PATIENT INFORMATION LEAFLET

Amlodipino VIR 5 mg tablets

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you, and you should not give it to others even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you are experiencing to be serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

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

2. Before taking Amlodipino VIR

3. How to take Amlodipino VIR

4. Possible side effects

5. Storage of Amlodipino VIR

6. Additional information

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

Amlodipino Vir 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 blood vessels, allowing blood to flow through them more easily. In patients with angina, Amlodipino Vir improves blood flow to the heart muscle, which receives more oxygen as a result, and thus prevents chest pain. This medicine does not provide immediate relief from chest pain due to angina.

Do not take Amlodipino Vir

?If you are allergic (hypersensitive) to amlodipine, or any of the other components of the

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 theheart is unable to pump

enough blood to the body).

?If you suffer from heart failure after a heart attack.

Be especially careful with Amlodipino Vir

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

?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

Use in children and adolescents

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

Use of other medications

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

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

??ketoconazole, itraconazole (antifungal medications)

??ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat HIV/AIDS)

??rifampicin, erythromycin, clarithromycin (antibiotics)

??Hypericum perforatum(St. John's Wort)

??verapamil, diltiazem (heart medications)

??dantrolene (in infusion for severe body temperature abnormalities)

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

Taking Amlodipino Vir with food and beverages

People taking Amlodipino Vir should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may cause an increase in the blood levels of the active ingredient amlodipine, which may lead to unpredictable lowering of blood pressure by Amlodipino Vir.

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 Amlodipino Vir.

Breastfeeding

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 Vir.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

Amlodipino Vir may affect your ability to drive or operate machinery. If the tablets make you feel sick, dizzy, or tired, or cause headaches, do not drive or operate machinery and consult your doctor immediately.

Always take your medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.

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

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

Use in children and adolescents

For children and adolescents (between 6-17 years of age), the usual recommended initial dose is 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 Vir 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 Vir than you should

Taking 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. Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing that can develop up to 24-48 hours after ingestion. If the drop in blood pressure is severe enough, it can cause shock. You may feel your skin is cold and wet and could lose consciousness. If you take too many Amlodipino Vir tablets, consult your doctor immediately or call the Toxicological Information Service, phone 91562 04 20.

If you forget to take Amlodipino Vir

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 interrupt treatment with Amlodipino Vir

Your doctor will tell you for how long you should take this medicine. Your condition may recur if you stop taking this medicine before your doctor tells you to.

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

Like all medications, Amlodipino Vir may cause side effects, although not everyone will experience them.

Consult your doctorimmediatelyif you experience any of the following severe side effects, which are very rare after taking this medication.

??Sudden wheezing while breathing (sudden wheezing), chest pain, shortness of breath

or difficulty breathing

??Swelling of the eyelids, face, or lips

??Swelling of the tongue and throat that causes great difficulty breathing

??Severe skin reactions that include intense skin rash, blisters, redness of the skin all over the body, itching, blistering, 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 great sense of discomfort

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

Common:affect between 1 and 10 of every 100 patients

??Headache, dizziness, drowsiness (especially at the beginning of treatment)

??Palpitations (feeling the heartbeat), shortness of breath

??Abdominal pain, feeling unwell (nausea)

??Swelling of the ankles (edema), fatigue

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

Uncommon:affect between 1 and 10 of every 1,000 patients

?Mood changes, anxiety, depression, insomnia

??Tremor, taste alterations, fainting, weakness

??Numbness or tingling in the extremities, loss of pain sensation

??Visual disturbances, double vision, tinnitus in the ears

??Decreased blood pressure

??Runny nose/ nasal secretion caused by inflammation of the nasal mucosa (rhinitis)

??Alteration of bowel habits, diarrhea, constipation, indigestion, dry mouth,

vomiting (discomfort)

??Hair loss, increased sweating, itching skin, red patches on the skin,

skin discoloration

??Urination disorders, increased need to urinate at night, increased number of times urinating

??Impotence, discomfort or breast tenderness in men

??Weakness, pain, feeling unwell

??Muscle or joint pain, muscle cramps, back pain

??Weight gain or loss

Rare:affect between 1 and 10 of every 10,000 patients

??Confusion

Very rare:affect fewer than 1 of every 10,000 patients

??Decreased white blood cell count, decreased platelet count that can cause easy bleeding or unusual bruising (damage to red blood cells)

??High blood sugar (hyperglycemia)

??A disorder of the nerves that can cause weakness, numbness, or tingling

??Cough, inflammation of the gums

??Abdominal swelling (gastritis)

??Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that can affect some medical tests

??Increased muscle tension

??Inflammation of blood vessels, often with skin eruptions

??Sensitivity to light

??Movements disorders combining stiffness, tremor, and/or movement disorders

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 prospectus. You can also report them directly through the Spanish System of 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 medication.

Keep out of the reach and sight 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.

No special storage conditions are required.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and the

medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your

pharmacist how to dispose of the packaging and the medicines you no longer need. In this way, you will help protect the environment.

Composition of Amlodipino Vir

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

The other components (excipients) are microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.

Appearance of Amlodipino Vir and packaging contents

White or slightly yellowish, round tablets with smooth surfaces, bisected edges, marked with “AM 5” on one face and scored on the other. The score is solely for breaking and facilitating swallowing, but not for dividing into equal doses.

Amlodipino Vir 5 mg tablets are available in blister packs containing 14 and 28

tablets.

Marketing authorization holder and manufacturer responsible

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, P.I. URTINSA II, 28923 Alcorcón (Madrid)

This leaflet was approved in June 2022

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