Home page Home page
AstraZeneca

Imprida HCT
amlodipine, valsartan, hydrochlorothiazide

PACKAGE LEAFLET: INFORMATION FOR THE USER


Imprida HCT 5 mg/160 mg/12.5 mg film-coated tablets

amlodipine/valsartan/hydrochlorothiazide


Read all of this leaflet carefully before you start taking this medicine.


In this leaflet:

  1. What Imprida HCT is and what it is used for

  2. Before you take Imprida HCT

  3. How to take Imprida HCT

  4. Possible side effects

  5. How to store Imprida HCT

  6. Further information


  1. WHAT IMPRIDA HCT IS AND WHAT IT IS USED FOR


    Imprida HCT tablets contain three substances called amlodipine, valsartan and hydrochlorothiazide. All of these substances help to control high blood pressure.

    Medicinal product no longer authorised

    • Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine stops calcium from moving into the blood vessel wall, which stops the blood vessels from

      tightening.

    • Valsartan belongs to a group of substances called “angiotensin-II receptor antagonists”.

      Angiotensin II is produced by the body and makes the blood vessels tighten, thus increasing the blood pressure. Valsartan works by blocking the effect of angiotensin II.

    • Hydrochlorothiazide belongs to a group of substances called “thiazide diuretics”.

      Hydrochlorothiazide increases urine output, which also lowers blood pressure.

      As a result of all three mechanisms, the blood vessels relax and blood pressure is lowered.


      Imprida HCT is used to treat high blood pressure in adult patients who are already taking amlodipine, valsartan and hydrochlorothiazide and who may benefit from taking one tablet containing all three substances.


  2. BEFORE YOU TAKE IMPRIDA HCT


    Do not take Imprida HCT

    • if you are more than 3 months pregnant. (It is also better to avoid Imprida HCT in early pregnancy – see Pregnancy section).

    • if you are allergic (hypersensitive) to amlodipine, valsartan, hydrochlorothiazide, sulphonamide-derived medicines (medicines used to treat chest or urinary infections), or any of the other ingredients of Imprida HCT (see section 6, “What Imprida HCT contains”).

      If you think you may be allergic, do not take Imprida HCT and talk to your doctor.

    • if you have liver disease, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to the build up of bile in the liver (cholestasis).

    • if you have severe kidney problems or if you are having dialysis.

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


      Take special care with Imprida HCT

    • if you have a low level of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm).

    • if you have a low level of sodium in your blood (with or without symptoms such as tiredness, confusion, muscle twitching, convulsions).

    • if you have a high level of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness and twitching).

    • if you are taking 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. It may be necessary to check the amount of potassium in your blood at regular intervals.

    • if you have kidney problems, have had a kidney transplant or if you had been told that you have a narrowing of your kidney arteries.

    • if you have liver problems.

    image

    if you have or have had heart failure or coronary artery disease, particularly if you are taking the maximum dose of Imprida HCT (10 mg/320 mg/25 mg)

    • if your doctor has told you that you have a narrowing of the valves in your heart (called “aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “obstructive hypertrophic cardiomyopathy”).

      Medicinal product no longer authorised

    • if you suffer from aldosteronism. This is a disease in which the adrenal glands make too much of the hormone aldosterone If this applies to you, the use of Imprida HCT is not recommended.

    • if you suffer from a disease called systemic lupus erythematosus (also called “lupus” or “SLE”).

    • if you have diabetes (high level of sugar in your blood).

    • if you have high levels of cholesterol or triglycerides in your blood.

    • if you experience skin reactions such as rash after sun exposure.

    • if you had an allergic reaction to other high blood pressure medicines or diuretics (a type of medicine also known as “water tablets”), especially if you suffer from asthma and allergies

    • if you have been sick (vomiting or diarrhoea).

    • if you experience dizziness and/or fainting during treatment with Imprida HCT, tell your doctor as soon as possible.

    • 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 a week of taking Imprida HCT. This can lead to permanent vision impairment, if not treated.

      If any of these apply to you, talk to your doctor.


      You must tell your doctor if you think that you are (or might become) pregnant. Imprida 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 this stage (see section “Pregnancy and breast- feeding”).


      The use of Imprida HCT in children and adolescents under 18 years of age is not recommended.


      Imprida HCT and older people (age 65 years and older)

      Imprida HCT can be used by people aged 65 years and over at the same dose as for other adults and in the same way as they have already taken the three substances called amlodipine, valsartan and hydrochlorothiazide. Elderly patients, particularly those taking the maximum dose of Imprida HCT (10 mg/320 mg/25 mg), should have their blood pressure checked regularly.

      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. Your doctor may need to change the dose or take other precautions. In some cases you may have to stop using one of the medicines. This is especially important if you are using any of the medicines listed below:


      Do not take together with:

      • 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.

        Caution should be used with:

      • alcohol, sleeping pills and anaesthetics (medicines allowing patients to undergo surgery and other procedures);

      • amantadine (anti-Parkinson therapy, 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);

      • anticonvulsant medicines and mood-stabilising medicines used to treat epilepsy and bipolar disorder (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);

      • cholestyramine, colestipol or other resins (substances used mainly to treat high levels of lipids in the blood);

      • simvastatin (a medicine used to control high cholesterol levels);

      • ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g: rheumatoid arthritis or atopic dermatitis);

        Medicinal product no longer authorised

      • cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide;

      • digoxin or other digitalis glycosides (medicines used to treat heart problems);

      • verapamil, diltiazem (heart medicines);

      • iodine contrast media (agents used for imaging examinations);

      • medicines for the treatment of diabetes (oral agents such as metformin or insulins);

      • medicines for the treatment of gout, such as allopurinol;

      • medicines that may increase blood sugar levels (beta blockers, diazoxide);

      • 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;

      • medicines that may reduce the amount of potassium in your blood, such as diuretics (water tablets), corticosteroids, laxatives, amphotericin or penicillin G;

      • medicines to increase blood pressure such as adrenaline or noradrenaline;

      • medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);

      • medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);

      • medicines used for oesophageal ulceration and inflammation (carbenoxolone);

      • medicines used to relieve pain or inflammation, especially non-steroidal anti-inflammatory agents (NSAIDs), including selective cyclooxygenase-2 inhibitors (Cox-2 inhibitors);

      • muscle relaxants (medicines to relax the muscles which are used during operations);

      • nitroglycerin and other nitrates, or other substances called “vasodilators”;

      • other medicines to treat high blood pressure, including methyldopa;

      • rifampicin (used, for example, to treat tuberculosis);

      • St. John’s wort;

      • dantrolene (infusion for severe body temperature abnormalities);

      • vitamin D and calcium salts.


      Talk to your doctor before drinking alcohol. Alcohol may make your blood pressure fall too much and/or increase the possibility of dizziness or fainting.

      Taking Imprida HCT with food and drink

      You can take Imprida HCT with or without food. Grapefruit and grapefruit juice should not be consumed by people who are taking Imprida HCT. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active substance amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Imprida HCT.


      Pregnancy and breast-feeding

      Pregnancy

      You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Imprida HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Imprida HCT. Imprida HCT 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 used after the third month of pregnancy.


      Breast-feeding

      Tell your doctor if you are breast-feeding or about to start breast-feeding. Imprida 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, especially if your baby is a newborn, or was born prematurely.


      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.


      Medicinal product no longer authorised

  3. HOW TO TAKE IMPRIDA HCT


    Always take this medicine exactly as your doctor has told you. You should check with your doctor if you are not sure. This will help you get the best results and lower the risk of side effects.


    The usual dose of Imprida HCT is one tablet per day.

    • It is best to take the tablet at the same time each day. Morning is the best time.

    • Swallow the tablet whole with a glass of water.

    • You can take Imprida HCT with or without food. Do not take Imprida HCT with grapefruit or grapefruit juice.


      Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.


      If you take more Imprida HCT than you should

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


      If you forget to take Imprida 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.


      If you stop taking Imprida HCT

      Stopping your treatment with Imprida HCT may cause your disease to get worse. Do not stop taking your medecine unless your doctor tells you to.

      Always take this medicine, even if you are feeling well

      People who have high blood pressure often do not notice any signs of the problem. Many feel 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 product ask your doctor or pharmacist.


  4. POSSIBLE SIDE EFFECTS


    Like all medicines, Imprida HCT can cause side effects, although not everybody gets them. These side effects may occur with certain frequencies, which are defined as follows:

    very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100

    uncommon: affects 1 to 10 users in 1,000

    rare: affects 1 to 10 users in 10,000

    very rare: affects less than 1 user in 10,000

    not known: frequency cannot be estimated from the available data


    Some side effects can be serious and need immediate medical attention:


    You should see your doctor immediately if you experience any of the following symptoms:

    Common

    • dizziness

    • low blood pressure (feeling of faintness, light-headedness, sudden loss of consciousness)


      Medicinal product no longer authorised

      Uncommon

    • severely decreased urine output (decreased kidney function)


      Rare

    • spontaneous bleeding

    • irregular heart beat

    • liver disorder


      Very rare

    • allergic reaction with symptoms such as rash, itching

    • angioedema: swelling of face or lips or tongue, difficulty of breathing

    • crushing/tight chest pain that gets worse or that does not go away

    • weakness, bruising, fever and frequent infections

    • stiffness


      Other possible side effects of Imprida HCT:

      Common

    • stomach discomfort after meal

    • tiredness

    • swelling

    • low level of potassium in the blood

    • headache

    • frequent urination

      Uncommon

    • fast heart beat

    • spinning sensation

    • vision disorder

    • stomach discomfort

    • chest pain

    • increase of urea nitrogen, creatinine and uric acid in the blood

    • high level of calcium, fat or sodium in the blood

    • decrease of potassium in the blood

    • breath odour

    • diarrhoea

    • dry mouth

    • nausea

    • vomiting

    • abdominal pain

    • weight increase

    • loss of appetite

    • disturbed sense of taste

    • back pain

    • joint swelling

    • muscle cramps/weakness/pain

    • pain in extremity

    • inability to either stand or walk in a normal manner

    • weakness

    • abnormal coordination

      Medicinal product no longer authorised

    • dizziness on standing up or after exercising

    • lack of energy

    • sleep disturbances

    • tingling or numbness

    • neuropathy

    • sleepiness

    • sudden, temporary loss of consciousness

    • low blood pressure on standing up

    • impotence

    • cough

    • breathlessness

    • throat irritation

    • excessive sweating

    • itching

    • swelling, reddening and pain along a vein

    • skin reddening

    • trembling


      Not known

    • changes in blood tests for kidney function, increase of potassium in your blood, low level of red blood cells

      Side effects reported with amlodipine or valsartan or hydrochlorothiazide alone, but not observed with Imprida HCT or observed in a higher frequency:


      Amlodipine

      Common

    • palpitations

    • abdominal pain

    • nausea

    • sleepiness

    • hot flushes


      Uncommon

    • ringing noise in ears

    • change of bowel habit

    • pain

    • weight decrease

    • joint pain

    • trembling

    • mood swings

    • urination disorders

    • urination at night

    • breast enlargement in men

    • runny nose

    • hair loss

    • skin eruption

    • purple skin patches

      Medicinal product no longer authorised

    • rash

    • skin discoloration


      Very rare

    • low level of white blood cells and blood platelets

    • irregular heart beat

    • heart attack

    • inflammation of the stomach lining or of the pancreas, gingival overgrowth, abnormal liver function test

    • liver disorder which can occur together with yellow skin and eyes, or dark-coloured urine

    • allergic reaction including swelling deeper in the skin and difficulty breathing

    • high level of sugar in the blood

    • increased muscle stiffness

    • skin reaction with skin reddening and peeling, blistering of lips, eyes or mouth

    • itchy rash

    • inflammation of blood vessels


      Not known

    • stiff limbs and trembling hands

      Valsartan

      Not known

    • abnormal red blood cell test

    • low level of a certain type of white blood cell and blood platelet

    • increase of potassium in the blood

    • increase of creatinine in the blood

    • abnormal liver function test

    • allergic reaction including swelling deeper in the skin and difficulty breathing

    • muscle pain

    • severely decreased urine output

    • itching

    • rash

      inflammation of blood vessels


      Hydrochlorothiazide

      Very common

    • low level of potassium in the blood

    • increase of lipids in the blood


      Common

    • 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

      Medicinal product no longer authorised

    • itchy rash and other types of rash

    • inability to achieve or maintain erection


      Rare

    • low level of blood platelets (sometimes with bleeding or bruising underneath the skin)

    • sugar in the urine

    • high level of sugar in the blood

    • worsening of the diabetic metabolic state

    • sad mood (depression)

    • irregular heart beat

    • abdominal discomfort

    • constipation

    • liver disorders which can occur together with yellow skin and eyes, or dark-coloured urine (haemolytic anaemia)

    • increased sensitivity of skin to sun

    • purple skin patches

    • kidney disorders


      Very rare

    • 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, abnormal breakdown of red blood cells either in the blood vessels or elsewhere in the body)

    • confusion, tiredness, muscle twitching and spasm, rapid breathing (hypochloraemic alkalosis)

    • severe upper stomach ache (inflammation of the pancreas)

    • rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)

    • difficulty breathing with fever, coughing, wheezing, breathlessness (respiratory distress, pulmonary oedema, pneumonitis)

    • 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

    • 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)

    • breathlessness

    • severely decreased urine output (possible signs of renal disorder or renal failure)

    • severe skin disease that causes rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (erythema multiforme)

    • muscle spasm

    • fever (pyrexia)


    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.


  5. HOW TO STORE IMPRIDA HCT


    Keep out of the reach and sight of children.

    Do not use Imprida HCT 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.

    Medicinal product no longer authorised

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

    Do not use any Imprida HCT pack that is damaged or shows signs of tampering.


  6. FURTHER INFORMATION


What Imprida HCT contains


Imprida HCT is available in packs containing 14, 28, 30, 56, 90, 98 or 280 film-coated tablets, in multipacks of 280 tablets (comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets), and in hospital packs containing 56, 98 or 280 tablets in single unit blisters. Not all pack sizes may be available in your country.

Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road

Horsham

West Sussex, RH12 5AB United Kingdom


Manufacturer Novartis Pharma GmbH Roonstraße 25

D-90429 Nuremberg Germany


For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:


België/Belgique/Belgien Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11

Luxembourg/Luxemburg Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11


България

Novartis Pharma Services Inc. Тел.: +359 2 976 98 28

Magyarország

Novartis Hungária Kft. Pharma Tel.: +36 1 457 65 00


Česká republika

Novartis s.r.o.

Tel: +420 225 775 111

Malta

Novartis Pharma Services Inc. Tel: +356 2298 3217


Medicinal product no longer authorised

Danmark

Novartis Healthcare A/S Tlf: +45 39 16 84 00

Nederland

Novartis Pharma B.V. Tel: +31 26 37 82 111


Deutschland

Novartis Pharma GmbH Tel: +49 911 273 0

Norge

Novartis Norge AS Tlf: +47 23 05 20 00


Eesti

Novartis Pharma Services Inc. Tel: +372 66 30 810

Österreich

Novartis Pharma GmbH Tel: +43 1 86 6570


Ελλάδα

Novartis (Hellas) A.E.B.E. Τηλ: +30 210 281 17 12

Polska

Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888


España

Lacer, S.A.

Tel: +34 93 446 53 00

Portugal

Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600


France

Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00

România

Novartis Pharma Services Romania SRL

Tel: +40 21 31299 01


Ireland

Novartis Ireland Limited Tel: +353 1 260 12 55

Slovenija

Novartis Pharma Services Inc. Tel: +386 1 300 75 50

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5439


Italia

Novartis Farma S.p.A. Tel: +39 02 96 54 1

Suomi/Finland

Novartis Finland Oy

Puh/Tel: +358 (0)10 6133 200


Κύπρος

Novartis Pharma Services Inc. Τηλ: +357 22 690 690

Sverige

Novartis Sverige AB Tel: +46 8 732 32 00


Latvija

Novartis Pharma Services Inc. Tel: +371 67 887 070

United Kingdom

Novartis Pharmaceuticals UK Ltd. Tel: +44 1276 698370


Lietuva

Novartis Pharma Services Inc. Tel: +370 5 269 16 50


This leaflet was last approved in


Medicinal product no longer authorised

a.europa.eu