PATIENT INFORMATION LEAFLET

Amlodipino VIR 10 mg Tablets

Read this leaflet carefully before you start taking the medicine.

?????????????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. Do not pass it on to others even if their symptoms are the same.

They may be harmed.

?????????????If you think you have suffered a side effect you can report it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

2. Before taking Amlodipino VIR

3. How to take Amlodipino VIR

4. Possible side effects

5. Storage of Amlodipino VIR

6. Further 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, 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 Vir improves blood flow to the heart muscle, which receives more oxygen as a result, and as a consequence, chest pain is prevented. This medicine does not provide immediate relief from chest pain due to angina.

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, redness of the skin, 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.

Be especially careful with Amlodipino Vir

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

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 aged 6 to 17 years (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, including 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 (intravenous for severe temperature anomalies)

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 drinks

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 cause an unpredictable increase in the effect of lowering blood pressure of 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 to. If you have any doubts, consult your doctor or pharmacist.

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

Currently, amlodipine 2.5 mg is not available and the 2.5 mg dose cannot be obtained with the Amlodipino Vir 5 mg tablets since 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

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

If the drop in blood pressure is severe enough, it can cause shock. You may feel your skin cold and moist and could lose consciousness. If you take too many Amlodipino Vir tablets, consult your doctor immediately or call the Toxicological Information Service, phone 91 562 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 compensate 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 reappear if you stop taking this medicine before your doctor tells you to.

If you have any other doubts 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.

You should consult your doctor immediately if you experience any of the following severe side effects, which are very rare after taking this medication.

?????????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 great difficulty breathing

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

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: affects 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), swelling

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.

Poorly frequent: affects between 1 and 10 of every 1,000 patients

?????????Changes in mood, anxiety, depression, insomnia

?????????Trembling, taste alterations, fainting, weakness

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

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

?????????Decreased blood pressure

?????????Nasal secretion and runny nose caused by inflammation of the nasal mucosa (rhinitis)

?????????Alteration of bowel habit, diarrhea, constipation, indigestion, mouth dryness, vomiting (discomfort)

?????????Hair loss, increased sweating, itching skin, red spots on the skin, skin discoloration

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

?????????Impotence, discomfort, or breast tenderness in men

?????????Weakness, pain, feeling unwell

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

?????????Weight gain or loss

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

?????????Confusion

Very rare: affects fewer than 1 patient in every 10,000

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

?????????High blood sugar (hyperglycemia)

?????????A disorder of the nerves that may 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 may affect some medical tests

?????????Increased muscle tension

?????????Inflammation of blood vessels, often with skin eruptions

?????????Sensitivity to light

?????????Movement disorders combining stiffness, trembling, and/or movement disorders

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products 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 disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so,you will help protect the environment.

Composition of Amlodipino Vir

The active ingredient of Amlodipino Vir 10 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, beveled edges, marked with “AM 10” 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 10 mg tablets are available in blister packs containing 14, 28, and 30 tablets.

Marketing authorization holder and responsible manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-68-70, Polígono Industrial Urtinsa II, 28923 Alcorcón (Madrid)

This leaflet was approved in May 2024

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