Patient Medication Information: uses, side effects, how to take - Arcosyl (Servier Canada, 5 mg)
ABOUT THIS MEDICATION
What the medication is used for:
Your doctor has prescribed ARCOSYL® to treat your mild to moderate hypertension. Hypertension is the medical term for high blood pressure.
You may be prescribed ARCOSYL® to treat mild to moderate congestive heart failure along with other medications.
ARCOSYL® is also indicated for the reduction of cardiovascular risk in patients with hypertension and/or those who have suffered a heart attack.
What it does:
ARCOSYL® belongs to a class of medicines called ACE inhibitors. These work by widening the blood vessels, which makes it easier for your heart to pump blood through them.
When blood pressure flows through the blood vessels it pushes against their walls. This pressure helps get your blood all around the body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are. You have high blood pressure when your blood pressure stays higher than is needed, even when you are calm or relaxed.
There are usually no symptoms of high blood pressure. When blood pressure is high, damage can occur to the heart and blood vessels. The only way of knowing that you have high blood pressure is to have your blood pressure checked on a regular basis.
Heart failure means that the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body. Heart failure may start off with no symptoms, but as the condition progresses, you may feel short of breath or may get tired easily after light physical activity such as walking. You may wake up short of breath at night.
When it should not be used:
Do not take ARCOSYL® if:
- you have experienced swelling of the face, tongue, lips or throat either spontaneously or in response to another medicine of the same family in the past (This rare condition is known as angioedema),
- you are allergic to the active substance or any of the other ingredients of ARCOSYL® (See “What all nonmedicinal ingredients are”).
- you are already taking a blood pressure-lowering medicine that contains aliskiren (such as Rasilez) and you have diabetes or kidney disease.
ARCOSYL® is not intended for use in children and adolescents (under 18 years old).
What the medicinal ingredient is:
The active substance of ARCOSYL® is perindopril arginine.
What all nonmedicinal ingredients are:
ARCOSYL® tablets: ingredients in the film-coated tablet are: glycerol, hydrophobic colloidal silica, hypromellose, lactose monohydrate, macrogol 6000, magnesium stearate, maltodextrin, sodium starch glycolate (type A), titanium dioxide, and for the 5mg and 10mg tablets, chlorophyllin (E141ii).
ARCOSYL® orodispersible tablets: acesulfame potassium, aspartame, lactose monohydrate, magnesium stearate, maize starch, silica colloidal anhydrous.
What dosage forms it comes in:
ARCOSYL® comes in film-coated tablets of 2.5 mg, 5 mg or 10 mg, and in orodispersible tablets of 2.5 mg, 5 mg or 10 mg.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
ARCOSYL® should not be used during pregnancy. If you discover that you are pregnant while taking ARCOSYL®, stop the medication and please contact your physician as soon as possible.
BEFORE you use ARCOSYL® talk to your doctor or pharmacist if:
You perform tasks which may require special attention (for example driving an automobile or operating dangerous machinery),
- You suffer from kidney or liver disease,
- You undergo surgery,
- You are taking diuretics (drug used to treat high blood pressure),
- You are taking vasodilators including nitrates (products that make the blood vessels become wider),
- You are taking a medicine that contains aliskiren, such as RASILEZ, used to lower high blood pressure. The combination with ARCOSYL® is not recommended.
- You are taking an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in "-SARTAN".
- You are taking, have recently taken or intend to take any other medicines, even those not prescribed,
- You have a heart condition,
- You undergo dialysis,
- You have diabetes,
- You have systemic lupus erythematosus (SLE),
- You have a skin condition known as “hard skin” (thickening of the skin),
- You are on a salt-restricted diet,
- You are receiving gold (sodium aurothiomalate) injections.
- You are suffering from severe diarrhea or vomiting,
- You have recently or are planning to get allergy shots for bee or wasp stings.
- You suffer from lactose intolerance or have hereditary galactose intolerance or glucose-galactose malabsorption because ARCOSYL® products contain lactose
Because ARCOSYL® orodispersible tablets contain aspartame, it can be harmful to the people suffering from phenylketonuria (a rare, hereditary disorder of the metabolism).
Be aware that excessive perspiration, dehydration and conditions such as diarrhea and vomiting can cause a drop in blood pressure and this may aggravate the side effects of ARCOSYL®, so consult your doctor when this occurs.
Taking ARCOSYL® during pregnancy can cause injury and even death to your baby. This medicine should not be used during pregnancy. If you become pregnant while taking ARCOSYL®, stop the medication and report to your doctor as soon as possible. It is possible that ARCOSYL® passes into breast milk. You should not breast-feed while taking ARCOSYL®.
INTERACTIONS WITH THIS MEDICATION
Before you take ARCOSYL®, talk to your doctor if you are undergoing kidney dialysis using polyacrylonitrile membranes.
Drugs that may interact with ARCOSYL®, and that you should not be taking without the advice of your doctor, include:
- diuretics (‘water tablets’)
- lithium tablets
- potassium supplements or potassium containing medicine,
- insulin or oral hypoglycemics,
- allopurinol,
- procainamide,
- non-steroidal anti-inflammatory drugs (NSAIDs),
- dextran sulphate,
- other medications for high blood pressure (e.g. nitroglycerin, nitrates),
- digoxin,
- gentamicin,
- tricyclic antidepressants,
- anaesthetics,
- medications for mental disorders,
- treatment for bee and wasp allergies,
- gold salts for the treatment of rheumatoid arthritis,
- blood pressure-lowering drugs, including diuretics (“water pills”), aliskiren-containing products (e.g. RASILEZ), or angiotensin receptor blockers (ARBs).
PROPER USE OF THIS MEDICATION
Usual dose (adult dosage):
Always follow your doctor's instructions about how to take ARCOSYL®. You should check with your doctor or pharmacist if you are not sure.
The recommended dose of ARCOSYL® to treat hypertension is one 5 mg-tablet taken in the morning. In some cases, as prescribed by your doctor, the dose could be doubled to 10mg taken in the morning in a single daily dose.
The recommended dose of ARCOSYL® to treat heart failure is one 2.5 mg tablet taken in the morning. In most cases, as prescribed by your doctor, the dose may be doubled to 5mg taken in the morning in a single daily dose.
The recommended dose of ARCOSYL® when used to reduce the risk of cardiovascular risk in patients with hypertension or those who have suffered a heart attack is one 5 mg tablet taken in the morning for 2 weeks. If the dose is tolerated, and as prescribed by your doctor, the dose should be increased to the maintenance dose of 10 mg per day taken in the morning. In older patients, the starting dose should be 2.5 mg once a day for the first week, followed by 5 mg once a day the second week and 10 mg once a day thereafter if tolerated.
Dosage should be adjusted at intervals of at least 2 to 4 weeks.
Do not stop taking your medicine without the advice of your doctor even if you feel better. If you stop, serious complications of the disease may occur.
ARCOSYL® is for oral use.
It is recommended that ARCOSYL® is taken once daily in the morning before a meal.
ARCOSYL® tablets should be swallowed whole with a glass of water.
ARCOSYL® orodispersible tablets should be placed on your tongue for disintegration and swallow with saliva or disperse the tablet in a glass of water and drink the resulting suspension.
Your doctor will monitor your progress with ARCOSYL® and may perform occasional blood tests to ensure your continued health and safety.
Overdose:
In case of accidental drug overdose, contact a health care practitioner, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
Do not take a double dose to make up for forgotten doses. Just carry on with the next dose at the usual time.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, ARCOSYL® can have side effects.
Most side effects are mild or moderate and usually transient. The most common side effects reported with ARCOSYL® are: cough (often described as dry and irritating, usually is worse at night or when lying down), headache, feeling weak, ringing in the ears. Other potential side effects are loss of taste or metallic taste in your mouth, rash. If you feel faint getting up (hypotension), an upper respiratory infection (ie. nose, larynx, lungs), back pain, diarrhea, swelling, discontinue the drug and contact your doctor.
Contact your doctor if these symptoms persist or get worse.
| 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 | Feeling tired or lethargic | ✓ | |||||
| Dizziness | ✓ | ||||||
| Nausea | ✓ | ||||||
| Uncommon | Angioedema (including swelling of the face, lips, tongue, throat, difficulties in breathing or swallowing. This is known to occur more frequently in black patients). | ✓ | |||||
| Liver problems (symptoms of abdominal pain, nausea, vomiting, loss of appetite, jaundice (yellowing of eyes and skin)). | ✓ | ||||||
| Infection (any signs of infection may be signs of a blood disorder). | ✓ | ||||||
| Kidney and urinary problems | ✓ | ||||||
| Erectile dysfunction | ✓ | ||||||
| Allergic reactions (viral-like symptoms such as fever, lack of energy, muscle pain, rash). | ✓ | ||||||
| Irregular heart rate or chest pains. | ✓ | ||||||
| Circulation problems | ✓ | ||||||
| Difficulty in breathing, severe coughing. | ✓ | ||||||
| Severe abdominal pain with or without nausea or vomiting. | ✓ | ||||||
| Rash, sun sensitivity, other unusual skin irritation. | ✓ | ||||||
This is not a complete list of side effects. For any unexpected effects while taking ARCOSYL®, contact your doctor or pharmacist.
HOW TO STORE IT
Keep out of reach and sight of children.
This medicinal product should be stored between 15°C-30°C.
Do not use after the expiry date stated on the carton and tube.
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: Fax toll-free to 1-866-678-6789, or Mail to: Canada vigilance Program Health Canada Postal Locator 0701C Ottawa, ON K1A 0K9 Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available in the MedEffectTM 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 the sponsor, Servier Canada Inc., at: 1-800-363-6093
SERVIER CANADA INC.
235, Boulevard Armand Frappier
Laval, Québec
H7V 4A7