SamscA 15 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Samsca 7.5mg tablets

Samsca 15mg tablets

Samsca 30mg tablets

tolvaptan

Read the 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents:

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. Package contents and additional information

1. What Samsca is and what it is used for

Samsca, which contains the active substance tolvaptan, belongs to a group of medicines 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, thereby reducing the amount of water in the body by increasing urine production, resulting in an increase in blood sodium levels.

Samsca is used to treat low serum sodium levels in adults. Your doctor has prescribed this medicine because you have low sodium levels in your blood as a result of a condition called "syndrome of inappropriate antidiuretic hormone secretion (SIADH)", in which the kidneys retain too much water. This condition leads to an inappropriate production of the hormone vasopressin, causing your blood sodium levels to become too low (hyponatremia). This may cause difficulties with concentration and memory or with 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 derivatives of benzazepine (e.g., benazepril, conivaptan, fenoldopam mesylate, or mirtazapine)
• if your kidneys do not work (no urine production)
• if you have any condition that increases blood sodium levels (“hypernatremia”)
• if you have any condition 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 starting to take Samsca:

• if you are unable to 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 previously experienced 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 may cause adverse effects such as dry mouth and thirst, and even more serious adverse effects such as kidney problems (see section 4). Therefore, it is important that you have access to water and can drink sufficient amounts whenever you feel thirsty.

Children and adolescents

Samsca must not be used in the treatment of 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 need to take any other medicines, including those obtained without a prescription.

The following medicines may increase the effects of this medicine:

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

The following medicines may decrease the effects of this medicine:

• barbiturates (used to treat epilepsy/seizures and certain sleep disorders);
• rifampicin (for tuberculosis);
• St. John’s wort, a herbal remedy used to treat depression.

This medicine may increase the effects of the following medicines:

• digoxin (used to treat irregular heartbeat 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 medicine:

• 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, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take this medicine if you are pregnant or breastfeeding.

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

Driving and using machines

It is unlikely that Samsca will negatively affect your ability to drive or use machines. However, you may occasionally feel dizzy, weak, or may briefly faint.

Samsca 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 Samsca

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

• Treatment with Samsca will be started in hospital.
• For the treatment of low sodium levels (hyponatremia), your doctor will instruct you to start with a dose of 15 mg and may then increase it up to a maximum of 60 mg to achieve the desired serum sodium level. To monitor the effects of Samsca, your doctor will request periodic blood tests. In some cases, to achieve the desired serum sodium level, your doctor may prescribe a dose of 7.5 mg.
• Swallow the tablet whole without chewing, with a glass of water.
• Take the tablets once daily, preferably in the morning, with or without food.

If you take more Samsca than you should

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

If you forget to take Samsca

If you forget to take your dose, you should take it as soon as you remember, on the same day. If you miss a dose on 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 Samsca

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

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

4. Possible adverse effects

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

If you notice any of the following adverse effects, you may need urgent medical attention. 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, wheezing, or shortness of breath (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 adverse 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
• loss of body water
• high levels of sodium, potassium, creatinine, uric acid, and blood sugar
• low blood sugar levels
• loss of appetite
• fainting
• headache
• dizziness
• low blood pressure upon standing
• constipation
• diarrhea
• dry mouth
• irregular bleeding under the skin
• itching
• increased need to urinate or urinating more frequently
• tiredness, general weakness
• fever
• general feeling of being unwell
• blood in the urine
• increased liver enzymes in the blood
• increased creatinine levels in the blood.

Uncommon (may affect up to 1 in 100 people)

• altered sense of taste
• kidney 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 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 indicated.

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

Medicines must 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 will help protect the environment.

6. Contents of the pack and other information

Composition of Samsca

• 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 components are monohydrate lactose, corn starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate and indigo carmine aluminium lake (E 132).

Appearance of the product and contents of the pack

Samsca 7.5 mg: blue, rectangular, slightly convex tablets, with dimensions of 7.7 × 4.35 × 2.5 mm, embossed 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, embossed with “OTSUKA” and “15” on one side.

Samsca 30 mg: blue, round, slightly convex tablets, with dimensions of 8 mm diameter × 3.0 mm, embossed 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 single-dose perforated unit dose blisters

30 × 1 tablet in PVC/Al single-dose perforated unit dose blisters

Samsca 15 mg and Samsca 30 mg tablets are available as:

10 × 1 tablet in PVC/Al single-dose perforated unit dose blisters

30 × 1 tablet in PVC/Al single-dose perforated unit dose blisters

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292

1101 CT, Amsterdam

The Netherlands

Manufacturer responsible for manufacturing

Millmount Healthcare Limited

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

Ireland

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: {MM/YYYY}.

Other sources of information

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