Vonozan® is contraindicated in:
• Patients with hypersensitivity to Vonoprazan or to any excipient of the product.
• Patients receiving atazanavir sulphate, nelfinavir or rilpivirine hydrochloride.

The plasma concentration of vonoprazan may increase when administered with
CYP3A4 inhibitors e.g., clarithromycin ...etc.
The effect of digoxin and methyldigoxin may be enhanced.
The effect of itraconazole and tyrosine kinase inhibitors (e.g., gefitinib, nilotinib,
erlotinib) may be diminished when co-administered with vonoprazan.

- No information available in pregnant women. Vonozan® should be used during
pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Vonozan® should not be used during lactation, no information available.

Vonoprazan may cause some side effects, including:
• A type of kidney problem (acute tubulointerstitial nephritis).

• Diarrhea caused by an infection (Clostridioides difficile) in your intestines.
• Bone fractures (hip, wrist, or spine).
• Severe skin reactions. Vonozan® can cause rare but severe skin reactions that
may affect any part of your body.
• Low Vitamin B-12 levels. Vonozan® lowers the amount of acid in your
stomach. Stomach acid is needed to absorb Vitamin B12 properly.
• Low magnesium levels in the body can happen in people who take Vonozan® .
• Stomach growths (fundic gland polyps). A certain type of stomach growth
called fundic gland polyps may happen in people who take Vonozan® for a long
time (more than a year).
-The mo stcommon side effects of Vonozan® for treatment of erosive
esophagitis and/or relief of heartburn related to gastroesophageal reflux
disease include:
• stomach inflammation, indigestion, diarrhea, constipation,stomach
bloating,high blood pressure, stomach pain, urinary tract infection, nausea
The mo stcommon side effect of Vonozan® when used with antibiotics for
treatment of H. pylori infection include:
• diarrhea, headache, temporary changes in sense of taste, high blood
pressure,vaginal yea stinfection, cold-like symptoms, stomach pain.

At the treatment, the course of the disease should closely be observed and the
minimum therapeutic necessity should be used according to the disease condition.
In the long-term, treatment with Vonoprazan, close observation by such means as
endoscopy should be made.
In the maintenance of healing of reflux esophagitis, Vonoprazan should be
administered only to the patients who repeat recurrence and recrudescence of the
condition.
Administration to the patients who do not necessitate maintenance of healing
should be avoided.
When the healing is maintained over a long period and when there is no risk of
recurrence, the dose reduction to a dose of 10mg from a dose 20mg, or suspension
of administration should be considered.
Impaired Renal Function
Vonoprazan should be administered with care in patients with renal disorders as a
delay in the excretion of Vonoprazan may occur, which may result in an increase
in the concentration of Vonoprazan in the blood.
Impaired Hepatic Function
Vonoprazan should be administered with care in patients with hepatic disorders as
a delay in the metabolism and excretion of Vonoprazan may occur, which may
result in an increase in the concentration of Vonoprazan in the blood. Hepatic
function abnormalities including liver injury have been reported. Discontinuation
of Vonoprazan is recommended in patients who have evidence of liver function
abnormalities or if they develop signs or symptoms suggestive of liver
dysfunction.
Elevation of intragastric pH
Administration of Vonoprazan results in elevation of intragastric pH and is
therefore not recommended to be taken with drugs for which absorption is
dependent on acidic intragastric pH. Symptomatic response to Vonoprazan does
not preclude the presence of gastric malignancy. It is therefore, necessary to
ascertain the ulcer is not of a malignant nature before initiating the administration
of this drug.
Clostridium difficile, serious colitis, including pseudomembranous colitis

There is an increased risk of gastrointestinal infection caused by Clostridium
difficile.

Serious colitis accompanied with bloody stools, such as pseudomembranous
colitis, may occur due to amoxicillin hydrate or clarithromycin being used for
Helicobacter pylori
eradication, in combination with Vonoprazan. If abdominal pain and frequent
diarrhea occur, appropriate measures, such as immediate discontinuation of the
treatment, should be taken.
Benign gastric polyps
Benign gastric polyp has been observed in patient on long-term administration of
PPIs.
Fractures
An increased risk for osteoporosis-related fractures of the hip, wri stor spine have
been reported in patients under treatment with proton pump inhibitors. The risk of
fracture was especially increased in the patients receiving high dose or long term
(a year or longer) treatment.
Hypomagnesemia
Severe hypomagnesemia has been reported in patients on prolonged treatment
with PPIs for at lea stthree months and in mo stcases for a year.
Use in elderly
Since the physiological functions such as hepatic or renal function are decreased
in elderly patients in general, Vonoprazan should be carefully administered.
Use in children less than 18 years of age
Vonoprazan has not been studied in patients under 18 years of age.

- Vonozan® 10 tablets :Blister of 10 tablets, pack of three blisters.
- Vonozan® 20 tablets :Blister of 10 tablets, pack of three blisters.

- Store in a dry place at a temperature below 25ºC.