TOLVAPTAN ACCORD 15 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Tolvaptán Accord 15 mg Tablets

tolvaptán

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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.

Contents of the pack:

1. What is Tolvaptán Accord and what is it used for
2. What you need to know before you take Tolvaptán Accord
3. How to take Tolvaptán Accord
4. Possible side effects
5. Storage of Tolvaptán Accord
6. Contents of the pack and other information

1. What is Tolvaptán Accord and what is it used for

Tolvaptán Accord, which contains the active substance tolvaptán, belongs to a group of medicines called vasopressin antagonists. Vasopressin is a hormone that helps prevent water loss from the body by reducing urine production. An antagonist prevents vasopressin from having its effect on water retention, which leads to a reduction in the amount of water in the body by increasing urine production and results in an increase in blood sodium levels.

Tolvaptán Accord is used to treat low sodium levels in the blood in adults. You have been prescribed this medicine because you have low sodium levels in the blood due to a condition called “syndrome of inappropriate antidiuretic hormone secretion (SIADH)”, in which the kidneys retain too much water. This condition leads to inadequate production of the vasopressin hormone, which has caused your blood sodium levels to decrease too much (hyponatremia). This can cause concentration and memory difficulties or difficulty maintaining balance.

2. What you need to know before you take Tolvaptán Accord

Do not take Tolvaptán Accord

• if you are allergic to tolvaptán 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 any condition that increases blood salt levels (“hypernatremia”)
• if you have any condition related to very low blood volume
• if you do not feel thirsty
• if you are pregnant
• if you are breast-feeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tolvaptán Accord:

• if you cannot drink enough water or if you have fluid restriction
• if you have difficulty urinating or have an enlarged prostate
• if you have liver disease
• if you have had an allergic reaction to benzazepine, tolvaptán 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

Tolvaptán Accord causes water loss because it increases urine production. This water loss can cause side effects such as dry mouth and thirst, and even more serious side effects such as kidney problems (see Section 4). Therefore, it is essential that you have access to water and can drink sufficient amounts when you feel thirsty.

Children and adolescents

Tolvaptán Accord should not be used in the treatment of children and adolescents (under 18 years).

Other medicines and Tolvaptán Accord

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

The following medicines may increase the effects of this medicine:

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

The following medicines may decrease the effects of this medicine:

• barbiturates (used for the treatment of epilepsy/convulsions and some sleep disorders);
• rifampicin (against tuberculosis).

This medicine may increase the effects of the following medicines:

• digoxin (used for the treatment of 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 medicines:

• desmopressin (used to increase blood clotting factors).

It may be suitable for you to take these medicines at the same time as your treatment with Tolvaptán Accord. Your doctor will decide what is suitable for you.

Taking Tolvaptán Accord with food and drinks

Avoid drinking grapefruit juice when taking Tolvaptán Accord.

Pregnancy and breast-feeding

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.

Do not takethis medicine if you are pregnant or breast-feeding.

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

Driving and using machines

Tolvaptán Accord is unlikely to affect your ability to drive or use machines. However, you may occasionally feel dizzy or weak or faint for a short period.

Tolvaptán Accord contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Tolvaptán Accord

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

• Treatment with Tolvaptán Accord will be started in the hospital.
• For the treatment of low sodium levels (hyponatremia), your doctor will tell you to start taking a dose of 15 mg and may then increase it up to a maximum of 60 mg to achieve the desired sodium level in your blood. To monitor the effects of Tolvaptán Accord, your doctor will ask you to have blood tests from time to time. To achieve the desired sodium level in your blood, your doctor may in some cases give you a dose of 7.5 mg.
• Swallow the tablet whole, with a glass of water.
• Take the tablets once a day, preferably in the morning, with or without food.

If you take more Tolvaptán Accord than you should

If you take more tablets than prescribed, drink plenty of water and contact your doctor or the nearest hospital immediately. Remember to take the medicine pack with you so that it is clear what you have taken.

If you forget to take Tolvaptán Accord

If you forget to take your medicine, you should take the dose as soon as you remember on the same day. If you do not take a tablet one day, take your normal dose the next day. DO NOTtake a double dose to make up for forgotten doses.

If you stop taking Tolvaptán Accord

If you stop taking Tolvaptán Accord, you may have low sodium levels again. Therefore, you should only stop taking Tolvaptán Accord if you experience side effects that require 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.

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 Tolvaptán Accord and contact a doctor or go to the nearest hospital immediately if:

• you have difficulty urinating
• you notice swelling of the face, lips or tongue, itching, rash, wheezing or shortness of breath (symptoms of an allergic reaction).

Tell your doctor if you experience symptoms of fatigue, loss of appetite, discomfort in the upper right abdomen, dark urine or jaundice (yellowing of the skin or eyes).

Other side 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
• water loss
• high sodium, potassium, creatinine, uric acid and blood sugar levels
• decrease in blood sugar levels
• decrease in appetite
• fainting
• headache
• dizziness
• low blood pressure when standing up
• constipation
• diarrhea
• dry mouth
• irregular bleeding in skin areas
• itching
• increased need to urinate or urinate more frequently
• fatigue, general weakness
• fever
• general feeling of discomfort
• blood in the urine
• increase in liver enzyme levels in the blood
• increase in creatinine levels in the blood.

Uncommon (may affect up to 1 in 100 people)

• taste disturbance
• kidney problems.

Frequency not known (cannot be estimated from the available data)

• allergic reactions (see above)
• liver problems
• acute liver failure
• increase in liver enzymes.

Reporting of side effects

If you experience 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.

5. Storage of Tolvaptán Accord

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 or CAD. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

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 protect the environment.

6. Contents of the pack and other information

Composition of Tolvaptán Accord

• The active substance is tolvaptán.

Tolvaptán Accord 15 mg tablets: each tablet contains 15 mg of tolvaptán.

• The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, magnesium stearate, sodium croscarmellose, hydroxypropylcellulose and aluminum lake of carmine (E 132).

Appearance and packaging

Tolvaptán Accord 15 mg: blue to light blue, triangular, biconvex tablets, approximately 6.7 x 6.3 x 3.3 mm, engraved with “MT” on one side, and with “7” on the other.

Tolvaptán Accord 15 mg tablets are available as unit dose blister packs of PVC/Alu, 7x1, 10x1, 28x1, 30x1 tablets in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorisation holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est, 6a Planta,

08039 Barcelona,

Spain

Manufacturer

Accord Healthcare Polska Sp. z.o.o.

ul.Lutomierska 50,

95-200, Pabianice, Poland

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park,

Paola PLA 3000, Malta

Accord Healthcare B.V.

Winthontlaan 200,

3526 KV Utrecht, Netherlands

Date of last revision of this leaflet:March 2023

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.