Rasilamlo
aliskiren hemifumarate, amlodipine besilate
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. See section 4.
What Rasilamlo is and what it is used for
What you need to know before you take Rasilamlo
How to take Rasilamlo
Possible side effects
How to store Rasilamlo
Medicinal product no longer authorised
Contents of the pack and other information
Rasilamlo contains two active substances, called aliskiren and amlodipine. Both of these substances help to control high blood pressure (hypertension).
Aliskiren is a renin inhibitor. It reduces 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.
Rasilamlo is used to treat high blood pressure in adult patients whose blood pressure is not sufficiently controlled with aliskiren or amlodipine alone.
if you are allergic to aliskiren or amlodipine, to any of the other ingredients of this medicine (listed in section 6) or to other dihydropyridine-derived medicines (known as calcium channel blockers)
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 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)
quinidine (a medicine used to correct heart rhythm)
if you have diabetes 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 or
an angiotensin II receptor blocker such as valsartan, telmisartan, irbesartan
if the patient is less than 2 years of age
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)
Medicinal product no longer authorised
if you have heart failure after an acute heart attack
Talk to your doctor before taking 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 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 Rasilamlo and contact your doctor
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 or
an angiotensin II receptor blocker such as valsartan, telmisartan, irbesartan
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 have impaired kidney function, your doctor will carefully consider whether Rasilamlo is suitable for you and may wish to monitor you carefully
if you suffer from liver problems (impaired liver function)
if you have renal artery stenosis (narrowing of the blood vessels to one of both kidneys)
if you have serious congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body)
Your doctor may check your kidney function, blood pressure and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under the heading “Do not take Rasilamlo”.
Rasilamlo is for use in adults.
Rasilamlo must not be used in children from birth to less than 2 years of age. It should not be used in children from 2 to less than 6 years of age, and is not recommended for use in children and adolescents from 6 to less than 18 years of age.
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.
an angiotensin II receptor blocker or an angiotensin converting enzyme inhibitor (see also information under the headings “Do not take Rasilamlo” and “Warnings and precautions”)
Medicinal product no longer authorised
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
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)
antiepileptics (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone)
rifampicin, a medicine used to prevent or treat infections
St. John’s 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
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
You should avoid taking this medicine together with fruit juice and/or drinks containing plant extracts (including herbal teas).
Do not take this medicine if you are pregnant (see section Do not take Rasilamlo). 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 Rasilamlo before you become 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.
Amlodipine, one of the active substances in Rasilamlo, 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 Rasilamlo is one tablet a day.
Medicinal product no longer authorised
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.
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 avoid taking this medicine together with fruit juice and/or drinks containing plant extracts (including herbal teas). During your treatment, your doctor may adjust your dose depending on your blood pressure response.
If you have accidentally taken too many Rasilamlo 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 you only remember the forgotten dose the next day, 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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. 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.
As for any combination of two active substances, side effects associated with each individual component cannot be excluded. The adverse reactions previously reported with one or both of the two active substances (aliskiren and amlodipine) of Rasilamlo and listed below may occur with Rasilamlo.
A few patients have experienced these serious side effects. If any of the following occur, tell your doctor straight away:
Severe skin reactions (toxic epidermal necrolysis and/or oral mucosal reactions - red skin,
blistering of the lips, eyes or mouth, skin peeling, fever) (uncommon: may affect up to 1 in 100 people).
Severe allergic reaction with symptoms such as rash, itching, swelling of face or lips or tongue,
difficulty breathing, dizziness (rare: may affect up to 1 in 1,000 people).
Nausea, loss of appetite, dark coloured urine or yellowing of skin and eyes (may be signs of liver disorder) (frequency not known).
Other side effects may include:
Medicinal product no longer authorised
low blood pressure
swelling, including swelling of hands, ankles or feet (peripheral oedema)
diarrhoea
joint pain (arthralgia)
high level of potassium in the blood
dizziness
sleepiness
headache
hot flushes
abdominal pain
nausea
tiredness
palpitations (awareness of your heart beat)
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)
severe skin reactions (toxic epidermal necrolysis and/or oral mucosal reactions - red skin, blistering of the lips, eyes or mouth, skin peeling, fever)
cough
itching
rash (including itchy rash and urticaria)
increased liver enzymes
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
shortness of breath
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
generalised rash
muscle pain
muscle cramps
back pain
urination disorders
urination at night
frequent urination
impotence
Medicinal product no longer authorised
breast enlargement in men
chest pain
weakness
pain
feeling unwell
weight increase
weight decrease
severe allergic reaction (anaphylactic reaction)
allergic reactions (hypersensitivity) and 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)
confusion
low level of white blood cells and blood platelets
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
severe upper stomach pain
inflammation of the gastric lining
bleeding, tender or enlarged gums
inflammation of the liver
abnormal liver function test
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
dizziness with spinning sensation
low level of sodium in the blood
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Medicinal product no longer authorised
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 in the original package in order to protect from moisture.
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).
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.
Medicinal product no longer authorised
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
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
Medicinal product no longer authorised
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
Medicinal product no longer authorised
Taking into account the PRAC Assessment Report on the PSUR for aliskiren / aliskiren, amlodipine
/ aliskiren, hydrochlorothiazide, the scientific conclusions of CHMP are as follows:
During the reporting a number of serious and non-serious adverse drug reactions (ADRs) from post- marketing data sources regarding “hyponatraemia” raised a concern that led to the submission of a cumulative review from the Marketing Authorisation Holder (MAH). The cumulative review retrieved 187 cases out of which 57 were sufficiently documented, in 8 of these cases a causal relationship could not be ruled out. In 3 additional cases where severe hyponatremia was associated with neurological symptoms such as brain oedema or major confusion and cerebral oedema, causality could also not be excluded.
The MAH submitted an analysis with 1407 cases of “dyspnoea”, in 13 of them there was positive dechallenge and three cases with positive rechallenge. The PRAC considered the cases of dechallenge and rechallenge to be important causal relationship information that contributes to confirm the safety signal.
Therefore, in view of available data regarding aliskiren/ aliskiren,amlodipine / aliskiren, hydrochlorothiazide, the PRAC considered that changes to the product information were warranted. The CHMP agrees with the scientific conclusions made by the PRAC.
Medicinal product no longer authorised
On the basis of the scientific conclusions for aliskiren / aliskiren, amlodipine / aliskiren, hydrochlorothiazide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing aliskiren / aliskiren, amlodipine / aliskiren, hydrochlorothiazide is favourable subject to the proposed changes to the product information.
The CHMP recommends that the terms of the Marketing Authorisations should be varied.