Sertraline can make anxiety worse

Sertraline Accord 50 mg film-coated tablets

Patient information sheet for Sertraline Accord 50 mg film-coated tablets

1.What Sertraline Accord 50 mg film-coated tablets is and what it is used for

1.1 What are the properties of the medicinal product?

Sertraline Accord 50 mg film-coated tablets contains the active substance sertraline, a medicine from a group of so-called selective serotonin reuptake inhibitors (SSRIs). These medicines are used to treat depression and anxiety disorders.

Sertraline Accord 50 mg film-coated tablets requires a prescription and may only be used on medical advice.

1.2 What strengths and dosage forms are there?

Sertraline is usually available in the following strengths and dosage forms:

- tablets / film-coated tablets containing 50 or 100 mg sertraline,

- Concentrate for the preparation of an oral solution containing 20 mg of sertraline in 1 ml.

Your doctor will determine which strength and dosage form are suitable for your treatment.

1.3.Sertraline is used for

Treatment of:

- Depression and to prevent depression from recurring (in adults),

- social anxiety disorder (in adults),

- Post Traumatic Stress Disorder (PTSD) (in adults),

- panic disorder (in adults),

Obsessive-compulsive disorder (in adults and children and adolescents 6-17 years of age).

Depression is a clinical illness with symptoms such as sadness, insomnia or a reduced zest for life.

Obsessive-compulsive disorder and panic disorder are disorders that are associated with anxiety, such that, for example, you are constantly tormented by fixed ideas (obsessions) that lead you to repeated rituals (compulsions).

Post-traumatic stress disorder (PTSD) is a condition that can arise after an emotionally stressful event and that is associated with some ailments comparable to depression and anxiety.

Social anxiety disorder (social phobia) is a condition that is associated with anxiety. It manifests itself as being very anxious or tense in social situations (for example, talking to strangers, talking in front of a group of people, eating or drinking in front of others, or fear that you might be embarrassed).

2. What should you know before you use Sertraline Accord 50 mg film-coated tablets?

2.1.Sertraline Accord 50 mg film-coated tablets must not be used

- if you are allergic (hypersensitive) to sertraline or any of the other ingredients of Sertraline Accord 50 mg film-coated tablets.

- if you are using or have used medicines called monoamine oxidase inhibitors (MAOIs e.g. selegiline and moclobemide) or medicines similar to MAOIs (e.g. linezolid). After stopping sertraline, you must wait at least 1 week before starting treatment with an MAOI. After stopping an MAOI you must wait at least 2 weeks before starting treatment with sertraline.

- if you are taking another medicine containing the active substance pimozide (a medicine for psychiatric disorders such as psychosis).

- if you are currently taking disulfiram or have been taking it in the past 2 weeks.

2.2 Special care is required when taking Sertraline Accord 50 mg film-coated tablets

Please talk to your doctor or pharmacist before taking "Sertralin_50 mg_Filmtablette".

Medicines are not always suitable for everyone. Before taking Sertraline Accord 50 mg film-coated tablets, tell your doctor if you have or have ever had any of the following conditions or any of the following applies to you:

- if you have epilepsy (fits) or have had a history of seizure disorders.

Contact your doctor immediately if you have a seizure.

- if you have suffered from manic-depressive illness (bipolar disorder) or schizophrenia. Contact your doctor immediately if you have a manic phase.

- if you have or have ever had thoughts of harming or killing yourself.

- if you have serotonin syndrome. In rare cases, this syndrome can occur if you use certain medicines at the same time as sertraline. Your doctor will tell you whether you have had this condition in the past.

- if you have low levels of sodium in your blood, as this may occur as a result of treatment with Sertraline Accord 50 mg film-coated tablets. You should also tell your doctor if you are taking certain medicines to treat high blood pressure, as these medicines can also change the levels of sodium in the blood.

- if you are an elderly patient as you are at higher risk of low levels of sodium in your blood.

- if you have liver disease: your doctor may decide that you should take a lower dose of Sertraline Accord 50 mg film-coated tablet.

- if you have diabetes: your blood sugar levels may be changed as a result of Sertraline Accord 50 mg film-coated tablets. Your diabetes medicines may need to be adjusted.

- if you have suffered from bleeding disorders or have taken medicines that thin the blood (e.g. acetylsalicylic acid or warfarin), which may increase the risk of bleeding.

- if you are a child or a young person under the age of 18. "Sertralin_50 mg_Filmtablette" should only be used in children and adolescents between 6 and 17 years of age for the treatment of obsessive-compulsive disorder. If you are being treated for this disease your doctor will want to monitor you closely (see "Children and adolescents" below).

- if you are receiving electroconvulsive therapy (ECT).

- if you have eye problems such as certain types of glaucoma (increased pressure in the eye).

- if you have been told by your doctor that your electrocardiogram (EKG) shows an abnormal heart curve, also called a prolonged QT interval.

- If you have heart disease, low levels of potassium or magnesium, a family history of prolonged QT interval, low heart rate, or are using medicines that prolong the QT interval at the same time.

- Psychomotor restlessness / akathisia

The use of sertraline has been associated with agonizing agitation and the urge to move, often with an inability to sit or stand still (akathisia). This is most likely to happen during the first few weeks of treatment. Increasing the dose can be harmful so speak to your doctor if you experience these symptoms.

- withdrawal reactions

When treatment is stopped, side effects (withdrawal reactions) are common, especially if treatment is stopped suddenly. The risk of withdrawal reactions depends on the duration of treatment, the dose and the speed at which the dose is reduced. In general, these symptoms are mild to moderate, but they can be severe in some patients. They usually appear within the first few days after stopping treatment. These symptoms usually resolve on their own and subside within 2 weeks. In some people, they can last longer (2 to 3 months or more). It is therefore recommended that when stopping treatment with sertraline, the dose is gradually reduced over a period of several weeks or months. In any case, you should discuss with your doctor how best to end treatment.

- Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and / or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These thoughts may be aggravated the first time you use antidepressants because all of these medicines take time to work, usually about 2 weeks, sometimes longer.

Such thoughts are more likely to occur

- if you have had thoughts of killing yourself or harming yourself in the past.

- if you are a young adult. Results from clinical trials have shown an increased risk of suicidal behavior in young adults aged 25 and under who have had a psychiatric illness and have been treated with an antidepressant.

Contact your doctor or go to a hospital straight away if you have thoughts of harming or killing yourself at any time. It can be helpful to tell a friend or relative that you are depressed or have an anxiety disorder. Ask them to read the package insert. Ask them to let you know if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

- Sexual problems

Medicines such as Sertraline Accord 50 mg film-coated tablets (called SSRIs) can cause symptoms of sexual dysfunction. In certain cases these symptoms persisted after treatment was stopped.

- Impairment of urine tests

False positive test results for benzodiazepines have been reported in urine immunoassays in patients taking sertraline. The reason for this is the lack of specificity of the immunoassays. Such false-positive test results can be expected for several days after discontinuing sertraline therapy. Confirmatory examinations such as gas chromatography / mass spectrometry differentiate between sertraline and benzodiazepines.

- angle-closure glaucoma

SSRIs, including sertraline, can affect pupil size, resulting in mydriasis. Especially in predisposed patients, this mydriatic effect can narrow the corner of the eye, which can increase intraocular pressure and develop narrow-angle glaucoma. Therefore, caution should be exercised in patients with a history of narrow-angle glaucoma or a history of glaucoma.

Important information about certain other ingredients: Please only take Sertraline Accord 50 mg film-coated tablets after consulting your doctor if you know that you suffer from an intolerance to certain ingredients of this medicinal product.

2.2.a) Children

Sertraline Accord 50 mg film-coated tablets should normally not be used in children and adolescents under 18 years of age, with the exception of patients with obsessive-compulsive disorder. You should also know that patients under the age of 18 have an increased risk of side effects such as attempting suicide, thoughts of harming or committing suicide (suicidal thoughts), and hostility (predominantly aggressiveness, oppositional behavior and anger) when they take this class of medicines ) exhibit.

However, your doctor may prescribe "Sertraline_50 mg_Filmtablette" for a patient under the age of 18 if he decides that this medicine is in the best interests of the patient. If you are under 18 years of age and your doctor has prescribed Sertraline Accord 50 mg film-coated tablets for you and you want to discuss this, please go back to your doctor. You should also notify your doctor if you develop or worsen any of the symptoms listed above while taking Sertraline Accord 50 mg film-coated tablets. In addition, the long-term safety-relevant effects of "Sertraline_50 mg_Filmtablette" in terms of growth, maturation and learning ability (cognitive development) as well as behavioral development in this age group have not yet been proven.

2.2.b) Elderly patients

If you are an elderly patient, you are at greater risk of having low levels of sodium in your blood. Therefore, the dosage should be done carefully.

2.2.c) Pregnancy

Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant.

There are insufficient data on the safety of sertraline in pregnant women. Sertraline will only be given to you during pregnancy if, in the judgment of your doctor, the benefit to you is greater than the possible risk to the unborn child. Medicines such as Sertraline Accord 50 mg film-coated tablets, when taken during pregnancy, especially in the last 3 months of pregnancy, can lead to a serious health impairment of the newborn, which is called primary or persistent pulmonary hypertension of the newborn (PPHN) This shows that the newborn is breathing faster and that the skin is blue. These symptoms usually begin during the first 24 hours after giving birth. In such a case, please inform your midwife and / or doctor immediately.

Your newborn child may have other impairments, which usually begin during the first 24 hours after it is born. The symptoms are:

- breathing problems,

- Blue discoloration of the skin, overheating or hypothermia,

- blue lips,

- vomiting or feeding problems,

- severe tiredness, difficulty falling asleep or constant screaming,

- stiff or slack muscles,

Tremors or seizures

- increased reflexes,

- irritability,

- low blood sugar levels.

If your child has any of these symptoms after it is born, or if you are concerned for your child's health, tell your doctor or midwife. They will advise you.

2.2.d) Breastfeeding

The available data show that sertraline is excreted in breast milk. Sertraline should only be used by breastfeeding women if, in the judgment of the doctor, the benefit outweighs the potential risk to the infant.

Studies in animals have shown that some medicines that are similar to sertraline can affect the quality of sperm. Theoretically, this could affect fertility, but no effect on fertility in humans has been observed so far.

2.2.e) Ability to drive and use machines

Psychotropic drugs such as sertraline can affect your ability to drive and use machines. You should therefore only drive or use machines if you know how this medicine affects your ability to carry out these activities.

2.3 Which interactions with other medicinal products have to be considered?

Some medicines can affect the way Sertraline Accord 50 mg film-coated tablets work, or Sertraline Accord 50 mg film-coated tablets itself can make other medicines less effective when used at the same time. Simultaneous use of Sertraline Accord 50 mg film-coated tablets and the following medicines can cause serious side effects:

- Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression) and selegiline (used to treat Parkinson's disease), the antibiotic linezolid or methylene blue (used to treat high levels of methaemoglobin in the blood) . Sertraline Accord 50 mg film-coated tablets must not be used together with these medicines.

- Medicines used to treat psychiatric illnesses such as psychosis (pimozide). Sertraline Accord 50 mg film-coated tablets must not be used together with pimozide.

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

- Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder [ADHD], sleeping sickness and obesity)

- herbal medicines containing St. John's wort (Hypericum perforatum). The effects of St. John's wort can last for 1 to 2 weeks.

- Medicines that contain the amino acid tryptophan

- medicines used to treat severe pain (e.g. tramadol)

- Medicines used as anesthetics or to treat chronic pain (e.g. fentanyl, mivacurium and suxamethonium)

- Medicines used to treat migraines (e.g. sumatriptan)

- medicines to thin the blood (warfarin)

- Medicines to treat pain / arthritis (non-steroidal anti-inflammatory drugs [NSAIDs] such as ibuprofen, acetylsalicylic acid [aspirin])

Sedatives (diazepam)

- diuretics (so-called "water tablets")

- medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine)

- Medicines used to treat diabetes (tolbutamide)

- Medicines to treat excess stomach acid, ulcers and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole)

- medicines used to treat mania and depression (lithium)

- other medicines used to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine)

- Medicines used to treat schizophrenia and other psychiatric conditions (such as perphenazine, levomepromazine and olanzapine)

- Medicines to treat high blood pressure, chest pain and to regulate the heartbeat rate and rhythm (e.g. verapamil, diltiazem, flecainide, propafenone)

- Medicines to treat bacterial infections (e.g. rifampicin, clarithromycin, telithromycin, erythromycin)

- Medicines to treat fungal infections (e.g. ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole)

- Medicines to treat HIV / AIDS and hepatitis C (protease inhibitors such as ritonavir, telaprevir)

- Medicines to prevent nausea and vomiting after surgery or chemotherapy (e.g. aprepitant)

- Medicines known to increase the risk of changes in the electrical activity of the heart muscle (e.g. antipsychotics and antibiotics).

2.4 What should be taken into consideration when taking Sertraline Accord 50 mg film-coated tablets with food, beverages and tobacco?

Alcohol should be avoided while taking Sertraline Accord 50 mg film-coated tablets.

Taking sertraline with grapefruit juice is not recommended.

3. How to take Sertraline Accord 50 mg film-coated tablets

Always take Sertraline Accord 50 mg film-coated tablets exactly as your doctor has told you. Please ask your doctor or pharmacist if you are not sure.

3.1 Nature and duration of ingestion

Sertraline Accord 50 mg film-coated tablets can be taken between or with meals. Take Sertraline Accord 50 mg film-coated tablets once a day in the morning or in the evening.

Tablets are swallowed whole with sufficient liquid.

Your doctor will tell you how long you will take this medicine. This will depend on the type of illness you have and how well you respond to treatment. It can take several weeks for your symptoms to improve. Treatment for depression should usually be continued for 6 months after the symptoms have improved.

3.2 Unless otherwise prescribed by the doctor, the usual dose is

3.2.a) Initial treatment

3.2.a.1.Depression and Obsessive Compulsive Disorder

Sertraline treatment should be started with an initial dose of 50 mg / day.

3.2.b) Panic Disorder, PTSD, and Social Anxiety Disorder

Therapy should be initiated at 25 mg / day and the dose increased to 50 mg once daily after 1 week. This dose regimen reduced the incidence of the side effects typically associated with panic disorder early in treatment.

Titration

Depression, obsessive-compulsive disorder, panic disorder, social anxiety disorder, and PTSD: dose increases may be of benefit in patients who do not respond to a 50 mg dose. Dose changes should be made in 50 mg increments at intervals of at least 1 week up to a maximum daily dose of 200 mg. Because of the 24-hour elimination half-life of sertraline, dose changes should not be made more than once a week.

The therapeutic effect can occur within 7 days. However, a therapeutic response can usually only be demonstrated after a long period of time. This is especially true for obsessive-compulsive disorder.

3.2.c) Maintenance therapy

The lowest effective dose should be used during long-term treatment. During the course of treatment, the dose may need to be adjusted based on the patient's therapeutic response.

3.2.c.1.Depression

Long-term treatment can also be suitable for preventing recurrence of major depression (MDE) episodes. In most cases, the dose recommended for preventing recurrence of episodes of major depression is the same as that used during the acute episode. Depressed patients should be treated for a sufficient period of at least 6 months to ensure that they are symptom-free.

3.2.c.2.Panic disorder and obsessive-compulsive disorder

The continuation of treatment in panic disorder and obsessive-compulsive disorder should be checked at regular intervals, as relapse prophylaxis has not been proven for these diseases.

3.2.d) Elderly patients

Dosage should be used cautiously in elderly patients as they are at greater risk of developing hyponatremia.

3.2.e) Patients with impaired liver function

Caution should be exercised when using sertraline in patients with liver disease. If the liver is not functioning properly, a lower dose should be selected or the doses should be administered at longer intervals. Sertraline should not be used in severe hepatic impairment as no clinical data are available.

3.2.f) Patients with impaired renal function

No dose adjustment is required in patients with impaired renal function.

3.2.g) Children and adolescents

3.2.g.1.Children and adolescents with obsessive-compulsive disorder

13 to 17 years: Initially 50 mg once daily.

6 to 12 years: Initially 25 mg once a day. After 1 week, the dosage can be increased to 50 mg once a day.

If the response is inadequate, the further doses can be increased as required over a period of several weeks in steps of 50 mg each. The maximum daily dose is 200 mg. When increasing the dose to over 50 mg, however, the generally lower body weight of children compared to adults should be taken into account. There should be an interval of at least 1 week between the individual dose changes.

Its effectiveness in treating major depressive episodes in children has not been established.

No data are available for children under 6 years of age.

3.3 If you take more Sertraline Accord 50 mg film-coated tablets than you should

Contact your doctor immediately or go to the emergency department of the nearest hospital! Always take the medicine pack with you, regardless of whether there is anything left of the contents or not. Symptoms of overdose include: Light-headedness, nausea and vomiting, rapid heartbeat, tremors, agitation, dizziness and, in rare cases, loss of consciousness.

3.4 If you forget to take Sertraline Accord 50 mg film-coated tablets

Do not take the missed dose to make up for a forgotten dose. Just take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

3.5 Effects if treatment with Sertraline Accord 50 mg film-coated tablets is stopped

Do not stop taking Sertraline Accord 50 mg film-coated tablets until your doctor tells you to. Your doctor will gradually reduce your dose of Sertraline Accord 50 mg film-coated tablet over a period of several weeks before you finally stop taking this medicine. Suddenly stopping treatment can cause side effects such as dizziness, abnormal sensation, difficulty sleeping, agitation or anxiety, headache, nausea, vomiting, and tremors.

If you suddenly stop taking this medicine you may experience side effects such as dizziness, abnormal sensation, difficulty sleeping, agitation or anxiety, headache, nausea, vomiting and tremors. Please talk to your doctor if you experience these or any other side effects when you stop taking Sertraline Accord 50 mg film-coated tablets.

4. What are the possible side effects?

Like all medicines, Sertraline Accord 50 mg film-coated tablets can cause side effects, although not everybody gets them.

When evaluating side effects, the following frequencies are used as a basis:

- very common: more than 1 in 10 people

- common: less than 1 in 10, but more than 1 in 100 patients

- uncommon: less than 1 in 100, but more than 1 in 1,000 patients

- rarely: less than 1 in 1,000 but more than 1 in 10,000 people treated

- very rare: less than 1 in 10,000 patients, including isolated cases

- Frequency not known: frequency cannot be calculated from the available data

4.1 Which side effects can occur in detail?

Nausea is reported as the most common side effect. The side effects are dose-dependent. They often go away or get better with continued treatment. Notify your doctor immediately:

If you get any of the following symptoms after taking this medicine, it could be serious.

- If you develop a severe rash with blistering (erythema multiforme) (this may affect the mouth and tongue). This could be a sign of a condition known as Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN). In this case your doctor will stop the treatment.

- Allergic reaction or allergy that may include symptoms such as an itchy rash, difficulty breathing, wheezing, swollen eyelids, face or lips.

- If you experience agitation, confusion, diarrhea, high body temperature and blood pressure, excessive sweating and rapid heartbeat. These are symptoms of what is known as serotonin syndrome. In rare cases, this syndrome can occur if you use certain other medicines at the same time as sertraline. Your doctor may then order that your treatment be stopped.

- If your skin and eyes turn yellow, which may indicate liver damage.

- If you develop depression with thoughts of harming or killing yourself (thoughts of suicide).

- If you start to feel restless and cannot sit or stand still after taking. You should tell your doctor if you start feeling restless.

- If you have a fit (seizure).

- If you are currently suffering from a manic episode.

The following side effects have been observed in adult clinical trials and in the post-marketing setting:

4.1.a) Very common

- Insomnia, dizziness, drowsiness, headache, diarrhea, nausea, dry mouth, lack of ejaculation, tiredness

4.1.b) Often

- cold, sore throat, runny nose,

- loss of appetite, increased appetite,

- Anxiety, depression, agitation, decreased sexual interest, nervousness, feeling strange to yourself, nightmares, grinding of teeth,

- tremors, muscle movement problems (such as excessive movement, tense muscles, difficulty walking and stiffness, cramps and involuntary muscle movements), decreased sensitivity to touch stimuli, tingling, tense muscles, lack of attention, altered taste,

- visual disturbances,

- ringing in the ears,

- palpitations,

- hot flush,

- yawn,

- upset stomach, constipation, abdominal pain, vomiting, gas,

- increased sweating, skin rash,

- back pain, joint pain, muscle pain,

- menstrual disorders, erectile dysfunction,

- malaise, chest pain, weakness, fever,

- weight gain,

- injury.

4.1.c) Occasionally

- gastrointestinal inflammation, ear infection,

- tumor,

- hypersensitivity, seasonal allergy,

- low thyroid hormones,

- Thoughts of suicide, suicidal behavior, psychotic disorder, disturbed thinking, indifference, hallucination, aggressiveness, excessive happiness, paranoia,

- Amnesia, decreased sensation, involuntary muscle contractions, fainting, excessive movement activity, migraines, seizures, dizziness when standing up, changed coordination, speech disorder,

- dilated pupils,

- earache,

- fast heartbeat, heart problem,

- bleeding problems (such as stomach bleeding) *, high blood pressure, flushing, blood in the urine,

Shortness of breath, nosebleed, difficulty breathing, wheezing,

- tarry stools, dental disease, inflammation of the esophagus, tongue problem, hemorrhoids, increased salivation, difficulty swallowing, belching, tongue disease,

- Eye swelling, hives, hair loss, itching, reddish-purple spots on the skin, blistering skin problem, dry skin, facial edema, cold sweat,

Osteoarthritis, muscle twitching, muscle cramps *, muscle weakness,

- Increase in the frequency of urination, urination disorder, inability to empty the bladder, urinary incontinence, increased urination, urination at night,

- sexual dysfunction, excessive vaginal bleeding, vaginal bleeding, sexual dysfunction in women,

Swelling of the legs, chills, difficulty walking, thirst,

- increased liver enzymes, weight loss.

- Cases of suicidal thoughts and behavior have been reported with or shortly after treatment with sertraline.

4.1.d) Rarely

Diverticulitis, swollen lymph glands, decrease in blood clotting cells, decrease in white blood cells,

- severe allergic reaction,

- endocrine problems,

- high cholesterol, problems controlling blood sugar levels (diabetes), low blood sugar, increased blood sugar levels, low blood salts,

- physical symptoms related to stress or emotions, unusual frightening dreams, drug addiction, sleepwalking, premature ejaculation,

Coma, abnormal movements, difficulty moving, increased sensation, sudden severe headache (which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome [RCVS]), abnormal sensation,

- spots in front of the eyes, glaucoma, double vision, sensitivity to light, blood in the eye, unequal size of pupils *, abnormal vision, tear disorder,

- Heart attack, light-headedness, fainting, or chest discomfort which may be signs of changes in electrical activity (seen on an electrocardiogram) or an abnormal heart rhythm, slow heartbeat

- poor blood circulation in the arms and legs,

- fast breathing, progressive scarring of the lung tissue (interstitial lung disease), tightness in the throat, difficulty speaking, slow breathing, hiccups,

- mouth ulcers, pancreatitis, blood in stool, tongue ulcer, sore mouth,

- liver problems, severe liver problems, yellowing of the skin and eyes (jaundice),

- skin reaction to sunlight, skin edema, changes in hair structure, changes in skin smell, rash in the scalp area,

- breakdown of muscle tissue, bone disease,

- delayed urination, decreased urination,

- Discharge from the mammary gland, dry vaginal area, vaginal discharge, red painful penis and foreskin, breast enlargement, prolonged erection,

- hernia, impaired drug tolerance,

- increased cholesterol levels in the blood, abnormal laboratory values, changes in semen, coagulation disorders,

- vasodilatation.

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

- masticatory muscle spasm,

- bed wetting,

- partial loss of vision.

- (Source: AkdÄ Drug Safety Mail / 2020 to 46) Microscopic colitis.

4.1.e) Additional side effects in children and adolescents

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

An increased risk of bone fractures has been observed in patients treated with this group of medicines.

4.2 What countermeasures should be taken if side effects occur?

Let your doctor know if you experience any side effects. He will decide on possible measures.

If you have a sudden or severe side effect, inform a doctor immediately, as certain drug side effects (e.g. excessive drop in blood pressure, hypersensitivity reactions) can have serious consequences under certain circumstances. In such cases, do not continue to take the medicine without doctor's advice.

Tell your doctor or pharmacist if you notice any side effects not listed here or in the package insert. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sertraline Accord 50 mg film-coated tablets

Store Sertraline Accord 50 mg film-coated tablets at normal room temperature and keep the medicine in the original package, away from light and moisture.

Medicines should generally be kept out of the reach of children.

Do not use the medicine after the expiry date stated on the pack.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer need. This measure helps to protect the environment.

6. Source and processing status

Information from the SCHOLZ database based on the data approved by the Federal Office for Drugs and Medical Devices

Copyright by ePrax GmbH, Munich; July 2020 (4)