Patient Medication Information: uses, side effects, how to take - Sandoz Riociguat
What is Sandoz Riociguat used for?
Sandoz Riociguat is used to treat pulmonary hypertension (high blood pressure in the lungs) in adults with the following conditions:
- pulmonary arterial hypertension (PAH; WHO Group 1). It can be taken on its own or with other PAH medications as prescribed by your health care provider.
- chronic thromboembolic pulmonary hypertension (CTEPH; WHO Group 4) when CTEPH cannot be resolved with a surgery, or if CTEPH is persistent or reoccurring after surgery.
How does Sandoz Riociguat work?
Sandoz Riociguat belongs to a class of medicines called soluble guanylate cyclase (sGC) stimulators. It works by stimulating an enzyme (sGC) in the blood vessels in the lungs, causing the blood vessels to relax and widen. This helps to lower the blood pressure in the lungs and improve the symptoms of pulmonary hypertension.
What are the ingredients in Sandoz Riociguat?
Medicinal ingredient: Riociguat.
Non-medicinal ingredients: Crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The film coating is composed of hypromellose 3 mPas, hydroxypropyl cellulose, iron oxide yellow, iron oxide red, propylene glycol, titanium dioxide. Iron oxide yellow is present in the Sandoz Riociguat 1 mg, 1.5 mg, 2 mg and 2.5 mg strengths, and iron oxide red is present in Sandoz Riociguat 2 mg and 2.5 mg strengths.
Sandoz Riociguat comes in the following dosage forms:
Film-coated tablets: 0.5 mg (white to off white), 1 mg (pale yellow), 1.5 mg (cream yellow-orange), 2 mg (light brown), 2.5 mg (pale orange).
Do not use Sandoz Riociguat if:
- you are allergic to riociguat or any of the other ingredients in Sandoz Riociguat.
you are pregnant or planning to become pregnant.
- you are breast-feeding or planning to breast-feed.
you are taking any of the following medicines:
- sildenafil (e.g., VIAGRA or REVATIO), tadalafil (e.g., CIALIS or ADCIRCA), or vardenafil (e.g., LEVITRA and STAXYN) used to treat high blood pressure or erectile dysfunction.
- nitrates or nitric oxide donors (e.g., amyl nitrite) used to treat high blood pressure of coronary artery disease (CAD; a heart condition involving the heart arteries that do not supply enough blood, oxygen and nutrients to the heart).
- other sGC stimulators used to treat heart failure and PAH.
These are the common uses for each medicine. If you are unsure if you are taking these medicines, ask your healthcare professional.
- you have high blood pressure in your lungs associated with scarring of the lungs from an unknown cause (idiopathic interstitial pneumonias).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sandoz Riociguat. Talk about any health conditions or problems you may have, including if you:
are at a higher risk of bleeding. This can include if you:
- are receiving treatment or medicines used to prevent blood clots (anticoagulants).
- have a history of coughing up blood from the lungs (hemoptysis).
- have previously undergone a procedure called bronchial arterial embolization to stop coughing up blood from the lungs.
- are receiving or plan to receive dialysis treatment.
- have experienced a sudden drop in blood pressure when you stand from a sitting position or when you stand after lying down.
- have heart or circulation problems.
- have kidney problems.
- have liver problems.
- have low blood pressure.
- have low fluid levels in your body (hypovolemia).
- have lung or breathing problems.
- have problems affecting your autonomic nervous system (ANS), which controls the automatic functions of the body.
- have problems digesting certain sugars (e.g., lactose intolerance). Sandoz Riociguat contains lactose, a milk sugar.
- smoke cigarettes. You should not smoke during your treatment with Sandoz Riociguat. Tell your healthcare professional, if you plan to stop or start smoking cigarettes during treatment.
Other warnings you should know about:
Driving and using machines: Sandoz Riociguat can cause dizziness. Before you drive or do tasks that require special attention, wait until you know how you respond to Sandoz Riociguat.
Pregnancy: Do not take Sandoz Riociguat if you are pregnant. If there is a chance you could become pregnant, use reliable forms of birth control while you are taking Sandoz Riociguat. If you are unsure about your birth control options, talk to your healthcare professional. Tell your healthcare professional right away if you become pregnant while taking Sandoz Riociguat.
Testing and check-ups: Your healthcare professional will monitor your health throughout your treatment. They may do this by performing certain tests before and regularly during your treatment. This can include specific tests to monitor your blood pressure and risk of bleeding. If you notice any unexpected or excessive bleeding, tell your healthcare professional.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions Serious drug interactions with Sandoz Riociguat include:
Do not take Sandoz Riociguat if you are taking any of these medicines. Ask your healthcare professional if you are unsure. |
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The following may interact with Sandoz Riociguat:
- antacids, medicines used to treat indigestion, heart burn, and upset stomach (e.g., aluminum hydroxide and magnesium hydroxide). Antacids should be taken at least 1 hour after Sandoz Riociguat.
- antiepileptics, medicines used to control seizures or fits (e.g., phenytoin, carbamazepine, and phenobarbitone).
- antifungals, medicines used to treat fungal infections (e.g., ketoconazole, clotrimazole, miconazole, and itraconazole).
- carvedilol, a medicine used to treat heart failure and high blood pressure.
- cigarette smoking.
- cyclosporine, a medicine used to prevent rejection of transplanted organs.
- erlotinib (e.g., TARCEVA) or gefitinib (e.g., IRESSA), medicines used to treat cancer.
- granisetron, a medicine used to treat nausea and vomiting.
- medicines that can increase the pH of the upper gastrointestinal tract. Ask your healthcare professional if you are unsure.
- medicines used to treat human immunodeficiency virus (HIV) infection (e.g., abacavir, atazanavir, cobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabine, indinavir, lamivudine, rilpivirine, ritonavir, saquinavir, and tenofovir).
- niflumic acid, a medicine used to treat joints and muscular pain and inflammation.
- quinidine, a medicine used to treat irregular heart rhythm and malaria.
- St. John´s Wort, a herbal treatment for depression.
- tyrosine kinase inhibitors, medicines used to prevent the rejection of transplanted organs (e.g., imatinib, sorafenib and sunitinib).
These are the common uses for each medicine. If you are unsure if you are taking these medicines, ask your healthcare professional.
How to take Sandoz Riociguat:
- Always take this medicine exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
- Treatment should only be initiated and monitored by a healthcare professional experienced in the treatment of CTEPH or PAH.
Sandoz Riociguat can be taken with or without food.
Usual dose:
Your healthcare professional will determine the right dose for you. This may depend on your age, condition, health, and how you respond to Sandoz Riociguat.
The usual starting dose is 1 mg three times a day (approximately every 6 to 8 hours apart) for 2 weeks. Your healthcare professional may increase your dose every 2 weeks to a maximum of 2.5 mg three times a day (total of 7.5 mg a day).
Overdose:
| If you think you, or a person you are caring for, have taken too much Sandoz Riociguat, 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 a dose of Sandoz Riociguat, skip the missed dose and take the next dose as scheduled. Do not double the dose to make up for the missed dose.
If you miss or forget to take Sandoz Riociguat for 3 days or more, tell your healthcare professional. Your healthcare professional may need to adjust your dose.
What are possible side effects from using Sandoz Riociguat?
These are not all the possible side effects you may have when taking Sandoz Riociguat. If you experience any side effects not listed here, tell your healthcare professional.
Side effects of Sandoz Riociguat may include:
- abdominal pain or discomfort;
- abdominal swelling or bloating;
- constipation;
- diarrhea;
- dizziness;
- headache;
- indigestion
- nasal congestion;
- nausea;
- vomiting.
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 | ||
| VERY COMMON | |||
| Bleeding events: nose bleeds, bleeding from the lungs, or coughing up blood. | √ | ||
| 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). | √ | ||
| Peripheral edema (swelling of the arms, hands, legs, or feet). | √ | ||
| COMMON | |||
| Anemia (decreased number of red blood cells): fatigue, loss of energy, irregular heartbeats, pale complexion, shortness of breath, weakness. | √ | ||
| Dysphagia (difficulty swallowing): coughing or choking while eating or drinking, pain while swallowing, unable to swallow, drooling, hoarseness, regurgitating, heartburn, food or stomach acid backing up into the throat, or weight loss. | √ | ||
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 | ||
| Gastritis (inflammation of the lining of the stomach): nausea, vomiting, feeling full in the upper abdomen after eating, or pain or burning in the upper abdomen that may get worse or better with eating. | √ | ||
| Gastroenteritis (inflammation of the stomach and intestines): abdominal pain, diarrhea, nausea, or vomiting. | √ | ||
| Gastroesophageal reflux disease (GERD) (stomach acid repeatedly flows back into the throat): heartburn after eating and might get worse at night or while lying down, regurgitating food or sour liquid, upper abdominal pain, chest pain, difficulty swallowing, sensation of a lump in your throat, cough, or inflammation of the vocal cords. | √ | ||
| Palpitations: heart is skipping beats, beating too fast, pounding, or fluttering rapidly. | √ | ||
| Syncope (fainting): a temporary loss of consciousness due to a sudden drop in blood pressure. | √ | ||
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:
Store Sandoz Riociguat at room temperature between 15°C and 30°C. Do not use after the expiry date stated on the label.
Keep out of reach and sight of children.
If you want more information about Sandoz Riociguat:
- 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 www.sandoz.ca, or by calling 1-800-361-3062.