5 mg / 80 mg & 5 mg / 160 mg & 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 can harm them, even if they show signs of illness 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 STADA is and what it is used for 
2. What you need to know before you use Amlodipine / Valsartan STADA 
3. How to use Amlodipine / Valsartan STADA 
4. Possible side effects 
5. How to store Amlodipine / Valsartan STADA 6. Contents of the pack 
and other information 

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

Amlodipine / Valsartan Stada tablets contain two substances, amlodipine, and valsartan. Both of these substances help keep blood pressure under control.

  • Amlodipine belongs to a group of substances called ‘calcium channel blockers’. Amlodipine prevents calcium from entering the blood vessel wall, which prevents the blood vessels from constricting.
  • 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.

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

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

Do not use Amlodipine / Valsartan STADA

  • 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 Stada.
  • if you have severe liver or bile problems, such as biliary cirrhosis or bile stasis.
  • pregnant women should not use Amlodipine / Valsartan Stada during the last 6 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Amlodipine / Valsartan Stada, 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 applies to you, do not take Amlodipine / Valsartan Stada and talk to your doctor.

Warnings and cautions

Talk to your doctor before taking Amlodipine / Valsartan Stada.

  • if you have been sick to the stomach (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 adrenal 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 heart valves (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 Stada and contact your doctor immediately. You should never take Amlodipine / Valsartan Stada 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 Stada”.

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

Children and young people

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

Other medicines and Amlodipine / Valsartan STADA

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 inhibitors or aliskiren (see also information under the headings “Do not take Amlodipine / Valsartan Stada” 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 ( antibiotics 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).

Amlodipine / Valsartan STADA with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Pregnancy

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

Amlodipine, one of the two active substances in Amlodipine / Valsartan Stada passes into breast milk in small amounts. If you are breast-feeding or about to start breast-feeding, you must tell your doctor before taking Amlodipine / Valsartan Stada.

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.

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.

Amlodipine / Valsartan STADA contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.

How to use Amlodipine / Valsartan STADA

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 recommended dose of Amlodipine / Valsartan Stada 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 Stada with or without food. Do not take Amlodipine / Valsartan Stada 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 Stada 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 STADA

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 STADA

If you stop taking Amlodipine / Valsartan Stada, 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 of Amlodipine / Valsartan Stada:

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 pulse or palpitations
  • dizziness when standing up
  • cough
  • diarrhea
  • constipation
  • skin rash, reddening of the skin
  • swollen joints, back pain
  • joint pain.

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

  • anxiety
  • ringing in the ears ( tinnitus )
  • fainting
  • the greater amount of urine than usual or increased frequency of urination
  • 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 Stada or observed at a higher frequency than with Amlodipine / Valsartan Stada:

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 the eyelids, face, or lips.
  • swelling of the tongue and throat that 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.
  • heart attack, abnormal heart rate ( pulse ).
  • 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, tremor, and/or movement disorders.

Valsartan

Has been reported (occurs in an unknown number of users):

  • reduction in red blood cells, fever, sore throat or mouth sores due to infection s
  • spontaneous bleeding or bruising
  • high level of potassium in the blood
  • abnormal liver values
  • impaired renal function and severely impaired renal function
  • swelling mainly in the face and throat
  • muscle pain
  • skin rash, reddish-purple spots
  • fever
  • itching
  • allergic reaction, blistering of the skin (signs of a condition called bullous dermatitis ).

If any of these occur, 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. 

How to store Amlodipine / Valsartan STADA

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. Store in the original package. Moisture sensitive.

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 in Amlodipine / Valsartan Stada are amlodipine (as amlodipine besylate) and valsartan.

Each 5 mg / 80 mg film-coated tablet contains 5 mg amlodipine (as amlodipine besilate) and 80 mg valsartan.

Each 5 mg / 160 mg film-coated tablet contains 5 mg amlodipine (as amlodipine besilate) and 160 mg valsartan.

Each 10 mg / 160 mg film-coated tablet contains 10 mg amlodipine (as amlodipine besilate) and 160 mg valsartan.

Other ingredients are:

Tablet core: microcrystalline cellulose, povidone, pregelatinized maize starch, colloidal anhydrous silica, crospovidone, sodium starch glycolate, magnesium stearate.

Film coating :

5 mg / 80 mg and 5 mg / 160 mg

Hypromellose, titanium dioxide (E171), yellow iron oxide (E172), talc, macrogol, black iron oxide (E172).

10 mg / 160 mg

Hypromellose, titanium dioxide (E171), yellow iron oxide (E172), talc, macrogol.

What the medicine looks like and the contents of the pack

Amlodipine / Valsartan Stada 5 mg / 80 mg film-coated tablets are dark yellow, round, biconvex, film-coated tablets.

Amlodipine / Valsartan Stada 5 mg / 160 mg film-coated tablets are dark yellow, oval, biconvex film-coated tablets.

Amlodipine / Valsartan Stada 10 mg / 160 mg film-coated tablets are pale yellow, oval, biconvex film-coated tablets.

The film-coated tablets are available in transparent PVC / TE / PVdC foil and aluminum foil blisters

7, 10, 14, 28, 30, 56, 60, 84, 90, 98, 100 film-coated tablets.

The film-coated tablets are available in transparent PVC / TE / PVdC foil and aluminum foil single-dose blisters with 7, 10, 14, 28, 30, 56, 60, 84, 90, 98, 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimitel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Other manufacturers

STADA Arzneimittel GmbH

Muthgasse 36/2, 1190 Vienna, Austria

Centrafarm Services BV

Nieuwe Donk 9, 4879 AC Etten-Leur, The Netherlands

STADA Nordic ApS

Marielundvej 46A, 2730 Herlev, Denmark

Clonmel Healthcare Ltd.

Waterford Road, Clonmel, Co. Tipperary, Ireland

Local representative

STADA Nordic ApS

Marielundvej 46A

2730 Herlev

Denmark

Muhammad Nadeem

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