Sertraline krka: detailed information

Package leaflet: Information for the patient

Sertralina Krka, 50 mg, film-coated tablets
Sertralina Krka, 100 mg, film-coated tablets
sertralinum
Please read this leaflet carefully before taking this medicine, as it contains important
information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

What Sertralina Krka is and what it is used for
What you need to know before taking Sertralina Krka
How to take Sertralina Krka
Possible side effects
How to store Sertralina Krka
Contents of the pack and other information

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

The active substance in Sertralina Krka is 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.
Sertralina Krka may be used to treat:

depression and prevention of recurrence of depression (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 an illness characterised by symptoms such as sadness, difficulty sleeping or loss of enjoyment in life.
OCD and panic disorder are anxiety-related conditions, associated with persistent worry due to intrusive thoughts (obsessions), leading to repetitive rituals (compulsions).
Post-traumatic stress disorder (PTSD) is a condition that may occur after a traumatic experience and is characterised by symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterised by intense fear 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 behaviour).
Your doctor has decided that this medicine is suitable for treating your condition.
You should consult your doctor if you are unsure why you are taking Sertralina Krka.

2. Important information before using Sertralina Krka

When not to use Sertralina Krka

If the patient is allergic to sertraline or to any of the other ingredients of this medicine (listed in section 6).
If the patient is currently taking or has recently taken monoamine oxidase inhibitors (MAO inhibitors, e.g. selegiline, moclobemide) or drugs similar to MAO inhibitors (e.g. linezolid). At least one week must elapse after stopping treatment with sertraline before starting treatment with an MAO inhibitor. At least two weeks must elapse after stopping treatment with an MAO inhibitor before starting treatment with sertraline.
If the patient is taking pimozide (a medicine used in psychiatric disorders such as psychosis).

Warnings and precautions
Before starting to take Sertralina Krka, discuss this with your doctor or pharmacist.
Not every medicine is suitable for everyone. Tell your doctor before taking Sertralina Krka if you have or have previously had any of the following conditions:

Epilepsy (seizures) or a history of convulsive seizures. If a seizure occurs, contact your doctor immediately.
A history of bipolar affective disorder (manic-depressive illness) or schizophrenia. If a manic episode occurs, contact your doctor immediately.
Current or past thoughts of self-harm or suicide (see below – "Suicidal thoughts, worsening of depression or anxiety disorders").
Serotonin syndrome. In rare cases, this syndrome may occur in patients taking certain medicines at the same time as sertraline (symptoms, see section 4 "Possible side effects"). Your doctor should ask whether you have previously experienced serotonin syndrome.
Low sodium levels in the blood, which may occur as a result of treatment with Sertralina Krka. You should also inform your doctor if you are taking certain medicines used to treat high blood pressure, as these may also affect sodium levels in the blood.
Elderly patients; they may be more susceptible to reduced sodium levels in the blood (see above).
Liver disease; your doctor may decide to reduce the dose of Sertralina Krka.
Diabetes; Sertralina Krka may affect blood glucose levels, so dosage adjustments of antidiabetic medicines may be necessary.
Bleeding disorders or previous use of blood-thinning medicines [e.g. acetylsalicylic acid (aspirin) or warfarin] or medicines that may increase the risk of bleeding, or if the patient is pregnant (see "Pregnancy").
Children or adolescents under 18 years of age. In children and adolescents aged 6 to 17 years, Sertralina Krka may be used only for the treatment of obsessive-compulsive disorder. Patients being 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 function abnormalities seen on ECG, referred to as prolonged QT interval.
Heart disease, low potassium or magnesium levels, prolonged QT interval in any family member, slow heart rate, and concomitant use of medicines causing QT prolongation.

Psychomotor agitation (akathisia)
Treatment with sertraline has been associated with a condition characterised by motor restlessness and a compelling need to move, often with an inability to sit still or remain motionless (akathisia). This condition usually occurs during the first weeks of treatment. Contact your doctor if the dose is increased, as this may be harmful in patients experiencing such symptoms.

Withdrawal symptoms
Unwanted effects (withdrawal symptoms) often occur after stopping treatment, especially if treatment is stopped abruptly (see section 3 "Stopping Sertralina Krka" and section 4 "Possible side effects"). The risk of withdrawal symptoms depends on the duration of treatment, dose, and speed of dose reduction. These symptoms are generally mild or moderate in intensity, but may be severe in some patients. They usually occur within the first few weeks after stopping treatment. They usually resolve spontaneously within 2 weeks, but may persist longer in some patients (for 2-3 months or longer).
If you decide to stop treatment with sertraline, it is recommended to gradually reduce the dose over several weeks or months and to consult your doctor about the best way to discontinue treatment.

Suicidal thoughts, worsening of depression or anxiety disorders
People with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behaviours may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually take about 2 weeks, sometimes longer, to start working.
The likelihood of such thoughts is higher if:

the patient has previously had suicidal thoughts or self-harming behaviour;
the patient is a young adult; clinical trial data indicate an increased risk of suicidal behaviour in people under 25 years of age with psychiatric disorders who are being treated with antidepressant medicines. If the patient experiences suicidal thoughts or thoughts of self-harm, contact a doctor immediately or go to 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 relatives or friends for help and ask them to inform him/her if they notice that depression or anxiety worsens or if there are worrying changes in behaviour.

Sexual dysfunction
Medicines such as Sertralina Krka (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.

Children and adolescents
Sertraline should generally not be used in children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorder. In patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, thoughts of self-harm or suicide (suicidal thoughts), and hostility (mainly aggressive, defiant behaviour and anger) when taking medicines from this group. However, your doctor may decide to prescribe Sertralina Krka to a patient under 18 years of age if it is in the patient's best interest. If your doctor prescribes Sertralina Krka to a patient under 18 years of age and the child's caregiver wishes to discuss this, contact the doctor. Furthermore, if any of the symptoms listed above appear or worsen during treatment with Sertralina Krka, inform your doctor.
In a long-term observational study lasting 3 years involving over 900 children aged 6 to 16 years, the long-term safety of Sertralina Krka was evaluated with regard to its effects on growth, maturation, learning (cognitive functions), and behaviour. Overall, study results showed that children treated with sertraline developed normally, except for a small increase in body weight in children treated with higher doses.

Sertralina Krka and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some medicines may affect how Sertralina Krka works, or Sertralina Krka may reduce the effectiveness of other medicines taken at the same time.
Taking Sertralina Krka together with the following medicines may cause serious adverse effects:

Monoamine oxidase inhibitor (MAOI) medicines, 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 levels of methemoglobin in the blood). Sertralina Krka must not be taken at the same time as these medicines.
Medicines used to treat psychiatric disorders such as psychosis (pimozide). Sertralina Krka must not be taken at the same time as pimozide.

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

Medicines containing amphetamine derivatives [used to treat attention deficit hyperactivity disorder (ADHD), excessive sleepiness and obesity].
Herbal medicines containing St. John's wort (Hypericum perforatum). The effect of St. John's wort may persist for 1 to 2 weeks.
Medicines containing the amino acid tryptophan.
Medicines used to treat severe pain (e.g. tramadol).
Buprenorphine, a medicine used to treat pain or opioid dependence.
Medicines used during anaesthesia or for the treatment of chronic pain (fentanyl, mivacurium and suxamethonium).
Medicines used to treat migraines (e.g. sumatriptan).
Blood-thinning medicines (warfarin).
Medicines used to treat pain and (or) joint inflammation [non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen, acetylsalicylic acid (aspirin)].
Sedative medicines (diazepam).
Diuretic medicines (so-called diuretics).
Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
Medicines used to treat diabetes (tolbutamide).
Medicines used to treat excessive stomach acid secretion, ulcers and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
Medicines used to treat mania and depression (lithium).
Other medicines used in depression (e.g. amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
Medicines used to treat schizophrenia and other mental illnesses (e.g. perphenazine, levomepromazine and olanzapine).
Medicines used to treat high blood pressure, chest pain or to regulate heart rate and rhythm (such as verapamil, diltiazem, flecainide, 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 increasing the risk of changes in the heart's electrical activity (e.g. antipsychotics and antibiotics).
Metamizole, a medicine used to treat pain and fever.

Taking Sertralina Krka with food, drink and alcohol
Sertralina Krka can be taken with or without food.
Do not drink alcohol while taking Sertralina Krka.
Do not take Sertralina Krka with grapefruit juice, as this may lead to increased levels of sertraline in the body.

Pregnancy, breastfeeding and effects on fertility
Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
The safety of using sertraline during pregnancy has not been fully established. Sertraline may be used in pregnant women only if, according to the doctor's assessment, the benefits to the mother outweigh the potential risk to the developing child.
Inform your doctor and (or) midwife that you are taking Sertralina Krka. Medicines such as Sertralina Krka, taken during pregnancy, particularly 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 characterised by rapid breathing and cyanosis. These symptoms usually appear within the first day after birth. If such symptoms occur in the newborn, contact your doctor and (or) midwife immediately.
Other symptoms may also occur in the newborn, usually within the first day after birth. These symptoms include:

breathing difficulties,
blue skin, too low or too high body temperature,
blue lips,
vomiting or difficulty feeding,
excessive tiredness, insomnia or excessive crying,
muscle stiffness or floppiness,
tremors, shakiness or seizures,
increased reflexes,
irritability,
low blood sugar levels.

If any of these symptoms appear in the newborn or if you are concerned about the baby's health, contact your midwife or doctor.
Taking Sertralina Krka towards the end of pregnancy may increase the risk of serious vaginal bleeding occurring shortly after delivery, especially if the patient has a history of bleeding disorders. If you are taking Sertralina Krka, inform your doctor or midwife so they can provide appropriate advice.

Breastfeeding
There is evidence that sertraline is excreted in human milk. Sertralina Krka may be used in breastfeeding women if the doctor considers that the benefits to the mother outweigh the risks to the infant.

Fertility
Animal studies have shown that certain medicines such as sertraline may reduce semen quality. This effect may theoretically impair fertility, although no effect on fertility has been observed in humans to date.

Driving and using machines
Psychotropic medicines such as sertraline may affect the ability to drive and operate machinery. Wait before performing the above activities until you know how Sertralina Krka affects your ability to perform them.

Sertralina Krka contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. this medicine is considered "sodium-free".

3. How to use Sertralina Krka

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
Recommended dose:
Adults:
Depression and obsessive-compulsive disorder (OCD)
The usual effective dose for treating depression and OCD is 50 mg once daily. The daily dose may be
increased by 50 mg every few weeks, allowing at least one week between dose adjustments. The maximum
recommended dose is 200 mg per day.
Panic disorder, social anxiety disorder, and post-traumatic stress disorder (PTSD)
Treatment of panic disorder, social anxiety disorder, and PTSD should be initiated at a dose of 25 mg per day,
increased after one week to 50 mg per day. The daily dose may then be increased by 50 mg every few weeks.
The maximum recommended dose is 200 mg per day.
Use in children and adolescents
Sertralina Krka may be used in children and adolescents aged 6 to 17 years only for the treatment of
obsessive-compulsive disorder.
Obsessive-compulsive disorder:
Children aged 6 to 12 years: the recommended starting 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 starting 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 the doctor’s advice.
Method of administration
Sertralina Krka may be taken with or without food.
The medicine should be taken once daily, either in the morning or in the evening.
Your doctor will inform you how long you should continue taking this medicine. The duration of treatment
depends on the type of illness and your response to treatment. Improvement in health may not begin until
several weeks after starting treatment. Treatment of depression should usually continue for at least
6 months after improvement is achieved.
Taking more Sertralina Krka than recommended
If you take more Sertralina Krka than the recommended dose, you should immediately contact your doctor
or go to the nearest hospital emergency department. Always bring the medicine packaging with you,
regardless of whether any medicine remains in it.
Symptoms of overdose may include: drowsiness, nausea, vomiting, rapid heartbeat, tremor, agitation,
dizziness, and rarely – loss of consciousness.
Missing a dose of Sertralina Krka
If you forget to take a dose, do not take the missed dose. Take the next dose at your usual time.
Do not take a double dose to make up for a missed dose.
Stopping Sertralina Krka
Do not stop taking Sertralina Krka without consulting your doctor. Before stopping treatment, your doctor
will gradually reduce the dose of Sertralina Krka over several weeks. If you stop taking the medicine suddenly,
you may experience the following adverse effects: dizziness, numbness, sleep disturbances, agitation or
restlessness, headache, nausea, vomiting, and tremor. If any of these or any other adverse effects occur while
discontinuing Sertralina Krka, contact your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effect is nausea. Side effects are dose-dependent and often
diminish or weaken with continued treatment.
You should inform your doctor immediately if any of the following symptoms occur after taking this medicine, as they may be serious:

Severe skin rash causing blistering (erythema multiforme) (may involve the mouth and tongue). These may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis. In such a case, the doctor will decide to discontinue treatment.
Allergic reaction or allergy, which may manifest as itchy rash, breathing difficulties, wheezing, swelling of the eyelids, face or lips.
Agitation, confusion, diarrhoea, high body temperature and blood pressure, excessive sweating and rapid heartbeat. These are symptoms of serotonin syndrome. Serotonin syndrome rarely may occur when certain medicines are taken concomitantly with sertraline. The doctor may decide to discontinue 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).
Motor restlessness – the patient is unable to sit or stand still after starting treatment with Sertralina Krka. If the patient begins to experience motor restlessness, the doctor should be informed.
Seizure (epileptic fit).
Manic episodes (see section 2 "Warnings and precautions").

In clinical trials in adult patients and following marketing of the medicine, the following side effects have been observed.
Very common (may affect more than 1 in 10 people):

insomnia, dizziness, drowsiness, headache, diarrhoea, nausea, dry mouth, ejaculation disorders, fatigue.

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

bronchitis, sore throat, nasal congestion,
decreased appetite, increased appetite,
anxiety, depression, agitation, decreased interest in sex, nervousness, unusual feeling, nightmares, teeth grinding,
muscle tremors, movement disorders (such as increased motor activity, increased muscle tension, difficulty walking, muscle stiffness, cramps and involuntary muscle movements)*, numbness and tingling, increased muscle tension, lack of concentration, taste disturbances,
visual disturbances,
tinnitus,
palpitations,
hot flushes,
yawning,
gastrointestinal discomfort, constipation, abdominal pain, vomiting, flatulence,
increased sweating, rash,
back pain, joint pain, muscle pain,
irregular menstruation, erectile dysfunction,
malaise, chest pain, weakness, fever,
weight gain,
injuries.

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

gastritis and enteritis, ear infection,
tumour,
hypersensitivity, seasonal allergy,
decreased levels of thyroid hormones,
suicidal thoughts, suicidal behaviour*, psychotic disorders, thinking disorders, emotional blunting, hallucinations, aggression, feeling of euphoria, paranoia,
memory impairment, reduced sensation, involuntary muscle contractions, loss of consciousness, increased motor activity, migraine, seizures, dizziness upon standing, coordination disorders, speech disorders,
pupil dilation,
ear pain,
increased heart rate, heart problems,
haemorrhagic disorders (including gastrointestinal bleeding)*, high blood pressure, sudden skin redness, blood in urine,
shortness of breath, nosebleeds, breathing difficulties, wheezing,
black stools, dental disorders, oesophagitis, tongue problems, haemorrhoids, increased salivation, difficulty swallowing, belching, tongue diseases,
eye swelling, urticaria, hair loss, itching, purpuric skin spots, blistering skin disorders, dry skin, facial swelling, cold sweats,
degenerative joint disease, muscle tics, painful muscle cramps*, decreased muscle strength,
increased frequency of urination, problems with urination, inability to urinate, urinary incontinence, increased volume of urine, nocturnal urination,
sexual disorders, excessive vaginal bleeding, vaginal haemorrhage, sexual disorders in women,
swelling of legs, chills, difficulty walking, excessive thirst,
increased liver enzyme activity, weight loss,
Cases of suicidal thoughts and behaviours have been reported during treatment with sertraline or shortly after discontinuation (see section 2).

Rare (may affect up to 1 in 1,000 people):

diverticulitis, lymph node swelling, 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, increased blood sugar*, low blood sodium levels*,
physical symptoms caused by stress or emotions, nightmares*, drug dependence, sleepwalking, premature ejaculation,
coma, abnormal movements, difficulty moving, increased sensitivity to touch, sudden severe headache (which may be a symptom of a serious condition called reversible cerebral vasoconstriction syndrome)*, sensory disturbances,
spots before the eyes, glaucoma, double vision, photophobia, blood in the eye, unequal pupil size*, visual disturbances*, tear secretion disorders,
myocardial infarction, sensation of "emptiness" in the head, fainting or discomfort in the chest which may be symptoms of changes in the heart's electrical activity (visible on electrocardiogram) or abnormal heart rhythm*, slowed heart rate,
worsening of blood circulation in the upper and lower limbs,
rapid breathing, progressive lung tissue fibrosis (interstitial lung disease)*, throat closure (laryngospasm), difficulty speaking, slowed breathing, hiccups,
a form of lung disease in which eosinophils (a type of white blood cells) appear in increased numbers in the lungs (eosinophilic pneumonia),
oral ulceration, pancreatitis*, blood in stool, tongue ulceration, oral pain,
liver function disorders, severe liver function disorders*, yellowing of the skin and eyes (jaundice)*,
skin reaction to sunlight*, skin swelling*, abnormal hair structure, abnormal skin odour, rash on hairy skin,
muscle tissue breakdown*, bone disorders,
difficulty initiating urination, reduced urine output,
nipple discharge, vaginal dryness, genital discharge, redness and pain of the penis and foreskin, breast enlargement*, prolonged penile erection,
hernia, decreased drug tolerance,
increased blood cholesterol levels, abnormal laboratory test results*, abnormal semen analysis results, blood clotting problems*,
vasodilation.

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

partial loss of vision,
colitis (causing diarrhoea),
bruxism*,
nocturnal enuresis*,
severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection "Pregnancy" in section 2,
muscle weakness and severe muscle pain, which may be symptoms of a disorder resembling glutaric aciduria type II.

*Adverse reaction reported after marketing of the medicine.
Additional adverse reactions in children and adolescents
In clinical trials in children and adolescents, adverse reactions were generally similar to those
in adults (see above). The most common adverse reactions in children and adolescents
were: headache, insomnia, diarrhoea and nausea.
Symptoms occurring after discontinuation
After abrupt discontinuation of the medicine, adverse reactions such as dizziness,
numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting and muscle
tremors may occur (see section 3 "Discontinuing treatment with Sertralina Krka").
An increased risk of bone fractures has been observed in patients taking medicines of this class.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sertralina Krka

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the word
"EXP". The expiry date refers to the last day of the stated month.
The batch number is shown on the packaging following the word "Lot".
No special storage precautions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Sertralina Krka contains

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

What Sertralina Krka looks like and contents of the pack
50 mg, coated tablets: white, oval, slightly biconvex coated tablets with a division line on one side and the mark S3 on the other side. The tablet can be divided into equal doses.
100 mg, coated tablets: white, round coated tablets with a division line on one side. The tablet can be divided into equal doses.
Pack sizes: 10, 14, 20, 28, 30, 50, 98 or 100 coated tablets in blisters, in a cardboard box or a HDPE container with a PP closure containing 250 coated tablets, in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation 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
For further information on product names in other European Economic Area countries, please contact the representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
Tel. 22 57 37 500