Skudexa

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Skudexa (Enanplus)

75 mg + 25 mg, coated tablets
Tramadol hydrochloride + Dexketoprofen
Skudexa and Enanplus are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine because 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.
• 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor. See section 4.

Table of contents of the leaflet:

• 1. What is Skudexa and what is it 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 packaging and other information

1. What is Skudexa and what is it used for

Skudexa 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).
Skudexa is used for the symptomatic short-term treatment of moderate to severe acute pain in adults.
The doctor should be told if the patient does not feel better or feels worse after taking the medicine.

2. Important information before taking Skudexa

When not to take Skudexa:

• if the patient is allergic to dexketoprofen, tramadol hydrochloride, or 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 a history of asthma attacks, acute allergic rhinitis (short-term inflammation of the nasal mucosa), nasal polyps (growths in the nose caused by allergies), urticaria (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) when taking ketoprofen (NSAID) or

fibrates (drugs used to lower blood lipid levels)

• if the patient has stomach or duodenal ulcer disease or gastrointestinal bleeding or if gastrointestinal bleeding, ulceration, or perforation has occurred in the past, including cases due to previous NSAID use
• if the patient has chronic gastrointestinal problems (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 kidney failure, or severe liver failure
• if the patient has a tendency to bleed or 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 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 "Skudexa 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 to take Skudexa, the patient should discuss it with their doctor:

• if the patient has an allergy or has had allergy problems 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., due to high blood pressure, diabetes, high cholesterol, or smoking). In such cases, the doctor should be consulted before taking Skudexa. Taking such medicines as Skudexa may be associated with a slight increase in the risk of heart attack ("myocardial infarction") 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, the doctor should be contacted immediately
• in women with fertility problems: this medicine may affect 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, section entitled "Infections"
• if the patient is taking other medicines that increase the risk of stomach ulcers and/or duodenal ulcers or bleeding, e.g., oral steroids, certain antidepressants (SSRI, i.e., selective serotonin reuptake inhibitors), blood-thinning medicines such as acetylsalicylic acid or anticoagulants such as 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 "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 thinks 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 sign of this condition)
• 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.

Tramadol may lead to physical and psychological dependence. If the medicine is taken 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 Skudexa should be short-term and under close medical supervision. The doctor should be informed if any of these problems occur during treatment with Skudexa or have occurred in the past. If the patient experiences any of the following symptoms while taking Skudexa, they should tell their doctor: excessive tiredness, 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 doctor should be contacted, 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. The patient should stop taking the medicine and contact their doctor immediately if they experience any of the following side effects: slow breathing or shallow breathing, feeling confused, 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 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

Skudexa 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

Skudexa may mask the symptoms of an infection, such as fever and pain. Therefore, Skudexa may delay the use of appropriate infection treatment and consequently lead to an increased 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 the symptoms of the infection persist or worsen, they should immediately consult their doctor. This medicine should be avoided 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.

Skudexa 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 over-the-counter medicines. Some medicines should not be taken at the same time as Skudexa, and for others, the dose may need to be changed when taking Skudexa. The doctor should always be informed if the patient is taking any of the following medicines with Skudexa:
Concomitant use not recommended:

• 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 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.
• Concomitant use of Skudexa with sedative medicines such as benzodiazepines or other medicines with similar effects to benzodiazepines may increase the risk of sedation, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible. If the doctor prescribes Skudexa 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 doctor's instructions. It may be helpful to inform friends and relatives that such symptoms may occur. The doctor should be contacted 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 diseases and transplants
• 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 an abortion pill
• Selective serotonin reuptake inhibitor (SSRI) antidepressants
• Antiplatelet medicines used to reduce platelet aggregation and blood clot formation
• Tenofovir, deferiprone, 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 epilepsy)
• Buprenorphine, nalbuphine, or pentazocine (painkillers)
• Ondansetron (prevents nausea).

The risk of side effects increases:

• if the patient takes sedative medicines, sleeping pills, other painkillers, such as morphine and codeine (also for cough), or alcohol while taking Skudexa. The patient may feel drowsy or may feel faint. If this happens, the doctor should be told
• if the patient takes medicines that can cause seizures (convulsions), 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 anticoagulant medicines (blood-thinning medicines), e.g., warfarin, with this medicine. The effect of these medicines on blood clotting may be disrupted, and bleeding may occur.

Using Skudexa with alcohol

The patient should not drink alcohol while being treated with Skudexa, as this may enhance the effect of the medicine.
Instructions for taking Skudexa - 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 the 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.
Taking Skudexa is contraindicated during pregnancy and breastfeeding.

Driving and using machines

Skudexa may affect the 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 Skudexa is taken with medicines that affect mood and emotions or with alcohol.
If such symptoms are observed, the patient should not drive vehicles or operate machinery in motion until the symptoms have resolved.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially sodium-free.

3. How to take Skudexa

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

Use in children and adolescents

Skudexa should not be used in children and adolescents.

Elderly patients

In patients aged 75 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 (failure)/dialysis patients

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

Overdose

If the patient takes more than the recommended dose of Skudexa, they should immediately inform their doctor or go to the emergency department of the nearest hospital. It is essential to bring the packaging or patient information leaflet with them.
Symptoms of overdose are:

• 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).

Missed dose

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

Stopping Skudexa

It is unlikely that the patient will experience any effects after stopping Skudexa.
However, in rare cases, patients who have taken Skudexa for some time may feel unwell if treatment is stopped abruptly. They may feel agitated, anxious, nervous, or uncertain, confused, restless, sleep disturbances, and gastrointestinal disorders. Rarely, patients may experience panic attacks, hallucinations, delusions, paranoia, 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 any of these symptoms occur after stopping Skudexa, the doctor should be consulted.
If the patient has any further doubts about taking this medicine, they should consult their doctor.

4. Possible side effects

Like all medicines, Skudexa can cause side effects, although not everybody gets them.
Possible side effects are listed below and are grouped according to how often they may occur.
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 urticaria with breathing difficulties.
Skudexa should be stopped as soon as possible if the patient notices the appearance of a rash or any changes in the mouth or mucous membranes or any signs of allergy.
Very common side effects(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 sleep disturbances
• anxiety/nervousness
• hot flashes
• bloating
• fatigue
• pain
• feeling of heat and chills, general malaise
• abnormal blood test results
• nausea (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 and/or 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/anaphylactic reactions (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
• sensory disturbances (e.g., itching, tingling, numbness)
• tremors, muscle spasms, uncoordinated movements, weak muscles
• confusion
• sleep disturbances and nightmares
• perception disorders
• blurred vision, pinpoint pupils
• shortness of breath.

Psychological side effects may occur after treatment with Skudexa. 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.

Asthma has been reported to worsen.
When treatment is stopped abruptly, withdrawal symptoms may occur (see "Stopping Skudexa").
Seizures have mainly occurred 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, lip, eye, 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 status (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 Skudexa)
• speech disorders
• extreme pupil dilation
• low blood sugar
• 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 start of treatment, especially if they have had similar side effects in the past due to long-term use of anti-inflammatory medicines, particularly in elderly patients. The most common side effects during treatment with Skudexa 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 Skudexa may be associated with a slight increase in the risk of heart attack ("myocardial infarction") 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 neck stiffness.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can also be reported directly to the Department of Adverse Reaction Monitoring 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 can be collected on the safety of the medicine.

5. How to store Skudexa

Keep out of 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 month.
There are no special storage temperature requirements.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Skudexa contains

• The active substances of Skudexa are tramadol hydrochloride and dexketoprofen. Each tablet contains 75 mg tramadol hydrochloride and 25 mg dexketoprofen.
• Other ingredients are: Tablet core: microcrystalline cellulose, maize starch, sodium carboxymethylcellulose, sodium stearyl fumarate, colloidal anhydrous silica. Tablet coating: Opadry II white 85F18422 containing: 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 dividing line on one side and an "M" embossing on the other side.
Packaging contents: 10, 20, 30, 50, or 100 coated tablets.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Spain, the country of export:

LABORATORIOS MENARINI, S.A.
Alfons XII, 587 - Badalona (Barcelona)
Spain

Manufacturer:

Menarini – Von Heyden GmbH
Leipziger Strasse 7-13
01097 Dresden
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Spanish marketing authorization number:711033.0

Parallel import authorization number: 315/24

This medicinal product is authorized in the Member States of 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

Date of revision of the leaflet: 05.08.2024

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