Tolvaptan Tevagen 30 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tolvaptan Tevagen 15 mg tablets EFG

Tolvaptan Tevagen 30 mg tablets EFG

Read the entire 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 your doctor or pharmacist.

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

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

Leaflet contents

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

2. What you need to know before taking Tolvaptan Tevagen

3. How to take Tolvaptan Tevagen

4. Possible side effects

5. Storage of Tolvaptan Tevagen

6. Contents of the pack and other information

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

This medicine, which contains the active substance tolvaptan, 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 blocks vasopressin from exerting its water-retaining effect, thereby reducing the amount of water in the body by increasing urine production, resulting in an increase in blood sodium levels.

Tolvaptan is used to treat low serum sodium levels in adults. Your doctor has prescribed this medicine because you have low sodium levels in your blood as a result of a condition called "syndrome of inappropriate antidiuretic hormone secretion (SIADH)", in which the kidneys retain too much water. This condition leads to an inappropriate production of the hormone vasopressin, causing your blood sodium levels to become too low (hyponatremia). This may cause difficulties with concentration and memory or maintaining balance.

2. What you need to know before taking Tolvaptán Tevagen

Do not take Tolvaptán Tevagen:

• if you are allergic to tolvaptan or to 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 sodium 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 breastfeeding

Warnings and precautions

Talk to your doctor or pharmacist before starting tolvaptan:

• if you are unable to 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 previously had an allergic reaction to benzazepine, 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 by increasing urine production. This water loss may lead to adverse effects such as dry mouth and thirst, and even more serious adverse effects such as kidney problems (see section 4). Therefore, it is important that you have access to water and are able to drink sufficient amounts whenever you feel thirsty.

Children and adolescents

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

Taking Tolvaptán Tevagen with other medicines

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

The following medicines may increase the effects of this medicine:

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

The following medicines may decrease the effects of this medicine:

• barbiturates (used to treat epilepsy/seizures and certain sleep disorders);
• rifampicin (for tuberculosis);
• St. John’s wort, a herbal medicine used to treat depression.

This medicine may increase the effects of the following medicines:

• digoxin (used to treat heart rhythm disorders 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 medicine:

• desmopressin (used to increase blood clotting factors).

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

Taking Tolvaptán 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 medicine.

Do not take this medicine if you are pregnant or breastfeeding.

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

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, weak, or briefly faint.

Use in athletes

This medicine contains tolvaptan, which may result in a positive doping test.

Tolvaptán Tevagen contains lactose and sodium

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Tolvaptan Tevagen

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• Treatment with tolvaptan will be initiated in the hospital.
• For the treatment of low sodium levels (hyponatremia), your doctor will instruct you to start with a dose of 15 mg and may then increase it up to a maximum of 60 mg to achieve the desired serum sodium level. To monitor the effects of tolvaptan, your doctor will request periodic blood tests. In some cases, to achieve the desired serum sodium level, your doctor may prescribe a dose of 7.5 mg.

Tolvaptan Tevagen 15 mg tablets

• The tablet may be divided into equal doses.
• Swallow the tablet without chewing, with a glass of water.
• Take the tablets once daily, 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 medicine package so it is clear what you have taken.

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

If you forget to take Tolvaptan Tevagen

If you forget to take your medicine, 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 missed dose.

If you stop taking Tolvaptan Tevagen

If you stop taking tolvaptan, you may experience a recurrence of low sodium levels. Therefore, you should only stop taking this medicine if you experience adverse effects requiring urgent medical attention (see section 4) or if instructed by your doctor.

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

4. Possible adverse effects

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

If you notice any of the following adverse 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 notice swelling of the face, lips, or tongue, itching, widespread 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 part of the abdomen, dark urine, or jaundice (yellowing of the skin or eyes).

Other adverse 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
• decreased blood sugar levels
• decreased appetite
• fainting
• headache
• dizziness
• low blood pressure upon standing
• constipation
• diarrhea
• dry mouth
• irregular bleeding under the skin
• itching
• increased need to urinate or urinating more frequently
• tiredness, general weakness
• fever
• general feeling of being unwell
• blood in the urine
• increased levels of liver enzymes 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 adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage 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 outer packaging and blister after CAD or EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Return empty packaging and unused medicines to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of packaging and unused medicines. This 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 of the product and contents of the pack

Tolvaptan Tevagen 15 mg:

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

Tolvaptan Tevagen 30 mg:

Uncoated, white to off-white, round tablets marked “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 forming foil PVC/Aclar/PVC and peelable foil of paper/PET/Aluminium.
• Blister pack with forming foil PVC/Aclar/PVC and peelable foil of aluminium.
• Blister pack with forming foil OPA/Aluminium/PVC and peelable foil of paper/PET/Aluminium.

Tolvaptan Tevagen 15 mg tablets EFG:

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

Tolvaptan Tevagen 30 mg tablets EFG:

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

The Netherlands

Manufacturer responsible for manufacturing

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

ul. Mogilska 80

PL-31-546 Kraków

Poland

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U.

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

Alcobendas, 28108 – Madrid

Spain

Date of the most recent review of this leaflet: August 2025

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