RASILEZ 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rasilez 150 mg film-coated tablets Rasilez 300 mg film-coated tabletsaliskiren

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Rasilez and what is it used for

1. What you need to know before you take Rasilez

1. How to take Rasilez

1. Possible side effects

1. Storage of Rasilez

1. Contents of the pack and other information

1. What is Rasilez and what is it used for

This medicine contains the active substance aliskiren. Aliskiren belongs to a class of medicines called renin inhibitors. Renin inhibitors reduce the amount of angiotensin II that the body can produce. Angiotensin II causes blood vessels to narrow, which increases blood pressure. The reduction of angiotensin II levels allows blood vessels to relax, which lowers blood pressure.

This helps to lower high blood pressure in adult patients. High blood pressure increases the workload of the heart and arteries. If this continues for a long time, it can damage the blood vessels of the brain, heart, and kidneys, which can lead to stroke, heart failure, myocardial infarction, or kidney failure. Lowering blood pressure to normal levels reduces the risk of developing these diseases.

2. What you need to know before you take Rasilez

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.

• if you are taking cyclosporine (a medicine used in transplants to prevent organ rejection or for other diseases, e.g., rheumatoid arthritis or atopic dermatitis), itraconazole (a medicine to treat fungal infections), or quinidine (a medicine used to correct heart rhythm).

• if you have diabetes or kidney problems and are being treated with one of the following classes of medicines used to treat high blood pressure:

• an angiotensin-converting enzyme inhibitor such as enalapril, lisinopril, ramipril

or

• an 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 that increases the amount of urine).
• if you are taking any of the following classes of medicines used to treat high blood pressure:

• an angiotensin-converting enzyme inhibitor such as enalapril, lisinopril,

ramipril

or

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

• if you have kidney problems, your doctor will carefully consider whether this medicine is suitable for you and may want to monitor you closely.

• if you have already experienced angioedema (difficulty breathing or swallowing, or swelling of the face, hands, and feet, eyes, lips, and/or tongue). If this happens, stop taking this medicine and contact your doctor.

• if you have a narrowing of the renal artery (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) in your blood at regular intervals.

See also the section “Do not take Rasilez”.

Children and adolescents

This medicine must not be used in babies from birth to less than 2 years of age. It must not be used in children from 2 years to less than 6 years of age, and it 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 of this medicine in this population are not known.

Elderly

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

Other medicines and Rasilez

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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, medicines that belong to the group of medicines known as diuretics used to increase the amount of urine.

or

• an angiotensin II receptor antagonist or an angiotensin-converting enzyme inhibitor (see 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.

• certain types of pain medicines 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 that contain 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 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will usually advise you to stop taking this medicine before you become pregnant and recommend that you take another anti-hypertensive medicine instead of this medicine. It is not recommended to use it at the start of pregnancy and in no case should it be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby when administered from that time on.

Breastfeeding

Tell your doctor if you are about to start or are already breastfeeding, as this medicine is not recommended for use in women during this period. Your doctor may decide to give you another treatment if you want to breastfeed.

Driving and using machines

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

3. How to take Rasilez

Always take this medicine exactly as your doctor has told you.

If you are unsure, consult your doctor or pharmacist.

Hypertensive patients often do not notice any symptoms of their problem. Many may feel normal. It is very important that you take this medicine exactly as your doctor has told you to get the best results and reduce the risk of side 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-lowering effect appears within two weeks after starting treatment.

Elderly

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

Depending on how you respond to treatment, your doctor may increase your dose to 300 mg once a day. Your doctor may prescribe this medicine in combination with other medicines to treat high blood pressure.

Method of administration

Swallow the tablet whole with a little water. You should take this medicine once a day, always with food or always without food, preferably at the same time each day. You should establish a suitable schedule to take the medicine in the same way each day, according to a regular pattern regarding your meal times. You should avoid taking this medicine with fruit juice and/or drinks that contain plant extracts (including infusions). During your treatment, your doctor may adjust your dose depending on your blood pressure response.

If you take more Rasilez than you should

If you have accidentally taken too many tablets of this medicine, consult your doctor immediately. You may need medical attention.

If you forget to take Rasilez

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Some patients have experienced these serious side effects. If you notice any of the following side effects, tell your doctor immediately:

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

Possible side effects:

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

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

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

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

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

Reporting of side effects

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

5. Storage of Rasilez

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 carton and blister.

The expiry date is the last day of the month stated.

Do not store above 25°C.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rasilez

• The active substance is aliskiren (as hemifumarate).

Rasilez 150 mg film-coated tablets

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

Rasilez 300 mg film-coated tablets

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

Appearance and packaging of the product

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

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

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

• Unit packs containing 7, 14, 28, 30, 50, 56, 90, or 98 tablets

• Unit packs containing 56x1 tablets in perforated unit-dose blisters

• Multiple packs containing 84 (3x28), 98 (2x49), or 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 packs:

• Unit packs containing 7, 14, 28, 30, 50, 56, 90, or 98 tablets

• Unit packs containing 56x1 tablets in perforated unit-dose blisters

• Multiple packs containing 84 (3x28), 90 (3x30), 98 (2x49), or 280 (20x14) tablets
• Multiple packs containing 98 (2x49x1) tablets in perforated unit-dose blisters

Not all pack sizes may be marketed.

Marketing authorization holder

Noden Pharma DAC

D'Olier Chambers

16A D'Olier Street

Dublin 2

Ireland

Manufacturer

Noden Pharma DAC

D'Olier Chambers

16A D'Olier Street

Dublin 2

Ireland

Novartis Farma S.p.A.

Via Provinciale Schito 131

80058 Torre Annunziata (NA)

Italy

Date of last revision of this leaflet:

Other sources of information

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