Enanplus 75 mg/25 mg drinking solution / Skudexa

Active ingredient: tramadol hydrochloride / dexketoprofen

20 bag

What this leaflet says
1 What is Enanplus 75 mg / 25 mg and what is it used for?
2) What should you be aware of before taking Enanplus?
3) How should Enanplus be taken?
4. what are the possible side effects?
5. how should enanplus be stored?
6. contents of the pack and other information
1. what is enanplus and what is it used for?

Enanplus contains the active substances tramadol hydrochloride and dexketoprofen. Tramadol hydrochloride is an analgesic substance which belongs to the group of opioids that act in the central nervous system. It relieves pain through its effect on certain nerve cells in the brain and spinal cord. Dexketoprofen is an analgesic that belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Enanplus is used in adults for the short-term symptomatic treatment of acute, moderate to severe pain.
If you do not feel better or if you feel worse, contact your doctor.
What should you know before taking Enanplus?

Enanplus must not be taken

- if you are allergic to dexketoprofen, tramadol hydrochloride or any of the other ingredients of this medicine listed in section 6.
- if you are allergic to acetylsalicylic acid or other NSAIDs.
- if you have asthma or have had asthma attacks, acute allergic rhinitis (short-lived inflammation of the lining of the nose), nasal polyps (allergy-related outpouchings of the lining of the nose), urticaria (hives), angioedema (swelling of the face, eyes, lips or tongue, or shortness of breath) or a whistling breathing sound in your chest after taking acetylsalicylic acid or other NSAIDs.
- If you have ever had a photoallergic or phototoxic reaction (redness/blistering of skin exposed to sunlight) during therapy with ketoprofen (an NSAID) or fibrates (a medicine that lowers blood lipids).
- if you have a history of gastrointestinal ulceration, gastrointestinal bleeding or if you have a history of gastrointestinal bleeding, gastrointestinal ulceration or gastrointestinal perforation, including those due to previous 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 muscle weakness (cardiac insufficiency), moderate to severe kidney dysfunction or severe liver dysfunction
- if you have an abnormal bleeding tendency or a blood clotting disorder
- if you are severely dehydrated (significant loss of fluid from the body), e.g. due to vomiting, diarrhoea or insufficient fluid intake
- If you are suffering from acute intoxication by alcohol, sleeping pills, painkillers or medicines that affect your mood or emotional life.
- if you are taking MAO inhibitors (certain medicines that work against morbid sadness (depression)) at the same time or have taken them within the last 14 days before treatment with this medicine (see "Taking Enanplus with other medicines")
- if you have epilepsy or are prone to seizures, as the risk of seizures may be increased
- if you have difficulty breathing
- if you are pregnant or breastfeeding

Warnings and precautions

Please talk to your doctor or pharmacist before taking Enanplus
- if you suffer or have suffered from allergies
- if you currently have or have had kidney, liver or heart disease (high blood pressure and/or heart failure) or water retention in the tissues (oedema)
- if you are taking diuretics (diuretic medicines)
- if you have heart problems or a previous 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 your treatment with your doctor. Medicines like S Enanplus may be associated with a slightly increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and longer treatment. Do not exceed the recommended dose or duration of treatment!
- if you are an elderly patient: You may experience side effects more frequently (see section 4.). If side effects occur, inform your doctor immediately.
- if you are a woman who has problems getting pregnant: This medicine may make it difficult for you to get pregnant. Therefore, you should not take it if you are planning to become pregnant or are undergoing tests for reproductive ability.
- if you have a blood formation or blood cell development disorder.
- if you have systemic lupus erythematosus or mixed connective tissue diseases (i.e. diseases of the immune system that affect connective tissue)
- You have a history of inflammatory bowel disease (ulcerative colitis, Crohn's disease).
- If you are currently suffering or have suffered in the past from other gastrointestinal disorders.
- If you have a varicella infection (chickenpox infection), as NSAIDs can in rare cases make the infection worse.
- if you are taking other medicines at the same time that may increase the risk of stomach/duodenal ulcers or bleeding, such as oral corticosteroids, certain medicines for depression (of the SSRI type, called selective serotonin reuptake inhibitors), medicines to prevent blood clots such as acetylsalicylic acid, or anti-clotting medicines such as warfarin: In these cases, ask your doctor for advice before using this medicine. Your doctor may advise you to take an additional medicine that protects the stomach lining.
- if you are taking medicines containing the same active ingredients as this medicine at the same time, do not exceed the maximum daily dose of dexketoprofen or tramadol!
- if you think you are dependent on other painkillers (opioids)
- if you have a disorder of consciousness (if you feel close to fainting)
- if you are in a state of shock (cold sweat may be a sign of this)
- if you have conditions with increased intracranial pressure (possibly following a head injury or disease of the brain)
- If you have difficulty breathing
- If you have porphyria
Tramadol can lead to mental and physical dependence. With prolonged
the effect of this medicine may decrease and you may need to take more medicine.
higher doses of the medicine have to be taken (development of tolerance). In patients who are prone to
patients who are prone to abuse or dependence on medicines.
Enanplus should only be given for a short period of time and under strict medical supervision.
Tell your doctor if any of these problems occur while you are taking Enanplus or if you have experienced them in the past.

Children and adolescents

Enanplus has not been studied in children and adolescents. Therefore, the safety and efficacy in them has not been established, Enanplus must not be used in children and adolescents.
Taking Enanplus with other medicines

Tell your doctor or pharmacist if you are using, have recently used or intend to use any other medicines, including medicines obtained without a prescription. There are some medicines that must not be used together and some that require an adjustment of dosages when used together.
Always inform your doctor if you are using or have received any of the following medicines in addition to Enanplus:
Combination with Enanplus not recommended:
- Acetylsalicylic acid, glucocorticoids or other anti-inflammatory drugs (NSAIDs).
- Warfarin, heparin or other medicines used to prevent blood clots.
- Lithium (used to treat some mental illnesses)
- Methotrexate (used to treat rheumatoid arthritis and cancer)
- Hydantoin derivatives and phenytoin (used to treat epilepsy)
- Sulfamethoxazole (for the treatment of bacterial infections)
- Monoamine oxidase inhibitors (MAO inhibitors, medicines used to treat depression).
Precautions are needed when combining with Enanplus:
- ACE inhibitors, diuretics, beta-blockers and angiotensin II antagonists (used to treat high blood pressure and heart disease).
- Pentoxifylline (for the treatment of chronic venous ulcers)
- Zidovudine (for the treatment of viral infections)
- Chlorpropamide and glibenclamide (for the treatment of diabetes mellitus)
- Aminoglycoside antibiotics (for the treatment of bacterial infections)
Care should be taken when combining with Enanplus:
- Quinolone antibiotics, e.g. ciprofloxacin, levofloxacin (for the treatment of bacterial infections)
- Ciclosporin or Tacrolimus (for the treatment of certain immune diseases and to prevent transplant rejection)
- Streptokinase and other thrombolytics or fibrinolytics (to dissolve blood clots)
- Probenecid (for the treatment of gout)
- Digoxin (used to treat heart muscle weakness)
- Mifepristone (medicine used to terminate pregnancy)
- Certain antidepressants (selective serotonin reuptake inhibitors/SSRIs)
- Platelet aggregation inhibitors (to reduce blood clots)
- Tenofovir, deferasirox, pemetrexed
The pain-relieving effect of tramadol may be reduced and the duration of action may be shortened if you are taking medicines containing any of the following active ingredients:
- Carbamazepine (for epileptic seizures).
- buprenorphine, nalbuphine or pentazocine (painkillers)
- Ondansetron (for nausea)
The risk of side effects increases
- if you use sedatives, sleeping pills and certain painkillers such as morphine and codeine (also used as cough suppressants) and alcohol at the same time as Enanplus. You may feel dizzy or close to fainting. If this happens, please tell your doctor.
- if you are taking medicines that can cause convulsions (epileptic seizures), such as certain medicines for depression or psychosis. The risk of seizures may increase if you take Enanplus at the same time. Your doctor will tell you if Enanplus is suitable for you.
- if you are taking certain medicines for depression. The effects of these medicines and Enanplus may interact and you may experience symptoms such as involuntary rhythmic muscle twitching, including eye twitching (twitching of the muscles that control eye movement), restlessness, excessive sweating, involuntary tremor, increased reflexes, increased muscle tension, body temperature above 38°C.
- if you are taking anticoagulants (medicines that prevent normal blood clotting), e.g. warfarin, at the same time as this medicine. The anticoagulant effect of these medicines may be affected and bleeding may occur.

Taking Enanplus with alcohol

Do not take alcohol during treatment with Enanplus as it may increase the (side) effects of this medicine.
Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Enanplus must not be taken during pregnancy or breast-feeding.
Driving and ability to use machines

Enanplus may affect your ability to drive and use machinery due to the possible side effects of dizziness/drowsiness, blurred vision and drowsiness. This is especially true if you use Enanplus with medicines that affect mood and emotional life or if you take alcohol.
If you experience any of these side effects, do not drive or operate machinery until the symptoms have subsided.
How should Enanplus be taken?

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Use in adults
The dose of Enanplus you need depends on the type, intensity and duration of your pain. Your doctor will tell you how many film-coated tablets to take each day and for how long.
The recommended dose is usually 1 film-coated tablet (equivalent to 75 mg tramadol hydrochloride and 25 mg dexketoprofen) every 8 hours, and no more than 3 film-coated tablets (equivalent to 225 mg tramadol hydrochloride and 75 mg dexketoprofen) per day. The duration of treatment should not exceed 5 days.
Use in children and adolescents 
Enanplus is not suitable for children and adolescents.
Elderly patients
If you are 75 years or older, your doctor may advise you to increase the interval between doses because your body may process the medicine more slowly.
Severe liver or kidney dysfunction/dialysis patients.
Patients with severe liver and/or kidney dysfunction must not take Enanplus.
If the kidney dysfunction in your case is only mild, your doctor may advise you to extend the interval between doses.
If liver dysfunction is only mild or moderate in your case, your doctor may advise you to increase the interval between doses.
Take the film-coated tablet with plenty of liquid (preferably a glass of water).
Eating delays the absorption of Enanplus into the body. For a faster onset of action, take the film-coated tablet at least 30 minutes before a meal.
The break notch is only for dividing the film-coated tablet if you have difficulty taking it whole.
If you take more Enanplus than you are supposed to

If you have taken too much of this medicine, tell your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Remember to take the medicine pack or this leaflet with you.
The signs of an overdose with this medicine are:
- vomiting, loss of appetite, abdominal pain, tiredness, (spinning) dizziness, confusion, headache (due to dexketoprofen)
- Narrow pupils, vomiting, heart failure, unconsciousness, seizures and difficulty breathing (due to tramadol).

If you forget to take Enanplus

Do not take double the dose if you have forgotten to take it before. Take the next dose as directed in the treatment schedule (see section 3. "How to take Enanplus").
If you stop taking Enanplus

Generally, stopping treatment with Enanplus will not have any after-effects.
However, in exceptional cases, patients who have been taking Enanplus for a long period of time and who suddenly stop the medicine may experience after-effects. You may feel restless, anxious, nervous or shaky. You might be confused or hyperactive, have trouble sleeping or gastrointestinal problems. Very few people might have panic attacks, hallucinations, delusions, persecutory delusions (paranoia) or loss of identity. They might experience false sensations such as tingling, prickling and numbness or ringing in the ears (tinnitus). Other unusual central nervous system symptoms, such as confusion, delusions, altered perception of self (depersonalisation) and reality (derealisation), and paranoia, have been observed very rarely. If you experience any of these side effects after stopping treatment with Enanplus, please contact your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
What side effects may I get?

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The possible side effects are listed below according to how often they occur.
You should consult a doctor immediately if you notice any symptoms of an allergic reaction, such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives/rash accompanied by difficulty breathing.
Stop taking Enanplus immediately if you notice a skin rash, any sores in the mouth or mucous membranes and any sign of allergy.
Very common side effects (may affect more than 1 in 10 people treated):

- Nausea
- Dizziness/lightheadedness
Common side effects (may affect up to 1 in 10 people treated):

- Vomiting
- Abdominal pain
- Diarrhoea
- indigestion
- Headache
- drowsiness, fatigue
- constipation
- dry mouth
- Increased sweating
Occasional side effects (may affect up to 1 in 100 people treated):

- Increased number of blood platelets
- Affection of the heart and blood circulation (palpitations, fast heartbeat, fainting and circulatory collapse), low blood pressure. These side effects can occur especially with an upright posture and physical exertion.
- High or very high blood pressure
- Swelling around the larynx (laryngeal oedema).
- Decreased potassium level in the blood
- Psychosis
- Swelling around the eyes
- Shallow or slow breathing
- Discomfort, altered feelings
- Blood in the urine
- (spinning) dizziness
- Insomnia or difficulty falling asleep
- Restlessness/anxiety
- Blushing
- Flatulence
- tiredness
- aches and pains
- Chills, general malaise
- Abnormal blood test results
- retching
- Stomach pressure, feeling of fullness
- Inflammation of the stomach lining
- Skin reactions (e.g. itching, rash)

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

- Swelling of the lips and throat (angioedema).
- Stomach/duodenal ulcer, bleeding or rupture of a stomach/duodenal ulcer (which may be recognised by vomiting blood or black coloured stools).
- Prostate problems
- Liver inflammation (hepatitis), liver damage
- Acute kidney failure
- Slow heartbeat
- Epileptic seizures
- Allergic/anaphylactic reactions (e.g. shortness of breath, wheezing breath, swelling of the skin) and shock reactions (sudden circulatory failure)
- Temporary loss of consciousness (syncope)
- hallucinations
- Water retention, swollen ankles
- Loss of appetite, appetite disorders
- acne
- back pain
- Frequent urination, even less urine than normal, difficult or painful urination
- Menstrual irregularities
- Sensory disturbances (e.g. itching, tingling, numbness)
- Tremors, muscle twitching, coordination problems, muscle weakness
- Confusion
- Sleep disturbances and nightmares
- Altered perception
- Blurred vision, pupil constriction
- shortness of breath
Psychological after-effects may occur after treatment with Skudexa, although their intensity and nature may vary from individual to individual (depending on the patient's personality and duration of use).
- Mood swings (mostly uplifted, sometimes irritable mood).
- Changes in activity (usually dampened, occasionally increased)
- Decreased attention
- Decreased judgement, which may lead to errors in decision-making.
Exacerbation of asthma has been reported.
If Enanplus is taken over a long period of time, dependence may develop, although the risk is low. Withdrawal reactions may occur after stopping the medicine (see "If you stop taking Enanplus").
Epileptic seizures occurred predominantly after use of high doses of tramadol or after concomitant use of medicines that can trigger seizures.
Very rare side effects (may affect up to 1 in 10,000 people treated):

- Inflammation of the pancreas
- kidney problems
- reduced number of white blood cells (neutropenia)
- reduced number of blood platelets (thrombocytopenia)
- Blistering/ulceration of the skin, mouth, eyes and genital area (Stevens-Johnson and Lyell syndromes)
- Swelling of the face
- Shortness of breath due to narrowing of the airways
- Ringing in the ears (tinnitus)
- Sensitive skin - sensitivity to light

Not known (frequency cannot be estimated based on available data):

- Speech disorders
- Severe pupil dilation
- Drop in blood sugar level
Inform your doctor immediately if you experience any abdominal side effects (e.g. abdominal pain, heartburn or bleeding) at the start of treatment, as well as if you have suffered from such side effects in the past with long-term use of NSAIDs, especially if you are elderly.
The most common side effects during treatment with Enanplus are nausea and dizziness/lightheadedness, which occur in more than 1 in 10 people treated.
Water retention in the tissues and swelling (especially in the ankles and legs), high blood pressure and heart muscle weakness have been reported during treatment with NSAIDs.
Medicines such as Enanplus may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke.
In patients with certain immune disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), NSAIDs may rarely cause fever, headache and stiff neck.
5. How should Enanplus be stored?

Keep this medicine out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after "use by" and "used by" respectively. The expiry date refers to the last day of the month indicated.
No special storage conditions are required for this medicinal product with regard to temperature. Store in the original packaging to protect the contents from light.
Do not dispose of medicinal products in waste water. Ask your pharmacist how to dispose of the medicine when you stop using it. You will be helping to protect the environment.
6. contents of the pack and other information

What Enanplus contains

The active substances are tramadol hydrochloride and dexketoprofen. Each film-coated tablet contains 75 mg tramadol hydrochloride and 25 mg dexketoprofen.
The other ingredients are:
Tablet core: microcrystalline cellulose, pregelatinised starch (maize), croscarmellose sodium, sodium stearyl fumarate (Ph. Eur.), highly dispersed silicon dioxide.
Film coating: poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc.