InfoCons Consumer Protection informs you – Rasilez – Package Leaflet

Before anything else

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 si gns of illness are the same as yours.
• If you get any side effects, ta lk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is i n this leaflet 1. What Rasilez is and what it is used for 2. What you need to know b efore you take Rasilez 3. How to take Rasilez 4. Possible side effects 5. How to store Rasilez 6. Contents of the pack and other information

ℹ️ 1. What Rasilez is and what it is used for

This medicine contain s an active substance cal led aliskiren. Aliskiren belongs to a class of medicines called renin inhibitors. Renin inhibitors reduce the amount of angiotensin II the body can produce.

Angiotensin II causes blood vessels to tighten, which increases the blood pressure. Reducing the amount of angiotensin II allows the bloo d vessels to relax, which lower s 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 c an damage the blood vessels of the bra in, heart and kidneys, and may r esult in a stroke, heart failure, heart attack or kidney failure. Lowering the blood pressure to a normal level reduces the risk of developing these disorders.

⚠️ 2. What you need to know before you take Rasilez

Do not take Rasilez

• if you are allergic to a liskiren or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice.
• if you have experienced the following forms of angioedema (difficulties in breathing or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue) :
• angioedema when taking aliskiren.
• hereditary angioedema.
• angioedema without any known cause.
• during the last 6 months of pregnancy or if you are breast -feeding, see sect ion “Pregnancy and breastfeedin g”.
• if you are taking ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis) , itraconazole (a medicine used to treat fungal infectio ns) or quinidine (a medicine us ed to correct heart rhythm).

42 – if you have diabetes or impaired kidney function and you are treated with either 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 blocker such as valsartan, te lmisartan, irbesartan.
• if the patient is less than 2 years of age.

Warnings and precautions

Talk to your doctor befor e taking Rasilez:

• if you are taking a diuretic (a type of medicine al so known as “water” tablets which increases the amount of urine you produce).
• if you are taking either of the following classes of medicines used to treat high blood pressure:
• an angiotensin converting enzyme inhibitor such a s enalapril, lisinopril, ramipr il or
• an angiotensin II receptor blocker such as valsartan, te lmisartan, irbesartan .
• if you have impaired kidney function, your doctor will carefully consider whether this medicine is sui table for you and may wish to monitor you carefully.
• if you have alre ady experienced angioedema (difficulties in breathing or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue). If this happens, stop taking this medicine and con tact your doctor.
• if you have renal ar tery stenosis (narrowing of the blood vessels to one or both kidneys).
• if you have serious congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body) .

If you have sever e and persistent diarrhoea you should stop taking Rasilez.

Your doct or may check your kidney function, blood pressure and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also section “Do not take Rasilez”.

Children and adolescents

This medicine must not b e used in babies from birth to less than 2 years of age. It should not be used in children from 2 to less than 6 years of age, and is not recommended for use in children and adolescents from 6 to less than 18 years of age . This is because the safety and benefits of this medicine are not known in this population.

Elderly The usual recommended starting dose of aliskiren in elderly patients aged 65 years or older is 150 mg.

In the majority of patients aged 65 years or o lder, the 300 mg dose of Rasilez shows no additional benefit in reduc ing blood pressure compared to the 150 mg dose .

Other medicines and Rasilez

Tell your doctor or pharmacist if you are taking , have recently taken or might take any other medicines.

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

• medicines that increase the amount of potassium in your blood. These include potassium -sparing diuretics, potassium supplements .
• furosem ide or torasemide , medicine s belonging to the type known as diuretics , or “water” tablets, which are used to increase the amount of urine you produce.
• an angiotensin II receptor blocker or an angiotensin converting enzyme inhibitor (see sections “Do not ta ke Rasilez” and “Warnings and precauti ons”) .
• ketoconazole, a medicine used to treat fungal infections.
• verapamil, a medicine used to lower high blood pressure, to correct heart rhythm or to treat 43 angina pectoris.
• certain types of pain killers called non -steroidal anti- inflammatory medicines (N SAIDs).

Rasilez with food and drink You should take this medicine either with a light meal or without a meal once a day, preferably at the same time each day . You should avoid taking this medicine together with fruit juice and/or drinks containing plant extracts (including herbal teas) , as it could cause a decrease in the effectiveness of this medicine.

Pregnancy and breast -feeding

Pregnancy

Do not take this medicine if you are pregnant (see section “Do not take Rasil ez”). If you become pregnant while tak ing this medicine, stop taking it immediately and talk to your doctor. If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will normally advise you to stop takin g this medicine before you beco me pregnant and will advise you to take another medicine instead of this medicine . It is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast -feeding Tell your doctor if you are breast -feeding or about to start breast-feeding. This medicine is not recommended for mothers who are breast -feeding, and your doctor may choose another treatment for you if you wish to breast- feed.

Driving and using machines

This medicine may make you feel dizzy and this can affect your ability to concentrate. Before you drive a vehicle, use machinery, or carry out other activities t hat require concentration, you should make sure you know how you react to the effects of this medicine.

💊 3. How to take Rasilez

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Peop le who have high blood pressure often do not notice any signs of the problem. Many may feel quite normal. It is very important that you take this medicine exactly as your doctor tells you to get the best results and reduce the risk of side effects. Keep yo ur appointments with the doctor even i f you are feeling well.

The usual starting dose is one 150 mg tablet once daily. The blood pressure lowering effect is present within two weeks after beginning treatment.

Elderly people The usual recommended startin g dose of aliskiren in elderly patient s is 150 mg. In the majority of patients aged 65 years or older , the 300 mg dose of aliskiren shows no additional benefit in reducing blood pressure compared to the 150 mg dose.

Depending on how you respond to the tre atment your doctor may prescribe a higher dose of one 300 mg tablet o nce daily. Your doctor may prescribe this medicine together with other medicines used to treat high blood pressure.

Method of administration Swallow the tablet whole with some water. You should take this medicine once a day, always with or always without food, preferably at the same time each day. You should establish a convenient daily schedule to take the medicine the same way each day, in a regular pattern with respect to the timing of 44 your meals. You should avoid taking t his medicine together with frui t juice and/or drinks containing plant extracts (including herbal teas). 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 a doctor immediately. You may require medical attention.

If you forget to take Rasilez

If you forget to take a dose of this medicine , take it as soon as y ou remember and then take the next dose at its usual time. However, i f it is almost time for your next dose you should simply take the next tablet at the usual time. Do not take a double dose to make up for a forgotten dose.

❗ 4. Possible side effects

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

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

A few patients have experienced these serious side effects. If any of the following occur, tell your doctor straight away:

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

Possible side effects:

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

Uncommon (ma y affect up to 1 i n 100 people) : Skin rash (this may also be a sign of allergic reactions or angioedema – see “Rare” side effects below), kidney problems including acute renal failure (severely decreased u rine output) , swelling of hands, ankle s or feet (peripheral oedema) , severe skin reactions (toxic epidermal necrolysis and/or oral mucosal reactions – red skin, blistering of the lips, eyes or mouth, skin peeling, fever), low blood pressure, palpitations, cough, itching , itchy rash (urticaria) , increased liver enzymes.

Rare (ma y affect up to 1 in 1 ,000 people) : increased level of creatinine in the blood , decreased level of haemoglobin in the blood (anaemia), decreased level of red bloo d cells, red skin (erythema) .

Not known ( frequency cannot be estimated from the available data) : spinning sensation, low level of sodium in the blood, shortness of breath, nausea, vomiting, signs of liver disorder (nausea, loss of appetite, dark colo ured urine or yellowing of s kin and eyes) .

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

Reporting of side effects

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

🌡️ 5. How to store 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 expir y date refers to the last day of that month.

Do not store above 25°C.

Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 45 throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Content s of the pack and other information

What Rasilez contains

• The active substance is aliskiren (as hemifumarate) .

Rasilez 150 mg film -coated tablets

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

What Rasilez looks like and contents of the pack

Rasilez 150 mg film- coated tablet s are light-pink, bic onvex round tablet s, impr inted “ IL” on one side and “ NVR ” on the other side.

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

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

• Unit packs containing 14, 28, 30, 50, 56, 90 or 98 tablets
• Unit packs containing 56×1 tablets in perforated unit- dose blisters
• Multipacks containing 280 (20×14) tablets
• Multipacks containing 9 8 (2x49x1) tablets in perforated unit- dose blisters Rasilez 300 mg film- coated tablets are available in the following packs:
• Unit packs containing 14, 28, 30, 50, 56, 90 or 98 tablets
• Unit packs containing 56×1 tablets in perforated unit- dose blist ers
• Mult ipacks containi ng 280 (20×14) tablets
• Multipacks containing 98 (2x49x1) tablets in perforated unit- dose blisters Not all pack sizes may be available in your country.

Marketing Authorisation Holder

Noden Phar ma DAC D’Olier Chambers 16A D’Olier Street Dublin 2 Ireland

Manufacturer

Delpharm Milano S.R.L., Via Carnevale, 1, Segra te (MI), 20054, Italy.

46 This leaflet was last revi sed in 02/2023 Other sources of information Detailed info rmation on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Rasilez (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/07/405).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.