Benazepril Hydrochloride Tablets 5mg
Benazepril Hydrochloride Tablets 10mg
Benazepril Hydrochloride Tablets 20mg
Benazepril Hydrochloride Tablets 40mg
(Benazepril Hydrochloride)
Package Leaflet: Important for the user
Read this carefully before you start taking Benazepril and each time you get a refill. This leaflet is a summary and will not tell you everything about Benazepril. Talk to your doctor, nurse, or pharmacist about your medical condition and treatment and ask if there is any new information about Benazepril.
ABOUT THIS MEDICATION
What the medication is used for:
Benazepril lowers high blood pressure.
What it does:
Benazepril is an angiotensin-converting enzyme (ACE) inhibitors. You can recognize ACE inhibitors because their medicinal ingredient ends in ‘-PRIL’.
This medicine does not cure your disease. It helps to control it. Therefore, it is important to continue taking Benazepril regularly even if you feel fine.
When it should not be used:
Do not take Benazepril if you:
- Are allergic to Benazepril or to any of the other nonmedicinal ingredient in the formulation.
- Have experienced an allergic reaction (angioedema) with swelling of the hands, feet, or ankles, face, lips, tongue, throat, or sudden difficulty breathing or swallowing, to any ACE inhibitor, or any other medication, including medications for blood pressure, or without a known cause. Be sure to tell your doctor, nurse, or pharmacist that this has happened to you.
- Have been diagnosed with hereditary angioedema: an increased risk of getting an allergic reaction that is passed down through families. This can be triggered by different factors, such as surgery, flu, or dental procedures.
- Are pregnant or intend to become pregnant. Taking Benazepril during pregnancy can cause injury and even death to your baby.
- Are breastfeeding. Benazepril passes into breast milk.
- Are already taking a blood pressure-lowering medicine that contains aliskiren (such as RASILEZ) and you have diabetes or kidney disease.
What the medicinal ingredient is:
Benazepril hydrochloride.
What the important non-medicinal ingredients are: Benazepril tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose, microcrystalline cellulose, polyethene glycol, red iron oxide (20 mg only) titanium dioxide, yellow iron oxide (5 mg and 10 mg only) and zinc stearate.
What dosage forms it comes in:
Benazepril is available as 5 mg, 10 mg 2omg and 40 mg tablets.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions-Pregnancy
Benazepril should not be used during pregnancy. If you discover that you are pregnant while taking Benazepril, stop the medication and contact your doctor, nurse, or pharmacist as soon as possible.
Before taking Benazepril, talk to your doctor, nurse or pharmacist if you:
- Are allergic to any drug used to lower blood pressure.
- Have recently received or are planning to get allergy shots for bee or wasp stings.
- Have narrowing of an artery or a heart valve.
- Have had a heart attack or stroke.
- Have heart failure,
- Have liver or kidney disease.
- Have diabetes.
- Are dehydrated or suffer from excessive vomiting, diarrhoea, or sweating.
- Are on dialysis.
- Are taking a salt substitute that contains potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind of “water pill”),
- Are on a low-salt diet,
- Are receiving gold (sodium aurothiomalate) injections.
- Are less than 18 years old.
- Have collagen vascular diseases. Collagen vascular diseases are (diseases in which the body reacts against its own tissues, often causing joint pain and inflammation). Examples are systemic lupus erythematosus or scleroderma.
- Are taking a medicine that contains aliskiren, such as RASILEZ, used to lower high blood pressure. The combination with Benazepril is not recommended.
- Are taking an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”.
- Are taking medicine to treat some cancer and non-cancerous growths associated with genetic disorders ((e.g. temsirolimus, sirolimus, everolimus).
You may become sensitive to the sun while taking Benazepril. Exposure to sunlight should be minimized until you know how you respond.
If you are going to have surgery and will be given an anesthetic, be sure to tell your doctor or dentist that you are taking Benazepril.
Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to Benazepril. Dizziness, lightheadedness, or fainting can occur. Take care especially after the first dose and when the dose is increased.
INTERACTION WITH THIS MEDICATION
As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.
The following may interact with Benazepril:
- receptor blockers ARBs or aliskiren-containing products (e.g. RASILEZ).
- Cyclosporine, an immunosuppressant medicine used in transplanted patients to reduce the risk of organ rejection.
- Heparin, an anticoagulant medication used to prevent or treat blood clots.
- Erythropoietin, a medicine used to regulate the production of red blood cells.
- Gold for the treatment of rheumatoid arthritis.
- Medicine used to treat some cancers and also some non-cancerous growths associated with a genetic disorder (e.g. temsirolimus, sirolimus, everolimus)
PROPER USE OF THIS MEDICATION
Take Benazepril exactly as prescribed. It is recommended to take your dose at about the same time every day.
You can take Benazepril before, during or after a meal since food will not decrease its effectiveness. Swallow your tablet with a glass of water.
The dose of Benazepril must be individualized. Your doctor will prescribe the lowest possible dose for your needs, to be taken once or twice a day. Your doctor will tell you exactly how many tablets of Benazepril to take. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose. Do not exceed the recommended dose. Never change the dose unless told to do so.
Usual Adult Dose:
Recommended Initial Dose: 10 mg a day.
Usual Maintenance Dose: 20 mg a day.
Maximum Dose: 40 mg a day.
In patients with severe kidney disease:
Recommended Initial Dose: 5 mg a day.
Overdose:
If you think you have taken too much Benazepril contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
If you miss a dose of this medicine, take the missed dose as soon as possible. If it is almost time for your next dose, skip the missed dose and then take the next one at the usual time. Do not take a double dose on the next day to make up for the forgotten tablet(s).
SIDE EFFECTS AND WHAT TO DO ABOUT THEM:
Side effects may include:
- dizziness;
- drowsiness, fatigue, weakness;
- cough (dry, non-productive, mainly at night, continuing);
- sore throat and throat irritation;
- headache;
- abdominal pain; pain in your muscles, back or bones,
- rash, itching, increased sensitivity of the skin to sun, flushing;
- diarrhea, constipation, vomiting, nausea, stomach upset ;
- numbness or tingling in the hands, feet or lips;
- ringing in the ears;
- loss of taste;
- erectile dysfunction;
If any of these affects you severely, tell your doctor, nurse or pharmacist.
Benazepril can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
What Benazepril Tablet Contains:
The active constituent is Benazepril Hydrochloride.
a) Each tablet contains:
Benazepril Hydrochloride USP 5mg
Excipients q.s.
b) Each tablet contains:
Benazepril Hydrochloride USP 10mg
Excipients q.s.
c) Each tablet contains:
Benazepril Hydrochloride USP 20mg
Excipients q.s.
d) Each tablet contains:
Benazepril Hydrochloride USP 40mg
Excipients q.s.
Contents and Packing Information:
Benazepril Tablets are available in Bottle/Blister Packs of 7, 10, 15, 20, 30, 50, 60, 90, 100 and 250 tablets.
Not all a packs may be marketed.
7. Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)