Rasilamlo 300 mg/5 mg film-coated tablets

What Rasilamlo is

Rasilamlo contains two active substances, called aliskiren and amlodipine. Both of these substances help to control high blood pressure (hypertension).

Aliskiren is a substance that belongs to a 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 raises blood pressure. Lowering the amount of angiotensin II allows the blood vessels to relax; this lowers blood pressure.

Amlodipine belongs to a group of medicines known as calcium channel blockers, which help to control high blood pressure. Amlodipine causes blood vessels to dilate and relax, thus blood pressure is lowered.

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.

What Rasilamlo is used for

Rasilamlo is used to treat high blood pressure in adult patients whose blood pressure is not sufficiently controlled with aliskiren or amlodipine alone.

Do not take Rasilamlo

• if you are allergic (hypersensitive) to aliskiren or amlodipine, to any of the other ingredients of Rasilamlo or to other dihydropyridine-derived medicines (known as calcium channel blockers). If you think you may be allergic, do not take Rasilamlo 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 taking any of the following medicines
• ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis)
• itraconazole (a medicine used to treat fungal infections)
• verapamil (a medicine used to lower blood pressure, to correct heart rhythm or to treat angina pectoris)
• quinidine (a medicine used to correct heart rhythm)
• if you have very low blood pressure
• if you are suffering from shock, including cardiogenic shock
• if you have a narrowing of the aortic heart valve (aortic stenosis)
• if you have heart failure after an acute heart attack If any of the above applies to you, do not take Rasilamloand talk to your doctor.

Take special care with Rasilamlo

• if you are suffering from vomiting or diarrhoea or if you are taking a diuretic (a medicine to increase the amount of urine you produce)
• if you experience angioedema (difficulties in breathing, or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue). If this happens, stop taking Rasilamlo and contact your doctor
• if you have diabetes (high blood sugar)
• if you suffer from heart problems
• if you are on a low-salt diet
• if your urine flow has decreased markedly for 24 hours or more and/or if you have serious kidney problems (e.g. require dialysis) or a narrowing or blockage of the arteries that supply blood to your kidney
• if you suffer from liver problems (impaired liver function) Tell your doctor if any of the above applies to you.

Use in children

The use of Rasilamlo in children and teenagers up to 18 years of age is not recommended.

Taking 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.

Do not take Rasilamlo and talk to your doctor if you are taking any of the following medicines: - ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis)
- itraconazole (a medicine used to treat fungal infections)
- verapamil (a medicine used to lower blood pressure, to correct heart rhythm or to treat angina pectoris)
- quinidine (a medicine used to correct heart rhythm)

Tell your doctor if you are using the following medicines medicines used to lower blood pressure, diuretics medicines to increase the amount of urine you produce, especially potassium-sparing medicines, potassium supplements, potassium- containing salt substitutes, or heparin ketoconazole, a medicine used to treat fungal infections clarithromycin, telithromycin, erythromycin which are antibiotics used to treat infections amiodarone, a medicine used to treat abnormal heart rhythms atorvastatin, a medicine used to treat high cholesterol furosemide, a medicine belonging to the type known as diuretics, which is used to increase the amount of urine you produce and is also used to treat a certain kind of heart problem heart failure or oedema swelling antiepileptics e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone rifampicin, a medicine used to prevent or treat infections St. Johns wort hypericum perforatum, a herbal medicine used to elevate mood certain types of pain killers called non-steroidal anti-inflammatory medicines NSAIDs used especially in patients over 65 years old diltiazem, a medicine used to treat heart problems ritonavir, a medicine used to treat viral infection

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, which is used to increase the amount of urine you produce and is also used to treat a certain kind of heart problem (heart failure) or oedema (swelling)
• some medicines used to treat infections, such as ketoconazole

Taking Rasilamlo with food and drink

You should take Rasilamlo with a light meal once a day, preferably at the same time each day. You should not take Rasilamlo together with grapefruit juice.

Pregnancy and breast-feeding

- You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking Rasilamlo before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Rasilamlo. Rasilamlo is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if it is used after the third month of pregnancy.

Tell your doctor if you are breast-feeding or about to start breast-feeding. Rasilamlo is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

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

Driving and using machines

This medicine may make you feel dizzy and drowsy. If you experience this symptom, do not drive or use tools or machines.

Always take Rasilamlo exactly as your doctor has told you and do not exceed the recommended dose. You should check with your doctor or pharmacist if you are not sure.

The usual dose of Rasilamlo is one tablet a day. Swallow the tablet whole with some water. You should take Rasilamlo with a light meal once a day, preferably at the same time each day. You should not take Rasilamlo together with grapefruit juice.

The effect on blood pressure is seen within 1 week and maximum effect is reached at around 4 weeks. If your blood pressure is not controlled after 4 to 6 weeks, your doctor may adjust your dose.

If you take more Rasilamlo than you should

If you have accidentally taken too many Rasilamlo tablets, talk to a doctor immediately. You may require medical attention.

If you forget to take Rasilamlo

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 medicine, ask your doctor or pharmacist.

Like all medicines, Rasilamlo 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 patient in 10 common affects 1 to 10 patients in 100 uncommon affects 1 to 10 patients in 1,000 rare affects 1 to 10 patients in 10,000 very rare affects less than 1 patient in 10,000 not known frequency cannot be estimated from the available data.

Side effects reported for Rasilamlo are:

• Common: low blood pressure, swelling of hands, ankles or feet (peripheral oedema)

Fainting and/or light-headedness linked to low blood pressure could occur at the beginning of treatment with Rasilamlo. If you experience these, tell your doctor immediately.

The following, possibly serious, side effects have been reported with medicines containing aliskiren or amlodipine alone.

Aliskiren
In patients taking aliskiren alone, the following have been reported:

• Common: diarrhoea
• Uncommon: skin rash
• Rare: angioedema (difficulties in breathing, or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue)
• Not known: kidney problems, peripheral oedema (swelling of hands, ankles or feet) and increase in blood creatinine

Amlodipine
In patients taking amlodipine alone, the following have been reported:

• Common: sleepiness; dizziness; headache (especially at the beginning of treatment); hot flushes; abdominal pain; nausea; ankle swelling; swelling; tiredness.
• Uncommon: insomnia; mood changes (including anxiety); depression; trembling; disturbed sense of taste; sudden, temporary loss of consciousness; decreased skin sensitivity; tingling or numbness; vision disorder (including double vision); ringing noise in ears; palpitations; low blood pressure; breathlessness; runny nose; vomiting; stomach discomfort after meal; altered bowel habits (including diarrhoea and constipation); dry mouth; hair loss; purple skin patches; skin discolouration; excessive sweating; itching; rash; generalised rash; joint pain; muscle pain; muscle cramps; back pain; urination disorders; urination at night; frequent urination; impotence; breast enlargement in men; chest pain; weakness; pain; feeling unwell; weight increase; weight decrease.
• Rare: confusion
• Very rare: low level of white blood cells and blood platelets; allergic reaction with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness; high level of sugar in the blood; increased muscle stiffness and inability to stretch; sensation of numbness or tingling with sensation of burning in fingers and toes; heart attack; irregular heart beat; inflammation of blood vessels; cough; severe upper stomach pain; inflammation of the gastric lining; bleeding, tender or enlarged gums; inflammation of the liver; liver disorder which can occur together with yellow skin and eyes, or dark-coloured urine; abnormal liver function test; angioedema (difficulties in breathing, or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue); skin reaction with skin reddening and peeling, blistering of lips, eyes or mouth; dry skin, rash, itchy rash; skin rash with flaking or peeling; rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever; swelling mainly of the face and throat; increased sensitivity of the skin to sun.

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 Rasilamlo after the expiry date which is stated on the carton and blister after EXP. 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 Rasilamlo contains

• Each Rasilamlo 150 mg/5 mg film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 5 mg amlodipine (as besylate). The other ingredients are cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172) and red iron oxide (E172).
• Each Rasilamlo 150 mg/10 mg film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 10 mg amlodipine (as besylate). The other ingredients are cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, titanium dioxide (E171), macrogol, talc and yellow iron oxide (E172).
• Each Rasilamlo 300 mg/5 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 5 mg amlodipine (as besylate). The other ingredients are cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, titanium dioxide (E171), macrogol, talc and yellow iron oxide (E172).
• Each Rasilamlo 300 mg/10 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 10 mg amlodipine (as besylate). The other ingredients are cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, macrogol, talc and yellow iron oxide (E172).

What Rasilamlo looks like and contents of the pack

Rasilamlo 150 mg/5 mg film-coated tablets are light yellow, convex, oval film-coated tablets, with ?T2? debossed on one side and ?NVR? on the other.

Rasilamlo 150 mg/10 mg film-coated tablets are yellow, convex, oval film-coated tablets, with ?T7? debossed on one side and ?NVR? on the other.

Rasilamlo 300 mg/5 mg film-coated tablets are dark yellow, convex, oval film-coated tablets, with ?T11? debossed on one side and ?NVR? on the other.

Rasilamlo 300 mg/10 mg film-coated tablets are brown-yellow, convex, oval film-coated tablets, with ?T12? debossed on one side and ?NVR? on the other.

Rasilamlo is available in packs containing 14, 28, 56 or 98 tablets (in calendar blisters), 30 or 90 tablets (in normal blisters) and 56x1 tablet (as perforated unit dose blisters).

It is also available in multi-packs of 98 tablets (2 packs of 49) and 280 tablets (20 packs of 14) in calendar blisters and 98x1 tablet (2 packs of 49x1) as perforated unit dose blisters.

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 Provenciale 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 N.V. TélTel 32 2 246 16 11

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 66 30 810 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 22 375 4888

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 Romania SRL 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 50

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 358 010 6133 200

Novartis Pharma Services Inc. 357 22 690 690 Sverige Novartis Sverige AB Tel 46 8 732 32 00

Latvija Novartis Pharma Services Inc. Tel 371 67 887 070 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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