Riprazo
aliskiren
Aliskiren
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.
What Riprazo is and what it is used for
What you need to know before you take Riprazo
How to take Riprazo
Possible side effects
How to store Riprazo
Contents of the pack and other information
Medicinal product no longer authorised
Riprazo tablets contain an active substance called aliskiren. Aliskiren belongs to a class of medicines called renin inhibitors. Riprazo helps to lower high blood pressure in adult patients. 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 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 time, it can damage the blood vessels of the brain, heart and kidneys, and may result 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.
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 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 section Pregnancy and breastfeeding.
if you are taking ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumathoid arthritis or atopic dermatitis), itraconazole (a medicine used to treat fungal infections) or quinidine (a medicine used to correct heart rhythm).
if you have diabetes mellitus 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 etc. or
an “angiotensin II receptor blocker” such as valsartan, telmisartan, irbesartan etc.
Talk to your doctor before taking Riprazo:
if you are taking a diuretic (a type of medicine also 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 as enalapril, lisinopril, ramipril etc. or
an “angiotensin II receptor blocker” such as valsartan, telmisartan, irbesartan etc.
if you have impaired kidney function, your doctor will carefully consider whether Riprazo is suitable for you and may wish to monitor you carefully.
if you have already 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 Riprazo and contact your doctor.
if you have renal artery 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).
The use of Riprazo in children and adolescents up to 18 years of age is not recommended.
Medicinal product no longer authorised
In the majority of patients aged 65 years or older, the 300 mg dose of Riprazo shows no additional benefit in reducing blood pressure compared to the 150 mg dose.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Riprazo if you are taking ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumathoid arthritis or atopic dermatitis), itraconazole (a medicine used to treat fungal infections) or quinidine (a medicine used to correct heart rhythm).
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.
furosemide, a medicine belonging to the type known as diuretics, or “water” tablets, which is used to increase the amount of urine you produce.
one of the following classes of medicines used to treat high blood pressure:
an “angiotensin converting enzyme inhibitor” such as enalapril, lisinopril, ramipril etc. or
an “angiotensin II receptor blocker” such as valsartan, telmisartan, irbesartan etc.
ketoconazole, a medicine used to treat fungal infections.
verapamil, a medicine used to lower high blood pressure, to correct heart rhythm or to treat angina pectoris.
certain types of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).
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.
Do not take this medicine if you are pregnant or breast-feeding (see section Do not take Riprazo). 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. If you become pregnant while taking this medicine, stop taking it immediately and talk to your doctor.
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 that require concentration, you should make sure you know how you react to the effects of this medicine.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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 are feeling well.
Medicinal product no longer authorised
The usual starting dose is one 150 mg tablet once daily. The blood pressure lowering effect is present within two weeks after beginning treatment.
Depending on how you respond to the treatment your doctor may prescribe a higher dose of one 300 mg tablet once daily. Your doctor may prescribe Riprazo together with other medicines used to treat high blood pressure.
It is recommended that you 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 have accidentally taken too many Riprazo tablets, consult a doctor immediately. You may require medical attention.
If you forget to take a dose of Riprazo, take it as soon as you remember and then take the next dose at its 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 dose.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
A few patients have experienced these serious side effects (may affect up to 1 in 1,000 people). 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.
Common (may affect up to 1 in 10 people): Diarrhoea, joint pain (arthralgia), high level of potassium in the blood, dizziness.
Uncommon (may affect up to 1 in 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 urine output), swelling of hands, ankles 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 (may affect up to 1 in 1,000 people): Severe allergic reaction (anaphylactic reaction), allergic reactions (hypersensitivity) and angioedema (the symptoms of which can include difficulties in breathing or swallowing, rash, itching, hives or swelling of the face, hands and feet, eyes, lips and/or tongue, dizziness), increased level of creatinine in the blood, red skin (erythema).
Medicinal product no longer authorised
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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 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.
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).
Riprazo 150 mg film coated tablets are light-pink, biconvex round tablets, imprinted “IL” on one side and “NVR” on the other side.
Riprazo is available in packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets. Packs containing 84 (3x28), 98 (2x49) or 280 (20x14) tablets are multi-packs. Not all pack sizes may be available in your country.
Horsham
West Sussex, RH12 5AB United Kingdom
Novartis Farma S.p.A.
Via Provinciale Schito 131
I-80058 Torre Annunziata/NA Italy
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Medicinal product no longer authorised
Novartis Pharma Services Inc. Тел.: +359 2 489 98 28
Novartis Hungária Kft. Pharma Tel.: +36 1 457 65 00
Novartis s.r.o.
Tel: +420 225 775 111
Novartis Pharma Services Inc. Tel: +356 2122 2872
Novartis Healthcare A/S Tlf: +45 39 16 84 00
Novartis Pharma B.V. Tel: +31 26 37 82 111
Novartis Pharma GmbH Tel: +49 911 273 0
Novartis Norge AS Tlf: +47 23 05 20 00
Novartis Pharma Services Inc. Tel: +372 66 30 810
Novartis Pharma GmbH Tel: +43 1 86 6570
Novartis (Hellas) A.E.B.E. Τηλ: +30 210 281 17 12
Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
Laboratorios Dr. Esteve, S.A. Tel: +34 93 446 60 00
Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600
Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00
Novartis Pharma Services Romania SRL Tel: +40 21 31299 01
Novartis Ireland Limited Tel: +353 1 260 12 55
Novartis Pharma Services Inc. Tel: +386 1 300 75 50
Vistor hf.
Sími: +354 535 7000
Novartis Farma S.p.A. Tel: +39 02 96 54 1
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200
Novartis Pharma Services Inc. Τηλ: +357 22 690 690
Novartis Sverige AB Tel: +46 8 732 32 00
Medicinal product no longer authorised
Novartis Pharma Services Inc. Tel: +371 67 887 070
Novartis Pharmaceuticals UK Ltd. Tel: +44 1276 698370
Novartis Pharma Services Inc. Tel: +370 5 269 16 50