Novartis Voltadvance Powder 20 Sachets Of 25mg

Voltadvance 20 sachets what is it for?

Therapeutic indications

These sachets are very suitable for pains of various kinds such as, for example, pain in the joints, lumbago, muscle pain, head and toothache, menstrual pain, as an adjunct in the therapy of flu and in febrile states, thanks to action of the active ingredients contained in it manages to be very effective in a short time.

Possible contraindications deriving from taking the product

No major problems have been reported, but in some cases hypersensitivity to the active ingredient or to any of the excipients has been found; active gastrointestinal ulcer, bleeding or perforation; history of gastrointestinal haemorrhage or perforation related to previous NSAID treatment or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding); last trimester of pregnancy and during lactation; severe liver failure, severe kidney failure or severe heart failure; like other non-steroidal anti-inflammatory drugs (NSAIDs), diclofenac is also contraindicated in patients in whom asthma attacks, urticaria or acute rhinitis, anaphylactic or anaphylactoid reactions have occurred after taking acetylsalicylic acid or other NSAIDs; the product must not be used in case of hematopoiesis alterations; in case of intensive diuretic therapy; the product should not be taken in case of dark or bloody stools; overt congestive heart failure (NYHA class II-IV), ischemic heart disease, peripheral arterial disease and / or cerebral vascular disease; the medicine should not be given to children younger 'less than 14 years.

How is voltadvance 20 sachets taken?

In a very simple way, for adults and adolescents over 14 years 1-2 sachets of powder for oral solution are enough, for single administration about 1-2 times a day. It is important not to exceed the recommended doses, especially elderly patients must follow the minimum dosages indicated above. The sachets should be taken with water or other liquid, the powder sachets should be dissolved in a glass of water at room temperature before taking and drunk in small sips. We recommend taking the product preferably on a full stomach, as an antifebrile 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 lowest effective dose for the shortest duration necessary to control symptoms.

WARNINGS: After 2-3 days of treatment without noticeable results, consult your doctor. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. Avoid the use of diclofenac concomitantly with other systemic NSAIDs, including selective cyclo-oxygenase-2 inhibitors, due to the lack of any evidence demonstrating synergistic benefits and based on potential additive side effects. Caution in the elderly, especially frail elderly patients or those with a low body weight, the use of the lowest effective dose is recommended. Allergic reactions, including anaphylactic / anaphylactoid reactions, may also occur in rare cases without prior exposure to diclofenac. Diclofenac can mask the signs and symptoms of infections due to its pharmacodynamic properties. Prolonged use of any type of pain reliever for headaches can make them worse. If this situation has occurred or is suspected, medical advice should be sought and treatment should be discontinued. Suspect the diagnosis of medication overuse headache in patients who have frequent or daily headaches despite regular use of headache medications. During treatment with all reported NSAIDs and can appear at any time, with or without warning symptoms or a previous history of serious gastrointestinal events, gastrointestinal bleeding, ulceration or perforation, which can be fatal. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving clofenac, the medicinal product should be discontinued. Close medical surveillance and particular caution are required when prescribing diclofenac to patients with symptoms indicative of gastrointestinal disorders 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 doses of NSAIDs and in patients with a history of ulcer, especially if complicated with haemorrhage or puncture. The elderly have a higher frequency of adverse reactions, especially gastrointestinal bleeding and perforation which can be fatal. To reduce the risk of GI toxicity in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly, initiate treatment and maintained at the lowest effective dose. Consider concomitant use of protective agents for these patients and also for patients requiring concomitant use of medicinal products containing low doses of ASA or other medicinal products that may increase gastrointestinal risk. Patients with a history of GI toxicity, especially the elderly, should report any unusual abdominal symptoms. Caution in patients taking concomitant medications which may increase the risk of ulceration or bleeding. Close medical surveillance and caution should also be exercised in patients with ulcerative colitis or Crohn's disease as these conditions can be exacerbated. Close medical surveillance is required when prescribing diclofenac to patients with hepatic insufficiency as their condition may be exacerbated. The values of one or more liver enzymes can increase. During prolonged treatment with diclofenac, regular checks of liver function are indicated as a precautionary measure. If liver function parameters are persistently altered or worsened, if clinical signs or consistent symptoms of liver disease develop, or if other manifestations occur, discontinue treatment with diclofenac. Hepatitis with diclofenac use can occur without prodromal symptoms. Particular caution should be exercised in the use of diclofenac in patients with hepatic porphyria, as they can trigger an attack. Since fluid retention and edema have been reported in association with NSAID therapy, including diclofenac, special caution is required in case of renal insufficiency, history of hypertension, in the elderly, in patients receiving concomitant diuretics or medicinal products that may significantly affect on renal function and in those patients with substantial extracellular volume depletion due to any cause. In such cases, monitoring of renal function is recommended as a precaution when administering diclofenac. Discontinuation of therapy is usually followed by a return to pre-treatment conditions. Serious skin reactions, some of them fatal, including exfoliative dermatitis, SJS 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 higher risk for these reactions: the onset of the reaction occurs in most cases within the first month of treatment. Voltadvance should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. Clinical trials and epidemiological data consistently indicate an increased risk of arterial thrombotic events associated with the use of diclofenac, especially at high doses and with long-term treatment. Patients with significant risk factors for cardiovascular events should only be treated with diclofenac after careful consideration. Treat patients with congestive heart failure with diclofenac only after careful consideration. Since the cardiovascular risks of diclofenac may increase with dose and duration of exposure, use the shortest duration possible and the lowest effective daily dose. Patients should be advised to consult their physician if symptoms persist or do not improve within the recommended treatment duration. Pay attention to the signs and symptoms of severe thrombotic events, which can occur without warning symptoms. Contact a doctor right away if any of these events occur. During prolonged treatment with diclofenac, blood count checks are recommended. Diclofenac can temporarily inhibit platelet aggregation. Carefully monitor patients with hemostasis defects. In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa, chronic obstructive pulmonary disease or chronic respiratory tract infections, reactions to NSAIDs such as exacerbation of asthma, Quincke's edema or urticaria are more frequent than in other patients. Special precaution is therefore recommended in such patients. This also applies to patients who are allergic to other substances.

INTERACTIONS: Before using the product, if you are taking other drugs, it is advisable to inform your doctor as it may be necessary to change the dosage or interrupt the treatment. The following interactions include those seen with diclofenac gastro-resistant tablets and / or other pharmaceutical forms of diclofenac. Lithium: when administered concomitantly, diclofenac can 'elevate plasma concentrations of lithium. Monitoring of serum lithium levels is recommended. Digoxin: when administered concomitantly, diclofenac can 'elevate plasma concentrations of digoxin. Monitoring of serum digoxin levels is recommended. Diuretics and antihypertensive agents: Patients undergoing treatment with such drugs should consult their physician before taking the product. Like other NSAIDs, concomitant use of diclofenac with diuretics or antihypertensive agents (e.g. beta-blockers, angiotensin converting enzyme (ACE) inhibitors) may cause a decrease in their antihypertensive effect. Therefore, the combination should be taken with caution and patients, especially the elderly, should receive periodic 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, particularly for diuretics and ACE inhibitors due to an increased risk of nephrotoxicity. Other NSAIDs and corticosteroids: the concomitant use of diclofenac and other systemic non-steroidal anti-inflammatory drugs or corticosteroids may increase the incidence of gastrointestinal side effects. Anticoagulants and antiplatelet agents: Caution is recommended, as concomitant administration may increase the risk of bleeding. Although clinical investigations do not seem to indicate an influence of diclofenac on the action of anticoagulants, there are reports of an increased risk of haemorrhage in patients taking concomitant diclofenac and anticoagulants. Therefore, close monitoring of such patients is recommended. Selective Serotonin Reuptake Inhibitors (SSRIs): Co-administration of systemic NSAIDs, including diclofenac, and SSRIs may increase the risk of gastrointestinal bleeding. Antidiabetics: Clinical studies have shown that diclofenac can be administered together with oral antidiabetics without affecting their clinical effect. However, there have been isolated reports of both hypo- and hyperglycemic effects, with the need to modify the dosage of the antidiabetic agents administered during treatment with diclofenac. For this reason, monitoring of blood glucose levels is recommended as a precautionary measure in case of concomitant therapy. Methotrexate: diclofenac can inhibit renal tubular release of methotrexate by increasing its levels. Caution is advised when administering NSAIDs, including diclofenac, 24 hours before or after treatment with methotrexate as blood concentrations of methotrexate and consequently the toxicity of this substance may increase. Ciclosporin due to its effect on renal prostaglandins, diclofenac, like other NSAIDs, may increase the nephrotoxicity of cyclosporine. Therefore, diclofenac should be administered at lower doses than those used in patients not on cyclosporine therapy. Drugs known to cause hyperkalaemia: concomitant treatment with potassium-sparing diuretic drugs, cyclosporine, tacrolimus or trimethoprim may be associated with an increase in serum potassium levels, which should therefore be monitored frequently. Quinolone antibacterials: There have been isolated reports of seizures, possibly due to concomitant use of quinolones and NSAIDs. Phenytoin: When using phenytoin together with diclofenac, monitoring of phenytoin plasma concentrations is recommended due to an expected increase in phenytoin exposure. 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 colestipol / cholestyramine administration. Potent CYP2C9 inhibitors: Caution is advised when prescribing diclofenac together with potent C YP2C9 inhibitors (such as sulfinpyrazone and voriconazole); this can lead to a significant increase in peak plasma concentrations and diclofenac exposure due to inhibition of its metabolism. Diclofenac may also decrease the efficacy of intrauterine devices and the risk of inhibition of Interferon alfa has been reported.

UNDESIRABLE EFFECTS: Side effects are listed below by organ, organ / system, and MedDRA frequency. Frequencies are defined as: very common (> = 1/10); common (> = 1/100 to 1/10); uncommon (> = 1 / 1,000 to 1/100); rare (> = 1 / 10,000 to 1 / 1,000); very rare (1 / 10,000); not known (frequency cannot be estimated from the available data). The following side effects include those reported with short-term or long-term use. Should one of these effects appear during treatment with Voltadvance, it is advisable to discontinue the drug and consult your doctor. Disorders of the blood and lymphatic system. Very rare: thrombocytopenia, leukopenia, anemia (including haemolytic and aplastic anemia), agranulocytosis. Disorders of the immune system. Rare: hypersensitivity, anaphylactic and aaphylactoid reactions (including hypotension and shock); very rare: angioneurotic edema (including face edema). Psychiatric disorders. Very rare: of sorientation, depression, insomnia, nightmares, irritability, psychotic reactions. Nervous system disorders. Common: headache, dizziness; rare: drowsiness; very rare: paraesthesia, memory impairment, convulsions, anxiety, tremors, aseptic meningitis, taste disturbances, cerebrovascular accidents. Eye disorders. Ear and labyrinth disorders. Common: dizziness; very rare: tinnitus, hearing impairment. Cardiac pathologies. Uncommon: myocardial infarction, heart failure, palpitations, chest pain. Vascular pathologies. 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, haematemesis, haemorrhagic diarrhea, melaena, gastrointestinal ulcer (with or without bleeding or perforation), dry mouth and mucous membranes. Very rare: colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, oesophageal disorders, diaphragm-like intestinal stenosis, pancreatitis, constipation. Not known: ischemic colitis. Hepatobiliary disorders. Common: increased transaminases; rare: hepatitis, jaundice, liver disorders; very rare: fulminant hepatitis, hepatic necrosis, hepatic failure. Skin and subcutaneous tissue disorders. Common: rash; rare: urticaria; very rare: bullous rashes, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal 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 (for example, myocardial infarction or stroke) associated with the use of diclofenac, especially at high doses (150 mg / day) and with long-term treatment. Report any suspected adverse reactions via the national reporting system.

PREGNANCY AND LACTATION: Inhibition of prostaglandin synthesis can negatively affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was believed to increase with dose and duration of therapy. In animals, 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 administered 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 attempting to conceive, 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 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 oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, to: possible prolongation of the bleeding time, and antiplatelet effect which can occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, diclofenac is contraindicated during the third trimester of pregnancy. Breastfeeding Like other NSAIDs, diclofenac passes into breast milk in small amounts. Therefore, diclofenac should not be administered during breastfeeding to avoid undesirable effects in the infant. Fertility As with other NSAIDs, the use of diclofenac can alter female fertility and is not recommended in women wishing to conceive. The suspension of diclofenac should be considered in women who have difficulty conceiving or who are undergoing investigation of infertility.

Packaging and correct storage

Voltadvance 20 sachets should be stored in a cool place away from sources of heat and humidity, keep absolutely out of reach of children, the product is sold in packs of 20 sachets.