AMLODIPINE ARISTO 5 mg TABLETS

2. What you need to know before taking Amlodipine ARISTO

Do not take Amlodipine ARISTO

• If you are allergic to amlodipine or any other component of this medication (listed in section 6), or to any other calcium channel blocker. This can cause itching, skin redness, or difficulty breathing.
• If you have very low blood pressure (hypotension).
• If you have a narrowing of the aortic valve in your heart (aortic stenosis) or cardiogenic shock (a condition 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 conditions:

• Recent heart attack
• Heart failure
• Severe high blood pressure (hypertensive crisis)
• Liver disease
• You are elderly 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 between 6 and 17 years of age. (See section 3).

For more information, consult your doctor.

Using Amlodipine ARISTO with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Amlodipine ARISTO may affect or be affected by other medications, such as:

• ketoconazole, itraconazole (antifungal medications)
• ritonavir, indinavir, nelfinavir (also known as protease inhibitors used to treat AIDS)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum (St. John's Wort)
• verapamil, diltiazem (heart medications)
• dantrolene (in infusion for severe body temperature abnormalities)

If you are already taking other medications for 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 medication.

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 your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

The recommended 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 medication before or after meals. You should take it at the same time every 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 initial recommended 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 essential not to interrupt the administration of the tablets. Do not wait until the tablets are finished before consulting 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, experience dizziness when standing up, or weakness. If the drop in blood pressure is severe, it can lead to shock. You may feel your skin is cold and sweaty, and you could lose consciousness.

Excess fluid can 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 medication 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 missed dose.

If you stop taking Amlodipine Aristo

Your doctor will tell you how long you need to take this medication. Your condition may recur if you stop taking this medication before your doctor tells you to.

If you have any other questions about taking this medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medications, Amlodipine ARISTO can cause side effects, although not everyone will experience them.

Consult your doctor immediatelyif you experience any of the following serious side effects, which are very rare when taking this medication.

• 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 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 heartbeats), flushing
• Abdominal pain, feeling unwell (nausea)
• Swelling of the ankles (edema), fatigue

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
• Low blood pressure
• Sneezing/nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• Changes in bowel habits, diarrhea, constipation, indigestion, 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
• 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

• Decreased white blood cell count, decreased platelet count, which can cause easy bruising or unusual bleeding (red blood cell damage)
• High blood sugar (hyperglycemia)
• A nerve disorder 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
• Vasculitis, often with skin rashes
• Sensitivity to light
• Disorders combining stiffness, tremors, and/or movement disorders

Reporting side effects

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

5. Storage of Amlodipine ARISTO

Keep this medication out of the sight and reach of children

Do not use this medication after the expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Amlodipine ARISTO

The active ingredient in Amlodipine ARISTO 5 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 package contents

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

Amlodipine ARISTO 5 mg tablets are available in blister packs containing 30 and 500 (clinical packaging) 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 the last revision of this leaflet: June 2022

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