Leaflet: information for the user

Amlodipino Normon 5 mg tablets EFG

amlodipino

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

Amlodipino Normon 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 Normon 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 Normon

• If you are allergic (hypersensitive) to amlodipine, 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 Normon.

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 Normon has not been studied in children under 6 years of age. Amlodipino Normon 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 Amlodipino Normon with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

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

• ketoconazole, itraconazole (antifungal medications)
• ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat AIDS)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum (St. John's Wort)
• verapamil, diltiazem (heart medications)
• dantrolene (in infusion for severe body temperature abnormalities)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medications used to modify the functioning of the immune system)
• simvastatin (cholesterol-lowering medication)
• ciclosporin (immunosuppressant)

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

Taking Amlodipino Normon with food and drinks

People taking Amlodipino Normon 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 amlodipine in the blood, which may lead to an unpredictable increase in the effect of lowering blood pressure of Amlodipino Normon.

Pregnancy and breastfeeding

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 Amlodipino Normon.

Lactation

Amlodipine 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 Normon.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

Amlodipino Normon 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 Normon contains sodium

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

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

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

You can take this medication before or after meals. It should be taken at the same time every day, with a glass of water. Do not take Amlodipino Normon 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 5mg per day.

Amlodipino 2.5 mg is currently not available and the 2.5 mg dose cannot be obtained with the Amlodipino Normon 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 for the tablets to run out before consulting your doctor.

If you take more Amlodipino Normon 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 you could lose consciousness. If you take too many Amlodipino Normon tablets, consult your doctor immediately or call the Toxicology Information Service, phone 91 562 04 20.

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

If you forget to take Amlodipino Normon

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 Normon

Your doctor will indicate 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 may 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, 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 following side effect has been reported as very frequent. If this causes problems or lasts more than a week, consult your doctor.

Very frequent: may affect more than 1 in 10 people

• Edema (fluid retention)

The following side effects have been reported as frequent. If any of these cause problems or last more than a week, consult your doctor.

Frequent: 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 are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Frequent: may affect up to 1 in 100 people

• Changes in mood, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting
• Numbness or tingling sensation in the extremities, loss of pain sensation
• Ringing 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
• 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

• 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, bleeding gums
• Abdominal swelling (gastritis)
• Abnormal liver function, 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

Frequency not known: cannot be estimated from available data

• Tremor, stiff posture, mask-like face, slow movements, and a dragging and unsteady gait

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.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 25°C. Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Amlodipino Normon Composition

The active ingredient of Amlodipino Normon 5 mg tablets is amlodipine (as besilate).

The other components are: Microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium carboxymethyl starch (potato starch) and magnesium stearate.

Product appearance and packaging contents

White or almost white, round, flat tablets marked with A5 on one of their faces. Available packaging contains 28 and 30 tablets.

Amlodipino Normon 5 mg tablets are available in blister packaging containing 28 or 30 tablets, and in single-dose blisters containing 500 tablets (clinical packaging).

Marketing authorization holder and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Last review date of this leaflet:May 2024

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/68310/P_68310.html