Samsca

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 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

How to take Samsca

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 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 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 Samsca 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 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.

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 immediately contact a doctor or go to the nearest hospital if you:
• 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. 4

Other side effects

Very common (may affect more than 1 in 10 people)
• thirst
• feeling sick
• rapid rise in level of sodium.

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
• 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.

Uncommon (may affect up to 1 in 100 people)
• sense of taste altered
• kidney problems.

Not known (cannot be estimated from the available data)
• allergic reactions (see above)
• liver problems
• increase in liver enzymes
• acute liver failure (ALF).

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 via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine

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 expiry date refers to the last day of that month. Store in the original package in order to protect from light and moisture. 5 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.