JINARC 15 mg Таблетка

Содержание инструкции

1. Jinarc 15 mg tablets, 30 mg tablets, 45 mg tablets, 60 mg tablets, 90 mg tablets
   1. What is Jinarc and what is it 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. Package contents and other information

Jinarc 15 mg tablets, 30 mg tablets, 45 mg tablets, 60 mg tablets, 90 mg tablets

Tolvaptan

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 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

1. What is Jinarc and what is it 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 renal cysts in patients with ADPKD, reduces the 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 the formation of fluid-filled cysts in the kidneys, which
exert pressure on the surrounding tissues and reduce kidney function, also leading
to kidney failure. Jinarc is used to treat ADPKD in adults with chronic kidney disease
(CKD) stage 1 to 4, with evidence of rapidly progressing disease.

2. 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 (e.g. benazepril, conivaptan, fenoldopam mesylate or mirtazapine).
• if you have been told that you have increased levels of liver enzymes in your blood that do not allow treatment with tolvaptan.
• if your kidneys are not functioning (not producing urine).
• if you have a condition associated with a significant reduction in blood volume (e.g. severe dehydration or bleeding).
• if you have a condition that increases sodium levels in the blood.
• if you do not feel the urge to drink.
• if you are pregnant.
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor before taking Jinarc:

• if you suffer from a liver disease.
• if you are unable to drink enough water (see the section that follows "Drinking enough water") or if you need to limit fluid intake.
• if you have difficulty urinating (e.g. have an enlarged prostate).
• if you have too high or too low a level of sodium in your blood.
• if you have had an allergic reaction to benzazepine, tolvaptan or other benzazepine derivatives (e.g. benazepril, conivaptan, fenoldopam mesylate or mirtazapine) or any of the other ingredients of this medicine (listed in section 6) in the past.
• if you suffer from diabetes.
• if you have been told that you have very high levels of a chemical substance called uric acid in your blood (which can cause gout attacks).
• if you have advanced kidney disease.

This medicine may prevent the liver from functioning correctly. Therefore, immediately inform your
doctor if you experience signs that may indicate potential liver problems, such as:

• nausea
• vomiting
• fever
• fatigue
• loss of appetite
• abdominal pain
• dark urine
• jaundice (a yellowing of the skin or eyes)
• skin itching
• flu-like symptoms (joint and muscle pain associated with fever).

During treatment with this medicine, your doctor will prescribe you monthly blood tests to check for any changes in liver function.
Drinking enough water
This medicine causes fluid loss as it increases urine production. This fluid loss can cause side effects such as dry mouth and thirst, but also more serious effects
such as kidney problems (see section 4). It is therefore important that you have access to water and that
you drink enough when you feel thirsty. Before going to bed, you should drink
1 or 2 glasses of water even if you are not thirsty, and you should also drink water after urinating during the
night. You should be particularly careful if you have a condition that reduces your proper fluid intake,
or if you are at higher risk of fluid loss, for example in the case of vomiting or diarrhea. In
view of the increased urine production, it is also important that you always have access to a
bathroom.

Children and adolescents
Do not give this medicine to children and adolescents (under 18 years of age) because it has not
been studied in 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 those available without a prescription.
The following medicines can 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 disease and high blood pressure),
• Ciprofloxacin (an antibiotic),
• Diltiazem (used to treat high blood pressure and chest pain).

The following medicines can reduce 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 medicine used to improve mildly depressed mood or mild anxiety).

Jinarc can increase the effect of the following medicines:

• Digoxin (used to treat irregular heartbeat and heart failure),
• Dabigatran (used to thin the blood),
• Sulfasalazine (used to treat inflammatory bowel disease or rheumatoid arthritis),
• Metformin (used to treat diabetes).

Jinarc can reduce the effect of the following medicines:

• Vasopressin analogues such as desmopressin (used to increase blood clotting factors or to control urine production or involuntary urination during sleep).

These medicines can affect Jinarc or be affected by it:

• Diuretics (used to increase urine production). If taken together with Jinarc, they can increase the risk of side effects caused by fluid loss or cause kidney problems.
• Diuretics or other medicines for the treatment of high blood pressure. If taken together with Jinarc, they can increase the risk of a drop in blood pressure when getting up from a sitting or lying position.
• Medicines that increase sodium levels in the blood or contain large amounts of salt (e.g. effervescent tablets and remedies for indigestion). These can increase the effect of Jinarc. There is a risk that this may lead to an excess of sodium in the blood.

You may still be allowed to take these medicines together with Jinarc. The doctor will decide
what is right for you.

Jinarc with food and drink
Do not drink grapefruit juice during therapy with this medicine.

Pregnancy and breastfeeding
Donot take this medicine if you are pregnant or if you are breastfeeding.
Women of childbearing potential should use reliable contraceptive measures while using this
medicine.
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Some people may experience dizziness, weakness or fatigue after taking
Jinarc. If this happens to you, do not drive, or use tools or machinery.

Jinarc contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

3. How to take Jinarc

Jinarc can only be prescribed by doctors specializing in the treatment of ADPKD. Take
this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
Dosage
The daily amount of Jinarc is divided into two doses, one higher than the other. The higher dose must
be taken in the morning when you get up, at least 30 minutes before breakfast. The lower dose must
be taken 8 hours later.
The dose combinations are:
45 mg + 15 mg
60 mg + 30 mg
90 mg + 30 mg
Treatment will normally begin with a dose of 45 mg in the morning and a dose of 15 mg after 8 hours.
The doctor will then gradually increase the dose to a maximum combination of 90 mg in the
morning and 30 mg after 8 hours. To determine the best dose, the doctor will regularly assess your
tolerance to the prescribed dose. You should always take the highest dose combination tolerated
prescribed by your doctor.
If you are taking other medicines that may increase the effects of Jinarc, you may receive lower
doses. In this case, your doctor may prescribe you Jinarc tablets containing 30 mg or 15 mg of
tolvaptan to be taken once a day, 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 can be
taken with or without food.

If you take more Jinarc than you should
If you have taken a number of tablets greater than the prescribed dose, drink plenty of water and contact
your doctor or local hospital immediately. Remember to bring the package of the
medicine with you, so that doctors know exactly what you have taken. If you take the higher dose very late
in the day, you may need to go to the bathroom more frequently at night.

If you forget to take Jinarc
If you forget to take the medicine, you should take the dose as soon as you remember on the same
day. If you miss a day, take the normal dose the next day. DO NOT
take a double dose to make up for missed doses.

If you stop taking Jinarc
If you stop treatment with this medicine, your kidney cysts may grow as quickly as they did before
starting treatment with Jinarc. Therefore, stop treatment with this medicine only if you notice side
effects that require urgent medical attention (see
section 4) or if your doctor tells you to do so.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. 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 following side effects, you may need urgent medical attention.
Stop taking Jinarc and contact your doctor immediately or go to the nearest
hospital if:

• You have difficulty urinating.
• You notice swelling of the face, lips or tongue, itching, widespread rash or severe wheezing or shortness of breath (symptoms of an allergic reaction).

Jinarc may prevent the liver from working 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 associated with fever.

Other side effects:
Very common(may affect more than 1 in 10 people)

• Thirst (requiring excessive fluid intake)
• Headache
• Dizziness
• Diarrhoea
• Dry mouth
• Increased need to urinate, to urinate at night, or to urinate more frequently
• Fatigue.

Common(may affect up to 1 in 10 people)

• Dehydration
• Elevated levels of sodium, uric acid and sugar in the blood
• Decreased appetite
• Changes in taste
• Gout
• Difficulty sleeping
• Fainting
• Palpitations
• Shortness of breath
• Stomach pain
• Feeling of fullness, bloating or discomfort in the stomach
• Constipation
• Heartburn
• Abnormal liver function
• Dry skin
• Rash
• Itching
• Urticaria
• 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 bilirubin (a substance that can cause yellowing of the skin or eyes) in the blood.

Not known(frequency cannot be estimated from available data)

• Allergic reactions (see above)
• Widespread rash
• Acute liver failure (ALF)
• Increased level of creatine phosphokinase (an enzyme that measures muscle and heart function) in the blood

Reporting of side effects
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 through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. 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 box, on the pack and on the blister after “Exp”. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light and moisture.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Jinarc contains

• The active ingredient is tolvaptan. Each 15 mg tablet of Jinarc contains 15 mg of tolvaptan. Each 30 mg tablet of Jinarc contains 30 mg of tolvaptan. Each 45 mg tablet of Jinarc contains 45 mg of tolvaptan. Each 60 mg tablet of Jinarc contains 60 mg of tolvaptan. Each 90 mg tablet of Jinarc contains 90 mg of tolvaptan.
• The other ingredients are lactose monohydrate (see section 2), corn starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, aluminium lake containing indigo carmine.

Description of the appearance of Jinarc and contents of the pack
The different dosages of Jinarc tablets have different shapes and different inscriptions:
15 mg tablet: blue, triangular, with "OTSUKA" and "15" imprinted on one side.
30 mg tablet: blue, round, with "OTSUKA" and "30" imprinted on one side.
45 mg tablet: blue, square, with "OTSUKA" and "45" imprinted on one side.
60 mg tablet: blue, modified rectangular shape, with "OTSUKA" and "60" imprinted on one
side.
90 mg tablet: blue, pentagonal, with "OTSUKA" and "90" imprinted on one side.
The medicinal product is available in the following packs:

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 a wallet pack) containing
14 tablets (7 tablets of higher dosage + 7 tablets of lower dosage),
28 tablets (14 tablets of higher dosage + 14 tablets of lower dosage) or
56 tablets (28 tablets of higher dosage + 28 tablets of lower dosage).

Jinarc 60 mg tablets + Jinarc 30 mg tablets: packs (blisters with or without a wallet pack) containing
14 tablets (7 tablets of higher dosage + 7 tablets of lower dosage),
28 tablets (14 tablets of higher dosage + 14 tablets of lower dosage) or
56 tablets (28 tablets of higher dosage + 28 tablets of lower dosage).

Jinarc 90 mg tablets + Jinarc 30 mg tablets: packs (blisters with or without a wallet pack) containing
14 tablets (7 tablets of higher dosage + 7 tablets of lower dosage),
28 tablets (14 tablets of higher dosage + 14 tablets of lower dosage) or
56 tablets (28 tablets of higher dosage + 28 tablets of lower dosage).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Otsuka Pharmaceutical Netherlands B.V.
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
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Otsuka Pharmaceutical Netherlands B.V.
Tél/Tel: +31 (0) 20 85 46 555

Lietuva
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

България
Otsuka Pharmaceutical Netherlands B.V.
Teл: +31 (0) 20 85 46 555

Luxembourg/Luxemburg
Otsuka Pharmaceutical Netherlands B.V.
Tél/Tel: +31 (0) 20 85 46 555

Česká republika
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Magyarország
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Danmark
Otsuka Pharma Scandinavia AB
Tlf: +46854 528 660

Malta
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Deutschland
Otsuka Pharma GmbH
Tel: +49691 700 860

Nederland
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Eesti
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Norge
Otsuka Pharma Scandinavia AB
Tlf: +46854 528 660

Ελλάδα
Otsuka Pharmaceutical Netherlands B.V.
Thλ: +31 (0) 20 85 46 555

Österreich
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

España
Otsuka Pharmaceutical S.A
Tel: +3493 2081 020

Polska
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

France
Otsuka Pharmaceutical France SAS
Tél: +33147 080 000

Portugal
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Hrvatska
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

România
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Ireland
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Slovenija
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Ísland
Otsuka Pharma Scandinavia AB
Sími: +46854 528 660

Slovenská republika
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

Italia
Otsuka Pharmaceutical Italy S.r.l.
Tel: +39 02 00 63 27 10

Suomi/Finland
Otsuka Pharma Scandinavia AB
Puh/Tel: +46854 528 660

Κύπρος
Otsuka Pharmaceutical Netherlands B.V.
Thλ: +31 (0) 20 85 46 555

Sverige
Otsuka Pharma Scandinavia AB
Tel: +46854 528 660

Latvija
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

United Kingdom (Northern Ireland)
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

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

ANNEX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATION FOR VARIATIONS TO THE TERMS
OF THE MARKETING AUTHORISATION
Scientific conclusions
In light of the evaluation by the Pharmacovigilance and Risk Assessment Committee (PRAC) of the Periodic
Safety Update Reports (PSURs) for tolvaptan (indicated for adults with autosomal dominant polycystic
kidney disease (ADPKD)), the PRAC’s scientific conclusions are as follows:
In light of the available literature data on increased blood creatine phosphokinase (CPK), spontaneous
reports including in some cases a close temporal association, and a positive de-challenge,
the PRAC considers that a causal relationship between tolvaptan (indicated for adults with autosomal
dominant polycystic kidney disease (ADPKD)) and increased CPK is at least a reasonable possibility.
The PRAC concluded that the product information for products containing tolvaptan (indicated for adults
with ADPKD) should be amended accordingly.
Having examined the PRAC recommendation, the Committee for Medicinal Products for Human Use
(CHMP) agrees with the overall conclusions and with the justification of the recommendation.

Justification for variations to the terms of the marketing authorisation
Based on the scientific conclusions on tolvaptan (indicated for adults with autosomal dominant
polycystic kidney disease (ADPKD)) the CHMP considers that the benefit-risk balance of the medicinal
products containing tolvaptan (indicated for adults with autosomal dominant polycystic kidney disease
(ADPKD)) remains unchanged subject to the proposed amendments to the product information.
The CHMP recommends the variation to the terms of the marketing authorisation.