Rasitrio
aliskiren, amlodipine, hydrochlorothiazide
Rasitrio 150 mg/5 mg/12.5 mg film-coated tablets Aliskiren/amlodipine/hydrochlorothiazide
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 Rasitrio is and what it is used for
What you need to know before you take Rasitrio
How to take Rasitrio
Possible side effects
How to store Rasitrio
Contents of the pack and other information
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Rasitrio contains three active substances, called aliskiren, amlodipine and hydrochlorothiazide. All 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; 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.
Rasitrio is used to treat high blood pressure in adult patients who have their blood pressure already controlled by aliskiren, amlodipine and hydrochlorothiazide taken as separate medicines given at the same time. These patients may thus benefit from taking one tablet containing all three substances.
if you are allergic to aliskiren, to amlodipine, to other dihydropyridine-derived medicines (known as calcium channel blockers), to hydrochlorothiazide, to sulphonamide-derived medicines (medicines used to treat chest or urinary infections) or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, do not take Rasitrio and 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.
if you are more than 3 months pregnant. (It is also better to avoid Rasitrio in early pregnancy – see Pregnancy section).
if you have serious liver problems.
if you have serious kidney problems.
if you have problems to produce urine (anuria).
if the level of potassium in your blood is too low despite treatment.
if the level of sodium in your blood is too low.
if the level of calcium in your blood is too high.
if you have gout (uric acid crystals in the joints).
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),
quinidine (a medicine used to correct heart rhythm).
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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.
if you have a 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.
Talk to your doctor before taking Rasitrio:
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 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 Rasitrio and contact your doctor.
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), including if you have had a kidney transplant or a narrowing or blockage of the arteries that supply blood to your kidney.
if you have impaired kidney function, your doctor will carefully consider whether Rasitrio is suitable for you and may wish to monitor you carefully.
if you suffer from liver problems (impaired liver function).
if you have diabetes (high level of sugar in your blood).
if you have a high level of cholesterol or triglycerides 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 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 are 65 years of age or older (see section Elderly (age 65 years or older) below).
if you have signs and symptoms such as abnormal thirst, dry mouth, general weakness, drowsiness, restlessness, muscle pain or cramps, weakness, low blood pressure, reduced urine output, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Rasitrio).
if you experience skin reactions such as rash after sun exposure.
if you experience a decrease in vision or eye pain. These could be symptoms of an increase of pressure in your eye and can happen within hours to weeks of taking Rasitrio. This can lead to permanent vision impairment, if not treated.
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.
You must tell your doctor if you think you are (or might become) pregnant. Rasitrio is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see Pregnancy section).
The use of Rasitrio in children and adolescents up to 18 years of age is not recommended.
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You should tell your doctor if you are 65 years of age or older because you may be more susceptible to side effects related to low blood pressure (see section 4 on possible side effects). Your doctor will carefully consider whether Rasitrio is suitable for you. If you are 75 years of age or older, your doctor may wish to monitor your blood pressure more frequently.
In the majority of patients aged 65 years or older, the 300 mg dose of aliskiren 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.
ciclosporin (a medicine used in transplantation to prevent organ rejection and also in other conditions, e.g. rheumatoid arthritis or atopic dermatitis).
itraconazole (a medicine used to treat fungal infections).
quinidine (a medicine used to correct heart rhythm).
one of the following classes of medicines used to treat high blood pressure if you have diabetes mellitus or impaired kidney function:
an “angiotensin converting enzyme inhibitor” such as enalapril, lisinopril, ramipril etc. or
an “angiotensin II receptor blocker” such as valsartan, telmisartan, irbesartan etc.
medicines or substances that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin.
medicines that may reduce the amount of potassium in your blood, such as diuretics (water tablets), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G.
medicines to reduce blood pressure, including methyldopa.
medicines to increase blood pressure, such as noradrenaline or adrenaline.
medicines that may induce “torsades de pointes” (irregular heart beat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics.
ketonazole, 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.
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 or torasemide, medicines belonging to the type known as diuretics, which are used to increase the amount of urine you produce and are also used to treat a certain kind of heart problem (heart failure) or oedema (swelling).
medicines that may reduce the amount of sodium in your blood, such as antidepressants, antipsychotics, antiepileptics (carbamazepine).
rifampicin, a medicine used to prevent or treat infections.
St. John’s wort (hypericum perforatum), a herbal medicine used to elevate mood.
pain killers such as non-steroidal anti-inflammatory agents (NSAIDs), including selective cyclooxygenase-2 inhibitors (Cox-2 inhibitors) (used especially in the patients over 65 years old).
diltiazem, a medicine used to treat heart problems.
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ritonavir, a medicine used to treat viral infection.
lithium (a medicine used to treat some types of depression).
some laxatives.
medicines for the treatment of gout, such as allopurinol.
digoxin or other digitalis glycosides (medicines used to treat heart problems).
vitamin D and calcium salts.
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.
medicines used to control heart rhythm.
medicines for the treatment of diabetes (oral agents such as metformin or insulins).
medicines that may increase blood sugar level, such as beta blockers and diazoxide.
steroids.
cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide.
arthritis medicines.
medicines used to treat oesophageal ulceration and inflammation (e.g. carbenoxolone).
muscle relaxants (medicines to relax the muscles which are used during operations).
amantadine (a medicine used to treat Parkinson’s disease, also used to treat or prevent certain illnesses caused by viruses).
anticholinergic agents (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson’s disease and as an aid to anaesthesia).
cholestyramine, colestipol or other resins (substances used mainly to treat high levels of lipids in the blood).
alcohol, sleeping pills and anaesthetics (medicines allowing patients to undergo surgery and other procedures).
iodine contrast media (agents used for imaging examinations).
furosemide or torasemide, medicines belonging to the type known as diuretics, which are used
to increase the amount of urine you produce and are also used to treat a certain kind of heart problem (heart failure) or oedema (swelling).
some medicines used to treat infections, such as ketoconazole, amphotericin or penicillin G.
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 with grapefruit juice.
Due to hydrochlorothiazide contained in Rasitrio, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, especially when getting up from a sitting position.
Do not take this medicine if you are pregnant (see section Do not take Rasitrio). If you become pregnant while taking this medicine stop taking it immediately and talk to your doctor. 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. Your doctor will normally advise you to stop taking Rasitrio before you become pregnant and will advise you to take another medicine instead of Rasitrio. Rasitrio 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.
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Tell your doctor if you are breast-feeding or about to start breast-feeding. Rasitrio is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.
This medicine may make you feel dizzy and drowsy. If you experience this symptom, do not drive or use tools or machines.
Always take this medicine exactly as your doctor has told you and do not exceed the recommended dose. Check with your doctor or pharmacist if you are not sure.
The usual dose of Rasitrio is one tablet a day.
Swallow the tablet whole 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 Rasitrio tablets, talk to a doctor immediately. You may require medical attention.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects reported for Rasitrio are:
dizziness
low blood pressure
swelling of hands, ankles and feet (peripheral oedema).
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The following, possibly serious, side effects have been reported with medicines containing aliskiren, amlodipine or hydrochlorothiazide alone.
Aliskiren
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.
Nausea, loss of appetite, dark coloured urine or yellowing of skin and eyes (signs of liver disorder).
Possible side effects
diarrhoea
joint pain (arthralgia)
high level of potassium in the blood
dizziness.
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.
severe allergic reaction (anaphylactic reaction)
allergic reactions (hypersensitivity)
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).
Amlodipine
In patients taking amlodipine alone, the following have been reported:
sleepiness
dizziness
headache (especially at the beginning of treatment)
hot flushes
abdominal pain
nausea
ankle swelling
swelling
tiredness
palpitations (awareness of your heart beat).
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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
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.
confusion.
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
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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.
Hydrochlorothiazide
In patients taking hydrochlorothiazide alone, the following have been reported, however the frequency cannot be estimated from the available data:
low level of potassium in the blood
increase of lipids in the blood.
high level of uric acid in the blood
low level of magnesium in the blood
low level of sodium in the blood
dizziness, fainting on standing up
reduced appetite
nausea and vomiting
itchy rash and other types of rash
inability to achieve or maintain erection.
low level of blood platelets (sometimes with bleeding or bruising underneath the skin)
high level of calcium in the blood
high level of sugar in the blood
worsening of the diabetic metabolic state
sad mood (depression)
sleep disturbances
dizziness
headache
tingling or numbness
vision disorder
irregular heart beat
abdominal discomfort
constipation
diarrhoea
liver disorders which can occur together with yellow skin and eyes
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increased sensitivity of skin to the sun
sugar in the urine.
fever, sore throat or mouth ulcers, more frequent infections (lack or low level of white blood cells)
pale skin, tiredness, breathlessness, dark-coloured urine (haemolytic anaemia)
rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
confusion, tiredness, muscle twitching and spasm, rapid breathing (hypochloraemic alkalosis)
difficulty breathing with fever, coughing, wheezing, breathlessness (respiratory distress including pneumonitis and pulmonary oedema)
severe upper stomach pain (pancreatitis)
facial rash, joint pain, muscle disorder, fever (lupus erythematosus)
inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever (vasculitis)
severe skin disease that causes rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis).
weakness
bruising and frequent infections (aplastic anaemia)
decrease in vision or pain in your eyes due to high pressure (possible signs of acute-angle closure glaucoma)
severe skin disease that causes rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (erythema multiforme)
muscle spasm
severely decreased urine output (possible signs of renal disorder or renal failure), weakness (asthenia)
fever.
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 after “EXP”. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store Rasitrio tablets in the original package in order to protect from moisture and light.
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Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Each Rasitrio 150 mg/5 mg/12.5 mg film-coated tablet contains 150 mg aliskiren (as hemifumarate), 5 mg amlodipine (as besylate) and 12.5 mg hydrochlorothiazide. The other ingredients are cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, titanium dioxide (E171), macrogol, talc, iron oxide red (E172), iron oxide black (E172).
Rasitrio 150 mg/5 mg/12.5 mg film-coated tablets are violet white, oval tablets, with “YIY” debossed on one side and “NVR” on the other.
Rasitrio is available in packs containing 14, 28, 56, 98 tablets in calendar blisters. It is also available in multi-packs of 98 tablets (2 packs of 49) in calendar blisters.
Rasitrio is available in packs containing 30 or 90 tablets in blisters.
Rasitrio is available in packs containing 56x1 tablet in perforated unit dose blister.
It is also available in multi-packs of 98x1 tablet (2 packs of 49x1) in perforated unit dose blister. 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. Tel: +370 5 269 16 50
Novartis Pharma Services Inc. Тел.: +359 2 489 98 28
Novartis s.r.o.
Tel: +420 225 775 111
Novartis Hungária Kft. Pharma Tel.: +36 1 457 65 00
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Novartis Healthcare A/S Tlf: +45 39 16 84 00
Novartis Pharma Services Inc. Tel: +356 2122 2872
Novartis Pharma GmbH Tel: +49 911 273 0
Novartis Pharma B.V. Tel: +31 26 37 82 111
Novartis Pharma Services Inc. Tel: +372 66 30 810
Novartis Norge AS Tlf: +47 23 05 20 00
Novartis (Hellas) A.E.B.E. Τηλ: +30 210 281 17 12
Novartis Pharma GmbH Tel: +43 1 86 6570
Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00
Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00
Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600
Novartis Hrvatska d.o.o. Tel. +385 1 6274 220
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
Novartis Pharma Services Inc. Tel: +371 67 887 070
Novartis Pharmaceuticals UK Ltd. Tel: +44 1276 698370
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