amlodipine and valsartan

1. What Exforge is and what it is used for

Exforge tablets contain two substances, amlodipine, and valsartan. Both of these substances help control high blood pressure.

  • Amlodipine belongs to a group of substances called ‘calcium channel blockers. Amlodipine prevents calcium from entering the blood vessel wall, which reduces the tension in the blood vessels.
  • Valsartan belongs to a group of substances called ‘angiotensin II receptor antagonists. Angiotensin II is present in the body and causes the blood vessels to constrict. This raises blood pressure. Valsartan works by blocking the action of angiotensin II.

This means that both of these substances help prevent the narrowing of the blood vessels. The blood vessels relax and the blood pressure drops.

Exforge is used to treat high blood pressure in adults whose blood pressure cannot be adequately controlled on amlodipine or valsartan alone.

2. What you need to know before taking Exforge

Do not take Exforge

  • if you are allergic to amlodipine or other calcium channel blockers. This can mean 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, talk to your doctor before taking Exforge.
  • if you have severe liver or bile problems, such as biliary cirrhosis or bile stasis.
  • if you are pregnant: Pregnant women should not use Exforge during the last 6 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Exforge, see Pregnancy and breast-feeding).
  • 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 the heart cannot supply enough blood to the body).
  • if you suffer from heart failure after a heart attack.
  • if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above apply to you, do not take Exforge and talk to your doctor.

Warnings and cautions

Talk to your doctor before taking Exforge:

  • if you have been ill (vomiting or diarrhea).
  • if you have liver or kidney problems.
  • if you have had a kidney transplant or if you have a narrowing of the kidneys’ blood vessels.
  • if you have a disease that affects the kidney glands, so-called “primary hyperaldosteronism”.
  • if you have had heart failure or had a heart attack. Follow your doctor’s instructions for your starting dose carefully. Your doctor may also check your kidney function.
  • if your doctor has told you that you have narrow arches in your heart (so-called “aortic stenosis or mitral stenosis”) or that your heart muscle is abnormally thick (so-called “obstructive hypertrophic cardiomyopathy”).
  • if you have had swelling, especially on your face and throat, while taking other medicines (including ACE inhibitors ). If you get these symptoms, stop taking Exforge and contact your doctor immediately. You should never take Exforge again.
  • if you are taking any of the following medicines used to treat high blood pressure:
    • an ACE inhibitor (eg enalapril, lisinopril, ramipril), especially if you have diabetes-related kidney problems.
    • aliskiren.

Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.

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

If any of the above apply to you, talk to your doctor before taking Exforge.

Children and young people

The use of Exforge in children and adolescents is not recommended (under 18 years of age).

Other medicines and Exforge

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 take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially true of the medicines mentioned below:

  • ACE inhibitor or aliskiren (see also the information under the headings “Do not take Exforge” and “Warnings and precautions”)
  • diuretics (a type of medicine also known as diuretic tablets, which increase the amount of urine);
  • lithium (a drug 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 ) and selective cyclooxygenase 2 inhibitors (Cox 2 inhibitors). Your doctor may also check your kidney function;
  • antispasmodics (eg carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
  • St. John’s wort;
  • nitroglycerin and other nitrates or other substances, so-called “vasodilators”;
  • drugs for HIV / AIDS (eg ritonavir, indinavir, nelfinavir);
  • drugs used to treat fungal infections (eg ketoconazole, itraconazole);
  • drugs used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin, telithromycin);
  • verapamil, diltiazem (heart medicine);
  • simvastatin (a medicine used to control high cholesterol);
  • dantrolene ( infusion for severe body temperature disturbances);
  • drugs used to protect against graft rejection (cyclosporine).

Exforge with food and drink

Grapefruit and grapefruit juice should not be consumed by people taking Exforge. This is because grapefruit and grapefruit juice can lead to an increase in blood levels of the active substance amlodipine, which can cause an unpredictable increase in the blood pressure-lowering effect of Exforge.

Pregnancy and breastfeeding

Pregnancy

If you think you may be pregnant or become pregnant during treatment, consult your doctor. Usually, your doctor suggests that you stop taking Exforge before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Exforge should not be used in early pregnancy (first 3 months) and should not be used during the last 6 months of pregnancy as it may cause birth defects.

Breast-feeding

Tell your doctor if you are breast-feeding or planning to start breast-feeding. Amlodipine passes into breast milk in small amounts. Exforge is not recommended for breastfeeding and your doctor may choose another treatment for you if you want to breast-feed your baby, especially if your baby is newborn or born prematurely.

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

Driving and using machines

This medicine may make you dizzy. This can affect your ability to concentrate. So, if you do not know how this medicine will affect you, do not drive, use any machinery or engage in any activity that requires you to concentrate.

3. How to take Exforge

Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure. Then you get the best result and reduce the risk of side effects.

The usual dose of Exforge is one tablet daily.

  • You should take your 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 how you respond to treatment, your doctor may suggest a higher or lower dose.

Do not exceed the prescribed dose.

Exforge for the elderly (65 years or older)

Your doctor should exercise caution when increasing your dose.

If you have any further questions on the use of this product, 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, consult a doctor immediately.

If you forget to take Exforge

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

If you stop taking Exforge

If you stop taking Exforge, your disease may get worse. Do not stop taking your medicine unless your doctor tells you to.

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:

A few patients have experienced these serious side effects are (may affect up to 1 in 1000 people)If any of the following occur, talk to your doctor immediately:

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

Other possible side effects are with Exforge:

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

Uncommon (may affect up to 1 in 100 people): dizziness; nausea and abdominal pain; dry mouth; drowsiness, stinging sensation or numbness in the hands or feet; dizziness; rapid pulse or palpitations; dizziness when standing up; cough; diarrhea; constipation; skin rash, redness of the skin; swollen joints, back pain; joint pain.

Rare (may affect up to 1 in 1,000 people): anxiety; ear infections ( tinnitus ); fainting; greater urine output than usual or increased urination frequency; inability to get or maintain an erection; feeling of heaviness; low blood pressure with symptoms such as dizziness, confusion; heavy sweating; skin rash all over the body; itching, muscle cramps.

If any of these symptoms affect you severely, talk to your doctor.

Adverse reactions reported with either amlodipine or valsartan and either not observed with Exforge or observed at a higher frequency than with Exforge:

Amlodipine

See your doctor immediately if you get any of the following very rare and serious side effects after taking this medicine:

  • Sudden wheezing, chest pain, shortness of breath, or difficulty breathing.
  • Swelling of eyelids, face, or lips.
  • Swelling of the tongue and throat makes it very difficult to breathe.
  • Severe skin reactions such as severe rash, hives, redness all over the body, severe itching, blistering, skin flaking and swelling, inflamed mucous membranes ( Stevens-Johnson syndrome, toxic epidermal necrolysis ), or other allergic reactions.
  • Inflammation of the pancreas, which can cause severe abdominal and back pain and a strong feeling of illness.

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

Common (may affect up to 1 in 10 people): dizziness, drowsiness; palpitations (you feel the heartbeat); hot flashes, swollen ankles ( edema ); abdominal pain, nausea.

Uncommon (may affect up to 1 in 100 people): mood swings, anxiety, depression, insomnia, tremors, taste changes, fainting, inability to feel pain; acid disturbances, impaired vision, earrings; low blood pressure; sneezing / runny nose due to inflammation of the nasal mucosa ( rhinitis ); indigestion, vomiting; hair loss, increased sweating, itchy skin, skin discoloration; urination problems, increased need to urinate at night, increased urination frequency; impotence, discomfort from or enlarged breasts in men, weakness, pain, malaise, muscle aches, muscle cramps; weight gain or weight loss.

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

Very rare (may affect up to 1 in 10,000 people): decreased number of white blood cells, decreased number of platelets that can lead to bruising or bleeding easily (damage to red blood cells ); elevated blood sugar ( hyperglycemia ); swollen gums, swollen abdomen ( gastritis ); abnormal liver function, inflammation of the liver ( hepatitis ), yellowing of the skin (jaundice), elevated liver enzymes that may affect certain medical tests; increased muscle tone (muscle tension); inflammation of the blood vessels, often with rash, photosensitivity; diseases that combine rigidity, tremo, and/or movement disorders.

Valsartan

No known frequency (can not be calculated from the available data): reduction of red blood cells, fever, sore throat, or cold sores due to infections; spontaneous bleeding or bruising; high levels of potassium in the blood; abnormal liver values; impaired renal function and severe renal impairment; swelling mainly in the face and throat; muscle pain; skin rash, purple-red spots; fever; itching; allergic reaction; blistering of the skin (a sign of a condition called bullous dermatitis ).

If any of these occur, talk to your doctor immediately.

5. How to store 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 after EXP.

Do not store above 30 ° C.

Store in the original package. Moisture sensitive.

Do not use this medicine if you notice that the packaging is damaged or shows signs of change.

6. Contents of the packaging and other information

Content declaration

Exforge 5 mg / 80 mg film-coated tablets

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

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

Exforge 5 mg / 160 mg film-coated tablets

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

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

Exforge 10 mg / 160 mg film-coated tablets

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

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

What the medicine looks like and the contents of the pack

Exforge 5 mg / 80 mg tablets are round and dark yellow, debossed with “NVR” on one side and “NV” on the other. Approximate size: diameter 8.20 mm.

Exforge 5 mg / 160 mg tablets are oval and dark yellow, debossed with “NVR” on one side and “ECE” on the other. Approximate size: 14.2 mm (length) x 5.7 mm (width).

Exforge 10 mg / 160 mg tablets are oval and light yellow, imprinted 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 of 7, 14, 28, 30, 56, 90, 98, or 280 tablets and multiple packs of 4 cartons, each containing 70 tablets or 20 cartons, each containing 14 tablets. All packaging is 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.

Marketing Authorisation Holder

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

UK

Manufacturer

Novartis Pharmacéutica SA

Ronda de Santa Maria 158

08210 Barberà del Vallès, Barcelona

Spain

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 LithuaniaSIA “Novartis Baltics” Lithuanian branchesTel: +370 5 269 16 50
BulgariaNovartis Bulgaria EOODTel .: +359 2 489 98 28 Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11
Czech RepublicNovartis sroTel: +420 225 775 111 HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00
DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872
GermanyNovartis Pharma GmbHTel: +49 911 273 0 The NetherlandsNovartis Pharma BVTel: +31 26 37 82 111
EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 NorwayNovartis Norge ASTel: +47 23 05 20 00
GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 AustriaNovartis Pharma GmbHTel: +43 1 86 6570
SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888
FranceNovartis Pharma SASTel: +33 1 55 47 66 00 PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600
CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01
IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439
ItalyNovartis Farma SpATel: +39 02 96 54 1 Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200
LatviaSIA “Novartis Baltics”Tel: +371 67 887 070 United KingdomNovartis Pharmaceuticals UK Ltd.Tel: +44 1276 698370

Muhammad Nadeem

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