Leaflet: information for the user

Rasilez 150 mg film-coated tablets

Rasilez 300 mg film-coated tablets

aliskireno

Read this 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

This medication contains an active ingredient called aliskiren. Aliskiren belongs to a class of medications called renin inhibitors. Renin inhibitors reduce the amount of angiotensin II that the body can produce. Angiotensin II causes a narrowing of blood vessels, which increases blood pressure. The reduction of angiotensin II levels allows blood vessels to relax, which decreases blood pressure.

This helps to decrease high blood pressure in adult patients. Hypertension increases the workload of the heart and arteries. If this continues for a long time, the blood vessels of the brain, heart, and kidneys can become damaged, which may cause stroke, heart failure, myocardial infarction, or renal insufficiency. Decreasing blood pressure to a normal level reduces the risk of developing these diseases.

Do not take Rasilez

• if you are allergic to aliskiren or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor.
• if you have ever experienced the following types of angioedema (difficulty breathing or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue):

• angioedema when taking aliskiren.
• hereditary angioedema.
• angioedema of unknown cause.

• in the last 6 months of pregnancy or if you are breastfeeding, see the section “Pregnancy and breastfeeding”.
• if you are taking ciclosporin (a medicine used in transplants to prevent rejection of an organ or for other diseases, e.g. rheumatoid arthritis or atopic dermatitis), itraconazole (a medicine for treating fungal infections) or quinidine (a medicine used to correct heart rhythm).
• if you have diabetes or kidney failure and are being treated with one of the following classes of medicines used to treat high blood pressure (high blood pressure):
• a converting enzyme inhibitor such as enalapril, lisinopril, ramipril

or

• a angiotensin II receptor antagonist such as valsartan, telmisartan, irbesartan.
• if the patient is under 2 years of age.

Warnings and precautions

Consult your doctor before starting to take Rasilez:

• if you are taking a diuretic (a type of medicine to increase the amount of urine).
• if you are taking any of the following classes of medicines used to treat high blood pressure (high blood pressure):
• a converting enzyme inhibitor such as enalapril, lisinopril, ramipril

or

• a angiotensin II receptor antagonist such as valsartan, telmisartan, irbesartan.

• if you have kidney failure, your doctor will carefully consider whether this medicine is suitable for you and may want to monitor it closely.
• if you have ever experienced angioedema (difficulty breathing or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue). If this occurs, stop taking this medicine and contact your doctor.
• if you have a renal artery stenosis (narrowing of the blood vessels of one or both kidneys).
• if you have severe congestive heart failure (a type of heart disease in which the heart cannot pump enough blood to the whole body).

If you have severe and persistent diarrhea, you should stop taking Rasilez.

Your doctor may monitor your kidney function, blood pressure and electrolyte levels (e.g. potassium) at regular intervals.

See also the section “Do not take Rasilez”.

Children and adolescents

This medicine cannot be used in newborns up to less than 2 years of age. It should not be used in children from 2 years to less than 6 years of age, and is not recommended for use in children and adolescents from 6 years to less than 18 years of age. This is because the safety and risks in this population are unknown.

Older people

The usual starting dose of aliskiren in older patients aged 65 years or more is 150 mg. In most patients aged 65 years or more, the dose of 300 mg of Rasilez does not provide any additional benefit in reducing blood pressure compared to the dose of 150 mg.

Other medicines and Rasilez

Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medicine.

Your doctor may need to change your dose and/or take other precautions if you are using any of the following medicines:

• medicines that increase the amount of potassium in your blood, including potassium-sparing diuretics and potassium supplements.
• furosemide or torasemide, some medicines that belong to a group of medicines known as diuretics used to increase the amount of urine.
• an angiotensin II receptor antagonist or a converting enzyme inhibitor (see the sections “Do not take Rasilez” and “Warnings and precautions”).
• ketoconazole, a medicine used to treat fungal infections.
• verapamil, a medicine used to lower blood pressure, correct heart rhythm or treat angina pectoris.
• a certain type of medicine used to treat pain called non-steroidal anti-inflammatory drugs (NSAIDs).

Taking Rasilez with food and drink

You should take this medicine with a light meal or without food once a day, preferably at the same time each day. You should avoid taking this medicine with fruit juice and/or drinks containing plant extracts (including infusions), as this may reduce the effectiveness of this medicine.

Pregnancy and breastfeeding

Pregnancy

Do not take this medicine if you are pregnant (see the section “Do not take Rasilez”). If you become pregnant while taking this medicine, stop taking it immediately and consult your doctor. If you think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will usually advise you to stop taking this medicine before becoming pregnant and recommend taking another antihypertensive medicine instead of this medicine. It is not recommended to use it at the beginning of pregnancy and in any case should not be administered from the third month of pregnancy as it may cause serious harm to your baby when administered from that time.

Breastfeeding

Inform your doctor if you are planning to start or are breastfeeding, as it is not recommended to administer this medicine to women during this period. Your doctor may decide to administer another treatment if you want to breastfeed.

Driving and operating machinery

This medicine may make you feel dizzy and this may affect your ability to concentrate. Before driving a vehicle, operating machinery or performing other activities that require a certain level of concentration, make sure you know how this medicine affects you.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

People with hypertension often do not notice any symptoms of their problem. Many may feel normal. It is very important that you take this medication exactly as your doctor has instructed you to obtain the best results and reduce the risk of adverse effects. Keep your appointments with your doctor even if you feel well.

The usual starting dose is one 150 mg tablet once a day. The blood pressure-reducing effects appear in two weeks after starting treatment.

Older Adults

The usual starting dose of aliskiren is 150 mg. In most patients 65 years of age or older, the 300 mg dose of aliskiren is not more beneficial for reducing blood pressure than the 150 mg dose.

Your doctor may increase your dose to 300 mg once a day depending on how you respond to treatment. Your doctor may prescribe this medication along with other medications to treat hypertension.

Administration Form

Swallow the tablet whole with a little water. You should take this medication once a day either with food or without food, preferably at the same time each day. You should establish a suitable schedule to take the medication in the same way every day, in accordance with a regular pattern regarding the time of your meals. You should avoid taking this medication with fruit juice and/or beverages containing plant extracts (including infusions). During your treatment, your doctor may adjust your dose based on your blood pressure response.

If You Take More Rasilez Than You Should

If you accidentally take too many tablets of this medication, consult your doctor immediately. You may need medical assistance.

If You Forget to Take Rasilez

If you forget to take a dose of this medication, take it as soon as you remember and then take the next dose at the usual time. However, if it is almost time to take the next dose, take only the next tablet at the usual time. Do not take a double dose to make up for the missed doses.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some side effects may be serious (frequency not known):

Some patients have experienced these serious side effects.Notify your doctor immediately if you notice any of the following side effects:

• Severe allergic reaction with symptoms such as rash, itching, swelling of the face or lips or tongue, difficulty breathing, dizziness.

Possible side effects:

Frequent(may affect up to 1 in 10 people):Diarrhea, joint pain (arthralgia), elevated potassium levels in the blood, dizziness.

Infrequent(may affect up to 1 in 100 people):Skin rash (this may also be a sign of an allergic reaction or angioedema – see below rare side effects), kidney problems that include acute renal failure (seriously decreased urine production), peripheral edema (swelling of hands, ankles, or feet), severe skin reactions (toxic epidermal necrolysis and/or mucosal reactions – skin redness, blisters on lips, eyes, or mouth, skin peeling, fever), hypotension, palpitations, cough, itching, itchy rash (urticaria), increased liver enzymes.

Rare(may affect up to 1 in 1,000 people):Increased creatinine levels in the blood, decreased hemoglobin levels in the blood (anemia), decreased red blood cell count, skin redness (erythema).

Frequency not known(the frequency cannot be estimated from available data):Sensation of spinning, low sodium levels in the blood, difficulty breathing, nausea, vomiting, signs of liver alteration (nausea, loss of appetite, dark-colored urine, or yellowish skin and eyes).

If any of these severely affect you, notify your doctor. You may need to stop taking Rasilez.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the national notification system included in Appendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and blister. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Rasilez

• The active ingredient is aliskiren (as hemifumarate).

Rasilez 150 mg film-coated tablets

• Each tablet contains 150 mg of aliskiren (as hemifumarate). The other components are crospovidone type A, hypromellose type substitution 2910 (3 mPa s), magnesium stearate, macrogol 4000, microcrystalline cellulose, povidone K-30, anhydrous colloidal silica, talc, titanium dioxide (E 171), iron oxide black (E 172), iron oxide red (E 172).

Rasilez 300 mg film-coated tablets

• Each tablet contains 300 mg of aliskiren (as hemifumarate). The other components are crospovidone type A, hypromellose type substitution 2910 (3 mPa s), magnesium stearate, macrogol 4000, microcrystalline cellulose, povidone K-30, anhydrous colloidal silica, talc, titanium dioxide (E 171), iron oxide black (E 172), iron oxide red (E 172).

Appearance of the product and contents of the package

Rasilez 150 mg film-coated tablets are pale pink, biconvex, round, marked with “IL” on one face and “NVR” on the other.

Rasilez 300 mg film-coated tablets are pale red, biconvex, oval, marked with “IU” on one face and “NVR” on the other.

Rasilez 150 mg film-coated tablets are available in the following packaging:

• Unit packs containing 14, 28, 30, 50, 56, 90 or 98 tablets
• Unit packs containing 56x1 tablets in perforated unit dose blisters
• Multiple packs containing 280 (20x14) tablets
• Multiple packs containing 98 (2x49x1) tablets in perforated unit dose blisters

Rasilez 300 mg film-coated tablets are available in the following packaging:

• Unit packs containing 14, 28, 30, 50, 56, 90 or 98 tablets
• Unit packs containing 56x1 tablets in perforated unit dose blisters
• Multiple packs containing 280 (20x14) tablets
• Multiple packs containing 98 (2x49x1) tablets in perforated unit dose blisters

Not all package sizes may be marketed.

Marketing Authorization Holder

Noden Pharma DAC

D'Olier Chambers

16A D'Olier Street

Dublin 2

Ireland

Responsible for manufacturing

Delpharm Milano S.R.L.,

Via Carnevale, 1,

Segrate (MI),

20054,

Italy

Last review date of this leaflet 02/2023

Other sources of information

Further information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu