AMLODIPINE AUROVITAS 10 mg TABLETS

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 other calcium antagonists. 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 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 old. Amlodipine should only be used to treat high blood pressure in children and adolescents from 6 to 17 years old (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 are planning to have a baby, ask your doctor for advice before taking 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 give you a headache, 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 given 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 old), the recommended initial dose is usually 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 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 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 that 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 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 further questions on 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 that causes 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 that 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, somnolence (especially at the start 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 that 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.
• Tremor, taste disturbances, fainting.
• Numbness or tingling in the limbs, loss of pain sensation.
• Ringing in the ears.
• Decrease in blood pressure.
• Runny nose/sneezing caused by inflammation of the nasal mucosa (rhinitis).
• Cough.
• Dry mouth, vomiting (nausea).
• Hair loss, increased sweating, itching of the skin, red spots on the skin, skin discoloration.
• Urination disorders, increased need to urinate at night, increased number of times urinating.
• Impotence, discomfort or breast enlargement in men.
• Pain, feeling unwell.
• Pain in the muscles or joints, back pain.
• Weight gain or weight 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 that 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), increase in liver enzymes that can affect some medical tests.
• Increased muscle tension.
• Inflammation of blood vessels, often with skin rashes.
• Sensitivity to light.
• Disorders combining stiffness, tremor, and/or movement disorders.

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist or nurse, 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 any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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, round tablets (diameter of 9.5 mm), marked with the letter “C” on one face and “59” on the other.

Amlodipine Aurovitas 10 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 10 mg tablets

Spain: Amlodipino Aurovitas 10 mg tablets EFG

Poland: ApoAmlo

Portugal: Amlodipina Aurovitas

Czech Republic: Amlodipin Aurovitas 10 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)