Product Information for the User

Samsca 7.5 mg Tablets

Samsca 15 mg Tablets

Samsca 30 mg Tablets

tolvaptan

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

Samsca, which contains the active ingredient tolvaptán, belongs to a group of medications known as vasopressin antagonists. Vasopressin is a hormone that helps prevent water loss from the body by reducing urine production. An antagonist prevents vasopressin from exerting its effect on water retention, resulting in a reduction of the amount of water in the body by increasing urine production and leading to an increase in blood sodium levels.

Samsca is used to treat low serum sodium levels in adults. You have been prescribed this medication because you have low sodium levels in your blood as a result of a disease called "inadequate secretion of antidiuretic hormone syndrome (SIHAD)", in which the kidneys retain too much water. This disease leads to inadequate production of the vasopressin hormone, which has caused your sodium levels in the blood to decrease too much (hyponatremia). This can cause difficulties with concentration and memory or maintaining balance.

Do not take Samsca

• 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 (for example, benazepril, conivaptan, fenoldopam mesilate or mirtazapine)
• if your kidneys do not function (no urine production)
• if you have any disease that increases the levels of salt in the blood (“hypernatremia”)
• if you have any disease related to very low blood volume
• if you do not feel thirsty
• if you are pregnant
• if you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Samsca:

• if you cannot drink enough water or if you have a fluid restriction
• if you have difficulty urinating or have an enlarged prostate
• if you have liver disease
• if you have had in the past any allergic reaction to benzazepine, tolvaptan or other benzazepine derivatives (e.g. benazepril, conivaptan, fenoldopam mesilate or mirtazapine), or to any of the other ingredients of this medicine (listed in section 6)
• if you have a kidney disease called autosomal dominant polycystic kidney disease (ADPKD)
• if you have diabetes.

Drinking enough water

Samsca causes water loss because it increases urine production. This water loss may cause side effects such as dry mouth and thirst, and even more serious side effects such as kidney problems (see section 4). Therefore, it is essential that you have access to water and can drink sufficient amounts when you feel thirsty.

Children and adolescents

Samsca should not be used in the treatment of children and adolescents (under 18 years of age).

Other medicines and Samsca

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine, including those acquired without a prescription.

The following medicines may increase the effects of this medicine:

• ketoconazole (against fungal infections);
• macrolide antibiotics;
• diltiazem (treatment for high blood pressure and chest pain);
• other products that increase the concentration of salt in the blood or that contain large amounts of salt.

The following medicines may decrease the effects of this medicine:

• barbiturates (used for the treatment of epilepsy/convulsions and some sleep disorders);
• rifampicin (against tuberculosis).

This medicine may increase the effects of the following medicines:

• digoxin (used for the treatment of irregular heartbeats and heart failure);
• etexilate of dabigatran (used as an anticoagulant of the blood);
• metformin (for the treatment of diabetes);
• sulfasalazine (used to treat inflammatory bowel disease or rheumatoid arthritis).

This medicine may decrease the effects of the following medicines:

• desmopressin (used to increase blood clotting factors).

It may be appropriate for you to take these medicines at the same time as your Samsca treatment. Your doctor will decide what is suitable for you.

Taking Samsca with food and drinks

Avoid drinking grapefruit juice when taking Samsca.

Pregnancy and breastfeeding

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

Do not takethis medicine if you are pregnant or breastfeeding.

Appropriate contraceptive measures should be used during treatment with this medicine.

Driving and operating machinery

Samsca is unlikely to negatively affect your ability to drive or operate machinery. However, you may occasionally feel dizzy or weak or experience a brief period of fainting.

Samsca contains lactose.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• Treatment with Samsca will begin in the hospital.
• For the treatment of low sodium levels (hyponatremia), your doctor will instruct you to start taking a dose of 15 mg and may increase it up to a maximum of 60 mg to achieve the desired sodium level in your serum. Your doctor will ask you to have blood tests at regular intervals to control the effects of Samsca. To achieve the desired serum sodium level, your doctor may administer a dose of 7.5 mg in some cases.
• Swallow the tablet without crushing it, with a glass of water.
• Take the tablets once a day, preferably in the morning, with or without food.

If you take more Samsca than you should

If you take more tablets than the prescribed dose,drink large amounts of water and contact your doctor or the nearest hospital immediately. Remember to bring the medication packaging so it is clear what you have taken.

If you forget to take Samsca

If you forget to take your medication, take the dose as soon as you remember on the same day. If you miss a tablet one day, take your normal dose the next day.DO NOTtake a double dose to compensate for a missed dose.

If you interrupt treatment with Samsca

If you stop taking Samsca, you may experience low sodium levels again. Therefore, you should only stop taking Samsca if you observe urgent medical attention required side effects (see section 4) or if your doctor instructs you to do so.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

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

• You have difficulty urinating.
• You observe swelling of the face, lips, or tongue, itching, generalised rash, hissing breathing, or shortness of breath (symptoms of an allergic reaction).

Consult your doctor if you experience symptoms of fatigue, loss of appetite, upper right abdominal discomfort, dark urine, or jaundice (yellowing of the skin or eyes).

Other side effects

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

• Feeling unwell
• Thirst
• Rapid increase in sodium levels.

Common (may affect up to 1 in 10 people)

• Drinking too much water
• Water loss
• High levels of sodium, potassium, creatinine, uric acid, and blood sugar
• Low blood sugar levels
• Loss of appetite
• Fainting
• Headache
• Dizziness
• Low blood pressure when standing up
• Constipation
• Diarrea
• Dry mouth
• Irregular bleeding in skin areas
• Itching
• Increased need to urinate or urinating more frequently
• Fatigue, general weakness
• Fever
• General feeling of unwellness
• Blood in the urine
• Increased levels of liver enzymes in the blood
• Increased levels of creatinine in the blood.

Rare (may affect up to 1 in 100 people)

• Alteration of taste
• Renal problems.

Frequency not known (cannot be estimated from available data)

• Allergic reactions (see above)
• Liver problems
• Acute liver failure (ALF)
• Increased liver enzymes.

Reporting of 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 tothrough thenational reporting 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 carton after CAD and on the blister pack after EXP. The expiration date is the last day of the month indicated.

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

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

Composition of Samsca

• The active ingredient is tolvaptan.

Samsca 7.5 mg tablets: Each tablet contains 7.5 mg of tolvaptan.

Samsca 15 mg tablets: Each tablet contains 15 mg of tolvaptan.

Samsca 30 mg tablets: Each tablet contains 30 mg of tolvaptan.

• The other components are lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, and aluminum lake of indigo carmine (E 132).

Appearance of the product and contents of the package

Samsca 7.5 mg: Blue, rectangular, slightly convex tablets, with dimensions of 7.7 × 4.35 × 2.5 mm, and marked in relief with “OTSUKA” and “7.5” on one face.

Samsca 15 mg: Blue, triangular, slightly convex tablets, with dimensions of 6.58 × 6.2 × 2.7 mm, and marked in relief with “OTSUKA” and “15” on one face.

Samsca 30 mg: Blue, round, slightly convex tablets, with dimensions of 8 mm in diameter × 3.0 mm, and marked in relief with “OTSUKA” and “30” on one face.

Samsca 7.5 mg tablets are available as

10 tablets in blisters of PP/Al

30 tablets in blisters of PP/Al

10 × 1 tablet in pre-cut single-dose blisters of PVC/Al

30 × 1 tablet in pre-cut single-dose blisters of PVC/Al

Samsca 15 mg and Samsca 30 mg tablets are available as10 × 1 tablet in pre-cut single-dose blisters of PVC/Al

30 × 1 tablet in pre-cut single-dose blisters of PVC/Al

Only some package sizes may be marketed.

Marketing Authorization Holder

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292

1101 CT, Amsterdam

Netherlands

Responsible for manufacturing

Millmount Healthcare Limited

Block-7, City North Business Campus, Stamullen, Co. Meath, K32 YD60

Ireland

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last date of revision of this leaflet:{MM/AAAA}.

Other sources of information

Detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.