Samsca
tolvaptan
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Samsca is and what it is used for
What you need to know before you take Samsca
How to take Samsca
Possible side effects
How to store Samsca
Contents of the pack and other information
Samsca, which contains the active substance tolvaptan, belongs to a group of medicines called vasopressin antagonists. Vasopressin is a hormone that helps prevent the loss of water from the body by reducing urine output. Antagonist means that it prevents vasopressin having its effect on water retention. This leads to a reduction in the amount of water in the body by increasing urine production and as a result it increases the level or concentration of sodium in your blood.
Samsca is used to treat low serum sodium levels in adults. You have been prescribed this medicine because you have a lowered sodium level in your blood as a result of a disease called “syndrome of inappropriate antidiuretic hormone secretion” (SIADH) where the kidneys retain too much water. This disease causes an inappropriate production of the hormone vasopressin which has caused the sodium levels in your blood to get too low (hyponatremia). That can lead to difficulties in concentration and memory, or in keeping your balance.
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 (no urine production)
if you have a condition which increases the salt in your blood (“hypernatremia”)
if you have a condition which is associated with a very low blood volume
if you do not realise when you are thirsty
if you are pregnant
if you are breast-feeding.
Talk to your doctor or pharmacist before taking Samsca:
if you cannot drink enough water or if you are fluid restricted
if you have difficulties in urination or have an enlarged prostate
if you suffer from liver disease
if you had an allergic reaction in the past 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.
Drinking enough water
Samsca causes water loss because it increases your urine production. This water loss may result in side effects such as dry mouth and thirst or even more severe side effects like kidney problems (see
section 4). It is therefore important that you have access to water and that you are able to drink sufficient amounts when you feel thirsty.
Samsca is not suitable for children and adolescents (under age 18).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes all medicines obtained without a prescription.
The following medicines may increase the effect of this medicine:
ketoconazole (against fungal infections),
macrolide antibiotics,
diltiazem (treatment for high blood pressure and chest pain),
other products which increase the salt in your blood or which contain large amounts of salt.
The following medicines may lower the effect of this medicine:
barbiturates (used to treat epilepsy/seizures and some sleep disorders),
rifampicin (against tuberculosis).
This medicine may increase the effect of the following medicines:
digoxin (used for treatment of irregularities of heartbeat 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 lower the effect of the following medicines:
desmopressin (used to increase blood clotting factors).
It may still be alright for you to take these medicines and Samsca together. Your doctor will be able to decide what is suitable for you.
Avoid drinking grapefruit juice when taking Samsca.
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.
Adequate contraceptive measures must be used during use of this medicine.
Samsca is unlikely to adversely affect your ability to drive or to operate machinery. However, you may occasionally feel dizzy or weak or you may faint for a short period.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Treatment with Samsca will be initiated in hospital.
For treatment of your low sodium (hyponatremia), your doctor will start with a dose of 15 mg and may then increase it to a maximum of 60 mg to achieve the desired level of serum sodium.
To monitor the effects of Samsca your doctor will do regular blood tests. To achieve the desired
level of serum sodium your doctor can give in some instances a lower 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 have taken more tablets than your prescribed dose, drink plenty of water and contact your doctor or your local hospital immediately. Remember to take the medicine pack with you so that it
is clear what you have taken.
If you forget to take your medicine, you have to take the dose as soon as you remember on the same day. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for a forgotten dose.
If you stop taking Samsca this may lead to reoccurrence of your low sodium. Therefore, you should only stop taking Samsca if you notice side effects requiring 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
find it difficult to urinate
find a swelling of the face, lips or tongue, itching, generalised rash, or severe wheezing or breathlessness (symptoms of an allergic reaction).
Consult your doctor if symptoms of fatigue, loss of appetite, right upper abdominal discomfort, dark urine or jaundice (yellowing of skin or eyes) occur.
feeling sick
thirst
rapid rise in level of sodium.
excessive drinking of water
water loss
high levels of sodium, potassium, creatinine, uric acid and blood sugar
decrease in level of blood sugar
decreased appetite
fainting
headache
dizziness
low blood pressure when standing up
constipation
diarrhoea
dry mouth
patchy bleeding in the skin
itching
increased need to urinate, or to urinate more frequently
tiredness, general weakness
fever
general feeling of being unwell
blood in urine
raised levels of liver enzymes in the blood
raised levels of creatinine in the blood.
sense of taste altered
kidney problems
allergic reactions (see above)
liver problems
acute liver failure (ALF)
increase in liver enzymes.
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 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.
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 and blister after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light and moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is tolvaptan
Each Samsca 7.5 mg tablet contains 7.5 mg tolvaptan. Each Samsca 15 mg tablet contains 15 mg tolvaptan. Each Samsca 30 mg tablet contains 30 mg tolvaptan.
The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, indigo carmine aluminium lake (E 132).
Samsca 7.5 mg: Blue, rectangular, shallow-convex tablets with dimensions of 7.7 × 4.35 × 2.5 mm, debossed with “OTSUKA” and “7.5” on one side.
Samsca 15 mg: Blue, triangular, shallow-convex tablets with dimensions of 6.58 × 6.2 × 2.7 mm, debossed with “OTSUKA” and “15” on one side.
Samsca 30 mg: Blue, round, shallow-convex tablets with dimensions of Ø8 × 3.0 mm, debossed with “OTSUKA” and “30” on one side.
Samsca 7.5 mg tablets are available as 10 tablets in PP/Alu blisters
30 tablets in PP/Alu blisters
10 × 1 tablet in PVC/Alu perforated unit dose blisters 30 × 1 tablet in PVC/Alu perforated unit dose blisters
Samsca 15 mg and Samsca 30 mg tablets are available as 10 × 1 tablet in PVC/Alu perforated unit dose blisters
30 × 1 tablet in PVC/Alu perforated unit dose blisters
Not all pack sizes may be marketed.
1101 CT, Amsterdam Netherlands
Millmount Healthcare Limited
Block-7, City North Business Campus, Stamullen, Co. Meath, K32 YD60 Ireland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Otsuka Pharmaceutical Netherlands B.V. Tél/Tel: +31 (0) 20 85 46 555
Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Otsuka Pharmaceutical Netherlands B.V.
Teл: +31 (0) 20 85 46 555
Otsuka Pharmaceutical Netherlands B.V. Tel/ Tél: +31 (0) 20 85 46 555
Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Otsuka Pharma Scandinavia AB Tlf: +46854 528 660
Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Otsuka Pharma GmbH Tel: +49691 700 860
Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Otsuka Pharma Scandinavia AB Tlf: +46854 528 660
Otsuka Pharmaceutical Netherlands B.V.
Thλ: +31 (0) 20 85 46 555
Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Otsuka Pharmaceutical S.A Tel: +3493 2081 020
Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Otsuka Pharmaceutical France SAS Tél: +33147 080 000
Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Otsuka Pharma Scandinavia AB Sími: +46854 528 660
Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Otsuka Pharmaceutical Italy S.r.l. Tel: +39 02 00 63 27 10
Otsuka Pharma Scandinavia AB Tel/ Puh: +46854 528 660
Otsuka Pharmaceutical Netherlands B.V.
Thλ: +31 (0) 20 85 46 555
Otsuka Pharma Scandinavia AB Tel: +46854 528 660
Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555