Patient Medication Information: uses, side effects, how to take - Sandoz Aliskiren
ABOUT THIS MEDICATION
What the medication is used for:
Sandoz Aliskiren is a medication that helps to control high blood pressure (hypertension).
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.
This medicine does not cure your disease. It helps to control it. Therefore, it is important to continue taking Sandoz Aliskiren regularly even if you feel fine.
What it does:
Sandoz Aliskiren belongs to a new class of medicines called “direct renin inhibitors”. They prevent the body from producing angiotensin II, a substance that causes blood vessels to tighten, thus increasing blood pressure. As a result, blood vessels relax and blood pressure is lowered. It can be used alone or in combination with selected other agents to get a better reduction in blood pressure.
When it should not be used:
Do not take Sandoz Aliskiren if you:
- Are allergic to aliskiren or to any non-medicinal ingredient in the formulation (see What the nonmedicinal ingredients are:).
- Have experienced a severe allergic reaction called angioedema with swelling of the face, lips, tongue, or throat, or sudden difficulty breathing or swallowing while taking aliskiren 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.
- Have diabetes or kidney disease and are already taking a blood pressure-lowering medicine which is an angiotensin converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB).
- Are pregnant or plan to become pregnant
Are breastfeeding
Sandoz Aliskiren is only for use in adults. It must not be used in patients less than 2 years of age and should not be used in patients 2 to less than 6 years of age. Sandoz Aliskiren is not recommended for use in patients 6 to less than 18 years of age.
What the medicinal ingredient is:
aliskiren.
What the nonmedicinal ingredients are:
Colloidal silicon dioxide, crospovidone, hypromellose, iron oxide colorants, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide.
What dosage forms it comes in:
Tablets; 150 (light-pink) and 300 mg (light-red).
WARNINGS AND PRECAUTIONS
Serious Warning and Precaution - Pregnancy
Sandoz Aliskiren should not be used during pregnancy. If you discover that you are pregnant while taking Sandoz Aliskiren, stop the medication and contact your doctor, nurse, or pharmacist as soon as possible.
BEFORE you use Sandoz Aliskiren talk to your doctor, nurse, or pharmacist if you:
- Have or have had an impaired kidney function
- Are taking non-steroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling.
- Are taking a blood pressure-lowering medicine which is an angiotensin receptor blocker (ARB) or an angiotensin converting enzyme (ACE) inhibitor.
- Have severe and persistent diarrhea
- Are on a low salt diet
- Are taking cyclosporine, used in transplantation to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis
- Are taking itraconazole, used to treat fungal infections
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 Sandoz Aliskiren:
- Cyclosporine, used in transplantation to prevent graft rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis (red, flaky, itchy skin)
- Itraconazole, or ketoconazole, used to treat fungal infections
- Potassium-sparing diuretics (a specific kind of “water pill”), potassium supplements, or salt substitutes containing potassium.
- Other blood pressure lowering medications, such as furosemide, verapamil, angiotensin receptor blockers (ARBs), such as irbesartan or angiotensin converting enzyme
- (ACE) inhibitors.
- Non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (Cox-2) inhibitors, used to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.
PROPER USE OF THIS MEDICATION
Take Sandoz Aliskiren exactly as prescribed. You can take Sandoz Aliskiren with or without food, but it should be taken the same way each day. It is recommended to take your dose at about the same time every day. Swallow Sandoz Aliskiren tablets whole with a small amount of water. Do not chew or crush the tablets.
Usual adult dose:
The usual starting dose is one 150 mg tablet once a day. In some cases, your doctor may prescribe a higher dose of one 300 mg tablet once a day or an additional blood pressure-lowering medicine.
Do not exceed the maximum dose of 300 mg once a day.
Overdose:
| If you think you have taken too much Sandoz Aliskiren, 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 it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects may include:
- nasopharyngitis (common cold, viral infectious disease of the upper respiratory tract which affects primarily the nose, the throat and sinus), influenza, cough
- diarrhea, constipation, nausea, vomiting
- edema (accumulation of fluid in tissues that can cause swelling of hands, ankles or feet)
- headache, dizziness, fatigue
- back pain
- itching, skin reddening
- weakness
- low sodium levels in blood
If any of these affects you severely, tell your doctor, nurse, or pharmacist.
Sandoz Aliskiren 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 | Increased levels of potassium in the blood: irregular heartbeats, muscle weakness and generally feeling unwell | ✓ | ||
| Uncommon | Severe diarrhea | ✓ | ||
| Allergic reaction: rash, itching, hives, swelling of the face, lips, tongue or throat, difficulty breathing or swallowing, dizziness, vomiting, abdominal pain. | ✓ | |||
| Reduced kidney function: decreased urination, nausea, vomiting, swelling of extremities, fatigue | ✓ | |||
Low blood pressure: dizziness, fainting, lightheadedness May occur when you go from lying or sitting to standing up. | ✓ | |||
| Kidney failure or acute kidney failure: Severely decreased or lack of urination | ✓ | |||
| Unknown | Angioedema: (symptoms like difficulty breathing or swallowing, tightness of the chest, hives, general rash, swelling, itching, dizziness, vomiting, abdominal pain) | ✓ | ||
| 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 | ||
|---|---|---|---|
Liver disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✓ | ||
| Toxic epidermal necrolysis: severe skin peeling especially in mouth and eyes | ✓ | ||
| Stevens Johnson syndrome: blistering of the mucous membranes of the skin including mouth, lips, eyes or mouth eyelids, and genitals | ✓ | ||
This is not a complete list of side effects. For any unexpected effects while taking Sandoz Aliskiren, contact your doctor, nurse or pharmacist.
HOW TO STORE IT
- Do not store above 30°C.
- Do not use after the expiry date shown on the box.
- Store in the original package in order to protect from moisture.
- Keep 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: --------------------------------------------------------------------------
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 obtained by contacting the sponsor, Sandoz Canada Inc., at: 1-800-361-3062
or
by written request at:
145, Jules-Léger
Boucherville, (QC), Canada
J4B 7K8
or by e-mail at : medinfo@sandoz.com