PACKAGE LEAFLET: INFORMATION FOR THE USER

Sertraline PENSA 50 mg film-coated tablets, 100 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any 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 side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT SERTRALINA PENSA IS AND WHAT IT IS USED FOR

Sertralina PENSA contains the active substance sertraline. Sertraline belongs to a group of
medicinal products called Selective Serotonin Reuptake Inhibitors (SSRIs); these
medicines are used to treat depression and/or anxiety disorders.
Sertralina PENSA can be used to treat:

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 disorders (OCD) (in adults and 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 one used to.

OCD and panic disorder are anxiety-related conditions with symptoms such as persistent worrying thoughts (obsessions) that lead to repetitive ritualistic actions (compulsions).
PTSD is a condition that may occur after a strongly traumatic experience and has some symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterized by intense feelings of 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.
You should contact your doctor if you are unsure why Sertralina PENSA has been prescribed for you.

2. WHAT YOU SHOULD KNOW BEFORE TAKING SERTRALINE PENSA

Do not take Sertralina PENSA

If you are allergic to sertraline or to any of the other ingredients of this medicine (listed in section 6).
If you are taking or have recently taken medicines called monoamine oxidase inhibitors (MAOIs) (such as selegiline, moclobemide) or drugs with MAOI-like activity (such as linezolid). If you stop treatment with sertraline, you must wait at least one week before restarting treatment with an MAOI. After stopping treatment with an MAOI, you must wait at least 2 weeks before starting treatment with sertraline.
If you are taking another medicine called pimozide (a medicine for mental disorders such as psychosis). Warnings and precautions Talk to your doctor or pharmacist before taking Sertralina PENSA. Medicines are not always suitable for everyone. Inform your doctor before taking Sertralina PENSA if you suffer or have previously suffered from any of the following conditions:
Epilepsy or history of seizures. In case of a seizure (convulsions), 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 have 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 taking certain medicines together with sertraline (for symptoms, see section 4 “Possible Side Effects”). Your doctor will inform you if you have previously experienced this condition.
If you have low sodium levels in the blood, as this condition may occur as a result of treatment with Sertralina PENSA. You should also inform your doctor if you are taking certain medicines for high blood pressure, as these medicines can also alter sodium levels in the blood.
Pay particular attention 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 PENSA.
Diabetes: blood glucose levels may be altered by treatment with Sertraline PENSA, and it may be necessary to adjust the dose of your diabetes medicines.
If you have had bleeding problems or are taking medicines that thin the blood (e.g. acetylsalicylic acid (aspirin) or warfarin) or that may increase the risk of bleeding.
If you are a child or adolescent under 18 years of age. Sertralina PENSA should only be used to treat children and adolescents aged 6 to 17 years who suffer from obsessive-compulsive disorder (OCD). If the child or adolescent is being treated for this disorder, the doctor will want to monitor them closely (see below “Children and adolescents”).
If you are undergoing electroconvulsive therapy (ECT).
If you have eye problems, such as certain types of glaucoma (increased pressure inside the eye).
If you have been diagnosed with an abnormality in the heart trace on an electrocardiogram (ECG) known as QT interval prolongation:
If you have heart disease, low potassium or magnesium levels, a family history of QT interval prolongation, slow heart rate, or are taking concomitant medicines that prolong the QT interval.
If you are prone to bleeding or bruising easily, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”).
You are taking medicines containing buprenorphine or the buprenorphine-naloxone combination.

Restlessness/Akathisia
The use of sertraline has been associated with distressing restlessness and an urge to move, often
accompanied by an inability to sit still or remain motionless (akathisia). This condition is more likely
to occur during the first weeks of treatment. Increasing the dose may be harmful for patients
experiencing these symptoms; therefore, discuss this with your doctor.
Withdrawal reaction
Undesirable effects related to stopping treatment (withdrawal reactions) are common, especially if
treatment is stopped abruptly (see section 3 “If you stop taking Sertralina PENSA” and section 4
“Possible side effects”). The risk of withdrawal reactions depends on the duration of treatment, the
dose, and the extent of dose reduction. Generally, these symptoms are mild to moderate in intensity.
However, in some patients, they may be severe. They usually occur in the first few days after stopping
treatment. In general, these symptoms resolve on their own within 2 weeks. In some patients, they may
last longer (2–3 months or more). When discontinuing treatment with sertraline, it is recommended
to gradually reduce the dose over several weeks or months.
Always discuss with your doctor the best way to stop 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
yourself or of suicide. These thoughts may worsen when starting antidepressants for the first time, as
all these medicines require 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 harming yourself or of suicide.
You are a young adult. Available data from clinical trials 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 yourself or of suicide, 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 worsening, or if 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 (OCD). Patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, thoughts of harming oneself or of 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 PENSA to a patient under 18 years of age if it is in the patient’s best interest. If your doctor has prescribed Sertralina PENSA 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 develop or worsen while taking Sertralina PENSA, you must inform your doctor. Finally, the long-term safety of Sertralina PENSA on growth, maturation, learning ability (cognitive development), and behavioural development in this age group has not yet been established. Other medicines and Sertralina PENSA Inform your doctor or pharmacist 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 PENSA, or Sertralina PENSA may reduce the effectiveness of other medicines taken simultaneously. Sexual problems: Medicines such as Sertralina PENSA (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.

Taking Sertralina PENSA 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), the antibiotic linezolid, and methylene blue (used to treat high levels of methemoglobin in the blood). Do not use Sertralina PENSA together with these medicines.
Medicines for the treatment of mental disorders such as psychosis (pimozide). Do not use Sertralina PENSA together with pimozide.

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

Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, obesity).
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 for the treatment of severe pain (e.g. tramadol).
Medicines used in anaesthesia or for the treatment of chronic pain (fentanyl, mivacurium, and suxamethonium).
Medicines for the treatment of migraine (e.g. sumatriptan).
Medicines to thin the blood (warfarin).
Medicines for the treatment of pain/arthritis (non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)).
Sedatives (diazepam).
Diuretics
Medicines for the treatment of epilepsy (phenytoin, phenobarbital, carbamazepine).
Medicines for the treatment of diabetes (tolbutamide).
Medicines for the treatment of excess stomach acid, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
Medicines for the treatment of mania and depression (lithium).
Other medicines for the treatment of depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
Medicines for the treatment of schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
Medicines used for the treatment of high blood pressure, chest pain, or to regulate heart rate and rhythm (such as verapamil, diltiazem, flecainide, and propafenone).
Medicines used for the treatment of bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
Medicines used for the treatment of fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
Medicines used for the treatment of HIV/AIDS and hepatitis C (protease inhibitors such as ritonavir, telaprevir).
Medicines used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).
Medicines known to increase the risk of changes in the heart’s electrical activity (e.g. certain antipsychotics and antibiotics).
Buprenorphine and the buprenorphine-naloxone combination (used for opioid dependence treatment).

Sertralina PENSA with food, drinks and alcohol
Sertralina PENSA tablets may be taken with or without food.
Alcohol consumption should be avoided during treatment with Sertralina PENSA.
Sertraline should not be taken together with grapefruit juice, as it may increase sertraline levels in the body.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of sertraline in pregnant women has not been fully established. Sertraline should be given to pregnant women only if the doctor considers that the benefit to the mother outweighs any possible risk to the fetus. Make sure your midwife and/or doctor know that you are being treated with Sertralina PENSA. If taken during pregnancy, particularly during the last 3 months of pregnancy, medicines such as Sertralina PENSA may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN). This condition causes the newborn to breathe rapidly and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.
Your baby may also experience other conditions that generally occur within the first 24 hours after birth. Symptoms include:

Breathing difficulties
Bluish, too hot, or too cold skin
Bluish lips
Vomiting or inability to feed properly
Extreme tiredness, inability to sleep, or excessive crying
Stiff or floppy muscles
Tremors, restlessness, or seizures
Increased reflex responses
Irritability
Low blood sugar levels

If your baby shows any of these symptoms at birth or if you are concerned about your baby’s health, contact your doctor or midwife for advice.
If you take Sertralina PENSA near 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 easily). Inform your doctor or midwife that you are taking Sertralina PENSA so they can advise you on what to do.
There is evidence that sertraline is excreted in breast milk. Sertraline should be used during breastfeeding only if the doctor considers that the benefit outweighs any possible risk to the infant.
In animal studies, some medicines like sertraline may reduce sperm quality. In theory, this could affect fertility, but no impact on human fertility has been observed.
If you are a woman of childbearing potential, you should use an adequate method of contraception (such as the oral contraceptive pill) during treatment with sertraline.
Driving and using machines
Psychotropic medicines such as sertraline may affect your ability to drive vehicles or operate machinery. Therefore, do not drive or operate machinery until you know whether this medicine affects your ability to perform these activities.
Sertralina PENSA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. HOW TO TAKE SERTRALINE PENSA

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended 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
For panic disorder, social anxiety disorder, and post-traumatic stress disorder, 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:
Sertraline PENSA should only be used for the treatment of children and adolescents aged 6 to 17 years with Obsessive-Compulsive Disorder (OCD).
Obsessive-Compulsive Disorder
Children aged 6–12 years: the recommended initial dose is 25 mg daily.
After one week, your doctor may increase the dose to 50 mg daily. The maximum dose is 200 mg daily.
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 the instructions provided.
Method of administration
Sertraline PENSA tablets can be taken with or without food.
Take the medicine once daily, in the morning or in the evening.
Your doctor will tell you how long you should take this medicine. This will depend on the nature and duration of your illness and your response to treatment. It may take several weeks before symptoms begin to improve. Treatment for depression should generally continue for 6 months after improvement is observed.
The tablet may be divided into equal parts.
If you take more Sertraline PENSA than you should
If you accidentally take too much Sertraline PENSA, contact your doctor immediately or go to the nearest emergency department. Always bring the medicine pack with its label, whether or not it still contains medicine.
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 Sertraline PENSA
If you forget to take a dose, do not take the missed dose. Take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Sertraline PENSA
Do not stop taking Sertraline PENSA unless your doctor tells you to. Your doctor may wish to gradually reduce the dose of Sertraline PENSA over several weeks before stopping treatment completely. If you stop taking this medicine suddenly, you may experience unwanted effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, feeling unwell, vomiting, and tremor. If you experience any of these unwanted effects, or any other side effects during treatment with Sertraline PENSA, talk to your doctor.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Nausea is the most common adverse reaction. Adverse reactions are dose-dependent and often transient with continued treatment.

Contact 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 rash 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 that 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. Rarely, this syndrome may occur when certain medicines are taken together with sertraline. Your doctor may decide to discontinue treatment.
If you develop yellowing of the skin and eyes, which may indicate liver damage.
If you experience depressive symptoms with thoughts of self-harm or suicide (suicidal thoughts).
If you begin to feel inner restlessness and an inability to sit or stand still after starting treatment with Sertraline PENSA. You must inform your doctor if you start feeling restless.
If you have a seizure (convulsions).
If a manic episode occurs (see section 2 "Warnings and precautions").

The following adverse reactions have been observed in clinical studies conducted in adult patients and after marketing authorization.

Very common adverse reactions (may affect more than 1 in 10 people):

Insomnia, dizziness, drowsiness, headache, diarrhea, nausea, dry mouth, ejaculation failure, fatigue.

Common adverse reactions (may affect up to 1 in 10 people):

Bronchitis, sore throat, runny nose
Decreased appetite, increased appetite
Depression, feeling strange, nightmares, anxiety, agitation, nervousness, reduced sexual interest, teeth grinding
Numbness and tingling, movement disorders (such as frequent movements, tense muscles, difficulty walking, stiffness, spasms, and involuntary muscle movements)*, tremors, muscle tension, taste disturbances, lack of attention
Vision disturbances
Ringing in the ears (tinnitus)
Palpitations, hot flushes
Yawning
Abdominal pain, vomiting, constipation, stomach discomfort, gas in the stomach
Rash, increased sweating
Back pain, joint pain, muscle pain
Menstrual irregularities, erectile dysfunction
Chest pain, malaise, weakness, fever
Weight gain
Injuries

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

Intestinal problems, ear infections
Tumors
Hypersensitivity, seasonal allergies
Low levels of thyroid hormones
Suicidal thoughts, suicidal behaviour*, psychotic disorders, abnormal thinking, lack of care, hallucinations, aggression, euphoric mood, paranoia
Seizures, involuntary muscle contractions, coordination disturbances, excessive movements, amnesia, fainting, reduced sensation, speech disorders, dizziness when standing up, migraine
Pupil dilation
Ear pain
Rapid heartbeat, heart problems
Bleeding problems (such as stomach bleeding), high blood pressure, hot flushes, blood in urine
Breathing difficulties, possible wheezing, shortness of breath, nosebleeds
Inflammation of the esophagus, difficulty swallowing, hemorrhoids, increased salivation, tongue disorders, belching, tarry stools, dental problems
Swelling of the eyes, development of purplish spots on the skin, hair loss, cold sweats, dry skin, hives, itching, skin problems with blistering, facial edema, cold sweats
Osteoarthritis, muscle weakness, muscle contractions, muscle cramps*
Nocturnal urination, inability to urinate, increased urine volume, increased urinary frequency, urinary problems, inability to urinate, urinary incontinence
Vaginal bleeding, female sexual dysfunction, sexual dysfunction, excessive vaginal bleeding
Swelling of the legs, chills, difficulty walking, thirst
Increased liver enzyme levels, weight loss
Cases of suicidal ideation and suicidal behaviour have been reported in patients treated with sertraline or shortly after discontinuation of treatment (see section 2).

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

Diverticulitis, swollen glands, reduced number of platelets (cells responsible for blood clotting)*, reduced number of white blood cells*
Severe allergic reaction
Endocrine disorders*
Elevated cholesterol levels, problems controlling blood sugar levels (diabetes), low blood sugar, increased blood sugar*, low sodium levels in blood*
Physical symptoms due to stress or emotions, drug dependence, altered frightening dreams*, sleepwalking, premature ejaculation
Coma, abnormal movements, movement difficulties, increased sensations, sudden severe headaches (which may be signs of a serious condition known as Reversible Cerebral Vasoconstriction Syndrome (RCVS)*, sensory disturbances
Development of spots on the eye, glaucoma, double vision (diplopia), light sensitivity (photophobia), blood in the eye (hyphema), unequal pupil size, altered vision, altered tear production
Heart attack, slowed heartbeat, dizziness, fainting or chest pain, which could be signs of changes in the heart's electrical activity (as seen on electrocardiogram) or abnormal heart rhythm*
Poor circulation to arms and legs
Rapid breathing, progressive scarring of lung tissue (Interstitial Lung Disease)*, throat closure, slowed breathing, difficulty speaking, hiccups
Blood in stools, tongue ulceration, mouth ulceration, pancreatitis*, mouth pain
Liver function problems, severe liver function problems*, yellowing of the skin and eyes (jaundice)*
Skin reaction to sunlight*, skin edema*, skin problems with blistering, inflammation of hair follicles, changes in hair structure, changes in skin odor
Muscle tissue breakdown*, bone disorders
Initial difficulty in urination, reduced urination
Dryness of the vaginal area, red and painful penis and foreskin, genital discharge, prolonged erection, breast discharge, breast enlargement*
Hernia, reduced drug tolerance
Increased blood cholesterol, laboratory test abnormalities*, altered seminal fluid, coagulation problems*
Procedure for relaxing blood vessels

Adverse reactions with unknown frequency (cannot be estimated from available data):

Jaw locking*
Enuresis*
Partial loss of vision
Inflammation of the colon (causing diarrhea)
Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage); see section 2, "Pregnancy, breastfeeding and fertility", for further information.
Muscle weakness and severe muscle pain, which may be signs of a disorder similar to Multiple Acyl-CoA Dehydrogenase Deficiency (MADD).

*Adverse reaction reported after marketing authorization

Adverse reactions in children and adolescents
In clinical studies in children and adolescents, adverse reactions were generally similar to those observed in adults (see above). The most common adverse reactions in children and adolescents were headache, insomnia, diarrhea, and nausea.

Symptoms that may occur when treatment is discontinued
If you stop treatment with this medicine abruptly, you may experience adverse reactions such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, feeling unwell, vomiting, and tremor (see section 3 "If you stop taking Sertralina PENSA").

An increased risk of bone fractures has been observed in patients taking this type of medicine.

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

5. HOW TO STORE SERTRALINE PENSA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Sertralina PENSA contains

Sertralina Pensa 50 mg

The active substance is sertraline (as hydrochloride). Each coated tablet of Sertralina PENSA contains 50 mg of sertraline.
The other excipients are: calcium phosphate, microcrystalline cellulose, sodium starch glycolate (Type A), anhydrous colloidal silica, magnesium stearate (tablet core), and polyvinyl alcohol, titanium dioxide (E171), macrogol/PEG 300 and talc (tablet coating).

Sertralina Pensa 100 mg

The active substance is sertraline (as hydrochloride). Each coated tablet of Sertralina PENSA contains 100 mg of sertraline.
The other excipients are: calcium phosphate, microcrystalline cellulose, sodium starch glycolate (Type A), anhydrous colloidal silica, magnesium stearate (tablet core), and polyvinyl alcohol, titanium dioxide (E171), macrogol/PEG 300 and talc (tablet coating).

Description of the appearance of Sertralina PENSA and contents of the pack
Sertralina PENSA 50 mg and 100 mg is available as film-coated tablets packed in
PVC/aluminum blisters, in pack sizes of 15 and 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan - Italy
Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira
2710-228 Sintra
Portugal
This summary of product characteristics was last approved on:

Sertraline Pensà