TOLVAPTAN TEVAGEN 15 mg TABLETS

2. What you need to know before taking Tolvaptan Tevagen

Do not take Tolvaptan Tevagen:

• if you are allergic to tolvaptan or any of the other components of this medication (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 function (no urine production)
• if you have any disease that increases blood salt levels ("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 tolvaptan:

• 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 an allergic reaction to benzacepine, tolvaptan, or other benzazepine derivatives (e.g., benazepril, conivaptan, fenoldopam mesylate, or mirtazapine), 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 (ADPKD)
• if you have diabetes.

Adequate water intake

Tolvaptan 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

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

Taking Tolvaptan Tevagen with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription.

The following medications may increase the effects of this medication:

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

The following medications may decrease the effects of this medication:

• barbiturics (used to treat epilepsy/convulsions and some sleep disorders);
• rifampicin (against tuberculosis).
• St. John's Wort, a herbal medicine used to treat depression.

This medication may increase the effects of the following medications:

• digoxin (used to treat 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 medication may decrease the effects of the following medications:

• desmopressin (used to increase blood clotting factors).

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

Taking Tolvaptan Tevagen with food and drinks

Avoid drinking grapefruit juice when taking tolvaptan.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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.

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

Driving and using machines

It is unlikely that tolvaptan will negatively affect your ability to drive or use machines. However, you may occasionally feel dizzy or weak or faint for a short period.

Use in athletes

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

Tolvaptan 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".

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3. How to take Tolvaptan Tevagen

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

• Treatment with tolvaptan will be started in the hospital.
• For the treatment of low sodium levels (hyponatremia), your doctor will indicate that you 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 serum. To control the effects of tolvaptan, your doctor will ask you to have blood tests done from time to time. To achieve the desired sodium level, your doctor may administer a dose of 7.5 mg in some cases.

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 plenty of water and contact your doctor or the nearest hospital immediately. Remember to bring the medication package so that it is clear what you have taken.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the package and the medication leaflet to the healthcare professional.

If you forget to take Tolvaptan Tevagen

If you forget to take your medication, 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 not take a double dose to make up for a forgotten dose.

If you stop taking Tolvaptan Tevagen

If you stop taking tolvaptan, it may cause your sodium levels to drop again. Therefore, you should only stop taking this medication if you observe side effects that require urgent medical attention (see section 4) or if your doctor tells you to.

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

4. Possible side effects

Like all medications, this medication 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 tolvaptan and contact a doctor or go to the nearest hospital immediately if:

• you have difficulty urinating.

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

Consult 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
• decreased blood sugar levels
• decreased appetite
• fainting
• headache
• dizziness
• low blood pressure when standing up
• constipation
• diarrhea
• dry mouth
• bleeding in skin areas
• itching
• increased need to urinate or urinating more frequently
• fatigue, general weakness
• fever
• general feeling of discomfort
• blood in the urine
• increased liver enzyme levels in the blood

Uncommon (may affect up to 1 in 100 people)

• altered sense of taste
• kidney problems
• elevated bilirubin levels in the blood

Frequency not known (cannot be estimated from available data)

• allergic reactions (see above)
• liver problems
• acute liver failure (ALF)
• increased liver enzymes

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Tolvaptan Tevagen

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

Do not use this medication after the expiration date shown on the package and blister after CAD or EXP. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Keep it in the original packaging to protect it from light.

Medications should not be thrown away in drains or trash. Deposit the packages and medications you no longer need in the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

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 package contents

Tolvaptan Tevagen 15 mg:

White to off-white, round, uncoated tablets with a score line on both sides and marked with "A" and "3" on each side of the score line on one side. Dimensions: approximately 5.50 mm.

Tolvaptan Tevagen 30 mg:

White to off-white, round, uncoated tablets, marked with "T5" on one side and flat on the other side, with a diameter of approximately 6.80 mm.

The following package sizes are available:

• Blister pack with PVC/Aclar/PVC forming film and paper/PET/aluminum sealing film.
• Blister pack with PVC/Aclar/PVC forming film and aluminum sealing film.
• Blister pack with OPA/aluminum/PVC forming film and paper/PET/aluminum sealing film.

Tolvaptan Tevagen 15 mg tablets EFG:

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

Tolvaptan Tevagen 30 mg tablets EFG:

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

Not all package sizes may be marketed.

Marketing authorization holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Manufacturer

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

ul. Mogilska 80

PL-31-546 Kraków

Poland

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

Tevagen Pharma, S.L.U.

C/ Anabel Segura, 11, Edifício Albatros B, 1ª planta,

Alcobendas, 28108 – Madrid

Spain

Date of the last revision of thisleaflet:August 2025

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)