EXFORGE 5 mg/160 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Exforge 5mg/80mg film-coated tablets

Exforge 5mg/160mg film-coated tablets

Exforge 10mg/160mg film-coated tablets

amlodipine/valsartan

Read all of this 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 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.

Contents of the pack and other information

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

1. What is Exforge and what is it used for

Exforge tablets contain two active substances called amlodipine and valsartan. Both substances help to control high blood pressure.

• Amlodipine belongs to a group of substances known as “calcium channel blockers”. Amlodipine prevents calcium from entering the blood vessel wall, which prevents the 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 makes the blood vessels narrow, thereby increasing the blood pressure. Valsartan works by blocking the effect of angiotensin II.

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

Exforge is used to treat high blood pressure in adults whose blood pressure is not adequately controlled with amlodipine or valsartan alone.

2. What you need to know before you take Exforge

Do not take Exforge

• if you are allergic to amlodipine or any other calcium channel blocker. This may include itching, redness of the skin, or difficulty breathing.
• if you are allergic to valsartan or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, inform your doctor before taking Exforge.
• if you have severe liver problems or biliary problems such as cholestasis or biliary cirrhosis.
• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking this medicine during the first few months of pregnancy, see section Pregnancy).
• if you have severe low blood pressure (hypotension).
• if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a situation where your heart is unable to supply enough blood to your body).
• if you have heart failure after a heart attack.
• if you have diabetes or kidney problems and are being treated with a blood pressure lowering medicine containing aliskiren.

Do not take Exforge and inform your doctorif any of the above applies to you.

Warnings and precautions

Consult your doctor before starting to take Exforge:

• if you have been unwell (with vomiting or diarrhea).
• if you have liver or kidney problems.
• if you have had a kidney transplant or have been told you have narrowing of the arteries to your kidneys.
• if you have a condition affecting your adrenal glands called “primary hyperaldosteronism”.
• if you have had heart failure or have had a heart attack. Follow your doctor's instructions carefully to start taking the dose. 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 in an abnormal way (called “hypertrophic cardiomyopathy”).
• if you have experienced swelling, particularly in the face and throat, while taking other medicines (including ACE inhibitors).
• if you are taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.

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

Tell your doctor before taking Exforge if any of the above applies to you.

Children and adolescents

Exforge is not recommended for children and adolescents (under 18 years).

Other medicines and Exforge

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Your doctor may need to change 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:

• an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Exforge” and “Warnings and precautions”);
• diuretics (a type of medicine that increases the amount of urine);
• 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 painkillers called non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors. Your doctor may also check your kidney function;

• anticonvulsants (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St. John's Wort;
• nitroglycerin and other nitrates, or other substances called “vasodilators”;
• medicines used to treat 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 (in infusion for severe body temperature abnormalities);
• medicines used to protect against transplant rejection (cyclosporin).

Taking Exforge with food and drink

People taking Exforge should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in the levels of the active substance amlodipine in the blood, which can cause an unpredictable increase in the blood pressure lowering effect of Exforge.

Pregnancy and breast-feeding

Pregnancy

You should inform your doctor if you are pregnant, think you might be pregnant, or are planning to become pregnant. Your doctor will normally advise you to stop taking Exforge before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine to treat your high blood pressure. Exforge is not recommended during the first 3 months of pregnancy and must not be taken after the third month of pregnancy as it may cause serious harm to your baby when taken after this time.

Breast-feeding

Inform your doctor if you are breast-feeding or about to start breast-feeding. It has been shown that amlodipine passes into breast milk in small amounts. It is not recommended to take Exforge during breast-feeding. Your doctor will decide whether you should continue breast-feeding or take another treatment, especially if your baby is a newborn or premature.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

This medicine may make you feel dizzy. This may affect your ability to concentrate. If you are unsure how this medicine will affect you, do not drive, use machines, or perform other activities that require concentration.

3. How to take Exforge

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

The usual dose of Exforge is one tablet per day.

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

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

Do not exceed the recommended dose.

Exforge and older people (65 years or older)

Your doctor should exercise caution when increasing the dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you take more Exforge than you should

If you have taken too many Exforge tablets, or if someone else has taken your tablets, contact a doctor immediately. Excess fluid can build up in the lungs (pulmonary edema) causing difficulty breathing that can develop up to 24-48 hours after ingestion.

If you forget to take Exforge

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, do not take the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Exforge

Stopping your treatment with Exforge may cause your illness to get worse. Do not stop taking your medicine unless your doctor tells you to.

4. Possible side effects

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

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

A few patients have experienced these serious side effects (may affect up to 1 in 1,000 patients).If you notice any of the following, tell your doctor immediately:

Allergic reaction with symptoms such as skin rash, itching, swelling of the face, lips or tongue, difficulty breathing, low blood pressure (feeling of fainting, dizziness).

Other possible side effects of Exforge:

Common(may affect up to 1 in 10 patients):Flu; stuffy nose, sore throat and discomfort when swallowing; headache; swelling in the arms, hands, legs, ankles or feet; tiredness; weakness; redness 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 of the hands or feet; vertigo, rapid heartbeat including palpitations; dizziness when standing up; cough; diarrhea; constipation; skin rash, redness of the skin; joint inflammation, back pain; joint pain.

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

Tell your doctor if any of the above affects you seriously.

Side effects reported with amlodipine or valsartan alone and not observed with Exforge or observed with a higher frequency with Exforge:

Amlodipine

Tell your doctor immediately if you experience any of the following serious side effects, which are very rare (may affect up to 1 in 10,000 patients) 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, which may cause severe difficulty breathing.
• Severe skin reactions, including skin rash, redness of the skin all over the body, itching, blistering, peeling, and inflammation of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Heart attack, abnormal heartbeat.
• Pancreatitis, which may cause severe abdominal pain and back pain, accompanied by a feeling of being unwell.

The following side effects have been reported. If any of these cause problems or last more than a week, consult your doctor.

Common(may affect up to 1 in 10 patients):Dizziness, drowsiness; palpitations (feeling your heartbeat); flushing, 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, changes in taste, fainting, loss of pain sensation; visual disturbances, impaired vision, ringing in the ears; low blood pressure; runny or stuffy nose caused by inflammation of the nasal mucosa (rhinitis); indigestion, vomiting (nausea); hair loss, increased sweating, itching, skin discoloration; urinary disorders, increased need to urinate at night, increased number of times of urination; inability to get an erection, discomfort or enlargement of the breasts in men, pain, feeling unwell, muscle pain, muscle cramps; weight increase 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 the number of white blood cells, decrease in blood platelets which may cause easy bruising or bleeding (damage to red blood cells); high blood sugar (hyperglycemia); gum inflammation, abdominal swelling (gastritis); abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increase in liver enzymes 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 stiffness, tremor and/or movement disorders.

Valsartan

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

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

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

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 Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Exforge

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.

Do not store above 30°C.

Store in the original package to protect from moisture.

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

6. Package Contents and Additional Information

Composition ofExforge

Exforge 5mg/80mg film-coated tablets

The active substances of Exforge are amlodipine (as amlodipine besylate) and valsartan. Each tablet contains 5 mg of amlodipine and 80 mg of valsartan.

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

Exforge 5mg/160mg film-coated tablets

The active substances of Exforge are amlodipine (as amlodipine besylate) and valsartan. Each tablet contains 5 mg of amlodipine and 160 mg of valsartan.

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

Exforge 10mg/160mg film-coated tablets

The active substances of Exforge are amlodipine (as amlodipine besylate) and valsartan. Each tablet contains 10 mg of amlodipine and 160 mg of valsartan.

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

Appearance and Package Contents

Exforge 5 mg/80 mg tablets are round and dark yellow in color with «NVR» on one side and «NV» on the other side. Approximate size: diameter 8.20 mm.

Exforge 5 mg/160 mg tablets are oval and dark yellow in color with «NVR» on one side and «ECE» on the other side. Approximate size: 14.2 mm (length) x 5.7 mm (width).

Exforge 10 mg/160 mg tablets are oval and light yellow in color with «NVR» on one side and «UIC» on the other side. Approximate size: 14.2 mm (length) x 5.7 mm (width).

Exforge is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks containing 4 packs, each with 70 tablets, or 20 packs, each with 14 tablets. All packs are available with standard blisters; the packs of 56, 98 and 280 tablets are also available with perforated unit dose 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 Proviniciale Schito 131

80058 Torre Annunziata (NA)

Italy

Novartis Farmacéutica SA

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 Nürnberg

Germany

For further information, please contact the local representative of the Marketing Authorisation Holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu