COPALIA 5 mg/80 mg Tabletki Powlekane

Treść ulotki

1. Copalia 5 mg/80 mg film-coated tablets, 5 mg/160 mg film-coated tablets, 10 mg/160 mg film-coated tablets
   1. What Copalia is and what it is used for
   2. What you need to know before taking Copalia
   3. How to take Copalia
   4. Possible side effects
   5. How to store Copalia
   6. Contents of the pack and other information

Copalia 5 mg/80 mg film-coated tablets, 5 mg/160 mg film-coated tablets, 10 mg/160 mg film-coated tablets

amlodipine/valsartan

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4

Contents of this leaflet

• 1. What Copalia is and what it is used for
• 2. What you need to know before you take Copalia
• 3. How to take Copalia
• 4. Possible side effects
• 5. How to store Copalia
• 6. Contents of the pack and other information

1. What Copalia is and what it is used for

Copalia tablets contain two substances called amlodipine and valsartan. Both of these substances help to control high blood pressure.

• Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine prevents calcium from entering the walls of blood vessels and thus stops the narrowing of blood vessels.
• Valsartan belongs to a group of substances called “angiotensin II receptor blockers”. Angiotensin II is produced by the body and causes the narrowing of blood vessels, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II. This means that both of these substances help to prevent the narrowing of blood vessels. As a result, blood vessels relax and blood pressure decreases.

Copalia is used in the treatment of high blood pressure in adults in whom blood pressure is not sufficiently controlled with amlodipine or valsartan alone.

2. What you need to know before taking Copalia

Do not take Copalia

• if you are allergic to amlodipine or to any other calcium channel blocker. This may involve itching, redness of the skin or difficulty breathing.
• if you are allergic to valsartan or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor or pharmacist before taking Copalia.
• if you have severe liver problems or problems with the bile ducts such as biliary cirrhosis or cholestasis.
• if you are pregnant for more than 3 months (it is best to avoid taking Copalia even in the early stages of pregnancy, see the Pregnancy section).
• if you have very low blood pressure (hypotension).
• if you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which your heart is unable to pump enough blood to the body).
• if you suffer from heart failure following a heart attack.
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure containing aliskiren. If any of these apply to you, do not take Copalia and consult your doctor.

Warnings and precautions
Talk to your doctor before taking Copalia:

• if you have been feeling unwell (vomiting or diarrhoea).
• if you have problems with your liver or kidneys.
• if you have had a kidney transplant or if you have been told you have a narrowing of the renal arteries.
• if you suffer from a disease affecting the adrenal glands called “primary hyperaldosteronism”.
• if you have had heart failure or have had a heart attack. Carefully follow your doctor's instructions for the initial dose. Your doctor may also check your kidney function.
• if your doctor has told you that you have a narrowing of the heart valves (called “aortic or mitral stenosis”) or that the thickness of the heart muscle has increased abnormally (a condition called “obstructive hypertrophic cardiomyopathy”).
• if you have previously experienced swelling, especially of the face and throat, while taking other medicines (including angiotensin converting enzyme inhibitors). If you experience these symptoms, stop taking Copalia and contact your doctor immediately. You should never take Copalia again.
• if you are taking any of the following medicines used to treat high blood pressure:
• an “ACE inhibitor” (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes;
• aliskiren.

The doctor may check your kidney function, blood pressure, and the amount of electrolytes (such as potassium) in your blood at regular intervals.
See also what is stated under “Do not take Copalia”.

If any of these conditions apply to you, tell your doctor before taking Copalia.
Children and adolescents
The use of Copalia is not recommended in children and adolescents (under 18 years of age).

Other medicines and Copalia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may need to adjust your dose and/or take other precautions. In some cases, you may need to stop taking one of the medicines.
This is especially true for the medicines listed below:

• ACE inhibitors or aliskiren (see also “Do not take Copalia” and “Warnings and precautions”);
• diuretics (a type of medicine that increases the amount of urine produced);
• lithium (a medicine used to treat some types of depression);
• potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other substances that can increase potassium levels;
• some types of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors). Your doctor may also check your kidney function;
• anticonvulsant agents (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St John's wort;
• nitroglycerin and other nitrates or other substances called “vasodilators”;
• medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);
• medicines used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin, telithromycin);
• verapamil, diltiazem (heart medicines);
• simvastatin (a medicine used to control high cholesterol levels);
• dantrolene (infusion for severe body temperature abnormalities);
• tacrolimus (used to control the immune response, to allow the body to accept the transplanted organ);
• medicines used to protect against transplant rejection (cyclosporine).

Copalia with food and drink
Grapefruit and grapefruit juice should not be consumed by people who are taking Copalia. 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 Copalia’s blood pressure lowering effect.

Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). As a rule, your doctor will advise you to stop taking Copalia before becoming pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Copalia. Copalia is not recommended in the early stages of pregnancy (first 3 months) and should not be taken if you are pregnant for more than 3 months as it can cause serious harm to the baby if taken after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Amlodipine has been shown to pass into breast milk in small amounts. Copalia is not recommended for women who are breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed, especially if the baby is newborn or premature.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
This medicine can cause dizziness. This may affect your ability to concentrate. Therefore, if you are unsure how this medicine affects you, do not drive, operate machinery or perform other activities that require concentration.

3. How to take Copalia

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor. This will help you to obtain better results and to decrease the risk of undesirable effects.
The usual dose of Copalia is one tablet a day.

• It is preferable to take the medicine every day at the same time.
• Swallow the tablets with a glass of water.
• Copalia can be taken both on a full stomach and on an empty stomach. Do not take Copalia with grapefruit or grapefruit juice.

Based on your response to treatment, your doctor may suggest a lower or higher dose.
Do not take more than the prescribed dose.

Copalia and the elderly (65 years and over)
The doctor must exercise caution when increasing the dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

If you take more Copalia than you should
If you have taken too many Copalia tablets, or if someone else has taken your tablets, contact a
doctor immediately. Excess fluid may accumulate in the lungs (pulmonary edema)
causing shortness of breath that may develop up to 24-48 hours after taking it.

If you forget to take Copalia
If you forget to take this medicine, take it as soon as you remember. Then take the next
dose at the usual time. However, if it is almost time for the next dose, skip the missed dose. Do not
take a double dose to make up for the forgotten tablet.

If you stop taking Copalia
Stopping treatment with Copalia may cause a worsening of your condition. Do not
stop taking your medicine unless you have been told to do so by your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and require immediate medical attention:
Few patients have experienced these serious side effects (may affect up to 1 in

1,000). If you notice any of the following side effects, contact your doctor
immediately:
allergic reactions with symptoms such as skin rash, itching, swelling of the face, lips or
tongue, difficulty breathing, low blood pressure (feeling weak, light
headedness).

Other possible side effects of Copalia

Common(may affect up to 1 in 10 people):influenza; nasal congestion, sore throat and difficulty
swallowing, headache; swelling of the arms, hands, legs, ankles or feet; fatigue; asthenia
(weakness); redness and/or feeling of warmth of the face and/or neck.

Uncommon(may affect up to 1 in 100 people):dizziness; nausea and abdominal pain;
dry mouth; drowsiness, tingling or numbness of the hands or feet; vertigo; fast
heart rate, including palpitations; dizziness when standing up; cough; diarrhea; constipation; skin
rashes, skin redness; joint swelling, back pain; joint pain.

Rare(may affect up to 1 in 1,000 people):feeling of anxiety; ringing in the ears (tinnitus);
fainting; passing more urine than usual or needing to urinate more
urgently, inability to achieve or maintain an erection, feeling of heaviness;
low blood pressure with symptoms such as dizziness, feeling lightheaded; excessive
sweating; skin rashes all over the body; itching; muscle spasm.

If any of these effects is severe, tell your doctor.
Adverse reactions reported with amlodipine or valsartan alone and not observed with Copalia or
observed with a higher frequency than with Copalia:
Amlodipine

If you notice any of the following very rare and serious side effects, consult
your doctor immediately:

• Sudden shortness of breath, chest pain, wheezing or difficulty breathing.
• Swelling of the eyelids, face or lips.
• Swelling of the tongue and throat which can cause difficulty breathing.
• Severe skin reactions including intense skin rash, hives, skin redness all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Myocardial infarction, arrhythmia.
• Inflammation of the pancreas which can cause severe abdominal and back pain accompanied by a feeling of severe malaise.

The following side effects have been reported. If any of these occurs or persists for
more than a week, contact your doctor.

Common (may affect up to 1 in 10 people):Dizziness, drowsiness; palpitations (feeling your
heartbeat); flushing, swelling of the ankles (edema); abdominal pain, nausea.

Uncommon (may affect up to 1 in 100 people):Changes in mood, anxiety, depression,
insomnia, tremor, altered taste, fainting, loss of sensitivity to pain;
visual disturbances, impaired vision, ringing in the ears; low blood
pressure; sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis); indigestion,
vomiting; hair loss, increased sweating, skin itching, changes in skin
color; urinary disorders, needing to urinate at night, needing to urinate frequently; inability to
achieve an erection, discomfort or enlargement of the breasts in men, pain, malaise, muscle
pain, muscle cramps; weight gain or loss.

Rare (may affect up to 1 in 1,000 people):Confusion.

Very rare( may affect up to 1 in 10,000 people):Low levels of white blood cells and platelets
in the blood which can lead to unusual bruising or a tendency to bleed
(damage to red blood cells); high blood sugar levels (hyperglycemia); gum swelling,
abdominal swelling (gastritis); abnormal liver function, liver inflammation (hepatitis),
yellowing of the skin (jaundice), increased liver enzymes which can lead to changes in
some clinical tests; increased muscle tension; inflammation of blood vessels, often with
skin rash, sensitivity to light; disorders related to rigidity, tremor and/or movement disorders.
Valsartan

Not known (frequency cannot be estimated from available data):Decrease in
red blood cells, fever, sore throat or mouth pain caused by infections; spontaneous bleeding or
bruising; high potassium levels in the blood; abnormal results of liver function tests;
decreased kidney function and severe decrease in kidney function; swelling
especially of the face and throat; muscle pain; skin rash, purplish-red spots
on the skin; fever; itching; allergic reaction; formation of blisters on the skin (a sign of a
condition called bullous dermatitis).
If any of these effects affects you, tell your doctor immediately.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system reported in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Copalia

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 package and blister after Scad
or EXP. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Store in the original package to protect the medicine from moisture.
Do not use Copalia packs that are damaged or show signs of tampering.

6. Contents of the pack and other information

What Copalia contains
Copalia 5 mg/80 mg film-coated tablets
The active ingredients of Copalia are amlodipine (as amlodipine besilate) and valsartan. Each
tablet contains 5 mg of amlodipine and 80 mg of valsartan.
The other ingredients are microcrystalline cellulose; crospovidone (Type A); anhydrous colloidal silica;
magnesium stearate; hypromellose (degree of substitution 2910 (3 mPa.s)); macrogol 4000; talc; titanium
dioxide (E171); yellow iron oxide (E172).

Copalia 5 mg/160 mg film-coated tablets
The active ingredients of Copalia are amlodipine (as amlodipine besilate) and valsartan. Each
tablet contains 5 mg of amlodipine and 160 mg of valsartan.
The other ingredients are microcrystalline cellulose; crospovidone (Type A); anhydrous colloidal silica;
magnesium stearate; hypromellose (degree of substitution 2910 (3 mPa.s)); macrogol 4000; talc; titanium
dioxide (E171); yellow iron oxide (E172).

Copalia 10 mg/160 mg film-coated tablets
The active ingredients of Copalia are amlodipine (as amlodipine besilate) and valsartan. Each
tablet contains 10 mg of amlodipine and 160 mg of valsartan.
The other ingredients are microcrystalline cellulose; crospovidone (Type A); anhydrous colloidal silica;
magnesium stearate; hypromellose (degree of substitution 2910 (3 mPa.s)); macrogol 4000; talc; titanium
dioxide (E171); yellow iron oxide (E172); red iron oxide (E172).

Description of the appearance of Copalia and contents of the pack
Copalia 5 mg/80 mg tablets are round and dark yellow in colour with “NVR” on one side and
“NV” on the other side. Approximate dimensions: diameter 8.20 mm
Copalia 5 mg/160 mg tablets are oval and dark yellow in colour, with “NVR” on one side and
“ECE” on the opposite side. Approximate dimensions: 14.2 mm (length) x 5.7 mm (width)
Copalia 10 mg/160 mg tablets are oval and light yellow in colour, with “NVR” on one side and
“UIC” on the opposite side. Approximate dimensions: 14.2 mm (length) x 5.7 mm (width)
Copalia is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in
multipacks consisting of 4 boxes, each containing 70 tablets or 20 boxes,
each containing 14 tablets. All packs are available in standard blisters, the
56, 98 and 280 tablet packs are also available in unit-dose divisible blisters.
Not all pack sizes may be available in your country.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
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
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany
For further information on this medicine, contact the local representative of the Marketing Authorisation
Holder:

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

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел.: +359 2 976 98 28

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

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

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

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

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

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

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Vifor Pharma España, S.L.
Tel: +34 902 12 11 11

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

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

Portugal
Bialport-Produtos Farmacêuticos, S.A.
Tel: +351 22 986 61 00

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

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
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines
Agency, http://www.ema.europa.eu