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RANOLAZINE UMEDICA is a brand name for Ranolazine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ranolazine is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists).
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Ranolazine Umedica is available as 375 mg, 500 mg, and 750 mg prolonged-release tablets.
Adults:
The recommended initial dose of ranolazine is 375 mg twice daily. 1). g. dizziness, nausea, or vomiting), down-titration of ranolazine to 500 mg or 375 mg twice daily may be required. If symptoms do not resolve after dose reduction, treatment should be discontinued.
g. g. 5). 5). 2). 2). 2). 2). 4). 2). 8).
Low weight:
The incidence of adverse events was higher in patients with low weight (≤ 60 kg). 2). 2). Paediatric population The safety and efficacy of ranolazine in children below the age of 18 years have not been established. No data are available.
Method of administration Ranolazine Umedica should be swallowed whole and not crushed, broken, or chewed. They may be taken with or without food.
Undesirable effects in patients receiving ranolazine are generally mild to moderate in severity and often develop within the first 2 weeks of treatment. These were reported during the Phase 3 clinical development programme, which included a total of 1,030 chronic angina patients treated with ranolazine.
The adverse events, considered to be at least possibly related to treatment, are listed below by body system, organ class, and absolute 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).
Metabolism and nutrition disorders Uncommon: anorexia, decreased appetite, dehydration. Rare: hyponatremia Psychiatric disorders Uncommon: anxiety, insomnia, confusional state, hallucination. Rare: disorientation Nervous system disorders Common: dizziness, headache.
Uncommon: lethargy, syncope, hypoaesthesia, somnolence, tremor, postural dizziness, paresthesia. Rare: amnesia, depressed level of consciousness, loss of consciousness, coordination abnormal, gait disturbance, parosmia. Not known: myoclonus.
Eye disorders Uncommon: blurred vision, visual disturbance, diplopia. Ear and labyrinth disorders Uncommon: vertigo, tinnitus. Rare: impaired hearing. Vascular disorders Uncommon: hot flush, hypotension. Rare: peripheral coldness, orthostatic hypotension.
Respiratory, thoracic, and mediastinal disorders Uncommon: dyspnoea, cough, epistaxis. Rare: throat tightness. Gastrointestinal disorders Common: constipation, vomiting, nausea. Uncommon: abdominal pain, dry mouth, dyspepsia, flatulence, stomach discomfort.
Rare: pancreatitis, erosive duodenitis, oral hypoaesthesia. Skin and subcutaneous tissue disorders Uncommon: pruritus, hyperhydrosis. Rare: angioedema, allergic dermatitis, urticaria, cold sweat, rash. Musculoskeletal and connective tissue disorders Uncommon: pain in extremity, muscle cramp, joint swelling, muscular weakness.
5). 5). 2). 2). 2). 2). 2). In patients with a combination of these factors, additional exposure increases are expected. Dose- dependent side effects are likely to occur. If Ranolazine is used in patients with a combination of several of these factors, monitoring of adverse events should be frequent, the dose reduced, and treatment discontinued, if needed.
2). The above precautions are based on the risk in a CYP2D6 PM patient, and are needed when the CYP2D6 status is unknown. There is a lower need for precautions in patients with CYP2D6 EM status. g. by genotyping) or is previously known to be EM, Ranolazine Umedica can be used with caution in these patients when they have a combination of several of the above risk factors.
QT prolongation:
Ranolazine blocks IKr and prolongs the QTc interval in a dose-related manner. 4 msec per 1000 ng/ml, which is approximately equal to a 2- to 7- msec increase over the plasma concentration range for ranolazine 500 to 1000 mg twice daily.
5 also).
Drug-drug interaction:
Co-administration with CYP3A4 inducers is expected to lead to lack of efficacy. g. 5). 2).
Lactose:
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Sodium:
This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release tablet, that is to say essentially ‘sodium-free’.
1. 2). 2). g. 5). g. g. dofetilide, sotalol) antiarrhythmics other than amiodarone.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ranolazine in United Kingdom.
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Renal and urinary disorders Uncommon: dysuria, haematuria, chromaturia. Rare: acute renal failure, urinary retention. Reproductive system and breast disorders Rare: erectile dysfunction. General disorders and administration site conditions Common: asthenia.
Uncommon: fatigue, peripheral oedema.
Investigations Uncommon:
Increased blood creatinine, increased blood urea, prolonged QT corrected interval, increased platelet or white blood cell count, decreased weight.
Rare:
Elevated levels of hepatic enzyme. The adverse event profile was generally similar in the MERLIN-TIMI 36 study. In this long term study, acute renal failure was also reported with an incidence less than 1% in placebo and ranolazine patients.
g. patients with diabetes, Class I and II heart failure, or obstructive airway disease, confirmed that these conditions were not associated with clinically meaningful increases in the incidence of adverse events. 1) where patients with incomplete revascularization post-PCI were given ranolazine up to 1000 mg twice daily or placebo for approximately 70 weeks.
0% in placebo). 5%).
Elderly, renal impairment, and low weight:
In general, adverse events occurred more frequently among elderly patients and patients with renal impairment; however, the types of events in these subgroups were similar to those observed in the general population. Of the most commonly reported, the following events occurred more often with Ranolazine Umedica (placebo- corrected frequencies) in elderly (≥ 75 years of age) than younger patients (< 75 years of age): constipation (8% versus 5%), nausea (6% versus 3%), hypotension (5% versus 1%), and vomiting (4% versus 1%).
In patients with mild or moderate renal impairment (creatinine clearance ≥ 30–80 ml/min) compared to those with normal renal function (creatinine clearance > 80 ml/min), the most commonly reported events and their placebo-corrected frequencies included: constipation (8% versus 4%), dizziness (7% versus 5%), and nausea (4% versus 2%).
In general, the type and frequency of adverse events reported in patients with low body weight (≤ 60 kg) were similar to those of patients with higher weight (> 60 kg); however, the placebo-corrected frequencies of the following common adverse events were higher in low body weight than heavier patients: nausea (14% versus 2%), vomiting (6% versus 1%), and hypotension (4% versus 2%).
Laboratory findings:
Small, clinically insignificant, reversible elevations in serum creatinine levels have been observed in healthy subjects and patients treated with Ranolazine. There was no renal toxicity related to these findings. A renal function study in healthy volunteers demonstrated a reduction in creatinine clearance with no change in glomerular filtration rate consistent with inhibition of renal tubular secretion of creatinine.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side, you can help provide more information on the safety of this medicine.