Enanplus 75 mg/25 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Enanplus 75 mg/25 mg film-coated tablets

tramadol hydrochloride, dexketoprofen

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Enanplus is and what it is used for

2. What you need to know before taking Enanplus

3. How to take Enanplus

4. Possible side effects

5. How to store Enanplus

6. Package contents and other information

1. What Enanplus is and what it is used for

Enanplus contains the active substances tramadol hydrochloride and dexketoprofen.

Tramadol hydrochloride is an analgesic belonging to the opioid group that acts 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 the group of non-steroidal anti-inflammatory drugs (NSAIDs).

Enanplus is used for the short-term symptomatic treatment of moderate to severe acute pain in adults.

You should consult a doctor if you do not feel better or if your condition worsens.

2. What you need to know before taking Enanplus

Do not take Enanplus

• if you are allergic to dexketoprofen, tramadol hydrochloride, or any of the other components of this medicine (listed in section 6)
• if you are allergic to acetylsalicylic acid or to another NSAID
• if you have had asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (fleshy growths inside the nose due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips, or tongue, or difficulty breathing), or wheezing in the chest after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)
• if you have experienced photoallergic or phototoxic reactions (a special type of redness or sunburn-like skin damage on sun-exposed skin) while taking ketoprofen (an NSAID) or fibrates (medicines used to reduce blood fat levels)
• if you have peptic ulcer, stomach or intestinal bleeding, or have previously experienced gastrointestinal bleeding, ulceration, or perforation, including cases related to prior use of NSAIDs
• if you have chronic digestive problems (e.g., indigestion, heartburn)
• if you have chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
• if you have severe heart failure, moderate to severe renal failure, or severe hepatic impairment
• if you have bleeding disorders or blood coagulation disorders
• if you are severely dehydrated (have lost a large amount of body fluid) due to vomiting, diarrhea, or insufficient fluid intake
• if you have acute alcohol intoxication, or are under the influence of sleeping pills, analgesics, or medicines affecting mood and emotions
• if you are also taking monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression), or have taken them within the last 14 days before starting treatment with this medicine (see “Use of Enanplus with other medicines”)
• if you have epilepsy or suffer from seizures, as the risk of seizures may increase
• if you have difficulty breathing
• if you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor before starting to take Enanplus:

• if you are allergic or have had allergic problems in the past;
• if you have kidney, liver, or heart disease (hypertension and/or heart failure), fluid retention, or have had any of these conditions in the past;
• if you are taking diuretics;
• if you have heart problems, history of stroke, or think you may be at risk of these conditions (e.g., if you have high blood pressure, diabetes, high cholesterol, or are a smoker); you should discuss this treatment with your doctor. Medicines like this may be associated with a small increased risk of heart attacks (myocardial infarction) or stroke. The risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment;
• if you are elderly: you may be more likely to experience adverse effects (see section 4). If these occur, consult your doctor immediately;
• if you are a woman with fertility problems: This medicine may affect fertility, so you should not take it if you are planning to become pregnant or undergoing fertility investigations;
• if you have a disorder affecting blood and blood cell production;
• if you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• if you have previously suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
• if you currently have or have previously had stomach or intestinal disorders;
• if you have an infection; see the section titled “Infections” below;
• if you are taking other medicines that increase the risk of peptic ulcer or bleeding, such as oral corticosteroids, certain antidepressants (SSRIs, selective serotonin reuptake inhibitors), or agents that prevent blood clotting like aspirin or anticoagulants such as warfarin. In such cases, consult your doctor before taking this medicine: your doctor may prescribe an additional medicine to protect your stomach;
• if you have depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and Enanplus”);
• if you are taking other medicines containing the same active substances as this medicine, do not exceed the maximum daily dose of dexketoprofen or tramadol;
• if you think you may be addicted to other painkillers (opioids);
• if you have disturbances in consciousness (if you feel you might faint);
• if you are in shock (a sign of this condition may be cold sweating);
• if you have increased intracranial pressure (possibly after brain injury or brain disease);
• if you have difficulty breathing;
• if you have porphyria (a disorder characterized by abnormal heme metabolism).

Tolerance, dependence, and addiction

This medication contains Tramadol, which is an opioid. It may cause dependence and/or addiction.

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may cause the medicine to become less effective (you become accustomed to it, known as tolerance).

Repeated use of Enanplus may also lead to dependence, abuse, and addiction, which can result in potentially fatal overdose. The risk of these side effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you no longer control the amount of medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a higher risk of becoming dependent or addicted to Enanplus if:

• You or someone in your family has abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have previously had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs while taking Enanplus, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than advised by your doctor
• You need to take more than the recommended dose
• You feel that you need to keep taking the medicine, even when it does not help relieve your pain
• You use the medicine for reasons other than those prescribed, for example, "to stay calm" or "to sleep"
• You have repeatedly tried and failed to stop or control the use of the medicine
• When you stop taking the medicine, you feel unwell, and feel better when you start taking it again ("withdrawal effect")

If you notice any of these signs, speak with your doctor so they can advise you on the best course of treatment, including when it is appropriate to stop taking it and how to do so safely (see section 3, If you stop taking Enanplus).

Talk to your doctor if you experience any of the following symptoms while taking Enanplus: extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This may indicate adrenal insufficiency (low cortisol levels). If you experience any of these symptoms, inform your doctor, who will decide whether you need hormonal supplementation.

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may affect individuals differently. In some people, sufficient pain relief may not be achieved, while others may be more likely to experience serious adverse effects. If you notice any of the following adverse effects, you must stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, or vomiting, constipation, loss of appetite.

There is a weak risk that you may experience serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol as monotherapy. Seek immediate medical advice if you develop any symptoms related to this serious syndrome (see section 4, "Possible side effects").

Sleep-related breathing disorders

Enanplus may cause sleep-related breathing disorders such as central sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). These symptoms may include pauses in breathing during sleep, nighttime awakening due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Infections

Enanplus may mask signs of infection, such as pain. Therefore, Enanplus may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor without delay.

During chickenpox, it is recommended to avoid using this medicine.

Kounis syndrome

With dexketoprofen, cases of allergic reaction to this medicine have been reported, including breathing problems, swelling of the face and neck area (angioedema), and chest pain. Immediately discontinue treatment with Enanplus and contact your doctor or the nearest emergency service immediately if you notice any of these symptoms.

Children and adolescents

This medicine has not been studied in children or adolescents. Therefore, safety and efficacy have not been established, and the medicine should not be used in children or adolescents.

Use in children with breathing problems

The use of tramadol is not recommended in children with breathing problems, as symptoms of tramadol toxicity may worsen in these children.

Use of Enanplus with other medicines

Inform your doctor if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription. Some medicines should not be taken together, and others may require dose adjustments when taken together.

Always inform your doctor if, in addition to Enanplus, you are taking any of the following medicines:

Combinations with Enanplus not recommended:

• Acetylsalicylic acid, corticosteroids, or other anti-inflammatory medicines
• Warfarin, heparin, or other medicines used to prevent blood clotting
• Lithium, used to treat certain mood disorders
• Methotrexate, used for rheumatoid arthritis and cancer
• Hydantoins and phenytoin, used for epilepsy
• Sulfamethoxazole, used for bacterial infections
• Monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression)

Combinations with Enanplus requiring caution:

• ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists, used to control high blood pressure and heart disorders
• Pentoxifylline, used to treat chronic venous ulcers
• Zidovudine, used to treat viral infections
• Chlorpropamide and glibenclamide, used for diabetes
• Aminoglycoside antibiotics, used to treat bacterial infections
• Concomitant use of Enanplus and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Because of this, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes Enanplus together with sedative medicines, the dose and duration of concomitant treatment should be limited. Inform your doctor about all sedative medicines you are taking and follow carefully the dose recommended by your doctor. It may be helpful to inform friends or family members to watch for the signs and symptoms mentioned above. Contact your doctor if you experience these symptoms.

Combinations with Enanplus to be considered:

• Quinolones (e.g., ciprofloxacin, levofloxacin), used for bacterial infections
• Cyclosporine or tacrolimus, used to treat immune system disorders and in organ transplants
• Streptokinase and other thrombolytic and fibrinolytic medicines; i.e., medicines used to dissolve clots
• Probenecid, used for gout
• Digoxin, used in the treatment of chronic heart failure
• Mifepristone, used for termination of pregnancy
• Antidepressants of the Selective Serotonin Reuptake Inhibitors (SSRIs) type
• Antiplatelet agents used to reduce platelet aggregation and clot formation
  • Tenofovir, deferasirox, pemetrexed

The analgesic effect of tramadol may be reduced and its duration of action shortened if you also take medicines containing:

• Carbamazepine (for epileptic seizures)
• Buprenorphine, nalbuphine, or pentazocine (analgesics)
• Ondansetron (prevents nausea)

The risk of adverse effects increases:

• if you are taking gabapentin or pregabalin to treat epilepsy or nerve-related pain (neuropathic pain)
• if you take tranquilizers, sleeping pills, other analgesics such as morphine and codeine (also as a cough medicine), or alcohol while taking Enanplus. You may feel sleepy or feel like you might faint. Consult your doctor if this occurs
• if you are taking medicines that may cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take Enanplus at the same time. Your doctor will advise you whether Enanplus is suitable for you
• if you are taking certain antidepressants. Enanplus may interact with these medicines and you may experience serotonin syndrome (see section 4, "Possible side effects")
  • if you take anticoagulants (medicines to thin the blood), e.g., warfarin, together with this medicine. The effect of these medicines may affect blood clotting and bleeding may occur

Taking Enanplus with alcohol

Do not drink alcohol during treatment with Enanplus, as it may increase the effect of the medicine.

For instructions on how to take Enanplus, see section 3.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Dexketoprofen may cause kidney and heart problems in your unborn baby. It may affect your and your baby's tendency to bleed and may delay or prolong labor more than expected. From week 20 of pregnancy, dexketoprofen may cause kidney problems in your unborn baby, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or constriction of a blood vessel (ductus arteriosus) in the baby's heart.

Tramadol is excreted in breast milk.

The use of Enanplus is contraindicated during pregnancy and during breastfeeding.

Driving and using machines

Enanplus may affect your ability to drive and use machines, as it may cause dizziness, blurred vision, or drowsiness as side effects of treatment. This mainly occurs when Enanplus is taken with medicines that affect mood and emotions, or when taken with alcohol.

If you are affected, do not drive or use machines until symptoms resolve.

This medicine contains less than 1 mmol of sodium (23 mg) per dose unit; i.e., essentially "sodium-free".

3. How to take Enanplus

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor again.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (pain) persist or worsen (see section 2).

The dose of Enanplus you need may vary depending on the type, intensity, and duration of pain.

Before starting treatment and regularly during treatment, your doctor will explain what you can expect from using Enanplus, when and for how long you should take it, when you should contact your doctor, and when you should discontinue it (see also "If you stop taking Enanplus").

The recommended dose is generally 1 film-coated tablet (corresponding to 75 mg of tramadol hydrochloride and 25 mg of dexketoprofen) every 8 hours, without exceeding 3 film-coated tablets per day (corresponding to 225 mg of tramadol hydrochloride and 75 mg of dexketoprofen) and without exceeding 5 days of treatment.

Use in children and adolescents

Enanplus is not suitable for children and adolescents.

Elderly patients

If you are 75 years of age or older, your doctor may recommend prolonging the dosing interval, as your body may eliminate the medicine more slowly.

Patients with severe hepatic or renal impairment/dialysis:

Patients with severe hepatic or renal impairment must not take Enanplus.

In case of renal dysfunction, if the impairment is mild, your doctor may recommend prolonging the dosing interval.

In case of hepatic dysfunction, if the impairment is mild or moderate, your doctor may recommend prolonging the dosing interval.

Swallow the tablet with sufficient liquid (preferably with a glass of water).

Food delays the absorption of Enanplus; take the tablet at least 30 minutes before meals for faster action.

The score line is intended to help divide the tablet if you have difficulty swallowing it whole.

If you take more Enanplus than you should

If you have taken too much medicine, inform your doctor immediately or go to the nearest hospital emergency department or call the Toxicology Information Service at: 91.562.04.20, indicating the medicine and the amount taken. Please remember to always bring the medicine packaging or this leaflet with you.

Symptoms of overdose with this medicine are:

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

If you forget to take Enanplus

Do not take a double dose to make up for forgotten doses. Take the next dose at the scheduled time (according to section 3 "How to take Enanplus").

If you stop taking Enanplus

Generally, no withdrawal effects are expected after discontinuation of Enanplus treatment.

However, on rare occasions, patients who have been taking Enanplus tablets for some time may feel unwell if they stop taking it suddenly. They may experience restlessness, anxiety, nervousness or tremors, confusion, hyperactivity, difficulty sleeping, and gastrointestinal or stomach disorders. Rarely, people may experience panic attacks, hallucinations, delirium, paranoia, or a sense of loss of identity. They may experience unusual sensations such as itching, tingling, and numbness, or ringing in the ears (tinnitus). Very rarely, other unusual symptoms such as confusion, delirium, feeling detached from oneself (depersonalization), altered perception of reality (derealization), or delusions of persecution (paranoia) have been observed. Please consult your doctor if you experience any of these effects after stopping Enanplus.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The possible adverse effects are listed below according to their likelihood of occurrence.

You must contact a doctor immediately if you experience symptoms of an allergic reaction such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives together with difficulty breathing.

Stop using Enanplus if you experience a skin rash, any lesions inside the mouth or on mucous membranes, or any signs of allergy.

Very common adverse effects (may affect more than 1 in 10 people):

• Nausea/discomfort
• Dizziness

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

• Vomiting
• Stomach pain
• Diarrhea
• Digestive problems
• Headache
• Drowsiness, fatigue
• Constipation
• Dry mouth
• Increased sweating

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

• Increase in platelet count
• Effects on the heart and blood circulation (strong heartbeats, rapid heartbeats, feeling faint or collapse), low blood pressure. These adverse effects may occur especially when patients are in an upright position or under physical stress.
• High or very high blood pressure
• Inflammation of the larynx (laryngeal edema)
• Low levels of potassium in the blood
• Psychotic disturbances
• Swelling around the eyes
• Shallow or slow breathing
• Feeling unwell
• Blood in urine
• Sensation of spinning (vertigo)
• Lack of sleep or difficulty sleeping
• Nervousness/anxiety
• Hot flushes
• Flatulence
• Tiredness
• Pain
• Feeling of fever or chills, general feeling of malaise
• Abnormal blood test results
• Feeling of needing to vomit (nausea)
• Feeling of pressure or bloating in the stomach
• Inflammation of the stomach
• Skin reactions (e.g., itching, rash)
• Amnesia
• Swelling of the face

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

• Swelling of the lips and throat
• Peptic ulcer, perforation of peptic ulcer or bleeding, which may present as vomiting blood or black stools
• Prostate disorders
• Inflammation of the liver (hepatitis), liver damage
• Acute kidney failure
• Slow heart rate
• Seizures
• Allergic/anaphylactic reactions (e.g., difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure)
• Transient loss of consciousness (syncope)
• Hallucinations
• Fluid retention and swelling of ankles
• Loss of or changes in appetite
• Acne
• Lower back pain
• Need to urinate frequently, or less than normal, with difficulty or pain
• Menstrual disorders
• Abnormal sensations (e.g., itching, tingling, loss of sensitivity)
• Tremor, muscle spasms, uncoordinated movements, muscle weakness
• Confusion
• Sleep disturbances and nightmares
• Altered perception
• Blurred vision, pupil constriction
• Shortness of breath

Psychological adverse effects may occur after treatment with Enanplus. The intensity and nature of these effects may vary (depending on the patient's personality and duration of treatment):

• Changes in mood (mainly euphoria and occasionally irritability)
• Changes in activity (slowing down, although sometimes increased activity)
• Loss of consciousness
• Loss of decision-making ability, which may lead to impaired judgment.

Cases of worsening asthma have been reported.

Signs of withdrawal may occur when treatment is stopped suddenly (see "If you stop taking Enanplus").

Cases of seizures have been reported, mainly when high doses of tramadol are administered or when tramadol is taken concomitantly with other medicines that may provoke them.

Very rare (may affect up to 1 in 10,000 people):

• Inflammation of the pancreas
• Kidney problems
• Reduction in blood cell count (neutropenia)
• Reduction in platelets in blood (thrombocytopenia)
• Skin, mouth, eye and genital ulcers (Stevens-Johnson syndrome and Lyell syndrome)
• Breathing difficulty due to narrowing of the airways
• Ringing in the ears (tinnitus)
• Sensitive skin
• Light sensitivity

Unknown frequency (cannot be estimated from available data)

• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome
• Fixed drug eruption, an allergic skin reaction known as fixed drug eruption, which may include round or oval red patches and skin swelling, blisters and itching. Darkening of the skin in affected areas may also occur, which may persist after healing. Fixed drug eruption usually reappears in the same location(s) if the medicine is taken again
• Serotonin syndrome, which may present with changes in mental status (e.g., agitation, hallucinations, coma) and other effects 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, diarrhea) (see section 2 "What you need to know before taking Enanplus")
• Speech disturbances
• Extreme dilation of the pupils
• Decreased blood sugar levels
• Hiccups

Inform your doctor immediately if you notice any gastrointestinal adverse effects at the beginning of treatment (e.g., stomach pain or burning, or bleeding), especially if you have previously experienced any of these adverse effects due to long-term treatment with anti-inflammatory medicines, and particularly if you are an elderly patient.

The most common adverse effects during treatment with Enanplus are nausea and dizziness, which affect more than 1 in 10 patients.

During treatment with NSAIDs, cases of fluid retention and swelling (especially in ankles and legs), increased blood pressure, and heart failure have been reported.

Medicines such as Enanplus may be associated with a small increased risk of heart attack or stroke.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Enanplus

Keep this medicine out of the sight and reach of children.

Store this medicine in a safe and secure place, where others cannot access it. It may cause serious harm or even be fatal to individuals for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the packaging and sachet after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Keep in the original packaging to protect it from light.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to your pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Enanplus:

• The active substances are tramadol hydrochloride and dexketoprofen. Each tablet contains: 75 mg of tramadol hydrochloride and 25 mg of dexketoprofen.
• The other components are:

Tablet core: Microcrystalline cellulose; Pregelatinized corn starch; Sodium croscarmellose; Stearyl fumarate sodium; Colloidal anhydrous silica.

Coating: Opadry II white 85F18422 composed of polyvinyl alcohol; Titanium dioxide; Macrogol/PEG 3350; Talc.

Appearance of the product and contents of the pack:

Film-coated tablets, almost white or slightly yellowish, oval-shaped, with a score line on one side and an "M" imprinted on the other side, in plastic/aluminum blisters for manual push-through extraction.

Enanplus is available in packs of 2, 4, 10, 15, 20, 30, 50 or 100 film-coated tablets, and in multipacks composed of 5 packs, each containing 100 film-coated tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

LABORATORIOS MENARINI, S.A.

Alfons XII, 587 - Badalona (Barcelona)

Spain

Manufacturer

Menarini – Von Heyden GmbH

Leipziger Strasse 7-13

01097 Dresden

Germany

This medicinal product is authorized in the European Economic Area member states 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, Slovak Republic, Slovenia, Sweden, United Kingdom (Northern Ireland): Skudexa

France: Skudexum

Italy: Lenizak

Spain: Enanplus

Date of the most recent review of this leaflet: December 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/