TOLVAPTAN 7.5 mg Tablet

Зміст інструкції

1. Tolvaptan Accord 7.5 mg tablets, 15 mg tablets, 30 mg tablets
   1. What is Tolvaptan Accord and what it is used for
   2. What you need to know before taking Tolvaptan Accord
   3. How to take Tolvaptan Accord
   4. Possible side effects
   5. How to store Tolvaptan Accord
   6. Package contents and other information

Tolvaptan Accord 7.5 mg tablets, 15 mg tablets, 30 mg tablets

tolvaptan

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Tolvaptan Accord, 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 output. Antagonist means that it prevents vasopressin from acting on fluid retention. This in turn leads to a reduction in the amount
of water in the body by increasing urine production, and consequently increases the level or
concentration of sodium in the blood.
Tolvaptan Accord is used to treat patients with low sodium concentrations in the blood. This
medicine has been prescribed for you because you suffer from low sodium concentrations in the blood due to a
disease called "inappropriate secretion syndrome of antidiuretic hormone" (SIADH) in
which the kidneys retain too much water. This disease causes an inappropriate production
of the hormone vasopressin, due to which the levels of sodium in the blood become too low
(hyponatremia). This can cause difficulty concentrating and remembering, or maintaining
balance.

2. What you need to know before taking Tolvaptan Accord

Do not take Tolvaptan Accord

• 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 are not functioning (do not produce urine)
• if you suffer from a condition that increases the salt in the blood (“hypernatremia”)
• if you have a condition associated with a 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 taking Tolvaptan Accord.

• if you cannot drink enough water or if you have limitations in fluid intake
• if you find it difficult to urinate or if your prostate is enlarged
• if you suffer from a liver disease
• 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) in the past
• if you suffer from a kidney disease called autosomal dominant polycystic kidney disease (ADPKD)
• if you have diabetes.

Drink enough water
Tolvaptan Accord causes water loss because it increases urine production. This loss of
water can cause side effects, such as dry mouth and thirst, or even more serious side effects,
such as kidney problems (see section 4). Therefore, it is important that you have access
to water and can drink enough when you are thirsty.

Children and adolescents
Tolvaptan Accord is not suitable for children and adolescents (under 18 years of age).

Other medicines and Tolvaptan Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those bought without a prescription.
The following medicines can enhance the effect of this medicine:

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

The following medicines can reduce the effects of this medicine:

• barbiturates (used as treatment for epilepsy/convulsions and for some sleep disorders),
• rifampicin (for tuberculosis).

This medicine can enhance the effects of the following medicines:

• digoxin (used in the treatment of irregular heartbeats and heart failure),
• dabigatran etexilate (used to thin the blood),
• metformin (used to treat diabetes),
• sulfasalazine (used to treat inflammatory bowel disease or rheumatoid arthritis).

This medicine can reduce the effect of the following medicines:

• desmopressin (used to increase blood clotting factors).

There are cases where it may still be okay to take these medicines together with Tolvaptan
Accord. Your doctor will decide the appropriate treatment for you.

Tolvaptan Accord with food and drink
Avoid drinking grapefruit juice when taking Tolvaptan Accord.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Do not takethis medicine if you are pregnant or breastfeeding with breast milk.
During treatment with this medicine, adequate contraceptive methods must be used.

Driving and using machines
It is unlikely that Tolvaptan Accord will negatively affect your ability to drive or operate
machinery. However, you may experience occasional dizziness or weakness, or fainting for short
periods.

Tolvaptan Accord contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking
this medicine.

3. How to take Tolvaptan Accord

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

• Treatment with Tolvaptan Accord must begin in hospital.
• For the treatment of low sodium levels (hyponatremia), your doctor will start with a dose of 15 mg and may then increase it up to a maximum of 60 mg to reach the desired sodium level. To monitor the effects of Tolvaptan Accord, your doctor will take regular blood samples. To reach the desired sodium level, your doctor may, in some cases, administer a lower dose of 7.5 mg.
• Swallow the tablet with a glass of water, without chewing.
• Take the tablets once a day, preferably in the morning, with or without food.

If you take more Tolvaptan Accord than you should
If you have taken more tablets than prescribed, drink plenty of water and contact
your doctor or the nearest hospital immediately.Remember to bring the package of
medicine with you, so that it is clear what you have taken.

If you forget to take Tolvaptan Accord
If you forget to take the medicine, take the dose as soon as you remember, on the same day. If you do not
take the tablet on a particular 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 Accord
If you stop taking Tolvaptan Accord, this may lead to the reappearance of low sodium levels.
Therefore, stop taking Tolvaptan Accord only if you notice side effects that require urgent
medical attention (see section 4), or if your doctor tells you to.
If you have any further questions on 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 Accord 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 or severe wheezing or shortness of breath (symptoms of an allergic reaction).

Consult your doctor if you notice the appearance of symptoms such as: fatigue, loss of appetite, discomfort in the
upper right quadrant of the abdomen, dark urine or jaundice (yellowing of the skin or eyes).

Other side effects
Very common (may affect more than 1 in 10 people)

• nausea
• thirst
• rapid increase in sodium levels.

Common (may affect up to 1 in 10 people)

• excessive water intake
• water loss
• high levels of sodium, potassium, creatinine, uric acid and sugars in the blood
• reduction in blood sugar level
• decreased appetite
• fainting
• headache
• dizziness
• low blood pressure when standing up
• constipation
• diarrhoea
• dry mouth
• bruising
• itching
• increased need to urinate or more frequent urination
• tiredness, general weakness
• fever
• feeling unwell
• blood in urine
• high levels of liver enzymes in the blood
• high levels of creatinine in the blood.

Uncommon (may affect up to 1 in 100 people)

• taste alterations
• kidney problems.

Not known (frequency cannot be estimated from the available data)

• allergic reactions (see above)
• liver problems
• acute liver failure ( acute liver failure, ALF)
• increased levels of liver enzymes.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through
the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Tolvaptan Accord

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

Do not use this medicine after the expiry datewhich is stated on the pack after Scad. and on
each blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tolvaptan Accord contains

• The active ingredient is tolvaptan. Each Tolvaptan Accord 7.5 mg tablet contains 7.5 mg of tolvaptan. Each Tolvaptan Accord 15 mg tablet contains 15 mg of tolvaptan. Each Tolvaptan Accord 30 mg tablet contains 30 mg of tolvaptan.
• The other ingredients are lactose monohydrate, corn starch, microcrystalline cellulose, magnesium stearate, sodium croscarmellose, hydroxypropylcellulose, aluminium indigotine lake (E132).

Description of the appearance of Tolvaptan Accord and package contents
Tolvaptan Accord 7.5 mg: light blue to blue, round, biconvex, uncoated tablets,
with "MT" imprinted on one side and “18” on the other side, approximately 5.00 mm in size.
Tolvaptan Accord 15 mg: light blue to blue, triangular, biconvex, uncoated
tablets, with "MT" imprinted on one side and “7” on the other side, approximately 6.7 x 6.3 x 3.3 mm in size.
Tolvaptan Accord 30 mg: light blue to blue, round, biconvex, uncoated
tablets, with "MT" imprinted on one side and “8” on the other side, approximately 8.1 mm in size.
Tolvaptan Accord 7.5/15/30 mg tablets are available in boxes with divisible PVC/Alu blisters
for unit dose of 7x1, 10x1, 28x1, 30x1 tablet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est, 6 Planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp. z.o.o.
ul.Lutomierska 50,
95-200, Pabianice, Poland
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
Accord Healthcare B.V.
Winthontlaan 200,
3526 KV Utrecht, Netherlands

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .