Sertraline medical valley: detailed information

Package leaflet: Information for the patient

Sertraline Medical Valley, 50 mg, film-coated tablets
Sertraline Medical Valley, 100 mg, film-coated tablets
Sertraline Medical Valley, 150 mg, film-coated tablets
Sertralinum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Sertraline Medical Valley is and what it is used for
Important information before taking Sertraline Medical Valley
How to take Sertraline Medical Valley
Possible side effects
How to store Sertraline Medical Valley
Contents of the pack and other information

1. What Sertraline Medical Valley is and what it is used for

Sertraline Medical Valley contains the active substance sertraline. Sertraline belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are used in the treatment of depressive disorders and (or) anxiety disorders.
Sertraline Medical Valley is used in adults for the treatment of:

Major depressive episodes and prevention of relapse of major depression (in adults).
Social phobia (in adults).
Post-traumatic stress disorder (PTSD) (in adults).
Panic disorder with or without agoraphobia (in adults).
Obsessive-compulsive disorder (OCD) (in adults and in children and adolescents aged 6–17 years).

Depression is an illness characterized by symptoms such as feelings of sadness, difficulty sleeping, or inability to experience pleasure in life.
OCD and panic disorder with or without agoraphobia are anxiety-related disorders, involving persistent worry due to intrusive thoughts (obsessions), leading to repetitive rituals (compulsions).
Post-traumatic stress disorder (PTSD) is a condition that may occur following a traumatic experience and is characterized by symptoms similar to depression and anxiety.
Social anxiety (social phobia) is an anxiety-related disorder. It is characterized by intense fear or anxiety in social situations (such as talking to strangers, speaking in front of a group of people, eating or drinking in the presence of others, or worrying about potentially embarrassing behavior).

Your doctor has decided that this medicine is suitable for treating the condition you suffer from.
You should consult your doctor if you are unsure why you have been prescribed Sertraline Medical Valley.

2. Important information before taking Sertraline Medical Valley

When not to take Sertraline Medical Valley:

If the patient is allergic to sertraline or any of the other ingredients of this medicine (listed in section 6).
If the patient is currently taking or has recently taken monoamine oxidase inhibitors (MAO inhibitors, e.g. selegiline, moclobemide) or medicines similar to MAO inhibitors (e.g. linezolid). At least one week must elapse after stopping sertraline before starting treatment with an MAO inhibitor. At least two weeks must elapse after stopping treatment with an MAO inhibitor before starting sertraline.
If the patient is taking pimozide (a medicine used to treat psychiatric disorders such as psychosis).

Warnings and precautions
Before starting treatment with Sertraline Medical Valley, discuss this with your doctor or
pharmacist.
Medicines are not always suitable for everyone. You should tell your doctor before
taking Sertraline Medical Valley if you currently have or have previously had any of the following conditions:

Epilepsy (seizures) or a history of seizures. If a seizure occurs, contact your doctor immediately.
A previous diagnosis of bipolar disorder (manic depression) or schizophrenia. If a manic episode occurs, contact your doctor immediately.
Current or past thoughts of self-harm or suicide (see below – Suicidal thoughts, worsening of depression or anxiety disorders).
Serotonin syndrome. In rare cases, this syndrome may occur in patients taking certain medicines at the same time as sertraline. (Symptoms, see section 4. “Possible side effects”). Your doctor should ask whether you have previously experienced serotonin syndrome.
Low sodium levels in the blood, which may occur as a result of taking Sertraline Medical Valley. You should also inform your doctor if you are taking medicines for high blood pressure, as these may also affect sodium levels in the blood.
Advanced age – such patients may be more at risk of low sodium levels in the blood (see above).
Liver disease – your doctor may decide to reduce the dose of Sertraline Medical Valley.
Diabetes – Sertraline Medical Valley may alter blood glucose levels, so dosage adjustments of antidiabetic medicines may be necessary.
History of bleeding disorders (tendency to bruise easily), or if the patient is pregnant (see “Pregnancy, breastfeeding and fertility”) or has previously taken anticoagulant medicines [e.g. acetylsalicylic acid (aspirin) or warfarin] or medicines that may increase the risk of bleeding.
Age under 18 years. Sertraline Medical Valley may be used only in the treatment of children and adolescents aged 6 to 17 years with obsessive-compulsive disorder. Patients being treated for this condition should be closely monitored by their doctor (see below – Children and adolescents).
Electroconvulsive therapy (ECT) is being used.
Eye disorders, such as certain types of glaucoma (increased pressure in the eye).
If the patient has been diagnosed with a heart condition on electrocardiogram (ECG) known as prolonged QT interval.
Heart disease, low potassium or magnesium levels, family history of prolonged QT interval, slow heart rate, and concomitant use of medicines that may prolong the QT interval.

Psychomotor agitation/Akathisia:
Use of sertraline has been associated with a condition characterized by inner restlessness and a compulsion to move – often with an inability to sit still or remain motionless (akathisia). This condition usually occurs within the first few weeks of treatment. Increasing the dose of the medicine may be harmful; therefore, if such symptoms occur, the patient should inform their doctor.
Withdrawal symptoms:
After stopping treatment, adverse effects (withdrawal symptoms) often occur, especially if treatment is stopped abruptly (see section 3 “Stopping Sertraline Medical Valley” and section 4 “Possible side effects”). The risk of withdrawal symptoms depends on the duration of treatment, dose, and speed of dose reduction. These symptoms are generally mild or moderate in intensity, but may be severe in some patients. They usually occur within the first few weeks after stopping treatment. They usually resolve spontaneously within 2 weeks, although in some patients they may persist longer (2–3 months or more). When deciding to discontinue sertraline treatment, gradual dose reduction over several weeks or months is recommended. The patient should always discuss the best way to stop treatment with their doctor.
Suicidal thoughts, worsening of depression or anxiety disorders
People with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks to start working, sometimes longer.
The occurrence of suicidal thoughts, thoughts of self-harm or suicide is more likely if:

The patient has previously had suicidal thoughts or a desire to self-harm.
The patient is a young adult; clinical trial data indicate an increased risk of suicidal behaviour in people under 25 years of age with psychiatric disorders who are treated with antidepressants.

If the patient experiences suicidal thoughts or thoughts of self-harm, they should contact their doctor immediately or go to hospital.
It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask family or friends for support and ask them to inform them if they notice worsening depression or anxiety, or concerning changes in behaviour.
Sexual dysfunction:
Medicines such as Sertraline Medical Valley (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after stopping treatment.
Children and adolescents under 18 years of age
In general, sertraline should not be used in children and adolescents under 18 years of age, except for patients with obsessive-compulsive disorder (OCD). In patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, thoughts of self-harm or suicide (suicidal thoughts), and hostility (mainly aggressive, defiant behaviour and anger) when taking medicines from this group.
However, a doctor may decide to prescribe Sertraline Medical Valley to a patient under 18 years of age if it is in the patient's best interest. If the doctor prescribes Sertraline Medical Valley to a patient under 18 years of age and the child's caregiver wishes to discuss this, they should contact the doctor. Furthermore, if any of the above-mentioned symptoms appear or worsen during treatment with Sertraline Medical Valley, the doctor should be informed. In a long-term observational study lasting 3 years involving over 900 children aged 6 to 16 years, the long-term safety of sertraline was evaluated with regard to its effects on growth, maturation, learning (cognitive functions), and behaviour. Overall, study results showed that children treated with sertraline developed normally, except for a slightly reduced weight gain in children treated with higher doses.
Sertraline Medical Valley and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including over-the-counter medicines.
Some medicines may affect how Sertraline Medical Valley works, or Sertraline Medical Valley may reduce the effectiveness of other medicines taken at the same time.
Taking Sertraline Medical Valley together with the following medicines may cause serious side effects:

Medicines known as monoamine oxidase inhibitors (MAOIs), e.g. 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). Sertraline Medical Valley must not be taken together with these medicines.
Medicines used to treat psychiatric disorders such as psychosis (pimozide). Sertraline Medical Valley must not be taken together with pimozide.

The patient should inform their doctor if they are taking any of the following medicines:

Medicines containing amphetamine derivatives (used to treat attention deficit hyperactivity disorder (ADHD), excessive sleepiness, and obesity).
Herbal medicines containing St. John’s wort (Hypericum perforatum). The effect of St. John’s wort may persist for 1–2 weeks.
Products containing the amino acid tryptophan.
Medicines used to treat severe or chronic pain (opioids such as tramadol, fentanyl).
Medicines used in anaesthesia (e.g. fentanyl, mivacurium, and suxamethonium).
Medicines used to treat migraines (e.g. sumatriptan).
Medicines that prevent blood clotting (warfarin).
Medicines used to treat pain and (or) joint inflammation (e.g. metamizole, non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, acetylsalicylic acid (aspirin)).
Sedatives (diazepam).
Diuretics (“water tablets”).
Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
Medicines used to treat diabetes (tolbutamide).
Medicines used to treat excess stomach acid, peptic ulcer disease, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
Medicines used to treat mania and depression (lithium).
Other medicines used to treat depression (e.g. amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
Medicines used to treat schizophrenia and other psychiatric 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 surgery or chemotherapy (aprepitant).
Medicines known to increase the risk of changes in the heart’s electrical activity (e.g. certain antipsychotics and antibiotics).

Sertraline Medical Valley with food, drink and alcohol
Do not drink alcohol while taking Sertraline Medical Valley.
Sertraline should not be taken together with grapefruit juice, as it may increase the concentration of sertraline in the body.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.
The safety of sertraline use in pregnant women has not been fully established. Sertraline may be used during pregnancy only if, in the doctor’s opinion, the benefits outweigh the potential risks to the developing baby.
Taking Sertraline Medical Valley late in pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Sertraline Medical Valley, she should inform her doctor or midwife so they can provide appropriate advice.
Medicines such as Sertraline Medical Valley, when taken by women during pregnancy, especially during the last 3 months, may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and skin blueness (cyanosis). These symptoms usually appear within the first day of the baby’s life. If such symptoms occur, contact the midwife and (or) doctor immediately.
Other symptoms may also occur in the newborn, usually within the first 24 hours after birth. These symptoms include:

Breathing difficulties,
Bluish skin or skin that is too hot or too cold,
Bluish lips,
Vomiting or feeding problems,
Excessive tiredness, difficulty sleeping, or constant crying,
Increased or decreased muscle tone,
Tremors, muscle twitches, or seizures,
Increased reflexes,
Irritability,
Low blood sugar levels.

If any of these symptoms occur in the baby after birth, or if the baby’s health condition is concerning, contact the doctor or midwife, who will be able to provide advice.
There is evidence that sertraline passes into human milk. The medicine may be used in breastfeeding women if, in the doctor’s opinion, the benefits outweigh the potential risks to the infant.
Animal studies have shown that some medicines similar to sertraline may reduce semen quality. Theoretically, this could affect fertility, although no effect on fertility has been observed in humans so far.
Driving and operating machinery
Psychotropic medicines such as sertraline may affect the ability to drive or operate machinery. Patients should wait until they know how this medicine affects them before performing such activities.
Sertraline Medical Valley contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e. it is considered “sodium-free”.

3. How to take Sertraline Medical Valley

This medicine should always be taken as directed by the physician or pharmacist. If in
doubt, consult a physician or pharmacist.
Recommended dose:
Adults:
Depression and obsessive-compulsive disorder (OCD)
The usual effective dose for treating depression and OCD is 50 mg/day. The daily dose may be
gradually increased by 50 mg, with intervals of at least one week, over several weeks. The maximum
recommended dose is 200 mg/day.
Anxiety disorders with panic attacks (panic disorder), social phobia, and post-traumatic stress
disorder (PTSD)
Treatment of anxiety disorders with panic attacks (panic disorder), social phobia, and post-traumatic
stress disorder should begin with a dose of 25 mg/day, increasing after one week to 50 mg/day. The
daily dose may then be gradually increased by 50 mg at a time, over several weeks. The maximum
recommended dose is 200 mg/day.
Use in children and adolescents:
Sertraline Medical Valley may be used only in the treatment of children and adolescents aged 6–17
years with obsessive-compulsive disorder (OCD).
Obsessive-compulsive disorder (OCD):
Children aged 6 to 12 years: the recommended initial dose is 25 mg once daily. After one week,
the physician may increase the dose to 50 mg once daily. The maximum dose is 200 mg/day.
Adolescents aged 13 to 17 years: the recommended initial dose is 50 mg once daily. The
maximum dose is 200 mg/day.
Patients with liver or kidney disease should inform their physician and follow medical advice.
Method of administration:
Sertraline Medical Valley tablets may be taken with or without food.
The medicine should be taken once daily, either in the morning or in the evening.
The physician will inform the patient how long the treatment should continue. The duration of
treatment depends on the type of illness and the patient's response to therapy. Improvement in
symptoms may not begin until after several weeks of treatment. Typically, treatment for depression
should continue for 6 months after symptoms have improved.
Taking more Sertraline Medical Valley than recommended
If a patient accidentally takes more Sertraline Medical Valley than prescribed, contact a physician
immediately or go to the nearest hospital emergency department.
Always bring the medicine packaging and label with you, regardless of whether any medicine
remains.
Symptoms of overdose may include: drowsiness, nausea and vomiting, increased heart rate, muscle
tremors, agitation, dizziness, and in rare cases, loss of consciousness.
Missing a dose of Sertraline Medical Valley
Do not take a double dose to make up for a missed dose. If a patient forgets to take a tablet, they
should not take the missed tablet. Simply take the next tablet at the usual scheduled time.
Stopping Sertraline Medical Valley
Do not stop taking Sertraline Medical Valley unless advised by a physician. The physician will
recommend gradually reducing the dose of Sertraline Medical Valley over several weeks until the
patient finally stops taking it. In patients who abruptly discontinue the medicine, adverse effects may
occur, such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea,
vomiting, and muscle tremors. If any of these adverse effects or any other side effects occur after
stopping Sertraline Medical Valley, consult a physician.
If there are any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The most commonly occurring adverse effect is nausea. Adverse effects depend on
dose and often diminish or weaken as treatment continues.
You should contact a doctor immediately
if any of the following symptoms occur in the patient after taking this medicine, as they
may be serious.

If the patient develops a severe skin rash causing blistering (erythema multiforme) (blisters may appear in the mouth and on the tongue). These may be symptoms of a condition called Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN). In such cases, the doctor will discontinue the patient's treatment.
Allergic reaction or allergy, which may include symptoms such as itchy rash, breathing difficulties, wheezing, swelling of the eyelids, face or lips.
If the patient experiences: agitation, confusion, diarrhoea, high temperature and blood pressure, excessive sweating and increased heart rate. These are symptoms of
serotonin syndrome, which may rarely occur when the patient is taking
certain medicines at the same time as sertraline. The doctor may then discontinue
the patient's treatment.
If the patient develops yellowing of the skin and eyes, which may indicate liver damage.
If the patient experiences symptoms of depression with thoughts of self-harm or suicide (suicidal thoughts).
If, after taking Sertraline Medical Valley, the patient begins to feel restless and is unable to sit or stand still. If the patient experiences such restlessness, they should inform their doctor.
If the patient experiences seizures (fits).
If the patient experiences manic episodes (see section 2 "Warnings and precautions").

The following adverse effects have been observed in clinical trials and after the medicine has been marketed in adult patients:
Very common adverse effects (may affect more than 1 in 10 people)

insomnia, dizziness, drowsiness, headache
diarrhoea, nausea, dry mouth
ejaculation disorders
fatigue

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

cold, sore throat, runny nose
decreased appetite, increased appetite
anxiety, depression, agitation, reduced interest in sex, nervousness, strange feelings, nightmares, teeth grinding
muscle tremors, movement disorders (such as increased motor activity, increased muscle tension, difficulty walking, muscle stiffness, cramps and involuntary muscle movements)*, numbness and tingling, increased muscle tension, lack of concentration, taste disturbances
visual disturbances
tinnitus
palpitations
hot flushes
yawning
gastrointestinal disturbances, constipation, abdominal pain, vomiting, flatulence
increased sweating, rash
back pain, joint pain, muscle pain
irregular menstruation, erectile dysfunction
malaise, chest pain, weakness, fever
weight gain
injuries

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

gastritis and enteritis, ear infection
tumour
hypersensitivity, seasonal allergy
decreased levels of thyroid hormones
suicidal thoughts, suicidal behaviour*, psychotic disorders, thought disturbances, emotional blunting, hallucinations, aggression, feelings of euphoria, paranoia
memory loss, reduced sensation, involuntary muscle contractions, fainting, increased
motor activity, migraine, seizures, dizziness upon standing, coordination disturbances, speech disturbances
pupil dilation
ear pain
increased heart rate, heart-related problems
haemorrhagic disorders (including stomach bleeding)*, high blood pressure, sudden skin redness, blood in urine
shortness of breath, nosebleeds, breathing difficulties, possible wheezing
tarry stools, dental disorders, oesophagitis, tongue disorders, haemorrhoids, increased salivation, difficulty swallowing, belching, tongue diseases
eye swelling, urticaria, hair loss, itching, purpuric skin spots, skin disorders with blister formation, dry skin, facial swelling, cold sweats
degenerative joint disease, muscle tremors, muscle cramps*, decreased muscle strength
increased frequency of urination, problems with urination, inability to urinate, urinary incontinence, increased volume of urine, nocturia
sexual disorders, excessive vaginal bleeding, vaginal haemorrhage, sexual disorders in women
leg swelling, chills, difficulty walking, excessive thirst
increased liver enzyme activity, weight loss
Cases of suicidal thoughts and behaviours have been reported during treatment with sertraline or shortly after discontinuation (see section 2).

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

diverticulitis, lymph node swelling, decreased platelet count*, decreased white blood cell count*
severe allergic reactions
endocrine disorders*
high cholesterol levels, problems maintaining normal blood sugar levels (diabetes), low blood sugar, increased blood sugar*, low blood sodium levels*
physical symptoms caused by stress or emotions, frightening, nightmare-like dreams*, drug dependence, sleepwalking, premature ejaculation
coma, abnormal movements, difficulty moving, increased sensitivity to touch, sudden severe headache (which may be a symptom of a serious condition called reversible cerebral vasoconstriction syndrome)*, sensory disturbances
visual spots, glaucoma, double vision, feeling of harmful light effects on the eye, blood in the eye, unequal pupil size*, visual disturbances*, problems with tear production
myocardial infarction, feeling of emptiness in the head, fainting or discomfort in the chest, which may be symptoms of changes in the heart's electrical activity (visible on electrocardiogram) or irregular heart rhythm*, slowed heart rate
impaired blood circulation in the upper and lower limbs
rapid breathing, progressive lung tissue fibrosis (interstitial lung disease)*, eosinophilic pneumonia*, laryngospasm, difficulty speaking, slowed breathing, hiccups
oral ulceration, pancreatitis*, blood in stool, tongue ulceration, oral pain
liver function disorders, severe liver function disorders*, yellowing of the skin and eyes (jaundice)*
skin reaction to sunlight*, skin swelling*, abnormal hair structure, abnormal skin odour, rash of hairy skin
muscle tissue breakdown*, bone disorders
delayed urination, reduced urine output
nipple discharge, vaginal dryness, genital discharge, painful red penis and foreskin, breast enlargement*, prolonged penile erection
hernia, decreased drug tolerance
increased blood cholesterol levels, abnormal laboratory test results*, abnormal semen analysis, blood clotting problems*
vasodilation.

Frequency not known: frequency cannot be estimated from available data

bruxism*
partial loss of vision (maculopathy)
inflammation of the large intestine (microscopic colitis) (causing diarrhoea)*
severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection "Pregnancy, breastfeeding and effect on fertility" in section 2
muscle weakness and severe muscle pain, which may be symptoms of a disorder resembling glutaric aciduria type II*.

* Adverse effects reported after the medicine was marketed
Additional adverse effects in children and adolescents
In clinical trials involving children and adolescents, adverse effects were generally similar
to those occurring in adults (see above). The most commonly occurring adverse
effects in children and adolescents were headache, insomnia, diarrhoea and nausea.
Symptoms occurring after discontinuation
After abrupt discontinuation of this medicine, adverse effects such as dizziness,
numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting and
muscle tremors may occur (see section 3 "Discontinuing treatment with Sertraline Medical Valley").
An increased risk of bone fractures has been observed in patients taking medicines from this group.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the responsible entity.
By reporting adverse effects, more information on the safety of this medicine can be collected.

5. How to store Sertraline Medical Valley

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
Blister pack: Do not store above 25°C.
Bottle: No special storage conditions required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Packaging and Other Information

What Sertraline Medical Valley Contains
The active substance is sertraline. Each tablet contains 50 mg, 100 mg, or 150 mg of sertraline
(in the form of sertraline hydrochloride).
Other components of the medicine are:
Tablet core: microcrystalline cellulose (PH 101), sodium carboxymethyl starch (type A),
hydroxypropylcellulose, calcium hydrogen phosphate, magnesium stearate.
Tablet coating:
50 mg tablets (Opadry II Orange 85F93265):
Partially hydrolyzed polyvinyl alcohol
Titanium dioxide (E 171)
Macrogol
Talc
Yellow iron oxide (E 172)
Red iron oxide (E 172)
100 mg tablets (Opadry II 85F18422 White):
Partially hydrolyzed polyvinyl alcohol
Titanium dioxide (E 171)
Macrogol
Talc
150 mg tablets (Opadry II Blue 85F505120):
Partially hydrolyzed polyvinyl alcohol
Titanium dioxide (E 171)
Macrogol
Talc
Indigo carmine, aluminium lake (E 132)

What Sertraline Medical Valley Looks Like and Contents of the Packaging
50 mg coated tablets: orange, elongated, biconvex tablets with a division line on both sides of the tablet. The tablet dimensions are approximately 10 x 5 mm. The division line is intended only for identification and is not meant to divide the tablet into equal doses.
100 mg coated tablets: white, elongated, biconvex, smooth tablets, approximately 12 x 6 mm in size.
150 mg coated tablets: blue, elongated, biconvex, smooth tablets, approximately 13 x 8 mm in size.

Blister packs made of PVC/aluminum foil in a cardboard box.
50 mg tablets are available in packages containing 20, 30, 50, 90, or 100 tablets.
100 mg tablets are available in packages containing 20, 30, 50, or 100 tablets.
150 mg tablets are available in packages containing 7 or 14 tablets.

Plastic bottle containing silica gel as a desiccant, packed in a cardboard box.
50 mg tablets are available in packages containing 30, 32, 90, 100, 105, 112, or 250 tablets.
100 mg tablets are available in packages containing 30, 32, 90, 100, 105, 112, 210, or 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: [email protected]

Manufacturer
Laboratorios Liconsa, S.A.
Avda. Miralcampo, Nº 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark: Sertraline “Medical Valley”
Netherlands: Sertraline Xiromed 25 mg, 50 mg, 100 mg, 200 mg filmomhulde tabletten
Iceland: Sertraline Medical Valley 25 mg, 50 mg, 100 mg, 150 mg, 200 mg filmuhúðaðar töflur
Germany: Sertralin AXiromed 25 mg, 50 mg, 100 mg, 150 mg, 200 mg Filmtabletten
Norway: Sertraline Medical Valley
Poland: Sertraline Medical Valley
Sweden: Sertraline Medical Valley 25 mg, 50 mg, 100 mg, 150 mg, 200 mg Filmdragerad tablett