Patient Medication Information: uses, side effects, how to take - Ran-Fosinopril
ABOUT THIS MEDICATION
What the medication is used for:
RAN-FOSINOPRIL is used in the treatment of mild to moderate essential hypertension and in the management of symptomatic congestive heart failure.
What it does:
Fosinopril is in a class of medications called angiotensin converting enzyme (ACE) inhibitor. Its main action is to lower blood pressure by preventing the effects of angiotensin II (a chemical that narrows the blood vessels). By blocking angiotensin II effects, the blood vessels relax, letting the blood flow more smoothly, thereby lowering the blood pressure.
When it should not be used:
Do not use RAN-FOSINOPRIL if:
you are allergic to fosinopril or any other
component in the product or the container (see What the important non-medicinal ingredient are),
you are allergic to any other medication in the
same class called angiotensin-converting enzyme (ACE) inhibitors such as enalapril, captopril, lisinopril, quinapril, ramipril etc.
you have a history of angioedema
(angioneurotic edema), a condition that causes swelling of the face, extremities, eyes, lips, tongue, difficulty in breathing after taking an angiotensin-converting enzyme (ACE).
you have been diagnosed with hereditary
angioedema or idiopatic angioedema (angioedema of unknown cause).
What the medicinal ingredient is:
fosinopril sodium
What the important nonmedicinal ingredients are: anhydrous lactose, colloidal silicon dioxide, crospovidone, microcrystalline cellulose, povidone, and talc.
What dosage forms it comes in:
tablets, 10 mg and 20 mg
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
RAN-FOSINOPRIL should not be used during pregnancy. Stop the medication and contact your physician as soon as possible, if you discover that you are pregnant while taking RAN-FOSINOPRIL.
BEFORE you use RAN-FOSINOPRIL talk to your physician or pharmacist if:
You are pregnant. Taking RAN-
FOSINOPRIL during pregnancy can cause injury and even death to your baby.
You are breast-feeding. It is possible that
RAN-FOSINOPRIL passes into the breast milk. You should not breast-feed while taking RAN-FOSINOPRIL.
- You suffer from low blood pressure.
You have any of these conditions:
- heart or blood vessel disease
- liver disease
- kidney disease
- You are vomiting.
- You have diarrhea
- You are going to have any surgery.
- You want to use any potassium supplements or salt substitutes containing potassium.
- You find that you are excessively sweating and feel dehydrated.
- You have any allergies to this drug or its ingredients or components of the container.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with RAN-FOSINOPRIL include: other medicines used to reduce blood pressure, acetyl salicylic acid (Aspirin®); diuretics (water pills) ; lithium; potassium supplements; salt substitutes that contain potassium; medicines that contains potassium; antacids; and certain medications that tend to increase pressure, such as non-prescription preparations for appetite control, asthma, colds, coughs, hay fever and sinus problems.
PROPER USE OF THIS MEDICATION
Usual dose:
Based on your condition, your doctor will decide the usual dose of RAN-FOSINOPRIL you need to take.
The dosage of RAN-FOSINOPRIL must be individualized.
Overdose:
It is important to follow the instructions from your doctor or pharmacist. If you or someone have taken more than the recommended dose at once contact your doctor or nearest hospital emergency department immediately.
Missed Dose:
If a dose of this medication is missed, it should be taken as soon as possible. This will help to keep a constant amount of medication in the blood. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not double doses.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your physician or pharmacist | Stop taking drug and call your physician or pharmacist | ||
| Only if severe | In all cases | |||
| Common | Fatigue Dizziness/ Lightheadedness Hypotension Headache Rash/itching Nausea/Vomiting/ Diarrhea Cough Chest pain Dyspnea | T T T T | T T T T T | |
| Uncommon | Allergic reactions/ Angioedema Flu-like symptoms (such as fever, malaise, muscle pain) Liver impairment such as jaundice, dark/brown urine Abdominal pain Loss of appetite Fainting | T T | T T | T T |
If you notice any of the following, you may need medical attention.
- Symptoms of angioedema such as: sudden difficulty in breathing or swallowing, swelling of face, eyes, lips, tongue and/or throat, hands or feet. The black patients are at increased risk of these types of reactions to ACE inhibitors.
- Dizziness, light headedness or fainting following exercise, and/or when it is hot and you have lost a lot of water by sweating.
- Flu-like symptoms such as fever, malaise, muscle pain, rash, itching, abdominal pain,
nausea, vomiting, diarrhea, jaundice, loss of appetite.
The initial dose may cause a greater fall in
blood pressure than will occur following continued treatment. You may notice this as faintness or dizziness and it may help to lie down. If concerned, please consult your physician or pharmacist.
- Dry cough
- Unusual tiredness and/or weakness
- Headache
Contact your physician or pharmacist if you notice any of the above or have other side effects. Seek medical attention, if the condition persists or worsens.
This is not a complete list of side effects. For any unexpected effects while taking RAN-FOSINOPRIL contact your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature (15 -30ºC). Keep container tightly closed. Protect from high humidity.
Keep out of the reach of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345
toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at: www.ranbaxy.ca or by contacting the sponsor, Ranbaxy Pharmaceuticals Canada Inc. at: 1.866.840.1340.