Sertraline Medical Vallei

Leaflet attached to the packaging: patient information

Sertraline Medical Valley, 50 mg, film-coated tablets

Sertraline Medical Valley, 100 mg, film-coated tablets

Sertraline Medical Valley, 150 mg, film-coated tablets

Sertraline

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult your 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 you experience any side effects, including any not listed in this leaflet, you should tell your 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 depression and/or anxiety disorders.

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

• Episodes of major depression and prevention of recurrence 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 children and adolescents aged 6-17 years).

Depression is a condition where you may feel sad, have difficulty sleeping or enjoying life.
OCD and panic disorder are anxiety-related conditions where you may feel anxious, have persistent thoughts (obsessions) that cause you to perform repetitive rituals (compulsive acts).
PTSD is a condition that can occur after a very traumatic experience and has symptoms similar to depression and anxiety.
Social anxiety disorder (social phobia) is an anxiety-related condition where you feel intense fear or anxiety in social situations (such as talking to strangers, speaking in front of a group of people, eating or drinking in front of others, or worrying about your potentially embarrassing behavior).
Your doctor has decided that this medicine is suitable for the treatment of your condition.
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:

Warnings and precautions

Before taking Sertraline Medical Valley, you should discuss this with your doctor or pharmacist.
Medicines do not always suit everyone. You should tell your doctor before taking Sertraline Medical Valley if you have or have had any of the following conditions:

• Seizures (fits) or a history of seizures. If you have a seizure, you should contact your doctor immediately.
• A history of manic-depressive illness (bipolar disorder) or schizophrenia. If you have a manic episode, you should contact your doctor immediately.
• Current or past thoughts of self-harm or suicide (see below - Suicidal thoughts, worsening of depression or anxiety).
• Serotonin syndrome. This is a rare condition that can occur when certain medicines are taken at the same time as sertraline (see section 4 "Possible side effects"). Your doctor should tell you if you have had serotonin syndrome in the past.
• Low sodium levels in the blood, as this may occur when taking Sertraline Medical Valley. You should also tell your doctor if you are taking medicines for high blood pressure, as they can also affect sodium levels in the blood.
• Older adults - such patients may be more prone to 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 affect blood sugar levels, so it may be necessary to adjust the dose of antidiabetic medicines.
• Bleeding disorders in the past (tendency to bruise) or if you are pregnant (see "Pregnancy, breastfeeding and fertility") or have taken medicines that prevent blood clotting [e.g. acetylsalicylic acid (aspirin) or warfarin] or 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 condition should be closely monitored by their doctor (see below - Children and adolescents).

Children and adolescents under 18 years of age should not take Sertraline Medical Valley, except for patients with obsessive-compulsive disorder (OCD). In children and adolescents under 18 years of age, there is an increased risk of side effects such as suicidal attempts, suicidal thoughts, or hostility (mainly aggressive, defiant, and angry behavior) when taking medicines of this type. However, your 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 your doctor prescribes Sertraline Medical Valley to a patient under 18 years of age and the child's caregiver wants to discuss this with them, they should contact the doctor. Furthermore, 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

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you 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, selegiline, linezolid, and methylene blue). You should not take Sertraline Medical Valley with these medicines.
• Medicines used to treat psychiatric disorders, such as psychoses (pimozide). You should not take Sertraline Medical Valley with pimozide.

You should tell your doctor if you 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 tablets").
• 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 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, and propafenone).
• Medicines used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, and erythromycin).
• Medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, and fluconazole).
• Medicines used to treat HIV/AIDS and hepatitis C (protease inhibitors, e.g. ritonavir, telaprevir).
• Medicines used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).
• Medicines known to increase the risk of changes in heart rhythm (e.g. certain antipsychotics and antibiotics).

Sertraline Medical Valley with food, drink, and alcohol

You should not drink alcohol while taking Sertraline Medical Valley.
Sertraline Medical Valley should not be taken with grapefruit juice, as it may increase the level of sertraline in the body.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.
The safety of sertraline in pregnant women has not been fully established. Sertraline can only be used in pregnant women 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 you have a history of bleeding disorders. If you are taking Sertraline Medical Valley, you should inform your doctor or midwife so that they can give you appropriate advice.
Medicines like Sertraline Medical Valley, taken by women during the last three months of pregnancy, may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and bluish skin. These symptoms usually appear in the first day of life. If such symptoms occur, you should contact the midwife and/or doctor immediately.
The baby may also experience other symptoms, usually within the first 24 hours after birth, including:

• difficulty breathing,
• bluish skin or too hot or too cold skin,
• bluish lips,
• vomiting or problems with sucking,
• excessive tiredness, difficulty sleeping, or constant crying,
• increased or decreased muscle tone,
• tremors, muscle spasms, or seizures,
• increased reflexes,
• restlessness,
• low blood sugar.

If your baby experiences any of these symptoms or if you are concerned about their health, you should contact the doctor or midwife, who will be able to advise you.
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 reduce sperm quality. This could theoretically affect fertility, although no effect on fertility has been observed in humans.

Driving and using machines

Psychotropic medicines like sertraline can affect your ability to drive or use machines. You should wait until you know how this medicine affects you before performing these activities.

Sertraline Medical Valley contains sodium

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

3. How to take Sertraline Medical Valley

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult your 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 over several weeks. The maximum recommended dose is 200 mg/day.

Panic disorder with or without agoraphobia, social phobia, and post-traumatic stress disorder

Treatment of panic disorder with or without agoraphobia, social phobia, and post-traumatic stress disorder should be started at 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 starting 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 starting 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 film-coated tablets can be taken with or without food.
The medicine should be taken once a day, in the morning or evening.
Your doctor will tell you how long you 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. Treatment of depression should usually be continued for 6 months after improvement.

Taking a higher dose of Sertraline Medical Valley than recommended

If you accidentally take too much Sertraline Medical Valley, you should immediately contact your doctor or go to the emergency department of the nearest hospital.
You should always take the packaging and label with you, regardless of whether there is any medicine left in it or not.
Symptoms of overdose 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

You should not take a double dose to make up for a missed dose. If you forget to take a tablet, you should not take the missed tablet. You should simply take the next tablet at the right time.

Stopping Sertraline Medical Valley

You should not stop taking Sertraline Medical Valley unless your doctor tells you to. Your doctor will advise you to gradually reduce the dose of Sertraline Medical Valley over several weeks before you finally stop taking it. If you suddenly stop taking the medicine, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and muscle tremors. If you experience any of these side effects or any other side effects after stopping Sertraline Medical Valley, you should contact your doctor.
If you have any further questions about the use of this medicine, you should contact your 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.

You should contact your doctor immediately

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

• If you develop 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, your doctor will stop the treatment.
• An allergic reaction or allergy, which may include symptoms such as: itchy skin rash, difficulty breathing, wheezing, swelling of the eyelids, face, or lips.
• If you experience: agitation, confusion, diarrhea, high blood pressure, and sweating. These are symptoms of serotonin syndrome, which can occur in rare cases when certain medicines are taken at the same time as sertraline. Your doctor may stop the treatment.

If you experience yellowing of the skin and eyes, which may indicate liver damage.

• If you experience symptoms of depression with thoughts of self-harm or suicide (suicidal thoughts).
• If you experience restlessness and an inability to sit or stand still (akathisia). If you experience restlessness, you should tell your doctor.
• If you have seizures (fits).
• If you experience 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 disorder
• 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, nervousness, feeling strange, nightmares, teeth grinding
• tremors, movement disorders (such as increased muscle activity, increased muscle tone, difficulty walking, and muscle stiffness, spasms, and involuntary movements)*, numbness and tingling, increased muscle tone, lack of concentration, taste disturbances
• vision disturbances
• ringing in the ears
• palpitations
• hot flushes
• yawning
• gastrointestinal disturbances, constipation, abdominal pain, vomiting, gas
• increased sweating, rash
• back pain, joint pain, muscle pain
• irregular menstrual cycle, 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
• memory loss, decreased sensation, involuntary muscle spasms, fainting, increased muscle activity, migraine, seizures, dizziness when standing up, coordination disorders, speech disorders

visual disturbances

• pupil dilation
• ear pain
• rapid heartbeat, heart problems
• bleeding disorders (including gastrointestinal bleeding)*, high blood pressure, flushing, blood in the urine
• shortness of breath, nosebleeds, breathing difficulties, possible wheezing
• black 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
• degenerative joint disease, muscle tremors, muscle spasms*, muscle weakness
• increased urination frequency, urination problems, inability to urinate, incontinence, increased urine production, nocturia
• sexual disorders, excessive vaginal bleeding, vaginal bleeding, female sexual disorders
• 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)

• diverticulitis, lymphadenopathy, decreased platelet count*, decreased white blood cell count*
• severe allergic reactions
• endocrine disorders*
• high cholesterol, blood sugar control problems (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
• blind spots, glaucoma, double vision, sensitivity to light, blood in the eye, uneven pupil size*, visual disturbances*, eye problems
• heart attack, feeling of emptiness in the head, fainting or discomfort in the chest, which may be symptoms of changes in heart rhythm (visible on an electrocardiogram) or irregular heartbeat*, slow heartbeat
• worsening of blood circulation in the arms and legs
• rapid breathing, progressive scarring of lung tissue (interstitial lung disease)*, eosinophilic pneumonia*, laryngospasm, difficulty speaking, slow breathing, hiccups
• mouth ulcers, pancreatitis*, blood in the stool, tongue pain, mouth 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
• urinary retention, decreased urination
• breast discharge, vaginal dryness, genital discharge, painful penis and foreskin, breast enlargement*, prolonged erection
• hernia, decreased drug tolerance
• high cholesterol, abnormal laboratory test results*, abnormal semen analysis, bleeding disorders*
• vascular hypotension.

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

• jaw tightness*
• partial loss of vision (maculopathy)
• inflammatory bowel disease (microscopic colitis) (causing diarrhea)*
• severe postpartum bleeding, occurring shortly after delivery (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, you 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").
There is an increased risk of fractures in patients taking medicines of this type.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your 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.
Do 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.
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
Iron oxide yellow (E 172)
Iron oxide red (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 film-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 film-coated tablets: white, oval, biconvex, smooth tablets with dimensions of approximately 12 x 6 mm.
150 mg film-coated tablets: blue, oval, biconvex, smooth tablets with dimensions of approximately 13 x 8 mm.
Blister packs of PVC/Aluminum 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: