Copalia HCT
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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Copalia HCT is and what it is used for
What you need to know before you take Copalia HCT
How to take Copalia HCT
Possible side effects
How to store Copalia HCT
Contents of the pack and other information
Copalia HCT tablets contain three substances called amlodipine, valsartan and hydrochlorothiazide. All of these substances help to control high blood pressure.
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.
Copalia HCT is used to treat high blood pressure in adult patients whose blood pressure is already controlled while 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 recommended to avoid Copalia HCT in early pregnancy – see Pregnancy section.)
if you are allergic to amlodipine or to any other calcium channel blockers, valsartan, hydrochlorothiazide, sulphonamide-derived medicines (medicines used to treat chest or urinary
infections), or any of the other ingredients of this medicine (listed in section 6).
If you think you may be allergic, do not take Copalia 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 to increase the potassium or sodium levels in your blood.
if the level of calcium in your blood is too high despite treatment to reduce the calcium levels in your blood.
if you have gout (uric acid crystals in the joints).
if you have severe low blood pressure (hypotension).
if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body).
if you suffer from heart failure after a heart attack.
if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Talk to your doctor or pharmacist before taking Copalia 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 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 prescribed the maximum dose of Copalia HCT (10 mg/320 mg/25 mg).
if you have experienced a heart attack. Follow your doctor’s instructions for the starting dose carefully. Your doctor may also check your kidney function.
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”).
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 Copalia 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 have experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin converting enzyme inhibitors). If you get these symptoms, stop taking Copalia HCT and contact your doctor straight away. You should never take Copalia
HCT again.
if you experience dizziness and/or fainting during treatment with Copalia HCT, tell your doctor as soon as possible.
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 Copalia HCT. This can lead to permanent vision impairment, if not treated.
if you are taking any of the following medicines used to treat high blood pressure:
an ACE inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
aliskiren.
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 Copalia HCT.
if you experienced breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past. If you develop any severe shortness of breath or difficulty breathing after taking Copalia HCT, seek medical attention immediately.
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 information under the heading “Do not take Copalia HCT”.
The use of Copalia HCT in children and adolescents under 18 years of age is not recommended.
Copalia 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 Copalia HCT
(10 mg/320 mg/25 mg), should have their blood pressure checked regularly.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. Your doctor may need to change your dose and/or to 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;
ACE inhibitors or aliskiren –(see also information under the headings “Do not take Copalia HCT” and “Warnings and precautions”).
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);
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), erythromycin, clarithromycin (antibiotics);
St. John’s wort;
dantrolene (infusion for severe body temperature abnormalities);
vitamin D and calcium salts.
Grapefruit and grapefruit juice should not be consumed by people who are prescribed Copalia 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 Copalia HCT. 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.
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Copalia HCT before you become pregnant or as soon as you know
you are pregnant and will advise you to take another medicine instead of Copalia HCT. Copalia 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. Amlodipine has been shown to pass into breast milk in small amounts. Copalia 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.
This medicine may make you feel dizzy, drowsy, nauseous or have a headache. If you experience
these symptoms, do not drive or use tools or machines.
Always take this medicine exactly as your doctor has told you. 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 Copalia 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 Copalia HCT with or without food. Do not take Copalia HCT with grapefruit or grapefruit juice.
Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose. Do not exceed the prescribed dose.
If you have accidentally taken too many Copalia 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 Copalia HCT may cause your disease to get worse. Do not stop taking your medicine 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 medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
As for any combination containing three active substances, side effects associated with each individual component cannot be excluded. The side effects reported with Copalia HCT or one of its three active substances (amlodipine, valsartan and hydrochlorothiazide) are listed below and may occur with the use of Copalia HCT.
Common (may affect up to 1 in 10 people):
dizziness
low blood pressure (feeling of faintness, light-headedness, sudden loss of consciousness)
Uncommon (may affect up to 1 in 100 people):
severely decreased urine output (decreased kidney function)
Rare (may affect up to 1 in 1,000 people):
spontaneous bleeding
irregular heart beat
liver disorder
Very rare (may affect up to 1 in 10,000 people):
sudden wheeziness, chest pain, shortness of breath or difficulty breathing
swelling of eyelids, face or lips
swelling of the tongue and throat which causes great difficulty breathing
severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous
membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion)
heart attack
inflamed pancreas, which may cause severe abdominal and back pain accompanied with feeling of being very unwell
weakness, bruising, fever and frequent infections
stiffness
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):
sleepiness
palpitations (awareness of your heart beat)
flushing
ankle swelling (oedema)
abdominal pain
stomach discomfort after meal
tiredness
headache
frequent urination
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):
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
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
dizziness on standing up or after exercising
lack of energy
sleep disturbances
tingling or numbness
neuropathy
sudden, temporary loss of consciousness
low blood pressure on standing up
cough
breathlessness
throat irritation
excessive sweating
itching
swelling, reddening and pain along a vein
skin reddening
trembling
mood changes
anxiety
depression
sleeplessness
taste abnormalities
fainting
loss of pain sensation
visual disturbances
visual impairment
ringing in the ears
sneezing/runny nose caused by inflammation of the lining of the nose (rhinitis)
altered bowel habits
indigestion
hair loss
itchy skin
skin discolouration
disorder in passing urine
increased need to urinate at night
increased number of times of passing urine
discomfort or enlargement of the breasts in men
pain
feeling unwell
weight decrease
Rare (may affect up to 1 in 1,000 people):
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
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
confusion
Very rare (may affect up to 1 in 10,000 people):
decreased number of white blood cells
decrease in blood platelets which may result in unusual brusing or easy bleeding (red blood cell damage)
swelling of the gums
abdominal bloating (gastritis)
inflammation of the liver (hepatitis)
yellowing of the skin (jaundice)
liver enzyme increase which may have an effect on some medical tests
increased muscle tension
inflammation of blood vessels often with skin rash
sensitivity to light
disorders combining rigidity, tremor and/or movement disorders
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)
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 (frequency cannot be estimated from the available data):
changes in blood tests for kidney function, increase of potassium in your blood, low level of red blood cells
abnormal red blood cell test
low level of a certain type of white blood cell and blood platelet
increase of creatinine in the blood
abnormal liver function test
severely decreased urine output
inflammation of blood vessels
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)
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)
blistering skin (sign of a condition called dermatitis bullous)
skin and lip cancer (non-melanoma skin cancer)
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.
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 30°C.
Store in the original package in order to protect from moisture.
Do not use any Copalia HCT pack that is damaged or shows signs of tampering.
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.
The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and
hydrochlorothiazide. 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 (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, titanium dioxide (E171).
The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and
hydrochlorothiazide. Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate),160 mg valsartan, and 12.5 mg hydrochlorothiazide.
The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide. Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate),
160 mg valsartan and 25 mg hydrochlorothiazide.
The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous, magnesium stearate, hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172).
The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and
hydrochlorothiazide. Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan, and 25 mg hydrochlorothiazide.
The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous, magnesium stearate, hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, yellow iron oxide (E172).
The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide. Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate),
320 mg valsartan, and 25 mg hydrochlorothiazide.
The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous, magnesium stearate, hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, yellow iron oxide (E172).
Copalia 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. Approximate size: 15 mm (length) x 5.9 mm (width).
Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets are pale yellow, oval tablets with “NVR” on one side and “VDL” on the other side. Approximate size: 15 mm (length) x 5.9 mm (width).
Copalia HCT 5 mg/160 mg/25 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “VEL” on the other side. Approximate size: 15 mm (length) x 5.9 mm (width).
Copalia HCT 10 mg/160 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VHL” on the other side. Approximate size: 15 mm (length) x 5.9 mm (width).
Copalia HCT 10 mg/320 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VFL” on the other side. Approximate size: 19 mm (length) x 7.5 mm (width).
Copalia 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 perforated dose blisters. Not all pack sizes may be available in your country.
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road Dublin 4
Ireland
Novartis Farma S.p.A.
Via Provinciale Schito 131 80058 Torre Annunziata (NA)
Italy
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764 08013 Barcelona
Spain
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:
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50
Novartis Bulgaria EOOD Тел.: +359 2 489 98 28
Novartis s.r.o.
Tel: +420 225 775 111
Novartis Healthcare A/S
Tlf: +45 39 16 84 00
Novartis Pharma Services Inc.
Tel: +356 2122 2872
Novartis Pharma GmbH Tel: +49 911 273 0
Novartis Pharma B.V. Tel: +31 88 04 52 111
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810
Novartis Norge AS
Tlf: +47 23 05 20 00
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12
Novartis Pharma GmbH
Tel: +43 1 86 6570
J. Uriach y Cia., S.A. Tel: +34 93 864 96 92
Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600
Novartis Hrvatska d.o.o. Tel. +385 1 6274 220
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
SIA Novartis Baltics Tel: +371 67 887 070
Novartis Ireland Limited Tel: +44 1276 698370