Skudexa

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Skudexa
75 mg + 25 mg, coated tablets
Tramadoli hydrochloridum + Dexketoprofenum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• Consult your doctor if you have any doubts.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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

1. What Skudexa is and what it is used for

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

2. Important information before using Skudexa

When not to use Skudexa:

• if the patient is allergic to dexketoprofen, tramadol hydrochloride, 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 asthma or 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 or tongue, or respiratory failure), 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 gastric or duodenal ulcer disease and/or 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 gastrointestinal disorders (e.g. indigestion, heartburn)
• if the patient has inflammatory bowel diseases (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 bleeding disorders or coagulation disorders
• if the patient is severely dehydrated (excessive fluid loss from the body) 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 currently taking monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression) or has taken them within the last 14 days before starting treatment with this medicine (see "Skudexa and other medicines")
• if the patient has epilepsy or seizures, as seizure risk may increase
• if the patient has breathing difficulties
• if the patient is pregnant or breastfeeding.

Warnings and precautions
Before starting treatment with Skudexa, consult a doctor:

• if the patient has allergies or a history of allergic conditions
• if the patient has impaired kidney, liver or heart function (hypertension and/or heart failure), fluid retention, or if any of these conditions occurred previously
• in patients taking diuretics (medicines that increase urine production)
• if the patient has heart disorders, history of stroke, or is suspected of being at risk for these conditions (e.g. due to high blood pressure, diabetes, high cholesterol, or smoking). In such cases, consult a doctor before using Skudexa. Use of medicines such as Skudexa 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 exceed the recommended dose or duration of treatment
• if the patient is elderly: increased risk of adverse effects (see section 4). In such cases, contact a doctor immediately
• in women experiencing difficulty becoming pregnant: this medicine may impair female fertility and is not recommended in women planning pregnancy or undergoing fertility treatment
• if the patient has disorders of blood or blood cell formation
• 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 section below titled "Infections"
• if the patient is taking other medicines that increase the risk of gastric or duodenal ulceration or bleeding, e.g. oral corticosteroids, certain antidepressants (SSRIs – selective serotonin reuptake inhibitors), anticoagulants such as acetylsalicylic acid or anticoagulants such as warfarin. In such cases, consult a doctor before taking Skudexa; the doctor may decide to prescribe an additional medicine to protect the stomach
• if the patient has depression and is taking antidepressants, as some of these may interact with tramadol (see "Skudexa 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 (if the patient feels they may 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 (a disorder affecting heme metabolism).

Tramadol may lead to physical and psychological dependence. If used for a long time, its effect may diminish, requiring higher doses (development of tolerance). In patients with a tendency to drug abuse or dependence, treatment with Skudexa should be short-term and under strict medical supervision. Inform the doctor if any of these problems occur during treatment with Skudexa or have occurred in the past.
If any of the following symptoms occur while taking Skudexa, inform the doctor: excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may indicate adrenal insufficiency (low cortisol levels). If such symptoms occur, contact the doctor, who will decide whether hormone replacement is necessary.
Tramadol is metabolized in the liver by an enzyme. Some individuals have a variant of this enzyme, which may lead to different effects. In some people, pain relief may be insufficient, while in others, severe adverse effects may be more likely. Discontinue use and contact a 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.
When tramadol is taken with certain antidepressants or tramadol alone, there is a small risk of serotonin syndrome. If any symptoms of this serious condition occur, the patient should seek immediate medical advice (see section 4 "Possible side effects").
Sleep-related breathing disorders
Skudexa 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 pauses during sleep, nocturnal 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
Skudexa may mask symptoms of infection such as fever and pain. Therefore, Skudexa 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 infection 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. The safety and efficacy have not been established, and therefore, Skudexa 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 intensified.
Skudexa and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines. Some medicines should not be used together with Skudexa, and for others, dosage adjustment may be necessary when used concurrently with Skudexa. Always inform the doctor if taking any of the following medicines together with Skudexa:
Concomitant use not recommended:

• 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).

Concomitant use requiring caution:

• ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists used to treat high blood pressure and heart diseases
• 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 Skudexa 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, concomitant use should only be considered when no other treatment options are available. If the treating doctor prescribes Skudexa to be used together with sedatives, the dose and duration of treatment should be limited by the doctor. Inform the doctor about all sedative medicines being taken and strictly follow the treating doctor's instructions. It may be helpful to inform friends and family that the above-mentioned symptoms may occur. Contact the treating doctor if such symptoms occur.

Concomitant use 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) used as antidepressants
• 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 (due to 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 using Skudexa. The patient may feel drowsy or feel like fainting. If this occurs, inform the doctor
• if the patient takes medicines that may cause convulsions (seizures), such as certain antidepressants or antipsychotics. The risk of seizures may increase due to concomitant use of Skudexa. The doctor will decide whether Skudexa is suitable for the patient
• if the patient takes certain antidepressants. Skudexa may interact with these medicines and cause serotonin syndrome (see section 4 "Possible side effects")
• if the patient takes anticoagulants (blood-thinning medicines), e.g. warfarin, together with this medicine. The effect of these medicines on blood coagulation may be disturbed, leading to bleeding.

Use of Skudexa with alcohol
Do not drink alcohol during treatment with Skudexa, as this may intensify the medicine's effects.
Instructions for use of Skudexa – see section 3.
Pregnancy, breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a 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 the child and may delay or prolong labour. From the 20th week 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 Skudexa is contraindicated during pregnancy and while breastfeeding.
Driving and operating machinery
Skudexa 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 Skudexa is taken with medicines affecting mood and emotions or with alcohol.
If such symptoms occur, do not drive or operate machinery until symptoms resolve.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to take Skudexa

This medicine should always be taken exactly as directed by the doctor. In case of doubt, consult
your doctor.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.
If, during an infection, symptoms (such as fever and pain) persist or worsen, consult your doctor
immediately (see section 2).
Your doctor will inform you about the dose of Skudexa, which will depend on the type, severity,
and duration of your pain. The doctor will also inform you about the number of tablets to be taken
per day and the duration of treatment.
The usual recommended daily dose is 1 coated tablet (equivalent to 75 mg of tramadol hydrochloride
and 25 mg of dexketoprofen) every 8 hours. The total daily dose should not exceed 3 coated tablets
(equivalent 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
Skudexa must not be used in children and adolescents.

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

Patients with severe liver or kidney disease (impaired function)/dialysis patients
Patients with severe liver disease and/or kidney failure must not take Skudexa.
In case of impaired kidney function, if the patient has mild kidney failure, the doctor may recommend
prolonging the interval between doses.
In case of impaired liver function, if the patient has mild or moderate liver failure, the doctor may
recommend prolonging the interval between doses.

Skudexa tablets should be swallowed with sufficient fluid (preferably a glass of water).
Food delays the absorption of Skudexa; therefore, to achieve a faster effect, the tablet should be
taken at least 30 minutes before a meal. The division line visible on the tablet will help break the
tablet if you have difficulty swallowing it whole.

Taking more Skudexa than recommended
If you take more Skudexa than recommended, contact your doctor immediately or go to the
emergency department of your nearest hospital. Remember to bring the medicine pack or the patient
leaflet with you.
Symptoms of overdose include:

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

Missing a dose of Skudexa
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 Skudexa").

Stopping Skudexa treatment
Withdrawal effects after stopping Skudexa treatment are unlikely.
However, in rare cases, patients who have taken Skudexa for some time may feel unwell if treatment
is abruptly discontinued. They may experience restlessness, anxiety, nervousness, feel uneasy,
confused, hyperactive, have sleep disturbances, or gastrointestinal problems. Rarely, patients may
experience panic attacks, hallucinations, delusions, paranoia, or depersonalization. Unusual
sensations such as itching, tingling, numbness, and ringing in the ears (tinnitus) may occur. Very
rarely, additional unusual 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 Skudexa, consult your doctor.

If you have any further doubts about using this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The possible side effects are listed below, grouped according to the likelihood of their occurrence.
Contact a doctor immediately 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 Skudexa as quickly as possible if the patient notices the appearance of a rash or any changes inside the oral cavity or on mucous membranes, or any symptoms of allergy.

Very common side effects (may occur in more than 1 in 10 people):

• nausea
• dizziness.

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

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

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

• increased platelet count
• effects on the heart and blood circulation (palpitations, rapid heartbeat, feeling faint 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 oedema)
• decreased potassium levels in the blood
• psychotic disorders
• swelling around the eye
• shallow or slow breathing
• discomfort, abnormal sense of well-being
• blood in urine
• sensation of spinning
• insomnia or difficulty falling asleep
• nervousness/anxiety
• hot flushes
• bloating
• fatigue
• pain
• feeling feverish and chills, general malaise
• abnormal blood test results
• tendency to vomit (vomiting reflex)
• feeling of pressure in the stomach, bloating
• stomach inflammation
• skin reactions (e.g. itching, rash)
• memory impairment
• facial swelling.

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

• swelling of lips and throat
• peptic ulcer of the stomach and (or) duodenum, perforation or bleeding, which may present as bloody vomit or black stools
• prostate disorders
• liver inflammation (hepatitis), liver damage
• acute kidney failure
• slow heartbeat
• seizures
• allergic/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, changes in appetite
• acne
• back pain
• frequent urination or less than usual, with difficulty or pain
• menstrual disorders
• sensory disturbances (e.g. itching, tingling, numbness)
• tremor, muscle spasms, uncoordinated movements, weak muscles
• confusion
• sleep disturbances and nightmares
• perceptual disturbances
• blurred vision, pinpoint pupils
• shortness of breath.

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

• mood changes (mostly elevated mood, sometimes irritability)
• changes in activity (slowing down, but sometimes increased activity)
• feeling less aware
• reduced decision-making ability, which may lead to errors in judgment.

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

Very rare side effects (may occur in up to 1 in 10,000 people):

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

Frequency not known (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 Skudexa)
• speech disorders
• extreme dilation of the pupils
• decreased blood sugar levels
• hiccups.

Inform the doctor if the patient experiences any gastrointestinal side effects at the beginning of treatment (e.g. stomach pain, heartburn or bleeding), especially if the patient has previously experienced similar side effects due to long-term use of anti-inflammatory medicines, particularly in elderly individuals.
The most common side effects during treatment with Skudexa are nausea and dizziness, occurring in more than 1 in 10 patients.
When administering non-steroidal anti-inflammatory drugs, fluid retention and oedema (especially of the ankles and legs) may occur, as well as increased blood pressure and heart failure.
Taking medicines such as Skudexa may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
In patients with immunological connective tissue disorders (systemic lupus erythematosus or mixed connective tissue disease), administration of anti-inflammatory medicines may rarely cause fever, headache and neck stiffness.

Reporting of side effects
If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects 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
By reporting side effects, more information on the safety of this medicine can be collected.

5. How to store Skudexa

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special temperature storage conditions are required.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Skudexa contains

• The active substances in this medicine are tramadol hydrochloride and dexketoprofen. Each tablet contains 75 mg of tramadol hydrochloride and 25 mg of dexketoprofen.
• Other ingredients are:
  Tablet core: microcrystalline cellulose, pregelatinized maize starch, sodium croscarmellose, sodium stearyl fumarate, colloidal anhydrous silica.
  Tablet coating: Opadry II white 85F18422, which contains: polyvinyl alcohol, titanium dioxide (E 171), macrogol (PEG) 3350, talc.

What Skudexa looks like and contents of the pack
Skudexa tablets are almost white to slightly yellowish, oblong coated tablets with a break line on one side and an embossed "M" on the other.
Pack contents: 10, 20, 30, 50 or 100 coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Greece, the country of export:
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

Manufacturer:
Menarini - Von Heyden GmbH
Leipziger Strasse 7-13, 01097 Dresden, Germany

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Relabelled and/or repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorisation Number in Greece, the country of export: 3874/18-01-2017
Parallel Import Licence Number: 97/26

This medicine is authorised for sale in the European Economic Area under the following names:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, Greece, Hungary, Ireland, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, United Kingdom (Northern Ireland): Skudexa
France: Skudexum
Spain: Enanplus
Italy: Lenizak