Prospect: information for the patient

Tolvaptán Accord 7.5 mg tablets

tolvaptan

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only to you, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before taking Tolvaptán Accord

3.How to take Tolvaptán Accord

4.Possible adverse effects

5.Storage of Tolvaptán Accord

6.Contents of the package and additional information

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

Tolvaptán Accord is used to treat low serum sodium levels in adults. You have been prescribed this medication because you have low sodium levels in your blood as a result of a disease called "inadequate secretion of antidiuretic hormone syndrome (SIHAD)", in which the kidneys retain too much water. This disease leads to inadequate production of the vasopressin hormone, which has caused your blood sodium levels to decrease too much (hyponatremia). This can cause difficulties with concentration and memory or maintaining balance.

Do not take Tolvaptán Accord

•if you are allergic to tolvaptán or any of the other components of this medication (listed in section 6) or if you are allergic to benzazepine or benzazepine derivatives (for example, benazepril, conivaptán, mesilato de fenoldopam or mirtazapina)

•if your kidneys do not function (no urine production)

•if you have any disease that increases the levels of salt in the blood (“hypernatremia”)

•if you have any disease related to very low blood volume

•if you do not feel thirsty

•if you are pregnant

•if you are breastfeeding.

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 in the past any allergic reaction to benzazepine, tolvaptán or other benzazepine derivatives (e.g. benazepril, conivaptán, mesilato de fenoldopam or mirtazapina), or to any of the other components of this medication (listed in section 6)

•if you have a kidney disease called autosomal dominant polycystic kidney disease (PQRAD)

•if you have diabetes.

Drink enough water

Tolvaptán Accord causes water loss because it increases urine production. This water loss may 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 important that you have access to water and that you can drink enough when you feel thirsty.

Children and adolescents

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

Other medications and Tolvaptán Accord

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medication, including those purchased without a prescription.

The following medications may increase the effects of this medication:

•ketoconazol (against fungal infections);

•macrolide antibiotics;

•diltiazem (treatment for high blood pressure and chest pain);

•other products that increase the concentration of salt in the blood or that contain large amounts of salt.

The following medications may decrease the effects of this medication:

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

•rifampicina (against tuberculosis).

This medication may increase the effects of the following medications:

•digoxina (used for the treatment of irregular heartbeats and heart failure);

•etexilato de dabigatrán (used as an anticoagulant of the blood);

•metformina (for the treatment of diabetes);

•sulfasalazina (used to treat inflammatory bowel disease or rheumatoid arthritis).

This medication may decrease the effects of the following medications:

•desmopresina (used to increase blood clotting factors).

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

Taking Tolvaptán Accord with food and drinks

Avoid drinking grapefruit juice when taking Tolvaptán Accord.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Do not takethis medicationif you are pregnant or breastfeeding.

Appropriate contraceptive measures should be used during treatment with this medication.

Driving and operating machinery

It is unlikely that Tolvaptán Accord will negatively affect your ability to drive or operate machinery.However, you may occasionally feel dizzy or weak or experience a brief period of fainting.

Tolvaptán Accord contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

•Tolvaptan Accord treatment will start in the hospital.

•For the treatment of low sodium levels (hypontremia), your doctor will instruct you to start taking a dose of 15 mg and may increase it up to a maximum of 60 mg to achieve the desired sodium level in serum. Your doctor will ask you to have blood tests at regular intervals to control the effects of Tolvaptan Accord. To achieve the desired serum sodium level, your doctor may administer a dose of 7.5 mg in some cases.

•Swallow the tablet without crushing it, with a glass of water.

•Take the tablets once a day, preferably in the morning, with or without food.

If you take more Tolvaptan Accord than you should

If you take more tablets than the prescribed dose,drink large amounts of water and contact your doctor or the nearest hospital immediately. Remember to bring the medication packaging to clarify what you have taken.

If you forget to take Tolvaptan Accord

If you forget to take your medication, take the dose as soon as you remember the same day. If you miss a tablet, take your normal dose the next day.DO NOTtake a double dose to compensate for the missed doses.

If you interrupt treatment withTolvaptan Accord

Ifyou stop taking Tolvaptan Accord, you mayproduce low sodium levels again. Therefore, you should only stop takingTolvaptan Accord if you observe urgent medical attention required side effects (see section 4) or if your doctor instructs you to do so.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you notice any of the following side effects, you may need urgent medical attention.Stop taking Tolvaptán Accord and contact a doctor immediately or go to the nearest hospital if:

•you have difficulty urinating

•you observe swelling of the face, lips, or tongue, itching, generalised rash, wheezing, or shortness of breath (symptoms of an allergic reaction).

Consult your doctor if you experience symptoms of fatigue, loss of appetite, upper right abdominal discomfort, 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 levels of sodium, potassium, creatinine, uric acid, and blood sugar

•low blood sugar levels

•loss of appetite

•syncope

•headache

•dizziness

•orthostatic hypotension

•constipation

•diarrhea

•dry mouth

•irregular bleeding in skin areas

•itching

•increased need to urinate or urinating more frequently

•fatigue, general weakness

•fever

•general feeling of unwellness

•blood in the urine

•increased levels of liver enzymes in the blood

•increased levels of creatinine in the blood.

Uncommon (may affect up to 1 in 100 people)

•alteration of taste

•renal problems.

Frequency not known (cannot be estimated from available data)

•allergic reactions (see above)

•liver problems

•acute liver failure (ALF)

•increased liver enzymes.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister pack after EXP or CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Tolvaptan Accord

-The active ingredient is tolvaptan.

Tolvaptan Accord 7.5 mg tablets: each tablet contains 7.5 mg of tolvaptan.

-The other components are lactose monohydrate, cornstarch, microcrystalline cellulose, magnesium stearate, sodium croscarmellose, hydroxypropyl cellulose, and aluminium lake carmine (E 132).

Appearance of the product and contents of the packaging

Tolvaptan Accord7.5 mg: blue to blue-coloured, round, biconvex, approximately 5.0 mm tablets, engraved with “MT” on one face, and with “18” on the other.

Tolvaptan Accord 7.5 mgtabletsare available asblister packsof perforated PVC/Alu, in sizes 7x1, 10x1, 28x1, 30x1 tablets in a cardboard box.

Only some sizes of packaging may be commercially available.

Marketing authorisation holder

Accord Healthcare S.L.U.

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

Edifici Est, 6afloor,

08039 Barcelona,

Spain

Responsible for manufacturing

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

Last revision date of this leaflet:March 2023

Other sources of information

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