Package Insert: Information for the Patient

Amlodipine Alter 5 mg Tablets EFG

Amlodipine

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

Amlodipino Alter is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, which includes a less common type known as Prinzmetal's angina or variant angina.

In patients with high blood pressure, this medicine works by relaxing blood vessels, allowing blood to flow through them more easily. In patients with angina, Amlodipino Alter improves blood flow to the heart muscle, which receives more oxygen as a result, and as a consequence, prevents chest pain. This medicine does not provide immediate relief from chest pain due to angina.

Do not take Amlodipino Alter

• If you are allergic to amlodipino, or any of the other components of this medication (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) in your heart 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 Amlodipino Alter.

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

• Recent heart attack
• Heart failure
• Severe high blood pressure (hypertensive crisis)
• Liver disease
• You are an elderly person and your dose needs to be increased.

Children and adolescents

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

Taking Amlodipino Alter with other medications

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

Amlodipino Alter may affect or be affected by other medications, such as:

• ketoconazol, itraconazol (antifungal medications)
• ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat HIV/AIDS)
• rifampicina, eritromicina, claritromicina (antibiotics)
• Hypericum perforatum(St. John's Wort)
• verapamilo, diltiazem (heart medications)
• dantroleno (in infusion for severe body temperature abnormalities)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medications used to modify the functioning of the immune system
• simvastatina (cholesterol-lowering medication)
• ciclosporina (immunosuppressant).

If you are already taking other medications to treat high blood pressure, Amlodipino Alter may lower your blood pressure even further.

Taking Amlodipino Alter with food and drinks

People taking Amlodipino Alter should not consume grapefruit, or grapefruit juice. This is because grapefruit and grapefruit juice may cause an increase in the levels of the active ingredient amlodipino in the blood, which may cause an unpredictable increase in the effect of lowering blood pressure of Amlodipino Alter.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The safety of amlodipino 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 Amlodipino Alter.

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

Driving and operating machinery

Amlodipino Alter may affect your ability to drive or operate machinery. If the tablets make you feel sick, dizzy, or tired, or give you a headache, do not drive or operate machinery and consult your doctor immediately.

Amlodipino Alter contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

You can take your medication before or after meals. It should be taken at the same time every day, with a glass of water. Do not take Amlodipino Alter with grapefruit juice.

Use in children and adolescents

For children and adolescents (between 6-17 years of age), the usual recommended initial dose is typically 2.5 mg per day. The maximum recommended dose is 5 mg per day.

Amlodipino 2.5 mg is currently not available and the 2.5 mg dose cannot be obtained with the Amlodipino Alter 5 mg tablets as these tablets are not manufactured to be divided into equal parts.

It is essential not to interrupt the administration of the tablets. Do not wait until the tablets run out to visit your doctor.

If you take more Amlodipino Alter than you should

Consuming too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, disoriented, experience postural dizziness when standing up, or weakness. If the drop in blood pressure is severe enough, it can cause shock. You may feel your skin is cold and moist and could lose consciousness.

Excess fluid can accumulate in the lungs (pulmonary edema) causing difficulty breathing that can develop up to 24-48 hours after consumption.

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

If you forget to take Amlodipino 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 compensate for the missed dose.

If you interrupt treatment with Amlodipino Alter

Your doctor will instruct you for how long you should take this medication. Your condition may reappear if you stop taking this medication before your doctor tells you to.

If you have any other doubts about the use of this medication, consult your doctor or pharmacist.

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

Go to your doctorimmediatelyif you experience any of the following side effects after taking this medicine.

• Sudden hissing sounds when breathing (sudden sibilance), chest pain, shortness of breath, or difficulty breathing.
• Swelling of the eyelids, face, or lips.
• Swelling of the tongue and throat that causes severe difficulty breathing.
• Severe skin reactions that include intense skin rash, blisters, skin redness all over the body, severe itching, blister formation, skin peeling, and skin inflammation, mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Heart attack, abnormal heart rhythm.
• Pancreatitis that can cause severe abdominal pain and back pain accompanied by a strong feeling of discomfort.

The followingvery commonside effect has been reported. 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. 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), shortness of breath
• Abdominal pain, feeling of discomfort (nausea)
• Alteration of bowel habit, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

The following side effects have been reported. If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Uncommon: may affect up to 1 in 100 people

• Changes in mood, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting
• Numbness or tingling in the extremities, loss of pain sensation
• Tinnitus in the ears
• Decreased blood pressure
• Runny nose/ nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting (discomfort)
• Hair loss, increased sweating, itching skin, red spots on the skin, skin discoloration
• Urinary disorders, increased need to urinate at night, increased frequency of urination
• Impotence, discomfort or breast tenderness in men
• Pain, feeling of discomfort
• Pain in the muscles or joints, 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

• Decreased white blood cell count, decreased platelet count that may cause easy bleeding or unusual bruising
• High blood sugar (hyperglycemia)
• A disorder of the nerves that may cause muscle weakness, numbness, or tingling
• Gingivitis
• Abdominal swelling (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that may affect some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin eruptions
• Sensitivity to light
• Movement disorders combining rigidity, tremor, and/or movement disorders

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificarm.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or trash. Deposit the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Amlodipino Alter

• The active ingredient is amlodipine (as besilate). Each tablet contains 5 mg of amlodipine (as besilate).

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

Appearance of the product and contents of the packaging

White and biconvex tablets.

Amlodipino Alter 5 mg tablets are available in blister packs containing 28 or 30 tablets.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Last review date of this leaflet: June 2022.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.