Delanxara

Leaflet accompanying the packaging: patient information

Delanxara, 75 mg + 25 mg, coated tablets

Tramadol hydrochloride + Dexketoprofen

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Delanxara and what is it used for

Delanxara contains tramadol hydrochloride and dexketoprofen as active substances.
Tramadol hydrochloride is a pain reliever belonging to the 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.
Dexketoprofen is a pain reliever belonging to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Delanxara is used for the symptomatic short-term treatment of moderate to severe acute pain in adults.
You should tell your doctor if, after taking the medicine, you do not feel better or feel worse.

2. Important information before taking Delanxara

When not to take Delanxara

• if the patient is allergic to tramadol hydrochloride, dexketoprofen, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is hypersensitive to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has a history of asthma attacks, acute allergic rhinitis (short period of inflammation of the nasal mucosa), nasal polyps (growths in the nose caused by allergy), hives (rash on the skin), angioedema (swelling of the face, eyes, lips, tongue, or respiratory distress) or wheezing after taking acetylsalicylic acid or another NSAID;
• if the patient has a history of photosensitivity reactions: photoallergic or phototoxic reactions (especially in the form of redness and

(or) blisters on the skin exposed to the sun) while taking ketoprofen (NSAID) or fibrates (drugs used to lower blood lipid levels);

• if the patient has stomach or duodenal ulcer disease or bleeding from the stomach or intestines, or if they have had bleeding from the stomach or intestines, ulcers, or perforation in the past, including cases due to previous use of NSAIDs;
• if the patient has chronic gastrointestinal problems (e.g., indigestion, heartburn);
• if the patient has intestinal diseases with chronic inflammation (Crohn's disease or ulcerative colitis);
• if the patient has severe heart failure, moderate or severe kidney failure, or severe liver failure;
• if the patient has a tendency to bleed excessively or has coagulation disorders;
• if the patient is severely dehydrated (excessive fluid loss from the body) due to vomiting, diarrhea, or inadequate fluid intake;
• in case of acute alcohol poisoning, sleeping pills, painkillers, or drugs that affect mood and emotions;
• if the patient is also taking monoamine oxidase inhibitors (MAOIs) (certain drugs 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 has had seizures, as the risk of seizures may increase;
• if the patient has difficulty breathing;
• if the patient is pregnant or breastfeeding.

Warnings and precautions

Before starting treatment with Delanxara, you should discuss it with your doctor:

• if the patient has an allergy or has had problems related to allergies in the past;
• if the patient has kidney, liver, or heart problems (hypertension and/or heart failure), as well as fluid retention, or if any of these problems have occurred in the patient in the past;
• in patients taking diuretics;
• if the patient has heart problems, has had a stroke, or is suspected to be at risk of these conditions (e.g., in the case of high blood pressure, diabetes, high cholesterol, or smoking). In such cases, the doctor should be consulted before using this medicine. Taking such medicines as this one may be associated with a slight increase in the risk of heart attack ("heart attack") or stroke. This risk increases with long-term use of high doses of the medicine. Do not exceed the recommended dose and duration of treatment;
• if the patient is elderly: there is an increased risk of side effects (see section 4). In this case, you should contact your doctor immediately;
• in women with fertility problems: this medicine may disrupt female fertility and is not recommended for women planning pregnancy or being treated for infertility;
• if the patient has blood disorders or blood cell disorders;
• if the patient has systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• if the patient has had chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease) in the past;
• if the patient has other stomach or intestinal diseases;
• if the patient has an infection - see below, the section entitled "Infections";
• if the patient is taking other medicines that increase the risk of stomach ulcers and/or duodenal ulcers or bleeding, such as oral steroids, certain antidepressants (SSRI, i.e., selective serotonin reuptake inhibitors), or anticoagulant medicines such as acetylsalicylic acid or warfarin. In such cases, the doctor should be consulted before taking the medicine, who may decide to administer an additional medicine with a protective mechanism;
• if the patient has depression and is taking antidepressants, as some of them 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 impaired consciousness (if the patient feels they may faint);
• if the patient is in shock (cold sweat may be a symptom of this condition);
• if the patient has increased intracranial pressure (e.g., due to head injury or brain disease);
• if the patient has difficulty breathing;
• if the patient has porphyria.

Tramadol may lead to physical and psychological dependence. If the medicine is administered for a long time, its effect may weaken, and higher doses may be needed (development of tolerance). In patients with a tendency to abuse medicines or dependent on medicines, treatment with Delanxara should be short-term and under close medical supervision. You should inform your doctor if any of these problems occur during treatment with Delanxara or have occurred in the past.
If the patient experiences any of the following symptoms while taking Delanxara, they should tell their doctor: excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This may indicate that the patient has adrenal insufficiency (low cortisol levels). If such symptoms occur, the patient should contact their doctor, who will decide whether the patient needs hormone replacement.
Tramadol is converted in the liver by an enzyme. In some people, there is a certain variant of this enzyme, which can have different effects. In some people, pain relief may not be sufficient, and in others, the risk of serious side effects may be higher. You should stop taking the medicine and contact your doctor immediately if the patient experiences any of the following side effects: slow breathing or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea, or vomiting, constipation, loss of appetite.
After taking tramadol in combination with certain antidepressants or tramadol alone, there is a small risk of so-called serotonin syndrome. If the patient experiences any symptoms of this syndrome with a severe course, they should immediately seek medical attention (see section 4 "Possible side effects").

Respiratory disorders during sleep

Delanxara may cause respiratory disorders during sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood) .
Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or another person observes these symptoms, they should contact their doctor. The doctor may recommend reducing the dose.

Infections

Delanxara may mask the symptoms of an infection, such as fever and pain. As a result, Delanxara may delay the use of appropriate infection treatment and consequently lead to an increased risk of complications. This has been observed in the course of bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an infection, and the symptoms of the infection persist or worsen, they should immediately consult their doctor.
It is recommended to avoid taking this medicine during chickenpox.

Children and adolescents

This medicine has not been studied in children and adolescents. The safety and efficacy of this medicine have not been established, and therefore, it should not be used in children and adolescents.
Use in children with respiratory disorders
Tramadol is not recommended in children with respiratory disorders, as the symptoms of tramadol toxicity may be exacerbated.

Delanxara and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
Certain medicines should not be taken at the same time, and in the case of other medicines, the dose may need to be changed due to concurrent use.
The patient should always inform their doctor if they are taking any of the following medicines with Delanxara:
It is not recommended to take the following medicines with Delanxara:

• Acetylsalicylic acid, corticosteroids, or other anti-inflammatory medicines;
• Warfarin, heparin, or other anticoagulant medicines;
• 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).

Concomitant use with Delanxara, which requires 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;
• Concomitant use of Delanxara with sedative medicines such as benzodiazepines or other medicines with similar effects to benzodiazepines may increase the risk of sedation, respiratory depression, coma, and can be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible. If the attending doctor prescribes Delanxara to be taken concomitantly with sedative medicines, the dose and duration of treatment should be limited by the doctor. The patient should tell their doctor about all sedative medicines they are taking and strictly follow the attending doctor's instructions. It may be helpful to inform friends and relatives that such symptoms may occur. The patient should contact their attending doctor if such symptoms occur.

Concomitant use with Delanxara, which requires special consideration:

• Quinolone antibiotics (e.g., ciprofloxacin, levofloxacin) used to treat bacterial infections;
• Cyclosporine and tacrolimus used to treat immune system diseases and transplants;
• Streptokinase and other thrombolytic or fibrinolytic medicines, i.e., medicines used to dissolve clots;
• Probenecid used to treat gout;
• Digoxin used to treat chronic heart failure;
• Mifepristone used as an abortion pill;
• Selective serotonin reuptake inhibitors (SSRIs) used to treat depression;
• Antiplatelet agents used to reduce platelet aggregation and blood clot formation;
• Tenofovir, deferasirox, pemetrexed.

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

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

The risk of side effects increases:

• if the patient is taking sedative medicines, sleeping pills, other painkillers, such as morphine and codeine (also for cough), or alcohol while taking Delanxara. The patient may feel drowsy or may feel faint. If this happens, they should tell their doctor;
• if the patient is taking medicines that can cause seizures (convulsions), such as certain antidepressants or antipsychotics. The risk of seizures may increase due to concomitant use of Delanxara. The doctor will decide whether Delanxara is suitable for the patient;
• if the patient is taking certain antidepressants. Delanxara may interact with these medicines and cause serotonin syndrome (see section 4 "Possible side effects");
• if the patient is taking anticoagulant medicines (blood thinners), such as warfarin, together with this medicine. The effect of these medicines on blood clotting may be disrupted, and bleeding may occur.

Delanxara with alcohol

The patient should not drink alcohol while being treated with Delanxara, as it may enhance the effect of the medicine.
Instructions for taking Delanxara - see section 3.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Dexketoprofen may cause kidney and heart problems in the unborn child.
This medicine may increase the risk of bleeding in the patient and child and may cause delayed or prolonged labor. From the 20th week of pregnancy, dexketoprofen may cause:
kidney problems in the unborn child - this may lead to a decrease in the amount of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart.
Tramadol is excreted into breast milk.
Delanxara is contraindicated during pregnancy and breastfeeding.

Driving and using machines

Delanxara may affect the patient's ability to drive and use machines, due to the possibility of dizziness, vision disturbances, or drowsiness as side effects during treatment. This is especially true when Delanxara is taken with medicines that affect mood and emotions or with alcohol.
If the patient observes such symptoms, they should not drive vehicles or operate machinery in motion until the symptoms have resolved.

Delanxara contains sodium

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

3. How to take Delanxara

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor.
The patient should use the smallest effective dose for the shortest duration necessary to relieve the symptoms. If the symptoms (such as fever and pain) persist or worsen during an infection, the patient should immediately consult their doctor (see section 2).
The dose of Delanxara depends on the type, severity, and duration of the pain. The doctor will inform the patient about the number of tablets to take per day and the duration of treatment.
The recommended dose is usually 1 coated tablet (corresponding to 75 mg of tramadol hydrochloride and 25 mg of dexketoprofen) every 8 hours, not more than 3 coated tablets per day (corresponding to 225 mg of tramadol hydrochloride and 75 mg of dexketoprofen), and treatment should not last longer than 5 days.

Use in children and adolescents

Delanxara should not be used in children and adolescents.

Elderly patients

In patients aged 75 or older, the 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 patients on dialysis:

Patients with severe liver and/or kidney disease should not take Delanxara.
In case of kidney problems, if the patient has mild kidney failure, the doctor may recommend prolonging the interval between doses.
In case of liver problems, if the patient has mild or moderate liver failure, the doctor may recommend prolonging the interval between doses.
Delanxara tablets should be swallowed with a sufficient amount of liquid (preferably a glass of water). Food delays the absorption of Delanxara, so for a faster effect, the patient should take the tablet at least 30 minutes before a meal. The dividing line visible on the tablet will help break the tablet in case of difficulty swallowing it whole.

Taking a higher dose of Delanxara than recommended

If the patient takes a higher dose of Delanxara than recommended, they should immediately inform their doctor or go to the emergency department of the nearest hospital. Remember to take the medicine packaging or patient information leaflet with you.
Symptoms of overdose include:

• vomiting, loss of appetite, abdominal pain, drowsiness, dizziness/spinning sensation, disorientation, headache (due to dexketoprofen);
• pupil constriction, vomiting, heart failure, loss of consciousness, seizures, and breathing difficulties (due to tramadol).

Missing a dose of Delanxara

The patient should not take a double dose to make up for a missed dose. The next dose should be taken according to the dosing schedule (see section 3 "How to take Delanxara").

Stopping treatment with Delanxara

It is unlikely that the patient will experience any effects after stopping treatment with Delanxara.
However, in rare cases, patients who have taken Delanxara for some time may feel unwell if treatment is stopped abruptly. They may feel agitated, anxious, nervous, or uncertain, feel confused, overexcited, have sleep problems, or have gastrointestinal disorders. Rarely, patients may experience panic attacks, hallucinations, delusions, or loss of identity. They may experience unusual sensations, such as itching, tingling, numbness, and ringing in the ears. Further unusual symptoms, such as confusion, delusions, depersonalization, and changes in perception of reality (derealization) and persecutory delusions (paranoia), have been observed very rarely. If the patient experiences any of these symptoms after stopping treatment with Delanxara, they should consult their doctor.
If the patient has any further doubts about taking this medicine, they should consult their doctor.

4. Possible side effects

Like all medicines, Delanxara can cause side effects, although not everybody gets them.
Possible side effects are listed below and are grouped according to their frequency:
The patient should immediately contact their doctor if they experience symptoms of an allergic reaction, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives with breathing difficulties.
The patient should stop taking Delanxara as soon as possible if they notice the appearance of a rash or any changes in the mouth or mucous membranes or any signs of an allergic reaction.
Very common(may affect more than 1 in 10 people):

• nausea,
• dizziness.

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

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

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

• increased platelet count,
• effects on the heart and circulation (palpitations, rapid heartbeat, feeling of fainting or collapse), low blood pressure. These side effects 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 edema),
• decreased potassium levels in the blood,
• psychotic disorders,
• swelling around the eyes,
• shallow or slow breathing,
• discomfort, feeling unwell,
• blood in the urine,
• feeling of spinning,
• insomnia or difficulty falling asleep,
• nervousness and/or anxiety,
• hot flashes,
• bloating,
• fatigue,
• pain,
• feeling of heat and chills, general malaise,
• abnormal blood test results,
• tendency to vomit (vomiting reflex),
• feeling of pressure in the stomach, bloating,
• gastritis,
• skin reactions (e.g., itching, rash),
• swelling of the face.

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

• swelling of the lips and throat,
• stomach or duodenal ulcer disease, perforation, or bleeding, which may manifest as bloody vomiting or black stools,
• prostate diseases,
• hepatitis (liver inflammation), liver damage,
• acute kidney failure,
• slow heartbeat,
• seizures,
• allergic reactions and/or anaphylaxis (e.g., difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure),
• transient loss of consciousness (fainting),
• hallucinations,
• fluid retention or swelling of the ankles,
• loss of appetite, changes in appetite,
• acne,
• back pain,
• frequent urination or less than usual, with difficulty or pain,
• menstrual disorders,
• disorders of sensation (e.g., itching, tingling, numbness),
• tremors, muscle spasms, uncoordinated movements, weak muscles,
• confusion,
• sleep disorders and nightmares,
• perception disorders,
• blurred vision, pinpoint pupils,
• shortness of breath.

Psychological side effects may occur after treatment with Delanxara. Their intensity and nature may vary (depending on the patient's personality and duration of treatment) and include:

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

Worsening of asthma has been reported.
Upon sudden cessation of treatment, withdrawal symptoms may occur (see "Stopping treatment with Delanxara").
Seizures have occurred mainly after administration of high doses of tramadol or when tramadol was used at the same time as other medicines that can cause seizures.
Very rare side effects(may affect up to 1 in 10,000 people):

• pancreatitis,
• kidney problems,
• decreased white blood cell count (neutropenia),
• decreased platelet count (thrombocytopenia),
• skin ulcers, mouth ulcers, eye ulcers, and genital ulcers (Stevens-Johnson syndrome and Lyell's syndrome),
• shortness of breath due to bronchospasm,
• ringing in the ears (tinnitus),
• skin hypersensitivity,
• hypersensitivity to light.

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

• serotonin syndrome, whose symptoms may include changes in mental state (e.g., agitation, hallucinations, coma), as well as other symptoms, such as fever, rapid heartbeat, unstable blood pressure, involuntary muscle contractions, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "Important information before taking Delanxara"),
• speech disorders,
• extreme pupil dilation,
• low blood sugar levels,
• hiccups.

The patient should inform their doctor if they notice any side effects related to the stomach or intestines (e.g., stomach pain, heartburn, or bleeding) at the beginning of treatment, if they have experienced similar side effects in the past due to long-term use of anti-inflammatory medicines, especially in the elderly.
The most common side effects during treatment with Delanxara are nausea and dizziness, which occur in more than 1 in 10 patients.
When taking non-steroidal anti-inflammatory medicines, fluid retention and swelling (especially of the ankles and feet) may occur, as well as increased blood pressure and heart failure.
Taking such medicines as Delanxara may be associated with a slight increase in the risk of heart attack ("heart attack") or stroke.
In patients with immune system disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), taking anti-inflammatory medicines may rarely cause fever, headache, and stiffness of the neck/cervical spine.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell 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 the medicine.

5. How to store Delanxara

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month.
There are no special storage temperature requirements for the medicine.
Store in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Delanxara contains

• The active substances of Delanxara are tramadol hydrochloride and dexketoprofen. Each tablet contains 75 mg of tramadol hydrochloride and 25 mg of dexketoprofen (in the form of dexketoprofen trometamol).
• The other ingredients (excipients) are: microcrystalline cellulose (E460), sodium croscarmellose (E 468), anhydrous colloidal 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 inscription K on one side and a dividing line on the other side of the tablet.
Tablet dimensions: approximately 13 mm x 8 mm.
The dividing line on the tablet is only to facilitate breaking the tablet, not to divide it into equal doses.
Delanxara is available in 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 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
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
phone: +48 22 573 75 00

Date of last revision of the leaflet: