Patient Medication Information: uses, side effects, how to take - Rhotral 100
ABOUT THIS MEDICATION
What the medication is used for:
Your doctor has prescribed RHOTRAL® to help control your mild to moderate high blood pressure (hypertension). Your doctor may prescribe RHOTRAL® to be used with or without other drugs.
RHOTRAL® is also used to treat chest pains (angina) due to ischemic heart disease.
Read this leaflet carefully. It does not replace your doctor’s or pharmacist’s advice. They may give you different instructions for your particular health condition. Be sure to follow their advice. If you have any questions, talk to your doctor or pharmacist. Do not decide on your own how to take RHOTRAL®.
What it does:
RHOTRAL® is part of a class of drugs called beta-adrenergic receptor blocking agents. These drugs block the action of certain chemicals on the heart that increase blood pressure and increase heart rate.
You may not notice any effects from taking RHOTRAL®. However, it is important to take RHOTRAL® as your doctor has prescribed it.
When it should not be used:
This medicine may not be right for you. You should speak to your doctor before taking this medicine if you suffer from any conditions other than high blood pressure and/or chest pains due to heart disease, or if any of the following applies to you:
You have any other medical problems, especially if you
have heart disease, heart failure, or other heart or circulation problems;
- You have a tumour of the adrenal gland;
You are allergic or hypersensitive to acebutolol or other
beta blocking drugs (“beta blockers”), or any of the other ingredients in RHOTRAL®;
You have low blood pressure or any other blood
circulatory problem.
What the medicinal ingredient is:
RHOTRAL® contains acebutolol hydrochloride.
What the important nonmedicinal ingredients are:
RHOTRAL® 100 mg contains: microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake, dibasic calcium phosphate, magnesium stearate, Opadry II White Y-22-7719, polyethylene glycol, povidone, talc.
RHOTRAL® 200 mg contains: microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C Blue No. 1 Aluminum Lake, magnesium stearate, Opadry II White Y-22-7719, polyethylene glycol, povidone, talc.
RHOTRAL® 400 mg contains: colloidal silicon dioxide, cornstarch, D&C Yellow No. 10 Aluminum Lake, lactose, magnesium stearate, methylcellulose, Opadry II White Y-22-7719, polyethylene glycol, povidone, talc.
What dosage forms it comes in:
Tablets, 100, 200, or 400 mg.
WARNINGS AND PRECAUTIONS
BEFORE you use RHOTRAL®, talk to your doctor or pharmacist (you may need to lower the dose) if:
$ You are performing any activities that require you to be alert, such as driving or operating machinery, especially in the first few weeks of taking RHOTRAL®or if your doctor increases your dose;
- You have psoriasis;
- You have hyperthyroidism
- You have any liver or kidney problems;
- You have experienced heart failure in the past or currently have any heart problems (e.g., heart disease);
- You have experienced a narrowing of the airways, such as bronchospastic disease;
- You are currently taking any other medications, whether prescribed by your doctor or otherwise. This is very important if you are taking any other medications for high blood pressure, which may increase the effects of RHOTRAL®;
- You are allergic or hypersensitive to acebutolol or other beta blocking drugs (“beta blockers”), or any of the other ingredients in RHOTRAL®, or any other known allergies;
- You have diabetes or other problems with blood sugar levels;
You are pregnant, breast-feeding, or thinking of becoming pregnant. Taking RHOTRAL® during pregnancy may cause injury to you or your baby. RHOTRAL® passes from the mother into breast milk. You should not breast-feed while taking RHOTRAL®; or
- If you are being treated for any other conditions by other doctors, inform them of which medications you are taking. Some drugs may have effects on other drugs.
- If you have to undergo any dental or other surgery, inform the dentist or the doctor that you are taking RHOTRAL®.
Some precautions you should take:
Keep RHOTRAL® out of the sight and out of the reach of children. Never take medicine in front of small children, as they may want to copy you.
Unused medicines that you know you will no longer need should be carefully disposed of. Small quantities may be disposed of in the toilet, or you may wish to talk to your pharmacist.
Remember:
You may not notice any signs of high blood pressure. Therefore, it is important to take RHOTRAL® even when you feel well. A constant amount of RHOTRAL® is needed in your body to control your high blood pressure. Do not stop taking RHOTRAL® without first talking to your doctor. In some cases, serious side effects can occur if you abruptly stop taking this medication.
Remember:
Use RHOTRAL® only as directed by your doctor. All drugs have both helpful and harmful effects. Both depend on the individual patient and his or her own health conditions. This leaflet alerts you to some of the times you should call your doctor. However, unexpected conditions may occur. If you have any questions or concerns while taking RHOTRAL®, you should call your doctor or pharmacist.
INTERACTIONS WITH THIS MEDICATION
Some other medications may interact with or affect the use of RHOTRAL®. You should tell your physician about all the drugs you are using or plan to use for any reason, especially for:
- High blood pressure;
Mental agitation (catecholamine-depleting drugs such as
reserpine);
- Cold or flu (α-adrenergic stimulants);
Heart irregularities (arrhythmia) (e.g., Verapamil or other
calcium antagonists, disopyramide (Rhythmodan®), or amiodarone);
Angina or other heart problems (e.g., calcium antagonists
like Diltiazem or other calcium antagonists, digoxin);
Asthma, bronchitis, emphysema, or lung disease
(sympathomimetic and xanthine bronchodilators);
Pain (e.g., non-steroidal anti-inflammatory drugs
(NSAIDs) or clonidine);
Depression, seizures, schizophrenia, or psychotic
disorders (e.g., tricyclic antidepressants, barbiturates, phenothiazines, and monoamine oxidase inhibitors); and
Anaesthetics (e.g., ether, cyclopropane, and
trichloroethylene).
If you have to undergo any dental or other surgery, inform the dentist or the doctor that you are taking RHOTRAL®.
PROPER USE OF THIS MEDICATION
Usual dose:
To treat high blood pressure: Your doctor will determine
your dose based on your individual medical needs. Your doctor will tell you when and how to take RHOTRAL®. Your doctor may start with a dose of 100 mg twice per day, and may increase the dose if needed, up to the maximum recommended dose. The maximum recommended dose is 400 mg twice per day. After your doctor has seen good results with your dose, your doctor may tell you to continue taking RHOTRAL® at that dose. Your doctor may prescribe RHOTRAL® in combination with other drugs.
To treat chest pains due to heart disease: Your doctor will determine your dose based on your individual medical needs. Your doctor will tell you when and how to take RHOTRAL®. Your doctor may start with a dose of 200 mg twice per day, and may increase the dose if needed, up to the maximum recommended dose. The maximum recommended dose to is 300 mg twice per day. After your doctor has seen good results with your dose, your doctor may tell you to continue taking RHOTRAL® at that dose.
For elderly patients: Your doctor will determine your dose based on your individual medical needs. Your doctor will tell you when and how to take RHOTRAL®. Smaller doses are generally used in older patients, particularly if you have kidney problems.
For patients with kidney/liver problems: Your doctor will determine your dose based on your individual medical needs. Your doctor will tell you when and how to take RHOTRAL®. Smaller doses are generally used in patients with kidney problems.
Do not stop taking RHOTRAL® without first talking to your doctor. In some cases, serious side effects can occur if you abruptly stop taking this medication.
Overdose:
If you have taken more than your dose of RHOTRAL®, contact your doctor or a poison control centre immediately. Do not take any more doses of RHOTRAL®.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Along with the intended effects, any medication, including RHOTRAL®, may cause side effects. With RHOTRAL®, the most common side effects are tiredness, shortness of breath or pain/difficulty breathing, nausea, dizziness, low blood pressure, and skin rashes.
Other side effects appear in a small number of patients taking RHOTRAL® and may be serious.
These side effects include muscle, chest, or joint pain, skin rashes, and dry eyes. You should report any side effects to your doctor. Your doctor may change your medication or reduce the dose.
If you experience any of the following side effects or conditions, see your doctor.
Do not stop taking RHOTRAL® without first talking to your doctor. In some cases, serious side effects can occur if you abruptly stop taking this medication.
| 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 phar-macist | ||||||
Only if severe | In all cases | |||||||
| Common | Dizziness or fainting, low blood pressure (hypotension). | T | ||||||
| Dry eyes or skin rashes. | T | |||||||
Narrowing of the airways (bronchospasm), or other lung effects. | T | |||||||
| Nausea. | T | |||||||
| Uncommon | Lupus-like syndrome, including joint pain, muscle pain, chest pain when you cough or breath, breathing difficulties (shortness of breath or labored breathing), or increased anti-nuclear antibody (ANA) titers. | T | ||||||
| Congestive heart failure, irregular heart beat, low heart rate, or other changes in heart symptoms. | T | |||||||
Lung inflammations (with cough, shortness of breath, chest pain, fever) Pneumonia. | T | |||||||
Increased sensitivity or reactions to allergens. | T | |||||||
This is not a complete list of side effects. For any unexpected effects while taking RHOTRAL®, contact your doctor or
pharmacist.
HOW TO STORE IT
Keep RHOTRAL® out of reach of children.
Store between 15-30°C.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada through the Canada Vigilance program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
By toll-free telephone: 866-234-2345
By toll-free fax: 866-678-6789
Online: www.healthcanada.gc.ca/medeffect By email: CanadaVigilance@hc-sc.gc.ca
By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and Effectiveness Information Bureau
Marketed Health Products Directorate Health Products and Food Branch
Health Canada
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
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
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, at: 1-800-265-7927.