AMLODIPINE ARISTO 10 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Contents of the pack and other information:

1. What Amlodipine ARISTO is and what it is used for
2. What you need to know before you take Amlodipine ARISTO
3. How to take Amlodipine ARISTO
4. Possible side effects
5. Storage of Amlodipine ARISTO
6. Contents of the pack and further information

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

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

Amlodipine ARISTO is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, including a rare form 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 ARISTO improves blood supply to the heart muscle, which receives more oxygen and as a result, chest pain 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 ARISTO

Do not take Amlodipine ARISTO

• If you are allergic to amlodipine or any other ingredients of this medicine (listed in section 6), or to other calcium antagonists. This may cause itching, skin redness, 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.

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 an elderly person and your dose needs to be increased

Children and adolescents

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

For more information, consult your doctor.

Using Amlodipine ARISTO with other medicines

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

Amlodipine ARISTO 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)

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

Taking Amlodipine ARISTO with food and drinks

People taking Amlodipine ARISTO 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 ARISTO.

Pregnancy and breastfeeding

Pregnancy

The safety of amlodipine during pregnancy has not been established. If you think you may be pregnant or are planning to become pregnant, you should inform your doctor before taking Amlodipine ARISTO.

Breastfeeding

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

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Amlodipine ARISTO 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.

3. How to take Amlodipine ARISTO

Follow exactly

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

The initial normal dose is 5 mg of Amlodipine Aristo, once a day. The dose can be increased to 10 mg of Amlodipine Aristo, once a day.

You can take your medicine before or after meals. You should take it at the same time each day, with a glass of water. Do not take Amlodipine Aristo with grapefruit juice.

Use in children and adolescents

For children and adolescents (between 6-17 years of age), the recommended initial dose is usually 2.5 mg per day. The maximum recommended dose is 5 mg per day.

Amlodipine 2.5 mg is not currently available and a dose of 2.5 mg cannot be obtained with Amlodipine Aristo 5 mg tablets, as these tablets are not designed to 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 Aristo 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. You may feel your skin cold and sweaty, and you could lose consciousness.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing, which can develop up to 24-48 hours after ingestion.

If you take too many Amlodipine ARISTO tablets, consult your doctor immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Amlodipine Aristo

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 the forgotten dose.

If you stop taking Amlodipine Aristo

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 other questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Amlodipine ARISTO can cause side effects, although not everybody gets them.

Go to your doctor immediatelyif you experience any of the following serious side effects, which are very rare when 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, skin redness all over the body, 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 great feeling of discomfort

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

Common:may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the beginning of treatment)

• Palpitations (feeling the heartbeat), flushing
• Abdominal pain, feeling unwell (nausea)
• Swelling of the ankles (edema), tiredness

Other side effects have been reported, which are included in the following list. If you think you are experiencing any side effect, even if it is not mentioned in this leaflet, inform your doctor or pharmacist.

Uncommon:may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia
• Tremors, taste disturbances, fainting, weakness
• Numbness or tingling in the limbs, loss of pain sensation
• Visual disturbances, double vision, ringing in the ears
• Decrease in blood pressure
• Sneezing/nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• Alteration of bowel habits, diarrhea, constipation, indigestion, dry mouth, vomiting (discomfort)
• 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 enlargement of the breasts in men
• Weakness, pain, feeling unwell
• Muscle or joint pain, muscle cramps, 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 white blood cell count, decrease in blood platelets, which can cause easy bleeding or unusual bruising (red blood cell damage)
• High blood sugar (hyperglycemia)
• A disorder of the nerves that can cause weakness, tingling, or numbness
• Cough, gum inflammation
• 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 tension
• Inflammation of blood vessels, often with skin rashes
• Sensitivity to light
• Disorders combining stiffness, tremors, and/or movement disorders

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not mentioned in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine ARISTO

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 shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, 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 ARISTO

The active substance of Amlodipine ARISTO 10 mg tablets is amlodipine (as besylate).

The other ingredients are microcrystalline cellulose, calcium hydrogen phosphate, sodium starch glycolate (potato starch), and magnesium stearate.

Appearance of Amlodipine ARISTO and contents of the pack

White, round, and scored tablets. The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Amlodipine ARISTO 10 mg tablets are available in blister packs containing 30 and 500 (clinical pack) tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer

Adamed Pharma S.A.

Ul. Marszalka J.Pilsudskiego, 5 (Pabianice)

95-200, Poland

Or

Laboratorio de Medicamentos Internacionales S.A. (MEDINSA)

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Date of last revision of this leaflet: June 2022

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