Riprazo HCT - patient leaflet, side effects, dosage

WHAT RIPRAZO HCT IS AND WHAT IT IS USED FOR

Riprazo HCT tablets contain two active substances, called aliskiren and hydrochlorothi­azide. Both of these substances help to control high blood pressure (hypertension).

Aliskiren is a substance that belongs to a new 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 makes blood pressure higher. Lowering the amount of angiotensin II allows the blood vessels to 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.

Riprazo HCT is used to treat high blood pressure.

• 2. BEFORE YOU TAKE RIPRAZO HCT

Do not take Riprazo HCT

• – if you are allergic (hypersensitive) to aliskiren or hydrochlorothi­azide, to sulphonamide-derived

medicines (medicines used to treat chest or urinary infections) or to any of the other ingredients of Riprazo HCT. If you think you may be allergic, do not take Riprazo HCT 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 Riprazo HCT in early

pregnancy – see Pregnancy section.)

if you are between three and nine months pregnant.

if you have serious liver or serious kidney problems.

if you are unable to produce urine (anuria).

if the level of potassium or sodium in your blood is too low despite treatment.

if the level of calcium in your blood is too high despite treatment.

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 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, li

  l, ramipril etc.

  
  

• – an “angiotensin 2 receptor blocker” such as valsartan, telmisartan, irbesartan etc.

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

Take special care with Riprazo HCT

– if you have impaired kidney function, your doctor will carefully consider whether Riprazo HCT

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 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 Riprazo HCT 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 etc.

or

• – an “angiotensin 2 receptor blocker” such as valsartan, telmisartan, irbesartan etc.

• – 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 (contained in Riprazo HCT).

• – 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 Riprazo HCT. This can lead to permanent vision impairment, if not treated.

Tell your doctor if any of the above applies to you.

You must tell your doctor if you think you are (or might become) pregnant. Riprazo 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 Pregnancy section).

The use of Riprazo HCT in children and adolescents up to 18 years of age is not recommended.

Using 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.

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.

• – 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, a medicine belonging to the type known as diuretics, or water tablets, which is 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.

Taking Riprazo HCT with food and drink

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

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Riprazo HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Riprazo HCT. Riprazo HCT 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. Riprazo HCT is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.

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

Driving and using machines

As with many other medicines used to treat high blood pressure, this medicine may make you feel dizzy. If you experience this symptom, do not drive or use tools or machines.

Important information about some of the ingredients of Riprazo HCT

Riprazo HCT 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.

Riprazo HCT contains wheat starch. It is suitable for people with coeliac disease. Patients with wheat allergy (different from coeliac disease) should not take this medicine.

3. HOW TO TAKE RIPRAZO HCT

Always take Riprazo HCT exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose of Riprazo HCT is one tablet a day. Swallow the tablet whole with some water. You should take Riprazo HCT with a light meal once a day, preferably at the same time each day. You should not take Riprazo HCT together with grapefruit juice. During your treatment, your doctor may adjust your dose depending on your blood pressure response.

Riprazo HCT may have been prescribed to you because your previous treatment did not lower your blood pressure enough. If this is the case, your doctor will tell you how to switch from that treatment to Riprazo HCT.

If you take more Riprazo HCT than you should

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

If you forget to take Riprazo 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 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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Riprazo HCT can cause side effects, although not everybody gets them.

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. You may need to stop Riprazo HCT.

Side effects reported in clinical studies for patients treated with Riprazo HCT were:

Common (affecting less than 1 in 10 patients):

• Diarrhoea

As for any combination of two active substances, side effects associated with each individual component cannot be excluded.

Aliskiren:

Common (affecting less than 1 in 10 patients):

• Diarrhoea
• Joint pain (arthralgia)
• High level of potassium in the blood
• Dizziness

Uncommon (affecting less than 1 in 100 patients):

• Skin rash (this may also be a sign of allergic reactions or angio

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

Rare (affecting less than 1 in 1,000 patients):

• 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.

Hydrochlorothi­azide:

Very common (affecting more than 1 in 10 patients):

• Low level of potassium in the blood
• Increase of lipids in the blood

Common (affecting less than 1 in 10 patients):

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

Rare (affecting less than 1 in 1,000 patients):

• 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
• Increased sensitivity of skin to the sun
• Sugar in the urine

Very rare (affecting less than 1 in 10,000 patients):

Fever, sore throat or mouth ulcers, more frequent infections (la 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):

• 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

5. HOW TO STORE RIPRAZO HCT

Keep out of the reach and sight of children.

Do not use Riprazo HCT after the expiry date which is stated on the carton. 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.

• 6. FURTHER INFORMATION

What Riprazo HCT contains

• – Each Riprazo HCT 150 mg/12.5 mg film-coated tablet contains 150 mg aliskiren (as

hemifumarate) and 12.5 mg hydrocholorot­hiazide. The other ingredients are: cellulose microcrystalline, crospovidone, lactose monohydrate, wheat starch, povidone, magnesium stearate, silica colloidal anhydrous, talc, hypromellose, macrogol, titanium dioxide (E171).

• – Each Riprazo HCT 150 mg/25 mg film-coated tablet contains 150 mg aliskiren (as

hemifumarate) and 25 mg hydrocholorot­hiazide. The other ingredients are: cellulose microcrystalline, crospovidone, lactose monohydrate, wheat starch, povidone, magnesium stearate, silica colloidal anhydrous, talc, hypromellose, macrogol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).

• – Each Riprazo HCT 300 mg/12.5 mg film-coated tablet contains 300 mg aliskiren (as

hemifumarate) and 12.5 mg hydrocholorot­hiazide. The other ingredients are: cellulose microcrystalline, crospovidone, lactose monohydrate, wheat starch, povidone, magnesium stearate, silica colloidal anhydrous, talc, hypromellose, macrogol, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172).

• – Each Riprazo HCT 300 mg/25 mg film-coated tablet contains 300 mg aliskiren (as

What Riprazo HCT looks like and contents of the pack

Riprazo HCT 150 mg/12.5 mg film-coated tablets are white, “LCI” on one side and “NVR” on the other.

Riprazo 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.

Riprazo 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.

Riprazo 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.

Riprazo HCT is available in packs containing 7, 14, 28, 30, 50, 56, 90,or 98 tablets. Packs containing 90 (3×30), 98 (2×49) or 280 (20×14) tablets are multi-packs.

Not all pack sizes or stren

Marketing Authorisation Holder

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Manufacturer

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:

Lietuva

Novartis Pharma Services Inc.

Tel: +370 5 269 16 50

This leaflet was last approved in

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

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