Rasilez HCT 150 mg/12.5 mg film-coated tablets

Rasilez HCT tablets contain two active substances, called aliskiren and hydrochlorothiazide. Both of these substances help to control high blood pressure (hypertension).

Aliskiren is a substance that belongs to a new group of medicines called renin inhibitors. These reduce the amount of angiotensin II the body can make. Angiotensin II causes blood vessels to tighten, which makes blood pressure higher. Lowering the amount of angiotensin II allows the blood vessels to relax; this lowers blood pressure.

Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. Hydrochlorothiazide increases urine output, which also 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.

Rasilez HCT is used to treat high blood pressure.

Do not take Rasilez HCT

• if you are allergic (hypersensitive) to aliskiren or hydrochlorothiazide, to sulphonamide-derived medicines (medicines used to treat chest or urinary infections) or to any of the other ingredients of Rasilez HCT . If you think you may be allergic, do not take Rasilez HCT and 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.
• if you are between three and nine months pregnant.
• if you are breast-feeding.
• if you have serious liver or serious kidney problems.
• if the level of potassium or sodium in your blood is too low despite treatment, or if the level of calcium in your blood is too high despite treatment.
• 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) 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 any of the above applies to you, do not take Rasilez HCTand talk to your doctor.

Take special care with Rasilez HCT

• if you suffer from kidney problems, including if you have had a kidney transplant.
• if you suffer from liver problems.
• if you suffer from heart problems.
• if you experience angioedema (difficulties in breathing, or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue).
• if you have diabetes (high blood sugar).
• if you have a high level of cholesterol or triglycerides in your blood.
• if you have a low level of potassium, sodium or magnesium in your blood or if you have a high level of calcium in your blood.
• if you suffer from a disease called lupus erythematosus (also called ?lupus? or ?SLE?).
• if you suffer from allergy or asthma.
• if you are on a low-salt diet.
• if you have signs and symptoms such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Rasilez HCT). Tell your doctor if any of the above applies to you.

The use of Rasilez HCT in children and adolescents up to 18 years of age is not recommended.

Using other medicinesPlease tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

It is especially important to tell your doctor if you are using the following medicines:

• medicines containing lithium used to treat some types of psychiatric illnesses.
• potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines.
• other diuretics (water tablets).
• some laxatives.
• medicines for the treatment of gout.
• therapeutic vitamin D supplements.
• medicines to control heart rhythm.
• medicines for the treatment of diabetes (oral agents or insulins).
• medicines to reduce blood pressure.
• steroids.
• medicines to treat cancer.
• certain types of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).
• arthritis medicines.

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

• furosemide, a medicine belonging to the type known as diuretics, or water tablets, which is used to increase the amount of urine you produce.
• some medicines used to treat infections, such as ketoconazole, amphotericin or penicillin G.

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

Pregnancy and breast-feeding

Do not take Rasilez HCT 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 Rasilez HCT.

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

Driving and using machines
As with many other medicines used to treat high blood pressure, this medicine may make you feel dizzy. If you experience this symptom, do not drive or use tools or machines.

Important information about some of the ingredients of Rasilez HCT

Rasilez HCT contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Rasilez HCT contains wheat starch. It is suitable for people with coeliac disease. Patients with wheat allergy (different from coeliac disease) should not take this medicine.

Always take Rasilez HCT exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose of Rasilez HCT is one tablet a day. Swallow the tablet whole with some water. You should take Rasilez HCT with a light meal once a day, preferably at the same time each day. You should not take Rasilez HCT together with grapefruit juice. During your treatment, your doctor may adjust your dose depending on your blood pressure response.

Rasilez HCT may have been prescribed to you because your previous treatment did not lower your blood pressure enough. If this is the case, your doctor will tell you how to switch from that treatment to Rasilez HCT.

If you take more Rasilez HCT than you should
If you have accidentally taken too many Rasilez HCT tablets, talk to a doctor immediately. You may require medical attention.

If you forget to take Rasilez HCT
If you forget to take a dose of this medicine, take it as soon as you remember and then take the next dose at its usual time. 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 (two tablets at once) to make up for a forgotten tablet.

Do not stop taking this medicine, even if you are feeling well (unless your doctor tells you to do so). 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.
If you have further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Rasilez HCT can cause side effects, although not everybody gets them.

These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data.

Side effects reported in clinical studies for patients treated with Rasilez HCT were:

• Common: Diarrhoea

As for any combination of two active substances, side effects associated with each individual component cannot be excluded.
Aliskiren:
In patients taking aliskiren alone, in addition to the side effects listed above, skin rash (uncommon), angioedema (difficulties in breathing, or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue) (rare), kidney problems and swelling of hands, ankles or feet (peripheral oedema) (not known) have also been reported.
Hydrochlorothiazide:
The other component of Rasilez HCT (hydrochlorothiazide) has been associated rarely with other more serious side effects mainly affecting the blood, the skin or the kidneys.
While these side effects were not observed with Rasilez HCT, occurrence of such side effects cannot be excluded.

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 Rasilez HCT after the expiry date which is stated on the carton. 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 Rasilez HCT contains

• Each Rasilez HCT 150 mg/12.5 mg film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 12.5 mg hydrocholorothiazide. The other ingredients are: cellulose microcrystalline, crospovidone, lactose monohydrate, wheat starch, povidone, magnesium stearate, silica colloidal anhydrous, talc, hypromellose, macrogol, titanium dioxide (E171).
• Each Rasilez HCT 150 mg/25 mg film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 25 mg hydrocholorothiazide. The other ingredients are: cellulose microcrystalline, crospovidone, lactose monohydrate, wheat starch, povidone, magnesium stearate, silica colloidal anhydrous, talc, hypromellose, macrogol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).
• Each Rasilez HCT 300 mg/12.5 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 12.5 mg hydrocholorothiazide. The other ingredients are: cellulose microcrystalline, crospovidone, lactose monohydrate, wheat starch, povidone, magnesium stearate, silica colloidal anhydrous, talc, hypromellose, macrogol, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172).
• Each Rasilez HCT 300 mg/25 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 25 mg hydrocholorothiazide. The other ingredients are: cellulose microcrystalline, crospovidone, lactose monohydrate, wheat starch, povidone, magnesium stearate, silica colloidal anhydrous, talc, hypromellose, macrogol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).

What Rasilez HCT looks like and contents of the pack

Rasilez HCT 150 mg/12.5 mg film-coated tablets are white, oval film-coated tablets imprinted with ?LCI? on one side and ?NVR? on the other.
Rasilez HCT 150 mg/25 mg film-coated tablets are pale yellow, oval film-coated tablets imprinted with ?CLL? on one side and ?NVR? on the other.
Rasilez HCT 300 mg/12.5 mg film-coated tablets are violet white, oval film-coated tablets imprinted with ?CVI? on one side and ?NVR? on the other.
Rasilez HCT 300 mg/25 mg film-coated tablets are light yellow, oval film-coated tablets imprinted with ?CVV? on one side and ?NVR? on the other.

Rasilez HCT is available in packs containing 7, 14, 28, 30, 50, 56, 90,or 98 tablets. Packs containing 90 (3x30), 98 (2x49) or 280 (20x14) tablets are multi-packs.

Not all pack sizes or strengths 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

Polska Novartis Hellas A.E.B.E. 30 210 281 17 12 Novartis Poland Sp. z o.o. Tel. 48 22 550 8888 Portugal Novartis Farma - Produtos Farmacêuticos, S.A. España Novartis Farmacéutica, S.A. Tel 34 93 306 42 00 France Novartis Pharma S.A.S. Tél 33 1 55 47 66 00 Tel 351 21 000 8600 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

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