Sastium leaflet – Poland

How to use Sastium

Package Leaflet: Information for the Patient

Sastium, 50 mg, Film-Coated Tablets

Sastium, 100 mg, Film-Coated Tablets

Sertraline

Read All of This Leaflet Carefully Before You Start Taking This Medicine.

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. 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 Pack and Other Information

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

1. What Sastium is and what it is used for

Sastium 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.

Sastium is used to treat:

depression and prevention of depression relapse (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 children and adolescents aged 6-17 years).

Depression is a condition where you feel sad, have trouble sleeping or lose interest in activities. Obsessive-compulsive disorder and panic disorder are anxiety disorders in which you have recurring, persistent thoughts or ideas (obsessions) that compel you to repeat specific rituals or behaviors (compulsions). Post-traumatic stress disorder is a condition that can occur after a person experiences a traumatic event, with symptoms similar to depression and anxiety. Social anxiety disorder is an anxiety disorder characterized by excessive anxiety or fear in social situations (such as talking to strangers, speaking in front of a group of people, eating or drinking in front of others, or fear of potential embarrassing behavior). Your doctor has decided that this medicine is suitable for treating your condition. You should ask your doctor if you are unsure why you have been given Sastium. You should tell your doctor if you do not feel better or if you feel worse.

2. Before You Take Sastium

Do Not Take Sastium

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). Wait at least 7 days after stopping sertraline before starting an MAOI. Wait at least 2 weeks after stopping an MAOI before starting sertraline;
if you are taking pimozide (a medicine used to treat mental disorders, such as psychoses).

Warnings and Precautions

Before taking Sastium, tell your doctor or pharmacist if you:

have epilepsy (seizures) or have had seizures in the past. If you have a seizure, contact your doctor immediately.
have a history of bipolar disorder or schizophrenia. If you have a manic episode, contact your doctor immediately.
have a history of suicidal thoughts or self-harm.
have serotonin syndrome. If you have had serotonin syndrome in the past, your doctor should tell you.
have low sodium levels in your blood, as this may occur with Sastium treatment. You should also tell your doctor if you are taking medicines for high blood pressure, as they may also affect sodium levels in your blood.
are elderly, as the risk of low sodium levels in your blood may be higher.
have liver disease, as your doctor may decide to reduce your Sastium dose.
have diabetes, as Sastium may affect your blood sugar levels, and your diabetes medication dose may need to be adjusted.
have a history of bleeding disorders (tendency to bruise) or are pregnant (see Pregnancy, Breast-feeding, and Fertility) or have taken medicines that prevent blood clotting (such as aspirin or warfarin) or may increase the risk of bleeding.
are under 18 years old. Sastium should only be used in children and adolescents aged 6-17 years for the treatment of obsessive-compulsive disorder (OCD). Patients with this condition should be closely monitored by their doctor (see Children and Adolescents).
are undergoing electroconvulsive therapy.
have eye problems, such as certain types of glaucoma (increased pressure in the eye).
have heart problems, such as abnormal heart rhythms (ECG changes), low potassium or magnesium levels, or a family history of abnormal heart rhythms.

Sexual Dysfunction

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

Psychomotor Restlessness/Akathisia

Sertraline treatment has been associated with the occurrence of psychomotor restlessness (a condition characterized by anxiety and agitation, often accompanied by an inability to sit or stand still). This usually occurs within the first few weeks of treatment. You should contact your doctor if your dose is increased, as this may be harmful to patients with these symptoms.

Withdrawal Effects

When stopping treatment with Sastium, withdrawal effects are common, especially if treatment is stopped abruptly (see section 3, Stopping Sastium, 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 and resolve within two weeks, but in some patients, they may be severe or prolonged (for more than 2-3 months). They usually occur within the first few days of stopping treatment. If you decide to stop taking Sastium, your doctor will advise you on how to reduce the dose gradually over several weeks or months.

Suicidal Thoughts, Depression, or Anxiety

Patients with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. These symptoms may worsen at the beginning of treatment with antidepressants, as these medicines start to work usually after 2 weeks, and sometimes later.

Suicidal Thoughts, Self-Harm, or Suicide Attempts Are More Likely to Occur:

if you have had thoughts of self-harm or suicide before,
if you are a young adult. Clinical trial data suggest an increased risk of suicidal behavior in patients under 25 years with mental disorders treated with antidepressants.

If you have thoughts of self-harm or suicide, 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 might ask them to tell you if they think your depression or anxiety has got worse, or if they are worried about changes in your behavior.

Children and Adolescents

Sertraline should not be used in children and adolescents under 18 years, except for patients with obsessive-compulsive disorder (OCD). In children and adolescents under 18 years treated with medicines of this type, there is a increased risk of side effects such as suicide attempts, thoughts of self-harm, or hostility (mainly aggression, oppositional behavior, and anger). However, your doctor may decide to prescribe Sastium to a patient under 18 years if it is in the patient's interest. If your doctor prescribes Sastium to a patient under 18 years and you wish to discuss this, you should contact your doctor. Furthermore, if any of the above symptoms occur while taking Sastium, you should tell your doctor. The long-term safety of Sastium in terms of its effects on growth, puberty, cognitive, and behavioral development in this age group has been evaluated in a 3-year study in over 900 children aged 6-16 years. The results showed that children treated with sertraline developed normally, except for a slight increase in body weight in children treated with higher doses.

Sastium and Other Medicines

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.

Using Sastium with the Following Medicines May Cause Serious Side Effects:

monoamine oxidase inhibitors (MAOIs, such as moclobemide, used to treat depression) and other MAOI-like medicines (such as linezolid, an antibiotic) and methylene blue (used to treat high levels of methemoglobin in the blood). Do not take Sastium with these medicines.
medicines used to treat mental disorders, such as psychoses (pimozide). Do not take Sastium with pimozide.

Tell Your Doctor If You Are Taking:

medicines containing amphetamines (used to treat attention deficit hyperactivity disorder, narcolepsy, 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 (opioids, such as tramadol, fentanyl),
medicines used for anesthesia (such as fentanyl, mivacurium, and suxamethonium),
medicines used to treat migraines (such as sumatriptan),
blood-thinning medicines (warfarin),
medicines used to treat pain/inflammation of the joints [such as metamizole, non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, aspirin],
sedatives (diazepam),
diuretics (water pills),
medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine),
medicines used to treat diabetes (tolbutamide),
medicines used to treat excessive stomach acid, stomach ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole),
medicines used to treat mania and depression (lithium),
other medicines used to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine),
medicines used to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine),
medicines used to treat high blood pressure, chest pain, or to regulate heart rate and rhythm (such as verapamil, diltiazem, flecainide, 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 chemotherapy (aprepitant),
medicines that increase the risk of changes in heart rhythm (such as antipsychotics and antibiotics).

Using Sastium with Food, Drink, and Alcohol

Sastium film-coated tablets can be taken with or without food.

Do not drink alcohol while taking Sastium.

Do not take Sastium with grapefruit juice, as it may increase the levels of sertraline in your body.

Pregnancy, Breast-Feeding, and Fertility

If you are pregnant or breast-feeding, 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 pregnant women has not been fully established. Sastium should only be used during pregnancy if your doctor considers it essential.

Taking Sastium at the end of pregnancy may increase the risk of severe bleeding from the vagina, occurring shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Sastium, you should inform your doctor or midwife so they can give you appropriate advice.

Taking Sastium during pregnancy, especially in the last trimester, may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), characterized by rapid breathing and blue discoloration of the skin. These symptoms usually occur within the first day of life. If your baby experiences these symptoms, contact your midwife or doctor immediately.

Newborns may also experience other complications, usually within the first 24 hours after birth, including:

breathing difficulties,
bluish skin or too hot or cold skin,
bluish lips,
vomiting or feeding problems,
excessive tiredness, difficulty sleeping, or constant crying,
increased or decreased muscle tone,
shivering, muscle contractions, or seizures,
increased reflexes,
restlessness,
low blood sugar.

If your baby experiences any of these symptoms or if you are concerned about your baby's health, contact your doctor or midwife.

Sertraline passes into breast milk. Sastium can be used during breast-feeding, but only if your doctor considers the benefits to the mother outweigh the potential risks to the baby.

Animal studies have shown that some medicines similar to sertraline may decrease sperm quality, which could affect fertility. However, this has not been observed in humans.

Driving and Using Machines

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

Sastium Contains Sodium

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

3. How to Take Sastium

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Recommended Dose of Sastium:

Adults:

Depression and Obsessive-Compulsive Disorder

The usual effective dose for treating depression and OCD is 50 mg per 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 per day.

Panic Disorder, Social Anxiety Disorder, and Post-Traumatic Stress Disorder

Treatment for panic disorder, social anxiety disorder, and PTSD should start with a dose of 25 mg per day, increasing to 50 mg per day after one week.

The daily dose can then be increased gradually by 50 mg at intervals of several weeks. The maximum recommended dose is 200 mg per day.

Use in Children and Adolescents

Sastium can be used in children and adolescents aged 6-17 years only for the treatment of obsessive-compulsive disorder (OCD).

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 inform their doctor and follow their advice.

Administration:

Sastium film-coated tablets can be taken with or without food.

Take one tablet per day, in the morning or evening.

Your doctor will tell you how long to take Sastium. The treatment period depends on the type of disease and your response to treatment. Improvement may occur only after several weeks of treatment. Treatment for depression should usually last for 6 months after improvement.

Take More Sastium Than You Should

If you accidentally take too much Sastium, contact your doctor or go to the emergency department of your nearest hospital immediately. Take the medicine pack with you, even if it is empty.

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

Miss a Dose of Sastium

Do not take a double dose of Sastium to make up for a missed dose.

If you forget to take a tablet, do not take the missed tablet.

Just take the next tablet at the right time.

Stop Taking Sastium

Do not stop taking Sastium without talking to your doctor. Your doctor will gradually reduce your dose of Sastium over several weeks before you stop taking it completely.

If you stop taking Sastium suddenly, you may experience side effects such as dizziness, numbness, sleep disturbances, restlessness or anxiety, headaches, nausea, vomiting, and muscle tremors. If you experience any of these side effects or any other side effects after stopping Sastium, contact your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

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

The most common side effect is nausea. Side effects are usually dose-dependent and often disappear or decrease in severity as treatment continues.

See Your Doctor Immediately:

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

severe skin rash, which may cause blisters (erythema multiforme; blisters may occur in the mouth and on the tongue). These may be symptoms of a condition called Stevens-Johnson syndrome or toxic epidermal necrolysis. Your doctor will stop treatment with Sastium.
allergic reaction or allergy, with symptoms such as itchy skin rash, difficulty breathing, wheezing, swelling of the eyelids, face, or lips.
if you experience: restlessness, confusion, diarrhea, high temperature and blood pressure, excessive sweating, and rapid heartbeat. These are symptoms of serotonin syndrome. In rare cases, this syndrome can occur when you are taking certain medicines at the same time as sertraline. Your doctor may stop your treatment.
if you experience yellowing of the skin and eyes, which may indicate liver damage.
if you experience symptoms of depression with thoughts of self-harm or suicide (suicidal thoughts).
if you experience restlessness and an inability to sit or stand still. If you experience restlessness, tell your doctor.
if you have a seizure (convulsion).
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 authorization:

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):

common cold, throat infection, sinusitis
decreased or increased appetite
anxiety, depression, restlessness, decreased sexual interest, nervousness, strange feelings, nightmares, teeth grinding
muscle tremors, movement disorders (such as increased muscle activity, increased muscle tone, difficulty walking, and stiffness, spasms, and involuntary muscle movements)*, numbness and tingling, muscle tension, lack of concentration, taste disturbances
vision disturbances
ringing in the ears
palpitations
hot flushes
yawning
gastrointestinal disturbances, constipation, abdominal pain, vomiting, gas
increased sweating, rash
back pain, joint pain, muscle pain
menstrual irregularities, erectile dysfunction
feeling unwell, chest pain, weakness, fever
weight gain
injuries

Uncommon (May Affect Up to 1 in 100 People):

appendicitis, inflammation of the small intestine, ear infection
tumor
allergic reaction, hay fever
decreased thyroid hormone levels in the blood
suicidal thoughts and behaviors*, psychotic disorders, thought disorders, apathy, hallucinations, aggression, euphoria, paranoia
memory loss, decreased sensitivity, involuntary muscle contractions, fainting, increased movement, migraine, dizziness when standing up, speech disturbances
pupil dilation
ear pain
rapid heartbeat, heart problems
bleeding disorders (including bleeding from the digestive tract)*, high blood pressure, flushing, presence of blood in the urine
shortness of breath, nosebleeds, breathing difficulties, wheezing
black stools, dental problems, esophagitis, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, speech disturbances
eye swelling, hives, hair loss, itching, skin disorders with blistering, dry skin, facial swelling, cold sweats
joint disease, muscle spasms*, muscle weakness
increased urination frequency, urination problems, inability to urinate, incontinence, increased urination at night
sexual dysfunction, heavy menstrual bleeding, menstrual irregularities, sexual dysfunction in women
swelling of the legs, chills, difficulty moving, increased thirst
increased liver enzymes, weight loss

Rare (May Affect Up to 1 in 1,000 People):

appendicitis, inflammation of the small intestine, ear infection
severe allergic reactions
endocrine disorders
high cholesterol, diabetes-related problems, low blood sugar, high blood sugar
physical symptoms caused by stress or emotions, nightmares*, drug dependence, sleepwalking, premature ejaculation
coma, abnormal movements, difficulty moving, increased sensitivity, severe headache (which may be a sign of a serious condition called reversible cerebral vasoconstriction syndrome), sensory disturbances
blind spots, glaucoma, double vision, photophobia, blood in the eye, unequal pupil size, vision disturbances, tearing problems
heart attack, feeling of emptiness in the head, fainting or discomfort in the chest, which may be symptoms of changes in heart rhythm (visible on an electrocardiogram) or abnormal heart rhythm*, slow heartbeat
worsening of blood circulation in the arms and legs
rapid breathing, pulmonary fibrosis (a lung disease), laryngospasm, difficulty speaking, slow breathing, hiccups
pulmonary eosinophilia (a lung disease characterized by the accumulation of eosinophils in the lungs)
mouth ulcers, pancreatitis*, bloody stools, tongue pain, oral discomfort
liver disorders, severe liver dysfunction*, jaundice (yellowing of the skin and eyes)*
sunburn*, skin swelling*, abnormal hair structure, abnormal skin odor, skin rash on hairy areas
muscle breakdown*, bone disorders
decreased urination, delayed urination
breast discharge, vaginal dryness, vaginal discharge, penis and foreskin pain, breast enlargement*, prolonged erection
hernia, decreased drug tolerance
increased blood cholesterol, abnormal laboratory test results, abnormal sperm test results, bleeding problems*
blood vessel disorders

Frequency Not Known (Cannot Be Estimated from the Available Data):

jaw stiffness*,
bedwetting*,
partial loss of vision,
inflammation of the colon (causing diarrhea)*,
severe bleeding from the vagina, occurring shortly after delivery (postpartum hemorrhage), see additional information in section 2, Pregnancy, Breast-Feeding, and Fertility*.
muscle weakness and severe muscle pain, which may be symptoms of a condition similar to glutaric aciduria type II.

*Side effects reported after marketing authorization.

Additional Side Effects in Children and Adolescents:

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

Withdrawal Symptoms:

When stopping treatment with Sastium, withdrawal symptoms may occur, such as dizziness, numbness, sleep disturbances, restlessness or anxiety, headaches, nausea, vomiting, and muscle tremors (see section 3, Stopping Sastium). Patients taking this type of medicine have an increased risk of bone fractures.

Reporting Side Effects

If you experience any side effects, talk to your doctor or pharmacist. You can also report side effects directly to the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Sastium

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 carton after EXP. and on the blister after EXP.

The expiry date refers to the last day of that month.

There are no special storage instructions for this medicine.

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 Sastium Contains

Each 50 mg film-coated tablet contains sertraline hydrochloride equivalent to 50 mg sertraline.

Each 100 mg film-coated tablet contains sertraline hydrochloride equivalent to 100 mg sertraline.

The other ingredients are:

Tablet core: calcium phosphate dibasic dihydrate, microcrystalline cellulose, hydroxypropyl cellulose, carboxymethyl cellulose sodium (type A), magnesium stearate

Tablet coating: hypromellose 2910, macrogol 400, polysorbate 80, titanium dioxide (E 171)

What Sastium Looks Like and Contents of the Pack

Sastium 50 mg is a white, oval, biconvex film-coated tablet, 10.5 mm in length, 4.2 mm in width, with the imprint "I" on one side and "C" on the other side of the score line on one side and plain on the other. The tablet can be divided into two equal doses.

Sastium 100 mg is a white, oval, biconvex film-coated tablet, 13.3 mm in length, 5.2 mm in width, with the imprint "IJ" on one side and plain on the other.

Sastium 50 mg/100 mg film-coated tablets are packaged in PVC/Aluminum blisters or HDPE bottles.

Pack sizes:

Blisters: 10, 14, 28, 30, 42, 50, 56, 84, 90, or 100 film-coated tablets in a cardboard box.

HDPE bottles: 50 mg - 250 film-coated tablets; 100 mg - 250, 500 film-coated tablets (hospital packs).

Not all pack sizes may be marketed.

Marketing Authorization Holder:

Accord Healthcare Polska Sp. z o.o.

ul. Taśmowa 7

02-677 Warszawa

Tel: + 48 22 577 28 00

Manufacturer/Importer:

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex HA1 4HF

United Kingdom

Accord Healthcare B.V.

Winthontlaan 200

3526 KV Utrecht

Netherlands