Tolvaptan Teva 15 mg + tolvaptan Teva 45 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tolvaptan Teva 15 mg tablets EFG

Tolvaptan Teva 30 mg tablets EFG

Tolvaptan Teva 15 mg + Tolvaptan Teva 45 mg tablets EFG

Tolvaptan Teva 30 mg + Tolvaptan Teva 60 mg tablets EFG

Tolvaptan Teva 30 mg + Tolvaptan Teva 90 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.

Contents of this leaflet

1. What Tolvaptan Teva is and what it is used for
2. What you need to know before taking Tolvaptan Teva
3. How to take Tolvaptan Teva
4. Possible side effects
5. How to store Tolvaptan Teva
6. Contents of the pack and other information

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

The active substance in this medicine is tolvaptan, which blocks the effect of vasopressin, a hormone involved in the formation of cysts in the kidneys of patients with autosomal dominant polycystic kidney disease (ADPKD). By blocking the effect of vasopressin, tolvaptan slows the progression of kidney cysts in patients with ADPKD, reduces disease symptoms, and increases urine production.

Tolvaptan is a medicine used to treat a condition known as "autosomal dominant polycystic kidney disease" (ADPKD). This disease leads to the development of fluid-filled cysts in the kidneys, causing pressure on surrounding tissues and reducing kidney function, potentially leading to kidney failure. Tolvaptan is used to treat ADPKD in adults with chronic kidney disease (CKD) stage 1 to 4 who show signs of rapid disease progression.

2. What you need to know before taking Tolvaptán Teva

Do not take Tolvaptán Teva

• 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 derivatives of benzazepine (for example, benazepril, conivaptan, phenoldopam mesylate, or mirtazapine).
• if you have been told that you have high levels of liver enzymes in your blood and that this prevents you from receiving treatment with tolvaptan.
• if your kidneys do not function (no urine production).
• if you have a disorder associated with very low blood volume (for example, severe dehydration or hemorrhage).
• if you have a condition that increases the amount of sodium in your blood.
• if you do not feel thirsty.
• if you are pregnant.
• if you are breastfeeding.

Warnings and precautions

Talk to your doctor before starting tolvaptan:

• if you have liver disease.
• if you cannot drink enough water (see "Drink a sufficient amount of water" below) or if you need to limit your fluid intake.
• if you have difficulty urinating or prostate enlargement (for example, enlarged prostate).
• if you have blood sodium levels that are too high or too low.
• if you have previously experienced an allergic reaction to benzazepine, tolvaptan, or other benzazepine derivatives (for example, benazepril, conivaptan, phenoldopam mesylate, or mirtazapine), or to any of the other ingredients of this medicine (listed in section 6).
• if you have diabetes.
• if you have been told that you have high levels of uric acid in your blood (which may have caused gout).
• if you have advanced kidney disease.

This medicine may cause your liver to malfunction. For this reason, please inform your doctor immediately if you experience signs that could indicate liver problems, such as:

• nausea
• vomiting
• fever
• fatigue
• loss of appetite
• abdominal pain
• dark urine
• jaundice (yellowing of the skin or eyes)
• itching (pruritus) of the skin
• flu-like syndrome (muscle and joint pain with fever)

During treatment with this medicine, your doctor will request monthly blood tests to monitor any changes in your liver function.

Drink a sufficient amount of water

This medicine causes water loss because it increases urine production. This water loss may lead to adverse effects such as dry mouth and thirst, or even more serious adverse effects such as kidney problems (see section 4). Therefore, it is important that you have access to water and can drink sufficient amounts of fluid when you feel thirsty. Before going to bed, you should drink one or two glasses of water even if you do not feel thirsty, and you should also drink water after urinating during the night. You should be especially careful if you have a condition that reduces adequate fluid intake or if you are at higher risk of dehydration, for example if you have vomiting or diarrhea. Due to the increased urine production, it is also important to always have a toilet nearby.

Children and adolescents

Do not give this medicine to children and adolescents (under 18 years of age) as it has not been studied in this population.

Other medicines and Tolvaptán Teva

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

The following medicines may increase the effect of Tolvaptán Teva:

• amprenavir, atazanavir, darunavir/ritonavir, and fosamprenavir (used to treat HIV/AIDS),
• aprepitant (used to prevent nausea and vomiting during chemotherapy),
• crizotinib and imatinib (used to treat cancer),
• ketoconazole, fluconazole, or itraconazole (used to treat fungal infections),
• macrolide antibiotics such as erythromycin or clarithromycin,
• verapamil (used to treat heart conditions and high blood pressure),
• ciprofloxacin (an antibiotic),
• diltiazem (used to treat high blood pressure and chest pain).

The following medicines may decrease the effect of Tolvaptán Teva:

• phenytoin or carbamazepine (used to treat epilepsy),
• rifampicin, rifabutin, or rifapentine (used to treat tuberculosis),
• St. John's wort (a herbal remedy used to relieve mild depression and mild anxiety).

Tolvaptán Teva may increase the effect of the following medicines:

• digoxin (used to treat irregular heartbeat and heart failure),
• dabigatran (used as a blood anticoagulant),
• sulfasalazine (used to treat irritable bowel disease or rheumatoid arthritis),
• metformin (for the treatment of diabetes).

Tolvaptán Teva may decrease the effect of the following medicines:

• vasopressin analogues such as desmopressin (used to increase blood clotting factors or to control urine production or urinary incontinence).

The following medicines may interact with Tolvaptán Teva or be affected by it:

• diuretics (used to increase urine production). When taken at the same time as Tolvaptán Teva, these medicines may increase the risk of adverse effects due to water loss or may cause kidney problems.
• diuretics or other medicines used to treat high blood pressure. When taken at the same time as Tolvaptán Teva, these medicines may increase the risk of low blood pressure when standing up or getting up.
• medicines that increase sodium levels in the blood or contain large amounts of salt (e.g., effervescent tablets and those used to treat indigestion). These could enhance the effects of Tolvaptán Teva. There is a risk that this could lead to excessive sodium levels in your blood.

It may not be a problem to take these medicines at the same time as tolvaptan. Your doctor will decide what is best for you.

Taking Tolvaptán Teva with food and drinks

Do not drink grapefruit juice while taking this medicine.

Pregnancy and breastfeeding

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

Women of childbearing age must use reliable contraceptive methods while being treated with this medicine.

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.

Use in athletes

This medicine contains tolvaptan, which may result in a positive finding in doping control tests.

Driving and use of machines

Some people may feel dizzy, weak, or tired after taking tolvaptan. If you experience these effects, do not drive or operate tools or machinery.

Tolvaptán Teva contains lactose and sodium

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

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

3. How to take Tolvaptan Teva

Only physicians specialized in the treatment of ADPKD may prescribe tolvaptan.

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

Dosage

The daily amount of tolvaptan should be divided into two doses, one higher than the other. The higher dose should be taken in the morning upon waking, at least 30 minutes before breakfast, while the lower dose should be taken 8 hours later.

The dose combinations are:

45 mg + 15 mg

60 mg + 30 mg

90 mg + 30 mg

Typically, your treatment will start with a dose of 45 mg in the morning and 15 mg 8 hours later. Your doctor may gradually increase your dose up to a maximum combination of 90 mg upon waking and 30 mg eight hours later. To determine the optimal dose, your doctor will regularly monitor how well you tolerate the prescribed dose. You must always take the highest tolerable dose combination prescribed by your doctor.

If you are taking other medicines that may increase the effects of tolvaptan, you may be given lower doses. In this case, your doctor may prescribe tolvaptan tablets containing 30 mg or 15 mg of tolvaptan, which you should take once daily in the morning.

Method of administration

Swallow the tablets without chewing and with a glass of water.

Tolvaptan Teva 15 mg tabletsTolvaptan Teva 15 mg + Tolvaptan Teva 45 mg tablets

The tablet may be divided into equal doses.

The morning dose should be taken at least 30 minutes before breakfast. The second daily dose may be taken with or without food.

If you take more Tolvaptan Teva than you should

If you have taken more tablets than prescribed, drink plenty of water and contact your doctor or nearest hospital immediately. Remember to bring the medicine package with you so it is clear what you have taken. If you take the higher dose too late, you may need to go to the bathroom more frequently during the night.

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 container and package leaflet to the healthcare professional.

If you forget to take Tolvaptan Teva

If you forget to take your medicine, take the missed dose as soon as you remember on the same day. If you have missed taking the tablets for one day, take the normal dose the next day. Do not take a double dose to make up for a forgotten dose.

If you stop taking Tolvaptan Teva

If you stop treatment with tolvaptan, kidney cysts may grow as rapidly as they did before starting treatment with this medicine. Therefore, you should only stop taking tolvaptan if you experience adverse effects requiring urgent medical attention (see section 4) or if your doctor instructs you to do so.

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 gets them.

Serious adverse effects:

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

• have difficulty urinating.

• develop swelling of the face, lips, or tongue, experience itching, widespread skin rash, wheezing (whistling sounds when breathing), or have difficulty breathing (symptoms of an allergic reaction).

Tolvaptan may cause your liver to malfunction.

Contact your doctor if you develop symptoms such as nausea, vomiting, fever, fatigue, loss of appetite, abdominal pain, dark urine, jaundice (yellowing of the skin or eyes), skin itching, or joint and muscle pain with fever.

Other adverse effects:

Very common: may affect more than 1 in 10 people

• thirst (need to drink excessive amounts of water)
• headache
• dizziness
• diarrhea
• dry mouth
• increased need to urinate, increased nighttime urination, or increased frequency of urination
• fatigue

Common: may affect up to 1 in 10 people

• dehydration
• elevated levels of sodium, uric acid, and blood sugar
• decreased appetite
• taste disturbances
• gout
• difficulty falling asleep
• fainting
• palpitations
• difficulty breathing
• abdominal pain
• feeling of fullness, bloating, or stomach discomfort
• constipation
• heartburn
• abnormal liver function
• dry skin
• skin rash
• pruritus (itching)
• urticaria (hives)
• joint pain
• muscle spasms
• muscle pain
• general weakness
• increased levels of liver enzymes in the blood
• weight loss
• weight gain

Uncommon: may affect up to 1 in 100 people

• increased concentration of bilirubin (a substance that may cause yellowing of the skin or eyes) in the blood

Frequency not known: cannot be estimated from available data

• allergic reactions (see above)
• widespread rash
• acute hepatic failure (AHF)
• increased blood levels of creatine phosphokinase (an enzyme that measures muscle and heart function)

Reporting of adverse effects

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

5. Storage of Tolvaptan Teva

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister after CAD or EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature.

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tolvaptán Teva

• The active substance is tolvaptan.

Each Tolvaptán Teva 15 mg tablet contains 15 mg of tolvaptan.

Each Tolvaptán Teva 30 mg tablet contains 30 mg of tolvaptan.

Each Tolvaptán Teva 45 mg tablet contains 45 mg of tolvaptan.

Each Tolvaptán Teva 60 mg tablet contains 60 mg of tolvaptan.

Each Tolvaptán Teva 90 mg tablet contains 90 mg of tolvaptan.

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

Nature of the product and contents of the container

The different strengths of Tolvaptán Teva tablets have different shapes and markings:

15 mg tablet: uncoated, white to off-white, triangular-shaped tablets, marked with “A3” on one side and flat on the other, with dimensions of approximately 5.50 mm x 5.30 mm.

30 mg tablet: uncoated, white to off-white, round-shaped tablets, marked with “T5” on one side and flat on the other, with a diameter of approximately 6.80 mm.

45 mg tablet: uncoated, white to off-white, square-shaped tablets, marked with “T8” on one side and flat on the other, with dimensions of approximately 7.70 mm x 7.70 mm.

60 mg tablet: uncoated, white to off-white, barrel-shaped tablets, marked with “A0” on one side and flat on the other, with dimensions of approximately 10.60 mm x 6.30 mm.

90 mg tablet: uncoated, white to off-white, pentagon-shaped tablets, marked with “AT” on one side and flat on the other, with dimensions of approximately 11.27 mm x 11.00 mm.

Available pack sizes:

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

Tolvaptán Teva 15 mg tablets EFG: blister packs containing 7 or 28 tablets, and unit-dose blister packs with 7x1 tablets.

Tolvaptán Teva 30 mg tablets EFG: blister packs containing 7 or 28 tablets, and unit-dose blister packs with 7x1 tablets.

Tolvaptán Teva 15 mg + Tolvaptán Teva 45 mg tablets EFG: blister packs containing 14 tablets (7 tablets of the higher dose + 7 tablets of the lower dose), 28 tablets (14 tablets of the higher dose + 14 tablets of the lower dose), or 56 tablets (28 tablets of the higher dose + 28 tablets of the lower dose), and unit-dose blister packs with 56x1 tablets (28x1 tablets of the higher dose + 28x1 tablets of the lower dose).

Tolvaptán Teva 30 mg + Tolvaptán Teva 60 mg tablets EFG: blister packs containing 14 tablets (7 tablets of the higher dose + 7 tablets of the lower dose), 28 tablets (14 tablets of the higher dose + 14 tablets of the lower dose), or 56 tablets (28 tablets of the higher dose + 28 tablets of the lower dose), and unit-dose blister packs with 56x1 tablets (28x1 tablets of the higher dose + 28x1 tablets of the lower dose).

Tolvaptán Teva 30 mg + Tolvaptán Teva 90 mg tablets EFG: blister packs containing 14 tablets (7 tablets of the higher dose + 7 tablets of the lower dose), 28 tablets (14 tablets of the higher dose + 14 tablets of the lower dose), or 56 tablets (28 tablets of the higher dose + 28 tablets of the lower dose), and unit-dose blister packs with 56x1 tablets (28x1 tablets of the higher dose + 28x1 tablets of the lower dose).

Only some pack sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

The Netherlands

Manufacturer responsible:

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 latest revision of this package leaflet: June 2025

Other sources of information

Detailed and up-to-date information on this medicinal product is available by scanning with your mobile phone (smartphone) the QR code included in the package leaflet. You can also access this information at the following web address:

Tolvaptán Teva 15 mg tablets EFG

https://cima.aemps.es/cima/publico/detalle.html?nregistro=84994

Tolvaptán Teva 30 mg tablets EFG

https://cima.aemps.es/cima/publico/detalle.html?nregistro=84992

Tolvaptán Teva 15 mg + Tolvaptán Teva 45 mg tablets EFG

https://cima.aemps.es/cima/publico/detalle.html?nregistro=84993

Tolvaptán Teva 30 mg + Tolvaptán Teva 60 mg tablets EFG

https://cima.aemps.es/cima/publico/detalle.html?nregistro=84991

Tolvaptán Teva 30 mg + Tolvaptán Teva 90 mg tablets EFG

https://cima.aemps.es/cima/publico/detalle.html?nregistro=84997