5 mg / 80 mg, 5 mg / 160 mg and 10 mg / 160 mg film-coated tablets 
amlodipine / valsartan

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It may harm them, even if they show symptoms similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Amlodipine / Valsartan Krka is and what it is used for 
2. What you need to know before you use Amlodipine / Valsartan Krka 
3. How to use Amlodipine / Valsartan Krka 
4. Possible side effects 
5. How to store Amlodipine / Valsartan Krka 6. Contents of the pack 
and other information 

What Amlodipine / Valsartan Krka is and what it is used for

Amlodipine / Valsartan Krka 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 produced by the body and causes the blood vessels to constrict, thus raising 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.

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

Amlodipine and valsartan contained in Amlodipine / Valsartan Krka may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Amlodipine / Valsartan Krka

Do not use Amlodipine / Valsartan Krka

  • 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 Amlodipine / Valsartan Krka.
  • if you have severe liver or bile problems, such as biliary cirrhosis or bile stasis.
  • if you are in the last 6 months of pregnancy (even earlier in the pregnancy it is good to avoid Amlodipine / Valsartan Krka, see section 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 high blood sugar levels and have type II diabetes (also called non-insulin-dependent diabetes mellitus ), or you have impaired kidney function, and are being treated with an antihypertensive medicine containing aliskiren.

If any of the above applies to you, do not take Amlodipine / Valsartan Krka and talk to your doctor.

Warnings and cautions

Talk to your doctor before taking Amlodipine / Valsartan Krka:

  • 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 of the face and throat, while taking other medicines (including ACE inhibitors ). If you get these symptoms, stop taking Amlodipine / Valsartan Krka and contact your doctor immediately. You should never take Amlodipine / Valsartan Krka 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 Amlodipine / Valsartan Krka”.

If any of the above applies to you, talk to your doctor before taking Amlodipine / Valsartan Krka.

Children and young people

The use of Amlodipine / Valsartan Krka in children and adolescents under 18 years of age is not recommended.

Other medicines and Amlodipine / Valsartan Krka

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 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:

  • other drugs used to lower blood pressure, so-called ACE inhibitors or aliskiren;
  • 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 ) or 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 used 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, tacrolimus).

Amlodipine / Valsartan Krka with food, drink, and alcohol

Grapefruit and grapefruit juice should not be consumed by people taking Amlodipine / Valsartan Krka. 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 Amlodipine / Valsartan Krka.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you think you may be pregnant (or become pregnant), contact your doctor. Usually, your doctor suggests that you stop taking Amlodipine / Valsartan Krka before pregnancy or as soon as you know you are pregnant and recommend another medicine for you instead of Amlodipine / Valsartan Krka. Amlodipine / Valsartan Krka 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

Amlodipine passes into breast milk in small amounts. Tell your doctor if you are breast-feeding or planning to start breast-feeding. Amlodipine / Valsartan Krka 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 a 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. If you do not know how this medicine will affect you, do not drive, use any machinery, or engage in any other activity that requires concentration.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to use Amlodipine / Valsartan Krka

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

The usual dose of Amlodipine / Valsartan Krka 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 Amlodipine / Valsartan Krka with or without food. Do not take Amlodipine / Valsartan Krka 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.

Amlodipine / Valsartan Krka 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 forget to use Amlodipine / Valsartan Krka

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 using Amlodipine / Valsartan Krka

If you stop taking Amlodipine / Valsartan Krka, your disease may get worse. Do not stop taking your medicine unless your doctor tells you to.

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

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 (may affect up to 1 in 1,000 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 Amlodipine / Valsartan Krka:

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; fast heart rate including 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 Amlodipine / Valsartan Krka or observed at a higher frequency than with Amlodipine / Valsartan Krka:

Amlodipine

Contact a 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 make 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.
  • Myocardial infarction, abnormal heart rate.
  • 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; visual 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, 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 ), yellow 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.

Has been reported (occurs in an unknown number of users): tremors, rigid posture, impaired facial expressions, slow movements, and trailing unbalanced gait.

Valsartan

Has been reported (occurs in an unknown number of users): reduction in 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 (the sign of a condition called bullous dermatitis ).

If you experience any of these, talk to your doctor immediately.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Amlodipine / Valsartan Krka

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 expiration date is the last day of the specified month.

Do not store above 30 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are valsartan and amlodipine.5 mg / 80 mg film-coated tabletEach 5 mg / 80 mg film-coated product contains 5 mg amlodipine (as amlodipine besilate) and 80 mg valsartan.5 mg / 160 mg film-coated tabletEach 5 mg / 160 mg film-coated product contains 5 mg amlodipine (as amlodipine besilate) and 160 mg valsartan.10 mg / 160 mg film-coated tabletEach 10 mg / 160 mg film-coated product contains 10 mg amlodipine (as amlodipine besilate) and 160 mg valsartan.
  • The other ingredients are microcrystalline cellulose, magnesium stearate, croscarmellose sodium, povidone K25, sodium lauryl sulfate, mannitol, and colloidal anhydrous silica in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, talc, and yellow iron oxide (E17).

What the medicine looks like and the contents of the pack

Amlodipine / Valsartan Krka 5 mg / 80 mg film-coated tablets (tablets):

brownish-yellow, round, slightly biconvex film-coated tablets with rounded edges and possibly dark dots (tablet diameter: 8 mm, thickness: 3.0 mm – 4.3 mm).

Amlodipine / Valsartan Krka 5 mg / 160 mg film-coated tablets (tablets):

brownish-yellow, oval, biconvex film-coated tablets, possibly with dark dots (tablet dimension: 13 mm x 8 mm, thickness: 3.8 mm – 5.4 mm).

Amlodipine / Valsartan Krka 10 mg / 160 mg film-coated tablets (tablets):

light brownish yellow, oval, biconvex film-coated tablets (tablet dimension: 13 mm x 8 mm, thickness: 3.8 mm – 5.4 mm).

5 mg / 80 mg tablets: Blister (OPA / Alu / PVC-Alu foil): 14, 28, 30, 56, 90, 98 and 100 tablets, in a carton.

5 mg / 160 mg and 10 mg / 160 mg tablets: Blister (OPA / Alu / PVC-Alu foil): 28, 30, 56, 90, 98 and 100 tablets, in a carton.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local representative

KRKA Sverige AB, Göta Ark 175, 118 72 Stockholm,

Manufacturer

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Krka-farma doo, V. Holjevca 20 / E, 10 450 Jastrebarsko, Croatia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Muhammad Nadeem

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