Patient Medication Information: uses, side effects, how to take - Sibboran
Serious Warnings and Precautions
SIBBORAN will be given to you by a qualified healthcare professional. They will also closely monitor your health during your treatment (e.g., heart rate, heart rhythm, and blood pressure).
What is SIBBORAN used for?
SIBBORAN is used to control heart rate in adults:
- who are having, or are recovering from, surgery and have rapid or irregular heart rhythms.
- when clinically deemed necessary for short-term use.
How does SIBBORAN work?
SIBBORAN belongs to a group of medicines known as “beta-blockers”. It works by blocking the effects of certain hormones, such as adrenaline and noradrenaline. This causes your heart to beat more slowly and with less force.
What are the ingredients in SIBBORAN?
Medicinal ingredient: landiolol hydrochloride.
Non-medicinal ingredients: mannitol and sodium hydroxide.
SIBBORAN comes in the following dosage forms:
Powder for solution: 300 mg per vial of landiolol hydrochloride.
Do not use SIBBORAN if:
- you are allergic to landiolol hydrochloride or any of the other ingredients in SIBBORAN.
you have any of the following heart problems:
- a very slow heartbeat (less than 50 beats per minute).
- sick sinus syndrome (heart’s natural pacemaker is unable to create normal heartbeats at a normal rate).
- second or third degree heart block (a type of irregular heart beat and rhythm).
- cardiogenic shock (heart is unable to pump enough blood to the organs of the body).
- decompensated heart failure (heart does not pump enough blood to the body and requires immediate medical treatment).
- you have very low blood pressure.
- you have increased pressure in the lungs (pulmonary hypertension).
- you have a disease known as pheochromocytoma (a tumour in the adrenal gland) which has not been treated.
- you have symptoms of an asthma attack that are rapidly worsening. • you have very high levels of acids in your body (severe metabolic acidosis) which can not be corrected.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take SIBBORAN. Talk about any health conditions or problems you may have, including if you:
- have diabetes or low blood sugar. Landiolol can mask the symptoms of low blood sugar.
- have low blood pressure.
- have or had heart problems (e.g., pre-excitation syndrome with atrial fibrillation, first degree heart block, heart attacks, congestive heart failure, heart conduction problems, heart rhythm disorders, or a chest pain called “Prinzmetal´s angina”).
- recently had a recent heart surgery.
- have kidney problems.
- have liver problems.
- have a disease known as pheochromocytoma (a tumour in the adrenal gland) and are receiving treatment for it.
- have problems breathing (e.g., narrowing of your airways or wheezing and asthma).
- have blood circulation problems (e.g., Raynaud’s disease).
- have any allergies or you are at risk of allergic reactions. SIBBORAN can make allergies more severe and more difficult to treat with epinephrine.
are pregnant, think you are pregnant, or plan to become pregnant.
- are breastfeeding or plan to breastfeed. It is not known if SIBBORAN can be passed into breast milk.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with SIBBORAN:
- anesthetics, medicines used during surgery to relax your muscles (e.g., succinylcholine chloride, midazolam, and isoflurane).
- antidiabetics, medicines used to treat diabetes (e.g., insulin).
- barbiturates, medicines used to relax the body and help with sleeping.
- digoxin, a medicine used to treat heart failure.
- dopamine, a medicine used to treat low blood pressure.
- Epinephrine, a medicine used to treat allergic reactions. fingolimod, a medicine used to treat multiple sclerosis.
- heparin, a medicine used to prevent blood clotting.
- medicines used to treat heart rhythm problems (e.g., verapamil, digitalis, procainamide, disopyramide, amiodarone, sotalol, and digoxin).
- medicines used to treat high blood pressure (e.g., diltiazem, ganglion blocking agents, dihydropyridine, nifedipine, reserpine, clonidine, and enalapril).
- medicines used to treat mental health problems (e.g., dexmedetomidine, phenothiazines, and amisulpride).
- morphine, a medicine used to relieve pain.
- neostigmine, a medicine used to reverse the effects of anesthetics.
- nitroglycerin, a medicine used to prevent chest pain caused by a heart condition known as coronary artery disease (CAD).
- non-steroidal anti-inflammatory agents (NSAIDS), medicines used to reduce pain and swelling (e.g., floctafenine).
- prostaglandin E1 (PGE1), a medicine used to manage erectile dysfunction. • tricyclic antidepressants, medicines used to treat depression.
Ask your healthcare professional if you are unsure. There may be more than one use for each medicine.
How to take SIBBORAN:
- SIBBORAN will be prepared and given to you by your healthcare professional in a hospital.
- You will receive SIBBORAN through your veins (i.e., “intravenously” or “IV”).
- During your treatment, your healthcare professional will closely monitor your health (e.g., your heart rate, heart rhythm, and blood pressure).
Usual dose:
Your healthcare professional will decide the right dose and frequency of SIBBORAN for you. This will depend on your medical condition, current health, and if you take other medicines. Your dose may change throughout your treatment depending on how you respond to SIBBORAN.
Overdose:
If you have the feeling that you have received too much SIBBORAN, tell your healthcare professional right away. Your doctor will take appropriate measures (your treatment may be stopped, and you may receive supportive therapy).
You may experience the following symptoms if you have been given too much of this medicine:
- severe drop in blood pressure (you may feel dizzy or light headed);
- very slow heart beat;
- reduced heart function;
- shock occurring due to decreased heart function;
- breathing difficulties;
- loss of consciousness ranging to coma;
- convulsions (e.g., cramps and seizures);
- nausea;
- vomiting;
- low blood sugar;
- high blood potassium level (hyperkalemia).
If you think you, or a person you are caring for, have taken too much SIBBORAN, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
What are possible side effects from using SIBBORAN?
These are not all the possible side effects you may have when taking SIBBORAN. If you experience any side effects not listed here, tell your healthcare professional.
Side effects of SIBBORAN include:
- cold sweat,
- hot flush.
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| COMMON | |||
| Bradycardia (abnormally slow heartbeat): dizziness, fainting, fatigue, light-headedness, confusion, or memory problems. | √ | ||
| Hyperbilirubinemia (high levels of bilirubin in the blood): jaundice (yellowing of the skin or whites of eyes), dark urine, loss of appetite, or fatigue. | √ | ||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, or fatigue (may occur when you go from lying or sitting to standing up). | √ | ||
| UNCOMMON | |||
| Breathing problems: coughing, chest tightness, wheezing, whistling sound when breathing, rapid breathing, confusion, tiredness, shortness of breath, or sweating. | √ | ||
| Cardiac arrest (heart suddenly stops beating): fatigue, loss of consciousness, dizziness, difficulty breathing, nausea, chest pain, or heart palpitations. | √ | ||
| Diabetes: excessive thirst, excessive urination, excessive eating, unexplained weight loss, poor wound healing, or infections. | √ | ||
| Erythema (a skin disorder): raised red or purple skin patches, possibly with blister or crust in the center, swollen lips, mild itching, or burning. | √ | ||
| Heart failure (heart does not pump blood as well as it should): shortness of breath, fatigue, weakness, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, or swelling in ankles, legs and feet. | √ | ||
| Heart rhythm or heartbeat problems: abnormally fast heartbeat, irregular heartbeat, abnormal heart rhythm, chest discomfort, heart palpitations, faintness, shortness of breath, weakness, or heartbeat pauses or stops. | √ | ||
| Hypertension (high blood pressure): shortness of breath, fatigue, dizziness, fainting, chest pain or pressure, swelling in your ankles and legs, bluish colour to your lips and skin, racing pulse, or heart palpitations. | √ | ||
| Hyponatremia (low sodium in the blood): lack of energy, confusion, muscular twitching, achy, stiff muscles, uncoordinated muscles, seizure, or coma. | √ | ||
| Hypoxia (low oxygen in the blood): confusion, restlessness, difficulty breathing, rapid heart rate, bluish skin, or headache. | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Ileus (temporary stoppage of the normal muscle contractions in the intestines): abdominal bloating, abdominal pain, constipation, loss of appetite, cramps, vomiting, nausea, or watery stool. | √ | ||
| Liver problems: yellowing of your skin and eyes, right upper stomach area pain or swelling, nausea, vomiting, unusual dark urine, or unusual tiredness. | √ | ||
| Mediastinitis (inflammation of the mediastinum which is the chest cavity): sudden and severe chest pain, shortness of breath, fever, or chills. | √ | ||
| Myocardial infarction (heart attack): shortness of breath, dizziness, fatigue, light-headedness, clammy skin, sweating, difficultly digesting, anxiety, feeling faint, irregular heartbeat, irregular pressure, pain between the shoulder blades, chest, jaw, left arm or upper abdomen. | √ | ||
| Pneumonia (infection in the lungs): cough which may produce phlegm, chest pain when you breath or cough, confusion, fatigue, fever, sweating, shaking chills, nausea, vomiting, diarrhea, or shortness of breath. | √ | ||
| Reduced blood supply to the brain: loss of movement in any part of the body, weakness, decreased sensation, numbness, tingling, trouble speaking clearly and swallowing, loss of memory, loss of coordination, vertigo, headache, dizziness, vomiting, fainting, loss of consciousness, difficulty urinating, or vision changes. | √ | ||
| Shock (heart is not able unable to pump enough blood to the organs of the body): fast breathing, fast heartbeat, loss of consciousness, sweating, pale skin, or cold hands or feet. | √ | ||
| Vocal cord paralysis (unable to control the muscles that control your voice): hoarseness, noisy breathing, shortness of breath, loss of vocal pitch, choking or coughing while swallowing food, drink or saliva, needing to take frequent breaths while speaking, inability to speak loudly, or frequent throat clearing. | √ | ||
| UNKNOWN FREQUENCY | |||
| Angina: (not enough oxygen to the heart muscle): chest pain, pressure in the chest, or discomfort in the shoulder, arm, back, throat, jaw, or teeth. | √ | ||
| Syncope (temporary loss of consciousness due to a sudden drop in blood pressure): feeling lightheaded, dizziness, drowsiness, groggy, fainting, headaches, changes in vision, or feeling unsteady or weak when standing. | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
|---|
Storage:
SIBBORAN will be stored by your healthcare professional at room temperature (15 oC to 25oC).
Keep out of reach and sight of children.
If you want more information about SIBBORAN:
- Talk to your healthcare professional.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s (AOP Orphan Pharmaceuticals GmbH) website (www.aop-health.com), or by calling Canadian distributor Innomar Strategies at 1 905-847-4310.