15 mg, 30 mg, 45 mg, 60 mg, 90 mg tablets
tolvaptan
What Jinarc is and what it is used for
Jinarc contains the active substance tolvaptan which blocks the effect of vasopressin, a hormone involved in the formation of cysts in the kidneys of patients with ADPKD. By blocking the effect of vasopressin, Jinarc slows the development of kidney cysts in patients with ADPKD, reduces the symptoms of the disease, and causes more urine to form.
Jinarc is a drug used to treat a disease called “autosomal dominant polycystic kidney disease” (ADPKD). This disease causes fluid-filled cysts to form in the kidneys, which press against the surrounding tissue and impair kidney function, which can lead to kidney failure. Jinarc is used to treat ADPKD in adults with chronic kidney disease (CKD) in stages 1 to 4 with signs of rapidly progressing disease.
What you need to know before taking Jinarc
Do not take Jinarc
- if you are allergic to tolvaptan or any of the other ingredients of this medicine (listed in section 6) or if you are allergic to benzazepine or benzazepine derivatives (eg benazepril, conivaptan, phenoldopammesylate or mirtazapine).
- if you have been told that you have elevated levels of liver enzymes in your blood which means that you cannot be treated with tolvaptan.
- if your kidneys are not working (no urine production).
- if you have a condition associated with a very low blood volume (eg severe dehydration or bleeding).
- if you have a condition that causes the amount of sodium in your blood to increase.
- if you do not feel when you are thirsty.
- if you are pregnant.
- if you are breast-feeding.
Warnings and cautions
Talk to your doctor before taking Jinarc:
- if you suffer from a liver disease.
- if you can not drink enough water (see “Drink enough water” below) or if you need to limit your fluid intake.
- if you have difficulty urinating (eg have an enlarged prostate ).
- if you suffer from too high or too low blood sodium.
- if you have previously had an allergic reaction to benzazepine, tolvaptan or other benzazepine derivatives (eg benazepril, conivaptan, phenoldopammesylate or mirtazapine), or to any of the other ingredients of this medicine (listed in section 6).
- if you have diabetes .
- if you have been told that you have too high levels of a substance called uric acid in your blood (which may have caused gout attacks ).
- if you have advanced kidney disease.
This medicine may cause the liver to not function normally. Therefore, you must immediately inform your doctor if you have signs that could indicate liver damage such as:
- nausea
- vomiting
- fever
- fatigue
- lost appetite
- abdominal pain
- dark urine
- jaundice (yellowing of the skin or whites of the eyes)
- itching of the skin
- flu-like syndrome (joint and muscle pain with fever)
During treatment with this medicine, your doctor will check your blood every month to see if your liver function has changed.
Drink enough water
This drug causes water loss because it increases urine production. This water loss can lead to side effects such as dry mouth and thirst or even more serious side effects like kidney problems (see section 4). Therefore, it is important that you have access to water and that you can drink sufficient amounts when you are thirsty. Before going to bed, you must drink 1 or 2 glasses of water even if you are not thirsty, and you must also drink water if you urinate at night. You must take special care if you have a disease that prevents you from getting enough fluids or if you have an increased risk of fluid loss, e.g. if you vomit or have diarrhea. Due to the increased urine production, it is also important that you always have access to a toilet.
Children and young people
Do not give this medicine to children and adolescents (under 18 years of age) as it has not been studied for these age groups.
Other medicines and Jinarc
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
The following medicines may increase the effect of Jinarc:
- amprenavir, atazanavir, darunavir / ritonavir and fosamprenavir (used to treat HIV / AIDS)
- aprepitant (used to prevent nausea and vomiting during chemotherapy)
- krizotinib and imatinib (used to treat cancer)
- ketoconazole , fluconazole or itraconazole (used to treat fungal infections)
- macrolide antibiotics such as erythromycin or clarithromycin
- verapamil (used to treat heart disease and high blood pressure )
- diltiazem (used to treat high blood pressure and chest pain).
The following medicines may reduce the effect of Jinarc:
- phenytoin or carbamazepine (used to treat epilepsy )
- rifampicin, rifabutin or rifapentin (used to treat tuberculosis )
- St. John’s wort (a traditional herbal remedy to relieve depression and alleviate anxiety).
Jinarc may increase the effect of the following medicines:
- digoxin (used to treat irregular heartbeat and heart failure )
- dabigatran (used as a blood thinner)
- methotrexate (used to treat cancer or joint inflammation)
- ciprofloxacin (an antibiotic )
- sulfasalazine (used to treat inflammatory bowel disease or rheumatoid arthritis )
- metformin (used to treat diabetes ).
Jinarc may reduce the effect of the following medicines:
- vasopressin analogues such as desmopressin (used to increase coagulation factors or to control urine production or bedwetting).
These medicines can affect or be affected by Jinarc:
- diuretics (used to influence urine production). Taken together with Jinarc, they may increase the risk of side effects due to fluid loss or lead to kidney problems.
- diuretics or other medicines to treat high blood pressure . When taken with Jinarc, they may increase the risk of low blood pressure when you get up from sitting or lying down.
- medicines that increase the sodium content of the blood or contain large amounts of salt (eg water-soluble tablets or medicines for indigestion). These may enhance the effect of Jinarc. There is a risk that this can lead to you getting too much sodium in your blood.
You may still be able to take these medicines with Jinarc. Your doctor can decide what is best for you.
Jinarc with food and drink
Do not drink grapefruit juice while taking this medicine.
Pregnancy and breastfeeding
Do not take this medicine if you are pregnant or breastfeeding.
Women of childbearing potential must use reliable contraception while taking this medicine.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Some people may feel dizzy, weak, or tired after taking Jinarc. If this happens to you, do not drive or use any tools or machines.
Jinarc contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Jinarc
Jinarc can only be prescribed by doctors with specialist knowledge of the treatment of ADPKD. Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dose
The daily amount of Jinarc is divided into two doses. One dose is higher than the other. The higher dose should be taken in the morning when you wake up, at least 30 minutes before breakfast. The lower dose should be taken 8 hours later.
The dose combinations are:
45 mg + 15 mg
60 mg + 30 mg
90 mg + 30 mg
Your treatment usually starts with a dose of 45 mg in the morning and 15 mg eight hours later. Your doctor may then gradually increase your dose up to the maximum dose combination of 90 mg when you wake up and 30 mg eight hours later. To find out which dose is best for you, your doctor will regularly check how well you tolerate a prescribed dose. You should always take the highest dose combination you can tolerate as prescribed by your doctor.
If you are taking other medicines that may increase the effects of Jinarc, you may be given a lower dose. In that case, your doctor may prescribe Jinarc tablets for you with 30 mg or 15 mg tolvaptan, which you should take once a day in the morning.
Method of administration
Swallow the tablets whole without chewing, together with a glass of water.
The morning dose should be taken at least 30 minutes before breakfast. The second daily dose one can take with or without food.
If you take more Jinarc than you should
If you take more tablets than your prescribed dose, drink plenty of water and contact your doctor or nearest hospital immediately. Take the medicine pack with you so that it is clear what you have taken. If you take the higher dose very late in the day, you may need to go to the toilet more often during the night.
If you forget to take Jinarc
If you forget to take your medicine, take dose one as soon as you remember on the same day. If you do not take the tablets for one day, you should take your usual dose the next day. DO NOT take a double dose to make up for forgotten individual doses.
If you stop taking Jinarc
If you stop taking this medicine, the cysts in your kidneys may grow as fast as they did before you started treatment with Jinarc. Therefore, you should only stop taking this medicine if you experience side effects that require urgent medical attention (see section 4) or if your doctor tells you to stop taking the medicine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects:
If you notice any of the side effects listed below, you may need urgent medical attention. Stop taking Jinarc and contact a doctor immediately or go to the nearest hospital if you:
- have difficulty urinating.
- may have swelling of the face, lips or tongue, itching , rash over large parts of the body, or wheezing or shortness of breath (symptoms of an allergic reaction ).
Jinarc can make your liver not function normally.
Contact your doctor if you experience symptoms such as nausea, vomiting, fever, fatigue, loss of appetite, abdominal pain, dark urine, jaundice (yellowing of the skin or whites of the eyes), itching of the skin or joints, and muscle pain with fever.
Other side effects:
Very common (may affect more than 1 in 10 people)
- thirst (which requires you to drink large amounts of water)
- headache
- dizziness
- diarrhea
- dry mouth
- increased urination, increased need to urinate at night, or to urinate more often
- fatigue
Common (may affect up to 1 in 10 people)
- dehydration
- high levels of sodium , uric acid and blood sugar
- decreased appetite
- altered sense of taste
- gout
- sleeping problems
- fainting
- severe heartbeat
- shortness of breath
- magont
- your stomach feels full or tense or you get stomach discomfort
- constipation
- heartburn
- abnormal liver function
- dry skin
- rash
- itching
- hives
- joint pain
- muscle spasms
- muscle pain
- general weakness
- higher levels of liver enzymes in the blood
- weight loss
- weight gain
Uncommon (may affect up to 1 in 100 people)
- increase in bilirubin (a substance that can cause the skin or whites of the eyes to turn yellow) in the blood
No known frequency (can not be calculated from the available data)
- allergic reactions (see above)
- generalized rash
- acute liver failure
How to store Jinarc
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, pocket pack, and blister after EXP. The expiration date is the last day of the specified month.
Store in the original package. Sensitive to light. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is tolvaptan.One Jinarc 15 mg tablet contains 15 mg tolvaptan.One Jinarc 30 mg tablet contains 30 mg tolvaptan.One Jinarc 45 mg tablet contains 45 mg tolvaptan.One Jinarc 60 mg tablet contains 60 mg tolvaptan.One Jinarc 90 mg tablet contains 90 mg tolvaptan.
- The other ingredients are lactose monohydrate (see section 2), maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, indigo carmine aluminum lacquer (E 132).
What the medicine looks like and contents of the pack
The different strengths of Jinarc tablets have different shapes and imprints:
15 mg tablet: blue, triangular, debossed with “OTSUKA” and “15” on one side.
30 mg tablet: blue, round, debossed with “OTSUKA” and “30” on one side.
45 mg tablet: blue, square, debossed with “OTSUKA” and “45” on one side.
60 mg tablet: blue, modified rectangular, debossed with “OTSUKA” and “60” on one side.
90 mg tablet: blue, five-sided, debossed with “OTSUKA” and “90” on one side.
Your medicine is available in the following pack sizes:
Jinarc 15 mg tablets: pack of 7 or 28 tablets
Jinarc 30 mg tablets: pack of 7 or 28 tablets
Jinarc 45 mg tablets + Jinarc 15 mg tablets: packs (blister with or without pocket pack) with
14 tablets (7 tablets with the higher strength + 7 tablets with the lower strength),
28 tablets (14 tablets with the higher strength + 14 tablets with the lower strength) or
56 tablets (28 tablets with the higher strength + 28 tablets with the lower strength).
Jinarc 60 mg tablets + Jinarc 30 mg tablets: packs (blister with or without pocket pack) with
14 tablets (7 tablets with the higher strength + 7 tablets with the lower strength),
28 tablets (14 tablets with the higher strength + 14 tablets with the lower strength) or
56 tablets (28 tablets with the higher strength + 28 tablets with the lower strength).
Jinarc 90 mg tablets + Jinarc 30 mg tablets: packs (blister with or without pocket pack) with
14 tablets (7 tablets with the higher strength + 7 tablets with the lower strength),
28 tablets (14 tablets with the higher strength + 14 tablets with the lower strength) or
56 tablets (28 tablets with the higher strength + 28 tablets with the lower strength).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Otsuka Pharmaceutical Netherlands BV
Herikerbergweg 292
1101 CT, Amsterdam
Netherlands
Manufacturer
Almac Pharma Service (Ireland) Limited
Finnabair Industrial Estate, Dundalk,
Co. Louth – A91 P9KD
Ireland
Millmount Healthcare Limited
Block-7, City North Business Campus, Stamullen, Co.
Meath, K32 YD60
Ireland
Contact the representative of the marketing authorization holder to find out more about this medicine: Show larger
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