TATIG 20 mg /Ml Оральный Раствор Концентрат

Содержание инструкции

1. Tatig 50 mg film-coated tablets, 100 mg film-coated tablets, 20 mg/ml oral solution concentrate
   1. What Tatig is and what it is used for
   2. What you need to know before taking Tatig
   3. How to take Tatig
   4. Possible side effects
   5. How to store Tatig
   6. Package contents and other information

Tatig 50 mg film-coated tablets, 100 mg film-coated tablets, 20 mg/ml oral solution concentrate

Sertraline

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Tatig is and what it is used for
• 2. What you need to know before you take Tatig
• 3. How to take Tatig
• 4. Possible side effects
• 5. How to store Tatig
• 6. Contents of the pack and other information

1. What Tatig is and what it is used for

Tatig 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.

Tatig can be used to treat the following conditions:

• Depression and prevention of depressive relapse (in adults).
• Social anxiety disorder (in adults).
• Post-traumatic stress disorder (PTSD) (in adults).
• Panic disorder (in adults).
• Obsessive-compulsive disorder (OCD) (in adults and in 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 usual.
OCD and panic disorder are illnesses related to anxiety with symptoms such as being
constantly worried by persistent thoughts (obsessions) which make them perform ritual actions
(compulsions).
PTSD is a condition that can occur after an emotionally strong traumatic experience and
some symptoms of this condition are similar to depression and anxiety. Social anxiety disorder
(social phobia) is an illness related to anxiety. It is characterised by feelings of intense anxiety or
distress in social situations (e.g. speaking to strangers, speaking in public, eating or drinking in
the presence of other people or the worry of behaving embarrassingly).
Your doctor has decided that this medicine is suitable for treating your condition.
Ask your doctor if you are not sure why Tatig has been prescribed for you.

2. What you need to know before taking Tatig

Do not take Tatig:

• If you are allergic to sertraline or any of the other ingredients of this medicine (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 treatment with 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).
• If you are taking or have taken disulfiram in the last 2 weeks. Tatig concentrate for oral solution must not be used in combination with disulfiram or within 2 weeks of stopping treatment with disulfiram.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tatig.
Medicines are not always suitable for everyone. Tell your doctor before taking Tatig 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 experience 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 taking 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 Tatig. You should also tell 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 Tatig.
• If you suffer from diabetes: blood glucose levels may be altered due to treatment with Tatig and it may be necessary to adjust the dose of your diabetes medications.
• If you have a history of bleeding problems (tendency to develop bruises), or if you are pregnant (see Pregnancy, breastfeeding and fertility) or if you have taken medicines that make your 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. Tatig should only be used to treat children and adolescents between 6 and 17 years of age 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 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 heart tracing following an electrocardiogram (ECG) known as prolongation of the QT interval.
• If you have heart disease, have low levels of potassium or magnesium, have a family history of prolonged QT interval, slow heart rate and are taking medicines that prolong the QT interval at the same time.

Restlessness/Akathisia
The use of sertraline has been associated with distressing restlessness and a need to move, often
associated with the inability to sit or stay 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 in this case, talk to your doctor.

Drug discontinuation reaction
Adverse effects related to stopping treatment (discontinuation reactions) are
common, especially if treatment is stopped abruptly (see section 3 If
you stop taking Tatig 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 can be severe. They usually occur in the first few days after stopping
treatment. In general, these symptoms resolve 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 determine 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 take antidepressants for the first time, because
all these medicines take time to become effective, usually about 2 weeks but
sometimes even longer.

You are more likely to have these thoughts if:

• You have thought about killing yourself or harming yourself in the past.
• 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 a disorder

depression or anxiety disorder are worsening, or if they are concerned about changes
in your behavior.

Sexual problems:
Medicines such as Tatig (so-called selective serotonin reuptake inhibitors (SSRIs)) can
cause symptoms of sexual dysfunction (see section 4). In some cases, persistence of these symptoms has been observed after stopping treatment.

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, the doctor may decide to prescribe Tatig to a patient under the age of
18 if this is in the patient's best interest. If the doctor has prescribed Tatig to you and you are under
18 and want to talk to the doctor about this decision, please contact them. Also, if any
of the above symptoms occur or worsen when a patient under the age of 18
is being treated with Tatig, you should tell your doctor.
The long-term safety of Tatig on growth, maturation, learning ability (cognitive development) and behavioral development has been assessed in a long-term study conducted on
more than 900 children aged 6 to 16 who were monitored for a period of 3 years.
Overall, the results of the study showed that children treated with sertraline have
had normal development, except for a slight weight gain in those who have been
treated with a higher dose.
Tatig concentrate for oral solution contains alcohol (ethanol) and may have effects on young children
(see “Tatig contains alcohol (ethanol)”).

Other medicines and Tatig
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription.
Some medicines can affect the activity of Tatig or Tatig can reduce the effectiveness of other
medicines taken at the same time.

Taking Tatig with the following medicines can cause serious adverse events:

• 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 Tatig with these medicines.
• Medicines for the treatment of mental disorders such as psychosis (pimozide). Do not use Tatig with pimozide.
• Do not use Tatig concentrate for oral solution with disulfiram.

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

• Medicines containing amphetamines (used to treat attention deficit-hyperactivity disorder (ADHD), narcolepsy and obesity).
• 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 or chronic pain (opioids e.g. tramadol, fentanyl).
• Medicines used in anesthesia (e.g. fentanyl, mivacurium and suxamethonium).
• 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 for the treatment of high blood pressure, chest pain or to regulate the heart rate and rhythm (such as verapamil, diltiazem, flecainide and propafenone).
• Medicines used for the treatment of bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
• Medicines used for the treatment of fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
• Medicines used for the treatment of 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. some antipsychotics and antibiotics).

Tatig with food, drinks and alcohol:
Tatig tablets can be taken with or without food.
Tatig concentrate for oral solution can be taken with or without food.
Consumption of alcohol should be avoided during treatment with Tatig.
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. The
sertraline should be administered to pregnant women only if the doctor believes that the benefit
for the mother outweighs any possible risk to the development of the child.
If you take Tatig near the end of pregnancy, there may be an increased risk of
heavy vaginal bleeding shortly after delivery, especially if you suffer from bleeding disorders (easy bruising). Inform your treating doctor or midwife/obstetrician that you are
taking Tatig, so they can advise you on what to do.
When taken during pregnancy, especially during the last three months, medicines like Tatig
may increase the risk of a serious condition in newborns called persistent pulmonary hypertension in the newborn (PPHN). This condition causes the newborn to have fast breathing and a
bluish skin color. These symptoms usually begin within the first 24 hours after delivery. If this happens to
your child, contact the midwife and/or doctor immediately.
Tatig concentrated oral solution contains alcohol (ethanol). If you are pregnant, ask
your doctor or pharmacist for advice before taking this medicine.
Your baby may also experience other conditions, which generally begin within the first 24 hours
after delivery.
The 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 newborn shows any of the above symptoms, or if you have any doubts
about your baby's health, contact the doctor or midwife who will be able to advise you.
There is evidence that sertraline is excreted in human breast milk. Sertraline should be
used during breastfeeding only if the doctor believes that the benefit for the mother outweighs any
possible risk to the child.
Tatig concentrated oral solution contains alcohol (ethanol). If you are breastfeeding with breast milk,
ask your doctor or pharmacist for advice before taking this medicine.
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 like 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.

Tatig contains sodium
Tatig 50 mg and 100 mg film-coated tablets contains less than 1 mmol (23 mg) of sodium per
tablet, i.e. essentially ‘sodium-free’.

Tatig contains alcohol (ethanol)
Each 25 mg (1.25 ml) of Tatig concentrated oral solution contains 181 mg of anhydrous ethanol, which
is equivalent to less than 5 ml of beer or 2 ml of wine.
Each 50 mg (2.5 ml) of Tatig concentrated oral solution contains 362 mg of anhydrous ethanol, which is
equivalent to less than 10 ml of beer or 4 ml of wine.
Each 200 mg (10 ml) of Tatig concentrated oral solution contains 1447 mg of anhydrous ethanol,
which is equivalent to less than 37 ml of beer or 15 ml of wine.
The amount of ethanol in this medicine is unlikely to have an effect on adults and adolescents and its
effects in children are not evident. Some effects may occur in small children, for
example feeling sleepy.
If you have an alcohol dependence, talk to your doctor or pharmacist before taking this
medicine.
The amount of alcohol in this medicine may alter the effects of other medicines. Talk to your doctor
or pharmacist if you are taking other medicines.

Tatig contains glycerol
At high doses it can cause headache, abdominal pain and diarrhoea.
The container of this medicine contains latex rubber. It may cause serious allergic reactions.

3. How to take Tatig

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have 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 (2.5 ml) 50 mg/day. The daily dose
may be increased by (2.5 ml) 50 mg and at intervals of at least one week over
several weeks. The maximum recommended dose is (10 ml) 200 mg/day.

Panic Disorder, Social Anxiety Disorder and Post-Traumatic Stress
Disorder:
For panic disorder, social anxiety and post-traumatic stress disorder, treatment should begin at a dose of (1.25 ml) 25 mg/day, then be increased to (2.5
ml) 50 mg/day after one week.
The daily dose may then be increased by (2.5 ml) 50 mg over several
weeks. The maximum recommended dose is (10 ml) 200 mg/day.

Use in children and adolescents:
Tatig 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 (1.25 ml) 25 mg/day.
After one week, the doctor may increase the dose to (2.5 ml) 50 mg/day. The maximum
dose is (10 ml) 200 mg/day.

Adolescents aged 13-17 years:The recommended starting dose is (2.5 ml) 50 mg/day. The maximum
dose is (10 ml) 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:
Tatig tablets can be taken with or without food.
Tatig oral solution concentrate 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. Several weeks may be necessary before
symptoms begin to improve. Treatment for depression should usually continue for 6
months from when improvement is observed.

Instructions for correct use of Tatig:
The oral solution concentrate must always be diluted before use. Never drink the
concentrate without first diluting it.
When opening the concentrate bottle for the first time, you must position the dropper
on the bottle as follows:

• 1. Unscrew the cap on the bottle by pushing hard on the cap and turning it simultaneously to the left (counterclockwise). Remove the cap.
• 2. Position the dropper on the bottle and close tightly. The dropper is inside the packaging.
• 3. When subsequently opening the bottle, push firmly down while simultaneously turning the dropper to the left (counterclockwise).
• 4. Replace the dropper on the bottle after use.

Dose measurement:
Use the dropper to measure the dose, as prescribed by your doctor.
Mix the measured dose with 120 ml (a glass) of liquid, which may be water, lemon soda,
lemonade and orange juice.
Do not mix the sertraline oral solution concentrate with other liquids other than those
listed. The solution should be taken immediately after dilution. The solution may
appear cloudy, but this is normal.

If you take more Tatig than you should:
If you accidentally take an excessive dose of Tatig, 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 Tatig:
Do not take a double dose to make up for a missed dose. If you forget to take
a dose, do not take the missed dose. Take the next dose at the right time.

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

4. Possible side effects

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

Tell your doctor immediately:
If you experience any of the following symptoms after taking this medicine, these
symptoms may be serious.

• If you develop a severe skin rash that causes blistering (erythema multiforme) (may affect the mouth and tongue). These may be signs of a condition known as Stevens Johnson Syndrome or Toxic Epidermal Necrolysis. In these cases, your doctor will stop treatment.
• Allergic reactions or allergies, which may include symptoms such as an itchy rash, breathing problems, wheezing, swelling of eyelids, face or lips.
• If you experience agitation, confusion, diarrhea, high fever and high blood pressure, excessive sweating and a fast heartbeat. These are the symptoms of Serotonin Syndrome. In rare cases, this syndrome can occur when taking certain medicines together with sertraline. Your doctor may want to stop treatment.
• If you develop a yellowing of the skin and eyes, which may be indicative of liver damage.
• If you develop depressive symptoms with thoughts of harming yourself or committing suicide (suicidal thoughts).
• If you start to feel restless and are unable to sit still or remain calm after starting treatment with Tatig. You should tell your doctor if you start to feel restless.
• If you have convulsions.
• If you experience a manic episode (see section 2 “Warnings and precautions”).

The following side effects have been observed in clinical studies conducted in adult patients and after
marketing authorization:

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

• Insomnia, dizziness, drowsiness, headache, diarrhea, feeling unwell, dry mouth, absence of ejaculation, fatigue.

Common (may affect up to 1 in 10 people):

• bronchitis, sore throat, runny nose,
• decreased appetite, increased appetite,
• anxiety, depression, agitation, decreased libido, nervousness, feeling strange, nightmares, teeth grinding,
• tremor, movement disorders (such as frequent movements, tense muscles, difficulty walking and stiffness, spasms and involuntary muscle movements), numbness and tingling, muscle tension, lack of attention, altered taste,
• vision disturbances,
• ringing in the ears,
• palpitations,
• hot flushes,
• yawning,
• stomach discomfort, constipation, abdominal pain, vomiting, gas in the stomach,
• increased sweating, rash,
• back pain, joint pain, muscle pain,
• irregular menstrual periods, erectile dysfunction,
• feeling unwell, chest pain, weakness, fever,
• weight gain,
• wounds.

Uncommon (may affect up to 1 in 100 people):

• problems with the intestines, ear infections,
• tumor,
• hypersensitivity, seasonal allergy,
• low levels of thyroid hormones,
• suicidal thoughts, suicidal behavior, psychotic disorders, abnormal thoughts, lack of self-care, hallucination, aggressiveness, euphoric mood, paranoia,
• amnesia, reduced sensations, involuntary muscle contractions, fainting, excessive movements, migraine, convulsions, dizziness when getting up, impaired coordination, speech disorders,
• pupil dilation,
• ear pain,
• fast heartbeat, heart problems,
• bleeding problems (such as stomach bleeding), high blood pressure, hot flushes, blood in urine,
• shortness of breath, nosebleeds, difficulty breathing, possible wheezing,
• tarry stools, dental problems, inflammation of the esophagus, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders,
• eye swelling, hives, hair loss, itching, formation of purple spots on the skin, skin problems with blister formation, dry skin, facial edema, cold sweats,
• osteoarthritis, muscle contractions, muscle cramps, muscle weakness,
• increased urinary frequency, problems with urination, inability to urinate, urinary incontinence, increased urine volume, nighttime urination,
• sexual dysfunction, excessive vaginal bleeding, vaginal hemorrhage, female sexual dysfunction,
• leg swelling, chills, difficulty walking, thirst,
• increased levels of liver enzymes, weight loss.
• Cases of suicidal ideation and suicidal behavior have been reported in patients treated with sertraline or shortly after discontinuation of treatment (see section 2).

Rare (may affect up to 1 in 1000 people):

• Diverticulitis, swollen glands, reduced number of cells responsible for blood clotting, reduced number of white blood cells,
• severe allergic reaction,
• endocrine problems,
• high levels of cholesterol, problems with controlling blood sugar (diabetes), low blood sugar levels, increased blood sugar levels, low sodium levels in the blood,
• physical symptoms due to stress or emotions, terrifying altered dreams, drug dependence, sleepwalking, premature ejaculation,
• coma, abnormal movements, difficulty moving, increased sensations, sudden severe headaches (which may be a sign of a serious condition known as Reversible Cerebral Vasoconstriction Syndrome (RCVS)), altered consciousness,
• spots in front of the eyes, glaucoma, double vision, light sensitivity, blood in the eye, unequal pupils, altered vision, problems with tear production,
• heart attack, feeling dizzy, fainting or chest pain, which may be signs of changes in the heart's electrical activity (as shown on an electrocardiogram) or irregular heartbeat, slowed heartbeat,
• poor blood circulation to the arms and legs,
• rapid breathing, progressive scarring of lung tissue (Interstitial Lung Disease), throat closure, difficulty speaking, slowed breathing, hiccups,
• mouth ulcers, pancreatitis, blood in the stool, tongue ulcers, mouth pain,
• liver dysfunction problems, severe liver dysfunction, yellowing of the skin and eyes (jaundice),
• skin reaction to sunlight, skin edema, altered skin odor, inflammation of hair follicles,
• muscle tissue rupture, bone disorders,
• initial difficulty urinating, reduced urination,
• breast secretion, vaginal dryness, genital discharge, red and painful penis and prepuce, enlarged breasts, prolonged erection,
• hernia, reduced tolerance to the medicine,
• increased cholesterol in the blood, altered laboratory results, altered semen, coagulation problems,
• procedure for relaxing blood vessels.

Not known: frequency cannot be estimated based on available data:

• jaw locking,
• enuresis,
• partial loss of vision,
• inflammation of the colon (causing diarrhea),
• heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), see Pregnancy, breastfeeding and fertility in section 2, for further information.

Side effect reported after marketing authorization.
Side effects in children and adolescents:
In clinical studies in children and adolescents, side effects were generally similar to
those observed in adults (see above). The most common side effects in children and
adolescents were headache, insomnia, diarrhea and nausea.

Symptoms that may occur when treatment is stopped:
If you suddenly stop taking this medicine, side effects such as dizziness, tingling, sleep
disturbances, agitation or anxiety, headache, nausea, vomiting and tremor may occur (see section 3 “If you stop taking Tatig”).
An increased risk of bone fractures has been observed in patients taking this type of medicine.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Tatig

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry
date refers to the last day of that month.
Tatig concentrate for oral solution:
Do not use this medicine more than 28 days after first opening the bottle.
Do not store at a temperature above 30°C
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tatig contains

Tatig film-coated tablets
Each film-coated tablet contains sertraline hydrochloride equivalent to 50 mg of sertraline
Each film-coated tablet contains sertraline hydrochloride equivalent to 100 mg of sertraline
The other excipients are:
Dihydrated calcium hydrogen phosphate (E341), Microcrystalline cellulose (E460), Hydroxypropylcellulose (E463),
Sodium starch glycolate (type A) (see paragraph 2 “Tatig contains sodium”), Magnesium stearate (E572),
Hypromellose 2910/3 mPas (E464), Hypromellose 2910/6 mPas (E464), Titanium dioxide (E171), Macrogol
400 (E1521), Macrogol 8000 (E1521) and Polysorbate 80 (E433).

Tatig 20 mg/ml concentrate for oral solution
Each ml of the concentrate contains 20 mg of sertraline (as hydrochloride).
The other excipients are: Glycerol (E422), ethanol (see paragraph 2 “Tatig contains alcohol
(ethanol) and Tatig contains glycerol”), levomenthol and butylhydroxytoluene (E321).

Description of the appearance of Tatig and contents of the pack

Tatig film-coated tablets
Tatig (sertraline) 50 mg film-coated tablets are white, capsule-shaped, divisible tablets
(10.3 x 4.2 mm) film-coated with “ZLT50” imprinted on one side and “Pfizer”
on the other. The tablets can be divided into equal parts.
Tatig (sertraline) 100 mg film-coated tablets are white, capsule-shaped tablets
(13.1 x 5.2 mm) film-coated with “ZLT100” imprinted on one side and “Pfizer” on the other .

Tatig 50 mg film-coated tablets
The tablets are packaged in blisters containing 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 98, 100, 200,
294, 300 or 500 tablets, and in blister strips containing 30x1 tablets.

Tatig 100 mg film-coated tablets
The tablets are packaged in blisters containing 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 98, 100, 200,
294, 300 or 500 tablets, and in blister strips containing 30x1 tablets.
Not all pack sizes may be marketed.

Tatig concentrate for oral solution:
Tatig 20 mg/ml concentrate for oral solution is a clear and colourless solution in a dark glass bottle
of 60 ml equipped with a graduated dropper.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milan

Manufacturer:

Tatig film-coated tablets
Haupt Pharma Latina S.r.l. - S.S. 156, Km 47,600 – Borgo San Michele, 04100 Latina
Pfizer Manufacturing Deutschland GmbH - Betriebsstätte Freiburg, Mooswaldallee 1, 79090 Freiburg
Germany

Tatig concentrate for oral solution
Pfizer Service Company BVBA - Hoge Wei 10, 1930 Zaventem (Belgium)
Farmasierra Manufacturing S.L. - Carretera de Irún, Km. 26.200, 28709 San Sebastián de los Reyes,
Madrid, Spain

This medicinal product is authorised in the member states of the European Economic Area and in the
United Kingdom (Northern Ireland) with the following names: