SAMSCA 15 mg Tablet

Зміст інструкції

1. Samsca 7.5 mg tablets, 15 mg tablets, 30 mg tablets
   1. What is Samsca and what is it 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

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

tolvaptan

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. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Samsca and what is it 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 output. Antagonist means that it prevents 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, and consequently increases 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 to you because you suffer from low sodium concentrations in the blood due to a disease
called “inappropriate secretion of antidiuretic hormone” (SIADH) in which the kidneys
retain too much water. This disease causes an inappropriate production of the hormone
vasopressin, due to which the levels of sodium in the blood become too low (hyponatremia).
This can cause difficulty concentrating and remembering, or maintaining balance.

2. What you need to know before taking 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 are not functioning (do not produce urine)
• if you suffer from a condition that increases the salt in your blood (“hypernatremia”)
• if you have a condition associated with a very low blood volume
• if you do not notice that you are thirsty
• if you are pregnant
• if you are breastfeeding.

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

• if you cannot drink enough water or if you have limitations in fluid intake
• if you find it difficult to urinate or if your prostate is enlarged
• if you suffer from a 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) in the past
• 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 can
cause side 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 when you are thirsty.

Children and adolescents
Samsca is not suitable for 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 bought without a prescription.
The following medicines can enhance the effect of this medicine:

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

The following medicines can reduce the effects of this medicine:

• barbiturates (used as treatment for epilepsy/convulsions and for some sleep disorders),
• rifampicin (for tuberculosis).

This medicine can enhance the effects of the following medicines:

• digoxin (used in the treatment of irregular heartbeats 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 can reduce the effect of the following medicines:

• desmopressin (used to increase blood clotting factors).

There are cases where it may still be okay 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, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Do not takethis medicine if you are pregnant or if you are breastfeeding with breast milk.
During treatment with this medicine, adequate contraceptive methods must be adopted.

Driving and using machines
It is unlikely that Samsca will negatively affect your ability to drive or operate
machinery. However, you may experience occasional dizziness or weakness, or fainting for short
periods.

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 following exactly the instructions of your doctor. If you have any doubts, consult your doctor or pharmacist.

• Treatment with Samsca must begin in hospital.
• For the treatment of low sodium levels (hyponatremia), the doctor will start with a dose of 15 mg and may then increase it up to a maximum of 60 mg to reach the desired sodium level. To monitor the effects of Samsca, the doctor will take regular blood samples from you. To reach the desired sodium level, the doctor may, in some cases, administer a lower dose of 7.5 mg.
• Swallow the tablet with a glass of water, without chewing.
• Take the tablets once a day, 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 package of medicine with you, so it is clear what you have taken.

If you forget to take Samsca
If you forget to take the medicine, take the dose as soon as you remember, on the same day. If you do not take the tablet on a particular day, take the normal 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, this may lead to the reappearance of low sodium levels. Therefore, stop taking Samsca only if you notice side effects that require urgent medical attention (see section 4), or if you are told to do so by your doctor.
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 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).

Consult your doctor if you notice the appearance of symptoms such as: fatigue, loss of appetite, discomfort in the
upper right quadrant 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
• high levels of sodium, potassium, creatinine, uric acid and sugars in the blood
• reduction in blood sugar levels
• decreased appetite
• fainting
• headache
• dizziness
• low blood pressure when standing up
• constipation
• diarrhea
• dry mouth
• bruising
• itching
• increased need to urinate or urinating more often
• tiredness, general weakness
• fever
• feeling unwell
• blood in urine
• high levels of liver enzymes in the blood
• high levels of creatinine in the blood.

Uncommon (may affect up to 1 in 100 people)

• taste alterations
• kidney problems.

Not known (frequency cannot be estimated from the available data)

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

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 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 pack after Scad. 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 wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Samsca contains

• The active ingredient 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 lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, aluminium lake of indigotine (E 132).

Description of Samsca and contents of the pack
Samsca 7.5 mg: blue, rectangular, slightly convex tablets, measuring 7.7 × 4.35 × 2.5 mm in
size, with "OTSUKA" and "7.5" imprinted on one side.
Samsca 15 mg: blue, triangular, slightly convex tablets, measuring 6.58 × 6.2 × 2.7 mm in
size, with "OTSUKA" and "15" imprinted on one side.
Samsca 30 mg: blue, round, slightly convex tablets, with a diameter of 8 mm × 3.0 mm, with
"OTSUKA" and "30" imprinted on one side.
Samsca 7.5 mg tablets is available as
10 tablets in PP/Al blisters
30 tablets in PP/Al blisters
10 × 1 tablet in unit dose divisible PVC/Al blisters
30 × 1 tablet in unit dose divisible PVC/Al blisters
Samsca 15 mg and Samsca 30 mg tablets are available as
10 × 1 tablet in unit dose divisible PVC/Al blisters
30 × 1 tablet in unit dose divisible PVC/Al 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
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.
Tel/ Tél: +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
Tel/ Puh: +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

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 .

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