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Voltadvance 25 mg - pain relief medication 30 coated tablets

Name: Voltadvance 25 mg - pain relief medication 30 coated tablets
Brand: Haleon
SKU: FRCM213930
Price: 10.62 EUR
Availability: InStock
Rating: 4.9 (47 reviews)

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Productor: Haleon

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30 coated tablets

€10.62
10 coated tablets

€7.76
20 capsules

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€9.61
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Product Description

Oral anti-inflammatory drug with analgesic action

Indications

Voltadvance 25 mg is useful in the treatment of various types of pain such as, for example, joint pain, lumbago, muscle pain, headache and toothache, menstrual pain.

Composition

Active ingredients

1 coated tablet contains: Diclofenac sodium 25 mg

Excipients

potassium bicarbonate; mannitol; sodium lauryl sulfate; crospovidone; magnesium stearate; glycerol dibehenate; Clear Opadry (hypromellose; macrogol).

How to use and Dosage

Adults and adolescents over 14 years of age:

1-3 coated tablets, with meals, even 2 in a single administration.

The maximum daily dose is 75 mg.

Do not exceed the recommended doses; in particular, elderly patients should adhere to the minimum dosages 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.

Special populations

Renal impairment

Voltadvance is contraindicated in patients with severe renal impairment. Caution is recommended when administering Voltadvance to patients with mild to moderate renal impairment.

Hepatic impairment

Voltadvance is contraindicated in patients with severe hepatic impairment. Caution is recommended when administering Voltadvance to patients with mild to moderate hepatic impairment.

Warnings

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

General information

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.

On the basis of basic medical considerations, caution is required in the elderly. Particularly in frail elderly patients or those with a low body weight, the use of the lowest effective dose for the shortest duration necessary to control symptoms is recommended. low effective dose.

As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, may occur in rare cases without previous exposure to diclofenac.

Hypersensitivity reactions may also develop into Kounis syndrome, a serious allergic reaction that can lead to myocardial infarction. Presenting symptoms may include chest pain that occurs in association with an allergic reaction 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 situation 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

Gastrointestinal 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 gastrointestinal events.

They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving diclofenac, the medicinal product should be discontinued.

As with all NSAIDs, including diclofenac, close medical surveillance is mandatory and particular caution should be used when prescribing diclofenac to patients with symptoms indicative of gastrointestinal (GI) disorders, or with a history suggestive of gastric or intestinal ulceration, bleeding or perforation, or chronic inflammatory bowel disease. The risk of GI bleeding is higher with increasing NSAID doses and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation. The elderly have an increased frequency of adverse reactions, especially gastrointestinal bleeding and perforation, which may 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, treatment should be initiated and maintained as early as possible after initiation of treatment. low 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 medicinal products containing low dose acetylsalicylic acid (ASA) or other medicinal products likely to increase gastrointestinal risk.

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding). Caution is advised in patients receiving concomitant medicinal products which could 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 they may be at increased risk of developing gastrointestinal ulcers. such conditions may be exacerbated.

NSAIDs, including diclofenac, may be associated with an increased risk of gastrointestinal anastomotic leakage. Caution and close medical supervision are recommended when using diclofenac following gastrointestinal surgery.

Hepatobiliary 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 persist or worsen, if clinical signs or symptoms consistent with liver disease develop, or if other manifestations occur (e.g., eosinophilia, rash), 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.

Skin effects

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 more susceptible to these reactions early in the course of therapy. high 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 sign of hypersensitivity.

Cardiovascular and cerebrovascular effects

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.

Patients with significant risk factors for cardiovascular events (e.g., hypertension, hyperlipidaemia, diabetes mellitus, smoking) should be treated with diclofenac only after careful consideration.

Patients with congestive heart failure (NYHA class I) should be treated with diclofenac only after careful consideration. evaluation.

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. Patients should be advised to consult their doctor if symptoms persist or do not improve within the recommended treatment duration.

Patients should be alert to the signs and symptoms of serious thrombotic events (e.g. chest pain, shortness of breath, weakness, slurred speech), which may occur without warning symptoms. Patients should be advised to contact a doctor immediately if any of these events occur.

Haematological effects

During prolonged treatment with diclofenac, as with other NSAIDs, blood count monitoring is recommended.

Like other NSAIDs, diclofenac may cause serious thrombotic events. temporarily inhibit platelet aggregation. Patients with haemostatic defects should be carefully monitored.

Respiratory effects (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 these patients (prepare for emergency). This also applies to patients allergic to other substances, e.g. with skin reactions, itching or urticaria.

Important information about some of the excipients:

Voltadvance 25 mg film-coated tablets contain less than 1 mmol sodium (23 mg) per dose, i.e. essentially 'sodium-free'.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed.
Active gastrointestinal ulcer, bleeding or perforation.
History of gastrointestinal bleeding 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 breastfeeding.
Severe hepatic insufficiency or severe renal insufficiency.
Like other nonsteroidal anti-inflammatory drugs (NSAIDs), diclofenac is also contraindicated in patients who have experienced asthma attacks, urticaria, angioedema or acute rhinitis, anaphylactic or anaphylactoid reactions after taking acetylsalicylic acid or other NSAIDs.
The product must not be used in case of alterations of haematopoiesis.
In case of intensive diuretic therapy.
The product must 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 cerebrovascular disease.

Voltadvance should not be administered to children under 14 years of age. years.

Undesirable effects

Undesirable effects (Table 1) are listed below by organ class, system organ class, 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 undesirable effects include those reported with short-term or long-term use. If any of these effects occur during treatment with Voltadvance, it is recommended to stop the drug and consult your doctor.

Blood and lymphatic system disorders
Very rare	Thrombocytopenia, leukopenia, anaemia (including haemolytic and aplastic anaemia), agranulocytosis.
Immune system disorders
Rare	Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock).
Very rare	Angioedema (including facial oedema).
Psychiatric disorders
Very rare	Disorientation, depression, insomnia, nightmares, irritability, psychotic reactions.
Nervous system disorders
Common	Headache, dizziness.
Rare	Drowsiness.
Very rare	Paraesthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident.
Eye disorders
Very rare	Vision disturbances, blurred vision, diplopia.
Ear and labyrinth disorders
Common	Vertigo.
Very rare	Tinnitus, hearing impairment.
Cardiac disorders
Uncommon*	Myocardial infarction, cardiac failure, palpitations, chest pain.
Not known	Kounis syndrome
Vascular disorders
Very rare	hypertension, vasculitis.
Respiratory, thoracic and mediastinal disorders
Rare	asthma (including dyspnoea).
Very rare	pneumonia.
Gastrointestinal disorders
Common	nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia.
Rare	gastritis, gastrointestinal haemorrhage, haematemesis, haemorrhagic diarrhoea, melaena, gastrointestinal ulcer (with or without bleeding or perforation, which may lead to peritonitis), dry mouth and mucous membranes, gastrointestinal stenosis.
Very rare	colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, esophageal disorders, intestinal diaphragm disease, 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 eruptions, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, hair loss, photosensitivity reaction, purpura, Henoch-Schonlein 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	Oedema.

Overdose

There is no typical clinical picture resulting from diclofenac overdose. Overdose may cause symptoms such as vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or convulsions. In cases of significant poisoning, acute renal failure and liver damage are possible.

Therapeutic measures

Treatment of acute poisoning with NSAIDs, including diclofenac, consists primarily of supportive measures and symptomatic treatment. In case of complications such as hypotension, renal failure, convulsions, gastrointestinal disturbances, and respiratory depression, supportive measures and symptomatic treatment should be adopted. Specific therapies, such as forced diuresis, dialysis, or hemoperfusion, are unlikely to help eliminate NSAIDs, including diclofenac, due to their high plasma protein binding and extensive metabolism. Further treatment modalities should take into account clinical indications or the recommendation of the poison control center, where available.

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%, up 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. From the twentieth week of pregnancy onwards, the use of diclofenac may cause oligohydramnios resulting from fetal renal dysfunction.

This condition may occur shortly after initiation of treatment and is usually reversible upon discontinuation of treatment. Furthermore, cases of constriction of the ductus arteriosus have been reported following treatment in the second trimester of pregnancy, most of which disappeared after discontinuation of treatment. Therefore, 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. as soon as possible.

Following exposure to diclofenac for several days from the twentieth week of gestation onwards, antenatal monitoring for oligohydramnios and constriction of the ductus arteriosus should be considered. If oligohydramnios or constriction of the ductus arteriosus occurs, treatment with diclofenac should be discontinued. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to:

cardiopulmonary toxicity (premature constriction/closure of the ductus arteriosus and pulmonary hypertension);
renal dysfunction (see above), which may lead to: 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.

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 may impair the ability to conceive. alter female fertility and is not recommended in women attempting to conceive. Discontinuation of diclofenac should be considered in women who have difficulties conceiving or who are undergoing investigation of infertility.