AMLODIPINE ACCORD 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Amlodipine Accord 5 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 further 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 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 reduces the frequency and severity of angina attacks, thereby increasing exercise tolerance. This medicine does not provide immediate relief of angina attacks.

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 condition where 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 taking Amlodipine Accord. You should inform your doctor if you have or have had any of the following conditions:

• 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 infusion for severe body temperature abnormalities)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the immune system)
• simvastatin (a medicine that lowers cholesterol)
• cyclosporin (immunosuppressant)

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

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 cause an increase in the levels of the active ingredient amlodipine in the blood, 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 taking 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 machines 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 instructions of administration of this medicine indicated 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. You should take it 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 (from 6 to 17 years old), the recommended initial dose is 2.5 mg daily. The maximum recommended dose is 5 mg daily. Amlodipine 2.5 mg is not available, and the 2.5 mg dose cannot be obtained with Amlodipine Accord 5 mg, as 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 before going 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, or weak, or experience dizziness when standing up. If the drop in blood pressure is severe, it can cause shock. Excess fluid can accumulate in the lungs (pulmonary edema) causing difficulty breathing, which can develop up to 24-48 hours after ingestion. You may feel your skin cold and clammy, 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 condition may come back if you stop taking this medicine before your doctor tells you to.

If you have any other questions about 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, causing great difficulty breathing
• Severe skin reactions, including 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, which can cause severe abdominal pain and back pain, accompanied by a feeling of being very unwell

The following very common side effecthas been reported. If this causes problems or if it lasts for more than a 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 a 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)
• Changes in bowel habits, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

Other side effects have been reported, which are listed below. If you think you are experiencing any of these side effects, or if you experience any side effect 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, changes in taste, fainting
• Numbness or tingling in the limbs, loss of pain sensation
• Ringing in the ears
• Low 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 disorders, increased need to urinate at night, increased frequency of urination
• Impotence, discomfort or breast enlargement 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, which can cause easy bruising or bleeding, high blood sugar (hyperglycemia)
• A disorder of the nerves, which can cause muscle weakness, tingling, or numbness
• Gingivitis
• Abdominal swelling (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes, which can affect some medical tests
• Increased muscle tone
• Inflammation of the 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 movements, and unsteady gait

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that the side effects are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at 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 further information

Composition of Amlodipine Accord

• The active substance is amlodipine. Each tablet contains 5 mg of amlodipine (as amlodipine besylate)
• The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose (type A), magnesium stearate, disodium hydrogen citrate, crospovidone, croscarmellose sodium.

Appearance of the product and packaging

White to off-white tablets, approximately 6.6 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 use 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/).