Voltadvance 25 mg - painkiller 10 coated tablets

Product Description

Voltadvance is a medicine based on Diclofenac Sodium, an active ingredient capable of acting on pain and the inflammation from which it originates. Particularly indicated in the treatment of pain of various kinds, but especially for lumbago (back pain), joint pain, muscle pain, toothache, headache, and as an adjuvant in the treatment of influenza and feverish states.

Therapeutic indications

Pain of various kinds, such as joint pain, lumbago, muscle pain, headache and toothache, menstrual pain. return to index

Dosage and Directions for Use

Adults and adolescents over 14 years: 1–3 coated tablets, with meals, or 2 in a single administration. The maximum daily dose is 75 mg. Do not exceed the recommended doses; elderly patients in particular should adhere to the minimum doses indicated above. The coated tablets should be swallowed whole, with water or other liquid.

It is recommended to take the product preferably on a full stomach. Do not exceed 3 days of treatment. Undesirable effects can be minimized by administering the lowest effective dose for the shortest duration necessary to control symptoms.

Composition

Active ingredient 

One film-coated tablet contains: active ingredient diclofenac sodium 25 mg.

Excipients

Film-coated tablets: potassium bicarbonate; mannitol; sodium lauryl sulfate; crospovidone; magnesium stearate; glycerol dibehenate; Clear Opadry (hypromellose; macrogol).

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Active gastrointestinal ulcer, bleeding, or perforation. History of gastrointestinal bleeding or perforation related to previous NSAID treatment or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding). Last trimester of pregnancy and during breastfeeding. Severe hepatic insufficiency, severe renal insufficiency, or severe cardiac insufficiency. Like other nonsteroidal anti-inflammatory drugs (NSAIDs), diclofenac is also contraindicated in patients who have experienced asthma attacks, urticaria, or acute rhinitis, anaphylactic, or anaphylactoid reactions after taking acetylsalicylic acid or other NSAIDs. The product should not be used in cases of impaired haematopoiesis. In cases of intensive diuretic therapy. The product should not be taken if the stools are dark or bloody. Established congestive heart failure (NYHA class II-IV), ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease. Voltadvance should not be administered to children under 14 years of age.

Warnings and precautions

After 2-3 days of treatment without noticeable results, consult your doctor.

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms. The use of diclofenac concomitantly with other systemic NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to the lack of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects. From a basic medical perspective, caution is advised in the elderly. Particularly in frail elderly patients or those with low body weight, the lowest effective dose is recommended. As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, may occur in rare cases without prior exposure to diclofenac. Like other NSAIDs, diclofenac may mask the signs and symptoms of infections due to its pharmacodynamic properties. Prolonged use of any type of painkiller for headaches may worsen them. If this condition has occurred or is suspected, medical advice should be sought and treatment should be discontinued. The diagnosis of medication-overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite the regular use of headache medications.

Gastrointestinal effects

GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs, including diclofenac, and may occur at any time during treatment, with or without warning symptoms or a previous history of serious GI events. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving diclofenac, the drug should be discontinued. As with all NSAIDs, including diclofenac, close medical supervision is mandatory and particular caution should be used when prescribing diclofenac to patients with symptoms indicative of gastrointestinal (GI) disorders or with a history of gastric or intestinal ulceration, bleeding, or perforation, or chronic inflammatory bowel disease. The risk of GI bleeding is higher with increased NSAID doses and in patients with a history of ulcers, particularly if complicated with haemorrhage or perforation. 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 ulcers, particularly if complicated with haemorrhage or perforation, and in the elderly, treatment should be initiated and maintained at the lowest effective dose. Concomitant use of protective agents (proton pump inhibitors or misoprostol) should be considered for these patients and also for patients requiring concomitant use of medications containing low-dose acetylsalicylic acid (ASA) or other medications that may increase gastrointestinal risk. Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding). Caution is advised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, antiplatelet agents, or selective serotonin reuptake inhibitors. Close medical supervision and caution should also be exercised in patients with ulcerative colitis or Crohn's disease, as these medications may increase the risk of gastrointestinal ulceration. These conditions may be exacerbated.

Hepatic effects

When prescribing diclofenac to patients with hepatic insufficiency, close medical supervision is necessary as their condition may be exacerbated. As with other NSAIDs, including diclofenac, values ​​of one or more liver enzymes may increase. During prolonged treatment with diclofenac, regular monitoring of liver function is indicated as a precautionary measure. If liver function tests are persistently abnormal or worsened, if clinical signs or symptoms consistent with liver disease develop, or if other manifestations (e.g., eosinophilia, rash) occur, treatment with diclofenac should be discontinued. Hepatitis with diclofenac use may occur without prodromal symptoms. Particular caution should be exercised when using diclofenac in patients with hepatic porphyria, as it may trigger an attack.

Renal effects

Since fluid retention and edema have been reported in association with NSAID therapy, including diclofenac, particular caution is required in patients with renal insufficiency, a history of hypertension, the elderly, patients receiving concomitant treatment with diuretics or medicinal products that can significantly affect renal function, and those with substantial extracellular volume depletion from any cause (e.g., before or after major surgery). In such cases, monitoring of renal function is recommended as a precaution when administering diclofenac. Discontinuation of therapy is usually followed by recovery 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. Patients appear to be at highest risk for these reactions early in the course of therapy, with the onset of the reaction occurring in the majority of cases within the first month of treatment. Voltadvance should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Cardiovascular and cerebrovascular effects 

Caution (discuss with your doctor or pharmacist) is advised before initiating treatment in patients with a history of hypertension since fluid retention, hypertension, and edema have been reported in association with NSAID treatment. Clinical trial and epidemiological data consistently point to an increased risk of arterial thrombotic events (for example, myocardial infarction or stroke) associated with the use of diclofenac, particularly at high doses (150 mg/day) and with long-term treatment. Available data do not suggest an increased risk with the use of low doses of diclofenac (25 mg to 100 mg/day). Patients with significant risk factors for cardiovascular events (e.g., hypertension, hyperlipidaemia, diabetes mellitus, smoking) should be treated with diclofenac only after careful consideration. Since the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The response to therapy and the need for symptomatic improvement should be reassessed periodically.

Hematological effects

During prolonged treatment with diclofenac, as with other NSAIDs, blood count monitoring is recommended. Like other NSAIDs, diclofenac may temporarily inhibit platelet aggregation. Patients with impaired hemostasis should be carefully monitored. Pre-existing asthma In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (e.g. nasal polyps), chronic obstructive pulmonary disease, or chronic respiratory tract infections (especially if associated with allergic rhinitis-like symptoms), reactions to NSAIDs such as asthma exacerbations (so-called analgesic intolerance/analgesic asthma), Quincke's edema, or urticaria are more frequent than in other patients. Special precautions are therefore recommended in such patients (prepare for emergency situations). This also applies to patients allergic to other substances, e.g., with skin reactions, pruritus, or urticaria.

Pregnancy and breastfeeding

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of miscarriage, 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 is believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased 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 trimesters of pregnancy, diclofenac should not be administered unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimesters 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 may expose

the fetus to:
– cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
– renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;
the mother and the newborn, at the end of pregnancy, to:
– possible prolongation of bleeding time, and antiaggregant effect which may occur even at very low doses;
– inhibition of uterine contractions resulting in delayed or prolonged labor.