Rioci 2mg Tablet 10'S

Introduction About RIOCI 2MG TABLET

RIOCI 2MG 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 RIOCI 2MG TABLET. Also inform your doctor if you are lactose
intolerant before you start taking RIOCI 2MG TABLET. Regular monitoring of blood
pressure by your doctor once the management for PAH has been started with RIOCI
2MG TABLET is mandatory.

RIOCI 2MG TABLET is not recommended for use in patients with severe kidney or
liver disease. RIOCI 2MG TABLET should be used with caution in patients with
moderate kidney disease or heart diseases. Avoid taking RIOCI 2MG TABLET on
empty stomach as it may cause lowering of blood pressure.

RIOCI 2MG TABLET is not recommended for use in pregnant and breastfeeding women
as it is not safe for the baby. RIOCI 2MG 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 RIOCI 2MG TABLET are headache, dizziness and
swelling of limbs. Contact your doctor if the symptoms do not improve or worsen.

Uses Of RIOCI 2MG TABLET

Manage:

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

How RIOCI 2MG TABLET Works

RIOCI 2MG 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, RIOCI 2MG TABLET helps improving your ability to carry
out physical activity.

How to use RIOCI 2MG TABLET

Take RIOCI 2MG 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
RIOCI 2MG TABLET unless your doctor advises you to stop.

Side Effects Of RIOCI 2MG TABLET

Common

• gastric problems (indigestion, diarrhoea, nausea, vomiting, swollen stomach and other parts of digestive system, pain in abdomen, stomach or intestine, heartburn, constipation, difficulty in swallowing, bloating)
• dizziness, headache
• swelling of limbs
• nose bleeding
• low blood pressure
• difficulty in breathing through nose (nasal congestion)
• being aware of rapid, irregular or throbbing heartbeat
• anaemia (reduced red blood cell count) – seen as weakness, pale skin or breathlessness

Rare

Stop taking RIOCI 2MG TABLET and contact your doctor immediately if you
experience any of the following side effects:

• presence of blood in cough (haemoptysis)
• acute bleeding from lungs (pulmonary haemorrhage)

How To Manage Side Effects

Vomiting:

Take RIOCI 2MG 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

RIOCI 2MG TABLET is not recommended for use in pregnant women. But if you are
taking RIOCI 2MG TABLET, it is advised to use reliable forms of contrace
and get pregnancy tests done every month. Consult your doctor before taking it.

!### Breastfeeding

RIOCI 2MG 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 RIOCI 2MG
TABLET.

!### Kidney

RIOCI 2MG 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

RIOCI 2MG TABLET is not recommended for use in patients with severe liver
disease (Ex. severe hepatic impairment, Child Pugh C). RIOCI 2MG 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 RIOCI 2MG TABLET if you are allergic to Riociguat or any of the
other ingredients of this medicine.

!### Lungs

RIOCI 2MG 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).

RIOCI 2MG 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

RIOCI 2MG TABLET should be used with caution in patients with heart diseases.
Consult your doctor before taking it.

Others

RIOCI 2MG TABLET is not recommended for use if you:

• have low blood pressure (systolic pressure <95mm Hg)

Before taking RIOCI 2MG TABLET inform your doctor if you:

• have undergone management to put a stop to coughing blood (bronchial artery embolisation)

Use in Pediatrics:

RIOCI 2MG TABLET is not recommended for children and adolescents (under the age
of 18 years) because of safety and efficacy issues. Consult your child’s doctor
for advice.

Use in Geriatrics:

RIOCI 2MG TABLET should be taken with caution in elderly patients (aged >65
years) as this age group have greater risk of getting low blood pressure.
Consult your doctor before taking it.

Interactions

A. Drug-Drug interactions:

Before taking RIOCI 2MG 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)
• gr
• 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 RIOCI 2MG 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

Drug	:	Riociguat
Pharmacological Category	:	Guanylate Cyclase (sGC)-Stimulator
Therapeutic Indication	:	Certain types of pulmonary hypertension
Dosage Forms	:	Tablet

More Information

• Keep RIOCI 2MG TABLET out of reach of children
• Store RIOCI 2MG TABLET at room temperature

FAQs About RIOCI 2MG TABLET

Will smoking cause any decrease in the beneficial effects of RIOCI 2MG
TABLET?

Yes, smoking can cause decrease in effectiveness of RIOCI 2MG 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 RIOCI 2MG TABLET.

Can patients with lactose intolerance take RIOCI 2MG TABLET?

Lactose intolerance is inability to digest, partially or totally, which may
cause bloating, abdominal pain and diarrhoea after consum
dairy products and is because of enzyme deficiency. And therefore, pateints with
lactose intolerance cannot take RIOCI 2MG TABLET. Consult your doctor for
advice.

What happens if you forget to take RIOCI 2MG TABLET?

If you miss a dose of RIOCI 2MG TABLET, take another as soon as you remember,
unless it is almost time for your next dose. Do not take RIOCI 2MG TABLET two
times to make up for the missed dose.

What will happen if I stop taking RIOCI 2MG TABLET without asking my doctor?

You cannot stop RIOCI 2MG TABLET without consulting your doctor as this medicine
manages further progression of disease and stopping RIOCI 2MG 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 RIOCI 2MG TABLET be taken simultaneously with sildenafil, if not, then how
it needs to be taken ?

No, you cannot take RIOCI 2MG TABLET simultaneously with sildenafil. If you want
to take then you need to follow a protocol for the same. If you are stopping
RIOCI 2MG TABLET and going to start sildenafil, wait for 24 hours after your
last dose of RIOCI 2MG TABLET and then take sildenafil. If you are stopping
sildenafil, you need to take RIOCI 2MG TABLET after 24 hours and not before
that.

What can be done for easy swallowing of RIOCI 2MG TABLET?

If you are facing difficulty in swallowing RIOCI 2MG 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 RIOCI 2MG
TABLET and not before.

Why regular monitoring of blood pressure essential while taking RIOCI 2MG
TABLET?

Regular monitoring of blood pressure is important for initial few months when
the management for PAH starts with RIOCI 2MG TABLET. Blood pressure monitoring
is helpful for the doctor in altering the corect dosage for you.

Useful Diagnostic Tests

• Pulmonary function test
• Electrocardiogram
• Chest X-ray