TOLVAPTAN TEVAGEN 30 mg TABLETS

2. What you need to know before you take Tolvaptan Tevagen

Do not take Tolvaptan Tevagen:

• if you are allergic to tolvaptan 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 (there is no urine production)
• if you have any disease that increases salt levels 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 breast-feeding

Warnings and precautions

Consult your doctor or pharmacist before starting to take tolvaptan:

• 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 suffered in the past from any allergic reaction to benzacepine, tolvaptan 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

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 medicines

Tell your doctor or pharmacist if you are using, have recently used or might use 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 salt concentration in the blood or contain large amounts of salt.

The following medicines may decrease the effects of this medicine:

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

This medicine may increase the effects of the following medicines:

• 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 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 tolvaptan. Your doctor will decide what is suitable for you.

Taking Tolvaptan Tevagen with food and drinks

Avoid drinking grapefruit juice when taking tolvaptan.

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

Tolvaptan 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.

Use in athletes

This medicine 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 some sugars, consult them before taking this medicine.

This medicine 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 exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• Treatment with tolvaptan will start 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 serum. To control the effects of tolvaptan, your doctor will ask you to have blood tests from time to time. To achieve the desired sodium level, your doctor may in some cases administer a dose of 7.5 mg.

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 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.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the medicine pack and leaflet to the healthcare professional.

If you forget to take Tolvaptan Tevagen

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 not take a double dose to make up for a forgotten dose.

If you stop taking Tolvaptan Tevagen

If you stop taking tolvaptan, you may have low sodium levels again. Therefore, you should only stop taking this medicine 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 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 tolvaptan 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, severe 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
• 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 urinate more frequently
• tiredness, 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 the available data)

• allergic reactions (see above)
• liver problems
• acute liver failure (ALF)
• increased 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 through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Tolvaptan Tevagen

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 is the last day of the month stated.

This medicine does not require any special storage temperature.

Keep in the original packaging to protect from light.

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 Tolvaptan Tevagen

• The active substance 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 and packaging

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 pack sizes are available:

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

Tolvaptan Tevagen 15 mg tablets EFG:

Blister packs of 10 or 30 tablets, and unit dose blisters of 10x1 tablets and 30x1 tablets.

Tolvaptan Tevagen 30 mg tablets EFG:

Blister packs of 10 or 30 tablets, and unit dose blisters of 10x1 tablets and 30x1 tablets.

Not all pack 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 medicine 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 last revision of thisleaflet:August 2025

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