Enviage
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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
What Enviage is and what it is used for
Before you take Enviage
How to take Enviage
Possible side effects
How to store Enviage
Further information
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Enviage belongs to a new class of medicines called renin inhibitors. Enviage helps to lower high blood pressure. 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 (hypersensitive) to aliskiren or any of the other ingredients of Enviage. If you think you may be allergic, ask your doctor for advice.
if you have already experienced angioedema (difficulties in breathing, or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue) when taking aliskiren.
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) or verapamil (a medicine used to lower blood pressure, to correct hearth rhythm or to treat angina pectoris) or quinidine (a medicine used to correct heart rhythm).
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 have impaired kidney function.
if you experience angioedema (difficulties in breathing, or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue).
If any of these apply to you, tell your doctor before you take Enviage.
The use of Enviage in children and adolescents is not recommended.
There are no special dose recommendations for patients aged 65 years or older.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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.
ketoconazole, a medicine used to treat fungal infections.
certain types of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).
You should take Enviage with a light meal once a day, preferably at the same time each day. You should not take Enviage together with grapefruit juice.
Do not take Enviage if you are pregnant. It is important to talk to your doctor immediately if you think you may be pregnant or are planning to become pregnant. Do not breast-feed if you are taking Enviage.
Medicinal product no longer authorised
Ask your doctor or pharmacist for advice before taking any medicine.
You may 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 Enviage.
Always take Enviage exactly as your doctor has told you. You should 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.
The usual starting dose is one 150 mg tablet once daily.
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 Enviage together with other medicines used to treat high blood pressure.
It is recommended that you take the tablets with some water. You should take Enviage with a light meal once a day, preferably at the same time each day. You should not take Enviage together with grapefruit juice.
If you have accidentally taken too many Enviage tablets, consult a doctor immediately. You may require medical attention.
If you forget to take a dose of Enviage, 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, Enviage can cause side effects, although not everybody gets them. Common (affecting less than 1 in 10 patients): Diarrhoea.
Uncommon (affecting less than 1 in 100 patients): Skin rash.
Rare (affecting less than 1 in 1,000 patients): Angioedema (difficulties in breathing, or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue).
Not known (frequency cannot be estimated from the available data): Kidney problems.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Medicinal product no longer authorised
Do not use Enviage 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).
Enviage 150 mg film coated tablets are light-pink, biconvex round tablets, imprinted “IL” on one side and “NVR” on the other side.
Enviage 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:
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 2298 3217
Novartis Healthcare A/S Tlf: +45 39 16 84 00
Novartis Pharma B.V. Tel: +31 26 37 82 111
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Novartis Pharma GmbH Tel: +49 911 273 0
Novartis Norge AS Tlf: +47 23 05 20 00
Novartis Pharma Services Inc. Tel: +372 60 62 400
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 22 550 8888
Novartis Farmacéutica, S.A. Tel: +34 93 306 42 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 Inc. Tel: +40 21 31299 01
Novartis Ireland Limited Tel: +353 1 260 12 55
Novartis Pharma Services Inc. Tel: +386 1 300 75 77
Vistor hf.
Sími: +354 535 7000
Novartis Farma S.p.A. Tel: +39 02 96 54 1
Novartis Finland Oy Puh/Tel: +358 9 61 33 22 11
Δημητριάδης και Παπαέλληνας Λτδ Τηλ: +357 22 690 690
Novartis Sverige AB Tel: +46 8 732 32 00
Novartis Pharma Services Inc. Tel: +371 7 887 070
Novartis Pharmaceuticals UK Ltd. Tel: +44 1276 698370
Novartis Pharma Services Inc. Tel: +370 5 269 16 50
Medicinal product no longer authorised