Copalia 10 mg/160 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Copalia 5mg/80mg film-coated tablets

Copalia 5mg/160mg film-coated tablets

Copalia 10mg/160mg film-coated tablets

amlodipine/valsartan

Read the entire leaflet carefully before you start taking this medicine, because 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Copalia is and what it is used for

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

• Amlodipine belongs to a group of substances known as «calcium channel antagonists». Amlodipine prevents calcium from entering the blood vessel wall, thus preventing blood vessels from narrowing.
• Valsartan belongs to a group of substances known as «angiotensin II receptor antagonists». Angiotensin II is produced by the body and causes blood vessels to narrow, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II.

This means that both substances help prevent the narrowing of blood vessels. As a result, blood vessels relax and blood pressure decreases.

Copalia is used to treat high blood pressure in adults whose blood pressure is not adequately controlled by 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 include itching, skin redness, 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, inform your doctor before taking Copalia.
• if you have severe liver problems or biliary disorders such as biliary cirrhosis or cholestasis.
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also during early pregnancy; see Pregnancy section).
• if you have severe low blood pressure (hypotension).
• if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which your heart cannot supply enough blood to the body).
• if you have heart failure following a heart attack.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Do not take Copalia and inform your doctor if any of the above apply to you.

Warnings and precautions

Talk to your doctor before starting to take Copalia:

• if you have been unwell (with vomiting or diarrhoea).
• if you have liver or kidney problems.
• if you have had a kidney transplant or if you have been told you have narrowing of the kidney arteries.
• if you have a disease affecting the adrenal glands called "primary hyperaldosteronism".
• if you have had heart failure or a heart attack. Follow your doctor's instructions carefully when starting treatment. Your doctor may also check your kidney function.
• if your doctor has told you that you have narrowing of the heart valves (called "aortic or mitral stenosis") or that the thickness of your heart muscle has increased abnormally (called "obstructive hypertrophic cardiomyopathy").
• if you have experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors). If you have these symptoms, stop taking Copalia and contact your doctor immediately. You must never take Copalia again.
• if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Copalia. Your doctor will decide whether to continue treatment. Do not stop taking Copalia on your own.
• if you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.

See also the information under the heading “Do not take Copalia”.

Tell your doctor before taking Copalia if any of the above situations apply to you.

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 need to 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 particularly applies to the following medicines:

• an ACE inhibitor or aliskiren (see also information under the headings “Do not take Copalia” and “Warnings and precautions”);
• diuretics (a type of medicine that increases urine output);
• lithium (a medicine used to treat certain types of depression);
• potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, and other substances that may increase potassium levels;
• certain types of pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors). Your doctor may also monitor 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 (administered by infusion for serious body temperature abnormalities);
• medicines used to prevent transplant rejection (cyclosporine).

Taking Copalia with food and drinks

People taking Copalia must not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can increase blood levels of the active substance amlodipine, which may cause an unpredictable increase in the blood pressure-lowering effect of Copalia.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will generally advise you to stop taking Copalia before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive treatment. The use of Copalia is not recommended during early pregnancy (first 3 months), and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that stage.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding. It has been shown that amlodipine passes into breast milk in small amounts. The administration of Copalia to women during this period is not recommended. Your doctor may decide to prescribe a treatment more suitable for breastfeeding, especially if the infant is a newborn or premature.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

This medicine may make you feel dizzy, which could affect your ability to concentrate. Therefore, if you are unsure how this medicine affects you, do not drive, operate machinery, or perform any activities requiring concentration.

3. How to take Copalia

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor again. This will help you achieve the best results and reduce the risk of adverse effects.

The usual dose of Copalia is one tablet daily.

• It is preferable to take the medicine at the same time each day.
• Swallow the tablets with a glass of water.
• You may take Copalia with or without food. Do not take Copalia with grapefruit or grapefruit juice.

Depending on your response to treatment, your doctor may suggest a higher or lower dose.

Do not exceed the prescribed dose.

Copalia and elderly people (65 years or older)

Your doctor should exercise caution when increasing your dose.

If you have any further questions about the use of this medicine, ask 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, consult a doctor immediately. Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop within 24–48 hours after ingestion.

If you forget to take Copalia

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

If you stop taking Copalia

Stopping your treatment with Copalia may cause your condition to worsen. Do not stop taking this medicine unless your doctor tells you to do so.

4. Possible adverse effects

Like all medicines, Copalia can cause adverse effects, although not everyone will experience them.

Some adverse effects may be serious and require immediate medical attention:

A small number of patients have experienced these serious adverse effects. If you notice any of the following, inform your doctor immediately:

Rare (may affect up to 1 in 1,000 patients): Allergic reaction with symptoms such as skin rash, itching, swelling of the face, lips or tongue, difficulty breathing, low blood pressure (feeling faint, dizziness).

Very rare (may affect up to 1 in 10,000 patients): Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Other possible adverse effects of Copalia:

Common (may affect up to 1 in 10 patients): Flu-like illness; stuffy nose, sore throat and discomfort when swallowing; headache; swelling in the arms, hands, legs, ankles or feet; fatigue; asthenia (weakness); flushing and warmth of the face and/or neck.

Uncommon (may affect up to 1 in 100 patients): Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling or numbness in the hands or feet; vertigo, rapid heartbeat including palpitations; dizziness upon standing; cough; diarrhea; constipation; skin rash, skin redness; joint swelling, back pain; joint pain.

Rare (may affect up to 1 in 1,000 patients): Feeling of anxiety; ringing in the ears (tinnitus); fainting; increased amount of urine or urgent need to urinate; inability to achieve or maintain an erection; feeling of heaviness; low blood pressure with symptoms such as dizziness, lightheadedness; excessive sweating; generalized skin rash, itching, muscle spasms.

Tell your doctor if any of the mentioned effects affect you severely.

Adverse effects reported with amlodipine or valsartan alone, not observed with Copalia or observed with higher frequency than with Copalia:

Amlodipine

Contact your doctor immediately if you experience any of the following serious adverse effects, which are very rare after taking this medicine:

• Sudden wheezing, chest pain, shortness of breath or difficulty breathing.
• Swelling of the eyelids, face or lips.
• Swelling of the tongue and throat causing severe difficulty breathing.
• Severe skin reactions including severe rash, hives, widespread skin redness, intense itching, blistering, peeling and swelling of the skin, swelling of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Heart attack, irregular heartbeat.
• Inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by a general feeling of being unwell.

The following adverse effects have been reported. If any of these cause problems or last longer than one week, consult your doctor.

Common (may affect up to 1 in 10 patients): Dizziness, drowsiness; palpitations (awareness of heartbeat); hot flushes, swelling of the ankles (edema); abdominal pain, feeling unwell (nausea).

Uncommon (may affect up to 1 in 100 patients): Mood changes, anxiety, depression, drowsiness, tremor, taste disturbances, fainting, loss of pain sensation; visual disturbances, impaired vision, ringing in the ears; low blood pressure; sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis); indigestion, vomiting (feeling unwell); hair loss, increased sweating, skin itching, skin discoloration; urinary disorders, increased need to urinate at night, increased frequency of urination; inability to achieve an erection, discomfort or enlargement of the breasts in men, pain, discomfort, muscle pain, muscle cramps; weight gain or weight loss.

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

Very rare (may affect up to 1 in 10,000 patients): Decrease in white blood cells, decrease in blood platelets which may cause easy bleeding or unusual bruising (damage to red blood cells); high blood sugar (hyperglycemia); gum inflammation, abdominal swelling (gastritis); abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect certain medical tests; increased muscle tension; inflammation of blood vessels often with skin rashes, photosensitivity; disorders involving rigidity, tremor and/or movement disorders.

Valsartan

Frequency not known (frequency cannot be estimated from available data): Decrease in red blood cells, fever, sore throat or mouth ulcers due to infection; spontaneous skin bleeding or bruising; increased potassium levels in blood; abnormal liver function test results; reduced kidney function and severely reduced kidney function; swelling, mainly of the face and throat; muscle pain; skin rash, purplish red spots; fever; itching; allergic reaction, blistering skin disease (sign of a condition called bullous dermatitis).

If you experience any of the above, consult your doctor immediately.

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system detailed in Annex V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Copalia

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister pack.

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Do not use Copalia if you notice that the container is damaged or shows signs of tampering.

6. Contents of the pack and other information

Composition of Copalia

Copalia 5 mg/80 mg film-coated tablets

The active substances in Copalia are amlodipine (as amlodipine besilate) and valsartan. Each tablet contains 5 mg of amlodipine and 80 mg of valsartan.

The other components are microcrystalline cellulose; crospovidone (type A); anhydrous colloidal silica; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)); macrogol 4000; talc; titanium dioxide (E171); iron oxide yellow (E172).

Copalia 5 mg/160 mg film-coated tablets

The active substances in Copalia are amlodipine (as amlodipine besilate) and valsartan. Each tablet contains 5 mg of amlodipine and 160 mg of valsartan.

The other components are microcrystalline cellulose; crospovidone (type A); anhydrous colloidal silica; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)); macrogol 4000; talc; titanium dioxide (E171); iron oxide yellow (E172).

Copalia 10 mg/160 mg film-coated tablets

The active substances in Copalia are amlodipine (as amlodipine besilate) and valsartan. Each tablet contains 10 mg of amlodipine and 160 mg of valsartan.

The other components are microcrystalline cellulose; crospovidone (type A); anhydrous colloidal silica; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)); macrogol 4000; talc; titanium dioxide (E171); iron oxide yellow (E172); iron oxide red (E172).

Appearance of the product and contents of the pack

Copalia 5 mg/80 mg tablets are round, dark yellow film-coated tablets marked with "NVR" on one side and "NV" on the other. Approximate size: 8.20 mm in diameter.

Copalia 5 mg/160 mg tablets are oval-shaped, dark yellow film-coated tablets marked with "NVR" on one side and "ECE" on the other. Approximate size: 14.2 mm (length) x 5.7 mm (width).

Copalia 10 mg/160 mg tablets are oval-shaped, light yellow film-coated tablets marked with "NVR" on one side and "UIC" on the other. Approximate size: 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 multiple packs containing 4 boxes with 70 tablets each, or 20 boxes with 14 tablets each. All packs are available with standard blisters; packs containing 56, 98 and 280 tablets are also available with single-dose perforated blisters.

Not all pack sizes may be marketed 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 SA
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nürnberg
Germany

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

Date of the most recent review of this summary:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.euopa.eu