Amlodipine Aristo 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amlodipine ARISTO 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 must not be given to other people, even if they have the same symptoms as you, since it could 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.

Leaflet contents:

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

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

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, 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, Amlodipino ARISTO 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 starting to take Amlodipine ARISTO

Do not take Amlodipine ARISTO

• If you are allergic 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, 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 suffer from heart failure following a heart attack.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take 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 ARISTO has not been studied in children under 6 years of age. Amlodipine ARISTO 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.

Use of Amlodipine ARISTO with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Amlodipine ARISTO may affect or may 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 (antibiotics)
• Hypericum perforatum (St. John's wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (intravenous infusion for serious body temperature abnormalities)

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

Taking Amlodipine ARISTO with food and drink

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

Pregnancy and breastfeeding

Pregnancy

The safety of amlodipine 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 Amlodipine ARISTO.

Breastfeeding

It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or about to start breastfeeding, you must inform your doctor before taking Amlodipine ARISTO.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Amlodipine ARISTO may affect your ability to drive or operate machinery. If the tablets make you feel unwell, dizzy, tired, or cause you to have headaches, do not drive or operate machinery and consult your doctor immediately.

3. How to take Amlodipino ARISTO

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

The usual starting dose is 5 mg of Amlodipino ARISTO once daily. The dose may be increased to 10 mg of Amlodipino ARISTO once daily.

You may take your medicine before or after meals. Take it at the same time each day with a glass of water. Do not take Amlodipino ARISTO with grapefruit juice.

Use in children and adolescents

For children and adolescents (aged 6–17 years), the recommended starting dose is usually 2.5 mg once daily. The maximum recommended dose is 5 mg once daily.

Currently, amlodipine 2.5 mg is not available, and the 2.5 mg dose cannot be achieved with Amlodipino ARISTO 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 Amlodipino ARISTO than you should

Taking too many tablets may cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, lightheaded, experience postural dizziness when standing up, or weakness. If the drop in blood pressure is severe enough, shock may occur. You may feel cold and clammy and could lose consciousness.

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

If you take too many Amlodipino ARISTO tablets, contact your doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medication and amount taken.

If you forget to take Amlodipino ARISTO

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 the missed dose.

If you stop taking Amlodipino ARISTO

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

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

4. Possible adverse effects

Like all medicines, Amlodipine ARISTO can cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if you experience any of the following serious adverse effects, which are very rare 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 breathing
• Severe skin reactions including severe rash, hives, redness of the skin all over the body, itching, blistering, peeling and skin inflammation, 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 frequent adverse effects have been reported. If any of these cause problems or if they last longer than one week, consult your doctor.

Frequent: may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of heartbeat), flushing
• Abdominal pain, feeling unwell (nausea)
• Swelling of ankles (oedema), fatigue

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 effects not listed 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, weakness
• Numbness or tingling sensation in the limbs, loss of pain sensation
• Visual disturbances, double vision, ringing in the ears (tinnitus)
• Decrease in blood pressure
• Sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis)
• Changes in bowel habits, diarrhoea, constipation, indigestion, 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 the breasts in men
• Weakness, pain, feeling unwell
• Muscle or joint pain, muscle cramps, 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 (damage to red blood cells)
• High blood sugar (hyperglycaemia)
• A nerve disorder which may cause weakness, tingling or numbness
• Cough, gum inflammation
• 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
• Light sensitivity
• Disorders combining rigidity, tremor and/or movement disorders

Reporting of adverse effects

If you experience any type of 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine ARISTO

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

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

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

6. Contents of the pack and other information

Composition of Amlodipine ARISTO

The active substance in Amlodipine ARISTO 10 mg tablets is amlodipine (as besylate).

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

Appearance of Amlodipine ARISTO and pack contents

White, round, scored tablets. The score line is intended only to facilitate breaking the tablet for ease of swallowing and does not guarantee equal dosing.

Amlodipine ARISTO 10 mg tablets are available in blister packs containing 30 and 500 tablets (hospital pack).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer

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

95-200, Poland

Or

Laboratorio de Medicamentos Internacionales S.A. (MEDINSA)

c/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Date of the most recent review of this leaflet: June 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/