PROSPECTO : INFORMATION FOR THE USER

Amlodipino ARISTO 5 mg tablets EFG

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

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• Keep this prospectus, as you may need to read it again.

• If you have any doubts, consult your doctor or pharmacist.

• This medicine has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

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

2. What you need to know before starting to take Amlodipino ARISTO

3. How to take Amlodipino ARISTO

4. Possible adverse effects

5. Storage of Amlodipino ARISTO

6. Contents of the package and additional information

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

Amlodipino ARISTO is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, which includes a less common type known as Prinzmetal's angina or variant angina.

In patients with high blood pressure, this medicine works by relaxing blood vessels, allowing blood to flow through them more easily. In patients with angina, Amlodipino ARISTO improves blood flow to the heart muscle, which receives more oxygen as a result, and as a consequence, chest pain is prevented. This medicine does not provide immediate relief from chest pain due to angina.

Do not take Amlodipino ARISTO

• If you are allergic to amlodipino, or any of the other components of this medication (including those listed in section 6), or to any other calcium antagonist. 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) in your heart or cardiogenic shock (a disease in which the heart is unable to pump enough blood to the body).

• If you suffer from heart failure after a heart attack.

Warnings and precautions

Consult your doctor or pharmacist before starting to take amlodipino.

You must 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

Amlodipino ARISTO has not been studied in children under 6 years of age. Amlodipino 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.

Use of Amlodipino ARISTO with other medications

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

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

• ketoconazol, itraconazol (antifungal medications)

• ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat AIDS)

• rifampicina, eritromicina, claritromicina (antibiotics)

•Hypericum perforatum(St. John's Wort)

• verapamilo, diltiazem (heart medications)

• dantroleno (in infusion for severe body temperature abnormalities)

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

Taking Amlodipino ARISTO with food and drinks

People taking Amlodipino ARISTO should not consume grapefruit, or grapefruit juice. This is because grapefruit and grapefruit juice may lead to an increase in the levels of the active ingredient amlodipino in the blood, which may cause an unpredictable increase in the effect of lowering blood pressure of Amlodipino ARISTO.

Pregnancy and breastfeeding

Pregnancy

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

Breastfeeding

Amlodipino has been shown to pass into breast milk in small amounts. If you are breastfeeding, or are about to do so, you must inform your doctor before taking Amlodipino ARISTO.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

Amlodipino ARISTO may affect your ability to drive or operate machinery. If the tablets make you feel sick, dizzy, or tired, or give you a headache, do not drive or operate machinery and consult your doctor immediately.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubts,consult your doctor or pharmacist again.

The recommended dose is 5 mg of Amlodipino Aristo, once a day. The dose can be increased to 10 mg of Amlodipino Aristo, once a day.

You can take your medication before or after meals. It should be taken at the same time every day, with a glass of water. Do not take Amlodipino 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 5mg per day.

Amlodipino 2.5 mg is currently not available and the 2.5 mg dose cannot be obtained with Amlodipino Aristo 5 mg tablets since these tablets are not manufactured to be divided into equal parts.

It is essential not to interrupt the administration of the tablets. Do not wait for the tablets to run out before consulting your doctor.

If you take more Amlodipino Aristothan you should

Consuming too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feeldizzy,dazed,experience postural dizziness when standing up or weakness.If the dropin blood pressureissevereenough, it can cause shock. You may feel your skincold andwetand couldloseconsciousness.

Excess fluid can accumulate in the lungs (pulmonary edema) causing breathing difficulties that can develop up to 24-48 hours after consumption.

If you take too many tablets ofAmlodipino Aristo,consult your doctor immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forgot to take AmlodipinoAristo

Do not worry. If you forgot to take a tablet, do not take that dose. Take the next doseat the correct time. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with AmlodipinoAristo

Your doctor will indicate for how long you should take this medication. Your condition may reappear if you stop taking this medication before your doctor tells you to.

If you have any other doubts about the use of this medication, consult your doctor or pharmacist.

Like all medicines, Amlodipino ARISTO can cause side effects, although not everyone will experience them.

Go to your doctorimmediatelyif you experience any of the following serious side effects, which are very rare after taking this medicine.

• Sudden hissing sounds when breathing (sudden sibilance), 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, blisters, skin redness all over the body, itching, blister formation, peeling, and skin inflammation, mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions

• Heart attack, abnormal heart rhythm

• Pancreatitis inflammation that can cause severe abdominal pain and back pain accompanied by great discomfort

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

Common:can affect up to 1 in 10 people

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

• Palpitations (feeling the heartbeat), shortness of breath

• Abdominal pain, feeling unwell (nausea)

• Swelling of the ankles (edema), fatigue

The following side effects have been reported. If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Uncommon:can affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia

• Tremors, taste alterations, fainting, weakness

• Numbness or tingling in the extremities, loss of pain sensation

• Visual disturbances, double vision, ringing in the ears

• Decreased blood pressure

• Runny nose/ nasal secretion caused by nasal mucosa inflammation (rhinitis)

• Alteration of bowel habit, diarrhea, constipation, indigestion, dry mouth, vomiting (discomfort)

• Hair loss, increased sweating, skin itching, red spots on the skin, skin discoloration

• Urinary disorders, increased need to urinate at night, increased frequency of urination

• Impotence, discomfort or breast tenderness in men

• Weakness, pain, feeling unwell

• Muscle or joint pain, muscle cramps, back pain

• Weight gain or loss

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

• Confusion

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

• Decreased white blood cell count, decreased platelet count that can cause easy bleeding or unusual bruising (damage to red blood cells)

• 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), yellow skin discoloration (jaundice), increased liver enzymes that can affect some medical tests

• Muscle tension increase

• Blood vessel inflammation, often with skin eruptions

• Light sensitivity

• Movement disorders combining stiffness, tremors, and/or movement disorders

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children

Do not use this medication after the expiration date that appears 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 drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.This will help protect the environment..

Composition of Amlodipino ARISTO

The active ingredient of Amlodipino ARISTO 5 mg tablets is amlodipine (as besilate).

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

Appearance of Amlodipino ARISTO and content of the packaging

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

Amlodipino ARISTO 5 mg tablets are available in blister packs containing 30 and 500 (clinical pack) tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Responsible for manufacturing

Adamed Pharma S.A.Ul.Marszalka J.Pilsudskiego,5 (Pabianice)

95-200-Poland

O

Laboratory of International Medicines S.A. (MEDINSA)

c/ Solana, 26

28850, Torrejón de Ardoz

Madrid - Spain

Last review date of this leaflet June 2022

The detailed and updated informationon this medication is available on theWebpageoftheSpanish Agency of Medicines and Medical Devices(AEMPS)http://www.aemps.gob.es/