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AstraZeneca

Rasilez HCT
aliskiren, hydrochlorothiazide

Package leaflet: Information for the user


Rasilez HCT 150 mg/12.5 mg film-coated tablets Rasilez HCT 150 mg/25 mg film-coated tablets Rasilez HCT 300 mg/12.5 mg film-coated tablets Rasilez HCT 300 mg/25 mg film-coated tablets Aliskiren/hydrochlorothiazide


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.


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


Rasilez HCT with food and drink

You should take this medicine either with a light meal or without a 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), as it could cause a decrease in the effectiveness of this medicine


Pregnancy

Medicinal Product no longer authorised

Do not take this medicine if you are pregnant (see section ‘Do not take Rasilez HCT’). 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 this medicine before you become pregnant and will advise you to take another medicine instead of this medicine. It is not recommended during pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.


Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. This medicine is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for

you if you wish to breast-feed.


Driving and using machines

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


Rasilez HCT contains lactose and wheat starch (containing gluten)

This medicine 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.


This medicinecontains wheat starch. Wheat starch in this medicine contains only very low levels of gluten and is very unlikely to cause problems if you have coeliac disease. One dosage unit contains no more than 100 micrograms of gluten. If you have wheat allergy (different from coeliac disease) you should not take this medicine. You should consult your doctor prior to taking this medicine.


  1. How to take Rasilez HCT


    Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

    Rasilez HCT may have been prescribed to you because your previous treatment with a medicine containing one of the active components of Rasilez HCT 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.


    The usual dose of Rasilez HCT is one tablet a day. The blood pressure lowering effect is present within one week after beginning treatment.


    Elderly people

    The usual recommended starting dose of aliskiren in elderly patients is 150 mg. 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.


    Method of administration

    Swallow the tablet whole with some water. You should take this medicine once a day, always with or always without food, preferably at the same time each day. You should establish a convenient daily

    schedule to take the medicine the same way each day, in a regular pattern with respect to the timing of your meals. 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 take more Rasilez HCT than you should

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


    If you forget to take Rasilez HCT

    Medicinal Product no longer authorised

    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 stop taking Rasilez HCT

    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 any further questions on the use of this medicine, ask your doctor or pharmacist.


  2. Possible side effects


    Like all medicines, this medicine can cause side effects, although not everybody gets them.


    Some side effects can be serious:

    A few patients have experienced these serious side effects. If any of the following occur, tell your doctor straight away:

    • 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). (rare: may affect up to 1 in 1,000 pople).

    • Nausea, loss of appetite, dark coloured urine or yellowing of skin and eyes (signs of liver disorder) (frequency not known: frequency cannot be estimated from the available data).

      Other side effects may include:

      Side effects associated with each individual component cannot be excluded. The adverse reactions previously reported with one of the two active substances (aliskiren and hydrochlorothiazide) of

      Rasilez HCT and listed below may occur with Rasilez HCT.


      Very common (may affect more than 1 in 10 people):

    • Low level of potassium in the blood

    • Increase of lipids in the blood


      Common (may affect up to 1 in 10 people):

    • Diarrhoea

    • Joint pain (arthralgia)

    • High level of potassium in the blood

    • Dizziness

    • 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


      Uncommon (may affect up to 1 in 100 people):

    • Low blood pressure

      Medicinal Product no longer authorised

    • 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)

    • Palpitations

    • Cough

    • Itching

    • Itchy rash (urticarial)

    • Increased liver enzymes


      Rare (may affect up to 1 in 1,000 people):

    • Increased level of creatinine in the blood

    • Red skin (erythema)

    • 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

    • Headache

    • Tingling or numbness

    • Vision disorder

    • Irregular heart beat

    • Abdominal discomfort

    • Constipation

    • Liver disorders which can occur together with yellow skin and eyes

    • Increased sensitivity of skin to the sun

    • Sugar in the urine


      Very rare (may affect up to 1 in 10,000 people):

    • 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)


      Not known (frequency cannot be estimated from the available data):

    • Skin and lip cancer (Non-melanoma skin cancer)

    • Weakness

    • Bruising and frequent infections (aplastic anaemia)

    • Decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or 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

      Medicinal Product no longer authorised

    • Severely decreased urine output (possible signs of renal disorder or renal failure), weakness (asthenia)

    • Fever

    • Dizziness with spinning sensation

    • Shortness of breath

    If any of these affect you severely, tell your doctor. You may need to stop Rasilez HCT. Reporting of side effects

    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

    image

    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.


  3. How to store Rasilez HCT


    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 25°C.

    Store in the original package in order to protect from moisture.

    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.


  4. Contents of the pack and other information What Rasilez HCT contains

section 2), wheat starch (see section 2), povidone K-30, magnesium stearate, silica colloidal

Medicinal Product no longer authorised

anhydrous, talc, hypromellose substitution type 2910 (3 mPa s), macrogol 4000, 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.


PA/Alu/PVC – Alu blisters

Single-packs containing 7, 14, 28, 30, 50 or 56 tablets.

Multi-packs containing 90 (3 packs of 30), 98 (2 packs of 49) or 280 (20 packs of 14) tablets.


PVC/polychlorotrifluoroethylene (PCTFE) – Alu blisters Single-packs containing 7, 14, 28, 30, 50, 56, 90 or 98 tablets.

Single-packs (perforated unit dose blister) containing 56 x 1 tablets. Multi-packs containing 280 (20 packs of 14) tablets.

Multi-packs (perforated unit dose blister) containing 98 (2 packs of 49 x 1) tablets.


Not all pack sizes or strengths may be available in your country.


Marketing Authorisation Holder

Noden Pharma DAC D'Olier Chambers

16A D'Olier Street Dublin 2

Ireland


Manufacturer Noden Pharma DAC D'Olier Chambers 16A D'Olier Street Dublin 2

Ireland


Novartis Farma S.p.A.

Via Provinciale Schito 131

I-80058 Torre Annunziata/NA

Italy


This leaflet was last revised in


Medicinal Product no longer authorised