Imprida HCT
amlodipine, valsartan, hydrochlorothiazide
amlodipine/valsartan/hydrochlorothiazide
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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
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.
What Imprida HCT is and what it is used for
Before you take Imprida HCT
How to take Imprida HCT
Possible side effects
How to store Imprida HCT
Further information
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.
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 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.
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.
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 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.
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.
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
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.
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
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 have accidentally taken too many Imprida HCT 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 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.
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.
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.
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
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
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
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)
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.
The active substances of Imprida HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Imprida HCT 5 mg/160 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide. The other ingredients are cellulose microcrystalline; crospovidone; silica, colloidal anhydrous; magnesium stearate; hypromellose, macrogol 4000, talc, titanium dioxide (E171).
Imprida HCT 5 mg/160 mg/12.5 mg film-coated tablets are white, oval tablets with “NVR” on one side and “VCL” on the other side.
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.
Horsham
West Sussex, RH12 5AB United Kingdom
D-90429 Nuremberg Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Novartis Pharma Services Inc. Тел.: +359 2 976 98 28
Novartis Hungária Kft. Pharma Tel.: +36 1 457 65 00
Novartis s.r.o.
Tel: +420 225 775 111
Novartis Pharma Services Inc. Tel: +356 2298 3217
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Novartis Healthcare A/S Tlf: +45 39 16 84 00
Novartis Pharma B.V. Tel: +31 26 37 82 111
Novartis Pharma GmbH Tel: +49 911 273 0
Novartis Norge AS Tlf: +47 23 05 20 00
Novartis Pharma Services Inc. Tel: +372 66 30 810
Novartis Pharma GmbH Tel: +43 1 86 6570
Novartis (Hellas) A.E.B.E. Τηλ: +30 210 281 17 12
Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
Lacer, S.A.
Tel: +34 93 446 53 00
Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600
Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01
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
Novartis Pharma Services Inc. Tel: +370 5 269 16 50
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