Sertraline Almus: detailed information

Package leaflet: Information for the user

SERTRALINE ALMUS 50 mg film-coated tablets, 100 mg film-coated tablets

Generic medicine
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What SERTRALINA ALMUS is and what it is used for

SERTRALINA ALMUS contains the active substance sertraline. Sertraline belongs to a group of
medicines known as Selective Serotonin Reuptake Inhibitors (SSRIs); these medicines
are used to treat depression and/or anxiety disorders.
SERTRALINA ALMUS may 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 one used to.
OCD and panic disorder are anxiety-related illnesses with symptoms such as persistent, intrusive worries (obsessions) leading to repetitive ritualistic behaviours (compulsions).
PTSD is a condition that may occur after a strongly traumatic experience, and some
symptoms of this condition are similar to those of depression and anxiety. Social anxiety disorder (social phobia)
is an anxiety-related illness. It is characterised by feelings of intense anxiety or distress in social situations
(e.g. speaking to strangers, speaking in public, eating or drinking in front 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 ALMUS has been prescribed for you.

2. What you should know before taking SERTRALINA ALMUS

Do not take SERTRALINA ALMUS

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 medicines known as monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide), or medicines with MAOI-like activity (such as linezolid). If you stop treatment with sertraline, you must wait at least one week before starting 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
Talk to your doctor or pharmacist before taking SERTRALINA ALMUS.
Medicines are not always suitable for everyone. Inform your doctor before taking SERTRALINA ALMUS if you suffer or have previously suffered from any of the following conditions:

If you have epilepsy (seizures) or a history of seizures. If you experience a seizure, contact your doctor immediately.
If you have suffered from bipolar disorder (manic-depressive illness) or schizophrenia. If you experience a manic episode, contact your doctor immediately.
If you are having or have ever had thoughts of harming or killing yourself (see below - Suicidal thoughts and worsening of depression or anxiety disorder).
If you suffer from serotonin syndrome. In rare cases, this syndrome may occur when certain medicines are taken together with sertraline (for symptoms, see section 4. Possible side effects). Your doctor will determine whether 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 ALMUS. You should also inform your doctor if you are taking certain medicines for high blood pressure, as these may also alter blood sodium levels.
If you are elderly, as you may be at increased risk of low blood sodium levels (see above).
If you have liver disease: your doctor may decide to prescribe a lower dose of SERTRALINA ALMUS.
If you have diabetes: blood glucose levels may be affected by treatment with SERTRALINA ALMUS, 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 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 ALMUS should only be used to treat children and adolescents aged 6 to 17 years who suffer from obsessive-compulsive disorder (OCD). If a child or adolescent is being treated for this disorder, the doctor will monitor them carefully (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 in the eye).
If you have been diagnosed with an abnormality in your 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.

Medicines such as SERTRALINA ALMUS (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.
Restlessness/Akathisia
Use of sertraline has been associated with anxious restlessness and an urge to move, often accompanied by an inability to sit or stand still (akathisia). This condition is more likely to occur during the first few weeks of treatment. Increasing the dose may be harmful for patients who develop these symptoms; therefore, speak with your doctor if this occurs.
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 ALMUS 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. These symptoms usually occur within the first few days after stopping treatment. Generally, these symptoms resolve on their own 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. Always talk to your doctor to determine 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 or killing yourself. These thoughts may worsen when starting antidepressants, 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 thought about killing yourself or harming yourself.
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 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 also 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 in 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 or killing oneself (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 ALMUS to a patient under 18 years of age if it is in the patient's best interest. If your doctor has prescribed SERTRALINA ALMUS to you and you are under 18 years of age and wish to discuss this decision with your doctor, please contact them. Furthermore, if any of the symptoms listed above appear or worsen while a patient under 18 years of age is being treated with SERTRALINA ALMUS, you must inform the doctor.
Finally, the long-term safety of SERTRALINA ALMUS on growth, maturation, learning ability (cognitive development), and behavioural development in this age group has not been established.
Other medicines and SERTRALINA ALMUS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Some medicines may affect the activity of SERTRALINA ALMUS, or SERTRALINA ALMUS may reduce the effectiveness of other medicines taken at the same time.
Taking SERTRALINA ALMUS with the following medicines may cause serious adverse events:

Medicines known as monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression) and selegiline (used to treat Parkinson’s disease), the antibiotic linezolid, and methylene blue (used to treat high levels of methaemoglobin in the blood). Do not use SERTRALINA ALMUS together with these medicines.
Medicines used to treat mental disorders such as psychosis (pimozide). Do not use SERTRALINA ALMUS together with pimozide.
Do not use SERTRALINA ALMUS together with disulfiram.

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

Medicines containing amphetamines (used to treat attention-deficit/hyperactivity disorder (ADHD), narcolepsy, and 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 used to treat severe pain (e.g. tramadol).
Medicines used in anaesthesia or for treatment of chronic pain (e.g. fentanyl, mivacurium, and suxamethonium).
Medicines used to treat migraine (e.g. sumatriptan).
Medicines 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, phenobarbital, carbamazepine).
Medicines used to treat diabetes (tolbutamide).
Medicines used to treat excess stomach acid, 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, and propafenone).
Medicines used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
Medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
Medicines used to treat HIV/AIDS and hepatitis C (protease inhibitors such as ritonavir, telaprevir).
Medicines used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).
Medicines known to increase the risk of changes in the heart's electrical activity (e.g. certain antipsychotics and antibiotics).

SERTRALINA ALMUS with food, drinks and alcohol
SERTRALINA ALMUS tablets can be taken with or without food.
Alcohol consumption should be avoided during treatment with SERTRALINA ALMUS.
Sertraline should not be taken together with grapefruit juice, as this may increase sertraline levels in the body.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or 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 developing baby.
If you take Sertralina Almus near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (a tendency to bleed easily). Inform your doctor or midwife that you are taking Sertralina Almus so they can advise you on what to do.
Ensure that your midwife and/or doctor are aware that you are being treated with SERTRALINA ALMUS.
When taken during pregnancy, particularly during the last three months, medicines such as SERTRALINA ALMUS 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 your baby develops these symptoms, contact your midwife and/or doctor immediately.
Your baby may also experience other conditions, which usually begin within the first 24 hours after birth.
Symptoms include:

Breathing difficulties,
Bluish skin colour or being too hot or too cold,
Bluish lips,
Vomiting or feeding difficulties,
Being very tired, unable to sleep, or crying excessively,
Stiff or floppy muscles,
Tremors, nervousness, jerks,
Increased reflexes,
Irritability,
Low blood sugar.

If your newborn shows any of the symptoms listed above, or if you have any concerns about your baby’s health, contact your doctor or midwife, who will be able to advise you.
There is evidence that sertraline is excreted in human breast milk. Sertraline should only be used during breastfeeding if the doctor considers that the benefit to the mother outweighs any possible risk to the baby.
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.
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 are certain that this medicine does not affect your ability to perform these activities.
SERTRALINA ALMUS 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 ALMUS

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
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 by 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 begin at a dose of 25 mg/day, which should then be increased to 50 mg/day after one week.
The daily dose may then be increased by 50 mg over several weeks. The maximum recommended dose is 200 mg/day.
Use in children and adolescents:
SERTRALINE ALMUS should only be used for the treatment of children and adolescents aged 6 to 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 by 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 the instructions provided by your doctor.
Method of administration
SERTRALINE ALMUS tablets may 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 depends on the duration of the 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 SERTRALINE ALMUS than you should
If you accidentally take an excessive dose of SERTRALINE ALMUS, contact your doctor immediately or go to the nearest emergency room. Always bring the medicine pack with you, whether it still contains medicine or not.
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 ALMUS
Do not take a double dose to make up for the forgotten dose. If you forget to take a dose, do not take the missed dose. Take the next dose at the usual time.
If you stop taking SERTRALINE ALMUS
Do not stop treatment with SERTRALINE ALMUS unless your doctor tells you to. Your doctor may wish to gradually reduce the dose of SERTRALINE ALMUS over several weeks before completely stopping this medicine. 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 SERTRALINE ALMUS, speak to your doctor.
If you have any questions about the use of SERTRALINE ALMUS, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Nausea is the most common side effect. Side effects depend on the dose and often disappear or decrease 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, which may include symptoms such as itchy rash, breathing difficulties, wheezing, swelling of the eyelids, face or lips.
If you experience agitation, confusion, diarrhoea, 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 discontinue treatment.
If you develop yellowing of the skin and eyes, which may indicate liver damage.
If you develop depressive symptoms with thoughts of harming yourself or of suicide (suicidal thoughts).
If you start feeling restless and unable to sit still or remain motionless after starting treatment with SERTRALINA ALMUS. You must inform your doctor if you begin to feel restless.
If you have seizures (fits).
If you experience a manic episode (see section 2 Warnings and precautions).

The following side effects have been observed in clinical studies conducted in adult patients and after marketing authorization:

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

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

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

Bronchitis, sore throat, runny nose,
Decreased appetite, increased appetite,
Anxiety, depression, agitation, reduced sexual desire, nervousness, feeling strange, nightmares, teeth grinding,
Tremor, movement disorders (such as frequent movements, tense muscles, difficulty walking, stiffness, spasms and involuntary muscle movements)*, numbness and tingling, muscle tension, lack of attention, altered taste,
Vision disturbances,
Ringing in the ears,
Palpitations,
Hot flushes,
Yawning,
Stomach discomfort, constipation, abdominal pain, vomiting, bloating,
Increased sweating, skin rash,
Back pain, joint pain, muscle pain,
Menstrual irregularities, erectile dysfunction,
Malaise, chest pain, weakness, fever,
Weight gain,
Injuries.

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

Bowel problems, ear infections,
Tumour,
Hypersensitivity, seasonal allergy,
Low levels of thyroid hormones,
Suicidal thoughts, suicidal behaviour*, psychotic disorders, abnormal thoughts, lack of self-care, hallucinations, aggression, euphoric mood, paranoia,
Amnesia, reduced sensations, involuntary muscle contractions, fainting, excessive movements, migraine, seizures, dizziness upon standing, coordination disturbances, speech disorders,
Dilated pupils,
Ear pain,
Rapid heartbeat, heart problems,
Bleeding problems (such as stomach bleeding)*, high blood pressure, hot flushes, blood in urine,
Shortness of breath, nosebleeds, difficulty breathing, possible wheezing,
Black/tarry stools, dental problems, oesophagitis, tongue disorders, haemorrhoids, increased salivation, difficulty swallowing, burping, tongue disorders,
Swelling of the eyes, hives, hair loss, itching, development of purplish spots on the skin, skin disorders with blister formation, dry skin, facial oedema, cold sweats,
Osteoarthritis, muscle contractions, muscle cramps*, muscle weakness,
Increased frequency of urination, difficulty urinating, inability to urinate, urinary incontinence, increased urine volume, nocturnal urination,
Sexual dysfunction, excessive vaginal bleeding, vaginal haemorrhage, female sexual dysfunction,
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 taking sertraline or immediately after stopping treatment (see section 2).

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

Diverticulitis, swollen glands, reduced number of blood clotting cells*, reduced number of white blood cells*,
Severe allergic reaction,
Endocrine disorders*,
Elevated cholesterol levels, problems controlling blood sugar levels (diabetes), low blood sugar levels, increased blood sugar levels*, low sodium levels in blood*,
Physical symptoms due to stress or emotions, disturbing nightmares*, drug dependence, sleepwalking, premature ejaculation,
Coma, abnormal movements, difficulty moving, increased sensitivity, sudden severe headaches (which may be a sign of a serious condition known as Reversible Cerebral Vasoconstriction Syndrome (RCVS))*, disturbance of consciousness,
Heart attack, feeling faint, fainting or chest pain, which could be signs of changes in the heart's electrical activity (as seen on electrocardiogram) or abnormal heart rhythm*, slow heartbeat,
Poor blood circulation to arms and legs,
Rapid breathing, progressive scarring of lung tissue (Interstitial Lung Disease), throat closure, difficulty speaking, slow breathing, hiccups,
Mouth ulceration, pancreatitis*, blood in stools, tongue ulceration, mouth pain,
Liver function problems, severe liver function problems*, yellowing of the skin and eyes (jaundice),
Skin reaction to sunlight*, cutaneous oedema*, changes in hair structure, altered skin odour, inflammation of hair follicles,
Muscle tissue breakdown*, bone disorders,
Initial difficulty urinating, reduced urination,
Breast secretion, vaginal dryness, genital discharge, red and painful penis and foreskin, breast enlargement*, prolonged erection,
Hernia, reduced tolerance to the medicine,
Increased blood cholesterol, altered laboratory test results, altered seminal fluid, coagulation problems*,
Blood vessel relaxation procedure,
Eye spots, glaucoma, double vision (diplopia), sensitivity to light (photophobia), blood collection in the front chamber of the eye (hyphaema), unequal pupil size, abnormal vision, altered tearing.

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

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

*Adverse effect reported after marketing authorization

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

Symptoms that may occur when treatment is discontinued
If you stop treatment with this medicine suddenly, you may experience side effects such as dizziness, tingling, sleep disturbances, agitation or anxiety, headache, nausea, vomiting and tremor (see section 3 “If you stop taking SERTRALINA ALMUS”).

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

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

5. How to store SERTRALINA ALMUS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
If taking half a 50 mg tablet, the unused half must be kept in the blister for use the following day.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SERTRALINA ALMUS contains
SERTRALINA ALMUS 50 mg film-coated tablets
The active substance is sertraline hydrochloride. Each tablet contains 55.95 mg of sertraline hydrochloride (equivalent to
50 mg of sertraline).
The other components are:

Tablet core: Calcium hydrogen phosphate, microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate, magnesium stearate;
Film coating: Titanium dioxide (E171), hypromellose E3, hypromellose E5, macrogol 400, macrogol 6000, polysorbate 80.

SERTRALINA ALMUS 100 mg film-coated tablets
The active substance is sertraline hydrochloride. Each tablet contains 111.90 mg of sertraline hydrochloride (equivalent to
100 mg of sertraline).
The other components are:

Tablet core: Calcium hydrogen phosphate, microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate, magnesium stearate;
Film coating: Titanium dioxide (E171), hypromellose E3, hypromellose E5, macrogol 400, macrogol 6000, polysorbate 80.

Description of the appearance of SERTRALINA ALMUS and contents of the pack
SERTRALINA ALMUS 50 mg film-coated tablets: pack of 30 divisible tablets
SERTRALINA ALMUS 100 mg film-coated tablets: pack of 30 tablets

Marketing Authorization Holder
Almus S.r.l. - Via Cesarea, 11/10 - 16121 Genoa
E-mail: [email protected]

Manufacturer
Doppel Farmaceutici S.r.l. - Via Volturno, 48 - 20089 Quinto de' Stampi - Rozzano (MI)