MIVARA SR. 1.5 mg. 30 tablets
Indapamide is a diuretic. Most diuretics increase the amount of urine produced by the kidney.
MIVARA SR. 1.5 mg. 30 tablets
What is Mivara SR 1,5 mg is and what it is used ?
Mivara SR 1,5 mg is a prolonged-release tablet containing indapamide as an active substance .
Indapamide is a diuretic . Most diuretics increase the amount of urine produced by the kidney .
Mivara SR 1,5 mg is used in the treatment of hypertension ( essential hypertension) .
2 . What you should know before taking Mivara SR 1,5 mg ?
Do not take Mivara SR 1,5 mg :
• If you are allergic to indapamide or other sulfonamides , or any of the excipients constituting the Mivara SR 1,5 mg, prolonged-release tablets ,
• If you suffer from severe renal failure
• If you have severe liver disease or suffer from a condition called hepatic encephalopathy ( degenerative brain disease that affects the mind )
• If you have low plasma levels of potassium in your blood ( hypokalemia ) .
Take special care before using Mivara SR 1.5 mg :
• If you have liver disease
• If you have diabetes (please check your blood sugar regularly )
• If you suffer from gout,
• If you have any problems with heart rhythm
• If you have kidney disease
• In Luciano, it is necessary to make a test to determine the condition of the parathyroid gland.
Cases of photosensitivity reactions have been reported with thiazides and thiazide - related diuretics. If you are experiencing photosensitivity reactions during treatment , tell your doctor who may discontinue treatment. In case of application of indapamide is advisable to protect areas of the body exposed to the sun or to artificial UVA rays.
If necessary function testing your parathyroid gland, please tell your doctor, who will terminate your treatment with Mivara SR 1,5 mg .
Your doctor may order laboratory tests (blood tests ) to check for low levels of sodium or potassium or high calcium levels in the blood. This is particularly important for patients who are at high risk to develop an electrolyte imbalance ( such are: elderly patients taking many medications or malnourished patients.
If you feel that you meet any of the above conditions or have any questions or concerns about taking your medication , please consult your doctor or pharmacist.
• Athletes should be aware that Mivara SR 1,5 mg contains an active substance that can give a positive reaction when conducting doping test.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
You should not take Mivara SR 1,5 mg lithium (used to treat depression) because of the risk of increased plasma levels of lithium in the blood.
Please make sure you tell your doctor if you are taking any of these medicines, as you may need special attention :
• medicines used to treat problems with heart rhythm
• antipsychotic drugs used in the treatment of psychiatric disorders such as phenothiazines, benzamides , butyrophenones
• tricyclic antidepressants (used for the treatment of depression ) , neuroleptics (used in the treatment of psychiatric disorders),
• bepridil ( used in the treatment of angina pectoris , a condition causing pain in the chest) ,
• cisapride ( used in the treatment of gastrointestinal problems)
• certain antibiotics (e.g. erythromycin injection )
• antiparasitic drugs such as halofantrine (used in the treatment of certain types of malaria ) , pentamidine (used in the treatment of certain types of pneumonia);
• mizolastine ( used in the treatment of allergic reactions such as hay fever ) ,
• vincamine injection (used in the symptomatic treatment of cognitive disorders such as poor memory , concentration or difficulty thinking in the elderly )
• diphemanil ( mainly used to treat infants with muscle contractions )
• non-steroidal anti-inflammatory drugs for the relief of pain (e.g. ibuprofen) , or high doses of aspirin ) cyclooxygenase-2 ( COX -2 ) inhibitors (such as celecoxib, etoricoxib),
• inhibitors of angiotensin converting enzyme ( ACE) inhibitors (such as, capropril, used in the treatment of hypertension and heart failure ) ,
• amphotericin B for injection (used in the treatment of fungal diseases)
• corticosteroids (such as prednisolone) used to treat various conditions including severe asthma and rheumatoid arthritis ,
• baclofen ( for the treatment of muscle stiffness occurring in diseases such as multiple sclerosis ) ,
• digitalis ( to treat heart failure and some irregular heart rhythm )
• potassium-sparing diuretics (spironolactone)
• some tablets which can cause a decrease in plasma potassium levels in blood ( such as furosemide)
• metformin ( for diabetes ) ,
• iodinated contrast agent (used in x-ray studies)
• Supplements containing calcium,
• immunosuppressants used in the treatment of autoimmune diseases or transplant (e.g. ciclosporin)
• tetracosactide ( to treat disease Crohn).
Taking Mivara SR 1,5 mg with food and drink :
No specific recommendations.
This medicine is not recommended during pregnancy . Please tell your doctor if you are pregnant or want to become pregnant.
The active substance is excreted in human milk. Breastfeeding is not recommended if you are taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
This product has a minimum impact on the ability to drive and use machines . Indapamide does not change alertness but different effects such as dizziness or fatigue associated with decreases in blood pressure can be expected in some patients , especially at the beginning of treatment or when added to other antihypertensive agents . If you experience such changes are driving and suspend work requiring the use of power tools or machines.
Important information about some of the ingredients of Mivara SR 1,5 mg :
Mivara SR 1,5 mg contains lactose monohydrate. If you have been told by your doctor that you have intolerance to some sugars, consult him before taking this medicine .
3 . How to take Mivara SR 1,5 mg ?
Always take Mivara SR 1,5 mg exactly as prescribed by your doctor . If you have doubts and questions , contact your doctor or pharmacist.
The usual dose is one tablet extended release : daily, preferably in the morning .
• Patients with impaired renal function
Patients with severe renal insufficiency (creatinine clearance less than 30 mL / min ) should be treated with Mivara SR 1,5 mg (see p.2 not take Mivara SR 1,5 mg in case ) thiazide and thiazide diuretics are fully effective only in the case of normal or mildly impaired renal function .
• Patients with impaired hepatic function
Patients with severe hepatic insufficiency should be treated with Mivara SR 1,5 mg (see p.2 not take Mivara SR 1,5 mg in case ) .
Elderly patients can be treated with Mivara SR 1,5 mg prolonged release tablets when renal function is normal or slightly impaired .
• Children and adolescents
Mivara SR 1,5 mg prolonged-release tablets are not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Method of administration
Tablets should be swallowed whole with a glass of water. Do not break or chew.
Duration of treatment
The duration of treatment will be determined by your doctor .
Do not change the dose yourself if you think Mivara SR 1,5 mg no necessary effect . If this is the case , please consult your doctor.
If you take more dose Mivara SR 1,5 mg :
If you take too many tablets , contact your doctor immediately or pharmacist.
Very high doses Mivara SR 1,5 mg may cause nausea , vomiting, hypotension, cramps, dizziness, drowsiness , confusion, change in amount of urine produced by the kidneys.
If you forget to take Mivara SR 1,5 mg :
If you forget to take Mivara SR 1,5 mg, take the next dose at the usual time . Do not take a double dose to make up for a missed dose.
If you stop taking Mivara SR 1,5 mg :
As the treatment of high blood pressure is usually for life you should discuss with your doctor before you stop taking this medicine.
If you have any questions about using this medicine, ask your doctor or pharmacist.
4 . What are the possible side effects
Like other drugs Mivara SR 1,5 mg can cause side effects , even though they do not occur in each treated with this drug .
• Very common: More than 1 in 10 patients treated
• Common : If less than 1 in 10 , but more than 1 in 100 patients treated
• Uncommon: Less than 1 in 100 but more than 1 in 1000 patients treated
• Rare : If less than 1 in 1,000 , but more than 1 in 10 000 patients treated
• very rare in less than 1 in 10 000 patients treated, including isolated instances
• Unknown: The available data can not be estimated .
The following side effects have been reported for Mivara SR 1,5 mg :
Skin rashes - macular and papular ( allergic reactions , especially in people who are predisposed to allergic or asthmatic reactions ) .
Purpura (red or purple skin rash , allergic reaction , especially in people who are predisposed to allergic or asthmatic reactions ) , vomiting .
Vertigo ( dizziness ) , fatigue (tiredness ), headache, a feeling of tingling , burning and numbness of the skin ( paresthesia ), nausea ( feeling sick) , constipation ( constipation due to irregular bowel movements , hard and dry stools ) , and dry mouth.
High levels of calcium in the blood ( hypercalcaemia) irregular heart rhythm ( arrhythmia) low blood pressure changes in blood cells, such as :
- Low platelet count (thrombocytopenia )
- Low white blood cell count ( leucopenia) , which can be a serious agranulocytosis
- Aplastic anemia ( bone marrow suppression )
- Hemolytic anemia ( anemia caused by abnormal decomposition of red blood cells)
Inflammation of the pancreas ( pancreatitis) impaired hepatic function ( determined by a blood test ) renal failure, allergic skin reactions , allergic reactions , in particular for people who are prone to allergic or asthmatic reactions ( angioneurotic edema , and / or urticaria , toxic epidermal necrolysis , ) . Angioedema is characterized by swelling of the lips or tongue , swelling of the mucous membranes of the throat or airways leading to difficulty breathing , or difficulty swallowing . If you get these symptoms , contact your doctor immediately .
• Low levels of sodium in the blood ( hyponatraemia)
• Loss of potassium , low blood potassium ( hypokalemia ) .
• Decreased blood volume ( hypovolemia ) with
- Orthostatic hypotension ( drop in blood pressure on standing up )
• Low level of chlorides in the blood, which can lead to a metabolic alkalosis (adjusted pH of blood).
• Elevated blood sugar levels .
• If you suffer from acute disseminated lupus erythematosus ( an autoimmune disease) , the disease may worsen .
• Photosensitivity reactions (see p.2 not take Mivara SR 1,5 mg in a case ) . If your liver is not working properly, Mivara SR 1,5 mg may cause hepatic encephalopathy.
• High levels of uric acid in the blood leads to attack of gout.
If any of those listed in this leaflet is serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5 . How to Store Mivara SR 1,5 mg ?
• Keep out of reach of children .
• Do not use Mivara SR 1,5 mg after the expiry date stated on the carton and blister. Date of expiry date refers to the last day of the indicated month.
• This medicinal product does not require any special storage conditions .
• Any unused medication should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. This will help to protect the environment .
6 . Additional information
What does Mivara SR 1,5 mg :
• The active substance is indapamide .
Each prolonged-release tablet contains 1.5 mg indapamide .
• The other ingredients are :
Tablet core : lactose monohydrate , pregelatinized corn starch , hypromellose, colloidal silicon dioxide, magnesium stearate
Film coating: hypromellose , macrogol 6000 , titanium dioxide (E 171).
Looks like Mivara SR 1,5 mg and contents of its container ?
Mivara SR 1,5 mg is a white to off-white , round, biconvex film-coated tablet.
Mivara SR 1,5 mg is available in packs of 10, 15, 30 , 50, 60 , 90 or 100 prolonged-release tablets in blister packs .
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer : Germany, Holland, Ireland