Amlodipine Aurovitas 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amlodipine Aurovitas 10 mg tablets EFG

Read the entire 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Amlodipine Aurovitas is and what it is 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, including a less common type known as Prinzmetal's angina or variant angina.

In patients with high blood pressure, this medicine works by relaxing the blood vessels, allowing blood to pass through them more easily. In patients with angina, amlodipine improves blood flow to the heart muscle, thereby increasing oxygen supply and preventing chest pain. This medicine does not provide immediate relief of chest pain caused by angina.

2. What you need to know before taking Amlodipine Aurovitas

Do not take Amlodipine Aurovitas

• If you are allergic (hypersensitive) to amlodipine or to any of the other ingredients of this medicine (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 heart valve (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 following a heart attack.

Warnings and precautions

Talk to your doctor or pharmacist before starting amlodipine.

You should inform your doctor if you have or have had any of the following conditions:

• Recent heart attack.
• Heart failure.
• Severe increase in blood pressure (hypertensive crisis).
• Liver disease.
• You are elderly and your dose may need 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 further information, consult your doctor.

Other medicines and Amlodipine Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 known as protease inhibitors used to treat AIDS).
• Rifampicin, erythromycin, clarithromycin (used for bacterial infections or antibiotics).
• Hypericum perforatum (St. John's wort).
• Verapamil, diltiazem (medicines for the heart).
• Dantrolene (intravenous infusion for serious disturbances in body temperature).
• Tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the function of the immune system).
• Simvastatin (a medicine that lowers cholesterol).
• Cyclosporine (an 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 may increase blood levels of the active ingredient amlodipine, which could lead to 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 become pregnant, consult your doctor before using this medicine.

Breastfeeding

It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or planning to breastfeed, you should 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 operate machinery. If the tablets make you feel unwell, dizzy, tired, or cause you to have 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 (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Amlodipine Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended starting dose is 5 mg of amlodipine once daily. The dose may be increased to 10 mg of amlodipine once daily.

You may take this medicine before or after food. Take it 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 usual recommended starting dose is 2.5 mg once daily. The recommended maximum dose is 5 mg daily. Currently, amlodipine 2.5 mg is not available, and the 2.5 mg dose cannot be achieved with Amlodipine Aurovitas 5 mg tablets, as these tablets are not manufactured to be divided into equal parts.

It is important not to interrupt treatment with the tablets. Do not wait until you run out of tablets before seeing your doctor.

If you take more Amlodipine Aurovitas than you should

Taking too many tablets may cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, lightheaded, faint, or weak. If the drop in blood pressure is severe enough, shock may occur. You may feel your skin cold and moist and you could lose consciousness.

Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop within 24–48 hours after ingestion.

In case of overdose or accidental ingestion, contact your doctor immediately or call the Toxicology Information Service at telephone: 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, skip that dose. Take the next dose at the regular scheduled time. Do not take a double dose to make up for forgotten doses.

If you stop taking Amlodipine Aurovitas

Your doctor will advise you on how long you should continue taking this medicine. Your condition may return if you stop taking this medicine before your doctor tells you to do so.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if you experience any of the following adverse 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 severe difficulty in breathing.
• Severe skin reactions including severe rash, hives, redness of the skin all over the body, severe itching, blistering, peeling and inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions.
• Heart attack, irregular heartbeat.
• Inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by a strong feeling of malaise.

The following very common adverse effect has been reported. If this causes problems or lasts longer than one week, consult your doctor.

Very common: may affect more than 1 in 10 people

• Edema (fluid retention).

The following common adverse effects have been reported. If any of these cause problems or last longer than one week, consult your doctor.

Common: may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the beginning of treatment).
• Palpitations (awareness of heartbeat), hot flush.
• Abdominal pain, feeling unwell (nausea).
• Changes in bowel habits, diarrhoea, constipation, indigestion.
• Tiredness, weakness.
• Visual disturbances, double vision.
• Muscle cramps.
• Swelling of ankles.

Other adverse effects have been reported and are listed below. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect 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 sensation in the limbs, loss of pain sensation.
• Ringing in the ears (tinnitus).
• Decrease in blood pressure.
• Sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis).
• Cough.
• Dry mouth, vomiting (feeling unwell).
• 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.
• Inability to achieve an erection, discomfort or enlargement of breasts in men.
• Pain, feeling unwell.
• Muscle or joint pain, 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 white blood cells, decrease in blood platelets which may cause easy bleeding or unusual bruising.
• High blood sugar (hyperglycaemia).
• A nerve disorder that may cause muscle weakness, tingling or numbness.
• Inflammation of the gums.
• Abdominal swelling (gastritis).
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect certain medical tests.
• Increased muscle tension.
• Inflammation of blood vessels, often with skin rashes.
• Sensitivity to light.
• Disorders combining rigidity, tremor and/or movement disorders.

Frequency not known (cannot be estimated from available data): tremor, postural rigidity, mask-like facial expression, slow movements and slow, unbalanced walking.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Amlodipine Aurovitas

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

Appearance of the medicine and contents of the pack

White to off-white, flat, bevel-edged, round tablets (9.5 mm in diameter), marked with the letter “C” on one side and “59” on the other.

Amlodipine Aurovitas 10 mg tablets EFG is available in PVC/PVdC-Aluminum blisters.

Pack sizes:

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

Only some 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 European Economic Area member states under the following names:

Belgium: Amlodipin AB 10 mg tabletten

Spain: Amlodipino Aurovitas 10 mg comprimidos EFG

Poland: ApoAmlo

Portugal: Amlodipina Aurovitas

Czech Republic: Amlodipin Aurovitas 10 mg tablety

Date of the most recent review of this leaflet: January 2023

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