Patient Medication Information: uses, side effects, how to take - Valsartan (Actavis Pharma)
ABOUT THIS MEDICATION
What the medication is used for:
High blood pressure (hypertension):
VALSARTAN lowers high blood pressure.
What it does:
VALSARTAN is an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”.
This medicine does not cure your disease. It helps to control it. Therefore, it is important to continue taking VALSARTAN regularly even if you feel fine.
When it should not be used:
Do not take VALSARTAN if you:
Are allergic to valsartan or to any non-medicinal
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 ARB. Be sure to tell your doctor, nurse, or pharmacist that this has happened to you.
Are taking a medicine that contains aliskiren (such as
Rasilez) and you have diabetes or kidney disease.
Are pregnant or intend to become pregnant. Taking
VALSARTAN during pregnancy can cause injury and even death to your baby.
Are breastfeeding. It is possible that VALSARTAN
passes into breast milk.
What the medicinal ingredient is:
Valsartan
What the nonmedicinal ingredients are:
VALSARTAN also contains the following non-medicinal ingredients:
40 mg tablets: Colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, sodium dodecyl sulphate, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and iron oxide yellow.
80 mg tablets: Colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, sodium dodecyl sulphate, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, iron oxide red, FD&C Yellow #6, and FD&C Blue #2.
160 mg tablets: Colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, sodium dodecyl sulphate, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, iron oxide yellow, and FD&C Yellow #6.
320 mg tablets: Colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, sodium dodecyl sulphate, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, iron oxide black, iron oxide red, iron oxide yellow, FD&C Red #40, and FD&C Blue #2.
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:
VALSARTAN is available in four tablet strengths containing valsartan 40 mg, 80 mg, 160 mg and 320 mg.
- VALSARTAN 40 mg tablets are yellow, film-coated, oval-shaped, biconvex tablet with “V” bisect “S” on one side and “ ” on the other side.
- VALSARTAN 80 mg tablets are pink, film-coated, round, biconvex tablet with “VS” over “80” on one side and “ ” on the other side.
- VALSARTAN 160 mg tablets are orange, film-coated, oval-shaped, biconvex tablet with “VS 160” on one side and “ ” on the other side.
- VALSARTAN 320 mg tablets are dark grey-violet, film-coated, oval-shaped, biconvex tablet with “VS 320” on one side and “ ” on the other side.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions - Pregnancy VALSARTAN should not be used during pregnancy. If you discover that you are pregnant while taking VALSARTAN, stop the medication and contact your doctor, nurse or pharmacist as soon as possible.
BEFORE you use VALSARTAN talk to your doctor, nurse or pharmacist if you:
- Have experienced an allergic reaction to any drug, including drugs used to lower blood pressure, such as angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARB).
- Have narrowing of an artery or a heart valve.
- Have had a heart attack or stroke.
- Have heart failure.
- Have diabetes, liver or kidney disease.
- Are on dialysis
Are dehydrated or suffer from excessive vomiting,
diarrhea, or sweating.
Are taking a salt substitute that contains potassium,
potassium supplements, or a potassium-sparing diuretic (a specific kind of “water pill” that makes your body keep potassium).
- Are on a low-salt diet.
Are taking a medicine that contains aliskiren, such as
Rasilez, used to lower high blood pressure. The combination with VALSARTAN is not recommended.
Are taking an angiotensin converting enzyme (ACE)
inhibitor.
- Are less than 18 years old.
Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to VALSARTAN. Dizziness, light headedness, or fainting can especially occur after the first dose and when the dose is increased.
INTERACTIONS 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 VALSARTAN:
Agents increasing serum potassium, such as a salt
substitute that contains potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind of “water pill”).
Lithium, a medicine used to treat some types of
psychiatric illness such as bipolar disease.
Non-steroidal anti-inflammatory drugs (NSAIDs), used
to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.
Other blood pressure lowering drugs, including diuretics
(“water pills”), ACE inhibitors or aliskiren.
- Rifampin an antibiotic.
Cyclosporine a drug used to protect against transplant
rejection.
Ritonavir a antiretroviral drug used to treat HIV/AIDS
infection.
PROPER USE OF THIS MEDICATION
Take VALSARTAN exactly as prescribed. Swallow VALSARTAN tablets with a glass of water. It is recommended to take your dose at about the same time everyday preferably in the morning. You can take VALSARTAN with or without food, but it should be taken the same way each day. Do not exceed the
recommended dose.
Usual Adult Dose:
High blood pressure (hypertension):
Recommended Initial dose: 80 mg once a day. Dose should be increased gradually.
Maximum dose: 320 mg a day
Overdose:
If you think you have taken too much VALSARTAN contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
If you have forgotten to take your dose during the day, carry on with the next one at the usual time. Do not double dose.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects may include:
- Dizziness, Light headedness,
- Drowsiness,
- Rash,
- Diarrhea, vomiting, nausea,
- Headache
- Back or leg pain, muscle cramps,
- Muscle pain, muscle weakness,
- Unusual tiredness, weakness,
- Cough,
- Impotence,
- Nose bleed
- Blistering skin (sign of dermatitis bullous)
If any of these affects you severely, tell your doctor, nurse or pharmacist.
VALSARTAN can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
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 seek immediate medical help | ||
Only if severe | In all cases | |||
| Common | Allergic reactions: Skin rash, skin eruption or other effect on the skin or eyes | √ | ||
Increased levels of potassium in the blood: Irregular heartbeats, muscle weakness and generally feeling unwell | √ | |||
| Uncommon | Low blood pressure (hypotension): Dizziness, fainting, light headedness may occur when you go from lying or sitting to standing up | √ | ||
Angioedema/ Allergic reactions: Rash, hives, swelling of the lips, face or neck, tongue or throat accompanied by difficulty in breathing, swallowing or speaking | √ | |||
Kidney Disorder: Change in frequency of urination, nausea, vomiting, swelling of the extremities, fatigue | √ | |||
Liver Disorder: Yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | √ | |||
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 seek immediate medical help | ||
Only if severe | In all cases | |||
| Uncommon | Rhabdomyolysis: Muscle pain that you cannot explain, muscle tenderness or weakness, dark brown urine | √ | ||
| Abdominal pain | √ | |||
Cardiac failure: Breathlessness, difficulty breathing when lying down, swelling of the feet or legs | √ | |||
Vasculitis: Inflammation of blood vessels purplish-red spots, fever, itching | √ | |||
Decreased Platelets: Bruising, unusual bleeding, fatigue and weakness | √ | |||
Anemia: Fatigue, loss of energy, weakness, shortness of breath | √ | |||
Decreased white blood cells: Infections, fatigue, fever, aches, pains, and flu-like symptoms, sore throat or mouth ulcers | √ | |||
| Insomnia | √ | |||
Flu like symptoms, joint pain, pharyngitis, inflammation of sinuses, runny or stuffy nose, swollen hands, ankles or feet, upper respiratory tract infection, viral infection | √ | |||
Palpitations: Irregular heartbeats | √ | |||
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 seek immediate medical help | ||
Only if severe | In all cases | |||
| Unknown | Change in libido | √ | ||
Blistering skin reactions with symptoms such as rash, red skin, blistering of the lips, eyes or mouth, skin peeling and fever | √ | |||
This is not a complete list of side effects. For any unexpected effects while taking VALSARTAN, contact your doctor, nurse or pharmacist.
HOW TO STORE IT
Do not use VALSARTAN past the expiry date shown on the pack.
Store your VALSARTAN tablets at room temperature, between 15°C to 30°C. Protect from heat and moisture.
Keep this medicine out of the reach and sight 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:
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- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program Health Canada
Postal Locator 0701E
Ottawa, ON K1A 0K9
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.
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| NOTE: Should you require information related to the | ||
| management of the side effect, please contact your health | ||
| care provider before notifying Canada Vigilance. 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 the sponsor, Actavis Pharma Company, at: 1-866-254-6111
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, ON
Canada, L5N 6J5