Properties
- Form
- tableti saghech i
- Dosage mg
- 100
- Pack
- 20
What is it?
1. What is Vacenac 100 mg film-coated tablets and what is it used for: Vacenac is an effective preparation for reducing pain and inflammation. Vacenac 100 mg is indicated for the relief of pain and inflammatory processes, such as low back pain (lumbago), toothache (odontalgia), and joint pain (scapulohumeral periarthritis and extra-articular rheumatoid). Vacenac is indicated for the treatment of chronic pain and inflammation associated with chronic joint conditions, such as: osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. 2. Before using Vacenac 100 mg film-coated tablets: It is important to use the lowest dose that relieves/controls pain. This preparation should not be used for longer than necessary. Do not take Vacenac 100 mg film-coated tablets: - if you are allergic (hypersensitive) to Vacenac or any of the other ingredients of the preparation; - if you are in the third trimester of pregnancy or breastfeeding; - if you have previously experienced sensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, resulting in asthma, rhinitis, urticaria or other allergic reactions; - if you have a history of stomach or duodenal ulcer, perforation or gastrointestinal bleeding; - if you have severe kidney disease; - if you have severe heart disease. Take special care when taking: - if you have had a stomach or duodenal ulcer, bleeding or perforation, manifested by intense abdominal pain or persistent and/or black stools, or without any prior warning symptoms; - the risk is greater with high doses and prolonged treatment in the elderly and in patients with a history of peptic ulcer. In such cases, your doctor will prescribe a stomach-protective preparation; - if you have severe liver disease; - if you have moderate kidney disease; - if you have had blood clotting problems (easy bleeding); - if you have recently had surgery. Tell your doctor - if you are also taking other medications that affect blood clotting, such as corticosteroids, oral anticoagulants, e.g. acetylsalicylic acid. The use of other medications that increase the risk of bleeding, such as steroids and antidepressants, serotonin reuptake inhibitors, should also be considered. - if you have Crohn's disease or ulcerative colitis, preparations of the Vacenac type may worsen these conditions. - It is important to use the lowest dose that relieves/controls pain. Aceclofenac should not be used for longer than necessary. Precautions regarding the cardiovascular system: Taking preparations similar to Vacenac may be associated with a slightly increased risk of heart attacks ("myocardial infarction"). The risk is likely present with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. If you have heart problems, have had a stroke, or think you are at risk of such conditions (e.g., high blood pressure, diabetes, high cholesterol, or if you are a smoker), consult your doctor before starting treatment. These preparations may also cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension). Taking other medicines: Tell your doctor or pharmacist if you are currently taking or have recently taken other medicines, including those obtained without a prescription. Interactions between aceclofenac and some medicines may occur. In such cases, dose adjustment or discontinuation of these medicines may be necessary. This is particularly important if you are taking lithium, digoxin, diuretics, antihypertensives, anticoagulants, hypoglycemic agents, methotrexate, aspirin, other non-steroidal anti-inflammatory drugs, or cyclosporine. Taking Vacenac 100 mg film-coated tablets with food and drink: Aceclofenac 100 mg can be taken with or without food. Pregnancy and breastfeeding: Pregnancy: Consult your doctor or pharmacist before taking any medicine. Do not take Vacenac if you are pregnant, suspect you are pregnant, or plan to become pregnant. Taking preparations similar to Vacenac is associated with an increased risk of congenital anomalies/abortions, therefore it is not recommended for use in the first and second trimesters of pregnancy, except in cases of extreme necessity. Even in such cases, the minimum dose should be used for the minimum duration. The use of Vacenac in the third trimester of pregnancy is contraindicated. Patients of reproductive age should be aware that preparations of the Vacenac type are associated with reduced fertility. Consult your doctor even if the above circumstances have occurred only once. Breastfeeding: Consult your doctor or pharmacist before taking any medicine. Taking Vacenac is contraindicated during breastfeeding. Driving and operating machinery: If you experience dizziness, fainting, or other central nervous system disorders while taking Vacenac, do not drive or operate machinery. 3. How to use Vacenac 100 mg film-coated tablets: Always take aceclofenac exactly as prescribed by your doctor. If you have any questions, ask your doctor or pharmacist. Aceclofenac is taken orally. The tablets should be swallowed whole with a small amount of water. The recommended dose is 200 mg per day, accordingly, one tablet in the morning and one tablet in the evening (1 tablet every 12 hours). The duration of treatment will be determined by your doctor. Do not stop treatment even if you feel well. If you take more Vacenac than you should, contact your doctor, pharmacist, or the nearest hospital immediately. If you forget to take Vacenac: Take the dose as soon as you remember. If it is almost time for your next dose, wait and take the tablet at the scheduled time. Do not take a double dose to make up for a missed dose. Take the next dose at the usual time. If you stop taking Vacenac: Do not stop treatment without consulting your doctor. If you have any further questions regarding this preparation, ask your doctor or pharmacist. 4. Possible side effects: Like all medicines, Vacenac can cause side effects, but not everyone gets them. Side effects disappear after stopping the medication. Undesirable effects are classified by frequency of occurrence: very common – in at least 1 in 10 patients common – in at least 1 in 100 patients uncommon – in at least 1 in 1000 patients rare – in at least 1 in 10,000 patients very rare in less than 1 in 1000 patients, including isolated cases. Disorders of the blood and lymphatic system: Rare: anemia Very rare and isolated cases: thrombocytopenia (decrease in platelet count), agranulocytosis (lack of leukocytes). Disorders of the immune system: Rare: allergies, including severe reactions such as anaphylactic shock. Disorders of metabolism and nutrition: Very rare and isolated cases: hyperkalemia (increased potassium levels in the blood). Psychiatric disorders: Very rare and isolated cases: depression, abnormal dreams, insomnia. Nervous system disorders: Very common: dizziness. Very rare and isolated cases: paresthesia (tingling, burning sensation), drowsiness, headache, dysgeusia (altered sense of taste), tremor. Eye disorders: Rare: visual disturbances. Ear and labyrinth disorders: Very rare: vertigo. Cardiovascular disorders: Very rare: palpitations, redness, flushing of the face, peripheral edema (swelling of ankles, feet and legs). Edema is observed in patients with heart failure and/or arterial hypertension during treatment with non-steroidal anti-inflammatory drugs. Preparations similar to aceclofenac tablets increase the risk of heart attacks ("myocardial infarction") or stroke. Respiratory disorders: Rare: dyspnea (difficulty breathing) Very rare: stridor (wheezing). Gastrointestinal disorders: The most common side effects of preparations similar to Vacenac may be gastrointestinal: peptic ulcer, gastrointestinal bleeding, perforation (sometimes fatal), especially in the elderly. Nausea, vomiting, diarrhea, abdominal bloating, constipation, heartburn, abdominal pain, bloody stools, stomatitis, exacerbation of ulcerative colitis and Crohn's disease have also been reported. Gastritis has been reported less frequently. Hepatobiliary disorders: Rare: liver damage. Preparations similar to Vacenac may be associated with disorders that cause yellowing of the skin and eyes, sometimes with high fever or swelling and increased sensitivity in the epigastric region. If your skin or eyes turn yellow, stop treatment and consult your doctor immediately. Skin and subcutaneous tissue disorders: Common: itching, rash, dermatitis, urticaria. Rare: facial edema (swelling is serious). Very rare: purpura, peeling, Stevens-Johnson syndrome and toxic epidermal necrolysis. Musculoskeletal and connective tissue disorders: Very rare: muscle spasms of the lower limbs. Kidney and urinary system disorders: Very rare: nephrotic syndrome (a type of kidney dysfunction). General disorders and administration site reactions: Very rare: edema (inflammation), fatigue. Laboratory findings: Very common: increased liver enzymes. Common: increased blood urea, increased blood creatinine. Very rare: increased alkaline phosphatase in the blood, weight gain. If any side effect worsens or you notice any side effect not listed in this leaflet, consult your doctor or pharmacist. 5. How to store Vacenac 100 mg film-coated tablets: Store at a temperature not exceeding 30°C. Keep out of reach of children. Do not use Vacenac (aceclofenac) after the expiry date indicated on the carton and blister. Medicines should not be disposed of in household waste or sewage. Ask your pharmacist how to dispose of medicines you no longer need. Such measures will help protect the environment. 6. Additional information: What Vacenac 100 mg film-coated tablets contain: The active substance is aceclofenac. Each film-coated tablet contains 100 mg of aceclofenac. Other ingredients are: microcrystalline cellulose, croscarmellose sodium, povidone, glyceryl palmitostearate, hydroxypropyl methylcellulose, microcrystalline cellulose, polyoxyethylene stearate 40, titanium dioxide (E-171). Description and contents of the package: Vacenac is a round, white, biconvex, film-coated tablet. Each package contains 20 or 40 tablets
