ALKAEFFER 20CPR

ALKAEFFER COMPRESENT EFFERENCES

active ingredients

Each dry-state tablet contains: active ingredients: acetylsalicylic acid 324 mg; sodium hydrogen carbonate 1744 mg (corresponding to 1625 mg sodium hydrogen carbonate anidro); citric acid anidro 965 mg. For the full list of excipients, see paragraph 6.1.

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Therapeutic indications

Symptomatic treatment of headaches, nerves, toothache, menstrual pain, rheumatic and muscle pain. Syntomatic therapy of fever states and flu and cooling syndromes.

Contraindications

Alkaeffer is contraindicated in the case of: - hypersensitivity to the active ingredients (acetylsalicylic acid, sodium hydrogen carbonate, citric acid) or to other analgesics (antidolorphic) /antipyretics (antifebbril) / nonsteroidal anti-inflammatory drugs (FANS) or any of the excipients listed in paragraph 6.1; - gastroduodenal ulcer; - hemorrhagic diathesis; - kidney, heart or severe liver failure; - glucose deficit -6-phosphate dehydrogenase (G6PD/favism);- concomitant treatment with metotrexate (at doses of 15 mg/week or more) or with warfarin (see paragraph 4.5); - anamnesi of asthma induced by the administration of salicylates or substances to similar activity, in particular non-steroidal anti-inflammatory drugs; - third trimester of pregnancy and nursing (see paragraph 4.6); - children and children under the age of 16; - hypophosphateemia.

Population

Population. . Adults: ALKAEFFER must always be dissolved completely in water before taking, which must take place on a full stomach: 1 or 2 tablets as a single dose in a glass of water, repeating, if necessary, the dose at intervals of 4-8 hours up to 4 times a day. Never exceed the maximum daily dosage of 8 tablets. Always use the effective minimum dosage and increase it only if it is not enough to relieve symptoms (sweet or fever). Use the medicine for the shortest period possible, do not take the product for more than 3- 5 days without the doctor's advice. Persons most exposed to the risk of serious undesirable effects, which may use the drug only if prescribed by the doctor, must carefully follow the instructions (see paragraph 4.4). Method of administration: Take the medicine preferably after main meals or, however, on a full stomach. Consult your doctor if your symptoms persist. Special popularity. Pediatric population: ALKAEFFER is not indicated for use in the pediatric population (see paragraph 4.3) Seniors: Older patients must comply with the minimum doses mentioned above. Patients with impairment of liver function: Acetylsalicylic acid must be used with caution in patients with impairment of liver function (see paragraph 4.4). Patients with renal function compromise: Acetylsalicylic acid should be used with caution in patients with renal function impairment (see paragraph 4.4).

Conservation

Store at a temperature below 25 °C

Warnings

Reactions of hypersensitivity: Acetylsalicylic acid and other NSAIDs can cause hypersensitivity reactions (including asthma, rhinitis, angioedema or urticaria). The risk is greater in the subjects that have already presented a reaction of hypersensitivity after the use of this type of medicines (see paragraph 4.3) and in those who have allergic reactions to other substances (eg skin, itching, hives). In subjects with asthma and/or rhinitis (with or without nasal polyposes) and/or urticaria reactions can be more frequent and severe. In rare cases reactions can be very serious and potentially fatal. In the following cases the administration of the drug requires the doctor's prescription after careful assessment of the risk/benefit ratio: - Subjects with greater risk of hypersensitivity reactions (see above); - Persons with greater risk of gastrointestinal injury: Acetylsalicylic acid and other NSAIDs can cause serious undesirable gastrointestinal effects (blood, ulcer, perforation). For this reason, these drugs should not be used by subjects suffering from gastrointestinal ulcer or gastrointestinal bleeding. It is prudent that they avoid the use even those who in the past have suffered from gastrointestinal ulcer or gastrointestinal bleeding. The risk of gastrointestinal lesions is a related dose effect, as gastrointestinacy is greater in individuals who make use of higher doses of acetylsalicylic acid. Persons with a habit of taking strong amounts of alcohol are also more exposed to the risk of gastrointestinal lesions (particularly bleeding) (see paragraph 4.5). - Subjects with clotting defects or in treatment with anticoagulants: In subjects with clotting defects or in treatment with anticoagulants acetylsalicylic acid and other NSAIDs can cause a severe reduction in hemostatic capacity by exposing at risk of hemorrhage. - Subjects with impairment of renal or cardiac or liver function: Acetylsalicylic acid and other NSAIDs can be a critical reduction in kidney function and water retention; the risk is greater in subjects in treatment with diuretics. This can be particularly dangerous for the elderly and subjects with impairment of renal or cardiac or liver function. - Subjects affected by Asma: Acetylsalicylic acid and other NSAIDs can cause asthma aggravation. - Geriatric age (especially over 75 years): The risk of serious side effects is greater in geriatric age subjects Subjects over 70 years of age, especially in the presence of concomitant therapies, should use Alkaeffer only after consulting the doctor. Alkaeffer should not be used in the pediatric population (see paragraph 4.3). Products containing acetylsalicylic acid must not be used in children or children under the age of 16. with viral infections, regardless of the presence or not of fever. In certain viral affections, especially affect A, influence B and chickenpox, there is the risk of Reye Syndrome, a very rare disease, but dangerous for life, which requires immediate medical intervention. The risk may be increased in the event of acetylsalicylic acid, although a causal relationship has not been demonstrated. Persistent vomiting in patients with these diseases can be a sign of Reye Syndrome. - Subjects with hyperuricemia/gotta: Acetylsalicylic acid may interfere with the elimination of uric acid: high doses have an uric effect while low doses (very) can reduce their excretion. It should also be considered that acetylsalicylic acid and other NSAIDs can mask the symptoms of gout by delaying diagnosis. Antagonist effect with uric drugs is also possible (see paragraph 4.5). - Association of unrecommended drugs or requiring special precautions or adjustment of the dosage: The use of acetylsalicylic acid in conjunction with certain drugs may increase the risk of serious side effects (see paragraph 4.5). Do not use acetylsalicylic acid along with another NSAID or, however, do not use more than one NSAID at a time. Surgery: If surgery is to be performed (even of a small entity, for example the extraction of a tooth) and in the previous days it has been made use of acetylsalicylic acid or another NSAID it is necessary to inform the surgeon for the possible effects on coagulation. Since acetylsalicylic acid can be caused by gastrointestinal bleeding, it is necessary to take into account in case it is necessary to perform a search for occult blood. Before administering any medicinal product, all precautions should be taken to prevent unwanted reactions; particularly important is the exclusion of previous hypersensitivity reactions to this or to other medicines and the exclusion of other contraindications or conditions that can expose at risk of potentially serious unwanted effects mentioned above. Intake of the product must take place on a full stomach. The sodium content per effervescent tablet (445 mg) must be considered in the case of a hypoxodic/poor diet of salt in patients with heart failure, high blood pressure and kidney failure. Information on excipients: This medicine contains 445 mg of sodium per effervescent tablet equivalent to 22.2% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult.

Interactions

Contraindicated associations (avoid concomitant use-see paragraph 4.3). - Metotrexato (dose greater or equal to 15 mg/week): increase in plasma levels and toxicity of metotrexate; the risk of toxic effects is greater if the kidney function is compromised. - Warfarin: severe increase in the risk of hemorrhage for strengthening the anticoagulant effect. Unrecommended associations (the concomitant use of the two drugs requires the doctor’s prescription after careful assessment of the risk/benefit ratio see paragraph 4.4): Anti-platelet aggregates: increased risk of hemorrhage by sum of the anti-aggregating effect. Trombolites or Oral or parental anticoagulants: increased risk of hemorrhage by enhancing the pharmacological effect. FANS (topical use excluded): increased risk of serious adverse effects. Methotrexate (doses less than 15 mg/week): the increase in the risk of toxic effects (see above) must also be considered for treatment with Metotrexato at low dosages. Serotonin reuptake selective inhibitors (SSRI): increased risk of upper gastrointestinal bleeding due to a possible synergistic effect.Combinations requiring special precautions or dosage adjustment (the concomitant use of the two drugs requires the doctor’s prescription after careful assessment of the risk/benefit ratio - see paragraph 4.4). ACE inhibitors: reduction of hypotensive effect; increased risk of renal function compromise. Valproic acid: increased effect of valproic acid (risk of toxicity). Antacids: antacids taken at the same time to other drugs can reduce their absorption; the excretion of acetylsalicylic acid increases in alkalineized urine. Antidiabetics (e.g. insulin and oral hypoglycemics): increased hypoglycemic effect; the use of acetylsalicylic acid in the subjects in treatment with antidiabetics must take into account the risk of inducing hypoglycemia. Digoxin: increased plasma concentration of digoxin due to decreased kidney elimination. Diuretics: increased risk of nephrotoxicity of acetylicylic acid and other NSAIDs; reduction of the effect of diuretics. Acetazolamide: reduced elimination of acetazolamide (toxicity risk). Fenitoine: increased effect of phenytoin. Courtesy (excluding those for topical use and those used for replacement therapy in corticosurrenal failure): a- increased risk of gastrointestinal injury; b- due to the increased elimination of salicylates induced by corticosteroids, plasma levels of salicylate were reduced. On the other hand, after termination of corticosteroid treatment, it is possible to overdose salicylates. Metoclopramide: an increase in the effect of acetylsalicylic acid by increase in absorption speed. Resurrection (e.g. probenecid, benzbromarone and sulfinpirazone): decrease in the uric effect. Zafirlukast: increased plasma concentration of zafirlukast. Alkaeffer contains a buffer system that could reduce the effects of the Levotiroxine thyroid hormone. Alcohol (see paragraph 4.4): The sum of the effects of alcohol and acetylsalicylic acid causes increased gastrointestinal mucosa damage and prolongation of bleeding time. However, other oral medications should not be administered within one or two hours of use of the product.

Effects

The most frequently observed side effects are on the gastrointestinal apparatus and can occur in about 4% of individuals taking acetylsalicylic acid as analgesic-antipyretic. This percentage increases significantly in the risk of gastrointestinal disturbances. These disorders can be partially alleviated by taking the medicine on a full stomach. Most side effects are dependent on both dose and duration of treatment. The undesirable effects observed with acetylsalicylic acid are generally common to other NSAIDs.

Classification for Systems and Organs	Undesirable effects
Vascular diseases	Epistassi
Emolinfopoietic system pathologies	Extension of bleeding time, anemia from gastrointestinal hemorrhage; reduction of platelets (trombocytopenia) in extremely rare cases. Following hemorrhage, hemorrhagic/sideropenic anemia (due, for example, to occult microemorrhages) may occur with the relative alterations of the laboratory parameters and its clinical signs and symptoms such as as athenia, pallor and hypoperfusion.
Diseases of the nervous system	Cephalea, chief. Rarely: Reye syndrome (*) From seldom to very rarely: cerebral hemorrhage, especially in patients with uncontrolled hypertension and/or in therapy with anticoagulants that, in isolated cases, may be potentially lethal.
Ear and labyrinth pathologies	Tinnitus (rontium/fruit/tintintinnium/auricular whistle).
Respiratory, chest and mediastinic pathologies	Respiratory disease exacerbated by acetylsalicylic acid, asthmatic syndrome, rhinitis (prose renorrhea, nasal congestion (associated with hypersensitivity reactions).
Heart disease	Cardiorespiratory stress (associated with hypersensitivity reactions).
Pathologies of the eye	Conjunctivitis (associated with hypersensitivity reactions).
Gastrointestinal diseases	Gastrointestinal bleeding (occult), gastric disorders, pirosis, gastrointestinal pain, gum. Vomito, diarrhea, nausea, abdominal crampiform pain (associated with hypersensitivity reactions). Rarely: gastrointestinal inflammation, gastrointestinal erosion, gastrointestinal ulceration, hematomesis (vomite of blood or material “coffee laying”), melena (emission of black feces, picee), esophagitis. Very rarely: hemorrhagic gastrointestinal ulcer and/or gastrointestinal perforation with its clinical signs and symptoms and alterations of laboratory parameters. Frequency not known (especially in long-term treatment): - Disease of intestinal diaphragms.
Hepatobiliary diseases	Rarely: hepatotoxicity (hepatocellular lesion generally mild and asymptomatic) that manifests with an increase of transamines.
Pathologies of skin and subcutaneous tissue	Skin rash, edema, hives, itching, erythema, angioedema (associated with hypersensitivity reactions) **.
Kidney and urinary pathologies	Alteration of renal function (in the presence of renal hemodynamic altered conditions) and acute kidney injury, urogenital hemorrhages.
Systemic pathologies and conditions for administration	Process bleeding, hematomas.
Immune system disorders	Hypersensitivity reactions Rarely: anaphylactic shock with its alterations of laboratory parameters and clinical manifestations.

(*) Reye Syndrome (SdR). The SdR initially manifests itself with vomiting (persistent or recurrent) and with other signs of encephalic suffering of different entities: from distress, drowsiness or alterations of personality (irritability or aggressiveness) to disorientation, confusion or delirium until convulsions or loss of consciousness. The variability of the clinical picture must be taken into account: vomiting can also be lacking or replaced by diarrhea. If these symptoms arise in the days immediately after an influenza episode (or flu or varicella or other viral infection) during which acetylsalicylic acid or other medicines containing salicylates the attention of the doctor must immediately be addressed to the possibility of a SdR. ** Severe skin reactions, Stevens-Johnson syndrome and epidermal necrolysis. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

The toxicity from salicylates (a dosage greater than 100 mg/kg/day for 2 consecutive days may induce toxicity) may be the result of chronic intake of excessive doses, or acute overdose, potentially dangerous for life and also includes accidental ingestion in children. Chronic intoxication by salicylates Poisoning chronic from salicylates can be insidious since signs and symptoms are aspecific. A mild chronic intoxication from salicylates, or salicylism, usually occurs only after repeated use of considerable doses. Symptoms include dizziness, dizziness, tinnitus, deafness, sweating, nausea and vomiting, headache and confusion. These symptoms can be controlled by reducing the dosage. Tinnitus can occur at plasma concentrations between 150 and 300 micrograms/ml, while at concentrations above 300 micrograms/ml there are more serious adverse events. Acute intoxication by salicylates The main characteristic of intoxication acute is a serious alteration of the acid-base balance, which may vary with the age and severity of intoxication; the most common presentation, in the child, is metabolic acidosis. It is not possible to estimate the severity of poisoning by plasma concentration alone; acetylsalicylic acid absorption can be delayed due to reduced gastric emptiness, concretion formation in the stomach, or as a result of ingestion of gastro-resistant preparations. The management of an intoxication from acetyllic acid is determined by the extent, stage and clinical symptoms of the latter, and must be implemented according to conventional poisoning management techniques. The main measures to be taken consist of the acceleration of the excretion of the drug and the restoration of electrolytic metabolism and acid-base. For complex physiopathological effects, connected with salicylate poisoning, signs and symptoms/results of biochemical and instrumental investigations, may include:

Signs and symptoms	Results of biochemical and instrumental investigations	Therapeutic measures
INTOSSICATIONAL BY LIEVE		Gastric lavender, repeated administration of activated carbon, forced alkaline diuresis
Tachypnea, hyperventilation, respiratory alkalosis	Alcalemia, Alcaluria	Liquid and electrolyte management
South Africa
Nausea, vomiting, dizziness headache
INTOSSICATION BY TRADE		Gastric lavender, repeated administration of activated carbon, forced alkaline diuresis, hemodialysis in severe cases
Respiratory alkalosis with compensatory metabolic acidosis	Acidemia, aciduria	Liquid and electrolyte management
Hyperpiressia		Liquid and electrolyte management
Respirators: variables from non cardiogenic hyperventilation and pulmonary edema to respiratory arrest and asphyxiation
Cardiovascular: variables from arrhythmias and hypotension to cardiocirculation arrest	For example, alteration of blood pressure, alteration of ECG
Loss of liquids and electrolytes: dehydration, from oliguria to kidney failure	For example hypokaliemia, hypernatriemia, hyponatriemia, altered kidney function	Liquid and electrolyte management
Alterations of glucidic metabolism, ketosis	Hyperglycemia, hypoglycemia (especially in children) Increased levels of ketones
Tinnitus, deafness
Gastrointestinal: gastrointestinal bleeding, gastric ulcer
Hematological: coagulopathy, sideropenic anemia	For example, PT extension, hypoprotrombinemia
Neurologic: Toxic encephalopathy and SNC depression with manifestations varying from letargy and confusion to coma and convulsions. Brain edema.
Hepatics: hepatitis damage	Increased liver enzyme levels

High dosages can also appear: Alterations of taste. Skin rashes (acneiform, erythematose, scarlattiniform, eczematoids, desquamative, bollose, purpuronic), itching. Others: conjunctivitis, anorexia, reduction of visual acuity, drowsiness. Rarely: aplastic anemia, agranulocytosis, intravascular coagulation scattered, pancytopenia, leukopenia, thrombocytopenia, eosinopenia, purple, heosinophilia associated with hepatotoxicity induced by the drug, nephrotoxicity (nephritial piline-interstitial allergic urine), hematuria (preservation). Acute allergic reactions resulting from intake of acetylsalicylic acid, can be treated, if necessary, with adrenaline, corticosteroids and an antihistamine. In case of overdosing, please contact a poison center or the nearest hospital immediately. Acetylsalicylic acid is dialysable.

Fertility: The use of acetylsalicylic acid as of any drug inhibitor of the synthesis of prostaglandins and cyclooxygenase could interfere with fertility; women who have fertility problems or who are subject to fertility surveys must be informed of this.

Pregnancy:

Inhibition of prostaglandin synthesis can adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis, in the early stages of pregnancy. The absolute risk of heart failure had increased from less than 1% to about 1.5%. It has been estimated that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre- and post-system and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disease, was reported in animals that had been given inhibitors of prostaglandin synthesis during the organogenetic period. During the first and second trimester of pregnancy, acetylsalicylic acid should not be administered if not in case of actual need. If drugs containing acetylsalicylic acid are used by a woman seeking pregnancy, or during the first and second quarter of pregnancy, the treatment will 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 arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress to renal failure with oligo-idroamnios; the mother and the unborn child, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect that can occur even at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. Consequently, acetylsalicylic acid is contraindicated during the third trimester of pregnancy.

Food

: Alkaeffer is contraindicated during lactation (see paragraph 4.3).

Source: Farmadati