Leaflet:information for the user

Tolvaptán Tevagen 15 mg tablets EFG

Tolvaptán Tevagen 30 mg tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask yourdoctor orpharmacist.

-This medicine has been prescribedonlyfor you, and you must not give it to others even if they havethe same symptomsas you,as it may harm them.

• If you experience any side effects,consult your doctor or pharmacist,even if they are not listed in this leaflet. See section 4.

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

2.What you need to knowbeforestarting totake Tolvaptán Tevagen

3.How to take Tolvaptán Tevagen

4.Possible side effects

5Storage of Tolvaptán Tevagen

6.Contents of the pack and additional information

This medication, which contains the active ingredient tolvaptan, 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.

Tolvaptan 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 Tevagen:

• 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:

• if you cannot drink enough water or if you have fluid restrictions
• if you have difficulty urinating or have an enlarged prostate
• if you have liver disease
• if you have had a past allergic reaction to benzacepina, 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 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 essential that you have access to water and can drink sufficient amounts when you feel thirsty.

Children and adolescents

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

Taking Tolvaptán Tevagen with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, even 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).

This medication may decrease the effects of the following medications:

• desmopresina (used to increase blood clotting factors).

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

Taking Tolvaptán Tevagen with food and drinks

Avoid drinking grapefruit juice when taking tolvaptán.

Pregnancy and breastfeeding

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

Do not takethis medication if 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 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.

Use in athletes

This medication contains tolvaptán, which may produce a positive result in doping control tests.

Tolvaptán Tevagen contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before

taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

.

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

• Tolvaptan treatment will start in the hospital.
• 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 serum sodium level. Your doctor will ask you to have blood tests at regular intervals to control the effects of tolvaptan. In some cases, your doctor may administer a dose of 7.5 mg to achieve the desired serum sodium level.

Tolvaptan Tevagen 15 mg Tablets

• The tablet can be divided into equal doses.
• 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 Tolvaptan Tevagen 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.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Tolvaptan Tevagen

If you forget to take your medication, take the dose as soon as you remember on the same day. If you miss a tablet, take your regular dose the next day. Do not take a double dose to compensate for a missed dose.

If you interrupt treatment with Tolvaptan Tevagen

If you stop taking tolvaptan, you may experience low sodium levels again. Therefore, you should only stop taking this medication 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 may cause side effects, although not everyone will experience them.

If you notice any of the following side effects, you may need to receive urgent medical attention. Stop taking tolvaptan 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, severe 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
• low blood pressure when standing up
• 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

Rare (may affect up to 1 in 100 people)

• alteration of taste
• kidney problems
• high levels of bilirubin in the blood

Unknown frequency (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 the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthecontainer and the blisterafter CAD or EXP. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash. Dispose of containers and medications you no longer need at the SIGREpoint at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tolvaptan Tevagen

• The active ingredient is tolvaptan.

Each Tolvaptan Tevagen 15 mg tablet contains 15 mg of tolvaptan.

Each Tolvaptan Tevagen 30 mg tablet contains 30 mg of tolvaptan.

• The other excipients are lactose monohydrate (see section 2), sodium lauryl sulfate, povidone, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Appearance of the product and contents of the package

Tolvaptan Tevagen 15 mg:

Round, uncoated tablets, white to off-white in color, with a notch, having a line of partition on both sides and marked with “A” and “3” on each side of the line of partition on one side. Dimensions: approximately 5.50 mm.

Tolvaptan Tevagen 30 mg:

Round, uncoated tablets, white to off-white in color, marked with “T5” on one face and flat on the other face, with a diameter of approximately 6.80 mm.

The following package sizes are available:

• Blister with PVC/Aclar/PVC forming foil and PET/Aluminum sealing foil.
• Blister with PVC/Aclar/PVC forming foil and aluminum sealing foil.
• Blister with OPA/Aluminum/PVC forming foil and PET/Aluminum sealing foil.

Tolvaptan Tevagen 15 mg tablets EFG:

Blister packs containing 10 or 30 tablets, and single-dose blister packs containing 10x1 tablets and 30x1 tablets.

Tolvaptan Tevagen 30 mg tablets EFG:

Blister packs containing 10 or 30 tablets, and single-dose blister packs containing 10x1 tablets and 30x1 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Responsible for manufacturing

Tevagen Operations Poland Sp. z.o.o. (BS 2)

ul. Mogilska 80

PL-31-546 Kraków

Poland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Tevagen Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 – Madrid

Spain

Last reviewed date of thisleaflet:April 2023

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)