CO Linipril. 10 mg. 12.5 mg. 30 tablets

CO   Linipril. 10 mg.  12.5 mg. 30 tablets
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Co-Linipril combined antihypertensive (blood pressure lowering) product containing lisinopril (drug from the group of so-called angiotensin converting enzyme) and hydrochlorothiazide (a thiazide diuretic, increasing urine output). 

CO - Linipril. 10 mg. / 12.5 mg. 30 tablets 

 
 
WHAT CO - Linipril AND USED
Co- Linipril combined antihypertensive ( blood pressure lowering ) product containing lisinopril ( drug from the group of so-called angiotensin converting enzyme ) and hydrochlorothiazide ( a thiazide diuretic, increasing urine output ) . Both components have a single action , and in combination exhibit mutually reinforcing effects in terms of lowering blood pressure .
 
Co - Linipril be used to treat hypertension (high blood pressure), when not adequately control blood pressure in a therapy with lisinopril and / or in patients who achieved stabilization of arterial pressure of the individual components given in the same doses.


2 . WHAT YOU SHOULD KNOW BEFORE YOU USE CO - Linipril

Do not use Co- Linipril :

If you are allergic (hypersensitive) to the active substances or to any of the ingredients contained in the product as well as other drugs from the group of ACE inhibitors or sulfonamides .
If you have a history of angioedema ( swelling of the tongue , lining of the mouth and / or throat ) , with previous therapy with ACE inhibitors or in the presence of congenital or idiopathic angioedema .
If you are more than 3 months. ( It is advisable to avoid the use of Perkarnil and no- early pregnancy.
Severe kidney and liver disorders.
Anuria ( a condition in which no urine ) .


Take special care with co- Linipril
Before you take co- Linipril , tell your doctor about all your medical problems as well as any allergies.

Risk of hypotension ( low blood pressure) and / or breach of the water and salt balance of the blood.
In some patients treated with the co- Linipril may occur marked decreases in blood pressure . In patients with uncomplicated hypertension, marked lowering of blood pressure is rarely seen , mainly in the initial application and after dose increases. This is more common in certain conditions , especially in the presence of hard water or salt depletion ( diet low in salt, prolonged diuretic therapy , dialysis, diarrhea or vomiting) , renal artery stenosis , heart failure and liver cirrhosis. In such cases, treatment with the Co- Linipril can cause a severe reduction of blood pressure and even the development of renal failure , especially in the first administration , with the dose and during the first two weeks of treatment. This can be done cause of organ damage in patients with cerebrovascular disease or ischemic heart disease due to reduced blood supply (such as stroke or acute myocardial infarction) . At-risk patients such as those with angina ( chest pain breakthrough ) or cerebrovascular disorders , treatment with Co- Linipril should start with a low dose and under medical supervision . In the case of previous treatment with diuretics ( drugs that increase the flow of urine) is recommended that it be discontinued at least 2-3 days before treatment with Co- Linipril . If this is impossible , initiate treatment with lisinopril at a dose of 5 mg.

Thiazides, including hydrochlorothiazide , may cause disturbances in electrolyte composition of blood , mainly to reduce the content of potassium, sodium and chlorine / hypokalemia , hyponatremia, hypochloremic alkalosis / . In such cases, it may be observed dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, low blood pressure, decreased urine output , fast heartbeat , nausea and vomiting. Contained in this combination product lisinopril, however, has the opposite effect and reduces these effects of hydrochlorothiazide .

If, during the treatment , severe decreases in blood pressure and renal insufficiency , it may be necessary to reduce the dose or discontinuation of the product.
In the event of a sharp drop in blood pressure, the patient should be placed in a horizontal position and need to infuse intravenous saline.

Impaired renal function
In the presence of renal impairment , the dose should be reduced according to the degree of impairment of renal function. In patients with renal failure is given to monitoring renal function and serum potassium during the first few weeks of treatment. Co - Linipril should not be administered to patients with severely impaired renal function , while the gradual increase in the dose of the individual components do not show the benefit of the combination.
There is an increased risk of worsening of renal function in patients with underlying renal insufficiency , congestive heart failure, bilateral renal artery stenosis or stenosis of the artery to a solitary kidney , and after renal transplantation . In these patients may occur urea and serum creatinine, usually transient and is being reversed after discontinuation of therapy.

Patients with renal vascular hypertension
There is risk of severely low blood pressure and renal failure in patients with renal vascular hypertension and presence of bilateral or unilateral stenosis of the renal artery during treatment with lisinopril and hydrochlorothiazide. In these patients, therapy should be initiated in hospital under close medical supervision with low doses .

Renal transplant patients :
No data on the use of lisinopril in patients who have recently undergone kidney transplantation. Co- treatment with Linipril not recommended.

Hypersensitivity / angioedema (swelling of the soft tissues )
Swelling of the face , lips , tongue , throat, and / or the larynx and the extremities were observed in patients treated with ACE inhibitors , including lisinopril , at any time during treatment .
If such edema occur , treatment should be discontinued and the patient observed the disappearance of the edema . In the case of a limited edema of the face and lips , it usually passes without treatment, but can be used as standard anti-allergic ( anti-histamines and steroids ) means to relieve the symptoms .
Angioedema progress to laryngeal edema is a life- threatening complication . When edema with involvement of the tongue, throat or larynx , leading to shortness of breath and difficulty breathing, immediate therapy is needed with subcutaneous adrenaline solution and / or take the necessary steps to release the airways. The patient must be under strict medical supervision until there is complete resolution of symptoms.

During treatment with thiazide diuretics, patients with asthma may exhibit hypersensitivity reactions. Or exacerbation of systemic lupus erythematosus can be observed in the treatment with a thiazide . It is possible that the occurrence of life-threatening allergic reactions in dealergizirashto treatment of bee venom , in patients of a certain type of hemodialysis and in procedures for the extraction of lipids from the blood. These reactions were avoided by temporarily interrupting therapy with Co- Linipril .

Patients with impaired liver function and liver failure - Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may provoke the development of hepatic coma . Patients receiving ACE inhibitors who receive yellow or marked elevations of hepatic enzymes should discontinue treatment and be under medical follow-up after that.

Surgery and anesthesia
It is possible , during major surgery with conduction anesthesia , lisinopril cause severe reduction in blood pressure. If there is such a lowering of blood pressure , it can be corrected with infusion of intravenous fluids .

Metabolic and endocrine changes
Treatment with thiazide diuretics may increase blood sugar levels in diabetes available . This may require dose adjustment of glucose-lowering medications , including insulin . Thiazides may cause mild, transient elevation of serum calcium and increase levels of cholesterol and triglycerides.
Thiazide therapy may cause an increase in uric acid and aggravation of existing gout. Conversely, lisinopril may increase urinary excretion of uric acid and thus minimize the effect of hydrochlorothiazide .

Changes in the blood :
Such changes occur rarely in uncomplicated patients but more frequently in patients with impaired renal function, especially in those with systemic connective tissue diseases , or immunosuppressive therapy ( immunosuppressive drugs) . They are reversible and disappear after cessation of therapy.

ethnic differences
It has been found that black patients with a high risk of angioedema during treatment with ACE inhibitors, as compared to Caucasians . As with other ACE inhibitors Lisinopril is less effective in lowering blood pressure in black patients as compared to non blacks .

cough
During treatment with ACE inhibitors may occur dry, nonproductive cough, which resolves after discontinuation of the drug.

Anti-doping test
The presence of hydrochlorothiazide in this combination can cause a positive shift results in an anti - doping test.


3 . Taking other medicines
Please tell your doctor shi pharmacist. if you are taking shi recently preneurs other medicines, including medicines obtained without a prescription.
Basically Co- Linipril can be taken with other medicines. Some drugs may, however, interfere with one another. To clarify the dose of Co- Linipril doctor is very important to know if you are taking other medications.

Pre-treatment with diuretics:
At the start of treatment with co- Linipril can be observed drop in blood pressure. This is more common in patients treated with diuretics preceding . In case that the patient has previously been treated with a diuretic, its use should be discontinued for 2-3 days prior to initiation of treatment with the Co- Linipril . If this is not possible, treatment should begin with lisinopril at a dose no higher than 5 mg.

lithium:
The concomitant administration of lithium with diuretics and ACE inhibitors, as they reduce renal radiation of lithium and increase the risk of lithium toxicity .

Serum potassium:
Thiazide diuretics have potassium depleting effect , but it is usually offset by the potassium-sparing effect of lisinopril . The use of potassium supplements, potassium-sparing diuretics or potassium salt , especially in patients with impaired renal function may lead to a significant increase in serum potassium . If the application of Co- Linipril simultaneously with any of these products are deemed necessary , they should be used cautiously with frequent monitoring of serum potassium.

Other means :
Concomitant administration of ACE inhibitors with antidiabetic agents may enhance the blood glucose lowering effect of the latter and increase the risk of hypoglycaemia , which require an adjustment of their doses . Nonsteroidal anti-inflammatory drugs (used to treat muscle and joint pain and inflammation) may reduce the effect of co- Linipril on blood pressure. In some patients with impaired renal function treated with NSAIDs , concomitant administration of lisinopril may result in deterioration of renal function.

It is necessary to inform your doctor if you are being treated with any of the following drugs: allopurinol , cyclosporine , lovastatin, trimethoprim, cardiac glycosides, sotalol, cholestyramine, colestipol , tubocurarine , tricyclic antidepressant , antiarrhythmics , antipsychotics , corticosteroids, carbenoxolone , corticotropin , laxatives , other antihypertensives , sympathomimetics . procainamide , cytostatics , immunosuppressive agents , gold -containing drugs , calcium salts, dialysis with a high- flux membranes .


Taking Co- Linipril with food and drink
No evidence of a need for a special diet or restrictions on certain types of food and beverages during treatment with this product.


Pregnancy and lactation
Ask your doctor your pharmacist before taking any medicine .

It is necessary to inform your doctor if you think you are ( or might become ) pregnant. Usually the doctor will advise you to stop taking Co- Linipril before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine in place of Co- Linipril . Lisinopril is not recommended in the early months of pregnancy , and should not be taken after the third month of pregnancy because it may cause serious harm to your baby if used at that stage . Hydrochlorothiazide during the 2nd and 3rd trimester of pregnancy can cause adverse effects on the fetus and newborn ( jaundice, electrolyte disturbances , decreased platelet count ) .

Tell your doctor if you are breastfeeding you are breast-feeding. Co- Linipril not recommended for nursing mothers , and your doctor may choose another treatment for you if you want to breast-feed , especially if your baby is newborn, or was born prematurely .


Driving and using machines
As with other blood pressure lowering medicines , the ability to drive and use machines may be mild to moderately affected. This is more likely at the initiation of therapy , following dose changes or concomitant use of alcohol , depending on individual sensitivity.


4 . HOW TO CO - Linipril
Always take Co- Linipril exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist !

Co- Linipril taken once daily at the same time of day. Typically, administration of the fixed combination of lisinopril / hydrochlorothiazide occurs after the initial determination of the dose of the individual components. With appropriate clinical condition after npetsenka by your doctor , you may proceed directly to treatment with lisinopril to administration of the fixed combination .
 
adults:
Usual dose :
Co- Linipril 10mg/12.5mg and Co- Linipril 20mg/12.5mg - one tablet once daily. If about 2 to 4 weeks did not achieve a sufficient effect , the dose may be increased to two tablets once per day. The maximum daily dose of 40 mg of lisinopril and hydrochlorothiazide 25 mg should not be exceeded.

Patients with renal insufficiency:
Co- Linipril is contraindicated in patients with severely impaired renal function. Co - Linipril can be used in subjects with moderate renal impairment , but only after prior determination dose of the individual components .
If such patients pending the conduct of treatment with this combination , you must first determine the degree of renal failure and begin initial treatment with lisinopril under strict control of serum urea and creatinine. The recommended starting dose of lisinopril as sole therapy for these patients is 5-10 mg daily. Thiazides are not particularly suitable for diuretic therapy in patients with impaired renal function and are ineffective in moderate and severe renal insufficiency.

Elderly :
Dosage in the elderly is the same as for adults. It is not necessary to reduce the dose in these patients if they have normal renal and hepatic function.

children:
This product is not recommended for children. Its safety and effectiveness has not been proven .

Renal transplant patients :
No data on the use of lisinopril in patients who have recently undergone kidney transplantation. Co- treatment with Linipril not recommended.


5 . OVERDOSE
If you take an overdose of Co- Linipril , immediately contact a doctor !
 
Symptoms of overdose include nausea, vomiting , weakness, dizziness , anxiety , palpitations, shortness of breath , cough, disturbances of water and electrolyte balance , very low blood pressure, shock . In clinical evidence of overdose , symptomatic treatment with correction of electrolyte abnormalities , dehydration and very low blood pressure, remove the stomach contents and gastric lavage. The patient should be under close medical supervision.


If you forget to take Co- Linipril
Do not take a double dose to make up for a missed dose. Make it in the next regular dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.


6 . POSSIBLE SIDE EFFECTS
Like all medicines, Co- Linipril can cause side effects, although not everybody gets them .

The following adverse reactions have been observed and described in the course of treatment with lisinopril and / or hydrochlorothiazide with the frequency: very common (> 1/10 ), common (> 1/100 to <1 /10) , uncommon (> 1/ 1000 to < 1/100 ), rare (> 1/10 , 000 to < 1/1 , 000), very rare ( <1/ 10, 000) , not known (can not be estimated from available data).

The most frequently reported adverse events were cough , dizziness , low blood pressure, headache , which may be up to 1 to 10 % of patients. In clinical trials , adverse effects were usually mild and transient, and in most cases did not require discontinuation of treatment.


lisinopril

Blood and lymphatic system disorders:
Rare : changes in blood count ( decrease in hemoglobin and hematocrit ) . Very rare suppression of bone marrow function ( anemia , thrombocytopenia, leukopenia, neutropenia, agranulocytosis, hemolytic anemia ) , swollen lymph nodes , autoimmune diseases .

Metabolism and nutrition
Very rare: decreased blood glucose values .

Psychiatric disorders
Uncommon : mood swings , depression .
Rare : Confusion .

Nervous System Disorders
Common: dizziness , headache, syncope ( fainting ) .
Uncommon : numbness , dizziness, dysgeusia, sleep disorders.

cardiac disorders
Uncommon : myocardial infarction or cerebrovascular accident , possibly secondary, due to a strong decrease in blood pressure in high -risk patients , a sense of palpitations, rapid heartbeat .

vascular disorders
Common: lowering blood pressure on standing .
Uncommon : Raynaud's syndrome .

respiratory disorders
Common: cough.
Uncommon : Fever .
Very rare: narrowing of airways with shortness of breath , sinusitis , allergic pneumonia.

Gastrointestinal Disorders
Common: diarrhea , vomiting .
Uncommon : nausea , abdominal pain , abnormal digestion.
Rare: dry mouth .
Very rare : pancreatitis , swelling of the intestinal wall.

Hepatobiliary disorders
Uncommon : increased chernodrovnite enzymes and bilirubin .
Very rare: liver inflammation (hepatitis - hepatocellular or cholestatic ) , jaundice, liver failure.

Skin and subcutaneous tissue disorders
Uncommon : rash, itching.
Rare: srahchuvstvitelnost / angioneurotic edema: swelling of the face , extremities, lips, tongue , throat and / or vocal cords , urticaria, alopecia, psoriasis. Very rare: sweating, pemphigus , toxic epidermal necrolysis , Stevens -Johnson syndrome, erythema multiforme , skin psevdolimfoma . There was an appearance of a syndrome that may include the following symptoms: fever, vascular inflammation, muscle and joint pain , positive ANA , elevated erythrocyte sedimentation rate , changes in the blood ( eosinophilia , leukocytosis ), rash, photosensitivity, other skin manifestations.

Renal and urinary disorders
Common: impaired renal function.
Rare: blood urea increased , renal failure acute .
Very rare: reduced and absent urine output .

Reproductive system and breast disorders
Uncommon : impotence.
Rare: breast enlargement in men.

General disorders
Uncommon : fatigue , weakness .

research
Uncommon : increase in blood urea , serum creatinine, liver enzymes, potassium.
Rare: increase in serum bilirubin levels of sodium .


Hydrochlorothiazide ( not known )

infections
Inflammation of the salivary glands.

Blood and lymphatic system
Changes in the blood ( leucopenia , neutropenia / agranulocytosis , thrombocytopenia, aplastic anemia, hemolytic anemia) and suppression of bone marrow function .

Metabolism and nutrition
Anorexia, a high blood sugar , excretion of sugar in the urine , increased uric acid , low blood potassium and sodium in the blood , increased cholesterol and triglyceride levels , gout .

Psychiatric disorders
Anxiety, depression, sleep disorders.

Nervous System Disorders
Loss of appetite , numbness , dizziness .

Eye disorders
Color vision , transient blurred vision .

Ear and labyrinth
Vertigo.

cardiac disorders
Low blood pressure .

vascular disorders
Inflammation and damage to the vessels.

respiratory disorders
Lung inflammation and pulmonary edema.

Gastrointestinal Disorders
Stomach inflammation , diarrhea, constipation, pancreatitis.

Hepatobiliary disorders
Jaundice ( intrahepatic cholestatic jaundice) .

Skin and subcutaneous tissue disorders
Photosensitivity reactions , rash , activation of cutaneous lupus erythematosus , urticaria, allergic reactions ( anaphylaxis ) , toxic epidermal necrolysis .

Disorders of the musculoskeletal system and connective tissue
Muscle spasms , muscular weakness .

Renal and urinary disorders
Impaired renal function, and renal inflammation.

General disorders
Fever, weakness.

If any of the side effects gets serious, or you notice any not listed in this leaflet, please tell your doctor or pharmacist.


7 . STORAGE
Keep out of reach of children. At temperatures below 25 ° C.
Do not use Co- Linipril after the expiry date stated on the carton .
The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.


8 . ADDITIONAL INFORMATION

What does co- Linipril

The active ingredients in one tablet were :

Co- Linipril 10mg/12.5 mg - lisinopril dihydrate / lisinopril dihydrate /, equivalent to 10mg lisinopril / lisinopril / hydrochlorothiazide / hydrochlorothiazide / 12.5 mg.

Co- Linipril 20mg/12, 5mg - lisinopril dihydrate / lisinopril dihydrate /, equivalent to 20mg lisinopril / lisinopril / hydrochlorothiazide / hydrochlorothiazide/12, 5 mg.

The other ingredients are mannitol , calcium hydrogen phosphate dihydrate. pregelatinised maize starch , croscarmellose sodium, magnesium stearate, E 172 colorant .
 
 
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