Jinarc 15 mg + 45 mg tablets

Package Leaflet: Information for the User

Introduction

Package leaflet: 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 medicinal product is subject to additional monitoring, which will allow for faster detection of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is included at the end of section 4.

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
  • This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
  • If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Jinarc is and what it is used for
2. What you need to know before taking Jinarc
3. How to take Jinarc
4. Possible side effects
5. How to store Jinarc
6. Contents of the pack and other information

1. What Jinarc is and what it is used for

The active substance in Jinarc is tolvaptan, which blocks the effect of vasopressin, a hormone involved in the formation of kidney cysts in patients with autosomal dominant polycystic kidney disease (ADPKD). By blocking the effect of vasopressin, Jinarc slows the progression of kidney cyst development in patients with ADPKD, reduces disease symptoms, and increases urine production.

Jinarc is a medicine used to treat a condition 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) stage 1 to 4 who show signs of rapidly progressing disease.

2. What you need to know before taking Jinarc

Do not take Jinarc

• If you are allergic to tolvaptan or to any of the other components of this medicine (listed in section 6), or if you are allergic to benzazepine or derivatives of benzazepine (e.g., benazepril, conivaptan, phenoldopam mesylate, or mirtazapine).
• If you have been told that you have high levels of liver enzymes in your blood and that this prevents you from receiving treatment with tolvaptan.
  • If your kidneys are not functioning (no urine production).
  • If you have a condition associated with very low blood volume (e.g., severe dehydration or hemorrhage).
  • If you have a disorder that increases the amount of sodium in your blood.
  • If you do not feel thirsty.
  • If you are pregnant.
  • If you are breastfeeding.

Warnings and precautions

Talk to your doctor before starting Jinarc:

• If you have liver disease.
• If you are unable to drink enough water (see "Drink an adequate amount of water" below) or if you need to limit your fluid intake.
• If you have difficulty urinating (e.g., enlarged prostate).
• If you have blood sodium levels that are too high or too low.
• If you have previously had an allergic reaction to benzazepine, tolvaptan, or other benzazepine derivatives (e.g., benazepril, conivaptan, phenoldopam mesylate, or mirtazapine), or to any of the other components of this medicine (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).
• If you have advanced kidney disease.

This medicine may cause your liver to malfunction. For this reason, please inform your doctor immediately if you experience signs that could indicate liver problems, such as:

• nausea
• vomiting
• fever
• fatigue
• loss of appetite
• abdominal pain
• dark urine
• jaundice (yellowing of the skin or eyes)
• itching (pruritus) of the skin
• pseudoinfluenza syndrome (muscle and joint pain with fever)

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

Drink an adequate amount of water

This medicine causes water loss because it increases urine production. This water loss may lead to adverse effects such as dry mouth and thirst, or even more serious adverse effects such as kidney problems (see section 4). Therefore, it is important that you have access to water and are able to drink sufficient amounts of fluid 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 you should also drink water after urinating during the night. You should be especially careful if you have a condition that reduces adequate fluid intake or if you are at higher risk of dehydration, for example if you have vomiting or diarrhea. Due to the increased urine production, it is also important to have a toilet nearby at all times.

Children and adolescents

Do not give this medicine to children and adolescents (under 18 years of age) as it has not been studied in this population.

Other medicines and Jinarc

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those not requiring 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),
• crizotinib 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 conditions and high blood pressure),
• ciprofloxacin (an antibiotic),
• diltiazem (used to treat high blood pressure and chest pain).

The following medicines may decrease the effect of Jinarc:

• phenytoin or carbamazepine (used to treat epilepsy),
• rifampicin, rifabutin, or rifapentine (used to treat tuberculosis),
• St. John’s wort (a traditional herbal remedy used to relieve mild low mood and mild anxiety).

Jinarc may increase the effect of the following medicines:

• digoxin (used to treat irregular heartbeat and heart failure),
• dabigatran (used as a blood anticoagulant),
• sulfasalazine (used to treat irritable bowel disease or rheumatoid arthritis),
• metformin (for the treatment of diabetes).

Jinarc may decrease the effect of the following medicines:

• vasopressin analogues such as desmopressin (used to increase blood clotting factors or to control urine production or urinary incontinence).

The following medicines may affect Jinarc or be affected by Jinarc:

• diuretics (used to increase urine production). When taken at the same time as Jinarc, these medicines may increase the risk of adverse effects due to water loss or may cause kidney problems.
• diuretics or other medicines for the treatment of high blood pressure. When taken together with Jinarc, these medicines may increase the risk of low blood pressure upon standing up or getting up from a sitting or lying position.
• medicines that increase blood sodium levels or contain large amounts of salt (e.g., effervescent tablets or those used to treat indigestion). These could enhance the effects of Jinarc. There is a risk that this could lead to excessive sodium levels in your blood.

Taking these medicines together with Jinarc may not necessarily be a problem. Your doctor will decide what is best for you.

Use of Jinarc with food and alcohol

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 contraceptive methods while being treated with this medicine.

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

Driving and use of machines

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

Jinarc contains lactose.

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Jinarc

Only doctors specialized in the treatment of ADPKD may prescribe Jinarc. Always follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Dosage

The daily dose of Jinarc must 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

Typically, 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 up to a maximum combination of 90 mg upon waking and 30 mg taken 8 hours later. To determine the best dose for you, your doctor will regularly monitor how well you tolerate the prescribed dose. You must 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 be given lower doses. In this case, your doctor may prescribe Jinarc tablets containing 30 mg or 15 mg of tolvaptan, which you will take once daily in the morning.

Method of administration

Swallow the tablets whole without chewing, with a glass of water.

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

If you take more Jinarc than you should

If you have taken more tablets than prescribed, drink plenty of water and contact your doctor or the nearest hospital immediately. Remember to bring the medicine carton with you so it is clear which medicine and how much you have taken. If you take the higher dose too late in the day, you may need to go to the bathroom more frequently during the night.

If you forget to take Jinarc

If you forget to take your dose, take it as soon as you remember on the same day. If you have missed taking the tablets for one day, take your usual dose the next day. Do not take a double dose to make up for a missed dose.

If you stop taking Jinarc

If you stop treatment with this medicine, kidney cysts may begin to grow as quickly as they did before starting treatment. Therefore, you should only stop taking this medicine if you experience adverse effects requiring urgent medical attention (see section 4) or if your doctor advises you to do so.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

Serious adverse effects:

If you experience any of the following adverse effects, you may need urgent medical attention. Stop taking Jinarc and contact a doctor immediately or go immediately to the nearest hospital if you:

• have difficulty urinating;
• develop swelling of the face, lips, or tongue, feel itchy, have a widespread rash, or experience wheezing (whistling sounds when breathing) or difficulty breathing (symptoms of an allergic reaction).

Jinarc may cause your liver to malfunction.

Contact your doctor if you develop symptoms such as 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 adverse effects:

Very common (may affect more than 1 in 10 people)

• thirst (need to drink excessive amounts of water)
• headache
• dizziness
• diarrhea
• dry mouth
• increased need to urinate, urinating at night, or more frequent urination
• fatigue

Common (may affect up to 1 in 10 people)

• dehydration

• elevated levels of sodium, uric acid, and blood sugar

• decreased appetite

• taste disturbances

• gout

• difficulty falling asleep

• fainting

• palpitations

• difficulty breathing

• abdominal pain

• feeling full, bloated, or having stomach discomfort

• constipation

• heartburn

• abnormal liver function

• dry skin

• rash

• itching

• hives

• joint pain

• muscle spasms

• muscle pain

• general weakness

• increased levels of liver enzymes in the blood

• weight loss

• weight gain

Uncommon (may affect up to 1 in 100 people)

• increased concentration of bilirubin (a substance that may cause yellowing of the skin or eyes) in the blood

Frequency not known (cannot be estimated from available data)

• allergic reactions (see above)
• generalized rash
• acute liver failure (ALF)
• increased concentration of creatine phosphokinase (an enzyme that measures muscle and heart function) in the blood

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Jinarc

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

Do not use this medicine after the expiry date stated on the outer carton, on the box with blister pack, and on the blister after the abbreviation "CAD". The expiry date refers to the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Jinarc

• The active substance is tolvaptan.

Each Jinarc 15 mg tablet contains 15 mg of tolvaptan.
Each Jinarc 30 mg tablet contains 30 mg of tolvaptan.
Each Jinarc 45 mg tablet contains 45 mg of tolvaptan.
Each Jinarc 60 mg tablet contains 60 mg of tolvaptan.
Each Jinarc 90 mg tablet contains 90 mg of tolvaptan.

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

Appearance of Jinarc and contents of the pack

The different dosage strengths of Jinarc tablets have different shapes and engravings:

15 mg tablet: blue, triangular, engraved with «OTSUKA» and «15» on one side.
30 mg tablet: blue, round, engraved with «OTSUKA» and «30» on one side.
45 mg tablet: blue, square, engraved with «OTSUKA» and «45» on one side.
60 mg tablet: blue, modified rectangular, engraved with «OTSUKA» and «60» on one side.
90 mg tablet: blue, pentagonal, engraved with «OTSUKA» and «90» on one side.

The 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 (blister packs with or without carton) 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 (blister packs with or without carton) 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 (blister packs with or without carton) 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).

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292
1101 CT, Amsterdam
The Netherlands

Manufacturer

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 the most recent review of this leaflet:

Other sources of information

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