Amlodipine Sandoz

Amlodipine Sandoz

amlodipine

Manufacturer:

Sandoz

Distributor:

Zuellig
Full Prescribing Info
Contents
Amlodipine besylate.
Description
Each 5- and 10-mg tablet also contains the following excipients: Microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium starch glycolate (type A) and magnesium stearate.
Action
Amlodipine Sandoz is a calcium antagonist which relaxes blood vessels, so that blood can easily pass through. It also improves blood supply to the heart muscle which then receives more oxygen, and as a result, chest pain is prevented. Amlodipine Sandoz does not provide immediate relief of chest pain from angina.
Indications/Uses
Treatment of high blood pressure; chest pain due to narrowing of the coronary arteries of the heart muscle (angina pectoris) or the more rare form of chest pain caused by cramping of the coronary arteries of the heart muscle (vasospastic angina).
Dosage/Direction for Use
Adults: Usual Starting Dose: 5 mg once daily, may be increased to 10 mg once daily.
Elderly: There is no special dosage for the elderly; however, care must be taken when the dose is increased.
Renal Impairment: The normal dosage is recommended. Amlodipine Sandoz cannot be removed from the blood by dialysis (artificial kidney). Amlodipine Sandoz should be administered with particular caution to patients undergoing dialysis.
Hepatic Impairment: The exact dose needed for patient with liver problems has not been determined. If the patient has liver problems, Amlodipine Sandoz should be used very carefully (see also Precautions).
Missed Dose: If there is a missed dose, the patient can still take the tablet up to 12 hrs after the usual time. If it is >12 hrs after the usual time, patient should not take the missed dose and should take the next tablet at the usual time. Never take a double dose of Amlodipine Sandoz tablets to make up for the dose that the patient have missed.
Amlodipine Sandoz is usually used for long-term treatment. Do not stop the treatment earlier than agreed without discussing this with the doctor.
Administration: Swallow the tablets with a glass of water. It can be taken with or without food.
Overdosage
Symptoms: Extreme dizziness and/or feeling very lightheaded, problems with breathing, having to urinate very often.
Treatment: In case of overdose, contact the doctor, an emergency department or a poisoning center immediately. The person concerned should be made to lie down with their arms and legs up (eg, resting on a couple of cushions).
Contraindications
Patients who are allergic to amlodipine besylate or similar calcium channel blockers (the so-called dihydropyridine derivates) or to any of the excipients of Amlodipine Sandoz; have very low blood pressure; suffering from insufficient blood supply to tissues with symptoms eg, low blood pressure, low pulse, fast heartbeat [shock, including cardiogenic shock (shock due to severe heart troubles)]; heart failure after a heart attack within the last 4 weeks; suffering from narrowing of the aorta (aortic stenosis); heart-associated chest pain at rest or with minimal effort (unstable angina pectoris).
Special Precautions
Patients who have heart failure; reduced liver and kidney function should inform the doctor before start of treatment.
Effects on the Ability to Drive or Operate Machinery: Caution should be taken when driving or operating machinery while taking Amlodipine Sandoz. Amlodipine Sandoz may not directly affect the ability to drive or operate machinery. However, some patients experience side effects eg, dizziness or somnolence related to the fall in the blood pressure (see Side Effects). Such side effects are more likely to occur after beginning to take Amlodipine Sandoz or after dose increases. If the patient experience these side effects, patient should refrain from driving and other activities requiring alertness.
Use in pregnancy & lactation: If the patient is pregnant or becomes pregnant during treatment, Amlodipine Sandoz should not be taken unless specifically prescribed by the doctor.
There are insufficient data to evaluate the risk for the baby when taking Amlodipine Sandoz during pregnancy.
Amlodipine Sandoz should not be taken if the patient is breastfeeding. Inform the doctor.
Use in children and adolescents (<18 years): Amlodipine Sandoz should not be used in children because of insufficient experience.
Use in the elderly: The dose should be increased with caution.
Use In Pregnancy & Lactation
Use in pregnancy & lactation: If the patient is pregnant or becomes pregnant during treatment, Amlodipine Sandoz should not be taken unless specifically prescribed by the doctor.
There are insufficient data to evaluate the risk for the baby when taking Amlodipine Sandoz during pregnancy.
Amlodipine Sandoz should not be taken if the patient is breastfeeding. Inform the doctor.
Side Effects
Like all medicines, Amlodipine Sandoz can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if the patient notice any side effects not listed as follows, inform the doctor or pharmacist.
For the assessment of side effects, the following descriptions of frequency have been used: Very common (>1/10); common (<1/10, >1/100); uncommon (<1/100, >1/1000); rare (<1/1000, >1/10,000); very rare (<1/10,000, including isolated cases).
The following side effects have been observed during treatment with Amlodipine Sandoz: Blood and Lymph (Blood and Lymphatic System Disorders): Very Rare: Reduced number of white blood cells which may cause unexplained fever, sore throat and flu-like symptoms (leukopenia); reduced number of blood platelets, which may cause easy bruising or nasal bleeding (thrombocytopenia).
Hormone System (Endocrine Disorders): Uncommon: Enlarged breasts in men.
Metabolism Disorders: Very Rare: Increased blood sugar level.
Mind (Psychiatric Disorders): Uncommon: Sleep disorders, irritability, depression. Rare: Confusion, mood changes including anxiety.
Nerves (Nervous System Disorders): Common: Headache (especially at the beginning of treatment), sleepiness, dizziness, weakness. Uncommon: Feeling unwell, dry mouth, uncontrolled shaking (tremor), pins and needles (paraesthesia), increased sweating. Rare: Change in taste. Very Rare: Pain or numbness in hands and feet (peripheral neuropathy).
Eyes (Eye Disorders): Uncommon: Eyesight problems (visual disturbances).
Ears (Ear and Labyrinth Disorders): Uncommon: Ringing or buzzing in the ears (tinnitus).
Heart (Cardiac Disorders): Common: Quicker or irregular heart beat (palpitations). Uncommon: Fainting, increased heart rate (tachycardia), chest pain, aggravation of angina may occur at the beginning of the treatment. In isolated cases, the following side effects have occurred but the relationship to treatment with Amlodipine Sandoz is uncertain: Heart attack (myocardial infarction), irregular heartbeat and chest pain (angina pectoris).
Circulation (Vascular Disorders): Uncommon: Low blood pressure, inflammation of the blood vessels.
Lungs, Breathing and Chest (Respiratory, Thoracic and Mediastinal Disorders): Uncommon: Breathing difficulties, inflammation of the nasal mucosa (rhinitis). Very Rare: Cough.
Stomach and Bowel (Gastrointestinal Disorders): Common: Nausea, digestive problems, stomach pain. Uncommon: Vomiting, diarrhoea, constipation, swollen gums (gingival hyperplasia). Very Rare: Inflammation of the stomach lining (gastritis), inflammation of the pancreas (pancreatitis).
Liver and Bile (Hepatobiliary Disorders): Rare: Increase of certain liver enzymes; yellowing of the skin or whites of the eyes, this could be the result of abnormal liver function or inflammation of the liver.
Muscles and Bones (Musculoskeletal and Bone Disorders): Uncommon: Muscle cramps, back pain, muscle and joint pain.
Kidneys (Renal and Urinary Disorders): Uncommon: Increased need to urinate (increased micturition frequency).
Sexual Organs and Breast (Reproductive System and Breast Disorders): Uncommon: Impotence.
General Disorders: Uncommon: Increased or decreased weight.
Drug Interactions
Some medicines (including medicines obtained without prescription, herbal medications or natural products) may interact with Amlodipine Sandoz. This means that the action of both medicines can be changed. Therefore, it is important to tell the doctor if the patient takes any of the following medicines: Medicines that can lower blood pressure eg, β-blockers, ACE inhibitors, α1-blockers and diuretics. Amlodipine Sandoz may enhance the blood pressure-lowering effects of these medicines.
Diltiazem (cardiac medicine); ketoconazole and itraconazole (antifungal medicines); HIV-protease inhibitors (antiviral medicines to treat HIV infections eg, ritonavir); clarithromycin, erythromycin and telithromycin (antibiotics); nefazodone (medicine to treat depression) may intensify the effect of Amlodipine Sandoz.
Rifampicin and rifabutin (antibiotics); St. John's wort (Hypericum perforatum; herbal medicine for depression); dexamethasone (cortisone); phenobarbital, phenytoin and carbamazepine (medicines for epilepsy); nevirapine (antiviral medicine) may reduce the effect of Amlodipine Sandoz.
Inform the doctor or pharmacist if the patient is taking or have recently taken any other medicines, including medicines obtained without a prescription.
Amlodipine Sandoz with Food and Drink: Amlodipine Sandoz should be taken with a glass of liquid (eg, a glass of water) with or without food.
Simultaneous intake of grapefruit or grapefruit juice has no influence on the effect of Amlodipine Sandoz.
Storage
Protect from light.
ATC Classification
C08CA01 - amlodipine ; Belongs to the class of dihydropyridine derivative selective calcium-channel blockers with mainly vascular effects. Used in the treatment of cardiovascular diseases.
Presentation/Packing
Tab 5 mg (white or almost white, oblong, with bevelled edges, score line on one side and marked with a "5" on the other side) x 30's. 10 mg (white or almost white, oblong, with bevelled edges, score line on one side and marked with a "10" on the other side) x 30's.
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