Alkaeffer 20 Compresse Effervescenti

NAME
ALKAEFFER EFFERVESCENT TABLETS

PHARMACOTHERAPEUTIC CATEGORY
Analgesics and antipyretics.

ACTIVE PRINCIPLES
Acetylsalicylic acid; sodium hydrogen carbonate (corresponding to 1625 mg anhydrous sodium hydrogen carbonate); anhydrous citric acid.

EXCIPIENTS
Nobody.

INDICATIONS
Symptomatic treatment of headache, neuralgia, toothache, menstrual pain, rheumatic and muscular pain; symptomatic therapy of febrile states and flu and cold syndromes.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance (acetylsalicylic acid), to other analgesics (painkillers) / antipyretics (feverfeels) / non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients; gastroduodenal ulcer; hemorrhagic diathesis; severe kidney, heart or liver failure; glucose -6-phosphate dehydrogenase deficiency (G6PD / favism); concomitant treatment with methotrexate (at doses of 15 mg / week or more) or with warfarin; history of asthma induced by the administration of salicylates or substances with similar activity, in particular non-steroidal anti-inflammatory drugs; third trimester of pregnancy and lactation; children and young people under the age of 16; hypophosphatemia.

DOSAGE
The product must always be dissolved completely in water before taking, which must take place on a full stomach: 1 or 2 single comedose tablets in a glass of water, repeating, if necessary, the dose at intervals of 4-8 hours until 4 times a day. Never exceed the maximum daily dosage of 8 tablets. In particular, elderly patients should adhere to the minimum dosages indicated above. Always use the lowest effective dosage and only increase it if it is not sufficient to relieve symptoms (pain or fever). Use the medicine for the shortest possible period, do not take the product for more than 3-5 days without medical advice. People most at risk of serious side effects, who can only use the drug if prescribed by their doctor, must strictly follow its instructions. Take the medicine preferably after main meals or, in any case, on a full stomach. See your doctor if symptoms persist.

STORAGE
Do not store above 25 degrees C.

WARNINGS
Hypersensitivity reactions ': acetylsalicylic acid and other NSAIDs can cause hypersensitivity reactions' (including asthma attacks, rhinitis, angioedema or urticaria). The risk is greater in subjects who have already experienced a hypersensitivity reaction in the past after the use of this type of drug and in subjects who have allergic reactions to other substances (eg skin reactions, itching, hives). In subjects with asthma and / or rhinitis (with or without nasal polyposis) and / or urticaria the reactions may be more frequent and severe. In rare cases, the reactions can be very serious and potentially fatal. In the following cases, the administration of the drug requires a doctor's prescription after careful evaluation of the risk / benefit ratio: subjects at greater risk of hypersensitivity reactions'; subjects at greater risk of gastrointestinal lesions. Acetylsalicylic acid and other NSAIDs can cause serious gastrointestinal side effects (bleeding, ulcer, perforation). For this reason these drugs should not be used by subjects suffering from gastrointestinal ulcer or gastrointestinal bleeding. It is prudent that even those who in the past have suffered from gastrointestinal ulcer or gastrointestinal bleeding avoid its use. The risk of gastrointestinal lesions is a dose related effect, as gastrolysis is greater in subjects who use higher doses of acetylsalicylic acid. Even subjects with a habit of taking large quantities of alcohol are more exposed to the risk of gastrointestinal lesions (bleeding in particular). Subjects with coagulation defects or treated with anticoagulants: in subjects suffering from coagulation defects or treated with anticoagulants, acetylsalicylic acid and other NSAIDs can cause a serious reduction in haemostatic capacities, exposing them to the risk of bleeding. Subjects with impaired renal, cardiac or hepatic function: acetylsalicylic acid and other NSAIDs can cause a critical reduction in renal function and water retention; the risk is higher in subjects being treated with diuretics. This can be particularly dangerous for the elderly and for those with impaired renal or cardiac or hepatic function. People with asthma: Acetylsalicylic acid and other NSAIDs can cause worsening of asthma. Geriatric age (especially over 75 years old): the risk of serious side effects is greater in geriatric subjects. after medical consultation. The medicine should not be used in children and young people under the age of 16. Subjects with hyperuricemia / gout: acetylsalicylic acid can interfere with the elimination of uric acid: high doses have a uricosuric effect while (very) low doses can reduce its excretion. It should also be considered that acetylsalicylic acid and other NSAIDs can mask the symptoms of gout by delaying its diagnosis. An antagonistic effect with uricosuric drugs is also possible. Combination of drugs not recommended or requiring special precautions or dosage adjustment. The use of acetylsalicylic acid in combination with some drugs can 'increase the risk of serious side effects. Do not use acetylsalicylic acid together with another NSAID or, in any case, do not use more than one NSAID at a time. The use of acetylsalicylic acid as any drug inhibiting prostaglandin synthesis and cyclooxygenase could interfere with fertility; of this' must be informed female subjects and in particular women who have fertility problems' or who are undergoing investigation of fertility '. Contains sodium. If you have to undergo surgery and in the previous days you have used acetylsalicylic acid or another NSAID, you must inform the surgeon about the possible effects on coagulation. Since acetylsalicylic acid can cause gastrointestinal bleeding, it must be taken into account in case it is necessary to carry out a search for occult blood. Before administering any medicine, all the necessary precautions must be taken to prevent unwanted reactions; particularly important is the exclusion of previous hypersensitivity reactions to this or other medicines and the exclusion of other contraindications or conditions that may expose you to risk of potentially serious side effects listed above. The product must be taken on a full stomach.

INTERACTIONS
>> Combinations contraindicated (avoid concomitant use). Methotrexate (doses greater than or equal to 15 mg / week): increase in plasma levels and toxicity of methotrexate; the risk of toxic effects is greater if renal function is impaired. Warfarin: severe increased risk of haemorrhage due to potentiation of the anticoagulant effect. >> Combinations not recommended (concomitant use of the two drugs requires a doctor's prescription after careful evaluation of the risk / benefit ratio). Antiplatelet agents: increased risk of haemorrhage due to the sum of the antiplatelet effect. Thrombolytics or oral or parenteral anticoagulants: increased risk of haemorrhage due to enhancement of the pharmacological effect. NSAIDs (topical use excluded): increased risk of serious side effects. Methotrexate (doses below 15 mg / week): the increased risk of toxic effects should also be considered for treatment with low dose methotrexate. Selective Serotonin Re-uptake Inhibitors (SSRIs): increased risk of upper gastrointestinal bleeding due to a possible synergistic effect. >> Combinations requiring special precautions or dosage adjustment (concomitant use of the two drugs requires a doctor's prescription after careful evaluation of the risk / benefit ratio). ACE inhibitors: reduction of the hypotensive effect; increased risk of impaired renal function. Valproic acid: increased effect of valproic acid (risk of toxicity). Antacids: antacids taken at the same time as other drugs can reduce their absorption; excretion of acetylsalicylic acid increases in alkalized urine. Antidiabetics (eg insulin and oral hypoglycemic agents): increase in the hypoglycemic effect; the use of acetylsalicylic acid in subjects treated with antidiabetics must take into account the risk of inducing hypoglycaemia. Digoxin: increase in plasma digoxin concentration due to decreased renal elimination. Diuretics: increased risk of nephrotoxicity of acetylsalicylic acid and other NSAIDs; decreased effect of diuretics Acetazolamide: decreased elimination of acetazolamide (risk of toxicity). Phenytoin: increased effect of phenytoin. Corticosteroids (excluding those for topical use and those used for replacement therapy in adrenocortical insufficiency): increased risk of gastrointestinal lesions; due to the increased elimination of salicylates induced by corticosteroids there is a reduction in plasma levels of salicylate. On the other hand, after discontinuation of corticosteroid treatment, an overdose of salicylates can occur. Metoclopramide: increase in the effect of acetylsalicylic acid by increasing the speed of absorption. Uricosurics (e.g. probenecid, benzbromarone and sulfinpyrazone): decrease in the uricosuric effect. Zafirlukast: increased plasma concentration of zafirlukast. The medicine contains a buffer system which may reduce the effects of the thyroid hormone Levothyroxine. Alcohol: the sum of the effects of alcohol and acetylsalicylic acid causes increased damage to the gastrointestinal mucosa and prolongation of bleeding time. It is however advisable not to administer other drugs by mouth within one or two hours of using the product.

SIDE EFFECTS
The most frequently observed side effects are affecting the gastrointestinal tract and can occur in about 4% of subjects who take acetylsalicylic acid as an analgesic-antipyretic. This percentage increases significantly in subjects at risk of gastrointestinal disorders. These disorders can be partially alleviated by taking the medicine on a full stomach. Most of the undesirable effects are dependent on both the dose and the duration of treatment. Side effects seen with acetylsalicylic acid are generally common to other NSAIDs. Pathologies of the blood and lymphatic system: prolonged bleeding time, gastrointestinal bleeding anemia; reduction of platelets (thrombocytopenia) in extremely rare cases. Following haemorrhage, acute and chronic post-haemorrhagic / iron deficiency anemia may occur (due, for example, to occult micro-haemorrhages) with the relative alterations of laboratory parameters and the relative clinical signs and symptoms such as asthenia, pallor and hypoperfusion. Nervous system disorders: headache, dizziness; rarely: Reye's syndrome; rarely to very rarely: cerebral haemorrhage, especially in patients with uncontrolled hypertension and / or on anticoagulant therapy which, in isolated cases, can be life threatening. Ear and labyrinth disorders: tinnitus (ringing / rustling / ringing / ringing in the ears). Respiratory, thoracic and mediastinal disorders: asthmatic syndrome, rhinitis (profuse rhinorrhea, nasal congestion (associated with 'hypersensitivity' reactions). Epistaxis. Cardiac disorders: cardiorespiratory distress (associated with hypersensitivity reactions'). Eye disorders: conjunctivitis (associated with hypersensitivity reactions'). Gastrointestinal disorders: gastrointestinal bleeding (occult), gastric disturbances, heartburn, gastrointestinal pain, gingivorrhagia. Vomiting, diarrhea, nausea, crampy abdominal pain (associated with hypersensitivity reactions); rarely: gastrointestinal inflammation, gastrointestinal erosion, gastrointestinal ulceration, haematemesis (vomiting of blood or coffee material), melaena (emission of black stools, picee), esophagitis; very rarely: gastrointestinal hemorrhagic ulcer and / or gastrointestinal perforation with related signs and clinical symptoms and changes in laboratory parameters Hepatobiliary disorders Raramen te: hepatotoxicity (usually mild and asymptomatic hepatocellular lesion) manifested by an increase in transaminases. Skin and subcutaneous tissue disorders: rash, edema, urticaria, pruritus, erythema, angioedema (associated with hypersensitivity reactions). Renal and urinary disorders: alteration of renal function (in the presence of conditions of impaired renal haemodynamics), urogenital bleeding. General disorders and administration site conditions: peri-operative haemorrhages, hematomas. Disorders of the immune system. Rarely: anaphylactic shock with related changes in laboratory parameters and clinical manifestations. The SdR initially manifests itself with vomiting (persistent or recurrent) and with other signs of brain pain of different entities: from listlessness, drowsiness or personality changes (irritability or aggression) to disorientation, confusion or delirium up to convulsions or loss of consciousness. The variability of the clinical picture should be kept in mind: vomiting can also be missing or be replaced by diarrhea. If these symptoms arise in the days immediately following a flu (or flu-like or chickenpox or other viral infection) during which acetylsalicylic acid or other salicylate-containing medicinal products have been administered, medical attention should be directed immediately. to the possibility of a SdR. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
Inhibition of prostaglandin synthesis can negatively affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor, in the early stages of pregnancy. It has been estimated that the risk increases with dose and duration of therapy. In animals the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, acetylsalicylic acid should not be administered unless clearly needed '. If drugs containing acetylsalicylic acid are used by a woman trying to become pregnant, or during the first and second trimester of pregnancy, treatment should be as short as possible and the dose as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); renal dysfunction, which can progress to renal failure with oligohydroamnios; the mother and the unborn child, at the end of pregnancy, to: possible prolongation of the bleeding time, an antiplatelet effect that can occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, acetylsalicylic acid is contraindicated during the third trimester of pregnancy. The drug is contraindicated during breastfeeding.