Prospect: information for the patient

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, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, because

it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people
• who may have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist even if they are
• adverse effects that do not appear in this prospect. See section 4.

Jinarc is a medication used to treat a disease known as «autosomal dominant polycystic kidney disease» (ADPKD). This disease leads to the development of fluid-filled cysts in the kidneys, causing pressure on surrounding tissues and reducing kidney function, potentially leading to kidney failure. Jinarc is used to treat ADPKD in adults with chronic kidney disease (CKD) in stages 1 to 4 with signs of rapid disease progression.

The active ingredient of Jinarc is 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 disease symptoms, and increases urine production.

Do not take Jinarc:

• If you are allergic to tolvaptan or any of the other components of this medication (listed in section 6) or if you are allergic to benzazepine or benzazepine derivatives (for example, benazepril, conivaptan, mesilato de fenoldopam or mirtazapina).

• If you have been told that you have high levels of liver enzymes in your blood and this prevents you from receiving treatment with tolvaptan.
• If your kidneys do not function (no urine production)
• If you have a condition associated with very low blood volume (e.g., severe dehydration or hemorrhage).
• • If you have a condition that increases the amount of sodium in your blood.
  • If you do not feel the sensation of thirst.
  • If you are pregnant (see "Pregnancy and breastfeeding").
  • If you are breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions

Consult your doctor before starting to take Jinarc:

• If you cannot drink enough water (see "Drink a sufficient amount of water" below) or if you have to limit your liquid intake.
• • If you have difficulty urinating or prostate hypertrophy (enlargement of the prostate).
  • If you have a blood sodium level that is too high or too low.
• If you have had a past allergic reaction to benzazepine, tolvaptan or other benzazepine derivatives (e.g., benazepril, conivaptan, mesilato de fenoldopam or mirtazapina), or to any of the other components of this medication (listed in section 6).
• • If you have diabetes.
  • If you have been told that you have high levels of uric acid in your blood (which may have caused gout).
• Inform your doctor immediately if you experience signs that may indicate liver problems, such as:

During treatment with Jinarc, your doctor will request monthly blood tests to monitor any changes in your liver function.

Drink a sufficient amount of water

Jinarc causes water loss because it increases urine production. This water loss may lead to side effects such as dry mouth and thirst, or even more serious side effects such as kidney problems (see section 4). Therefore, it is essential that you have access to water and can ingest sufficient amounts of liquid when you feel thirsty. Before going to bed, you should drink one or two glasses of water even if you do not feel thirsty, and also drink water after urinating at night. You should be especially careful if you have a disease that reduces your ability to ingest adequate liquids or if you have a higher risk of dehydration, for example if you have vomiting or diarrhea. Due to the increased urine production, it is also essential to always have a bathroom nearby.

Children and adolescents

Jinarc has not been studied in children and adolescents (under 18 years) and is therefore not recommended for use in this population.

Other medications and Jinarc

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

Particularly, inform your doctor that you are taking:

• Treatments containing ketoconazole for fungal infections, macrolide antibiotics such as clarithromycin, or diltiazem for hypertension and chest pain.
• These medications may increase the effects of Jinarc.
• Medications that increase the level of sodium in the blood or that contain large amounts of salt, such as tablets that dissolve in water and those used to treat indigestion. These may increase the effects of Jinarc.
• Digoxin (a medication for treating irregular heart rhythm and heart failure), dabigatran (used as an anticoagulant), rosuvastatin or pitavastatin (used to reduce blood cholesterol levels), methotrexate (used to treat cancer and arthritis), ciprofloxacin (an antibiotic), sulfasalazine (for the treatment of irritable bowel disease or rheumatoid arthritis) or metformin (for the treatment of diabetes). Jinarc may increase the effect of these medications.
• Phenobarbital or carbamazepine (medications for treating epilepsy), rifampicin (a medication for treating tuberculosis) or St. John's Wort (a traditional herbal medication for mild depression and anxiety). It is advisable to avoid the use of any of these medications in combination with Jinarc because they may reduce the effects of Jinarc.
• Diuretics (used to increase urine production). When taken at the same time as Jinarc, these medications may increase the risk of experiencing side effects due to water loss.
• Diuretics or other medications for treating hypertension. When taken at the same time as Jinarc, these medications may increase the risk of experiencing drops in blood pressure when standing up or getting up.
• Desmopressin (used to increase blood clotting factors or to control urine production or urinary incontinence). Jinarc may reduce the effect of desmopressin.

It may not be a problem to take these medications at the same time as Jinarc. Your doctor will decide what is best for you.

Use of Jinarc with beverages and alcohol

Do not take grapefruit juice while taking Jinarc.

Pregnancy and breastfeeding

Do nottake this medication if you are pregnant or breastfeeding.

Potentially fertile women should use reliable contraceptive methods while being treated with this medication.

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

Some people may feel dizzy, weak, or tired after taking Jinarc. If you experience these effects, do not drive or use tools or machinery.

Jinarc contains lactose.

If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

Only specialized doctors in the treatment of PQRAD can prescribe Jinarc. Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dose

The daily dose of Jinarc should be divided into two doses, one higher than the other. The higher dose should be taken in the morning upon waking, at least 30 minutes before breakfast, while 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

Normally, your treatment will start with a dose of 45 mg in the morning and 15 mg 8 hours later. Your doctor may gradually increase your dose to a maximum combination of 90 mg in the morning and 30 mg 8 hours later. Your doctor will regularly check how you tolerate the prescribed dose to determine the best dose for you. You should always take the highest tolerable dose combination prescribed by your doctor.

If you are taking other medications that may increase the effects of Jinarc, you may receive lower doses. In this case, your doctor may prescribe Jinarc tablets with 30 or 15 mg of tolvaptan, which you should take once a day in the morning.

Administration form

Swallow the tablets without chewing and accompanied by a glass of water.

The morning dose should be taken at least 30 minutes before breakfast. The second daily dose can be taken with or without food.

If you take more Jinarc than you should

In case you have taken more tablets than the prescribed dose,drink plenty of water and immediately contact your doctor or the nearest hospital.Remember to carry the medication packaging with you so it is clear what you have taken. If you take the higher dose too late, you may have to go to the bathroom more frequently at night.

If you forget to take Jinarc

If you forget to take your medication, take the dose as soon as you remember on the same day. If you have not taken the tablets for a day, take the normal dose the next day.Do not take a double dose to compensate for the missed individual doses.

If you interrupt treatment with Jinarc

If you interrupt treatment with Jinarc, the kidney cysts may grow as quickly as before starting treatment with this medication. Therefore, you should only stop taking Jinarc if you notice emergency medical attention required side effects (see section 4) or if your doctor advises you to do so.

If you have any doubts about the use of this medication, consult your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects:

If you experience any of the following side effects, 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;

• You experience facial, lip, or tongue swelling, itching, a generalised skin rash, or wheezing or difficulty breathing (symptoms of an allergic reaction).

Jinarc may cause your liver not to function properly.

Consult your doctor if you experience symptoms of nausea, vomiting, fever, fatigue, loss of appetite, abdominal pain, dark urine, jaundice (yellowing of the skin or eyes), skin itching, or joint and muscle pain with fever.

Other side effects:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Rare: may affect up to 1 in 100 people

Unknown frequency: cannot be estimated from available data

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the outer box, on the blister pack, and on the blister after the abbreviation «CAD». The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light and moisture.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This will help protect the environment.

Composition of Jinarc

The active ingredient is tolvaptan.

Each Jinarc tablet of 15 mg contains 15 mg of tolvaptan.

Each Jinarc tablet of 30 mg contains 30 mg of tolvaptan.

Each Jinarc tablet of 45 mg contains 45 mg of tolvaptan.

Each Jinarc tablet of 60 mg contains 60 mg of tolvaptan.

Each Jinarc tablet of 90 mg contains 90 mg of tolvaptan.

The other components are lactose monohydrate (see section 2), maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate and aluminium lake of indigo carmine.

Appearance of Jinarc and contents of the pack

The different doses of Jinarc tablets have different shapes and markings:

15 mg tablet: blue, triangular, marked with "OTSUKA" and "15" on one side.

30 mg tablet: blue, round, marked with "OTSUKA" and "30" on one side.

45 mg tablet: blue, square, marked with "OTSUKA" and "45" on one side.

60 mg tablet: blue, modified rectangular, marked with "OTSUKA" and "60" on one side.

90 mg tablet: blue, pentagonal, marked with "OTSUKA" and "90" on one side.

The medicinal product is supplied in the following pack sizes:

Jinarc 15 mg tablets: blisters with 7 or 28 tablets.

Jinarc 30 mg tablets: blisters with 7 or 28 tablets.

Jinarc 45 mg tablets + Jinarc 15 mg tablets: blisters with or without a carton with 14 (7 high-dose tablets + 7 low-dose tablets), 28 (14 high-dose tablets + 14 low-dose tablets) or 56 (28 high-dose tablets + 28 low-dose tablets) tablets.

Jinarc 60 mg tablets + Jinarc 30 mg tablets: blisters with or without a carton with 14 (7 high-dose tablets + 7 low-dose tablets), 28 (14 high-dose tablets + 14 low-dose tablets) or 56 (28 high-dose tablets + 28 low-dose tablets) tablets.

Jinarc 90 mg tablets + Jinarc 30 mg tablets: blisters with or without a carton with 14 (7 high-dose tablets + 7 low-dose tablets), 28 (14 high-dose tablets + 14 low-dose tablets) or 56 (28 high-dose tablets + 28 low-dose tablets) tablets.

Only some pack sizes may be marketed.

Marketing authorisation holder

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292

1101 CT, Amsterdam

Netherlands

Responsible for manufacturing

AndersonBrecon (UK) Limited

Units 2-7, Wye Valley Business Park, Brecon Road, Hay-on-Wye

Hereford - HR3 5PG

UK

Almac Pharma Services Ltd.

Almac House, 20 Seagoe Industrial Estate

Craigavon - BT63 5QD

UK

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

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Date of last revision of this leaflet: MM/AAAA.

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.