Sprimeo 300 mg film-coated tablets

Sprimeo belongs to a new class of medicines called renin inhibitors. Sprimeo 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.

Do not take Sprimeo

• if you are allergic (hypersensitive) to aliskiren or any of the other ingredients of Sprimeo. 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).

Take special care with Sprimeo

• 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 Sprimeo.

The use of Sprimeo in children and adolescents is not recommended.
There are no special dose recommendations for patients aged 65 years or older.

Using other medicines
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).

Taking Sprimeo with food and drink
You should take Sprimeo with a light meal once a day, preferably at the same time each day. You should not take Sprimeo together with grapefruit juice.

Pregnancy and breast-feeding

Do not take Sprimeo 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 Sprimeo.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
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 Sprimeo.

Always take Sprimeo 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 Sprimeo together with other medicines used to treat high blood pressure.

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

If you take more Sprimeo than you should
If you have accidentally taken too many Sprimeo tablets, consult a doctor immediately. You may require medical attention.

If you forget to take Sprimeo
If you forget to take a dose of Sprimeo, 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, Sprimeo 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.
Do not use Sprimeo 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.

What Sprimeo contains

• The active substance is aliskiren (as hemifumarate) 300 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 Sprimeo looks like and contents of the pack

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

Sprimeo is available in packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets. Packs containing 84 (3x28), 90 (3x30), 98 (2x49) or 280 (20x14) tablets are multi-packs. Not all pack sizes may be available in your country.

Marketing Authorisation Holder

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom

Manufacturer

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:

BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma GmbH TélTel 49 911 273 0

Novartis Pharma Services Inc. . 359 2 489 98 28 Magyarország Novartis Hungária Kft. Pharma Tel. 36 1 457 65 00

eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217

Danmark Novartis Healthcare AS Tlf 45 39 16 84 00 Nederland Novartis Pharma B.V. Tel 31 26 37 82 111

Deutschland Novartis Pharma GmbH Tel 49 911 273 0 Norge Novartis Norge AS Tlf 47 23 05 20 00

Eesti Novartis Pharma Services Inc. Tel 372 60 62 400 Österreich Novartis Pharma GmbH Tel 43 1 86 6570

Novartis Hellas A.E.B.E. 30 210 281 17 12 Polska Novartis Poland Sp. z o.o. Tel. 48 22 550 8888

España Novartis Farmacéutica, S.A. Tel 34 93 306 42 00 Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel 351 21 000 8600

France Novartis Pharma S.A.S.Tél 33 1 55 47 66 00 România Novartis Pharma Services Inc. Tel 40 21 31299 01

Ireland Novartis Ireland Limited Tel 353 1 260 12 55 Slovenija Novartis Pharma Services Inc. Tel 386 1 300 75 77

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Novartis Slovakia s.r.o. Tel 421 2 5542 5439

Italia Novartis Farma S.p.A. Tel 39 02 96 54 1 SuomiFinland Novartis Finland Oy PuhTel 358 9 61 33 22 11

357 22 690 690 Sverige Novartis Sverige AB Tel 46 8 732 32 00

Latvija Novartis Pharma Services Inc. Tel 371 7 887 070 United Kingdom Novartis Pharmaceuticals UK Ltd. Tel 44 1276 698370

Lietuva
Novartis Pharma Services Inc.
Tel: +370 5 269 16 50

This leaflet was last approved in