Enantyum 25 mg granules for oral solution - analgesic 10 sachets

Product Description

Painkiller with anti-inflammatory action.

Indications

Enantyum is a painkiller belonging to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

It is used for the short-term symptomatic treatment of mild to moderate pain, such as acute muscle pain, joint pain, painful menstruation (dysmenorrhea), toothache.

Composition

Active ingredients

dexketoprofen (as dexketoprofen trometamol)

Excipients

Ammonium glycyrrhizinate, neohesperidin dihydrochalcone, quinoline yellow (E104), lemon flavouring, sucrose and colloidal silica hydrates.

Each sachet contains 2.40 - 2.44 g of sucrose with colloidal silica.

Directions for use and Dosage

Dissolve the entire contents of each sachet in a glass of water; shake/stir well to facilitate complete dissolution. The solution obtained must be drunk immediately after reconstitution.

Enantyum with food and drinks: In case of severe pain, take the sachet on an empty stomach, i.e. at least 15 minutes before meals, to allow the medicine to act more quickly.

Adults over 18 years of age

The recommended dose is 1 sachet (25 mg) every 8 hours, no more than 1 hour before meals. 3 sachets per day (75 mg).

Contact your doctor if you do not notice any improvement or if you notice worsening of your symptoms after 3-4 days. Your doctor will tell you how many sachets you should take daily and for how long. The dose of Enantyum you need depends on the type, intensity and duration of your pain.

If you are elderly or if you suffer from kidney or liver problems

You should start treatment with a total daily dose of no more than 2 sachets (50 mg).

In elderly patients, this initial dose may later be increased to the generally recommended dose (75 mg dexketoprofen) if Enantyum has been well tolerated.

If the pain is severe and you want to obtain faster relief, take the sachets on an empty stomach (at least 15 minutes before meals), because it is better to take the sachets on an empty stomach (at least 15 minutes before meals). This will facilitate absorption (see point 2 “Taking Enantyum with food and drink”).

Use in children and adolescents

This medicine should not be used in children and adolescents (under 18 years of age).

If you forget to take Enantyum

Do not take a double dose to make up for the forgotten dose. Take the next regular dose at the usual time (as written in point 3 ‘How to use Enantyum”).

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Warnings

Talk to your doctor or pharmacist before taking Enantyum:

• if you suffer from allergies, or have had problems with allergies in the past;
• if you have kidney, liver or heart problems (high blood pressure and/or heart failure) and fluid retention, or if you have suffered from one of these conditions in the past;
• if you are taking diuretics or if you are poorly hydrated and if you have a reduced blood volume due to excessive fluid loss (e.g. due to excessive urination, diarrhoea, vomiting);
• if you suffer from heart problems, if you have had a If you have had a stroke or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes, or high cholesterol, or if you smoke), discuss your treatment with your doctor or pharmacist. Medicines like Enantyum may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. These risks are more likely with high doses of the medicine and with prolonged treatment. Do not exceed the recommended dose or duration of treatment.
• If you are elderly: the risk of side effects is higher (see point 4). If these occur, consult your doctor immediately;
• if you are a woman with fertility problems (Enantyum may reduce female fertility, therefore you should not take the medicine if you are planning a pregnancy or if you are undergoing fertility tests);
• if you suffer from a disorder of blood and blood cell formation;
• if you suffer from systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting the connective tissue);
• if you have suffered in the past from a chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• if you have suffered in the past from other stomach or intestinal disorders;
• if you have chickenpox, because, in exceptional cases, NSAIDs may worsen the infection;
• if you are taking other medicines that increase the risk of peptic ulcer or bleeding, for example oral steroids, some antidepressants (for example SSRIs, selective serotonin reuptake inhibitors), antiplatelet drugs such as aspirin, or anticoagulants such as warfarin. In these cases, consult your doctor before taking Enantyum: he or she may prescribe an additional drug to protect your stomach (for example misoprostol or other drugs that reduce the production of gastric acid);
• if you suffer from asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyps, as you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs than the rest of the population. Administration of this medicine may cause asthma attacks or bronchospasm, especially in subjects allergic to acetylsalicylic acid or NSAIDs.

Children and adolescents

The use of Enantyum has not been studied in children and adolescents. Therefore, safety and efficacy have not been established and the medicine should not be used in children and adolescents.

Interactions

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Some medicines cannot be used in combination, while others require dosage adjustments if taken at the same time.

Always tell your doctor, dentist or pharmacist if you are using or are being given any of the following medicines in addition to Enantyum:

Combinations not recommended

• Acetylsalicylic acid (aspirin), corticosteroids or other anti-inflammatory drugs;
• Warfarin, heparin or other medicines used to prevent blood clots;
• Lithium, used to treat mood disorders;
• Methotrexate (an anticancer medicine or immunosuppressant), used at doses greater than 15 mg/week;
• Hydantoin and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for infections bacterial;

Combinations requiring caution

• ACE inhibitors, diuretics and angiotensin II antagonists, used for hypertension and heart problems;
• Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers;
• Zidovudine, used in the treatment of viral infections;
• Aminoglycoside antibiotics, used in the treatment of bacterial infections;
• Chlorpropamide and glibenclamide used for diabetes;
• Methotrexate, used at low doses, less than 15 mg / week;

Combinations to be carefully evaluated

• Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used for bacterial infections;
• Cyclosporin or tacrolimus, used to treat immune system disorders and as therapy in organ transplantation;
• Streptokinase and other thrombolytic or fibrinolytic drugs, i.e. medicines used to dissolve blood clots;
• Probenecid, used for gout;
• Digoxin, used in the treatment of chronic heart failure;
• Mifepristone, used to induce abortion (to terminate a pregnancy);
• Selective serotonin reuptake inhibitor (SSRI) antidepressants;
• Antiplatelet agents used to reduce platelet aggregation and the formation of blood clots;
• Beta-blockers, used for high blood pressure and heart problems;

If you have any doubts about taking other medicines in combination with Enantyum, consult your doctor or pharmacist.

Contraindications

Do not take Enantyum:

• if you are allergic to dexketoprofen trometamol or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs;
• if you suffer from asthma or have suffered from asthma attacks, acute allergic rhinitis (short periods of inflammation of the nasal mucosa), nasal polyps (polypoid masses in 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 aspirin or other non-steroidal anti-inflammatory drugs;
• if you have suffered from photoallergic reactions or phototoxic (a particular form of redness and/or irritation of the skin exposed to sunlight) in conjunction with taking ketoprofen (an NSAID) or fibrates (medicines used to lower the level of lipids in the blood);
• if you suffer from peptic ulcer/bleeding of the stomach or intestine or if you have suffered in the past from bleeding, ulceration or perforation of the stomach or intestine;
• if you have chronic digestive problems (e.g. indigestion, heartburn);
• if you have suffered in the past from bleeding or perforation of the stomach or intestine due to the use of non-steroidal anti-inflammatory drugs (NSAIDs) for pain;
• if you suffer from chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• if you suffer from severe heart failure, moderate or severe kidney failure, severe liver failure;
• if have bleeding problems or clotting disorders;
• if you are severely dehydrated (have lost a lot of fluids) due to vomiting, diarrhoea or insufficient fluid intake;
• if you are in the third trimester of pregnancy or if you are breast-feeding;

Side effects

Like all medicines, Enantyum can cause side effects, although not everybody gets them.

Possible side effects are listed below, ordered by how likely they are to occur. Since the list is partly based on side effects of the Enantyum tablet formulation, and Enantyum granules are absorbed more quickly, the side effects should be taken into account. If you take Enantyum granules more quickly than tablets, it is possible that the actual frequency of (gastrointestinal) side effects may be higher with Enantyum granules.

• Common side effects (may affect up to 1 in 10 people): nausea and/or vomiting, abdominal pain mainly in the upper quadrants, diarrhoea, digestive problems (dyspepsia).
• Uncommon side effects (may affect up to 1 in 100 people): feeling dizzy (vertigo), dizziness, drowsiness, insomnia, nervousness, headache, palpitations, hot flushes, inflammation of the stomach wall (gastritis), constipation, dry mouth, flatulence, skin rash, tiredness, pain, feeling of fever and chills, feeling generally unwell (malaise).
• Rare side effects (may affect up to 1 in 100 people): feeling dizzy (vertigo), dizziness, drowsiness, insomnia, nervousness, headache, palpitations, hot flushes, inflammation of the stomach wall (gastritis), constipation, dry mouth, flatulence, skin rash, tiredness, pain, feeling of fever and chills, feeling generally unwell (malaise).
• affect up to 1 in 1,000 people): peptic ulcer, peptic ulcer haemorrhagic or perforated (shown by haematemesis, i.e. vomiting blood, or black stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral oedema (e.g. swollen ankles), laryngeal oedema, loss of appetite (anorexia), altered sensation (especially touch), itchy rash, acne, increased sweating, lower back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute kidney failure.
• Very rare side effects (may affect up to 1 in 10,000 people): anaphylactic reactions (hypersensitivity reactions which may also lead to collapse), open sores on the skin, mouth, eyes and genital area (Stevens-Johnson and Lyell syndromes), facial swelling or swelling of the lips and throat (angioneurotic edema), shortness of breath due to contraction of the muscles surrounding the airways (bronchospasm), shortness of breath, rapid heartbeat, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), sensitive skin, sensitivity to light, itching, kidney problems. Reduced number of white blood cells (neutropenia), decreased number of blood platelets (thrombocytopenia).