SAMSCA 30 mg TABLETS

2. What you need to know before you take Samsca

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 (e.g. benazepril, conivaptan, fenoldopam mesylate or mirtazapine)
• if your kidneys do not work (there is no urine production)
• if you have any disease that increases blood salt levels (“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 breast-feeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Samsca:

• if you cannot drink enough water or if you have fluid restrictions
• if you have difficulty urinating or have an enlarged prostate
• if you have liver disease
• if you have had an allergic reaction to benzazepine, tolvaptan or other benzazepine derivatives (e.g. benazepril, conivaptan, fenoldopam mesylate 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.

Adequate water intake

Samsca causes water loss because it increases urine production. This water loss can 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 important that you have access to water and can drink sufficient amounts when you feel thirsty.

Children and adolescents

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

Other medicines and Samsca

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained 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 blood salt levels or contain large amounts of salt.

The following medicines may decrease the effects of this medicine:

• barbiturates (used to treat epilepsy/convulsions and some sleep disorders);
• rifampicin (against tuberculosis).

This medicine may increase the effects of the following medicines:

• digoxin (used to treat irregular heartbeats and heart failure);
• dabigatran etexilate (used as a blood anticoagulant);
• 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 suitable for you to take these medicines at the same time as your treatment with Samsca. Your doctor will decide what is suitable for you.

Taking Samsca with food and drinks

Avoid drinking grapefruit juice when taking Samsca.

Pregnancy and breast-feeding

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.

Do not takethis medicine if you are pregnant or breast-feeding.

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

Driving and using machines

Samsca is unlikely to affect your ability to drive or use machines. However, you may occasionally feel dizzy or weak or faint for a short period of time.

Samsca contains lactose.

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Samsca

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

• Treatment with Samsca will start in the hospital.
• For the treatment of low sodium levels (hyponatremia), your doctor will tell you to start taking a dose of 15 mg and may then increase it up to a maximum of 60 mg to achieve the desired sodium level in your blood. To monitor the effects of Samsca, your doctor will ask you to have blood tests from time to time. To achieve the desired sodium level in your blood, your doctor may in some cases give you a dose of 7.5 mg.
• Swallow the tablet without chewing, 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 prescribed, drink plenty of water and contact your doctor or the nearest hospital immediately. Remember to take the medicine pack with you so that it is clear what you have taken.

If you forget to take Samsca

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 a tablet one day, take your normal dose the next day. DO NOTtake a double dose to make up for a forgotten dose.

If you stop taking Samsca

If you stop taking Samsca, you may have low sodium levels again. Therefore, you should only stop taking Samsca if you experience side effects that require 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.

4. Possible side effects

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 Samsca and contact a doctor or go to the nearest hospital immediately if:

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

Consult your doctor if you experience symptoms of fatigue, loss of appetite, discomfort in the upper right abdomen, 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 sodium, potassium, creatinine, uric acid and blood sugar levels
• decrease in blood sugar levels
• decrease in appetite
• fainting
• headache
• dizziness
• low blood pressure when standing up
• constipation
• diarrhoea
• dry mouth
• irregular bleeding in skin areas
• itching
• increased need to urinate or urinate more frequently
• fatigue, general weakness
• fever
• general feeling of being unwell
• blood in the urine
• increase in liver enzyme levels in the blood
• increase in creatinine levels in the blood.

Uncommon (may affect up to 1 in 100 people)

• alteration of taste
• kidney problems.

Rare (cannot be estimated from the available data)

• allergic reactions (see above)
• liver problems
• acute liver failure
• increase in liver enzymes.

Reporting of side effects

If you experience 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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Samsca

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 after EXP and on the blister after EXP. The expiry date refers to the last day of the month shown.

Store in the original package 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 no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Samsca contains

• The active substance 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 ingredients are lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate and aluminium lake of indigo carmine (E 132).

Appearance and packaging

Samsca 7.5 mg: blue, rectangular, slightly convex tablets, with dimensions of 7.7 × 4.35 × 2.5 mm, and engraved with “OTSUKA” and “7.5” on one side.

Samsca 15 mg: blue, triangular, slightly convex tablets, with dimensions of 6.58 × 6.2 × 2.7 mm, and engraved with “OTSUKA” and “15” on one side.

Samsca 30 mg: blue, round, slightly convex tablets, with a diameter of 8 mm × 3.0 mm, and engraved with “OTSUKA” and “30” on one side.

Samsca 7.5 mg tablets are available as

10 tablets in PP/Al blisters

30 tablets in PP/Al blisters

10 × 1 tablet in PVC/Al unit dose blisters

30 × 1 tablet in PVC/Al unit dose blisters

Samsca 15 mg and Samsca 30 mg tablets are available as 10 × 1 tablet in PVC/Al unit dose blisters

30 × 1 tablet in PVC/Al unit dose blisters

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292

1101 CT, Amsterdam

Netherlands

Manufacturer

Millmount Healthcare Limited

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

Ireland

You can request more information about this medicine from the local representative of the Marketing Authorisation Holder:

Date of last revision of this leaflet:{MM/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.