Buy Lotensin Malaysia

Package insert: Information for the user Lotensin 5/10 mg film-coated tablets Medical equivalent

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this brochure. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has only been prescribed for you. Do not pass it on to others, even if the symptoms of the disease are the same as yours, as this can be dangerous.
• If you experience side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See paragraph 4.

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this brochure. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has only been prescribed for you. Do not pass it on to others, even if the symptoms of the disease are the same as yours, as this can be dangerous.
• If you experience side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See paragraph 4.

Contents of this brochure:

1. What Lotensin is and what it is used for
2. What you need to know before you get Lotensin
3. How to take Lotensin
4. possible side effects

5. How do I store Lotensin?

6. Contents of the pack and other information

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1. What is Lotensin and what is it used for?

1. What is Lotensin and what is it used for?

Lotensin contains the active substance benazepril. It belongs to a class of medicines known as ACE inhibitors (angiotensin converting enzyme inhibitors). They work by relaxing and dilating blood vessels, which leads to a drop in blood pressure and an increase in blood flow that leaves the heart.

Lotensin is used to treat:

• High blood pressure (hypertension);
• A condition in which the heart cannot pump enough blood into the body, which is known as "heart failure".

  In severe heart failure, Lotensin is used in combination with diuresis (diuretics) and digoxin tablets (digitalis glycosides).

  2. What you need to know before you receive Lotensin

  2. What you need to know before you receive Lotensin

  Do NOT take Lotensin

• if you are allergic to benazepril hydrochloride or any of the other ingredients in this medicine (see section 6 "Contents of the pack and other information" at the end of this leaflet);
• if you are allergic to another ACE inhibitor (e.g. enalapril, lisinopril, ramipril);
• if you have a history of a severe reaction characterized by swelling of the skin and mucous membranes, especially in the face, mouth, tongue and throat (angioedema), in connection with the use of an ACE inhibitor or without pharmacological Treatment (hereditary angioedema);

• if the kidney's blood vessels are narrowed (bilateral renal artery stenosis);

• if you have had a kidney transplant;
• if you have a narrowing of the heart valves (aortic or mitral valve stenosis), a disease that prevents the flow of blood from the heart;
• Your heart muscle is abnormally thick (hypertrophic cardiomyopathy);
• Your body produces too much aldosterone, a hormone that increases blood pressure (primary hyperaldosteronism).
• If you have been pregnant for more than 3 months (it is advisable to avoid Lotensin for the first few months

Advertising months of pregnancy - see section pregnancy);

• If you have diabetes or impaired kidney function and you are treated with an antihypertensive medicine that contains aliskiren.

  Warnings and precautions

  Talk to your doctor or pharmacist before taking Lotensin.

  pregnancy

  You must tell your doctor if you suspect (or plan to) become pregnant. The use of Lotensin in the early stages of pregnancy is not recommended and the drug should not be taken if you were more than 3 months pregnant as it can cause serious harm to your baby if taken at this time of pregnancy (see section). Pregnancy).

  Tell your doctor if you have or have suffered from an illness or medical condition, particularly the following: If you have any of the following illnesses or conditions, your doctor will keep you under close supervision:

• Collagen vascular disease (autoimmune systemic disease such as lupus erythematosus)

  systemic or scleroderma);

• Diarrhea;

• Vomit;

• severe renal hypertension (a type of hypertension);

• decreased blood supply to the heart (ischemia, e.g. coronary artery disease or angina pectoris);

• decreased blood supply to the brain (cerebrovascular disease);

• severe heart failure;

• if your kidney function is impaired;

• Narrowing of the renal arteries (renal artery stenosis);

• very high blood pressure;

• Decrease in blood volume;

• Dehydration (excessive loss of water from the body).

  Your doctor will monitor you closely if you are receiving any of the following treatments:

• Taking tablets that promote diuresis (diuretics, medicines that increase the amount of water that enters the urine);

• low sodium diet;

• If you are taking any of the following medicines used to treat high blood pressure:
  • an "angiotensin II receptor antagonist" (AIIRA) (also known as sartane - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
  • Aliskiren.

    Your doctor may check your kidney function, blood pressure and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

    See also information under the heading "Do not take Lotensin".

    If you are taking any of the following medications, the risk of angioedema (rapid subcutaneous swelling in places like the neck) is greater:

    - sirolimus, everolimus and other medicines of the mTOR inhibitor class (to prevent rejection of transplanted organs).

    Low blood pressure

    If your blood pressure is too low, lie down. If this condition persists, you should see a doctor.

    Dialysis / dialysis for cholesterol (LDL apheresis): Lotensin can cause allergic (anaphylactic) reactions in patients who are on a certain type of dialysis (see section 4 "Possible side effects").

    Desensitization with hymenoptera venom

    Tell your doctor if you are undergoing desensitizing treatment with hymenoptera venom. In fact, life-threatening allergic reactions have been reported.

    Infections: Tell your doctor straight away if you notice signs of infection (e.g. local redness, heat, swelling, and pain).

    Proteinuria

    Urine protein levels (proteinuria) may increase during treatment with Lotensin, especially if you have kidney problems or after taking relatively high doses of Benazepril. Talk to your doctor for advice.

    Liver disease

    If you develop jaundice (yellowing of the skin and whites of your eyes) or if you develop inflammation of the liver (hepatitis) you must stop treatment with Lotensin and contact your doctor immediately (see section 4 "Possible side effects").

    Ethnic differences

    As with other ACE inhibitors, Lotensin may be less effective in black patients. These patients are also at higher risk of allergic reactions (angioedema) (see section 4 "Possible side effects").

    Surgical intervention / anesthetics

    Tell your doctor that you are taking Lotensin before you have any surgery. This is due to the pressure drop that can occur during operation itself.

    diabetes

    Tell your doctor if you have diabetes and are treated with oral antidiabetic or insulin. The blood sugar level should be carefully monitored.

    to cough

    Cough has been reported after administration of ACE inhibitors. This cough is usually unproductive (dry cough), persists, and disappears after treatment is stopped.

    Older people

    If you are over 65 years of age your doctor will monitor you closely to determine if there is a drop in pressure.

    Children and adolescents

    Children and adolescents under the age of 18 should not take Lotensin because the safety and effectiveness of Benazepril (the active ingredient in Lotensin) has not been established in this patient group.

    Other drugs and Lotensin

    Tell your doctor or pharmacist if you are taking, have recently taken, or may be taking other medicines.

    Concomitant use of the following medicines and Lotensin may increase the risk of changes in the blood picture (haematological reactions). Your doctor will monitor you closely while you are taking Lotensin if you are already taking one or more of the following medicines:

• Allopurinol (used to treat high levels of uric acid in the blood, including gout);

• Procainamide (used to treat irregular heart rate);

• Cancer medicines (cytostatic drugs);
• Medicines that reduce the activity of the immune system (immunosuppressive medicines) that are used to prevent rejection of a transplanted organ and to treat allergic or inflammatory diseases such as autoimmune diseases and asthma;
• Medicines to treat inflammation (systemic corticosteroids), for example cortisol;
• other medicines that can change your blood count.

  You should also tell your doctor if you are already taking one or more of the following medicines:

  • Medicines used to treat high blood pressure (antihypertensive agents).

    Your doctor may consider changing the dose and / or taking other precautions:

    If you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also information under the headings "Do not take Lotensin" and "Warnings and precautions").

  • Tablets that promote diuresis (diuretics) - The risk of a drop in blood pressure is higher in

    Patients who are dehydrated and / or have little salt in the body (e.g. who are low on sodium). Some of these patients may need to stop diuretics. Talk to your doctor for advice.

  • some medicines to treat depression (tricyclic antidepressants);
  • Medicines to treat psychoses (antipsychotics) - hallucinations and changes in thoughts, feelings or behavior, for example schizophrenia;

  • Anesthetics;

  • Medicines used to enlarge your blood vessels (vasodilators), such as nitroglycerin (used to treat angina) and other medicines that contain nitrates;
  • Medicines with a stimulating effect that increase blood pressure (sympathomimetics);
  • Nonsteroidal anti-inflammatory drugs to relieve pain and inflammation (e.g. ibuprofen, indomethacin) - may reduce the blood pressure lowering effect and worsen kidney function.

  • Aspirin (acetylsalicylic acid) to relieve pain and inflammation (benazepril)

    can be used with aspirin when used to prevent heart attacks and strokes. This can reduce the blood pressure lowering effect and impair kidney function.

  • Potassium: the potassium-sparing diuretics (e.g. spironolactone, triamterene, amiloride,

    Eplerenone), potassium supplements or salt substitutes containing potassium, other medicines that can increase the level of potassium in the body (including heparin and co-trimoxazole, also known as trimethoprim / sulfamethoxazole - a significant increase in the level of serum potassium (hyperkalemia), especially in patients with impaired kidney function should be checked regularly by your doctor.

  • Ciclosporin (an immunosuppressant used to prevent transplant rejection

    Organ) - Increased risk of increased levels of potassium in the blood;

  • Medicines to prevent rejection of organ transplants and against cancer (e.g. temsirolimus, sirolimus, everolimus) - Increased risk of angioedema;

  • Lithium (used to treat bipolar disorders) - Reversible increase in the level of lithium in the blood, with

    Increase in the toxic effects of lithium on heart and nerve cells;

  • Antidiabetic drugs: insulin and oral antidiabetic drugs - an excessive drop in blood sugar (hypoglycemia) is possible, especially at the start of treatment and with kidney problems;

  • injectable gold (sodium aurothiomalate) - nitritoid reactions (symptoms

    including facial flushing, nausea, vomiting and hypotension).

  • Medicines that are normally used to prevent rejection of transplanted organs (sirolimus, everolimus and other medicines in the class of mTOR inhibitors). See section "Warnings and Precautions".

  Lotensin with food, drink and alcohol

  Table salt (sodium chloride) may reduce the effects of Lotensin and thus cause your blood pressure to rise. Talk to your doctor to check the amount of salt in the diet.

  Alcohol can increase the effects of Lotensin, which in turn can increase the effects of alcohol. You should take this into account if you drink alcohol while taking Lotensin.

  The tablets can be taken regardless of food.

  pregnancy and breast feeding period

  If you are pregnant, breastfeeding, planning to become pregnant, or plan to breastfeed, ask your doctor or pharmacist for advice before taking this medicine.

  pregnancy

  You must tell your doctor if you suspect (or plan to) become pregnant. Your doctor will usually advise you to stop taking Lotensin before you become pregnant or as soon as you are pregnant and to prescribe another medicine to be used instead of Lotensin. The use of Lotensin in the early stages of pregnancy is not recommended and the product should not be taken if it was more than 3 months pregnant as it can cause serious harm to your baby after the third month of pregnancy.

  Breastfeeding

  Tell your doctor if you are breast-feeding or about to breast-feed your baby. Breastfeeding infants (in the first few weeks after birth) and especially premature babies during treatment with Lotensin is not recommended.

  In older children, the doctor must tell you about the benefits and risks of using Lotensin while breastfeeding compared to other treatments.

  Driving vehicles and using machines

  When driving vehicles or using machines, you should be aware that dizziness or tiredness may occasionally occur. Do not drive if you notice these effects.

  Lotensin contains milk sugar (lactose).

  If your doctor has diagnosed that you have an intolerance to some sugars, contact him before taking this medicine.

  3.How to take Lotensin

  3.How to take Lotensin

  Always take this medicine exactly as your doctor has told you. If you are not sure, contact your doctor or pharmacist.

  The tablets can be taken regardless of food and with a sufficient amount of liquid (e.g. a glass of water).

  Patients with high blood pressure

  Your doctor will prescribe you to take a dose of 10 to 20 mg of Lotensin, which is divided into a single dose in the morning or divided into two doses in the morning and evening.

  The maximum daily dose is 40 mg.

  Heart failure patients

  You should start with 2.5 mg Lotensin once a day. After 2-4 weeks, the doctor can increase the dose to 5 mg / day. This dose can be taken in the morning or divided into two doses (2.5 mg Lotensin morning and evening).

  The maximum daily dose is 20 mg.

  Patients with renal impairment

  Under certain conditions (creatinine clearance 30 ml / min), the doctor may reduce the dose. In this case, you should NOT take more than 10 mg Lotensin per day.

  If you take more Lotensin than you should

  If you accidentally take too many tablets, contact your doctor or the nearest emergency room immediately. Symptoms of an overdose include a drop in blood pressure, shock, loss of consciousness, slow heart rate, changes in blood chemical levels (electrolyte imbalance), dehydration and kidney failure.

  If you forget to take Lotensin

  Do not worry. Simply leave out the dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

  If you stop taking Lotensin

  Do not stop taking Lotensin without consulting your doctor first. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

  4. Possible side effects

  4. Possible side effects

  Like all medications, this medication can cause side effects, although not everyone gets them.

  The following side effects are serious and should be treated immediately if they occur:

  • Allergic reactions lead to swelling of the lips, tongue or throat (angioedema)

  They can cause severe breathing difficulties. It is a rare reaction that can be serious if it occurs. In case of occurrence, you have to stop taking Lotensin and consult your doctor immediately

  The following side effects are serious and should be treated immediately if they occur:

  • Allergic reactions lead to swelling of the lips, tongue or throat (angioedema)

  They can cause severe breathing difficulties. It is a rare reaction that can be serious if it occurs. In case of occurrence, you have to stop taking Lotensin and consult your doctor immediately

  The following side effects have been reported:

  Common (may affect up to 1 in 10 people):

• Noticeable drop in blood pressure (dizziness or drowsiness), for example when you get up (orthostatic hypotension), especially if you are a high-risk patient. If your blood pressure is too low, lie down. If this condition persists, you should see a doctor.
• Dizziness;
• Fainting (syncope);
• Visual impairment;
• Kidney dysfunction;
• dry and persistent cough that disappears spontaneously after the end of treatment;
• Inflammation of the airways (bronchitis);
• Symptoms of upper respiratory tract infection;
• feeling sick (nausea);
• stomach pain
• Indigestion;
• Stomach and intestinal problems;
• a headache
• Tiredness (tiredness);
• Balance disorders;
• Drowsiness (sleepiness);
• Lack of emotion or enthusiasm (apathy);
• Decrease in the number of red blood cells (hemoglobin, hematocrit), white blood cells (leukocytes) and platelets (platelets);
• Sensation of your heartbeat (palpitations);
• Reddening of the skin, feeling hot (flushing);
• increased sensitivity to light (sensitivity to light);
• Rash;
• Itching;
• increased urge to urinate.

  Uncommon (may affect up to 1 in 100 people):

• high urine protein levels (proteinuria);
• Worsening of kidney dysfunction;
• Shortness of breath (dyspnea);
• Inflammation of the nasal cavity (sinusitis);
• runny nose (rhinitis);
• Vomit;
• Diarrhea;
• Constipation;
• Loss of appetite (anorexia);
• Swelling of the intestinal mucosa (intestinal edema);
• Gallstones (cholelithiasis), especially in patients with inflammation of the gallbladder (cholecystitis);
• Mood swings;
• Feeling of needles and needles (paraesthesia);
• Feeling of spinning or dizziness (dizziness);
• Changes in taste
• Sleep disorder, sleep disorders;
• mental confusion;
• Feeling of nervousness;
• Impotence;
• blurred vision;
• Reduction in the number of red blood cells (anemia);
• Bone marrow depression (aplastic anemia);
• Reduction in the number of blood platelets (thrombocytopenia);

• Reduction in the number of white blood cells (leukopenia, neutropenia, agranulocytosis).

  Rare (may affect up to 1 in 1,000 people):

• acute kidney failure;
• Accumulation of urea in the blood due to kidney failure (uremia);
• Hives;
• an autoimmune disease that causes blisters on the skin (pemphigus);
• a severe skin condition characterized by rash, blistering, red spots and sores on the skin and mucous membranes (Stevens-Johnson syndrome);
• allergic reactions (hypersensitivity): swelling of the skin and mucous membranes (angioedema) on the face,

  Arms and legs, lips, tongue and / or neck.

  In case of occurrence you have to stop the treatment with Lotensin and consult your doctor immediately

• Low pressure symptoms such as dizziness or drowsiness (symptomatic hypotension);
• Angina pectoris (chest pain due to poor oxygenation of the heart);
• irregular heartbeat (arrhythmia);
• Inflammation of the liver (hepatitis) or yellowing of the skin and whites of the eyes (jaundice). You must stop treatment with Lotensin and consult your doctor.
• Joint pain, inflammation of the joints;
• Muscle pain.

  Very rare (may affect up to 1 in 10,000 people):

• Heart attack (myocardial infarction) or stroke (cerebrovascular accident), possibly as a result of a drastic drop in blood pressure in high-risk patients;
• fast heartbeat (tachycardia);
• Bronchospasm (chest tightness that makes breathing difficult);
• Tongue pain (glossitis);
• dry mouth (xerostomia);
• Inflammation of the pancreas (pancreatitis);
• Reduction in bowel movements (ileus);
• hemolytic anemia (anemia due to abnormal red blood cell breakdown);
• Hair loss (alopecia);
• Skin diseases that cause red spots and inflammation (psoriasis);
• Discoloration of fingers and toes (Raynaud phenomenon);
• Taste disorders (dysgeusia);
• Ringing in the ear (tinnitus).

  Not known (frequency cannot be estimated from the available data):

• allergic reactions (hypersensitivity) associated with abdominal pain, including nausea and colic (angioedema of the small intestine);
• severe allergic reaction that causes difficulty breathing or dizziness;
• high levels of potassium in the blood, which can cause an abnormal heart rhythm;
• sharp decrease in the number of white blood cells.

  Reporting of side effects

  If you get any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-signalare-a- suspected side effects. . By reporting side effects you can provide more information on the safety of this medicine.

  5. How do I store Lotensin?

  5. How do I store Lotensin?

  Keep this medicine out of the sight and reach of children. Do not store above 25 ° C.

  Do not use this medicine after the EXP expiry date which is stated on the blister and the PP container. The expiry date refers to the last day of this month.

  Do not throw medication into wastewater or household waste. Ask your pharmacist how to get rid of medicines you no longer use. This helps protect the environment.

  6. Contents of the pack and other information

  6. Contents of the pack and other information

  What Lotensin contains

  The active substance is benazepril.

  One 5 mg film-coated tablet contains 5 mg benazepril hydrochloride. One 10 mg film-coated tablet contains 10 mg benazepril hydrochloride.

  The other ingredients are:

  Tablet core:

• Lactose monohydrate
• Pre-gelatinized corn starch
• Croscarmellose sodium
• Hydrogenated castor oil

  Coating:

• Hypromellose
• Macrogol 8000
• talc
• Titanium dioxide (E 171)
• Yellow iron oxide (E 172)

Description of the appearance of Lotensin and the contents of the pack

Lotensin 5 mg: film-coated, oval (4 × 8 mm), light yellow tablets with a notch on both sides.

Lotensin 10 mg: film-coated tablets, oval (11 × 5.5 mm), colored yellow and notched on both sides.

If the prescription calls for half a tablet, it can be divided in half.

Lotensin is available in blister packs (PVC / OPA / Al / Al) and in a PP container with an LDPE cap with desiccant (silica gel).

Packaging:

Blisters: 10, 14 (only for 10 mg), 20, 28, 30, 42, 50, 98 and 100 film-coated tablets. PP container: 50 and 100 film-coated tablets.

Not all pack sizes may be marketed.