Package Leaflet: Information for the User

Amlodipino Aurovitas 5 mg Tablets EFG

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isAmlodipino Aurovitasand what it is used for

2. What you need to know before you start takingAmlodipino Aurovitas

3. How to takeAmlodipino Aurovitas

4. Possible side effects

5. Storage ofAmlodipino Aurovitas

6. Contents of the pack and additional information

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

Amlodipino Aurovitas 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, amlodipine 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 Aurovitas

• If you are allergic (hypersensitive) to amlodipine or any of the other components of this medication (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 amlodipine.

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

Amlodipine has not been studied in children under 6 years of age. Amlodipine should only be used to treat high blood pressure in children and adolescents aged 6 to 17 years (see section 3). For more information, consult your doctor.

Other medications and Amlodipino Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

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

• Ketoconazole, itraconazole (antifungal medications).
• Ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat AIDS).
• Rifampicin, erythromycin, clarithromycin (for bacterial infections or antibiotics).
• Hypericum perforatum(St. John's Wort).
• Verapamil, diltiazem (heart medications).
• Dantrolene (intravenous for severe body temperature abnormalities).
• Tacrolimus, sirolimus, temsirolimus, and everolimus (medications used to modify the functioning of the immune system).
• Simvastatin (cholesterol-lowering medication).
• Ciclosporin (immunosuppressant).

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

Taking Amlodipino Aurovitas with food and drinks

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

Pregnancy and breastfeeding

Pregnancy

The safety of amlodipine during pregnancy has not been established. If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Breastfeeding

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

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

Amlodipine 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.

Amlodipino Aurovitas contains sodium

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

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

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

You can take this medication before or after meals. It should be taken at the same time every day, with a glass of water. Do not take amlodipino 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. Currently, amlodipino 2.5 mg is not available and the 2.5 mg dose cannot be obtained with Amlodipino Aurovitas 5 mg tablets as 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 Aurovitas than you should

Consuming too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, disoriented, faint, or weak. If the drop in blood pressure is severe enough, it can cause shock. You may feel your skin is cold and clammy and could lose consciousness.

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

In case of overdose or accidental ingestion, consult your doctor immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Amlodipino Aurovitas

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 compensate for the missed doses.

If you interrupt treatment with Amlodipino Aurovitas

Your doctor will indicate for how long you should be taking 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 the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Go to your doctorimmediatelyif you experience any of the following side effects 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, severe itching, blister formation, peeling, and skin inflammation, Stevens-Johnson syndrome, toxic epidermal necrolysis, or other allergic reactions.
• Heart attack, abnormal heart rhythm.
• Pancreatitis that can cause severe abdominal pain and back pain accompanied by great discomfort.

The following side effect has been reported as very frequent. If this causes problems or lasts more than a week, consult your doctor.

Very frequent: may affect more than 1 in 10 people

• Edema (fluid retention).

The followingside effects have been reported as frequent. If any of these cause problems orlast more than a week, consult your doctor.

Frequent: may 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 of discomfort (nausea).
• Alteration of bowel habit, diarrhea, constipation, indigestion.
• Fatigue, weakness.
• Visual disturbances, double vision.
• Muscle cramps.
• Swelling of the ankles

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

Frequent: may affect up to 1 in 100 people

• Changes in mood, anxiety, depression, insomnia.
• Tremor, alterations in taste, fainting.
• Numbness or tingling sensation in the extremities, loss of pain sensation.
• Ringing in the ears.
• Decreased blood pressure.
• Runny nose/ nasal secretion caused by inflammation of the nasal mucosa (rhinitis).
• Cough.
• Dry mouth, vomiting (discomfort).
• Hair loss, increased sweating, itching skin, red spots on the skin, skin discoloration.
• Urinary disorders, increased need to urinate at night, increased frequency of urination.
• Impotence, discomfort or breast enlargement in men.
• Pain, feeling of discomfort.
• 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

• Decreased white blood cell count, decreased platelet count that may cause easy bleeding or unusual bruising.
• High blood sugar (hyperglycemia).
• A disorder of the nerves that may cause muscle weakness, numbness, or tingling.
• Gingivitis.
• Abdominal swelling (gastritis).
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that may affect some medical tests.
• Increased muscle tension.
• Inflammation of blood vessels, often with skin eruptions.
• Sensitivity to light.
• Movements combining stiffness, tremor, and/or movement disorders.

Frequency not known (cannot be estimated from available data):tremor, postural rigidity, face with a mask-like appearance, slow movements, and walking slowly and unsteadily.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the 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.

This medication does not require special storage conditions.

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.

Medications should not be disposed of through drains or in the trash. Dispose of 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. By doing so, you will help protect the environment.

Composition of Amlodipino Aurovitas

• The active ingredient is amlodipine, as besilate of amlodipine.
• The other components are: microcrystalline cellulose, calcium hydrogen phosphate, carboxymethylstarch sodium (type A) (derived from potato starch) and magnesium stearate.

Appearance of the product and contents of the packaging

White to off-white, flat, beveled-edge, cylindrical tablets, marked with the letter “C” on one face and “58” on the other. The size is 7.9 mm x 5.6 mm.

Amlodipino Aurovitas 5 mg tablets EFG are available in PVC/PVdC-Aluminium blisters.

Packaging sizes:

Blister packs: 20, 28, 30, 56, 60, 98 and 100 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of the European Economic Area under the following names:

Belgium:Amlodipin AB 5 mg tablets

Spain:Amlodipino Aurovitas 5 mg tablets EFG

Poland:ApoAmlo

Portugal:Amlodipina Aurovitas

Czech Republic:Amlodipin Aurovitas 5 mg tablets

Last review date of this leaflet:January 2023

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