartbeat, tremors, restlessness, dizziness, and loss of consciousness.

If you forget to take Miravil

Do not take a double dose to make up for a forgotten dose. If you forget to take a tablet, do not take the missed tablet. Just take the next tablet at the right time.

Stopping treatment with Miravil

Do not stop taking Miravil without talking to your doctor first. Your doctor will gradually reduce your dose over a period of weeks or months. If you stop taking Miravil suddenly, you may experience side effects such as dizziness, numbness, sleep disturbances, restlessness or anxiety, headaches, nausea, vomiting, and tremors. If you experience any of these side effects, or any other side effects, you should talk to your doctor.

4. Possible side effects

Like all medicines, Miravil can cause side effects, although not everybody gets them.

The most common side effect is nausea.

See a doctor immediately

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

• if you develop a severe skin rash, which may include blistering (Stevens-Johnson syndrome or toxic epidermal necrolysis). Your doctor will stop your treatment with Miravil
• an allergic reaction or allergy, which may include symptoms such as itching, difficulty breathing, wheezing, swelling of the face, lips, tongue, or throat
• if you experience: restlessness, confusion, sweating, fever, and rapid heartbeat. These are symptoms of serotonin syndrome, which can occur when taking certain medicines, including sertraline. Your doctor may stop your treatment with Miravil
• if you experience yellowing of the skin and eyes, which may indicate liver damage
• if you experience suicidal thoughts or thoughts of harming yourself
• if you experience restlessness and an inability to sit still. If you experience restlessness, you should talk to your doctor
• if you experience 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, cough
• decreased or increased appetite
• anxiety, depression, agitation, nervousness, abnormal dreams, teeth grinding
• 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
• flushing
• yawning
• gastrointestinal disorders, constipation, abdominal pain, vomiting
• increased sweating, rash
• back pain, joint pain, muscle pain
• menstrual disorders, erectile dysfunction
• malaise, chest pain, fatigue, fever
• weight gain
• injuries

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

• gastrointestinal disorders, ear infection
• cancer
• hypersensitivity, seasonal allergy
• decreased thyroid hormone levels
• suicidal thoughts, suicidal behaviour, psychotic disorders, thinking disorders, apathy, aggression, euphoria, paranoia
• amnesia, decreased sensitivity, involuntary muscle contractions, loss of consciousness, increased muscle activity, migraine, seizures, dizziness when standing up, coordination disorders, speech disorders
• pupil dilation
• ear pain
• rapid heartbeat, heart problems
• bleeding disorders (including gastrointestinal bleeding), high blood pressure, flushing
• shortness of breath, nosebleeds, breathing difficulties (which may include wheezing)
• black stools, dental disorders, oesophagitis, tongue disorders, haemorrhoids, increased salivation, difficulty swallowing, belching
• eye swelling, urticaria, hair loss, pruritus, purpura, skin disorders with blistering, dry skin, facial swelling, cold sweats
• osteoarthritis, muscle twitches, painful muscle contractions, muscle weakness
• increased urination, urinary disorders, urinary incontinence, increased urine production, sexual disorders, menstrual disorders, vaginal haemorrhage
• oedema, chills, difficulty walking
• increased liver enzyme levels, weight loss

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, diabetes, low blood sugar, high blood sugar
• 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)
• visual disturbances, glaucoma, double vision, sensitivity to light, eye pain, unequal pupil size, visual disturbances, eye problems
• heart attack, feeling of fainting or discomfort in the chest, which may be signs of changes in the electrical activity of the heart (seen on an electrocardiogram) or irregular heartbeat
• worsening of blood circulation in the arms and legs
• rapid breathing, progressive scarring of the lungs (interstitial lung disease), constriction of the airways, difficulty speaking, slow breathing, hiccups
• a condition where eosinophils (a type of white blood cell) accumulate in the lungs (eosinophilic pneumonia)
• mouth ulcers, pancreatitis, rectal haemorrhage, tongue disorders, gum disorders, tooth disorders
• liver disorders, severe liver disorders, yellowing of the skin and eyes (jaundice)
• skin reactions to sunlight, skin swelling, abnormal hair structure, abnormal skin odour, rash on hairy skin
• rhabdomyolysis (breakdown of muscle tissue), bone disorders
• urinary retention, decreased urination
• galactorrhoea, vaginal discharge, breast enlargement, prolonged erection
• hernia, decreased tolerance to medicines
• increased cholesterol levels, abnormal laboratory test results, abnormal sperm test results, bleeding disorders
• vasodilation

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

• bruxism
• nocturnal enuresis
• partial loss of vision
• ulcerative colitis
• postpartum haemorrhage (excessive bleeding after delivery), see additional information in section 2 "Pregnancy, breastfeeding, and fertility"

* 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

When stopping treatment with Miravil, you may experience side effects such as dizziness, numbness, sleep disturbances, restlessness or anxiety, headaches, nausea, vomiting, and tremors (see section 3 "Stopping treatment with Miravil").

An increased risk of bone fractures has been observed in patients taking medicines like Miravil.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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 carton.

No special storage precautions are required.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. 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: Each film-coated tablet contains sertraline hydrochloride, equivalent to 50 mg of sertraline.

Miravil 100 mg film-coated tablets: Each film-coated tablet contains sertraline hydrochloride, equivalent to 100 mg of sertraline.

The other ingredients are: Tablet core: calcium phosphate, 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 "A" on one side and "8" and "1" separated by a score line on the other side. The tablets can be divided into two equal doses.

Miravil 100 mg tablets are white, biconvex, capsule-shaped, film-coated, marked with "A" on one side and "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 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, contact your 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

Date of last revision of the leaflet: 30.05.2024