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This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet is: PLGB 50697/0018.
Jinarc tablets
Jinarc 15 mg tablets
Jinarc 30 mg tablets
Jinarc 45 mg tablets
Jinarc 60 mg tablets
Jinarc 90 mg tablets
Tolvaptan
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
1. What Jinarc is and what it is used for
2. What you need to know before you take Jinarc
3. How to take Jinarc
4. Possible side effects
5. How to store Jinarc
6. Contents of the pack and other information
Jinarc contains the active substance tolvaptan which blocks the effect of vasopressin, a hormone involved in the formation of cysts in the kidneys of ADPKD patients. By blocking the effect of vasopressin, Jinarc slows the development of kidney cysts in patients with ADPKD, reduces symptoms of the disease and increases urine production.
Jinarc is a medicine used to treat a disease called “autosomal dominant polycystic kidney disease” (ADPKD). This disease causes growth of fluid-filled cysts in the kidneys, which put pressure on surrounding tissues and reduce kidney function, possibly leading to kidney failure. Jinarc is used to treat ADPKD in adults with chronic kidney disease (CKD) stages 1 to 4 with evidence of rapidly progressing disease.
Talk to your doctor before taking Jinarc
Drinking enough water
This medicine causes water loss because it increases your urine production. This water loss may result in side effects such as dry mouth and thirst or even more severe side effects like kidney problems (see section 4). It is therefore important that you have access to water and that you are able to drink sufficient amounts when you feel thirsty. Before bed-time you must drink 1 or 2 glasses of water even if you do not feel thirsty and you must also drink water after you urinate at night. Special care must be taken if you have a disease that reduces appropriate fluid intake or if you are at an increased risk of water loss e.g. in case of vomiting or diarrhoea. Due to the increased urine production, it is also important that you always have access to a toilet.
Do not give this medicine to children and adolescents (under age of 18 years) because it has not been studied in these age groups.
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:
The following medicines may lower the effect of Jinarc:
Jinarc may increase the effect of the following medicines:
Jinarc may lower the effect of the following medicines:
These medicines can affect or be affected by Jinarc:
It may still be alright for you to take these medicines and Jinarc together. Your doctor will be able to decide what is suitable for you.
Do not drink grapefruit juice when taking this medicine.
Do not take this medicine if you are pregnant or breast-feeding.
Women of childbearing age must use reliable contraceptive measures during use of this medicine.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Some people may feel dizzy, weak or tired after being given Jinarc. If this happens to you, do not drive or use any tools or machines.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Jinarc can only be prescribed by doctors who are specialised in the treatment of ADPKD. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Dose
The daily amount of Jinarc is split into two doses, one bigger than the other. The higher dose should be taken in the morning when you wake up, at least 30 minutes before the morning meal. The lower dose is taken 8 hours later.
The dose combinations are:
45 mg + 15 mg
60 mg + 30 mg
90 mg + 30 mg
Your treatment will normally start with a dose of 45 mg in the morning and 15 mg 8 hours later. Your doctor may gradually increase your dose up to a maximum combination of 90 mg on waking and 30 mg after 8 hours. To find the best dose your doctor will regularly check how well you are tolerating a prescribed dose. You should always take the highest tolerable dose combination prescribed by your doctor.
If you take other medicines, which can increase the effects of Jinarc you may receive lower doses. In this case your doctor may prescribe you Jinarc tablets with 30 mg or 15 mg tolvaptan which have to be taken once a day in the morning.
Method of administration
Swallow the tablets without chewing, with a glass of water.
The morning dose is to be taken at least 30 minutes before the morning meal. The second daily dose can be taken with or without food.
If you have taken more tablets than your prescribed dose, drink plenty of water and contact your doctor or your local hospital immediately. Remember to 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 have to go to the toilet at night more frequently.
If you forget to take your medicine, you should take the dose as soon as you remember on the same day. If you do not take your tablets on one day, take your normal dose on the next day. DO NOT take a double dose to make up for forgotten individual doses.
If you stop taking this medicine your kidney cysts may grow as fast as they did before you started treatment with Jinarc. Therefore, you should only stop taking this medicine if you notice side effects requiring urgent medical attention (see section 4) or if your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following side effects, you may need urgent medical attention. Stop taking Jinarc and immediately contact a doctor or go to the nearest hospital if you:
Consult your doctor if symptoms of nausea, vomiting, fever, tiredness, loss of appetite, pain in the abdomen, dark urine, jaundice (yellowing of skin or eyes), itching of your skin or joint and muscle pain with fever occur.
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Not known (frequency cannot be estimated from the available data)
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
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, wallet card and the blister after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light and moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The different strengths of Jinarc tablets have different shapes and embossing:
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, pentagonal, debossed with “OTSUKA” and “90” on one side
Your medicine is supplied in the following pack sizes:
Jinarc 15 mg tablets: packs containing 7 tablets or 28 tablets
Jinarc 30 mg tablets: packs containing 7 tablets or 28 tablets
Jinarc 45 mg tablets + Jinarc 15 mg tablets: packs (blisters with or without wallet card) containing
14 tablets (7 tablets of the higher strength + 7 tablets of the lower strength),
28 tablets (14 tablets of the higher strength + 14 tablets of the lower strength) or
56 tablets (28 tablets of the higher strength + 28 tablets of the lower strength).
Jinarc 60 mg tablets + Jinarc 30 mg tablets: packs (blisters with or without wallet card) containing
14 tablets (7 tablets of the higher strength + 7 tablets of the lower strength),
28 tablets (14 tablets of the higher strength + 14 tablets of the lower strength) or
56 tablets (28 tablets of the higher strength + 28 tablets of the lower strength).
Jinarc 90 mg tablets + Jinarc 30 mg tablets: packs (blisters with or without wallet card) containing
14 tablets (7 tablets of the higher strength + 7 tablets of the lower strength),
28 tablets (14 tablets of the higher strength + 14 tablets of the lower strength) or
56 tablets (28 tablets of the higher strength + 28 tablets of the lower strength).
Not all pack sizes may be marketed.
For any information about this medicine, please contact:
This leaflet was last revised in 11/2022.
705454
P-3273-02