RASILEZ 150 mg. 14 tablets

What is Rasilez and what it is used
Rasilez contains an active substance called aliskiren. Aliskiren belongs to the class of medicines called renin inhibitors. Rasilez helps to lower high blood pressure in adults. Renin inhibitors reduce the amount of by angiotensin II. Angiotensin II leads to constriction of blood vessels, which increases blood pressure. Reducing the amount of angiotensin II allows the blood vessels to relax, which lowers blood pressure.
High blood pressure increases the workload of the heart and arteries. If this continues for a long period of time, can damage the blood vessels of the brain, heart and kidneys, and may result in a stroke, heart failure, myocardial or renal failure. Lowering the blood pressure to normal 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, ask your doctor;
if you have experienced any of the following forms of angioedema (difficulties in breathing or swallowing, or swelling of the face, hands and feet, eyes, lips and / or tongue):
angioedema with aliskiren;
HAE;
angioedema without any known cause;
in the last 6 months of pregnancy or if breast-feeding, see section "Pregnancy and lactation"
if taking cyclosporin (a medicine used in transplantation to prevent rejection of a transplanted organ or for other conditions such as rheumatoid arthritis or atopic dermatitis), itraconazole (a medicine used for the treatment of fungal infections) or quinidine (drug that is used to correct heart rhythm);
if you have diabetes or renal impairment and are treated with any of the following classes of drugs used to treat high blood pressure:
"angiotensin converting enzyme", as enalapril, lisinopril, ramipril etc .;
"angiotensin II receptor blockers" as valsartan, telmisartan, irbesartan and others.
Warnings and Precautions
Talk to your doctor before you take Rasilez:
if you are taking a diuretic (a type of medicine known as' water tablets which increases the amount of urine);
if you take any of the following classes of drugs used to treat high blood pressure:
"angiotensin converting enzyme", as enalapril, lisinopril, ramipril etc .;
"angiotensin II receptor blockers" as valsartan, telmisartan, irbesartan, etc .;
if you have impaired kidney function, your doctor will carefully consider whether Rasilez is suitable for you and you may want to monitor you carefully;
if you have 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 Rasilez and contact your doctor;
if you have renal artery stenosis (narrowing of the blood vessels to one or both kidneys);
if you have severe congestive heart failure (a type of heart disease where the heart can not pump enough blood around the body).
You should tell your doctor if you are (or think you may be) pregnant. Rasilez is not recommended in early pregnancy and must not be taken if you are pregnant after 3 months, as it may cause serious harm to your baby if used during this period (see "Pregnancy").

Children and adolescents
Not recommended use of Rasilez in children and adolescents under 18 years.

elderly
In the majority of patients aged 65 years and older, use of Rasilez in the 300 mg dose did not show additional benefits in terms of lowering blood pressure compared with the dose of 150 mg.

Other medicines, Rasilez
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Rasilez, if you are taking ciclosporin (a medicine used in transplantation to prevent rejection of the transplanted organ or for other conditions, eg. Rheumatoid arthritis or atopic dermatitis), itraconazole (a medicine
used to treat fungal infections) or quinidine (a drug that is used to correct heart rhythm).

May be necessary for your doctor to change your dose and / or to take other precautions if you are taking any of the following medications:
drugs that increase the amount of potassium in the blood. These include potassium-sparing diuretics, potassium supplements;
torasemide or furosemide, a medicine belonging to the type known as diuretics, or water tablets, which is used to increase the amount of urine;
any of the following classes of drugs used to treat high blood pressure:
"angiotensin converting enzyme", as enalapril, lisinopril, ramipril etc .;
"angiotensin II receptor blockers" as valsartan, telmisartan, irbesartan, etc .;
ketoconazole, a drug used to treat fungal infections;
verapamil, a drug used to lower blood pressure, to correct heart rhythm or to treat angina pectoris;
certain types of painkillers called non-steroidal anti-inflammatory drugs (NSAIDs).
Rasilez with food and drink
You should take this medicine with a light meal once a day, preferably at the same time each day. You should not take this medicine together with grapefruit juice.

pregnancy
Do not take this medicine if you are pregnant (see section "Do not take Rasilez"). If you become pregnant while taking this medication, stop taking it and contact your doctor immediately. If you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine. Your doctor will advise you to stop taking Rasilez before you become pregnant and will advise you to take another medicine instead of Rasilez. Rasilez is not recommended in early pregnancy and must not be taken if you are pregnant after 3 months, as it may cause serious harm to your baby if used after the third month of pregnancy.

breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. Treatment with Rasilez is not recommended for mothers who are breastfeeding, and your doctor may prescribe other treatments, 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, use machinery, or performing other activities that 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 prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
People 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 your appointments with the doctor even if you feel well.
The usual starting dose is one 150 mg tablet once daily. The effect of lowering blood pressure occurs within two weeks of starting treatment.
Depending on how you respond to the treatment, your doctor may prescribe a higher dose - one tablet of 300 mg once daily. Your doctor may prescribe Rasilez together with other medicines used to treat high blood pressure.

Method of administration
It is recommended to take the tablets with some water. You should take this medicine with a light meal once a day, preferably at the same time each day. You should not take this medicine together with grapefruit juice.

If you take more Rasilez than
If you accidentally take too many tablets Rasilez, immediately consult a doctor. You may need medical attention.

If you forget to take Rasilez
If you forget to take a dose of Rasilez, take it as soon as you remember and then take the next dose at the usual time. However, if 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 tablet.

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

Some side effects can be serious (not known):
Several patients have received such serious side effects (may affect up to 1 in 1000 people). If any of the following side effects, tell your doctor immediately:
Severe allergic reaction with symptoms such as rash, itching, swelling of the face, lips or tongue, difficulty breathing, dizziness;
Nausea, loss of appetite, dark-colored urine, or yellowing of the skin or eyes (signs of liver disorders).
Possible side effects:
Common (may affect up to 1 in 10 people): diarrhea, joint pain (arthralgia), high potassium levels in the blood, dizziness.

Uncommon (may affect up to 1 in 100 people): rash (may also be a sign of allergic reactions or angioedema - see "Rare" side effects below), kidney problems including acute renal failure (severe reduction urine output), swelling of the hands, ankles or feet (peripheral edema), severe skin reactions (toxic epidermal necrolysis and / or oral mucosal reactions - red skin, blistering of the lips, eyes or mouth, skin peeling, high temperature), low blood pressure, palpitations, cough, pruritus, rash (urticaria), elevation of liver enzymes.

Rare (may affect up to 1 in 1000 people): severe allergic reaction (anaphylactic reaction), allergic reactions (hypersensitivity) and angioedema (whose symptoms may include difficulty breathing, rash, itching, hives or swelling of the face , hands and feet, eyes, lips and / or tongue, dizziness), increased level of creatinine in the blood, skin redness (erythema).

If any of these affects you severely, tell your doctor. You may need to stop taking Rasilez.
If you get any side effects, tell your doctor or pharmacist. This includes any possible effects not listed in this leaflet.

5. How to store Rasilez
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
Do not store above 30 ° C.
Store in the original package in order to protect from moisture.
Do not dispose of medications in wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information
What Rasilez contains
The active substance is aliskiren (as hemifumarate) 150 mg.
The other ingredients are crospovidone, hypromellose, magnesium stearate, macrogol, microcrystalline cellulose, povidone, 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 tablets are light-pink, biconvex, round tablets imprinted with 'IL' on one side and 'NVR' on the other.