Rasilez HCT - patient leaflet, side effects, dosage

Patient leaflet - Rasilez HCT

What Rasilez HCT is used for

This medicine is used to treat high blood pressure in adult patients. It is used in patients whose blood pressure is not adequately controlled by aliskiren or hydrochlorothiazide taken alone. It can also be used in patients whose blood pressure is adequately controlled with aliskiren and hydrochlorothiazide taken as separate tablets, to replace the same doses of the two active substances.

2. What you need to know before you take Rasilez HCT

Do not take Rasilez HCT

– if you are allergic to aliskiren or hydrochlorothiazide, to sulfonamide-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 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 this medicine in early

pregnancy – see section ‘Pregnancy’.

– if you have serious liver or serious kidney problems.
– if you are unable 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 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) or 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

– an angiotensin II receptor blocker such as valsartan, telmisartan, irbesartan.

– if the patient is less than 2 years of age.

If any of the above applies to you, do not take Rasilez HCT and talk to your doctor.

Warnings and precautions

Talk to your doctor before taking Rasilez HCT:

– if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.

Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Rasilez HCT.

– if you have impaired kidney function, your doctor will carefully consider whether this medicine

is suitable for you and may wish to monitor you carefully.

– if you have had a kidney transplant.
– if you suffer from liver problems.
– if you suffer from heart problems.
– 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 this medicine and contact your doctor.

– 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

– an angiotensin II receptor blocker such as valsartan, telmisartan, irbesartan.

– 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.

– 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 fluid

accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to a week of taking Rasilez HCT. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this.

– 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).

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 section “Do not take Rasilez HCT”.

You must tell your doctor if you think you are (or might become) pregnant. Rasilez HCT 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 section “Pregnancy”).

Children and adolescents

This medicine must not be used in babies 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. This is because the safety and benefits of this medicine are not known in this population.

Elderly people

The usual recommended starting dose of aliskiren in elderly patients aged 65 years or older 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.

Other medicines and Rasilez HCT

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

– lithium (a medicine used to treat some types of depression).
– 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 that may induce “torsades de pointes ” (irregular heart beat), such as antiarrhythmics

(medicines used to treat heart problems) and some antipsychotics.

– medicines that may reduce the amount of sodium in your blood, such as antidepressants,

antipsychotics, antiepileptics (carbamazepine).

– pain killers such as non-steroidal anti-inflammatory agents (NSAIDs), including selective

cyclooxygenase-2 inhibitors (Cox-2 inhibitors).

– medicines to reduce blood pressure, including methyldopa, an angiotensin II receptor blocker or

an angiotensin converting enzyme inhibitor (see sections “Do not take Rasilez HCT” and “Warnings and precautions”).

– medicines to increase blood pressure, such as noradrenaline or adrenaline.
– digoxin or other digitalis glycosides (medicines used to treat heart problems).
– vitamin D and calcium salts.
– 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.
– medicines for the treatment of gout, such as allopurinol.
– 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).

– amantadine (a medicine used to treat Parkinson’s disease, also used to treat or prevent certain

illnesses caused by viruses).

– cholestyramine, colestipol or other resins (substances used mainly to treat high levels of lipids

in the blood).

– cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide.
– muscle relaxants (medicines to relax the muscles which are used during operations).
– alcohol, sleeping pills and anaesthetics (medicines allowing patients to undergo surgery and

other procedures).

– iodine contrast media (agents used for imaging examinations).
– 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 or torasemide, medicines belonging to the type known as diuretics, or water tablets,

which are used to increase the amount of urine you produce.

– some medicines used to treat infections, such as ketoconazole.
– verapamil, a medicine used to lower high blood pressure, to correct heart rhythm or to treat

angina pectoris.

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

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.

3. 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

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.

4. 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
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
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 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.

5. 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.

6. Contents of the pack and other information

What Rasilez HCT contains

– The active substances are aliskiren and hydrocholorothiazide.

Rasilez HCT 150 mg/12.5 mg film-coated tablets

– Each tablet contains 150 mg aliskiren (as hemifumarate) and 12.5 mg hydrocholorothiazide. The

other ingredients are: Microcrystalline cellulose, crospovidone type A, lactose monohydrate and wheat starch (see section 2 under ‘Rasilez HCT contains lactose and wheat starch’), povidone K-30, magnesium stearate, silica colloidal anhydrous, talc, hypromellose substitution type 2910 (3 mPa s), macrogol 4000, titanium dioxide (E171).

Rasilez HCT 150 mg/25 mg film-coated tablets

– Each tablet contains 150 mg aliskiren (as hemifumarate) and 25 mg hydrocholorothiazide. The

other ingredients are: Microcrystalline cellulose, crospovidone type A, lactose monohydrate (see section 2), wheat starch (see section 2), povidone K-30, magnesium stearate, silica colloidal anhydrous, talc, hypromellose substitution type 2910 (3 mPa s), macrogol 4000, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).

Rasilez HCT 300 mg/12.5 mg film-coated tablets

– Each tablet contains 300 mg aliskiren (as hemifumarate) and 12.5 mg hydrocholorothiazide. The

other ingredients are: Microcrystalline cellulose, crospovidone type A, lactose monohydrate (see section 2), wheat starch (see section 2), povidone K-30, magnesium stearate, silica colloidal anhydrous, talc, hypromellose substitution type 2910 (3 mPa s), macrogol 400, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172).

Rasilez HCT 300 mg/25 mg film-coated tablets

– Each tablet contains 300 mg aliskiren (as hemifumarate) and 25 mg hydrocholorothiazide. The

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 × 1 tablets.

Multi-packs containing 280 (20 packs of 14) tablets.

Multi-packs (perforated unit dose blister) containing 98 (2 packs of 49 × 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

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http : //

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