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, so you can read it again if you need to.
• 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 as yours.
• If the patient experiences any side effects, including any 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 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 disorder) (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 disorder) are anxiety-related diseases, characterized by feelings of 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 patient's disease.
The patient should consult a doctor if they are unsure why they 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 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 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 (fits) 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 due to the use of Sertraline Medical Valley. The patient should also inform their doctor about 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 with this disease should be closely monitored by a doctor (see below - Children and adolescents).

Children and adolescents under 18 years of age should not be treated with sertraline, 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, thoughts of self-harm or suicide (suicidal thoughts), and hostility (mainly aggressive, defiant, and angry behavior), during treatment with medicines of this class. 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 appear or worsen while taking Sertraline Medical Valley, the caregiver should inform the doctor.

Sertraline Medical Valley with 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 with 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 levels of methemoglobin in the blood). Sertraline Medical Valley should not be taken with these medicines.
• Medicines used to treat mental disorders, such as psychoses (pimozide). Sertraline Medical Valley should not be taken with pimozide.

The patient should tell 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 last 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 inflammation of the joints (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 heart electrical activity (e.g., certain antipsychotic and antibiotic medicines).

Sertraline Medical Valley with food, drink, and alcohol

The patient should not drink alcohol while taking Sertraline Medical Valley.
Sertraline should not be taken with 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 baby, 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, occurring 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 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 baby, called persistent pulmonary hypertension of the newborn (PPHN), causing rapid breathing and blue discoloration of the baby's skin. These symptoms usually appear in the first day of life. If such symptoms occur, the patient should contact the midwife and/or doctor immediately.
Other symptoms may also occur in newborns, usually within the first 24 hours after birth. These symptoms include:

• Difficulty breathing,
• 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 baby 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 breast 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.

Driving and using machines

Psychotropic medicines, such as sertraline, can affect driving or operating machinery. The patient should wait until they know how this medicine affects their ability to perform these activities.

Sertraline Medical Valley contains sodium

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

3. How to take Sertraline Medical Valley

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult 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 disorder), social phobia, and post-traumatic stress disorder

Treatment of anxiety disorders with panic attacks (panic disorder), social phobia, and post-traumatic stress disorder should be started with a dose of 25 mg/day, increasing 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 only be used in 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. Depression treatment should usually be continued for 6 months after 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 any 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 Sertraline Medical Valley

The patient should not stop taking Sertraline Medical Valley unless their doctor advises them to do so. The doctor will advise gradual reduction of the dose of Sertraline Medical Valley over several weeks, until the patient finally stops 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 doubts about taking this medicine, they should consult 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 often disappear or decrease as treatment continues.

The patient should contact their doctor immediately

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

• If the patient develops a severe skin rash that forms blisters (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 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 feels restless and unable to sit or stand still (akathisia). If the patient experiences such symptoms, they should tell their doctor.
• If the patient has seizures (fits).
• If the patient experiences manic episodes (see section 2 "Warnings and precautions").

The following side effects have been observed in clinical trials in adults 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 sexual interest, apathy, hallucinations, aggression, feelings of euphoria, paranoia
• Tremors, movement disorders (such as increased muscle activity, increased muscle tone, difficulty walking, and stiffness, spasms, and involuntary movements)*, numbness and tingling, increased muscle tone, lack of concentration, taste disturbances
• Visual disturbances
• Ringing in the ears
• Rapid heartbeat
• Hot flushes
• Yawning
• Gastrointestinal disturbances, 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, feelings of euphoria, paranoia
• Memory loss, decreased sensation, involuntary muscle spasms, fainting, increased muscle activity, migraine, dizziness when standing up, coordination disorders, speech disorders

Other side effects observed in clinical trials and after the medicine was marketed include:

• Eye pain
• Rapid heartbeat, heart problems
• Bleeding disorders (including gastrointestinal bleeding)*, high blood pressure, hot flushes, blood in the urine
• Difficulty breathing, nosebleeds, breathing difficulties, possible wheezing
• Tarry stools, dental problems, esophagitis, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders
• Eye swelling, hives, hair loss, itching, purpura, skin disorders with blistering, dry skin, facial swelling, cold sweats
• Arthrosis, muscle tremors, muscle spasms*, muscle weakness
• Increased urination frequency, urination problems, inability to urinate, incontinence, increased urine production, nocturia
• Sexual disorders, excessive menstrual bleeding, menstrual bleeding, sexual disorders in women
• Leg swelling, 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)

• Diverticulitis, lymphadenopathy, decreased platelet count*, decreased white blood cell count*
• Severe allergic reactions
• Endocrine disorders*
• High cholesterol, problems with maintaining normal blood sugar levels (diabetes), low blood sugar, high blood sugar*, low sodium levels in the blood*
• Physical symptoms caused by stress or emotions, terrifying dreams*, 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

Other side effects observed in clinical trials and after the medicine was marketed include:

• Blurred vision, glaucoma, double vision, sensitivity to light, eye pain, unequal pupil size*, visual disturbances*, eye problems
• Myocardial infarction, feeling of emptiness in the head, fainting or discomfort in the chest, which may be symptoms of changes in heart electrical activity (visible on an electrocardiogram) or abnormal heart rhythm*, slow heart rate
• Worsening of blood circulation in the arms and legs
• Rapid breathing, progressive pulmonary fibrosis (interstitial lung disease)*, eosinophilic pneumonia*, laryngospasm, difficulty speaking, slow breathing, hiccups
• Oral ulcers, pancreatitis*, blood in the stool, tongue ulcers, oral pain
• Liver function disorders, severe liver function disorders*, yellowing of the skin and eyes (jaundice)*
• Sunburn*, skin swelling*, abnormal hair structure, abnormal skin odor, hairy skin rash
• Muscle breakdown*, bone disorders
• Urination delay, decreased urination
• Breast discharge, vaginal dryness, genital discharge, painful red penis and foreskin, breast enlargement*, prolonged erection
• Hernia, decreased drug tolerance
• Increased cholesterol levels in the blood, abnormal laboratory test results*, abnormal sperm test results, bleeding disorders*
• Vasodilation.

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

• Jaw tightness*
• Partial loss of vision (maculopathy)
• Microscopic colitis (causing diarrhea)*
• Severe postpartum hemorrhage (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.

Withdrawal symptoms

After stopping this medicine, the patient may experience side effects 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 of this class.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety of the 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 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 score line on both sides of the tablet. The tablet dimensions are approximately 10 x 5 mm. The score line on the tablet is only for identification purposes 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.
Blisters with PVC/Aluminum foil 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: [email protected]

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: