Sertraline Medical Vallei

Leaflet accompanying the packaging: patient information

Sertraline Medical Valley, 50 mg, coated tablets

Sertraline Medical Valley, 100 mg, coated tablets

Sertraline Medical Valley, 150 mg, coated tablets

Sertraline

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Sertraline Medical Valley and what is it used for
• 2. Important information before taking Sertraline Medical Valley
• 3. How to take Sertraline Medical Valley
• 4. Possible side effects
• 5. How to store Sertraline Medical Valley
• 6. Contents of the packaging and other information

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

Sertraline Medical Valley contains the active substance sertraline. Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs); these medicines are used to treat depressive disorders and/or anxiety disorders.

Sertraline Medical Valley is used in adults for the treatment of:

• Episodes of severe depression and prevention of recurrence of severe depression (in adults).
• Social phobia (in adults).
• Post-traumatic stress disorder (PTSD) (in adults).
• Anxiety disorders with panic attacks (panic anxiety) (in adults).
• Obsessive-compulsive disorder (OCD) (in adults and children and adolescents aged 6-17 years).

Depression is a disease characterized by symptoms of feeling sad, difficulty sleeping or feeling pleasure in life.
OCD and anxiety disorders with panic attacks (panic anxiety) are anxiety-related diseases, feeling constant anxiety due to persistent thoughts (obsessions) that cause repetitive rituals (compulsive actions).
Post-traumatic stress disorder (PTSD) is a condition that can occur after a very traumatic experience and is characterized by symptoms similar to depression and anxiety.
Social anxiety (social phobia) is an anxiety-related disease. It is characterized by a feeling of intense anxiety or stress 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).
The doctor has decided that this medicine is suitable for the treatment of the disease in the patient.
The patient should consult a doctor if they are not sure why they are taking 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 taking or has taken monoamine oxidase inhibitors (MAOIs, e.g. selegiline, moclobemide) or medicines similar to MAOIs (e.g. linezolid). After stopping sertraline treatment, the patient should wait at least one week before starting MAOI treatment. After stopping MAOI treatment, the patient should wait at least two weeks before starting sertraline treatment.
• If the patient is taking pimozide (a medicine used to treat mental disorders, such as psychoses).

Warnings and precautions

Before starting treatment with Sertraline Medical Valley, the patient should discuss it with their doctor or pharmacist.
Medicines do not always suit everyone. The patient should tell their doctor before taking Sertraline Medical Valley if they currently have or have had any of the following conditions:

• Seizures (epilepsy) or a history of seizures. If a seizure occurs, the patient should contact their doctor immediately.
• A history of manic-depressive disorder (bipolar) or schizophrenia. If a manic episode occurs, the patient should contact their doctor immediately.
• Current or past thoughts of self-harm or suicide (see below - Suicidal thoughts, worsening of depression or anxiety).
• Serotonin syndrome. This syndrome can occur in rare cases in patients taking certain medicines at the same time as sertraline. (Symptoms, see section 4. "Possible side effects"). The doctor should tell the patient if they have had serotonin syndrome in the past.
• Low sodium levels in the blood, as this may occur as a result of taking Sertraline Medical Valley. The patient should also inform their doctor if they are taking blood pressure medications, as they can also change sodium levels in the blood.
• Older adults - these patients may be more susceptible to low sodium levels in the blood (see above).
• Liver disease - the doctor may decide to reduce the dose of Sertraline Medical Valley.
• Diabetes - Sertraline Medical Valley may change blood sugar levels, so a change in the dosage of antidiabetic medications may be necessary.
• Bleeding disorders in the past (tendency to bruise) or if the patient is pregnant (see "Pregnancy, breastfeeding, and fertility") or has taken blood-thinning medications in the past [e.g. acetylsalicylic acid (aspirin) or warfarin] or medications that may increase the risk of bleeding.
• Age under 18. Sertraline Medical Valley should only be used in children and adolescents aged 6-17 years with obsessive-compulsive disorder (OCD). Patients being treated for this condition should be closely monitored by their doctor (see below - Children and adolescents).

Obsessive-compulsive disorder (OCD) is a condition where the patient experiences recurring thoughts (obsessions) that cause repetitive behaviors (compulsive actions).
The doctor should discuss the best way to stop treatment with the patient.

• Electroconvulsive therapy (ECT).
• Eye diseases, such as certain types of glaucoma (increased pressure in the eye).
• If the patient has been informed of a heart defect based on an electrocardiogram (ECG) known as a prolonged QT interval.
• Heart disease, low potassium or magnesium levels, a prolonged QT interval in any of the patient's relatives, slow heart rate, and concurrent use of medications that prolong the QT interval.

Psychomotor restlessness/Akathisia:
Sertraline use has been associated with the occurrence of a state characterized by psychomotor restlessness and a compulsion to move - often with an inability to sit or stand still (akathisia). This condition usually occurs within the first few weeks of treatment. Increasing the dose of the medicine may be harmful, so if the patient experiences such symptoms, they should tell their doctor.
Withdrawal symptoms:
After stopping treatment, side effects often occur, especially if treatment is stopped suddenly (see section 3 "Stopping Sertraline Medical Valley" and section 4 "Possible side effects"). The risk of withdrawal symptoms depends on the duration of treatment, dosage, and rate of dose reduction. These symptoms are usually mild or moderate, but in some patients, they can be severe.
They usually occur within the first few weeks after stopping treatment. They usually resolve on their own within two weeks, but in some patients, they can persist for longer (for 2-3 months or longer). If the patient decides to stop treatment with sertraline, it is recommended to gradually reduce the dose over several weeks or months, and the patient should discuss the best way to stop treatment with their doctor.
Suicidal thoughts, worsening of depression or anxiety
Patients with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressant medications, as these medications usually start working after two weeks, sometimes later.
Suicidal thoughts, self-harm, or suicidal behavior are more likely if:

• The patient has had suicidal thoughts or self-harm in the past.
• The patient is a young adult; clinical trial data indicate an increased risk of suicidal behavior in people under 25 years of age with mental disorders who are being treated with antidepressant medications.

If the patient experiences suicidal thoughts or self-harm, they should contact their doctor or go to the hospital immediately.
It may be helpful to inform relatives or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask relatives or friends for help and ask them to inform them if they notice that the depression or anxiety has worsened or if there are worrying changes in behavior.
Sexual dysfunction:
Medicines like Sertraline Medical Valley (SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Children and adolescents under 18 years of age

Essentially, 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 side effects such as suicidal attempts, self-harm, or suicidal thoughts (suicidal thoughts) and hostility (mainly aggressive, defiant, and angry behavior), during treatment with medicines from this group.
However, the 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 wants to discuss it with them, they should contact the doctor. Moreover, if any of the above symptoms occur or worsen while taking Sertraline Medical Valley, the caregiver should inform the doctor. In a long-term observational study lasting three years with over 900 children aged 6-16 years, the safety of long-term use of sertraline was evaluated in terms of its effect on growth, maturation, learning (cognitive function), and behavior. Overall, the study results showed that children treated with sertraline developed normally, except for a small increase in body weight in children treated with a higher dose.

Sertraline Medical Valley and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
Some medicines may affect the way Sertraline Medical Valley works or Sertraline Medical Valley may reduce the effectiveness of other medicines taken at the same time.
Taking Sertraline Medical Valley at the same time as the following medicines may cause serious side effects:

• Medicines called 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 methemoglobin levels in the blood). The patient should not take Sertraline Medical Valley at the same time as these medicines.
• Medicines used to treat mental disorders, such as psychoses (pimozide). The patient should not take Sertraline Medical Valley at the same time as 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, e.g. tramadol, fentanyl).
• Medicines used in anesthesia (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), e.g. ibuprofen, acetylsalicylic acid (aspirin)).
• Sedatives (diazepam).
• Diuretics ("water pills").
• Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines used to treat diabetes (tolbutamide).
• Medicines used to treat excessive stomach acid production, stomach ulcers, 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 mental disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medicines used to treat high blood pressure, chest pain, or to regulate heart rate and rhythm (such as verapamil, diltiazem, flecainide, propafenone).
• Medicines used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
• Medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
• Medicines used to treat HIV/AIDS and hepatitis C (protease inhibitors, such as ritonavir, telaprevir).
• Medicines used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).
• Medicines known to increase the risk of changes in the electrical activity of the heart (e.g. certain antipsychotic and antibiotic medications).

Sertraline Medical Valley with food, drink, and alcohol

The patient should not drink alcohol while taking Sertraline Medical Valley.
Sertraline should not be taken at the same time as grapefruit juice, as it may increase the level of sertraline in the body.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The safety of sertraline in pregnant women has not been fully established. Sertraline can be used in pregnant women only if the doctor considers that the benefits of the medicine outweigh the potential risks to the unborn child.
Taking Sertraline Medical Valley at the end of pregnancy may increase the risk of severe bleeding from the vagina, which can occur shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Sertraline Medical Valley, they should inform their doctor or midwife so that they can provide the patient with appropriate advice.
Medicines like Sertraline Medical Valley, taken by pregnant women, especially during the last three months, may increase the risk of a serious disease in the newborn called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and blue discoloration of the skin. These symptoms usually appear within the first day of life. If such symptoms occur, the patient should contact the midwife and/or doctor immediately.
Newborns may also experience other symptoms, which usually appear within the first 24 hours after birth. These symptoms include:

• breathing difficulties,
• blue discoloration of the skin or too hot or too cold skin,
• blue lips,
• vomiting or problems with sucking,
• excessive tiredness, difficulty sleeping, or constant crying,
• increased or decreased muscle tone,
• shivering, muscle spasms, or seizures,
• increased reflexes,
• restlessness,
• low blood sugar.

If the newborn experiences any of these symptoms or if their condition is worrying, the patient should contact the doctor or midwife, who will be able to provide advice.
There is evidence that sertraline passes into human milk. The medicine can be used in breastfeeding women if the doctor considers that the benefits of the medicine outweigh the potential risks to the baby.
In animal studies, some medicines similar to sertraline have been shown to decrease sperm quality. This could theoretically affect fertility, although no effect on fertility has been observed in humans so far.

Driving and using machines

Psychotropic medicines, such as sertraline, can affect driving or operating machinery. The patient should wait until they know how the medicine affects them before performing these activities.

Sertraline Medical Valley contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means that the medicine is considered "sodium-free".

3. How to take Sertraline Medical Valley

The patient should always take this medicine exactly as their doctor or pharmacist has told them. If they are not sure, they should ask their doctor or pharmacist.

Recommended dose:

Adults:

Depression and obsessive-compulsive disorder

The usual effective dose for the treatment of depression and OCD is 50 mg/day. The daily dose can be increased gradually by 50 mg at intervals of at least one week for several weeks. The maximum recommended dose is 200 mg/day.

Anxiety disorders with panic attacks (panic anxiety), social phobia, and post-traumatic stress disorder

Treatment of anxiety disorders with panic attacks (panic anxiety), social phobia, and post-traumatic stress disorder should be started with a dose of 25 mg/day, which can be increased to 50 mg/day after one week. The daily dose can then be increased gradually by 50 mg at intervals of several weeks. The maximum recommended dose is 200 mg/day.

Use in children and adolescents:

Sertraline Medical Valley can be used only in the treatment of children and adolescents aged 6-17 years with obsessive-compulsive disorder (OCD).

Obsessive-compulsive disorder:

Children aged 6-12 years:the recommended initial dose is 25 mg/day. After one week, the 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.
Patients with liver or kidney disease should inform their doctor and follow their advice.
Method of administration:
Sertraline Medical Valley coated tablets can be taken with or without food.
The medicine should be taken once a day, in the morning or evening.
The doctor will inform the patient how long they should take the medicine. The treatment period depends on the type of disease and the patient's response to treatment. Improvement of symptoms may start only after several weeks of treatment. Usually, treatment of depression should be continued for six months from the time of improvement.

Taking a higher dose of Sertraline Medical Valley than recommended

If the patient accidentally takes too much Sertraline Medical Valley, they should immediately contact their doctor or go to the emergency department of the nearest hospital.
The patient should always take the packaging with the label with them, regardless of whether there is medicine left in it or not.
Overdose symptoms may include: drowsiness, nausea, and vomiting, rapid heartbeat, muscle tremors, agitation, dizziness, and in rare cases, loss of consciousness.

Missing a dose of Sertraline Medical Valley

The patient should not take a double dose to make up for a missed dose. If the patient forgets to take a tablet, they should not take the missed tablet. They should simply take the next tablet at the right time.

Stopping treatment with Sertraline Medical Valley

The patient should not stop taking Sertraline Medical Valley unless their doctor tells them to. The doctor will advise the patient to gradually reduce the dose of Sertraline Medical Valley over several weeks until they finally stop taking it. If the patient suddenly stops taking the medicine, they may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and muscle tremors. If the patient experiences any of these side effects or any other side effects after stopping Sertraline Medical Valley, they should contact their doctor.
If the patient has any further questions about the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effect is nausea. Side effects depend on the dose and usually disappear or decrease as treatment continues.

The patient should contact their doctor immediately

If the patient experiences any of the following symptoms after taking this medicine, as they can be serious.

• If the patient develops a severe skin rash that causes 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 stop the treatment.
• An allergic reaction or allergy, which may include symptoms such as: itchy skin rash, breathing problems, wheezing, swelling of the eyelids, face, or lips.
• If the patient experiences: agitation, confusion, diarrhea, high temperature, and high blood pressure, excessive sweating, and rapid heartbeat. These are symptoms of serotonin syndrome, which can occur in rare cases when the patient takes certain medicines at the same time as sertraline. The doctor may then stop the treatment.
• If the patient experiences 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 the patient experiences restlessness and inability to sit or stand still. If the patient experiences restlessness, they should tell their doctor.
• If the patient experiences seizures (seizures).
• If the patient experiences manic episodes (see section 2 "Warnings and precautions").

The following side effects have been observed in clinical trials in adult patients and after the medicine was marketed:

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

• insomnia, dizziness, drowsiness, headaches
• diarrhea, nausea, dry mouth
• ejaculation disorders
• fatigue

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

• cold, sore throat, runny nose
• decreased appetite, increased appetite
• anxiety, depression, agitation, decreased interest in sex, nervousness, strange feelings, nightmares, teeth grinding
• muscle tremors, movement disorders (such as increased muscle activity, increased muscle tone, difficulty walking, and stiffness, spasms, and involuntary muscle movements)*, numbness and tingling, increased muscle tone, lack of concentration, taste disorders
• vision disturbances
• ringing in the ears
• palpitations
• hot flashes
• yawning
• gastrointestinal disorders, constipation, abdominal pain, vomiting, gas
• increased sweating, rash
• back pain, joint pain, muscle pain
• irregular menstrual periods, erectile dysfunction
• general malaise, chest pain, weakness, fever
• weight gain
• injuries

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

• gastroenteritis, ear infection
• tumor
• hypersensitivity, seasonal allergy
• decreased thyroid hormone levels
• suicidal thoughts, suicidal behavior*, psychotic disorders, thought disorders, apathy, hallucinations, aggression, euphoria, paranoia
• amnesia, decreased sensation, involuntary muscle spasms, fainting, increased muscle activity, migraine, coordination disorders, speech disorders

and others

• eye pain
• rapid heartbeat, cardiac problems
• bleeding disorders (including gastrointestinal bleeding)*, high blood pressure, flushing, blood in the urine
• breathing difficulties, nosebleeds, breathing problems, possible wheezing
• black stools, dental problems, esophageal inflammation, tongue problems, hemorrhoids, increased salivation, swallowing difficulties, belching, tongue disease
• eye swelling, hives, hair loss, itching, purple spots on the skin, skin disorders with blistering, dry skin, facial swelling, cold sweats
• osteoarthritis, muscle spasms*, muscle weakness
• increased urination, urinary problems, inability to urinate, urinary incontinence, increased urine production, nocturia
• sexual dysfunction, excessive vaginal bleeding, vaginal bleeding, sexual dysfunction in women
• swelling of the legs, chills, walking difficulties, increased thirst
• increased liver enzyme activity, weight loss
• * Side effects reported after the medicine was marketed

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

• appendicitis, lymphadenopathy, decreased platelet count*, decreased white blood cell count*
• severe allergic reactions
• endocrine disorders*
• high cholesterol, diabetes-related problems, low blood sugar, high blood sugar*, low sodium levels in the blood*
• physical symptoms caused by stress or emotions, terrifying, nightmares*, drug dependence, sleepwalking, premature ejaculation
• coma, abnormal movements, difficulty moving, increased sensitivity, sudden severe headache (which may be a sign of a serious condition called reversible cerebral vasoconstriction syndrome)*, sensory disturbances
• blind spots, glaucoma, double vision, sensitivity to light, blood in the eye, unequal pupil size*, vision disturbances*, eye problems
• heart attack, feeling of emptiness in the head, dizziness or discomfort in the chest, which may be symptoms of changes in the electrical activity of the heart (visible on an electrocardiogram) or irregular heartbeat*, slow heartbeat
• worsening of blood circulation in the arms and legs
• rapid breathing, progressive pulmonary fibrosis (interstitial lung disease)*, eosinophilic pneumonia*, laryngospasm, speech difficulties, slow breathing, hiccups
• mouth ulcers, pancreatitis*, blood in the stool, tongue ulcers, oral pain
• liver function disorders, severe liver function disorders*, jaundice (yellowing of the skin and eyes)*
• sun allergy*, skin swelling*, abnormal hair structure, abnormal skin odor, hairy skin rash
• muscle breakdown*, bone disorders
• urinary retention, decreased urination
• breast discharge, vaginal dryness, genital discharge, painful penis and foreskin, breast enlargement*, prolonged erection of the penis
• hernia, decreased drug tolerance
• increased blood cholesterol, abnormal laboratory test results*, abnormal sperm test results, bleeding disorders*
• vasodilation.

Frequency not known: frequency cannot be estimated from the available data

• jaw pain*
• partial loss of vision (maculopathy)
• inflammatory bowel disease (microscopic colitis) (causing diarrhea)*
• severe postpartum bleeding (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2
• 2.

*Side effects reported after the medicine was marketed

Additional side effects in children and adolescents

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

Symptoms after stopping treatment

After suddenly stopping treatment with this medicine, side effects may occur, such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and muscle tremors (see section 3 "Stopping Sertraline Medical Valley").
An increased risk of bone fractures has been observed in patients taking medicines from this group.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Sertraline Medical Valley

The medicine should be stored out of the sight and reach of children.
The patient should not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month stated.
Blister: Do not store above 25°C.
Bottle: No special storage precautions.

6. Contents of the packaging and other information

What Sertraline Medical Valley contains

The active substance of the medicine is sertraline. Each tablet contains 50 mg, 100 mg, or 150 mg of sertraline (as sertraline hydrochloride).
The other ingredients of the medicine are:
Tablet core: microcrystalline cellulose (PH 101), sodium carboxymethylcellulose (type A), hydroxypropylcellulose-, calcium hydrogen phosphate, magnesium stearate.
Coating:
50 mg tablets (Opadry II Orange 85F93265)
Polyvinyl alcohol, partially hydrolyzed
Titanium dioxide (E 171)
Macrogol
Talc
Yellow iron oxide (E 172)
Red iron oxide (E 172)
100 mg tablets (Opadry II 85F18422 White):
Polyvinyl alcohol, partially hydrolyzed
Titanium dioxide (E 171)
Macrogol
Talc
150 mg tablets (Opadry II Blue 85F505120):
Polyvinyl alcohol, partially hydrolyzed
Titanium dioxide (E 171)
Macrogol
Talc
Indigo carmine, aluminum lake (E 132)

What Sertraline Medical Valley looks like and contents of the pack

50 mg coated tablets: orange, oval, biconvex tablets with a dividing line on both sides of the tablet. The tablet dimensions are approximately 10 x 5 mm. The dividing line on the tablet is for identification purposes only and is not intended to divide the tablet into equal doses.
100 mg coated tablets: white, oval, biconvex, smooth tablets with dimensions of approximately 12 x 6 mm.
150 mg coated tablets: blue, oval, biconvex, smooth tablets with dimensions of approximately 13 x 8 mm.
PVC/Aluminum blisters in a cardboard box.
50 mg tablets are available in packs of 20, 30, 50, 90, or 100 tablets.
100 mg tablets are available in packs of 20, 30, 50, or 100 tablets.
150 mg tablets are available in packs of 7 or 14 tablets.
A plastic bottle containing silica gel as a desiccant in a cardboard box.
50 mg tablets are available in packs of 30, 32, 90, 100, 105, 112, or 250 tablets.
100 mg tablets are available in packs of 30, 32, 90, 100, 105, 112, 210, or 250 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: safety@medicalvalley.se

Manufacturer

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

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark: Sertraline "Medical Valley"
Netherlands: Sertraline Xiromed 25 mg, 50 mg, 100 mg, 200 mg film-coated tablets
Iceland: Sertraline Medical Valley 25 mg, 50 mg, 100 mg, 150 mg, 200 mg film-coated tablets
Germany: Sertralin AXiromed 25 mg, 50 mg, 100 mg, 150 mg, 200 mg film-coated tablets
Norway: Sertraline Medical Valley
Poland: Sertraline Medical Valley
Sweden: Sertraline Medical Valley 25 mg, 50 mg, 100 mg, 150 mg, 200 mg film-coated tablets

Date of last revision of the leaflet: