Introduction About RIOTEPH 0.5MG TABLET

RIOTEPH 0.5MG TABLET contains Riociguat which belongs to a group of medicines called Guanylate cyclase stimulators. It is used in the management of chronic thromboembolic pulmonary hypertension (CTEPH) and some type of pulmonary arterial hypertension (PAH) such as idiopathic PAH (the cause of PAH is unknown), heritable PAH and PAH caused by connective tissue disease.

CTEPH is a condition in which the blood vessels of lungs are blocked or narrowed because of formation of blood clots. PAH is a condition in which the walls of the blood vessels of the lungs are thickened which causes narrowing of blood vessels. The heart of these patients works more and harder and this is the reason why patients with pulmonary hypertension experience dizziness, tiredness and shortness of breath.

Your doctor might advise you to stop smoking as smoking can decrease the effectiveness of RIOTEPH 0.5MG TABLET. Also inform your doctor if you are lactose intolerant before you start taking RIOTEPH 0.5MG TABLET. Regular monitoring of blood pressure by your doctor once the management for PAH has been started with RIOTEPH 0.5MG TABLET is mandatory.

RIOTEPH 0.5MG TABLET is not recommended for use in patients with severe kidney or liver disease. RIOTEPH 0.5MG TABLET should be used with caution in patients with moderate kidney disease or heart diseases. Avoid taking RIOTEPH 0.5MG TABLET on empty stomach as it may cause lowering of blood pressure.

RIOTEPH 0.5MG TABLET is not recommended for use in pregnant and breastfeeding women as it is not safe for the baby. RIOTEPH 0.5MG TABLET is not recommended for use in children and adolescents under 18 years of age. It should be used with caution among elderly patients.

The most common side effects of RIOTEPH 0.5MG TABLET are headache, dizziness and swelling of limbs. Contact your doctor if the symptoms do not improve or worsen.

Uses Of RIOTEPH 0.5MG TABLET

Manage:

• Chronic thromboembolic pulmonary hypertension (CTEPH)
• Some types of pulmonary arterial hypertension (PAH) (idiopathic, heritable and PAH caused by connective tissue disease)

How RIOTEPH 0.5MG TABLET Works

RIOTEPH 0.5MG TABLET works by widening the arteries that connect heart to lungs (pulmonary arteries) which makes blood pumping easier for the heart. By widening the narrowed arteries, RIOTEPH 0.5MG TABLET helps improving your ability to carry out physical activity.

How to use RIOTEPH 0.5MG TABLET

Take RIOTEPH 0.5MG TABLET as advised by your physician. Swallow with a glass of water and do not crush or chew it. But if you have difficulty in swallowing, your doctor will ask you to crush your medicine, just before it’s time for your dose and mix it with water or soft food such as apple sauce.

Your doctor will decide the correct dose and duration of management for you depending upon your age, body weight and disease condition. Do not stop taking RIOTEPH 0.5MG TABLET unless your doctor advises you to stop.

Side Effects Of RIOTEPH 0.5MG TABLET

How To Manage Side Effects

Vomiting:

Take RIOTEPH 0.5MG TABLET with or just after meals. Stick to simple meals. Avoid eating oil rich or spicy foods. If symptom persists, contact your doctor.

Dizziness:

If your feel dizzy, lie down, close your eyes and relax. Once you start feeling better, get up slowly and not with a jerk. Sit like that for 5-10 minutes and then you can continue working. If symptom persists, contact your doctor.

Headache:

Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the head if required. Do not consume too much of alcohol. If symptom persists, contact your doctor.

Constipation:

Eat plenty of fiber rich foods such as fresh fruits, vegetables and cereals and drink plenty of water. Exercise more regularly. If symptom persists, contact your doctor.

Diarrhoea:

Drink lots of fluids, such as water or fruit juice to keep yourself hydrated. Do not consume any medicine on your own without consulting your doctor. If symptom persists, contact your doctor.

Stomach pain:

Try to rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. If symptom persists, contact your doctor.

Warning & Precautions

Pregnancy

RIOTEPH 0.5MG TABLET is not recommended for use in pregnant women. But if you are taking RIOTEPH 0.5MG TABLET, it is advised to use reliable forms of contraception and get pregnancy tests done every month. Consult your doctor before taking it.

Breastfeeding

RIOTEPH 0.5MG TABLET is not recommended for use in breastfeeding women as it might harm the baby. Consult your doctor before taking it.

Driving and Using Machines

Do not drive or operate any machines if you feel dizzy after taking RIOTEPH 0.5MG TABLET.

Kidney

RIOTEPH 0.5MG TABLET is not recommended for use in patients in whom kidneys are not working properly (creatinine clearence < 30mL/min) or patients on dialysis. Consult your doctor before taking it.

Liver

RIOTEPH 0.5MG TABLET is not recommended for use in patients with severe liver disease (Ex. severe hepatic impairment, Child Pugh C). RIOTEPH 0.5MG TABLET should be taken with caution if you have moderate liver problems (Ex. hepatic impairment, Child Pugh B). Consult your doctor before taking it.

Allergy

Do not take RIOTEPH 0.5MG TABLET if you are allergic to Riociguat or any of the other ingredients of this medicine.

Lungs

RIOTEPH 0.5MG TABLET is not recommended for use in patients with idiopathic pulmonary pneumonia (increased blood pressure in pulmonary circulation which leads to scar tissue formation in lungs with unknown cause).

RIOTEPH 0.5MG TABLET should be used with caution in patients who had a recent and serious experience of bleeding from the lung. Consult your doctor before taking it.

Heart Disease

RIOTEPH 0.5MG TABLET should be used with caution in patients with heart diseases. Consult your doctor before taking it.

Interactions

A. Drug-Drug interactions:

Before taking RIOTEPH 0.5MG TABLET, inform your doctor if you are taking any of the following medicines:

• medicines used to manage heartburn or stomach disease (Ex. Magnesium hydroxide, calcium carbonate, sodium bicarbonate)
• granisetron (used in management for nausea or vomiting)
• erlotinib, gefitinib (used in management of cancer)
• niflumic acid (used in management of joint and muscular pain)
• ciclosporin (used in managing rejection of transplanted organs)
• St. John’s Wort (used in management of depression)
• medicines used in management of epilepsy (Ex. phenytoin, carbamazepine, phenobarbitone)
• medicines used in management of fungal infections (Ex. ketoconazole, posaconazole, itraconazole)
• sildenafil or tadalafil (used to manage erectile dysfunction and high blood pressure in the areteries of lungs)
• abacavir, atazanavir, cobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabine, rilpivirine or ritonavir (used to manage HIV infection)
• medicines used for high blood pressure or heart disease or reliving chest pains (Ex. nitroglycerin, isosorbide dinitrite)
• anticoagulants (used as blood-thinners) Ex. Warfarin

Overdosage:

If you or anyone else accidentally take more of RIOTEPH 0.5MG TABLET, consult your doctor immediately or visit the nearby hospital as it may cause sudden drop of blood pressure which can make you feel dizzy.

Synopsis

More Information

• Keep RIOTEPH 0.5MG TABLET out of reach of children
• Store RIOTEPH 0.5MG TABLET at room temperature

FAQs About RIOTEPH 0.5MG TABLET

Will smoking cause any decrease in the beneficial effects of RIOTEPH 0.5MG TABLET?

Yes, smoking can cause decrease in effectiveness of RIOTEPH 0.5MG TABLET as it affects the level of riociguat in your blood. That is the reason why you are advised to not smoke while getting management with RIOTEPH 0.5MG TABLET.

Can patients with lactose intolerance take RIOTEPH 0.5MG TABLET?

Lactose intolerance is inability to digest, partially or totally, which may cause bloating, abdominal pain and diarrhoea after consumption of milk and other dairy products and is because of enzyme deficiency. And therefore, pateints with lactose intolerance cannot take RIOTEPH 0.5MG TABLET. Consult your doctor for advice.

What happens if you forget to take RIOTEPH 0.5MG TABLET?

If you miss a dose of RIOTEPH 0.5MG TABLET, take another as soon as you remember, unless it is almost time for your next dose. Do not take RIOTEPH 0.5MG TABLET two times to make up for the missed dose.

What will happen if I stop taking RIOTEPH 0.5MG TABLET without asking my doctor?

You cannot stop RIOTEPH 0.5MG TABLET without consulting your doctor as this medicine manages further progression of disease and stopping RIOTEPH 0.5MG TABLET can sometimes make the condition worse. If you have stopped your medicine and it’s been more than 3 days, inform your doctor at once.

Can RIOTEPH 0.5MG TABLET be taken simultaneously with sildenafil, if not, then how it needs to be taken ?

No, you cannot take RIOTEPH 0.5MG TABLET simultaneously with sildenafil. If you want to take then you need to follow a protocol for the same. If you are stopping RIOTEPH 0.5MG TABLET and going to start sildenafil, wait for 24 hours after your last dose of RIOTEPH 0.5MG TABLET and then take sildenafil. If you are stopping sildenafil, you need to take RIOTEPH 0.5MG TABLET after 24 hours and not before that.

What can be done for easy swallowing of RIOTEPH 0.5MG TABLET?

If you are facing difficulty in swallowing RIOTEPH 0.5MG TABLET, you can crush the tablet and mix with water or soft food such as apple sauce and swallow the medicine. This needs to be done just before you are planning to take RIOTEPH 0.5MG TABLET and not before.

Why regular monitoring of blood pressure essential while taking RIOTEPH 0.5MG TABLET?

Regular monitoring of blood pressure is important for initial few months when the management for PAH starts with RIOTEPH 0.5MG TABLET. Blood pressure monitoring is helpful for the doctor in altering the corect dosage for you.

References

1. Brunton L.L., Hilal-Dandan R, Knollmann B.C. Immunosuppressnts and Toleroens. Goodman & Gilman's: The Pharmacological Basis of Therapeutics. Thirteenth Edition. 2017. Page - 577.

2. Khaybullina D, Patel A, Zerilli T. Riociguat (adempas): a novel agent for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. NIH National Library of Medicine, National center for biotechnology information. Pubmed Central. November 2014. [Accessed on 26th May 2022]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4218670/

3. Ghofrani HA, D'Armini AM, Grimminger F, et al. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. November 2014. [Accessed on 26th May 2022]. https://pubmed.ncbi.nlm.nih.gov/23883377/

4. Bayer AG HealthCare Pharmaceuticals Inc. Electronic Medicines Compendium (EMC). [Revised in April 2022] [Accessed on 26th May 2022]. https://www.medicines.org.uk/emc/files/pil.7926.pdf

Useful Diagnostic Tests

• Pulmonary function test
• Electrocardiogram
• Chest X-ray