7.5 mg tablets, 15 mg tablets, and 30 mg tolvaptan tablets respectively
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 fluid loss in the body by reducing the amount of urine. Antagonist means that the drug prevents vasopressin from retaining water in the body. This leads to a decrease in the amount of water in the body by increasing urine production, and as a result, it raises the level of concentration of sodium in the blood.
Samsca is used to treat low levels of serum sodium in adults. You have been prescribed this medicine because you have a decreased level of sodium in your blood as a result of a disease called SIADH (inadequate ADH secretion ) in which your kidneys retain too much water. This disease causes excessive production of the hormone et vasopressin, which has caused the sodium levels in your blood to become too low ( hyponatremia ). This can lead to problems with concentration and memory, or to keeping your balance.
What you need to know before taking Samsca
Do not use 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 (eg benazepril, conivaptan, phenoldopammesylate or mirtazapine)
- if your kidneys do not work (no urine production)
- if you have a disease that causes the salinity in the blood to rise (“hypernatremia”)
- if you have a disease that is associated with a very low blood volume
- if you do not feel like you are thirsty
- if you are pregnant
- if you are breastfeeding.
Warnings and cautions
Talk to your doctor or pharmacist before using Samsca:
- if you can not drink enough water or if you are not allowed to drink a lot of fluids
- if you have trouble urinating or if you have an enlarged prostate
- if you have liver disease
- if you have previously had an allergic reaction to benzazepine, tolvaptan, or other benzazepine derivatives (eg benazepril, conivaptan, fenoldopam style 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 as it increases your urine production. This water loss can lead to side effects, e.g. Dry mouth and thirst, or even more serious side effects are kidney problems (see section 4). Therefore, it is important that you have access to water and that you can drink enough water when you are thirsty.
Children and young people
Samsca is not suitable for children and adolescents (under 18 years).
Other medicines and Samsca
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including 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 that increase the amount of salt in the blood or contain large amounts of salt.
The following medicines may reduce the effect of this medicine:
- barbiturates (used to treat epilepsy/seizures and certain sleep disorders),
- rifampicin (for tuberculosis ).
This medicine may increase the effect of the following medicines:
- digoxin (used to treat irregular heartbeat and heart failure )
- dabigatran etexilate (used as a blood thinner)
- metformin (used to treat diabetes )
- sulfasalazine (used to treat inflammatory bowel disease or rheumatoid arthritis ).
This medicine may reduce the effect of the following medicines:
- desmopressin (used to increase the blood’s ability to coagulate).
It may still be the case that you can take these medicines and Samsca together. Your doctor can decide what is most suitable for you.
Samsca with food and drink
Avoid drinking grapefruit juice while taking Samsca.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, 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 take this medicine if you are pregnant or breastfeeding.
Adequate contraception must be used during treatment with this medicine.
Driving and using machines
Samsca probably has no negative effect on the ability to drive and use machines. However, you may sometimes feel dizzy or weak, or faint for a short time.
Samsca contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Samsca
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- Treatment with Samsca begins in the hospital.
- When treating 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 sodium in your blood. Your doctor will take regular blood tests to monitor the effect of Samsca. To achieve the desired level of sodium in the blood, the doctor may in some cases give 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 your prescribed dose, drink plenty of water and contact your doctor or nearest hospital immediately. Remember to bring 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 tablet, take one as soon as you remember the same day. If you do not take your tablet on the same day, you should take your normal dose the next day. Do not take a double dose to make up for a forgotten dose.
If you stop taking Samsca
If you stop taking Samsca, this may cause your low sodium content to return. Therefore, you should only stop taking Samsca if you notice side effects that require prompt medical attention (see section 4) or if your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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 immediately or go to the nearest hospital if you:
- notice that you have difficulty urinating
- notice that your face, lips, or tongue are swollen, you get itching, rash all over the body, or if it hisses loudly when you breathe or you get shortness of breath (symptoms of an allergic reaction ).
Contact a doctor if you get symptoms in the form of fatigue, loss of appetite, discomfort in the upper right part of the stomach, dark urine, or jaundice (skin or eyes yellowing).
Other side effects:
Very common (may affect more than 1 user in 10)
- nausea
- thirst
- the rapid rise in sodium levels.
Common (may affect up to 1 in 10 people)
- excessive drinking of water
- water loss
- high levels of sodium, potassium, creatinine, uric acid, and blood sugar
- lowered blood sugar levels
- decreased appetite
- fainting
- headache
- dizziness
- low blood pressure when you stand up
- constipation
- diarrhea
- dry mouth
- spotty bleeding in the skin
- itching
- increased need to urinate, or to urinate more often
- fatigue, general weakness
- fever
- general malaise
- blood in the urine
- elevated levels of liver enzymes in the blood
- elevated levels of creatinine in the blood.
Uncommon (may affect up to 1 in 100 people)
- changed taste experience
- kidney problems
No known frequency (can not be calculated from the available data)
- allergic reactions (see above)
- liver problem
- acute liver failure
- increase in liver enzymes.
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 carton and blister after “EXP”. The expiration date is the last day of the specified month.
Store in the original package. Sensitive to light. Moisture sensitive.
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 to protect the environment.
Contents of the packaging and other information
Content declaration
- The active substance is tolvaptan.One Samsca 7.5 mg tablet contains 7.5 mg tolvaptan.One Samsca 15 mg tablet contains 15 mg tolvaptan.One Samsca 30 mg tablet contains 30 mg tolvaptan.
- The other ingredients are lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, and indigo carmine aluminum lacquer (E 132).
What the medicine looks like and the contents of the pack
Samsca 7.5 mg: Blue, rectangular, slightly convex tablets measuring 7.7 × 4.35 × 2.5 mm, debossed with “OTSUKA” and “7.5” on one side.
Samsca 15 mg: Blue, triangular, slightly convex tablets measuring 6.58 × 6.2 × 2.7 mm, debossed with “OTSUKA” and “15” on one side.
Sams
ca 30 mg: Blue, round, slightly convex tablets measuring Ø8 × 3.0 mm, debossed with “OTSUKA” and “30” on one side.
Samsca 7.5 mg tablets are supplied as
10 tablets in blisters of PP / Al
30 tablets in blisters of PP / Al
10 × 1 tablet in perforated single-dose blisters of PVC / Al
30 × 1 tablet in perforated single-dose blisters of PVC / Al
Samsca 15 mg tablets and Samsca 30 mg tablets are provided as
10 × 1 tablet in perforated single-dose blisters of PVC / Al
30 × 1 tablet in perforated single-dose blisters of PVC / Al
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Otsuka Pharmaceutical Netherlands BV
Herikerbergweg 292
1101 CT, Amsterdam
Netherlands
Manufacturer
Millmount Healthcare Limited
Block-7, City North Business Campus, Stamullen, Co.
Meath, K32 YD60
Ireland
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 | LithuaniaOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 |
| BulgariaOtsuka Pharmaceutical Netherlands BVPhone: +31 (0) 20 85 46 555 | Luxembourg / LuxemburgOtsuka Pharmaceutical Netherlands BVTel / Tel: +31 (0) 20 85 46 555 |
| Czech RepublicOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 | HungaryOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 |
| DenmarkOtsuka Pharma Scandinavia ABTel: +46854 528 660 | MaltaOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 |
| GermanyOtsuka Pharma GmbHTel: +49691 700 860 | The NetherlandsOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 5550 |
| EestiOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 | NorwayOtsuka Pharma Scandinavia ABTel: +46854 528 660 |
| GreeceOtsuka Pharmaceutical Netherlands BVThλ: +31 (0) 20 85 46 555 | AustriaOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 |
| SpainOtsuka Pharmaceutical SATel: +3493 2081 020 | PolandOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 |
| FranceOtsuka Pharmaceutical France SASTel: +33147 080 000 | PortugalOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 |
| CroatiaOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 | RomaniaOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 |
| IrelandOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 | SloveniaOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 |
| IcelandOtsuka Pharma Scandinavia ABPhone: +46854 528 660 | Slovak RepublicOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 |
| ItalyOtsuka Pharmaceutical Italy SrlTel: +39 02 00 63 27 10 | Finland / FinlandOtsuka Pharma Scandinavia ABTel / Puh: +46854 528 660 |
| ΚύπροςOtsuka Pharmaceutical Netherlands BVThλ: +31 (0) 20 85 46 555 | SwedenOtsuka Pharma Scandinavia ABTel: +46854 528 660 |
| LatviaOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 | United Kingdom (Northern Ireland)Otsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 |