AMLODIPINE ALTER 10 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Amlodipine Alter 10 mg Tablets EFG

Amlodipine

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 pack and other information

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

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

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

Amlodipine Alter is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, including 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 Alter improves blood supply to the heart muscle, which receives more oxygen and as a result, the pain in the chest 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 Alter

Do not take Amlodipine Alter

• 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 valve (aortic stenosis) or cardiogenic shock (a disease in which the heart is unable to pump enough blood to the body).
• If you have heart failure after a heart attack.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amlodipine Alter.

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 an elderly person and your dose needs to be increased.

Children and adolescents

Amlodipine Alter has not been studied in children under 6 years of age. Amlodipine Alter 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.

Taking Amlodipine Alter with other medicines

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

Amlodipine Alter 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 (antibiotics)
• Hypericum perforatum(St. John's Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (in perfusion for severe body temperature abnormalities)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the functioning of the immune system)
• simvastatin (a medicine that lowers cholesterol)
• ciclosporin (immunosuppressant).

If you are already taking other medicines for high blood pressure, Amlodipine Alter may lower your blood pressure even further.

Taking Amlodipine Alter with food and drinks

People taking Amlodipine Alter 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 Alter.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The safety of amlodipine during pregnancy has not been established. If you think you might be pregnant, or are planning to become pregnant, you should tell your doctor before taking Amlodipine Alter.

Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding, or are about to start breastfeeding, you should tell your doctor before taking Amlodipine Alter.

Driving and using machines

Amlodipine Alter 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 machines and consult your doctor immediately.

Amlodipine Alter contains sodium

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

3. How to take Amlodipine Alter

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

The usual initial dose is 5 mg of Amlodipine Alter, once a day. The dose can be increased to 10 mg of Amlodipine Alter, once a day.

You can take your medicine before or after meals. You should take it at the same time each day, with a glass of water. Do not take Amlodipine Alter 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.

Amlodipine 2.5 mg is not currently available, and a dose of 2.5 mg cannot be obtained with Amlodipine Alter 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 run out to go to your doctor.

If you take more Amlodipine Alter than you should

Taking too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, faint, suffer from dizziness when standing up, or weakness. If the drop in blood pressure is severe, it can cause shock. You may feel your skin cold and sweaty, 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.

If you take too many Amlodipine Alter tablets, consult your doctor immediately or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Amlodipine Alter

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 forgotten dose.

If you stop taking Amlodipine Alter

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.

See your doctor immediately if 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, which can cause great difficulty breathing.
• Severe skin reactions, including intense skin rash, hives, skin redness 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 100 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)
• Changes in bowel habits, diarrhea, constipation, indigestion
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

The following side effects have been reported, and are listed below. If you think you have any of these side effects, or if you notice any side effects not listed in this leaflet, tell 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 disorders, increased need to urinate at night, increased frequency of urination
• 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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificarm.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine Alter

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

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

Do not store above 30°C.

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 Alter

• The active substance is amlodipine (as besylate). Each tablet contains 10 mg of amlodipine (as besylate).

• The other ingredients are microcrystalline cellulose, anhydrous dibasic calcium phosphate, sodium starch glycolate (type A) (from potato), and magnesium stearate.

Appearance of the product and contents of the pack

White, lenticular, scored tablets.

The tablet can be divided into equal doses.

Amlodipine Alter 10 mg tablets are available in blister packs containing 28 or 30 tablets.

Marketing authorization holder and manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Date of last revision of this leaflet: June 2022.

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