TOLVAPTAN TEVA 15 mg + TOLVAPTAN TEVA 45 mg TABLETS

Introduction

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 this leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack

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 Storage of Tolvaptan Teva

1. Contents of the pack and further information

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

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

Tolvaptan is a medicine used to treat a disease known as "autosomal dominant polycystic kidney disease" (ADPKD). This disease leads to the development of fluid-filled cysts in the kidneys, which can put pressure on the surrounding tissues and reduce kidney function, even leading to kidney failure. Tolvaptan is used to treat ADPKD in adults with chronic kidney disease (CKD) in stages 1 to 4 with signs of rapid disease progression.

2. What you need to know before taking Tolvaptan Teva

Do not take Tolvaptan 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 benzazepine derivatives (e.g., benazepril, conivaptan, fenoldopam 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 work (there is no urine production).
• if you have a disorder associated with very low blood volume (e.g., severe dehydration or bleeding).
• if you have a disorder 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 to take tolvaptan:

• if you have liver disease.
• if you cannot drink enough water (see "drinking enough water" below) or if you need to limit your fluid intake.
• if you have difficulty urinating or benign prostatic hyperplasia (e.g., enlarged prostate).
• if you have high or low sodium levels in your blood.
• if you have 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 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 affect your liver. For this reason, please tell your doctor immediately if you notice signs that may 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
• pseudogrippal syndrome (muscle and joint pain with fever)

During treatment with this medicine, your doctor will ask you to have monthly blood tests to monitor changes in your liver function.

Drinking enough water

This medicine causes water loss because it increases urine production. This water loss can lead to side effects such as dry mouth and thirst or 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 enough fluids when you feel thirsty. Before going to bed, drink one or two glasses of water, even if you do not feel thirsty, and also drink water after urinating at night. You should be particularly careful if you have a disease that reduces your ability to drink enough fluids 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 essential to have a bathroom nearby.

Children and adolescents

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

Other medicines and Tolvaptan Teva

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

The following medicines may increase the effect of Tolvaptan 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 disease 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 Tolvaptan Teva:

• phenytoin or carbamazepine (used to treat epilepsy),
• rifampicin, rifabutin, or rifapentine (used to treat tuberculosis),
• hypericum (a herbal medicine used to treat mild depression and anxiety)

Tolvaptan Teva may increase the effect of the following medicines:

• digoxin (used to treat irregular heartbeat and heart failure),
• dabigatran (used as a blood thinner),
• sulfasalazine (used to treat irritable bowel disease or rheumatoid arthritis),
• metformin (used to treat diabetes)

Tolvaptan Teva may decrease the effect of the following medicines:

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

These medicines may affect Tolvaptan Teva or be affected by it:

• diuretics (used to increase urine production). When taken at the same time as Tolvaptan Teva, these medicines may increase the risk of side effects due to water loss or may cause kidney problems.
• diuretics or other medicines for the treatment of high blood pressure. When taken at the same time as Tolvaptan 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 that dissolve in water and those used to treat indigestion). These may increase the effects of Tolvaptan Teva. There is a risk that this may lead to an excess of sodium 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 Tolvaptan Teva with food and drinks

Do not drink grapefruit juice while taking this medicine.

Pregnancy and breastfeeding

Do nottake 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 produce a positive result in doping tests.

Driving and using machines

Some people may feel dizzy, weak, or tired after taking tolvaptan. If you notice these effects, do not drive or use tools or machines.

Tolvaptan Teva contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

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

3. How to take Tolvaptan Teva

Only doctors specializing in the treatment of ADPKD can prescribe tolvaptan.

Follow the instructions for taking this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist again.

Dose

The daily dose of tolvaptan should be divided into two doses, one higher than the other. The higher dose should be taken in the morning when getting up, 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

Normally, 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 when getting up and 30 mg 8 hours later. To determine the best dose for you, your doctor will regularly check how you tolerate the prescribed dose. You should 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 receive lower doses. In this case, your doctor may prescribe tolvaptan 30 mg or 15 mg tablets, which you should take once a day in the morning.

Method of administration

Swallow the tablets whole with a glass of water.

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

The tablet can be divided into equal doses.

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

If you take more Tolvaptan Teva than you should

If you have taken more tablets than the prescribed dose, drink plenty of water and contact your doctor or the nearest hospital immediately. Remember to take the medicine package with you so that 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 at night.

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

If you forget to take Tolvaptan Teva

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

If you stop taking Tolvaptan Teva

If you stop taking tolvaptan, kidney cysts may grow as quickly as before starting treatment with this medicine. Therefore, you should only stop taking tolvaptan if you notice side effects that require urgent medical attention (see section 4) or if your doctor tells you to do so.

If you have any further 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.

Serious side effects:

If you experience 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.

• your face, lips, or tongue swell, you feel itchy, have a rash all over your body, or have wheezing (a whistling sound when you breathe) or difficulty breathing (symptoms of an allergic reaction).

Tolvaptan may affect your liver.

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

Other side 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, urinate at night, or urinate more frequently
• fatigue

Common: may affect up to 1 in 10 people

• dehydration
• high levels of sodium, uric acid, and sugar in the blood
• decreased appetite
• altered taste
• gout
• difficulty sleeping
• fainting
• palpitations
• difficulty breathing
• abdominal pain
• feeling full, bloated, or discomfort in the stomach
• constipation
• heartburn
• abnormal liver function
• dry skin
• rash
• itching
• 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 levels of bilirubin (a substance that can cause yellowing of the skin or eyes) in the blood

Frequency not known: cannot be estimated from the available data

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

Reporting side effects

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

5. Storage of Tolvaptan Teva

Keep this medicine out of the 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 is the last day of the month indicated.

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. Return the packaging and any unused medicine to a pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Tolvaptan Teva

• The active ingredient is tolvaptan.

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

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

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

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

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

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

Product Appearance and Package Contents

The different doses of Tolvaptan Teva tablets have different shapes and markings:

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

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

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

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

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

The following package 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 Teva 15 mg tablets EFG:blister packs with 7 or 28 tablets, and unit-dose blister packs with 7x1 tablets.

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

Tolvaptan Teva 15 mg + Tolvaptan Teva 45 mg tablets EFG:blister packs with 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).

Tolvaptan Teva 30 mg + Tolvaptan Teva 60 mg tablets EFG:blister packs with 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).

Tolvaptan Teva 30 mg + Tolvaptan Teva 90 mg tablets EFG:blister packs with 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 package sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Manufacturer:

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

ul. Mogilska 80

PL-31-546 Kraków

Poland

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

Teva Pharma, S.L.U.

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

Alcobendas, 28108 – Madrid

Spain

Date of the last revision of thisleaflet:June 2025

Other sources of information

You can access detailed and updated information about this medicinal product by scanning the QR code included in the leaflet with your mobile phone (smartphone). You can also access this information at the following internet address:

Tolvaptan Teva 15 mg tablets EFG

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

Tolvaptan Teva 30 mg tablets EFG

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

Tolvaptan Teva 15 mg + Tolvaptan Teva 45 mg tablets EFG

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

Tolvaptan Teva 30 mg + Tolvaptan Teva 60 mg tablets EFG

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

Tolvaptan Teva 30 mg + Tolvaptan Teva 90 mg tablets EFG

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