Prospecto: Information for the User

Amlodipino Vir-Pharma 10 mg Tablets

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

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

Contents of the package and additional information

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

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

Do not take Amlodipino Vir-Pharma

• If you are allergic (hypersensitive) 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 Vir-Pharma.

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

Children and adolescents

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

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Amlodipino Vir-Pharma 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)
• 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 Vir-Pharma may lower your blood pressure even further.

Taking Amlodipino Vir-Pharma with food, drinks, and alcohol

People taking Amlodipino Vir-Pharma 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 Vir-Pharma.

Pregnancy and breastfeeding

Pregnancy

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 Vir-Pharma.

Breastfeeding

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 Vir-Pharma.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

Amlodipino Vir-Pharma 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.

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 Vir-Pharma, once a day. The dose can be increased to 10 mg of Amlodipino Vir-Pharma, 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 Vir-Pharma 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 Vir-Pharma 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-Pharma 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 can accumulate in the lungs (pulmonary edema) causing difficulty breathing 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 is cold and moist, and you could lose consciousness. If you take too many Amlodipino Vir-Pharma tablets, consult your doctor immediately or call the Toxicological Information Service, phone 91 562 04 20.

If you forget to take Amlodipino Vir-Pharma

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-Pharma

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 can cause side effects, although not everyone will experience them.

See your doctorimmediatelyif you experience any of the following serious side effects, which are very rare 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, 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 effect has been reported to be very frequent. If this causes problems or lasts more than a week, consult your doctor.

Very frequent: may affect more than 1 in 10 patients

• Edema (fluid retention)

The followingside effects have been reported to be frequent. If any of these cause problems or if theylast more than a week, consult your doctor.

Frequent: may affect up to 1 in 10 patients

• 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.

Rare: may affect up to 1 in 100 patients

• Changes in mood, anxiety, depression, insomnia
• Tremor, alterations in taste, fainting
• Numbness or tingling 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
• Pain in the muscles or joints, back pain
• Weight gain or loss

Very rare: may affect up to 1 in 10,000 patients

• Confusion

Very rare: may affect up to 1 in 10,000 patients

• 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, 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, 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: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep 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.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines 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 medicines you no longer need. In this way, you will help protect the environment.

Composition of Amlodipino Vir-Pharma

The active ingredient of Amlodipino Vir-Pharma 10 mg tablets is amlodipine (as besilate).

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

Appearance of Amlodipino Vir-Pharma and content of the packaging

White or slightly yellowish, round tablets with smooth surfaces, bisected edges, marked with “AM 10” on one face and scored on the other. The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Amlodipino Vir-Pharma 10 mg tablets are available in blister packs containing 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial Urtinsa II,

28923 Alcorcón (Madrid)

Spain

Last review date of this leaflet: June 2022

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