Patient Medication Information: uses, side effects, how to take - Novo-Valsartan/HCTZ
ABOUT THIS MEDICATION
What is the medication used for:
NOVO-VALSARTAN/HCTZ is a combination of an angiotensin II AT1 receptor blocker (valsartan) and a diuretic (hydrochlorothiazide). Valsartan and hydrochlorothiazide work together to lower your blood pressure.
High blood pressure increases the workload of the heart and arteries. If this condition continues for a long time, damage to the blood vessels of the brain, heart, and kidneys can occur, and may eventually result in a stroke, heart failure or kidney failure. High blood pressure also increases the risk of heart attacks. Reducing your blood pressure decreases your risk of developing these illnesses.
What it does:
The valsartan ingredient in NOVO-VALSARTAN/HCTZ lowers blood pressure by specifically blocking angiotensin II. Angiotensin II is a natural hormone produced in the body to keep blood pressure at normal levels. One function of angiotensin II is to increase blood pressure, usually when it becomes too low. Valsartan works by blocking the effect of angiotensin II. As a result, blood pressure is lowered. The hydrochlorothiazide ingredient in NOVO-
VALSARTAN/HCTZ works by making your kidneys pass more water and salt. Together valsartan and
hydrochlorothiazide lower blood pressure.
When it should not be used:
You should not take NOVO-VALSARTAN/HCTZ if:
you have ever had an unusual or allergic reaction to
valsartan, hydrochlorothiazide or to any other component of this product;
you are allergic to any sulfonamide-derived drugs (ask
your physician or pharmacist if you are not sure what sulfonamidederived drugs are);
- you are not passing urine;
- you are pregnant or planning to become pregnant (See WARNINGS AND PRECAUTIONS below).
NOVO-VALSARTAN/HCTZ is not recommended for children.
What the medicinal ingredients are:
Valsartan and hydrochlorothiazide.
What the important nonmedicinal ingredients are:
NOVO-VALSARTAN/HCTZ tablets also contain the following non-medicinal ingredients:
- 80mg/12.5mg: Colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and starch. The coating contains FD&C yellow#6, hydroxypropyl methylcellulose, iron oxide red, polyethylene glycol, talc and titanium dioxide.
- 160mg/12.5mg: Colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and starch. The coating contains hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, polyethylene glycol, talc and titanium dioxide.
- 160mg/25mg: Colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and starch. The coating contains hydroxypropyl methylcellulose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, talc and titanium dioxide.
If you are on a special diet, or if you are allergic to any substance, ask your doctor or pharmacist whether any of these ingredients may cause a problem.
What dosage forms it comes in:
NOVO-VALSARTAN/HCTZ is available in three tablet strengths containing valsartan and hydrochlorothiazide 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
NOVO-VALSARTAN/HCTZ should not be used during pregnancy. If you discover that you are pregnant while taking NOVO-VALSARTAN/HCTZ, stop the medication and please contact your physician.
BEFORE you use NOVO-VALSARTAN/HCTZ talk to your doctor or pharmacist if:
- you have liver or kidney disease
- you have gout, diabetes, lupus erythematosus
- you are being treated with other diuretics (water pills)
- you are suffering from excess vomiting or diarrhea
- you have any allergies to this drug or its ingredients or components of the container
You are pregnant, breast-feeding or thinking of becoming pregnant?
Taking NOVO-VALSARTAN/HCTZ during pregnancy can cause injury and even death to your baby. This medicine should not be used during pregnancy. If you are planning to become pregnant while taking NOVO-VALSARTAN/HCTZ, contact immediately your doctor.
It is possible that NOVO-VALSARTAN/HCTZ passes into breast milk. You should discuss with your doctor about taking NOVO-VALSARTAN/HCTZ while breast-feeding.
Similar medicines were associated with serious harm to fetuses when they were taken during pregnancy. It is therefore important to tell your doctor immediately if you think you may have become pregnant, or planning to become pregnant. Your doctor will discus with you the potential risk of taking NOVO-VALSARTAN/HCTZ during pregnancy.
Although it is not known whether valsartan can pass into human breast milk, this does happen in animals. Hydrochlorothiazide appears in human milk. Therefore do not breast-feed during treatment. Tell your doctor if you are breast-feeding, so that other treatment options can be tried.
Like many other medicines used to treat high blood pressure, NOVO-VALSARTAN/HCTZ may rarely cause effects such as dizziness or fainting in some patients. So before you drive a vehicle, use machinery, or do other things that need concentration, make sure you know how you react to the effects of NOVO-VALSARTAN/HCTZ.
INTERACTIONS WITH THIS MEDICATION
As with other medicines, interactions with other drugs are possible. Therefore, do not take any other medicines unless you have discussed the matter with your physician or your pharmacist.
Certain medicines tend to increase your blood pressure, for example, non prescription preparations for appetite control, asthma, colds, coughs, hay fever and sinus problems.
Before surgery and general anesthesia (even at the dentist’s office), tell the physician or dentist that you are taking NOVO-VALSARTAN/HCTZ, as there may be a sudden drop in blood pressure associated with general anesthesia.
It is especially important for your physician and pharmacist to know if you are taking other drugs, such as:
- digoxin (a heart medicine)
- other diuretics (water pills)
- potassium-sparing agents
potassium supplement or salt substitutes containing
potassium
- resins (which reduce high cholesterol)
- medications to treat diabetes including insulin
- cucare derivatives (muscle relaxants)
- allopurinol (anti-gout treatment)
- amantadine
- cytotoxic drugs (cancer therapy)
- anticholonergic agents
cyclosporine
- pressor amines such as adrenaline
- steroids
- certain pain and arthritis medicines
- lithium (a drug used to treat a certain kind of depression).
- carbamazepine (a drug used to treat epilepsy, bipolar disorders, neuralgia and other conditions)
Taking carbamazepine with hydrochlorothiazide (a medicinal ingredient in NOVO-VALSARTAN/HCTZ) may cause a low sodium level in the blood. Symptoms of low sodium level in the blood may include: nausea, vomiting, headache, muscular cramps or weakness, and general uneasiness. As it worsens, confusion, decreased consciousness, convulsions (fits), or coma may occur. Tell your doctor if this happens to you.
Sedatives, tranquilizers, narcotics, alcohol and analgesics may increase the blood-pressure lowering effect of NOVO-VALSARTAN/HCTZ, so tell your physician or pharmacist if you are taking any of these.
PROPER USE OF THIS MEDICATION
Patients who have high blood pressure often do not notice any signs or symptoms of this condition. So even though you are feeling well, your health may be getting worse. This makes it all the more important for you to continue your treatment program and to keep your appointments with your doctor.
Remember that this medicine does not cure your high blood pressure; it only may help to control it. Therefore, if you want to lower your blood pressure and keep it down, you must continue to take NOVO-VALSARTAN/HCTZ as directed.
Usual dose:
Take NOVO-VALSARTAN/HCTZ as directed. Dosage must be individualized. NOVO-VALSARTAN/HCTZ is not for initial therapy. Once you are stabilized on both individual components of NOVO-VALSARTAN/HCTZ the usual dosage is one 80 mg/12.5mg tablet once a day. In some cases, your doctor may prescribe a higher dose (e.g., the 160mg/12.5mg, or 160mg/25mg tablet).
You can take NOVO-VALSARTAN/HCTZ with or without food, but it should be taken the same way each day.
Overdose:
If you experience severe dizziness and/or fainting, contact your doctor immediately so that medical attention may be given promptly.
For management of a suspected drug overdose, contact your regional Poison Control Centre.
Missed Dose:
Try to take your dose at the same time each day, preferably in the morning. However, if you have completely forgotten to take your dose during the day, carry on with the next one at the usual time. Do not double doses.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, NOVO-VALSARTAN/HCTZ may cause unwanted reactions, or side effects. Most patients do not experience side effects from NOVO-VALSARTAN/HCTZ, however, some patients may experience dizziness.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | |||||
| HAPPEN AND WHAT TO DO ABOUT THEM | |||||
| Symptom/effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |||
| Only if severe | In all cases | ||||
| Common | |||||
Allergic reactions Skin rash, skin eruption or other effect on the skin or eyes | ✓ | ||||
| Uncommon | |||||
| Low Blood Pressure (hypotension): Fainting, dizziness, blurred vision | ✓ | ||||
Allergic reactions Swelling of the lips, face or neck, accompanied by difficulty in breathing or speaking | ✓ | ||||
| Kidney and Liver disorder Symptoms such as nausea, vomiting dark/brown urine | ✓ | ||||
| Muscle tenderness or weakness, generalized weakness (sign of rhabdomyolysis | ✓ | ||||
| Abdominal pain | ✓ | ||||
This is not a complete list of side effects. For any unexpected effects while taking NOVO-VALSARTAN/HCTZ, contact your doctor or pharmacist.
HOW TO STORE IT?
Store your NOVO-VALSARTAN/HCTZ tablets in a dry place at room temperature (15-30°C).
Do not take NOVO-VALSARTAN/HCTZ past the expiry date shown on the pack.
Always remember
This medicine has been prescribed to you for your current medical problem only. Do not give it to other people.
It is very important that you take this medicine exactly as your doctor tells you in order to get the best results and reduce the chance of side effects.
Keep this medicine out of the reach of children.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways: $ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345 $ Complete a Canada Vigilance Reporting Form and:
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect. NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
Please consult your doctor or pharmacist with any questions or concerns you may have regarding your individual condition.
This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited.
at: 1-800-268-4127 ext. 5005 (English)
and at 1-877-777-9117 (French)
or druginfo@tevacanada.com
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Date: June 8, 2011