Package leaflet: Information for the patient

Delanxara, 75 mg + 25 mg, coated tablets
Tramadoli hydrochloridum + Dexketoprofenum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Delanxara is and what it is used for
Important information before taking Delanxara
How to take Delanxara
Possible side effects
How to store Delanxara
Contents of the pack and other information

1. What Delanxara is and what it is used for

Delanxara contains tramadoli hydrochloridum and dexketoprofenum as active substances.
Tramadoli hydrochloridum is an analgesic belonging to a group of medicines called opioids, which act on the central nervous system. It relieves pain by acting on specific nerve cells in the brain and spinal cord.
Dexketoprofenum is an analgesic belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Delanxara is used for the short-term symptomatic treatment of moderate to severe acute pain in adults.
Tell your doctor if the patient does not feel better or feels worse after taking the medicine.

2. Important information before taking Delanxara

When not to take Delanxara

if the patient is allergic to tramadol hydrochloride, dexketoprofen, or to any of the other ingredients of this medicine (listed in section 6);
if the patient has hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
if the patient has previously experienced asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (growths inside the nose caused by allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips, tongue or respiratory tract symptoms), or wheezing after taking acetylsalicylic acid or another NSAID;
if the patient has previously experienced photosensitivity reactions: photoallergic or phototoxic reactions (particularly redness and/or blisters on skin exposed to sunlight) while taking ketoprofen (an NSAID) or fibrates (medicines used to lower blood lipid levels);
if the patient has peptic ulcer disease of the stomach and/or duodenum or gastrointestinal bleeding, or if there has been previous gastrointestinal bleeding, ulceration, or perforation, including cases due to prior use of NSAIDs;
if the patient has chronic digestive problems (e.g. indigestion, heartburn);
if the patient has inflammatory bowel diseases with chronic inflammation (Crohn's disease or ulcerative colitis);
if the patient has severe heart failure, moderate or severe renal impairment, or severe hepatic impairment;
if the patient has a tendency to bleed excessively or has coagulation disorders;
if the patient is severely dehydrated (excessive loss of body fluids) due to vomiting, diarrhoea, or inadequate fluid intake;
in cases of acute alcohol intoxication, sedatives, analgesics, or medicines affecting mood and emotions;
if the patient is also taking monoamine oxidase inhibitors (MAOIs) (some medicines used to treat depression) or has taken them within the last 14 days before starting treatment with this medicine (see "Delanxara and other medicines");
if the patient has epilepsy or seizures, as the risk of seizure may increase;
if the patient has difficulty breathing;
if the patient is pregnant or breastfeeding.

Warnings and precautions
Before starting Delanxara, discuss with your doctor:

if the patient has allergies or has previously experienced allergic reactions;
if the patient has impaired kidney, liver, or heart function (hypertension and/or heart failure), fluid retention, or if any of these conditions occurred in the past;
in patients taking diuretics;
if the patient has heart problems, history of stroke, or suspected risk factors for these conditions (e.g. high blood pressure, diabetes, high cholesterol, or smoking). In such cases, consult your doctor before using this medicine. Use of medicines like this may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. This risk increases with long-term use of high doses. Do not use higher doses or longer treatment duration than recommended;
if the patient is elderly: increased risk of adverse effects (see section 4). In such cases, contact your doctor immediately;
in women with fertility problems: this medicine may impair female fertility and is not recommended for women planning pregnancy or undergoing infertility treatment;
if the patient has blood or blood cell formation disorders;
if the patient has systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
if the patient has previously had chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
if the patient has or has had other stomach or intestinal disorders;
if the patient has an infection – see below under "Infections";
if the patient is taking other medicines that increase the risk of gastric or duodenal ulcer disease or bleeding, e.g. oral corticosteroids, certain antidepressants (SSRIs, i.e. selective serotonin reuptake inhibitors), anticoagulants such as acetylsalicylic acid, or anticoagulants like warfarin. In such cases, consult your doctor before taking this medicine; the doctor may decide to prescribe an additional protective medicine;
if the patient has depression and is taking antidepressants, as some of these may interact with tramadol (see "Delanxara and other medicines");
if the patient is taking other medicines containing the same active substances, do not exceed the maximum daily dose of dexketoprofen or tramadol;
if the patient believes they are dependent on other painkillers (opioids);
if the patient has disturbances in consciousness (feeling faint);
if the patient is in shock (cold sweat may be a symptom);
if the patient has increased intracranial pressure (e.g. due to head injury or brain disease);
if the patient has breathing difficulties;
if the patient has porphyria.

Tolerance, dependence, and abuse
This medicine contains tramadol, an opioid medicine. It may lead to dependence and/or abuse.
This medicine contains tramadol, an opioid medicine. Repeated use of opioids may result in reduced effectiveness (the patient becomes tolerant to the medicine, known as tolerance).
Repeated use of Delanxara may also lead to the development of dependence, misuse, and addiction, which may result in life-threatening overdose. The risk of these adverse effects may increase with dose and duration of use.
Dependence may cause the patient to lose control over the dose or frequency of medicine use.
The risk of dependence varies between individuals. The risk of dependence on Delanxara may be higher if:

the patient or a family member has ever misused or been dependent on alcohol, prescription medicines, or illegal drugs ("substance dependence");
the patient smokes tobacco;
the patient has ever had mood disorders (depression, anxiety, or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

If any of the following symptoms occur during treatment with Delanxara, this may indicate dependence:

the patient needs to take the medicine longer than prescribed by the doctor;
the patient needs to take a higher dose than recommended;
the patient feels a need to continue taking the medicine despite it not relieving pain;
the patient uses the medicine for reasons other than recommended, e.g. "to calm down" or "to help sleep";
the patient has made repeated unsuccessful attempts to stop or control medicine use;
after stopping the medicine, the patient feels unwell and feels better after taking it again ("withdrawal effects").

If any of these symptoms occur, talk to your doctor to discuss the best treatment path, including when and how to stop the medicine safely (see section 3. "Stopping Delanxara"). If any of the following symptoms occur during treatment with Delanxara, inform your doctor: excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This may indicate adrenal insufficiency (low cortisol levels). If such symptoms occur, contact your doctor, who will decide whether hormone replacement is necessary.

Tramadol is metabolized in the liver by an enzyme. Some individuals have a variation of this enzyme, which may lead to different effects. In some people, pain relief may be insufficient, while in others, serious adverse effects may be more likely. Stop taking the medicine and contact your doctor immediately if any of the following adverse effects occur: slowed or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.
There is a small risk of serotonin syndrome when tramadol is taken with certain antidepressants or tramadol alone. If any symptoms of this serious syndrome occur, the patient should seek immediate medical advice (see section 4 "Possible side effects").
Allergic reactions to dexketoprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported. If any of these symptoms occur, stop taking Delanxara immediately and contact your doctor or emergency services without delay.

Sleep-related breathing disorders
Delanxara may cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing interruptions during sleep, nighttime awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or another person observes these symptoms, contact a doctor. The doctor may recommend reducing the dose.

Infections
Delanxara may mask symptoms of infection, such as fever and pain. Therefore, Delanxara may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an infection and symptoms persist or worsen, consult a doctor immediately.
Avoid using this medicine during chickenpox.

Children and adolescents
The use of this medicine has not been studied in children and adolescents. Safety and efficacy have not been established, and therefore, the medicine should not be used in children and adolescents.
Use in children with breathing disorders
Tramadol is not recommended in children with breathing disorders, as tramadol toxicity symptoms may be more severe in these patients.

Delanxara and other medicines
Inform your doctor about all medicines currently or recently taken, including over-the-counter medicines, and any medicines you plan to take. Some medicines should not be used together, while others may require dose adjustments when taken concurrently.
Always inform your doctor if you are taking any of the following medicines together with Delanxara:

Not recommended to be used simultaneously with Delanxara:

Acetylsalicylic acid, corticosteroids, or other anti-inflammatory medicines;
Warfarin, heparin, or other anticoagulants;
Lithium used to treat certain mood disorders;
Methotrexate used to treat rheumatoid arthritis and cancer;
Hydantoin derivatives and phenytoin used to treat epilepsy;
Sulfamethoxazole used to treat bacterial infections;
Monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression).

Simultaneous use with Delanxara requiring caution:

ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists used to treat high blood pressure and heart disease;
Pentoxifylline used to treat ulcers in chronic venous insufficiency;
Zidovudine used to treat viral infections;
Chlorpropamide and glibenclamide used to treat diabetes;
Aminoglycoside antibiotics used to treat bacterial infections;
Concurrent use of Delanxara with sedatives such as benzodiazepines or other medicines acting similarly to benzodiazepines may increase the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concurrent use should only be considered when no other treatment options are possible. If your doctor prescribes Delanxara to be used together with sedatives, the dose and duration of treatment should be limited by the doctor. Inform your doctor about all sedative medicines you are taking and strictly follow your doctor's instructions. It may be helpful to inform friends and family that the above symptoms may occur. Contact your doctor if such symptoms occur.

Simultaneous use with Delanxara requiring special consideration:

Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used to treat bacterial infections;
Cyclosporine and tacrolimus used to treat immune system disorders and in transplant patients;
Streptokinase and other thrombolytic or fibrinolytic medicines, i.e. medicines used to dissolve blood clots;
Probenecid used to treat gout;
Digoxin used to treat chronic heart failure;
Mifepristone used as a medicine to terminate pregnancy;
Selective serotonin reuptake inhibitors (SSRIs);
Antiplatelet medicines used to reduce platelet aggregation and blood clot formation;
Tenofovir, deferasirox, pemetrexed.

The pain-relieving effect of tramadol may be reduced and its duration shortened when the patient is also taking medicines containing:

Carbamazepine (for seizures);
Buprenorphine, nalbuphine, or pentazocine (analgesics);
Ondansetron (prevents nausea).

The risk of adverse effects increases:

if the patient takes sedatives, hypnotics, other analgesics such as morphine and codeine (also for cough) or alcohol while taking Delanxara. The patient may feel drowsy or faint. If this occurs, inform your doctor;
if the patient takes medicines that may cause seizures (convulsions), such as certain antidepressants or antipsychotics. The risk of seizures may increase due to concurrent use of Delanxara. The doctor will decide whether Delanxara is suitable for the patient;
if the patient takes certain antidepressants. Delanxara may interact with these medicines and cause serotonin syndrome (see section 4 "Possible side effects");
if the patient takes anticoagulants (blood thinners), e.g. warfarin, together with this medicine. The effect of these medicines on blood clotting may be disturbed, leading to bleeding;
if the patient takes gabapentin or pregabalin for epilepsy or nerve-related pain (neuropathic pain).

Delanxara and alcohol
Do not drink alcohol while being treated with Delanxara, as it may intensify the medicine's effects.
Instructions for use of Delanxara – see section 3.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine.
Dexketoprofen may cause kidney and heart problems in the unborn child. This medicine may increase the tendency to bleed in both the mother and child and may delay or prolong labour. From week 20 of pregnancy, dexketoprofen may cause:
kidney problems in the unborn child – this may lead to reduced amniotic fluid volume surrounding the child (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart.
Tramadol is excreted in breast milk.
Use of Delanxara is contraindicated during pregnancy and while breastfeeding.

Driving and operating machinery
Delanxara may affect the ability to drive and operate machinery due to possible side effects such as dizziness, visual disturbances, or drowsiness during treatment. This is particularly relevant when Delanxara is taken with medicines affecting mood and emotions or with alcohol.
If such symptoms occur, do not drive or operate machinery until symptoms resolve.

Delanxara contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Delanxara

This medicine should always be taken exactly as directed by the physician. In case of doubt, consult your doctor.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from taking Delanxara, when and for how long it should be taken, when to contact your doctor, and when to discontinue the medicine (see also Discontinuation of Delanxara treatment).

Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).

The dose of Delanxara depends on the type, severity, and duration of pain. Your doctor will inform you about the number of tablets to take per day and the duration of treatment.

The usual recommended dose is 1 coated tablet (equivalent to 75 mg tramadol hydrochloride and 25 mg dexketoprofen) every 8 hours, not exceeding 3 coated tablets per day (equivalent to 225 mg tramadol hydrochloride and 75 mg dexketoprofen), and treatment should not last longer than 5 days.

Use in children and adolescents
Delanxara must not be used in children and adolescents.

Elderly patients
In patients aged 75 years or older, your doctor may recommend longer intervals between doses, as the body may metabolize the medicine more slowly.

Patients with severe liver or kidney disease (failure) and/or dialysis patients:
Delanxara must not be used in patients with severe liver disease and/or kidney failure.

In case of impaired kidney function, if the patient has mild kidney impairment, your doctor may recommend extending the dosing interval.

In case of impaired liver function, if the patient has mild or moderate liver impairment, your doctor may recommend extending the dosing interval.

Delanxara tablets should be swallowed whole with sufficient liquid (preferably a glass of water). Food delays the absorption of Delanxara; therefore, to achieve a faster effect, take the tablet at least 30 minutes before a meal. The break line on the tablet helps to split it in case of difficulty swallowing the tablet whole.

Taking more than the recommended dose of Delanxara
If you take more than the recommended dose, contact your doctor immediately or go to the nearest hospital emergency department. Remember to bring the medicine packaging or patient leaflet with you.

Symptoms of overdose include:

vomiting, loss of appetite, abdominal pain, drowsiness, dizziness/vertigo, disorientation, headache (due to dexketoprofen);
pinpoint pupils, vomiting, cardiac failure, loss of consciousness, seizures, and breathing difficulties (due to tramadol).

Missed dose of Delanxara
Do not take a double dose to make up for a missed dose. Take the next dose according to the prescribed dosing schedule (see section 3 "How to take Delanxara").

Stopping Delanxara treatment
Withdrawal effects after stopping Delanxara are unlikely.
However, in rare cases, patients who have taken Delanxara for some time may feel unwell if treatment is abruptly stopped. Symptoms may include restlessness, anxiety, nervousness, uneasiness, confusion, hyperactivity, sleep disturbances, and gastrointestinal disturbances. Rarely, patients may experience panic attacks, hallucinations, delusions, paranoia, or depersonalization. Unusual sensations such as itching, tingling, numbness, and ringing in the ears may also occur. Very rarely, symptoms such as confusion, delusions, feelings of depersonalization, changes in perception of reality (derealization), and persecutory delusions (paranoia) have been observed. If any of these symptoms occur after stopping Delanxara, consult your doctor.

If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
The possible adverse reactions listed below are categorized according to the likelihood of their occurrence.
Seek immediate medical attention if symptoms of an allergic reaction occur, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives accompanied by breathing difficulties.
Stop taking Delanxara as quickly as possible if the patient notices the appearance of a rash or any changes inside the mouth or on mucous membranes, or any symptoms of allergy.
If any of the following symptoms occur, discontinue taking Delanxara and seek immediate medical help:
Frequency unknown (cannot be estimated from available data)
Chest pain, which may be a symptom of a potentially severe allergic reaction known as Kounis syndrome.

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

nausea,
dizziness.

Common adverse reactions (may affect up to 1 in 10 patients):

vomiting,
abdominal pain,
diarrhoea,
indigestion,
headache,
drowsiness, fatigue,
constipation,
dry mouth,
excessive sweating.

Uncommon adverse reactions (may affect up to 1 in 100 patients):

increased platelet count,
effects on the heart and blood circulation (palpitations, rapid heartbeat, feeling faint or collapse), low blood pressure. These adverse reactions may occur especially when the patient is in an upright position or during physical exertion,
high or very high blood pressure,
swelling of the vocal cords (laryngeal oedema),
decreased potassium levels in blood,
psychotic disorders,
eye-area swelling,
shallow or slow breathing,
discomfort, abnormal sense of well-being,
blood in urine,
sensation of spinning,
insomnia or difficulty falling asleep,
nervousness and/or anxiety,
hot flushes,
bloating,
fatigue,
pain,
feeling feverish and chills, general malaise,
abnormal blood test results,
tendency to vomit (vomiting reflex),
feeling of stomach pressure, bloating,
stomach inflammation,
skin reactions (e.g. itching, rash),
facial swelling.

Rare adverse reactions (may affect up to 1 in 1,000 patients):

swelling of lips and throat,
peptic ulcer of the stomach and/or duodenum, perforation or bleeding, which may present as vomiting blood or black stools,
prostate disorders,
liver inflammation (hepatitis), liver damage,
acute kidney failure,
slow heartbeat,
seizures,
allergic and/or anaphylactic reactions (e.g. difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure),
transient loss of consciousness (fainting),
hallucinations,
fluid retention or ankle swelling,
loss of appetite, appetite changes,
acne,
back pain,
frequent urination or less than usual, with difficulties or pain,
menstrual disorders,
sensory disturbances (e.g. itching, tingling, numbness),
tremor, muscle spasms, uncoordinated movements, muscle weakness,
confusion,
sleep disturbances and nightmares,
perceptual disturbances,
blurred vision, pupil constriction,
shortness of breath.

Psychiatric adverse reactions may occur during treatment with Delanxara. Their intensity and nature may vary (depending on the patient's personality and duration of treatment) and may include:

mood changes (mostly good mood, sometimes irritability),
changes in activity (slowing down, but sometimes increased activity),
feeling less aware,
reduced ability to make decisions, which may lead to reasoning errors.

Worsening of asthma has been reported.
Withdrawal symptoms may occur when stopping treatment abruptly (see "Stopping treatment with Delanxara").
Seizures occurred mainly after high doses of tramadol or when tramadol was used simultaneously with other medicines that may provoke seizures.

Very rare adverse reactions (may affect up to 1 in 10,000 patients):

pancreatitis,
kidney problems,
reduced white blood cell count (neutropenia),
reduced platelet count (thrombocytopenia),
skin, lip, eye and genital area ulceration (Stevens-Johnson syndrome and Lyell's syndrome),
shortness of breath due to airway constriction,
ringing in the ears (tinnitus),
skin hypersensitivity,
light sensitivity.

Frequency unknown (frequency cannot be estimated from available data):

serotonin syndrome, symptoms of which may include changes in mental state (e.g. agitation, hallucinations, coma), as well as other symptoms such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2. "Important information before taking Delanxara"),
speech disorders,
extreme pupil dilation,
decreased blood sugar levels,
hiccups,
fixed drug eruption: An allergic skin reaction known as fixed drug eruption, whose symptoms may include round or oval areas of redness and swelling of the skin, blister formation and itching. Darkening of the skin in affected areas may also occur, which may persist after healing. Fixed drug eruption usually recurs in the same location(s) upon re-administration of the medicine.

Inform the doctor if the patient experiences any adverse gastrointestinal effects (e.g. stomach pain, heartburn or bleeding) at the beginning of treatment, especially if the patient has previously experienced similar adverse reactions due to long-term use of anti-inflammatory medicines, particularly in elderly patients.

The most common adverse reactions during treatment with Delanxara are nausea and dizziness, which occur in more than 1 in 10 patients.

When administering non-steroidal anti-inflammatory drugs, fluid retention and oedema (especially of the ankles and legs), increased blood pressure and heart failure may occur.

Taking medicines such as Delanxara may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

In patients with immunological disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), administration of anti-inflammatory medicines may rarely cause fever, headache and neck stiffness.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 Delanxara

Keep this medicine out of sight and reach of children.
Store this medicine in a safe place inaccessible to others.
It may cause serious harm or be fatal to people to whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
There are no special storage temperature requirements for this medicine.
Store in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Delanxara contains

The active substances are tramadol hydrochloride and dexketoprofen. Each tablet contains 75 mg of tramadol hydrochloride and 25 mg of dexketoprofen (as dexketoprofen trometamol).
The other ingredients (excipients) are: microcrystalline cellulose (E460), sodium croscarmellose (E 468), colloidal anhydrous silica (E 551) and magnesium stearate (E 470b) in the tablet core, and polyvinyl alcohol (E 1203), macrogol 3350 (E 1521), titanium dioxide (E 171) and talc (E 553b) in the coating. See section 2 "Delanxara contains sodium".

What Delanxara looks like and contents of the pack
White or almost white, oval, biconvex coated tablets with the mark "K" on one side and a breakline on the other side.
Tablet dimensions: approximately 13 mm x 8 mm.
The breakline on the tablet is intended only to facilitate breaking for easier swallowing and does not guarantee equal dosing.
Delanxara is available in cardboard cartons containing:

10, 15, 20, 30 or 50 coated tablets in blisters,
10 x 1, 15 x 1, 20 x 1, 30 x 1 or 50 x 1 coated tablet in perforated, single-dose blisters.

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 this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5
02-235 Warsaw, Poland
Telephone: +48 22 573 75 00