Riociguat - Oral

Riociguat is used to treat chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs caused by the blood clots that block the blood vessels) and pulmonary arterial hypertension (high blood pressure in the blood vessels leading to the lungs).

Take Riociguat exactly as directed by your doctor or according to the instructions on the label. Do not take more or less than instructed by your doctor.

You may take this medicine with or without food. Try to take it at the same time each day.

Swallow the tablet whole with a glass of water. If you have difficulty swallowing the tablet, you may crush the tablet and mix it with water or soft foods (e.g. applesauce). Stir and drink the mixture immediately.

The dose of this medicine will be decided by your doctor. Your doctor will advise you on the treatment timeframe depending on the severity of your condition and your response to the medication.

Riociguat must be taken regularly for it to be effective. Continue taking this medicine even when you feel better. Do not stop taking it unless instructed by the doctor.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and return to your normal dosing schedule.

If you missed your doses for 3 or more days, inform your doctor immediately. Your doctor may require you to restart the treatment.

DO NOT double a dose under any circumstances.

If you often forget to take your medicine, let your doctor and pharmacist know.

Alert your doctor if you have the following conditions:

• pulmonary hypertension associated with idiopathic interstitial pneumonias (high pressure in the lungs related to scarring of lung tissue from an unknown cause)
• severe liver disease

as Riociguat may not be suitable for you.

Do not take this medicine if you are pregnant. If you become pregnant while on Riociguat therapy, alert your doctor immediately. This medicine may cause harm to your unborn child.

It is important that you do not get pregnant while taking this medicine. You must use proven birth control methods during Riociguat therapy and 1 month after stopping the treatment.

Do not breastfeed while you are being treated with this medicine.

Do not take Riociguat with medicines used to treat impotence, medicines for chest pain, certain blood-thinning medicine, asthma medicine, and medicine for heart failure (weakness and inability of the heart to pump blood). Please see the section "Can I take this with other medicines?" below for more information.

Inform your doctor if you have the following conditions:

• pulmonary veno-occlusive disease (blockage of blood vessels that carry blood from the lungs to the heart)
• recent serious bleeding particularly from the lungs or have undergone certain treatment to stop coughing up blood
• low volume of circulating fluids in the body
• low blood pressure
• heart problems
• kidney disease
• moderate liver disease

Be sure to check with your doctor or pharmacist before giving Riociguat to the elderly. Elderly people may be more sensitive to the side effects.

Let your doctor know if you start to smoke or stop smoking during your treatment with this medicine. Smoking may decrease the effectiveness of Riociguat, your doctor may need to adjust your dose if needed.

Why is it important to keep my appointments with the doctor?

Keep your appointments with your doctor. Your doctor needs to monitor your condition and check your response to the medication regularly.

• Pregnancy tests must be done before treatment initiation, during therapy, and after treatment discontinuation to know if this medicine is suited for you to take.
• Your blood pressure may fall to unsafe levels without you noticing it. Monitor your blood pressure regularly during treatment.
• Regular monitoring for signs and symptoms of low blood pressure and bleeding may also be needed.

Riociguat may cause dizziness. If affected, do not drive or take part in any activity in which you need to be alert.

Other side effects include any of the following: headache, nausea, vomiting, diarrhoea, stomach pain, constipation, indigestion, heartburn (burning pain in your chest caused by food or acid from your stomach that backs up into your mouth), fast and irregular heartbeat, and swelling of the ankles, feet or hands.

Some side effects may need immediate medical help. Alert your doctor quickly if you experience any of the following:

• coughing up blood, vomiting blood or ground coffee-like material
• fainting or passing out, lightheadedness, confusion, blurred vision, weakness

Inform your doctor if any of these side effects do not go away or are severe, or if you experience other side effects.

Do not take Riociguat with the following medicines:

• medicines used to treat impotence e.g. sildenafil, vardenafil
• medicines for chest pain e.g. glyceryl trinitrate, amyl nitrite
• dipyridamole (blood-thinning medicine)
• theophylline (asthma medicine)
• vericiguat (medicine for heart failure)

Inform your doctor and pharmacist if you are taking any of these medicines:

• other blood-thinning medicines
• medicines to treat fungal infection e.g. ketoconazole, itraconazole
• medicines for HIV infection e.g. ritonavir
• medicines for epilepsy (fits or seizures) e.g. carbamazepine, phenobarbital, phenytoin
• ciclosporin (medicine used in organ transplants or certain immune disorders)
• erlotinib (medicine for cancer)
• St. John's wort (herbal medicine)

This list does not include all medicines that may interact with Riociguat.

This medicine should not be taken with antacids (medicines that neutralise stomach acids) as they could reduce the effectiveness of Riociguat. If you must take antacids, take them at least 1 hour after you have taken Riociguat.

Always notify your doctor and pharmacist if you are taking any other medicines, including herbal tonics such as traditional Chinese medicines, supplements, and medicines that you buy without a prescription.

Avoid alcohol.

Store in a cool, dry place away from the reach of children.

Medicines must not be used past the expiry date.