5 mg and 10 mg tablets 
amlodipine

Read all of this leaflet carefully before you start using this medicine.

  • Save 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 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, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Amlodipine Accord is and what it is used for 
2. What you need to know before taking Amlodipine Accord 
3. How to take Amlodipine Accord 
4. Possible side effects 
5. How to store Amlodipine Accord 
6. Contents of the packaging and other information 

1. What Amlodipine Accord is and what it is used for

Amlodipine Accord contains the active substance amlodipine which belongs to a group of medicines called calcium channel blockers.

Amlodipine Accord is used to treat high blood pressure ( hypertension ) or a specific type of chest pain called angina. A rare form of this is Prinzmetal’s angina or variant angina.

In patients with high blood pressure, the drug reduces the resistance in the blood vessels, so that the blood can pass more easily. In patients with angina, Amlodipine Accord works by increasing blood flow to the heart muscle, which then receives more oxygen. That way, chest pain is prevented. This medicine does not provide immediate relief from chest pain in angina.

Amlodipine contained in the Amlodipine Accord may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

What you need to know before you take Amlodipine Accord

Do not take Amlodipine Accord

  • if you are allergic to amlodipine or any of the other ingredients of this medicine (listed in section 6), or to any other calcium channel blocker. Symptoms may include itching, redness of the skin, or difficulty breathing.
  • if you have very low blood pressure. ( hypotension ).
  • if you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition that means that the heart is unable to supply the body with sufficient amounts of blood).
  • if you have heart failure after a heart attack.

Warnings and cautions

Talk to your doctor or pharmacist before taking Amlodipine Accord. Tell your doctor if you have or have had any of the following:

  • recent heart attack
  • heart failure
  • very high blood pressure (hypertensive crisis)
  • liver disease
  • if you are older and your dose needs to be increased

Children and young people

Amlodipine Accord has not been studied in children under 6 years of age. Amlodipine Accord should only be used to treat hypertension in children and adolescents between 6 and 17 years of age (see section 3).

For more information, talk to your doctor.

Other medicines and Amlodipine Accord

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Amlodipine Accord may affect or be affected by other medicines, such as:

  • ketoconazole, itraconazole ( antifungal )
  • ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV )
  • rifampicin, erythromycin, clarithromycin (antibiotic)
  • Hypericum perforatum ( St. John’s wort )
  • verapamil, diltiazem (heart medicine)
  • dantrolene ( infusion for severe body temperature disturbances).
  • tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to change the way the immune system works) 
  • simvastatin (a cholesterol-lowering drug)
  • ciclosporin (medicines that suppress the immune system)

Amlodipine Accord may lower your blood pressure further if you are already taking other medicines for high blood pressure.

Amlodipine Accord with food and drink

If you are taking Amlodipine Accord, do not eat grapefruit or drink grapefruit juice. Grapefruit and grapefruit juice can lead to an increase in the amount of the active substance amlodipine in the blood, which can lead to an unpredictable increase in the blood pressure-lowering effect of Amlodipine Accord.

Pregnancy and breastfeeding

Pregnancy

The safety of amlodipine during pregnancy has not been established. If you think you are pregnant or planning to become pregnant, tell your doctor before taking Amlodipine Accord.

Breast-feeding

Amlodipine 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 Accord.

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

Driving and using machines

Amlodipine Accord may affect your ability to drive or use machines. If you feel unwell, dizzy, or tired, or have headaches from the tablets, do not drive or use machines. Contact your doctor immediately.

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 take Amlodipine Accord

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended starting dose is 5 mg Amlodipine Accord once daily. Dose one can be increased to 10 mg Amlodipine Accord tablets once daily.

This medicine can be taken before or after food or drink. You should take this medicine at the same time each day with a glass of water. Do not take Amlodipine Accord with grapefruit juice.

Use for children and adolescents

The recommended starting dose for children and adolescents (6‑17 years) is 2.5 mg daily. The maximum recommended dose is 5 mg daily. Amlodipine 2.5 mg is currently not available and a 2.5 mg dose can not be obtained with Amlodipine Accord 5 mg as these tablets are not manufactured in such a way that they can be divided into two equal parts.

It is important that you take the tablets at all times. Do not wait until the tablets run out before going to the doctor.

If you take more Amlodipine Accord than you should

If you take too many tablets, your blood pressure may be low or even dangerously low. You may feel dizzy, unsteady, faint, or weak. If the blood pressure drops low enough, you can experience shock. The skin then feels cold and moist and you can become unconscious. Seek immediate care if you have taken too much Amlodipine Accord.

If you forget to take Amlodipine ACcord

Do not worry. If you forget to take a tablet, just ignore that dose. Take the next dose at the right time. Do not take a double dose to make up for a forgotten dose .

If you stop taking Amlodipine Accord

Your doctor will tell you how long to take this medicine. Your illness may return if you stop taking this medicine earlier.

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.

See your doctor immediately if you get any of the following 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 very common side effects are reported. If any of these cause you problems or if they last for more than a weekconsult your doctor.

Very common (may affect more than 1 user in 10):

  • edema (swelling due to fluid)

The following common side effects are reported. If any of these cause you problems or if they last for more than a weekconsult your doctor.

Common (may affect up to 1 in 10 people):

  • headache, dizziness, drowsiness (especially at the beginning of treatment)
  • palpitations (you feel the heartbeat), hot flashes
  • abdominal pain, nausea
  • altered bowel habits, diarrhea, constipation, digestive problems
  • fatigue, weakness
  • visual disturbances, double vision
  • muscle cramps
  • swollen ankles

Other side effects reported are listed below. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Uncommon (may affect up to 1 in 100 people):

  • mood swings, anxiety, depression, insomnia
  • tremors, taste change, fainting
  • numbness or tingling in the arms and legs, inability to feel pain
  • earrings
  • low blood pressure
  • sneezing / runny nose due to inflammation of the nasal mucosa ( rhinitis )
  • cough
  • dry mouth, vomiting
  • hair loss, increased sweating, itchy skin, red spots on the skin, skin discoloration
  • urination problems, increased need to urinate at night, increased urination frequency
  • impotence, discomfort from or enlarged breasts in men
  • pain, feeling sick
  • joint or muscle pain, back pain
  • 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
  • elevated blood sugar (hyperglycemia)
  • a nerve disorder that can cause muscular weakness, tingling, or numbness
  • 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 a rash
  • photosensitivity
  • diseases that combine rigidity, tremor, and/or movement disorders

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 Accord

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 .:/EXP”

The expiration date is the last day of the specified month.

No special storage instructions.

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

Amlodipine accord 5 mg tablets: 

The active substance is amlodipine. Each tablet contains 5 mg of amlodipine (as belated).

The other ingredients are microcrystalline cellulose, sodium starch glycolate, magnesium stearate, disodium hydrogen citrate, crospovidone, croscarmellose sodium.

Amlodipine accord 10 mg tablets :

The active substance is amlodipine. Each tablet contains 10 mg of amlodipine (as besylate).

The other ingredients are microcrystalline cellulose, sodium starch glycolate, magnesium stearate, disodium hydrogen citrate, crospovidone, croscarmellose sodium.

What the medicine looks like and the contents of the pack

Amlodipine accord 5 mg tablets :

White, about 6.6 mm round, biconvex tablets.

Amlodipine accord 10 mg tablets :

White, about 8.5 mm round, biconvex tablets

Pack sizes

Blister:

5 mg: 10, 14, 20, 28, 30, 50, 60, 90, 98 and 100 tablets

10 mg: 10, 14, 20, 28, 30, 50, 60, 90, 98 and 100 tablets

Plastic jar:

250, 500, and 1000 tablets (only for hospital or dose dispensing)

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Accord Healthcare BV

Winthontlaan 200

3526 kV Utrecht

Netherlands

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

Muhammad Nadeem

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