Patient Medication Information: uses, side effects, how to take - Apo-Rupatadine
What is APO-RUPATADINE used for?
APO-RUPATADINE Tablets are used in patients 12 years of age and older, to treat the symptoms of:
- Seasonal Allergic Rhinitis (hay fever)
- Perennial Allergic Rhinitis (year-round allergies)
- Chronic Spontaneous Urticaria (hives and itching).
How does APO-RUPATADINE work?
APO-RUPATADINE is an antihistamine. It blocks the action of histamine and platelet-activating factor (PAF). They are released by the immune system when your body is affected by things you are allergic to. By blocking the action of histamine and PAF, APO-RUPATADINE helps relieve your allergy symptoms.
What are the ingredients in APO-RUPATADINE Tablets?
Medicinal ingredients: Rupatadine fumarate
Non-medicinal ingredients: Ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch.
APO-RUPATADINE comes in the following dosage forms:
Tablets: 10 mg rupatadine (as rupatadine fumarate)
Do not use APO-RUPATADINE Tablets if:
- You are allergic to rupatadine or to any of the other ingredients.
- You have heart problems or a family history of heart problems.
- You take medications called CYP3A4 inhibitors or any other medication that may affect the heart rate, such as ketoconazole or erythromycin.
Your child is younger than 12 years of age.
- You have a rare hereditary disease that means you should not eat food containing lactose. The diseases include galactose intolerance, glucose-galactose malabsorption or Lapp lactase deficiency. APO-RUPATADINE tablets contain lactose.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-RUPATADINE. Talk about any health conditions or problems you may have, including if you:
- have liver disease.
- have kidney disease.
- have heart problems or a family history of heart problems.
- have low levels of potassium and/or you have a certain abnormal pattern to your heart beat which can occur in some forms of heart disease.
- take medications called CYP3A4 inhibitors or any other medication that may affect the heart rate, such as ketoconazole or erythromycin.
Other warnings you should know about:
Allergic Reactions
Some patients taking rupatadine have experienced:
- sudden and severe allergic reactions, including life-threatening reactions.
- swelling that affects the skin, often around the eyes and lips.
- hives and itching.
Effects on Muscle
Some patients taking rupatadine have experienced muscle weakness or pain.
Pregnancy and Breast-Feeding
It is not recommended to use APO-RUPATADINE tablets if you are pregnant or breastfeeding. You should only use the medication if you doctor has told you to.
Lactose Intolerance
APO-RUPATADINE tablets contain lactose (a sugar found in milk). If your doctor has said that you cannot have foods with lactose, contact your doctor before taking this medicine.
Elderly Patients
If you are elderly, your doctor may use caution in deciding whether to prescribe you APO-RUPATADINE Tablets.
Blood Tests
Your doctor may order blood tests for you while you are taking APO-RUPATADINE Tablets. Rarely, some patients taking rupatadine had:
- an increase in certain blood levels.
- abnormal liver function.
Driving and Using Machines
At the correct dose, APO-RUPATADINE is not likely to affect driving or use of machines. However, when you first start taking APO-RUPATADINE, see how the treatment affects either of you before driving or using machines.
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 APO-RUPATADINE:
- ketoconazole, itraconazole, voriconazole, posaconazole (used to treat fungal infections)
- erythromycin, azithromycin and clarithromycin (used to treat bacterial infections)
- ritonavir (used to treat HIV/AIDS)
- simvastatin, lovastatin (used to lower cholesterol)
- nefazodone (an anti-depressant)
- diltiazem (used to treat high blood pressure)
- anxiety or sleep medicines that depress the central nervous system
- grapefruit or grapefruit juice (this may increase the level of rupatadine in the body)
At the recommended dose (10 mg), APO-RUPATADINE does not increase the drowsiness produced by alcohol.
How to take APO-RUPATADINE:
Always take APO-RUPATADINE exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Usual dose of APO-RUPATADINE Tablets:
Adults and adolescents (over 12 years of age):
One APO-RUPATADINE Tablet, 10 mg, once daily, with or without food. Swallow tablet whole with a glass of water.
Overdose:
| If you think you, or a person you are caring for, have taken too much APO-RUPATADINE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If you miss taking a dose of APO-RUPATADINE tablets, take it as soon as possible, unless it is almost time for the next dose. Do not take two APO-RUPATADINE doses at the same time to make up for a missed dose.
What are possible side effects from using APO-RUPATADINE Tablets?
These are not all the possible side effects you may feel when taking APO-RUPATADINE
Tablets. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- sleepiness
- headache
- dizziness
- dry mouth
- sensation of weakness
- fatigue
- nausea
- pain in the upper or lower abdomen (belly)
- abnormal blood test results (increase in enzyme called creatine phosphokinase)
- symptoms of the common cold and/or flu
- red eyes
- vomiting and diarrhea
- mucus in the back of the nose, throat or sinuses
- throat pain, tonsil pain, pain when swallowing
- cough
- pain during menstruation
- muscle pain and/or muscle weakness
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 | ||
RARE Heart Problems: heart racing or slowing, cold sweats, feeling faint, feeling your heart beat, light headed, nausea, shortness of breath | √ | ||
Allergic reaction: symptoms include swelling in the eyes, lips, mouth, tongue, face and throat, itching, rash, hives | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
Keep APO-RUPATADINE Tablets as follows:
Blister: Store at room temperature, 15°C to 30°C. Keep blister in carton to protect from light and moisture.
Bottle: Store at room temperature, 15°C to 30°C. Protect from light and moisture.
Keep out of reach and sight of children.
Do not use APO-RUPATADINE tablets after the expiry date which is stated on the carton and blister.
Do not dispose of medicine like APO-RUPATADINE via wastewater or household waste. Take it to a pharmacy. This will help to protect the environment.
If you want more information about APO-RUPATADINE:
- 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 website (http://www.apotex.ca/products), or by calling 1-800-667-4708.