AMLODIPINE ACCORD 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Amlodipine Accord 10 mg Tablets EFG

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Amlodipine Accord and what is it used for
2. What you need to know before you take Amlodipine Accord
3. How to take Amlodipine Accord
4. Possible side effects
5. Storage of Amlodipine Accord

Contents of the pack and other information

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

Amlodipine Accord contains the active substance amlodipine which belongs to a group of medicines known as calcium antagonists.

Amlodipine Accord is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, which includes a rare type called Prinzmetal's or variant angina.

In patients with high blood pressure, this medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina, Amlodipine Accord improves blood supply to the heart muscle, which receives more oxygen and as a result, the pain in the chest is prevented. This medicine does not provide immediate relief of chest pain due to angina.

2. What you need to know before you take Amlodipine Accord

Do not take Amlodipine Accord

• If you are allergic (hypersensitive) to amlodipine or any of the other ingredients of this medicine (listed in section 6), or to any other calcium antagonist. This may cause 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 disease in which the heart is unable to pump enough blood to the body).
• If you have heart failure after a heart attack.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amlodipine Accord. You should inform your doctor if you have or have had any of the following diseases:

• Recent heart attack
• Heart failure
• Severe increase in blood pressure (hypertensive crisis)
• Liver disease
• You are elderly and your dose needs to be increased

Children and adolescents

Amlodipine Accord has not been studied in children under 6 years old. Amlodipine Accord should only be used to treat high blood pressure in children and adolescents from 6 to 17 years old (see section 3).

For more information, consult your doctor.

Other medicines and Amlodipine Accord

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

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

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat AIDS)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum(St. John's Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (in perfusion for severe body temperature abnormalities)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the functioning of the immune system)
• simvastatin (a medicine that lowers cholesterol)
• cyclosporin (immunosuppressant)

If you are already taking other medicines to treat high blood pressure, Amlodipine Accord may further lower your blood pressure.

Amlodipine Accord with food and drinks

People taking Amlodipine Accord should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in blood levels of the active ingredient amlodipine, which can cause 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 might be pregnant or are planning to become pregnant, inform your doctor before taking Amlodipine Accord.

Breastfeeding

Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding or about to start breastfeeding, inform your doctor before taking Amlodipine Accord.

Consult your doctor or pharmacist before starting to take any medicine.

Driving and using machines

Amlodipine Accord may affect your ability to drive or use machines. If the tablets make you feel sick, dizzy, or tired, or cause you headaches, do not drive or use machinery and consult your doctor immediately.

Amlodipine Accord contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Amlodipine Accord

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended initial dose is 5 mg once daily. The dose can be increased to 10 mg once daily.

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

Use in children and adolescents

For children and adolescents (between 6-17 years old), the recommended initial dose is usually 2.5 mg daily. The maximum recommended dose is 5 mg daily. Amlodipine 2.5 mg is not available and the dose of 2.5 mg cannot be obtained with Amlodipine Accord 5 mg since the tablets cannot be divided into equal parts.

It is important not to interrupt the administration of the tablets. Do not wait until the tablets are finished to go to your doctor.

If you take more Amlodipine Accord than you should

Taking too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, faint, suffer from dizziness when standing up, or weakness. If the drop in blood pressure is severe, it can cause shock. Excess fluid can accumulate in the lungs (pulmonary edema) causing difficulty breathing that can develop up to 24-48 hours after ingestion. You may feel your skin cold and wet and you could lose consciousness. If you take too many Amlodipine Accord tablets, consult your doctor immediately or call the Toxicology Information Service, telephone 91 562 04 20.

If you forget to take Amlodipine Accord

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

If you stop taking Amlodipine Accord

Your doctor will tell you for how long you should take this medicine. Your illness may come back if you stop taking this medicine before your doctor tells you to.

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

4. Possible side effects

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

Go to your doctor immediatelyif you experience 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 causes great difficulty breathing
• Severe skin reactions that include intense skin rash, hives, redness of the skin all over the body, severe 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 that can cause severe abdominal pain and back pain accompanied by a great feeling of discomfort

The following very common side effecthas been reported. If this causes problems or if it lasts for more than one week, consult your doctor.

Very common: may affect more than 1 in 10 people

• Edema (fluid retention)

The following common side effectshave been reported. If any of these cause problems or if they last for more than one week, consult your doctor.

Common: may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the start of treatment)
• Palpitations (feeling your heartbeat), flushing
• Abdominal pain, feeling sick (nausea)
• Change in bowel habit, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

Other side effects have been reported that are included in the following list. If you think any of the side effects you are suffering from is serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Uncommon: may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia
• Trembling, taste disturbances, fainting
• Numbness or tingling in the limbs, loss of pain sensation
• Ringing in the ears
• Decrease in blood pressure
• Sneezing/nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting (nausea)
• Hair loss, increased sweating, itching, red spots on the skin, skin discoloration
• Urination disorder, increased need to urinate at night, increased number of times urinating
• Impotence, discomfort or enlargement of the breasts in men
• Pain, feeling unwell
• Pain in the muscles or joints, back pain
• Weight gain or loss

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

• Confusion

Very rare: may affect up to 1 in 10,000 people

• Decrease in the number of white blood cells, decrease in blood platelets that can cause easy bleeding or unusual bruising Excess sugar in the blood (hyperglycemia)
• A disorder of the nerves that can cause muscle weakness, tingling, or numbness
• Inflammation of the gums
• Abdominal swelling (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increase in liver enzymes that can have an effect on some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin rashes
• Sensitivity to light
• Disorders combining stiffness, trembling, and/or movement disorders

Not known: cannot be estimated from the available data

• Tremors, stiffness, mask-like face, slow and unsteady walking

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website (http://www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 packaging after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amlodipine Accord

• The active substance is amlodipine. Each tablet contains 10 mg of amlodipine (as amlodipine besylate)
• The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose (type A), magnesium stearate, disodium hydrogen citrate, crospovidone, sodium croscarmellose.

Appearance of the product and packaging

White to off-white tablets, approximately 8.5 mm in diameter, biconvex.

Pack sizes:

Blister packs:

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.

HDPE bottle:

250, 500, and 1,000 tablets (for hospital use or dispenser only).

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Accord Healthcare, S.L.U.

World Trade Center,

Moll de Barcelona, s/n,

Edifici Est, 6ª planta,

08039 Barcelona

Spain

Manufacturer

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Accord Healthcare Polska Sp.z o.o.

ul. Lutomierska 50

95-200 Pabianice

Poland

Accord Healthcare Single Member S.A.,

64th Km National Road Athens Lamia,

Schimatari, 32009, Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:July 2022.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/).