Background pattern
Sertralina Krka

Sertralina Krka

About the medicine

How to use Sertralina Krka

Package Leaflet: Information for the Patient

Sertraline Krka, 50 mg, Film-Coated Tablets

Sertraline Krka, 100 mg, Film-Coated Tablets

Sertraline

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

  • Keep this leaflet, as you may need to read it again.
  • In case of any doubts, consult a doctor or pharmacist.
  • This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
  • If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

  • 1. What is Sertraline Krka and what is it used for
  • 2. Important information before taking Sertraline Krka
  • 3. How to take Sertraline Krka
  • 4. Possible side effects
  • 5. How to store Sertraline Krka
  • 6. Contents of the pack and other information

1. What is Sertraline Krka and what is it used for

The active substance of Sertraline Krka is sertraline. Sertraline belongs to a group of medications called selective serotonin reuptake inhibitors (SSRIs); these medications are used to treat depression and/or anxiety disorders.

Sertraline Krka may be used to treat:

  • depression and prevention of depression 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, children, and adolescents aged 6-17 years).

Depression is a disease characterized by symptoms of sadness, difficulty sleeping, or loss of joy in life.
OCD and panic disorder are anxiety-related diseases with symptoms of persistent anxiety due to persistent thoughts (obsessions) that cause repetitive rituals (compulsive actions).
Post-traumatic stress disorder (PTSD) is a condition that may occur after a traumatic experience and is characterized by symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related disease. It is characterized by a feeling of intense anxiety or stress in social situations (such as talking to strangers, speaking in front of a group of people, eating or drinking in the presence of others, or worrying about potentially embarrassing behavior).
The doctor has decided that this medication is suitable for treating the patient's disease.
The patient should consult their doctor if they are unsure why they are taking Sertraline Krka.

2. Important information before taking Sertraline Krka

When not to take Sertraline Krka

  • If the patient is allergic to sertraline or any of the other ingredients of this medication (listed in section 6).
  • If the patient is taking or has taken monoamine oxidase inhibitors (MAOIs, e.g., selegiline, moclobemide) or medications similar to MAOIs (e.g., linezolid). After stopping sertraline treatment, the patient should wait at least one week before starting MAOI treatment. After stopping MAOI treatment, the patient should wait at least two weeks before starting sertraline treatment.
  • If the patient is taking pimozide (a medication used to treat mental disorders, such as psychoses).

Warnings and precautions

Before starting Sertraline Krka, the patient should discuss it with their doctor or pharmacist.
Not all medications are suitable for everyone. The patient should tell their doctor if they currently have or have had any of the following conditions:

  • Seizures (epilepsy) or a history of seizures. If a seizure occurs, the patient should contact their doctor immediately.
  • A history of manic-depressive illness (bipolar affective disorder) or schizophrenia. If a manic episode occurs, the patient should contact their doctor immediately.
  • A history of thoughts of self-harm or suicide (see below - "Suicidal thoughts, worsening depression, or anxiety").
  • Serotonin syndrome. In rare cases, this syndrome may occur in patients taking certain medications at the same time as sertraline (symptoms, see section 4 "Possible side effects"). The doctor should inform the patient if they have had serotonin syndrome in the past.
  • Low sodium levels in the blood, as this may occur due to Sertraline Krka treatment. The patient should also inform their doctor about taking certain medications used to treat high blood pressure, as they may also change sodium levels in the blood.
  • Elderly patients; they may be more susceptible to decreased sodium levels in the blood (see above).
  • Liver disease; the doctor may decide to reduce the dose of Sertraline Krka.
  • Diabetes; Sertraline Krka may affect blood sugar levels, so a change in the dosage of antidiabetic medications may be necessary.
  • Bleeding disorders or a history of taking blood-thinning medications [e.g., acetylsalicylic acid ("aspirin") or warfarin] or medications that may increase the risk of bleeding, or if the patient is pregnant (see "Pregnancy").
  • Children or adolescents under the age of 18. In the case of children and adolescents aged 6 to 17 years, Sertraline Krka can only be used to treat obsessive-compulsive disorder. Patients treated for this condition should be closely monitored by their doctor (see below - "Children and adolescents").
  • Electroconvulsive therapy (ECT).
  • Eye problems, such as certain types of glaucoma (increased eye pressure).
  • Heart rhythm disorders visible on an ECG, known as a prolonged QT interval.
  • Heart disease, low potassium or magnesium levels, a family history of prolonged QT interval, slow heart rate, and concurrent use of medications that prolong the QT interval.

Psychomotor restlessness (akathisia)

Sertraline treatment has been associated with the development of a condition characterized by psychomotor restlessness and a compulsion to perform movements - often with an inability to sit or stand still (akathisia). This condition usually occurs within the first few weeks of treatment. The patient should contact their doctor if they experience an increase in dose, as this may be harmful to patients with such symptoms.

Withdrawal symptoms

After stopping treatment, side effects (withdrawal symptoms) often occur, especially if treatment is stopped abruptly (see section 3 "Stopping Sertraline Krka treatment" and section 4 "Possible side effects"). The risk of withdrawal symptoms depends on the duration of treatment, dosage, and rate of dose reduction. These symptoms are usually mild or moderate, but in some patients, they can be severe. They usually occur within the first few weeks after stopping treatment. They usually resolve on their own within two weeks, but in some patients, they may persist for longer (2-3 months or longer). If the patient decides to stop sertraline treatment, it is recommended to gradually reduce the dose over several weeks or months and consult a doctor on the best way to stop treatment.

Suicidal thoughts, worsening depression, or anxiety

Patients with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such thoughts or behavior may worsen at the beginning of antidepressant treatment, as these medications usually start working after two weeks, sometimes later.

The likelihood of such thoughts is higher if:

  • the patient has had suicidal thoughts or self-harm in the past;
  • the patient is a young adult; clinical trial data indicate an increased risk of suicidal behavior in people under 25 years of age with mental disorders who were treated with antidepressants. If the patient experiences suicidal thoughts or self-harm, they should immediately contact their doctor or go to the hospital. It may be helpful to inform relatives or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask their relatives or friends for help and ask them to inform them if they notice that the depression or anxiety has worsened or if there are any worrying changes in behavior.

Sexual dysfunction

Medications like Sertraline Krka (SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was stopped.

Children and adolescents

Sertraline should not be used in children and adolescents under the age of 18, except for patients with obsessive-compulsive disorder. In patients under 18 years of age, there is an increased risk of side effects such as suicidal attempts, self-harm, or suicidal thoughts and hostility (mainly aggressive, defiant, and angry behavior) when using medications from this group. However, the doctor may decide to prescribe Sertraline Krka to a patient under 18 years of age if it is in the patient's best interest. If the doctor prescribes Sertraline Krka to a patient under 18 years of age and the child's caregiver wants to discuss this with the doctor, they should contact the doctor. Furthermore, if any of the above symptoms occur or worsen while taking Sertraline Krka, the doctor should be informed. Additionally, there is currently no data on the long-term safety of Sertraline Krka regarding its effects on growth, maturation, learning (cognitive function), and behavior.

Sertraline Krka and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
Some medications may affect how Sertraline Krka works or Sertraline Krka may reduce the effectiveness of other medications taken at the same time.

Taking Sertraline Krka with the following medications may cause serious side effects:

  • Monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression) and selegiline (used to treat Parkinson's disease), as well as the antibiotic linezolid and methylene blue (a substance used to treat high methemoglobin levels in the blood). Sertraline Krka should not be taken with these medications.
  • Medications used to treat mental disorders, such as psychoses (pimozide). Sertraline Krka should not be taken with pimozide.

The patient should inform their doctor about taking any of the following medications:

  • Medications containing amphetamine derivatives [used to treat attention deficit hyperactivity disorder (ADHD), excessive sleepiness, and obesity].
  • Herbal medications containing St. John's Wort (Hypericum perforatum). St. John's Wort may continue to work for 1 to 2 weeks.
  • Medications containing the amino acid tryptophan.
  • Medications used to treat severe pain (e.g., tramadol).
  • Buprenorphine, a medication used to treat pain or opioid addiction.
  • Medications used during anesthesia or to treat chronic pain (fentanyl, mivacurium, and suxamethonium).
  • Medications used to treat migraines (e.g., sumatriptan).
  • Blood-thinning medications (warfarin).
  • Medications used to treat pain and/or joint inflammation [non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen, acetylsalicylic acid ("aspirin")].
  • Sedatives (diazepam).
  • Diuretics.
  • Medications used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
  • Medications used to treat diabetes (tolbutamide).
  • Medications used to treat excessive stomach acid production, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
  • Medications used to treat mania and depression (lithium).
  • Other medications used to treat depression (e.g., amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
  • Medications used to treat schizophrenia and other mental disorders (e.g., perphenazine, levomepromazine, and olanzapine).
  • Medications used to treat high blood pressure, chest pain, or to regulate heart rate and rhythm (such as verapamil, diltiazem, flecainide, and propafenone).
  • Medications used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
  • Medications used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
  • Medications used to treat HIV/AIDS and hepatitis C (protease inhibitors, such as ritonavir, telaprevir).
  • Medications used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).
  • Medications that increase the risk of changes in heart electrical activity (e.g., antipsychotic medications and antibiotics).
  • Metamizole, a medication used to treat pain and fever.

Taking Sertraline Krka with food, drink, and alcohol

Sertraline Krka can be taken with or without food.
The patient should not drink alcohol while taking Sertraline Krka.
The patient should not take Sertraline Krka with grapefruit juice, as it may increase the levels of sertraline in the body.

Pregnancy, breastfeeding, and fertility

Pregnancy
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.
The safety of sertraline during pregnancy has not been fully established. Sertraline can be used in pregnant women only if the doctor believes that the benefits to the mother outweigh the potential risk to the developing child.
The patient should inform their doctor and/or midwife about taking Sertraline Krka. Medications like Sertraline Krka, taken during pregnancy, especially during the last three months of pregnancy, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN), which is characterized by rapid breathing and blue discoloration. These symptoms usually occur within the first day of life. If such symptoms occur in the newborn, the patient should immediately contact their doctor and/or midwife.
The newborn may also experience other symptoms, which usually occur within the first day of life. These symptoms include:

  • breathing difficulties,
  • blue discoloration of the skin, low or high body temperature,
  • blue lips,
  • vomiting or difficulty feeding,
  • excessive tiredness, insomnia, or frequent crying,
  • stiffness or floppiness of the muscles,
  • tremors, tremors, or seizures,
  • increased reflexes,
  • irritability,
  • low blood sugar levels.

If the newborn experiences any of these symptoms or if the patient is concerned about the child's health, they should contact the midwife or doctor.
Taking Sertraline Krka at the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Sertraline Krka, they should inform their doctor or midwife so that they can provide appropriate advice.
Breastfeeding
There is evidence that sertraline is excreted into human milk. Sertraline Krka can be used in breastfeeding women if the doctor believes that the benefits to the mother outweigh the risk to the child.
Fertility
Animal studies have shown that some medications, such as sertraline, may decrease sperm quality. This effect may theoretically limit fertility, although it has not been observed in humans.

Driving and using machines

Psychotropic medications, such as sertraline, may affect the ability to drive and use machines. The patient should wait until they know how Sertraline Krka affects their ability to perform these activities.

Sertraline Krka contains sodium

The medication contains less than 1 mmol (23 mg) of sodium per dose, which means it is considered "sodium-free).

3. How to take Sertraline Krka

This medication should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

Recommended dose:

Adults:

Depression and obsessive-compulsive disorder

In the treatment of depression and OCD, the usual effective dose is 50 mg per day. The daily dose can be increased by 50 mg over several weeks, with an interval of at least one week between dose changes. The maximum recommended dose is 200 mg per day.

Panic disorder, social anxiety disorder, and post-traumatic stress disorder

Treatment of panic disorder, social anxiety disorder, and post-traumatic stress disorder should be started with a dose of 25 mg per day, and after one week, the dose should be increased to 50 mg per day.
The daily dose can then be increased by 50 mg over several weeks. The maximum recommended dose is 200 mg per day.

Use in children and adolescents

Sertraline Krka can be used in children and adolescents aged 6 to 17 years only to treat obsessive-compulsive disorder.

Obsessive-compulsive disorder:

Children aged 6 to 12 years:the recommended initial dose is 25 mg per day.
After one week, the doctor may increase the dose to 50 mg per day. The maximum dose is 200 mg per day.
Adolescents aged 13 to 17 years:the recommended initial dose is 50 mg per day.
The maximum dose is 200 mg per day.
Patients with liver or kidney disease should inform their doctor and follow their instructions.
Method of administration
Sertraline Krka can be taken with or without food.
The medication should be taken once a day, in the morning or evening.
The doctor will inform the patient how long they should take this medication. The treatment period depends on the type of disease and the patient's response to treatment. Improvement in condition may begin only after several weeks of treatment. Depression treatment should usually be continued for 6 months after improvement.

Taking a higher dose of Sertraline Krka than recommended

If the patient takes more Sertraline Krka than the recommended dose, they should immediately inform their doctor or go to the nearest hospital emergency department. The patient should always take the medication packaging with them, whether or not it contains medication.
Overdose symptoms include: drowsiness, nausea, vomiting, rapid heart rate, tremors, agitation, dizziness, and rarely - loss of consciousness.

Missing a dose of Sertraline Krka

If the patient forgets to take a dose, they should not take the missed dose. They should take the next dose at the usual time.
The patient should not take a double dose to make up for the missed dose.

Stopping Sertraline Krka treatment

The patient should not stop taking Sertraline Krka without consulting their doctor. Before stopping treatment, the doctor will gradually reduce the dose of Sertraline Krka over several weeks. If the patient stops taking the medication abruptly, they may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors. If the patient experiences any of these or any other side effects while stopping Sertraline Krka, they should contact their doctor.
If the patient has any further doubts about taking this medication, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Sertraline Krka can cause side effects, although not everyone gets them.
The most common side effect is nausea. Side effects depend on the dose and usually disappear or decrease as treatment continues.
The patient should immediately inform their doctorif they experience any of the following symptoms after taking this medication, as they may be serious:

  • Severe skin rash with blisters (erythema multiforme) (may affect the mouth and tongue). These may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis. In this case, the doctor will decide to stop treatment.
  • Allergic reaction or allergy, which may cause itching skin rash, breathing difficulties, wheezing, swelling of the eyelids, face, or lips.
  • Agitation, confusion, diarrhea, high blood pressure, excessive sweating, rapid heart rate, serotonin syndrome. This syndrome may rarely occur when taking certain medications at the same time as sertraline (symptoms, see section 4 "Possible side effects"). The doctor may decide to stop treatment.
  • Yellowing of the skin and whites of the eyes, which may indicate liver damage.
  • Symptoms of depression with thoughts of self-harm or suicide (suicidal thoughts).
  • Psychomotor restlessness - the patient is unable to sit or stand still after starting Sertraline Krka. If the patient experiences psychomotor restlessness, they should inform their doctor.
  • Seizures (epileptic).
  • Manic episodes (see section 2 "Warnings and precautions").

In clinical trials in adults, the following side effects were observed.

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

  • insomnia, dizziness, drowsiness, headaches, diarrhea, nausea, dry mouth, ejaculation disorders, fatigue.

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

  • bronchitis, sore throat, cold,
  • decreased appetite, increased appetite,
  • anxiety, depression, agitation, decreased sexual interest, nervousness, abnormal sensations, nightmares, teeth grinding,
  • muscle tremors, movement disorders (such as increased muscle activity, increased muscle tone, difficulty walking, and stiffness, spasms, and involuntary muscle movements)*, numbness and tingling, increased muscle tone, lack of concentration, taste disorders,
  • vision disturbances,
  • ringing in the ears,
  • palpitations,
  • hot flashes,
  • yawning,
  • gastrointestinal disorders, constipation, abdominal pain, vomiting, gas,
  • increased sweating, rash,
  • back pain, joint pain, muscle pain,
  • irregular menstrual cycle, erectile dysfunction,
  • malaise, chest pain, weakness, fever,
  • weight gain,
  • injuries.

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

  • diverticulitis, ear infection,
  • tumor,
  • hypersensitivity, seasonal allergy,
  • decreased thyroid hormone levels,
  • suicidal thoughts, suicidal behavior*, psychotic disorders, thought disorders, apathy, hallucinations, aggression, euphoria, paranoia,
  • amnesia, decreased sensitivity, involuntary muscle contractions, loss of consciousness, increased muscle activity, migraine, seizures, dizziness when standing up, coordination disorders, speech disorders,
  • pupil dilation,
  • ear pain,
  • rapid heart rate, heart problems,
  • bleeding disorders (including gastrointestinal bleeding)*, high blood pressure, flushing, hematuria,
  • shortness of breath, nosebleeds, breathing difficulties, wheezing,
  • black stools, dental disorders, esophagitis, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders,
  • eye swelling, hives, hair loss, itching, purpura, skin disorders with blisters, dry skin, facial swelling, cold sweats,
  • degenerative joint disease, muscle twitches, painful muscle spasms*, muscle weakness,
  • increased urination frequency, urination problems, urinary retention, incontinence, increased urine production, nocturia,
  • sexual dysfunction, excessive menstrual bleeding, menstrual bleeding, sexual dysfunction in women,
  • leg swelling, chills, walking difficulties, increased thirst,
  • increased liver enzyme activity, weight loss,
  • During sertraline treatment or shortly after stopping it, there have been reports of suicidal thoughts and behaviors (see section 2).

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

  • diverticulitis, lymphadenopathy, decreased platelet count*, decreased white blood cell count*,
  • severe allergic reactions,
  • endocrine disorders*,
  • high cholesterol levels, problems with maintaining normal blood sugar levels (diabetes), low blood sugar levels, high blood sugar levels*, low sodium levels*,
  • physical symptoms caused by stress or emotions, nightmares*, 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,
  • eye spots, glaucoma, double vision, light sensitivity, eye bleeding, uneven pupil size*, vision disturbances*, tear disorders,
  • heart attack, feeling of "emptiness" in the head, fainting or discomfort in the chest, which may be symptoms of changes in heart electrical activity (visible on an ECG) or abnormal heart rhythm*, slow heart rate,
  • worsening circulation in the arms and legs,
  • rapid breathing, progressive pulmonary fibrosis (interstitial lung disease)*, laryngospasm, difficulty speaking, slow breathing, hiccups,
  • mouth ulcers, pancreatitis*, blood in stool, tongue pain, oral discomfort,
  • 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,
  • difficulty starting urination, decreased urination,
  • nipple discharge, vaginal dryness, genital discharge, penis and foreskin redness and pain, breast enlargement*, prolonged erection,
  • hernia, decreased drug tolerance,
  • increased cholesterol levels, abnormal laboratory test results*, abnormal sperm test results, bleeding disorders*,
  • vascular collapse.

Frequency not known (frequency cannot be estimated from available data):

  • -partial loss of vision,
  • colitis (causing diarrhea),
  • jaw spasm*,
  • nocturnal enuresis*,
  • severe postpartum hemorrhage (postpartum hemorrhage), see additional information in subsection "Pregnancy" in section 2.

*Side effect reported after the medication was marketed.

Additional side effects in children and adolescents

In clinical trials in children and adolescents, side effects were usually 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 abruptly stopping treatment, side effects may occur, such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors (see section 3 "Stopping Sertraline Krka treatment").
There is an increased risk of fractures in patients taking medications from this group.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 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 gather more information on the safety of this medication.

5. How to store Sertraline Krka

The medication should be stored out of sight and reach of children.
The patient should not use this medication after the expiration date stated on the packaging after "EXP". The expiration date refers to the last day of the month stated.
The batch number is stated on the packaging after "Lot".
There are no special precautions for storing the medication.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sertraline Krka contains

  • The active substance of Sertraline Krka is sertraline. Each film-coated tablet contains 50 mg or 100 mg of sertraline, in the form of sertraline hydrochloride.
  • Other ingredients are: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), hydroxypropylcellulose, talc, and magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E 171), talc, and propylene glycol in the tablet coating. See section 2 "Sertraline Krka contains sodium".

What Sertraline Krka looks like and contents of the pack

50 mg, film-coated tablets: white, oval, slightly biconvex film-coated tablets, with a score line on one side and an S3 mark on the other side. The tablet can be divided into equal doses.
100 mg, film-coated tablets: white, round film-coated tablets, with a score line on one side.
The tablet can be divided into equal doses.
Packaging:10, 14, 20, 28, 30, 50, 98, or 100 film-coated tablets in blisters, in a cardboard box or an HDPE container with a PP closure containing 250 film-coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße. 5, 27472 Cuxhaven, Germany
SPECIFAR ABEE, 1, 28 Octovriou Str., Ag. Varvara, 123-51 Athens, Greece
To obtain more detailed information on the names of medicinal products in other EU member states, the patient should contact the representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:24.06.2022

  • Country of registration
  • Active substance
  • Prescription required
    Yes
  • Manufacturer
  • Importer
    Krka, d.d., Novo mesto Specifar ABEE TAD Pharma GmbH

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  • Headaches, migraines, and minor injuries.
  • Wound care, health check-ups, and ongoing prescriptions.

With a patient-focused and evidence-based approach, Dr. Ben Ami supports individuals at all stages of life — offering clear medical guidance, timely interventions, and continuity of care.

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5.0(4)
Doctor

Salome Akhvlediani

Pediatrics11 years of experience

Dr Salome Akhvlediani is a paediatrician providing online consultations for children of all ages. She supports families with preventive care, diagnosis, and long-term management of both acute and chronic conditions.

Her areas of focus include:

  • Fever, infections, cough, sore throat, and digestive issues.
  • Preventive care – vaccinations, regular check-ups, and health monitoring.
  • Allergies, asthma, and skin conditions.
  • Nutritional advice and healthy development support.
  • Sleep difficulties, fatigue, and behavioural concerns.
  • Ongoing care for chronic or complex health conditions.
  • Guidance for parents and follow-up after medical treatment.

Dr Akhvlediani combines professional care with a warm, attentive approach – helping children stay healthy and supporting parents at every stage of their child’s growth.

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