Novartis Voltadvance 10 Tablets Covered 25mg
- Brand:GLAXOSMITHKLINE C.HEALTH.Srl
- Product Code: 035500014
- Availability: In Stock
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Voltadvance coated tablets what is it for?
These tablets are useful in cases of pain in the joints and muscles, they are also excellent for headaches and teeth and as an adjuvant in febrile states, thanks to its mix of components can be very effective in the short term.
Active ingredient: diclofenac sodium 25 mg.
Excipients: potassium bicarbonate; mannitol; sodium lauryl sulfate; crospovidone; magnesium stearate; glycerol dibeenate; Clear Opadry (hypromellose, macrogol).
What are the therapeutic indications for the drug Voltadvance tablets?
The Voltadvance over-the-counter medication, as indicated in the package insert, is indicated for back pain due to its double effect: it fights pain after taking it, then 10-20 minutes later, thanks to its rapid absorption; acts directly on the cause of inflammation.
The specific indications of Voltadvance in tablets, or sachets if you prefer, are those to fight back pain, a very common pain caused by a contraction of the muscles, often caused by incorrect postures, excessive efforts or by the natural processes of aging of the spine . However, along with regular exercise, there are small attentions and good daily habits that can help you prevent pain.
Unlike other anti-inflammatories, Voltadvance which contains the active ingredient Diclofenac sodium, is not to be used in case of headache, menstrual pain and hemorrhoids. For this type of problem, in fact, there are other over-the-counter drugs. Our advice is always to consult the leaflet or the lieutenant, taking into consideration the class of pharmacological belonging and the specific teraopeutical indococations. If you are not sure, take the advice of your doctor and pharmacist.
OTHER INDICATIONS OF VOLTADVANCE TABLETS
Pain of various kinds such as, for example, joint pain, lumbago, muscle pain, headache and tooth, menstrual pain; as an adjuvant in the treatment of influenza and in febrile states.
What contraindications does this product have?
Hypersensitivity to the active substance or to any of the excipients; ulcer, bleeding or gastrointestinal perforation in place; history of gastrointestinal haemorrhage or perforation related to previous treatments with NSAIDs or history of recurrent peptic hemorrhage / ulceration (two or more distinct episodes of demonstrated ulceration or bleeding); last trimester of pregnancy and during lactation; severe liver failure, severe renal insufficiency or severe heart failure; like other non-steroidal anti-inflammatory drugs (NSAIDs), diclofenac is also contraindicated in patients in whom, after intake of acetylsalicylic acid or other NSAIDs, asthmatic attacks, urticaria or acute rhinitis, anaphylactic or anaphylactoid reactions have occurred; the product must not be used in case of changes in the hematopoiesis; in the case of intensive diuretic therapy; the product should not be taken in case of dark stools or containing blood; congestive congestive heart failure (NYHA class II-IV), ischemic heart disease, peripheral arterial disease and / or cerebral vasculopathy; the medicine should not be given to children under 14 years of age.
Posology and intake modality
Adults and adolescents over 14 years: 1-2 coated tablets or powder bags for oral solution, for single administration, 1-2 times a day. Do not exceed the recommended dose; in particular, elderly patients must comply with the minimum dosages indicated above. The coated tablets should be swallowed whole, with water or other liquid; the sachets of powder should be dissolved in a glass of water before being taken. It is advisable to take the product preferably on a full stomach. As an antipyretic, use the product for a maximum of 3 days. As an analgesic do not exceed 5 days of treatment. Undesirable effects can be minimized by administering the minimum effective dose for the minimum duration needed to control the symptoms.
Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. Avoiding the use of diclofenac concomitantly with other systemic NSAIDs, due to the lack of any evidence that demonstrates synergistic benefits and based on potential additive side effects. In rare cases allergic reactions may also occur, including anaphylactic / anaphylactoid reactions, without prior exposure to diclofenac. Diclofenac can mask the signs and symptoms of infections due to its pharmacodynamic properties. Caution is required in the elderly. Particularly in frail elderly patients or those with low body weight, the use of the lowest effective dose is recommended. Prolonged use of any type of pain reliever for headaches can make them worse. If you have had or suspect this, stop the treatment. The diagnosis of drug overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite the regular use of headache medications. They have been reported and may appear at any time, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal bleeding, ulceration or perforation, which can be fatal. They generally have more severe consequences in the elderly. If you experience gastrointestinal bleeding or ulceration in patients taking diclofenac, stop the medicine. Close medical surveillance is mandatory and particular caution should be used when prescribing diclofenac to patients with symptoms indicative of gastrointestinal disorders (GI) or with a history indicative of gastric or intestinal ulceration, bleeding or perforation, chronic inflammatory bowel disease. The risk of GI bleeding is higher with increased NSAID doses and in patients with a history of ulcer, especially if complicated by bleeding or perforation. The elderly have a greater frequency of adverse reactions, especially gastrointestinal bleeding and perforation that can be fatal. To reduce the risk of GI toxicity in patients with a history of ulcer, particularly if complicated by bleeding or perforation, and in the elderly begin treatment and maintain it with the lowest effective dose. Concomitant use of protective agents should be considered for these patients and also for patients requiring concomitant use of medicinal products containing low doses of acetylsalicylic acid (ASA) or other medicinal products that may increase gastrointestinal risk. Caution is advised in patients taking concomitant medicinal products that may increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, antiplatelet agents, or selective serotonin reuptake inhibitors. Even in patients with ulcerative colitis or Crohn's disease, exercise close medical supervision and caution as these conditions may be exacerbated. If diclofenac is prescribed for patients with hepatic impairment, strict medical surveillance is necessary because their condition can be exacerbated. As with other NSAIDs, including diclofenac, they may increase the values of one or more liver enzymes. During prolonged treatments with diclofenac, regular controls of liver function are indicated as a precautionary measure. If the liver function parameters are persistently altered or worsened, if clinical signs or symptoms of liver disease develop, or if other manifestations occur, discontinue treatment. Hepatitis with the use of diclofenac can occur without prodromal symptoms. Caution should be exercised when using diclofenac in patients with hepatic porphyria, as this could trigger an attack. Since fluid and edema retention have been reported in association with NSAID therapy, particular caution is required in cases of renal insufficiency, history of hypertension, in the elderly, in patients receiving concomitant diuretics or medications that may significantly affect the renal function and in those patients with a substantial depletion of the extracellular volume due to any cause. In such cases, monitoring of renal function is recommended as a precaution when diclofenac is administered. Discontinuation of therapy is normally followed by a return to pre-treatment conditions. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. In the early stages of therapy, patients appear to be at a higher risk for these reactions: the onset of the reaction occurs in most cases within the first month of treatment. Stop the drug at the first appearance of skin rash, lesions of the mucosa or any other sign of hypersensitivity. Caution is required before starting treatment in patients with a history of hypertension as in association with NSAID treatment, fluid retention, hypertension and edema have been reported. Clinical trials and epidemiological data consistently indicate an increased risk of arterial thrombotic events associated with the use of diclofenac, especially at high doses (150 mg / d ') and long-term treatment. The available data do not suggest an increased risk with the use of low doses of diclofenac 25 mg up to 100 mg / day. Patients with significant risk factors for cardiovascular events should be treated with diclofenac only after careful consideration. As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the minimum duration possible and the minimum effective daily dose should be used. The response to therapy and the need for symptom improvement should be re-evaluated periodically. During prolonged treatments with diclofenac, blood crasis controls are recommended. Diclofenac may temporarily inhibit platelet aggregation. Monitor patients with haemostasis defects. In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa, chronic obstructive pulmonary diseases or chronic respiratory tract infections, NSAIDs such as asthma exacerbations, Quincke edema or urticaria are more common than in other patients.
Before using the product, if you are taking other drugs, as it may be necessary to change the dosage or stop the treatment. The following interactions include those observed with diclofenac gastroresistant tablets and / or other pharmaceutical forms of diclofenac. Lithium: if given concomitantly, diclofenac may elevate the plasma concentrations of lithium. Monitoring of serum lithium levels is recommended. Digoxin: if given concomitantly, diclofenac may elevate plasma digoxin concentrations. Monitoring of serum digoxin levels is recommended. Diuretics and antihypertensive agents: patients undergoing treatment with these drugs should consult a doctor before taking the product. Like other NSAIDs, the concomitant use of diclofenac with diuretics or antihypertensive agents may cause a decrease in their antihypertensive effect. Therefore, the association must be taken with caution and patients, especially the elderly, must receive regular monitoring of their blood pressure. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy and periodically thereafter, in particular for diuretics and ACE inhibitors due to an increased risk of nephrotoxicity. Concomitant treatment with potassium-sparing drugs may be associated with increased serum potassium levels which should therefore be monitored frequently. Other NSAIDs and corticosteroids: the concomitant use of diclofenac and other systemic non-steroidal anti-inflammatories or corticosteroids may increase the incidence of gastrointestinal side effects. Anticoagulants and antiplatelet agents: caution is recommended as concurrent administration may increase the risk of bleeding. Although there is no indication of an effect of diclofenac on the effect of anticoagulants from clinical trial data, there have been isolated reports of an increased risk of bleeding in patients receiving diclofenac concomitantly with anticoagulants. Close monitoring is therefore recommended for these patients. Selective serotonin reuptake inhibitors (SSRIs): the concomitant administration of systemic NSAIDs, including diclofenac, and SSRIs may increase the risk of gastrointestinal bleeding. Antidiabetics: clinical studies have shown that diclofenac can be given together with oral antidiabetics without affecting its clinical effect. However, isolated cases of both hypo- and hyperglycaemic effects have been reported, with the need to change the dosage of antidiabetic agents administered during treatment with diclofenac. For this reason, in the case of concomitant therapy, monitoring of blood glucose levels is recommended as a precautionary measure. Metotrexate: diclofenac may inhibit renal tubular release of methotrexate by increasing its levels. Caution is recommended when NSAIDs are administered, including diclofenac, 24 hours before or after treatment with methotrexate as blood concentrations of methotrexate and consequently the toxicity of this substance may increase. Cyclosporine: due to its effect on renal prostaglandins, diclofenac, like other NSAIDs, may increase the nephrotoxicity of ciclosporin. Therefore, diclofenac should be administered at doses lower than those used in patients not receiving ciclosporin. Quinolone antibacterials: isolated cases of convulsions have been reported, probably due to the concomitant use of quinolones and NSAIDs. Phenytoin: when phenytoin is used together with diclofenac, monitoring of plasma phenytoin concentrations is recommended. Colestipol and cholestyramine: these agents may induce a delay or decrease in the absorption of diclofenac. Therefore, it is recommended to administer diclofenac at least one hour before or 4-6 hours after administration of colestipol / cholestyramine. Potent CYP2C9 inhibitors: caution is recommended when diclofenac is prescribed together with potent CYP2C9 inhibitors (such as sulfinpyrazone and voriconazole); this can lead to a significant increase in peak plasma concentrations and diclofenac exposure, due to the inhibition of the metabolism of the same. Diclofenac may also decrease the efficacy of intrauterine devices and the risk of inhibition of Interferon alpha has been reported.
Adverse reactions are listed by frequency, the first most frequent, using the following convention: common (> = 1/100, <1/10); uncommon (> = 1 / 1,000, <1/100); rare (> = 1 / 10,000, <1 / 1,000); very rare (<1 / 10,000), not known. The following side effects include those reported with short or long term use. Should one of these effects occur during treatment with the medicine, it is advisable to stop the medication and consult your doctor. Blood and lymphatic system disorders. Very rare: thrombocytopenia, leucopenia, anemia (including haemolytic and aplastic anemia), agranulocytosis. Immune system disorders. Rare: hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock); very rare: angioneurotic edema (including facial edema). Psychiatric disorders. Very rare: disorientation, depression, insomnia, nightmares, irritability, psychotic reactions. Nervous system disorders. Common: headache, dizziness; rare: drowsiness; very rare: paresthesia, impaired memory, convulsions, anxiety, tremors, aseptic meningitis, changes in taste, cerebrovascular accidents. Eye disorders. Very rare: vision disorders, blurred vision, diplopia. Ear and labyrinth disorders. Common: vertigo; very rare: tinnitus, worsening of hearing. Cardiac disorders. Very rare: palpitations, chest pain, heart failure, myocardial infarction. Vascular diseases. Very rare: hypertension, vasculitis. Respiratory, thoracic and mediastinal disorders. Rare: asthma (including dyspnoea); very rare: pneumonia. Gastrointestinal disorders. Common: nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, anorexia; rare: gastritis, gastrointestinal haemorrhage, hematemesis, hemorrhagic diarrhea, melena, gastrointestinal ulceration (with or without bleeding or perforation), dry mouth and mucous membranes; very rare: colitis (including hemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, esophageal disorders, intestinal diaphragm-like stenosis, pancreatitis, constipation. Hepatobiliary disorders. Common: increase in transaminases; rare: hepatitis, jaundice, liver disorders; very rare: fulminant hepatitis, hepatic necrosis, hepatic failure. Skin and subcutaneous tissue disorders. Common: rash; rare: hives; very rare: bullous eruptions, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, epidermal toxic necrolysis (Lyell's syndrome), exfoliative dermatitis, hair loss, photosensitivity reaction, purpura, allergic purpura, pruritus. Renal and urinary disorders. Very rare: acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis. General disorders and administration site conditions. Rare: edema. Clinical trials and epidemiological data consistently indicate an increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke) associated with the use of diclofenac, especially at high doses (150 mg / d ') and long-term treatment . The reporting of suspected adverse reactions occurring after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk balance of the medicinal product.
Inhibition of prostaglandin synthesis may 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 was considered that the risk increases with the dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to increase the loss of pre- and post-implantation and embryo-fetal mortality. Furthermore, an increase in the incidence of various malformations, including cardiovascular disease, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, diclofenac should not be administered except in strictly necessary cases. If diclofenac is used by a woman awaiting conception, or during the first and second trimester of pregnancy, the dose should be kept as low as possible and the duration of treatment should be as short as possible. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which may progress into renal failure with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, to: possible prolongation of the bleeding time, and anti-aggregating effect which can also occur at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, diclofenac is contraindicated during the third trimester of pregnancy. Diclofenac passes into breast milk in small quantities. Therefore, diclofenac should not be given during breast-feeding to avoid side effects in the infant. The use of diclofenac can alter female fertility and is not recommended for women wishing to conceive. Discontinuation of diclofenac should be considered in women who have difficulty conception or who are subjected to infertility tests.
Expiration and conservation of the product
The expiry date indicated on the package refers to the product in packaging intact and properly stored away from sources of heat and humidity, do not use the medicine after the expiration date indicated on the package and / or in cases where provided, stick to the validity expressed after the first opening of the package, finally keep out of sight and reach of children.