AMLODIPINE AUROVITAS 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

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

Contents of the Package Leaflet

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

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

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

Amlodipine Aurovitas is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, which includes a rare type 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 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 Aurovitas

Do not take Amlodipine Aurovitas

• 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 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 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 elderly 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 from 6 to 17 years of age (see section 3). For more information, consult your doctor.

Other medicines and Amlodipine Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Amlodipine Aurovitas 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 (for bacterial infections or 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 functioning of the immune system).
• Simvastatin (a medicine that reduces cholesterol).
• Ciclosporin (immunosuppressant).

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

Taking Amlodipine Aurovitas with food and drinks

People taking amlodipine 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.

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 plan to become pregnant, consult your doctor before using this medicine.

Breastfeeding

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

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Amlodipine 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.

Amlodipine Aurovitas contains sodium

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

3. How to take Amlodipine Aurovitas

Follow exactly the administration instructions 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 of amlodipine, once a day. The dose can be increased to 10 mg of amlodipine, once a day.

You can take this medicine before or after meals. It should be taken at the same time each day, with a glass of water. Do not take amlodipine with grapefruit juice.

Use in children and adolescents

For children and adolescents (between 6-17 years of age), the recommended initial dose is normally 2.5 mg per day. The maximum recommended dose is 5 mg per day. Currently, amlodipine 2.5 mg is not available, and a dose of 2.5 mg cannot be obtained with Amlodipine Aurovitas 5 mg tablets, as these tablets are not manufactured 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 Aurovitas 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. If the drop in blood pressure is severe, it can cause shock. You may feel your skin cold and wet, 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.

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

If you forget to take Amlodipine 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 make up for forgotten doses.

If you stop taking Amlodipine Aurovitas

Your doctor will indicate how long you should be taking this medicine. Your disease may recur 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 great feeling of discomfort.

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

Very common: may affect more than 1 in 10 people

• Edema (fluid retention).

The following side effects have been reported frequently.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).
• Change in bowel habit, diarrhea, constipation, indigestion.
• Fatigue, weakness.
• Visual disturbances, double vision.
• Muscle cramps.
• Swelling of the ankles.

Other side effects have been reported, which are included in the following list. If you think any of the side effects you are suffering from is serious, or if you notice any side effects 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.
• Numbness or tingling in the limbs, loss of pain sensation.
• Ringing in the ears.
• Decrease in 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 disorder, increased need to urinate at night, increased number of times urinating.
• Impotence, discomfort or breast enlargement in men.
• Pain, feeling unwell.
• Muscle or joint pain, 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 bleeding or unusual bruising.
• High blood sugar (hyperglycemia).
• A disorder of the nerves that 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 tension.
• Inflammation of blood vessels, often with skin rashes.
• Sensitivity to light.
• Disorders combining stiffness, tremors, and/or movement disorders.

Frequency not known (cannot be estimated from available data):tremors, postural rigidity, mask-like face, slow and unsteady gait.

Reporting of side effects

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

5. Storage of Amlodipine Aurovitas

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, 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 other information

Composition of Amlodipine Aurovitas

• The active substance is amlodipine, as amlodipine besylate.
• The other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate, sodium carboxymethylcellulose (type A) (derived from potato starch), and magnesium stearate.

Appearance of the product and contents of the pack

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.

Amlodipine Aurovitas 5 mg tablets EFG are available in PVC/PVdC-Aluminum blisters.

Pack sizes:

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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: Amlodipine Aurovitas 5 mg tablets EFG

Poland: ApoAmlo

Portugal: Amlodipina Aurovitas

Czech Republic: Amlodipin Aurovitas 5 mg tablets

Date of last revision of this leaflet:January 2023

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