SERTRALINA 50 mg Film-Coated Tablets

Зміст інструкції

1. Sertraline
   1. Possible side effects

Sertraline

Generic medicine

Read this leaflet carefully before taking this medicine, as it contains important
information for you.

• If you have any questions, ask your doctor or pharmacist
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, because it could be dangerous
• If any undesirable effect occurs, including those not in this leaflet, ask your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What it is and what it is used for
• 2. What you need to know before you take it

Contents of the pack and other information
contains the active ingredient 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.

• Social anxiety disorder (in adults).
• Post-traumatic stress disorder (PTSD) (in adults).
• Panic disorder (in adults).
• Obsessive-compulsive disorder (OCD) (in adults and children and adolescents aged between 6 and 17 years).

Depression is a clinical illness with symptoms such as feeling sad, inability to sleep properly or to enjoy life as you used to.
OCD and panic disorder are illnesses related to anxiety with symptoms such as being
constantly worried about persistent thoughts (obsessions) that make you perform ritual actions
(compulsions).
PTSD is a condition that can occur after a traumatic emotional experience and some
symptoms of this condition are similar to depression and anxiety. Social anxiety disorder (social
phobia) is an anxiety-related illness. It is characterized by feelings of intense anxiety or distress in
social situations (e.g. talking to strangers, speaking in public, eating or drinking in the presence of others
or worrying about behaving embarrassingly).
Your doctor has decided that this medicine is suitable for treating your condition.
Ask your doctor if you are not sure why it has been prescribed for you

Do not take:

• sertraline or any of the other ingredients of SERTRALINA ALTER (listed in section 6).
• If you are taking or have taken medicines called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or medicines with an action similar to MAOIs (such as linezolid). If you stop taking sertraline, you must wait at least one week before starting treatment with an MAOI again. After stopping treatment with an MAOI, you must wait at least 2 weeks before starting treatment with sertraline. If you are taking another medicine called Pimozide (a medicine for mental disorders such as psychosis).

Warnings and precautions.
Talk to your doctor or pharmacist before taking SERTRALINA ALTER.
Medicines are not always suitable for everyone. Tell your doctor before taking if
you suffer or have suffered in the past from any of the following conditions:

• If you suffer from epilepsy (seizures) or a history of convulsions. If you have a seizure (convulsion), contact your doctor immediately.
• If you have suffered from manic-depressive disorder (bipolar disorder) or schizophrenia. If you have a manic episode, contact your doctor immediately.
• If you think you have or have ever thought about harming yourself or committing suicide (see below - Suicidal thoughts and worsening of depression or anxiety disorder).
• If you suffer from serotonin syndrome. In rare cases, this syndrome can occur when you take certain medicines together with sertraline (for symptoms, see section 4. Possible side effects). Your doctor will tell you if you have suffered from this condition in the past.
• If you have low levels of sodium in your blood, because this condition can occur as a result of treatment with and also inform your doctor if you are taking certain medicines for high blood pressure, because these medicines can also alter sodium levels in the blood.
• If you are elderly because you are at greater risk of low levels of sodium in the blood (see above).
• If you suffer from liver disease: your doctor may decide to prescribe you a lower dose of
• If you suffer from diabetes: blood glucose levels may be altered due to treatment with and it may be necessary to adjust the dose of your diabetes medications.
• If you have suffered from bleeding problems or if you have taken medicines that make the blood more fluid (e.g. acetylsalicylic acid (aspirin) or warfarin) or that can increase the risk of bleeding.
• Children or adolescents under the age of 18. should only be used to treat children and adolescents aged between 6 and 17 who suffer from obsessive-compulsive

disorder (OCD). If the child or adolescent is being treated for this disorder, the doctor will want to
monitor them carefully (see below Use in children and adolescents).

• If you are undergoing electroconvulsive therapy (ECT).
• If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
• If an abnormality has been found in your electrocardiogram (ECG)known as prolongation of the QT interval.

Restlessness/Akathisia
The use of sertraline has been associated with distressing restlessness and a need to move, often accompanied
by the inability to sit or stand still (akathisia). This condition is more likely to occur in the
early weeks of treatment. An increase in the dose may be harmful to patients who develop
these symptoms, so talk to your doctor in this case.

Drug discontinuation reaction
Adverse effects related to stopping treatment (discontinuation reactions) are common, in
particular if treatment is stopped abruptly (see section 3 If you stop taking SERTRALINA ALTER and section 4 Possible side effects). The risk of discontinuation reactions depends on the duration of treatment, the dosage and the extent of the dose reduction.
Generally these symptoms are mild to moderate in intensity; however, in some patients they may be
severe. They usually occur in the first few days after stopping treatment. In general
these symptoms disappear on their own within 2 weeks. In some patients they may have a longer duration
(2-3 months or more). When stopping treatment with sertraline, it is recommended to reduce the
dose gradually over a period of several weeks or months. Always talk to your doctor to establish
what is the best way to stop treatment.

Suicidal thoughts and worsening of depression or anxiety disorder:
If you are depressed and/or have anxiety disorders, you may sometimes think about harming yourself or committing suicide. These
thoughts may worsen when you start taking antidepressants for the first time, because all these
medicines take time to be effective, usually about 2 weeks but sometimes even longer.

You are more likely to have these thoughts if:

• You have previously thought about killing yourself or harming yourself.
• If you are a young adult. Information available from clinical studies has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric conditions treated with an antidepressant. If at any time you think about harming yourself or committing suicide, contact your doctor or go to the nearest hospital immediately. It may be helpful to tell a family member or close friend that you are depressed or have an anxiety disorder and

anxiety disorder are getting worse, or if they are concerned about changes in your behavior.

Use in children and adolescents:
Sertraline should not usually be used in children and adolescents under the age of 18
except for patients with Obsessive-Compulsive Disorder (OCD). Patients under the age of 18
have an increased risk of side effects, such as attempting suicide, thoughts of harming themselves or committing suicide (suicidal thoughts) and hostile behavior (mainly aggression,
oppositional behavior and anger) when treated with this class of medicines. However, it
is possible that the doctor may decide to prescribe to a patient under the age of 18
if this is in the patient's best interest. If the doctor has prescribed you 18 years
and you want to talk to the doctor about this decision, please contact them. In addition, if any of the
above symptoms occur
Finally, the long-term safety of on growth, maturation, learning ability (cognitive development) and behavioral development has not been
demonstrated in this age group.

Other medicines and SERTRALINA ALTER.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines..
Some medicines can influence the activity of

can cause serious adverse events with the following medicines:

• Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (for treating depression) and selegiline (for treating Parkinson's disease), the antibiotic linezolid and methylene blue (for treating high levels of methemoglobin in the blood). Do not use together with these medicines. Medicines for the treatment of mental disorders such as psychosis (pimozide). Do not use

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

• Herbal medicine containing St. John's Wort ( Hypericum perforatum). The effects of St. John's Wort can last for 1-2 weeks.
• Products containing the amino acid tryptophan.
• Medicines for the treatment of severe pain (e.g. tramadol).
• Medicines used in anesthesia or for the treatment of chronic pain (e.g. fentanyl).
• Medicines for the treatment of migraine (e.g. sumatriptan).
• Medicines for thinning the blood (warfarin).
• Medicines for the treatment of pain/arthritis (Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)).
• Sedatives (diazepam).
• Diuretics.
• Medicines for the treatment of epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines for the treatment of diabetes (tolbutamide).
• Medicines for the treatment of excess acid in the stomach, ulcers and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medicines for the treatment of mania and depression (lithium).
• Other medicines for the treatment of depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medicines for the treatment of 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 (such as verapamil, diltiazem, flecainide and 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. someantipsychotics and antibiotics).

SERTRALINA ALTER with food, drinks and alcohol:
The tablets of
.
Sertraline should not be taken in combination with grapefruit juice, as this may
increase the levels of sertraline in the body.

Pregnancy, breastfeeding and fertility:
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
The safety of sertraline has not been fully established in pregnant women. Sertraline
should only be administered to pregnant women if the doctor believes that the benefit to the mother
outweighs any possible risk to the development of the child. If you are a woman of childbearing age, you should use
a reliable method of contraception (such as a contraceptive pill) while being treated with
sertraline.
Make sure your midwife and/or doctor are aware that you are being treated with SERTRALINA ALTER.
When taken during pregnancy, especially during the last three months, medicines such as SERTRALINA
ALTER may increase the risk of a serious condition in newborns called persistent pulmonary hypertension in the newborn (PPHN). This condition causes rapid breathing and a bluish skin color in the newborn. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.
Your baby may also experience other conditions, which generally begin within the first 24 hours after
birth.
Symptoms include:

• difficulty breathing,
• bluish skin color or being too warm or too cold,
• blue lips,
• vomiting or difficulty feeding,
• being very tired, unable to sleep or crying a lot,
• stiff or floppy muscles,
• tremors, nervousness, jerks,
• increased reflex reactions,
• irritability,
• low blood sugar levels.

If your baby shows any of the above symptoms at birth, or if you have any doubts about the
health of your baby, contact your doctor or midwife who will be able to advise you.
There is evidence that sertraline is excreted in human breast milk. Sertraline should only be used
during breastfeeding if the doctor believes that the benefit to the mother outweighs any possible
risk to the baby.
In animal studies, some drugs like sertraline may reduce sperm quality. In theory this
may affect fertility, but the impact on human fertility has not yet been observed.

Driving and operating machinery:
Psychotropic medicines such as sertraline can affect the ability to drive vehicles and operate
machinery. Therefore, you should not drive vehicles or operate machinery until you have ascertained whether
this medicine alters your ability to perform these activities.
Take this medicine exactly as your doctor or pharmacist tells you.
If you have any doubts, consult your doctor or pharmacist.

The recommended dose is:
Adults:
Depression and Obsessive-Compulsive Disorder:
For depression and OCD, the usual effective dose is 50 mg/day. The daily dose may be increased
by

Panic Disorder, Social Anxiety Disorder and Post-Traumatic Stress Disorder:
For panic disorder, social anxiety and post-traumatic stress disorder, treatment should
start at a dose of 25 mg/day, then be increased to 50 mg/day after one week.
The daily dose can then be increased by
200 mg/day.

Children and adolescents:
should only be used for the treatment of children and adolescents with Obsessive-Compulsive Disorder (OCD) aged between 6 and 17 years.

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.
If you have liver or kidney problems, tell your doctor and follow the instructions given to you by your doctor.
Method of administration.
SERTRALINA ALTER tablets can be taken with or without food.
Take the medicine once a day, in the morning or evening.
Your doctor will tell you how long you will need to take this medicine. This will depend on the duration of the
illness and the response to treatment. It may take several weeks before symptoms
begin to improve. Treatment for depression should usually continue for 6 months from when you
see an improvement.

If you take more SERTRALINA ALTER than you should:
If you accidentally take an overdose of SERTRALINA ALTER, contact your doctor immediately or go to the
nearest emergency room. Always bring a package of the medicine with you, whether it contains medicine or not.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat,
tremors, agitation, dizziness and, in rare cases, loss of consciousness.

If you forget to take SERTRALINA ALTER:
Do not take a double dose to make up for forgotten doses. If you forget to take a dose,
do not take the forgotten dose. Take the next dose at the right time.

If you stop taking SERTRALINA ALTER:
Do not stop treatment with SERTRALINA ALTER unless your doctor has told you to. Your doctor
may want to gradually reduce the dose of SERTRALINA ALTER over several weeks, before
stopping use of this medicine completely. If you suddenly stop using this
medicine, side effects such as dizziness, numbness, sleep disturbances, may occur
agitation or anxiety, headache, nausea, vomiting and tremors. If you experience any of these effects
or other side effects during treatment with SERTRALINA ALTER, talk to your
doctor.
If you have any questions about the use of SERTRALINA ALTER, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everyone will experience them.
Do not
Laboratori ALTER