Package Leaflet

SERTRALINA DOC Generici 50 mg Film-coated Tablets, 100 mg Film-coated Tablets

Generic Medicine
Please read this leaflet carefully before taking this medicine.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What SERTRALINA DOC GENERICI is and what it is used for

SERTRALINA DOC Generici contains the active substance sertraline. Sertraline belongs to a
group of medicines known as Selective Serotonin Re-uptake Inhibitors (SSRIs); these
medicines are used to treat depression and/or anxiety disorders.
SERTRALINA DOC Generici can be used to treat the following conditions:

Depression and prevention of recurrence of depression (in adults).
Social anxiety disorder (in adults).
Post-traumatic stress disorder (PTSD) (in adults).
Panic disorder (in adults).
Obsessive-compulsive disorder (OCD) (in adults and in children and adolescents aged 6 to 17 years).

Depression is a clinical illness with symptoms such as feeling sad, inability to sleep properly, or to enjoy life as you used to.
OCD and panic disorder are anxiety-related conditions with symptoms such as persistent, intrusive worries (obsessions) leading to repetitive ritualistic behaviours (compulsions).
PTSD is a condition that may occur following a strongly traumatic experience, and some of its symptoms resemble those of depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterized by feelings of intense anxiety or stress in social situations (e.g. speaking to strangers, speaking in public, eating or drinking in the presence of others, or fear of behaving in an embarrassing way).

Your doctor has determined that this medicine is suitable for treating your condition.
Ask your doctor if you are unsure why SERTRALINA DOC Generici has been prescribed for you.

2. What you need to know before taking SERTRALINA DOC GENERICS

Do not take SERTRALINA DOC GENERICS:

If you are allergic to sertraline or to any of the other ingredients of this medicine (listed in section 6).
If you are currently taking or have recently taken monoamine oxidase inhibitors (MAOIs) (e.g. selegiline, moclobemide), or medicines with MAOI-like activity (such as linezolid). If you stop treatment with sertraline, you must wait one week before restarting treatment with an MAOI. After stopping treatment with an MAOI, you must wait at least two weeks before starting treatment with sertraline.
If you are taking another medicine called pimozide (a medicine used for mental disorders such as psychosis).

Warnings and precautions:
Medicines are not always suitable for everyone. Inform your doctor before taking SERTRALINA DOC GENERICS if you have or have previously had any of the following conditions:

Epilepsy or a history of seizures. In case of a seizure (convulsion), contact your doctor immediately.
If you have suffered from bipolar disorder (manic-depressive illness) or schizophrenia. In case of a manic episode, contact your doctor immediately.
If you are having or have previously had thoughts of harming or killing yourself (see below: Suicidal thoughts and worsening of depression or anxiety disorder).
Serotonin syndrome. In rare cases, this syndrome may occur when certain medicines are taken together with sertraline, for example triptans, antipsychotics, or buprenorphine (with or without naloxone) (for symptoms, see section 4. Possible side effects). Your doctor will inform you if you have previously experienced this condition.
If you have low levels of sodium in the blood, as this condition may occur as a result of treatment with SERTRALINA DOC GENERICS. You should also inform your doctor if you are taking certain medicines for high blood pressure, as these may also affect blood sodium levels.
Be cautious if you are elderly, as you may be at increased risk of low sodium levels in the blood (see above).
Liver disease: your doctor may decide to prescribe a lower dose of SERTRALINA DOC GENERICS.
Diabetes: blood glucose levels may be affected by treatment with SERTRALINA DOC GENERICS, and the dose of your diabetes medication may need to be adjusted.
If you have experienced bleeding problems or if you are taking medicines that thin the blood (e.g. acetylsalicylic acid (aspirin) or warfarin), or medicines that may increase the risk of bleeding, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”).
Children or adolescents under 18 years of age. SERTRALINA DOC GENERICS should only be used to treat children and adolescents aged 6 to 17 years suffering from obsessive-compulsive disorder. If a child or adolescent is being treated for this disorder, the doctor will monitor them closely (see below: Use in children and adolescents).
If you are undergoing electroconvulsive therapy (ECT).
If you have eye problems such as certain types of glaucoma (increased pressure in the eye).

Restlessness/Akathisia
Use of sertraline has been associated with akathisia (a distressing restlessness and urge to move, often associated with an inability to sit or stand still). This condition is most likely to occur during the first few weeks of treatment. Increasing the dose may be harmful; therefore, you should speak to your doctor if you develop these symptoms.

Withdrawal reactions
Side effects related to stopping treatment (withdrawal reactions) are common, especially if treatment is stopped abruptly (see section 3: “If you stop taking SERTRALINA DOC GENERICS” and section 4: Possible side effects). The risk of withdrawal symptoms depends on the duration of treatment, the dose, and the speed at which the dose is reduced. Generally, these symptoms are mild to moderate in intensity; however, in some patients they may be severe. They usually occur within the first few days after stopping treatment. In general, these symptoms resolve spontaneously within 2 weeks. In some patients, they may last longer (2–3 months or more). When stopping treatment with sertraline, it is recommended to gradually reduce the dose over several weeks or months. You should always discuss the best way to stop treatment with your doctor.

Medicines such as SERTRALINA DOC GENERICS (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)) may cause sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.

Suicidal thoughts and worsening of depression or anxiety disorder:
If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming or killing yourself.
These thoughts may worsen when you first start taking antidepressants, because all these medicines take time to become effective, usually about 2 weeks, but sometimes longer.

You are more likely to have such thoughts if:

You have previously had thoughts of killing yourself or harming yourself.
You are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric conditions treated with an antidepressant. If at any time you have thoughts of harming or killing yourself, contact your doctor or go immediately to the nearest hospital. It may be helpful to inform a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them whether they think your depression or anxiety disorder is getting worse, or whether they are concerned about changes in your behaviour.

Children and adolescents:
Sertraline should not routinely be used in children and adolescents under 18 years of age, except for patients with Obsessive-Compulsive Disorder. Patients under 18 years of age have an increased risk of side effects such as suicide attempts, thoughts of self-harm or suicide (suicidal thoughts), and hostile behaviour (mainly aggression, oppositional behaviour, and anger) when treated with this class of medicines. However, your doctor may decide to prescribe SERTRALINA DOC GENERICS to a patient under 18 years of age if it is in the patient’s best interest. If your doctor has prescribed SERTRALINA DOC GENERICS to a patient under 18 years of age and you wish to discuss this decision, please contact your doctor. Furthermore, if any of the symptoms listed above appear or worsen while a patient under 18 years of age is being treated with SERTRALINA DOC GENERICS, you must inform the doctor.
Finally, the long-term safety of SERTRALINA DOC GENERICS on growth, maturation, learning (cognitive development), and behavioural development in this age group has not been established.

Other medicines and SERTRALINA DOC GENERICS
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Some medicines may affect the activity of SERTRALINA DOC GENERICS, or SERTRALINA DOC GENERICS may reduce the effectiveness of other medicines taken at the same time.

Taking SERTRALINA DOC GENERICS with the following medicines may cause serious side effects:

Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression), selegiline (used to treat Parkinson’s disease), and the antibiotic linezolid. Do not use SERTRALINA DOC GENERICS together with these medicines.
Medicines used to treat mental disorders such as psychosis (pimozide). Do not use SERTRALINA DOC GENERICS together with pimozide.

Inform your doctor if you are taking any of the following medicines:

Herbal medicines containing St. John’s wort (Hypericum perforatum). The effects of St. John’s wort may last for 1–2 weeks.
Products containing the amino acid tryptophan.
Medicines used to treat severe pain (e.g. tramadol).
Medicines used to treat pain and opioid dependence (buprenorphine with or without naloxone).
Medicines used in anaesthesia or for treatment of chronic pain (fentanyl).
Medicines used to treat migraine (e.g. sumatriptan).
Medicines used to thin the blood (warfarin).
Medicines used to treat pain/arthritis (non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)).
Sedatives (diazepam).
Diuretics.
Medicines used to treat epilepsy (phenytoin).
Medicines used to treat diabetes (tolbutamide).
Medicines used to treat excess stomach acid and ulcers (cimetidine).
Medicines used to treat mania and depression (lithium).
Other medicines used to treat depression (such as amitriptyline, nortriptyline).
Medicines used to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
Medicines used to regulate heart rate and rhythm (such as flecainide, propafenone).

SERTRALINA DOC GENERICS with food and drink:
SERTRALINA DOC GENERICS tablets may be taken with or without food.
Alcohol consumption should be avoided during treatment with SERTRALINA DOC GENERICS.
SERTRALINA DOC GENERICS must not be taken together with grapefruit juice, as this may lead to increased levels of sertraline in the body.

Pregnancy, breastfeeding and fertility:
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The safety of sertraline in pregnant women has not been fully established. If you are pregnant, sertraline will only be prescribed if your doctor considers that the benefit to you outweighs any possible risk to the unborn child. If you are a woman of childbearing age, you should use an adequate method of contraception (such as the oral contraceptive pill) while being treated with sertraline.
Ensure that your midwife and/or doctor are aware that you are taking SERTRALINA DOC GENERICS.

Medicines such as SERTRALINA DOC GENERICS, if taken during pregnancy, particularly during the last three months of pregnancy, may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN), which is characterized by rapid breathing and a bluish skin colour. These symptoms usually appear within the first 24 hours after birth. Inform your midwife and/or doctor immediately if your baby shows these symptoms.

Your newborn baby may also experience other symptoms, which usually begin within the first 24 hours after birth. Symptoms include:

Breathing difficulties,
Bluish skin colour, skin too hot or too cold,
Bluish lips,
Vomiting, feeding difficulties,
Excessive tiredness, inability to sleep or continuous crying,
Muscle stiffness or floppy muscles,
Tremors, restlessness, seizures,
Increased reflex responses,
Irritability,
Low blood sugar levels.

If your newborn shows any of these symptoms after birth, or if you are concerned about your baby’s health, contact your doctor or midwife, who will be able to advise you.

If you take SERTRALINA DOC GENERICS close to the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (tendency to bleed). Inform your doctor or midwife that you are taking SERTRALINA DOC GENERICS so they can advise you on what to do.

There is evidence that sertraline is excreted in breast milk. Sertraline should only be used during breastfeeding if your doctor considers that the benefit to the mother outweighs any possible risk to the baby.

In animal studies, some medicines such as sertraline may reduce sperm quality. In theory, this could affect fertility, but no impact on human fertility has been observed.

Driving and using machines:
Psychotropic medicines such as sertraline may affect your ability to drive or operate machinery. Therefore, do not drive or operate machinery until you know whether this medicine affects your ability to perform these activities.

3. How to take SERTRALINA DOC Generici

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The SERTRALINA DOC Generici tablets can be taken with or without food.
The tablet may be divided into two equal doses.
Take the medicine once daily, in the morning or in the evening.

The usual dose is:
Adults:
Depression and Obsessive-Compulsive Disorder (OCD):
For depression and OCD, the usual effective dose is 50 mg/day.
The daily dose may be increased in increments of 50 mg at intervals of at least one week over several weeks. The maximum recommended dose is 200 mg/day.

Panic Disorder, Social Anxiety Disorder, and Post-Traumatic Stress Disorder (PTSD):
For panic disorder, social anxiety disorder, and PTSD, treatment should start at a dose of 25 mg/day, then increased to 50 mg/day after one week.
The daily dose may then be increased in increments of 50 mg over several weeks. The maximum recommended dose is 200 mg/day.

Use in children and adolescents:
SERTRALINA DOC Generici should only be used for the treatment of children and adolescents aged 6–17 years with Obsessive-Compulsive Disorder (OCD).

Obsessive-Compulsive Disorder (OCD):
Children aged 6–12 years: The recommended initial dose is 25 mg/day.
After one week, your doctor may increase the dose to 50 mg/day. The maximum dose is 200 mg/day.

Adolescents aged 13–17 years: The recommended initial dose is 50 mg/day. The maximum dose is 200 mg/day.

If you have liver or kidney problems, inform your doctor and follow their instructions.
Your doctor will advise you on how long to take this medicine. This depends on the duration of your illness and your response to treatment. It may take several weeks before symptoms begin to improve. Treatment for depression should usually continue for 6 months after improvement is observed.

If you take more SERTRALINA DOC Generici than you should:
If you accidentally take too much SERTRALINA DOC Generici, contact your doctor immediately or go to the nearest emergency room. Always carry a package of the medicine with you, whether or not it still contains tablets.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, tremors, agitation, dizziness, and in rare cases, loss of consciousness.

If you forget to take SERTRALINA DOC Generici:
If you miss a dose, do not take the missed dose. Take the next dose at the regular time. Do not take a double dose to make up for a forgotten dose.

If you stop taking SERTRALINA DOC Generici:
Do not stop treatment with SERTRALINA DOC Generici unless your doctor tells you to. Your doctor may wish to gradually reduce the dose of SERTRALINA DOC Generici over several weeks before stopping completely.
If you stop taking this medicine suddenly, you may experience unwanted effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and tremors. If you experience any of these unwanted effects, or any other side effects during treatment with SERTRALINA DOC Generici, speak to your doctor.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, SERTRALINA DOC Generici may cause side effects, although not everyone experiences them.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Nausea is the most common side effect. Side effects depend on the dose and are often temporary as treatment continues.

Inform your doctor immediately:
If you experience any of the following symptoms after taking this medicine, as they may be serious:

If you develop a severe skin reaction causing blistering (erythema multiforme), which may affect the mouth and tongue. These may be signs of a condition known as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis. In such cases, your doctor will discontinue treatment.
Allergic reactions or allergies, which may include symptoms such as an itchy rash, breathing difficulties, wheezing, swelling of the eyelids, face or lips.
If you experience agitation, confusion, diarrhea, high fever and high blood pressure, excessive sweating, and rapid heartbeat. These are symptoms of Serotonin Syndrome. In rare cases, this syndrome may occur when certain medicines are taken together with sertraline. Your doctor may decide to stop treatment.
If you develop yellowing of the skin or eyes, which may indicate liver damage.
If you develop depressive symptoms with thoughts of harming yourself or suicide (suicidal thoughts).
If you begin to feel inner restlessness and are no longer able to sit or stand still after starting treatment with SERTRALINA DOC Generici. You must inform your doctor if you start feeling restless.
If you have a seizure (convulsion).
In case of a manic episode (see "Special warnings and precautions for use" in section 2).

The following side effects have been observed in clinical studies conducted in adult patients and during the post-marketing phase:

Very common side effects (occur in more than 1 in 10 people):
Insomnia, dizziness, drowsiness, headache, diarrhea, nausea, dry mouth, ejaculation disorder, fatigue.

Common side effects (occur in 1 to 10 in 100 people):

Sore throat, anorexia, increased appetite,
depression, feeling strange, nightmares, anxiety, agitation, nervousness, reduced sexual interest, teeth grinding,
numbness and tingling, tremors, muscle tension, taste disturbances, lack of attention,
visual disturbances, ringing in the ears,
palpitations, hot flushes, yawning,
abdominal pain, vomiting, constipation, stomach discomfort, gas in the stomach,
skin rash, increased sweating, muscle pain, sexual dysfunction, erectile dysfunction, chest pain.

Uncommon side effects (occur in 1 to 10 in 1,000 people):

Cold chest, runny nose,
hallucinations, excessive feeling of happiness, lack of personal care, altered thinking,
seizures, involuntary muscle contractions, coordination disturbances, excessive movements, amnesia, reduced sensation, speech disorders, dizziness upon standing, migraine,
ear pain, rapid heartbeat, high blood pressure, facial flushing,
breathing difficulties, possible wheezing, shortness of breath, nosebleeds,
esophageal problems, difficulty swallowing, hemorrhoids, increased salivation, tongue disorders, belching,
eye swelling, red spots on the skin, hair loss, cold sweats, dry skin, hives,
osteoarthritis, muscle weakness, back pain, muscle cramps,
nocturnal urination, inability to urinate, increased urine volume, increased frequency of urination, urinary problems,
vaginal bleeding, female sexual dysfunction, malaise, chills, fever, weakness, thirst, weight loss, weight gain.

Rare side effects (occur in 1 to 10 in 10,000 people):

Intestinal problems, ear infections, cancer, swollen glands, elevated cholesterol levels, low blood sugar levels,
physical symptoms due to stress or emotions, drug dependence, psychotic disorders, aggression, paranoia, suicidal thoughts, sleepwalking, premature ejaculation,
coma, abnormal movements, movement difficulties, increased sensitivity, sensory disturbances,
formation of spots on the eye, glaucoma, double vision (diplopia), discomfort caused by light (photophobia), blood accumulation in the anterior chamber of the eye (hyphema), pupil dilation, altered tear production,
heart attack, slowed heartbeat, heart problems, poor blood circulation to arms and legs, throat closure, rapid breathing, slowed breathing, speech difficulties, hiccups,
blood in stools, sore throat, tongue ulceration, dental problems, tongue disorders, mouth ulceration, liver function problems,
skin problems with blister formation, inflammation of hair follicles, changes in hair structure, altered skin odor, bone disorders,
reduced urination, urinary incontinence, urinary hesitation,
excessive vaginal bleeding, dryness of the vaginal area, red and painful penis and foreskin, genital discharge, prolonged erection, breast secretion,
hernia, scar tissue formation at injection site, reduced drug tolerance, difficulty walking, changes in laboratory test values, altered seminal fluid, injuries, blood vessel dilation,
cases of suicidal ideation and suicidal behavior have been reported during treatment with sertraline or immediately after discontinuation of treatment (see section 2).

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

Partial loss of vision, pupils of unequal size,
inflammation of the colon (causing diarrhea),
heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage); see section 2, Pregnancy, breastfeeding and fertility for further information,
reduced number of white blood cells, reduced number of blood clotting cells, low thyroid hormone levels, endocrine problems, low blood sodium levels, difficulty controlling blood sugar levels (diabetes), increased blood sugar levels,
disturbing nightmares, altered dreams, suicidal behavior,
muscle movement problems (such as frequent movements, tense muscles, difficulty walking and stiffness, muscle spasms and involuntary muscle movements), fainting, sudden severe headache (which may be a sign of a serious condition known as Reversible Cerebral Vasoconstriction Syndrome (RCVS)),
muscle weakness and severe muscle pain, which may be signs of a disorder similar to Multiple Acyl-CoA Dehydrogenase Deficiency (MADD),
altered vision, bleeding problems (such as nosebleeds, stomach bleeding, or blood in urine), pancreatitis, severe liver function problems, yellowing of the skin and eyes (jaundice),
skin edema, skin reaction to sunlight, itching, joint pain, muscle cramps, breast enlargement, menstrual irregularities, leg swelling, coagulation problems, enuresis, and severe allergic reactions.

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

Symptoms that may occur when treatment is discontinued
If you stop taking this medicine suddenly, you may experience side effects such as dizziness, tingling sensations, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and tremor (see "If you stop taking SERTRALINA DOC Generici" in section 3).
An increased risk of bone fractures has been observed in patients taking this type of medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SERTRALINA DOC Generici

Keep this medicine out of the sight and reach of children.
Expiry date: See the date printed on the packaging.
The expiry date refers to the product in its original, unopened packaging, correctly stored.
Warning: Do not use this medicine after the expiry date stated on the packaging.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
It is important to always keep the information about the medicine available; therefore, retain both the
packaging and the leaflet.

6. Package contents and other information

What SERTRALINA DOC Generici contains
SERTRALINA DOC Generici 50 mg film-coated tablets
Active substance:
Sertraline hydrochloride 55.950 mg (equivalent to sertraline 50 mg)
Excipients: Microcrystalline cellulose, methylcellulose, anhydrous colloidal silica, magnesium stearate, hypromellose, hydroxypropylcellulose, polyethylene glycol 8000, titanium dioxide (E 171), FD & C aluminium lake (E 132)

SERTRALINA DOC Generici 100 mg film-coated tablets
Active substance:
Sertraline hydrochloride 111.900 mg (equivalent to sertraline 100 mg)
Excipients: Microcrystalline cellulose, methylcellulose, anhydrous colloidal silica, magnesium stearate, hypromellose, hydroxypropylcellulose, polyethylene glycol 8000, titanium dioxide (E 171), yellow iron oxide (E 172)

Description of the appearance of SERTRALINA DOC Generici and package contents
Film-coated tablets: tablets divisible into two equal doses.
SERTRALINA DOC Generici 50 mg film-coated tablets – 15 divisible tablets
SERTRALINA DOC Generici 50 mg film-coated tablets – 30 divisible tablets
SERTRALINA DOC Generici 100 mg film-coated tablets – 15 divisible tablets
SERTRALINA DOC Generici 100 mg film-coated tablets – 30 divisible tablets

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
DOC Generici S.r.l., Via Turati 40 - 20121 Milano - Italy

Manufacturers:
Fine Foods & Pharmaceuticals N.T.M. S.p.A., Via Grignano 43, - 24041 Brembate (BG) - Italy
Lamp San Prospero S.p.A., Via della Pace 25/A – 41030 San Prospero (MO) - Italy

Sertraline Doc Generici