SamscA

Package leaflet: Information for the user

Samsca 7.5 mg tablets, 15 mg tablets, 30 mg tablets

tolvaptan
Please read this leaflet carefully before taking this medicine because 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. Never give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Samsca is and what it is used for

Samsca, which contains the active substance tolvaptan, belongs to a group of medicines called
vasopressin antagonists. Vasopressin is a hormone that helps prevent water loss from the body by reducing urine excretion. An antagonist means that it blocks vasopressin from acting on fluid retention. This in turn leads to a reduction in the amount of water in the body by increasing urine production, thereby increasing the level or concentration of sodium in the blood.
Samsca is used to treat patients with low sodium concentrations in the blood. This medicine has been prescribed for you because you have low sodium levels in the blood due to a condition called “syndrome of inappropriate antidiuretic hormone secretion” (SIADH), in which the kidneys retain too much water. This condition causes inappropriate production of the hormone vasopressin, resulting in excessively low levels of sodium in the blood (hyponatremia).
This may cause difficulties with concentration and memory, or in maintaining balance.

2. What you need to know before taking Samsca

Do not take Samsca

• if you are allergic to tolvaptan or to 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 function (do not produce urine)
• if you suffer from a condition causing high levels of salt in the blood ("hypernatremia")
• if you have a disorder associated with very low blood volume
• if you do not feel thirsty
• if you are pregnant
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Samsca.

• if you are unable to drink enough water or if you have restrictions on fluid intake
• if you find it difficult to urinate or if you have an enlarged prostate
• if you suffer from liver disease
• if you have previously 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 suffer from a kidney disease called autosomal dominant polycystic kidney disease (ADPKD)
• if you have diabetes.

Drink enough water
Samsca causes water loss because it increases urine production. This water loss may cause unwanted effects such as dry mouth and thirst, or 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 enough whenever you feel thirsty.
Children and adolescents
Samsca is not suitable for children and adolescents (under 18 years of age).
Other medicines and Samsca
Inform 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 effect of this drug:

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

The following medicines may reduce the effects of this drug:

• barbiturates (used to treat epilepsy/seizures and certain sleep disorders),
• rifampicin (used for tuberculosis).

This medicine may increase the effects of the following medicines:

• digoxin (used to treat irregular heart rhythms and heart failure),
• dabigatran etexilate (used to thin the blood),
• metformin (used to treat diabetes),
• sulfasalazine (used to treat inflammatory bowel disease or rheumatoid arthritis).

This medicine may reduce the effect of the following medicine:

• desmopressin (used to increase blood clotting factors).

There may be cases where it is still acceptable to take these medicines together with Samsca. Your doctor will decide the appropriate treatment for you.
Samsca with food and drink
Avoid drinking grapefruit juice when taking Samsca.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine if you are pregnant or breastfeeding.
Adequate contraceptive methods must be used during treatment with this medicine.
Driving and using machines
It is unlikely that Samsca will negatively affect your ability to drive or operate machinery. However, you may occasionally experience dizziness or weakness, or brief episodes of fainting.
Samsca contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Samsca

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

• Treatment with Samsca must begin in a hospital setting.
• For the treatment of low sodium levels (hyponatremia), your doctor will start with a dose of 15 mg and may subsequently increase it up to a maximum of 60 mg to achieve the desired sodium level. To monitor the effects of Samsca, your doctor will perform regular blood tests. In some cases, to achieve the desired sodium level, your doctor may prescribe a lower dose of 7.5 mg.
• Swallow the tablet with a glass of water, without chewing.
• Take the tablets once daily, preferably in the morning, with or without food.

If you take more Samsca 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 package with you, so it is clear what you have taken.
If you forget to take Samsca
If you forget to take your dose, take it as soon as you remember, on the same day. If you miss a dose on a particular day, take your usual dose the next day. Do not take a double dose to make up for the forgotten dose.
If you stop taking Samsca
If you stop taking Samsca, this may lead to the recurrence of low sodium levels. Therefore, stop taking Samsca only if you experience side effects requiring urgent medical attention (see section 4), or if your doctor tells you to do so.
If you have any doubts about how to use this medicine, consult 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, urgent medical care may be required.
Stop taking Samsca and contact a doctor immediately, or go to the nearest hospital if you:

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

Consult your doctor if you develop symptoms such as fatigue, loss of appetite, discomfort in the upper right part of the abdomen, dark urine, or jaundice (yellowing of the skin or eyes).
Other side effects
Very common (may affect more than 1 in 10 people)

• nausea
• thirst
• rapid increase in sodium levels.

Common (may affect up to 1 in 10 people)

• excessive water intake
• water loss
• elevated levels of sodium, potassium, creatinine, uric acid, and blood sugar
• reduced blood sugar levels
• reduced appetite
• fainting
• headache
• dizziness
• low blood pressure when standing up
• constipation
• diarrhea
• dry mouth
• bruising
• itching
• increased need to urinate or more frequent urination
• tiredness, general weakness
• fever
• general feeling of being unwell
• blood in the urine
• elevated liver enzymes in the blood
• elevated creatinine levels in the blood.

Uncommon (may affect up to 1 in 100 people)

• taste disturbances
• kidney problems.

Not known (cannot be estimated from the available data)

• allergic reactions (see above)
• liver problems
• acute liver failure (acute liver failure, ALF)
• increased liver enzyme levels.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Samsca

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp." and on the
blister after "EXP." The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Samsca contains

• The active substance is tolvaptan. Each Samsca 7.5 mg tablet contains 7.5 mg of tolvaptan. Each Samsca 15 mg tablet contains 15 mg of tolvaptan. Each Samsca 30 mg tablet contains 30 mg of tolvaptan.
• The other ingredients are monohydrate lactose, maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, indigo carmine aluminium lake (E 132).

Description of the appearance of Samsca and contents of the pack
Samsca 7.5 mg: blue, rectangular, slightly convex tablets of 7.7 × 4.35 × 2.5 mm in size, imprinted with "OTSUKA" and "7.5" on one side.
Samsca 15 mg: blue, triangular, slightly convex tablets of 6.58 × 6.2 × 2.7 mm in size, imprinted with "OTSUKA" and "15" on one side.
Samsca 30 mg: blue, round, slightly convex tablets of 8 mm in diameter × 3.0 mm, imprinted 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 divisible unit-dose blisters
30 × 1 tablet in PVC/Al divisible unit-dose blisters

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

Not all pack sizes may be marketed.

Marketing Authorization 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 Authorization Holder:

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

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

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

Danmark Malta
Otsuka Pharma Scandinavia AB Otsuka Pharmaceutical Netherlands B.V.
Tlf: +46854 528 660 Tel: +31 (0) 20 85 46 555

Deutschland Nederland
Otsuka Pharma GmbH Otsuka Pharmaceutical Netherlands B.V.
Tel: +49691 700 860 Tel: +31 (0) 20 85 46 555

Eesti Norge
Otsuka Pharmaceutical Netherlands B.V. Otsuka Pharma Scandinavia AB
Tel: +31 (0) 20 85 46 555 Tlf: +46854 528 660

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

España Polska
Otsuka Pharmaceutical S.A Otsuka Pharmaceutical Netherlands B.V.
Tel: +3493 2081 020 Tel: +31 (0) 20 85 46 555

France Portugal
Otsuka Pharmaceutical France SAS Otsuka Pharmaceutical Netherlands B.V.
Tél: +33147 080 000 Tel: +31 (0) 20 85 46 555

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

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

Ísland Slovenská republika
Otsuka Pharma Scandinavia AB Otsuka Pharmaceutical Netherlands B.V.
Sími: +46854 528 660 Tel: +31 (0) 20 85 46 555

Italia Suomi/Finland
Otsuka Pharmaceutical Italy S.r.l. Otsuka Pharma Scandinavia AB
Tel: +39 02 00 63 27 10 Tel/ Puh: +46854 528 660

Κύπρος Sverige
Otsuka Pharmaceutical Netherlands B.V. Otsuka Pharma Scandinavia AB
Thλ: +31 (0) 20 85 46 555 Tel: +46854 528 660

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

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