AMLODIPINE VIR 5 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amlodipine VIR 5 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

1. What Amlodipine VIR is and what it is used for
2. Before taking Amlodipine VIR
3. How to take Amlodipine VIR
4. Possible side effects
5. Storage of Amlodipine VIR
6. Further information

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

Amlodipine VIR contains the active substance amlodipine, which belongs to a group of medicines known as calcium antagonists.

Amlodipine VIR is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, including a rare type called Prinzmetal's or variant angina.

In patients with high blood pressure, this medicine works by relaxing blood vessels, so blood can pass through them more easily. In patients with angina, Amlodipine VIR improves blood supply to the heart muscle, which receives more oxygen and as a result, prevents chest pain. This medicine does not provide immediate relief of chest pain due to angina.

2. Before taking Amlodipine VIR

Do not take Amlodipine VIR

? If you are allergic (hypersensitive) to amlodipine or any of the other ingredients of this medicine (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) or cardiogenic shock (a disease where the heart is unable to pump enough blood to the body).

? If you have heart failure after a heart attack.

Be cautious with Amlodipine VIR

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

? Recent heart attack

? Heart failure

? Severe increase in blood pressure (hypertensive crisis)

? Liver disease

? You are elderly and your dose needs to be increased

Use in children and adolescents

Amlodipine VIR has not been studied in children under 6 years of age. Amlodipine 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 medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Amlodipine VIR may affect or be affected by other medicines, such as:

?? Ketoconazole, itraconazole (antifungal medicines)

?? Ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat AIDS)

?? Rifampicin, erythromycin, clarithromycin (antibiotics)

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

?? Verapamil, diltiazem (heart medicines)

?? Dantrolene (in perfusion for severe body temperature abnormalities)

If you are already taking other medicines to treat high blood pressure, Amlodipine VIR may lower your blood pressure even further.

Taking Amlodipine VIR with food and drinks

People taking Amlodipine VIR should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure-lowering effect of Amlodipine 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 should inform your doctor before taking Amlodipine VIR.

Breast-feeding

Amlodipine has been shown to pass into breast milk in small amounts. If you are breast-feeding or about to start breast-feeding, you should inform your doctor before taking Amlodipine VIR.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

3. How to take Amlodipine VIR

Always take your medicine exactly as your doctor has told you. Consult your doctor or pharmacist if you are unsure.

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

You can take your medicine before or after meals. You should take it at the same time each day, with a glass of water. Do not take Amlodipine 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 once daily. The maximum recommended dose is 5 mg once daily.

Amlodipine 2.5 mg is not currently available and a dose of 2.5 mg cannot be obtained with Amlodipine VIR 5 mg tablets, as these tablets are not designed to be divided into equal parts.

It is important not to interrupt the administration of the tablets. Do not wait until the tablets are finished before going to see your doctor.

If you take more Amlodipine VIR than you should

Taking too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, faint, or experience fainting when standing up, or weakness. Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing, which 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 cold and sweaty, and you could lose consciousness. If you take too many Amlodipine VIR tablets, consult your doctor immediately or call the Toxicology Information Service, telephone 91562 04 20.

If you forget to take Amlodipine 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 forgotten dose.

If you stop taking Amlodipine VIR

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Amlodipine VIR can cause side effects, although not everybody gets them.

See your doctor immediatelyif you experience any of the following serious side effects, which are very rare when taking this medicine.

?? Sudden wheezing, chest pain, shortness of breath or difficulty breathing

?? Swelling of the eyelids, face, or lips

?? Swelling of the tongue and throat, which can cause great difficulty breathing

?? Severe skin reactions, including intense rash, hives, redness of the skin all over the body, itching, blistering, peeling, and inflammation of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions

?? Heart attack, abnormal heartbeat

?? Pancreatitis, which can cause severe abdominal pain and back pain, accompanied by a great feeling of discomfort

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

Common:affects between 1 and 10 in every 100 patients

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

?? Palpitations (feeling your heartbeat), flushing

?? Abdominal pain, feeling sick (nausea)

?? Swelling of the ankles (edema), tiredness

Other side effects have been reported, which are included in the following list. If you think any of the side effects you are experiencing is serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Uncommon:affects between 1 and 10 in every 1,000 patients

? Mood changes, anxiety, depression, insomnia

?? Tremor, taste disturbances, fainting, weakness

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

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

?? Decrease in blood pressure

?? Runny nose or stuffy nose caused by inflammation of the nasal mucosa (rhinitis)

?? Changes in bowel habits, diarrhea, constipation, indigestion, dry mouth, vomiting (nausea)

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

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

?? Impotence, discomfort or enlargement of the breasts in men

?? Weakness, pain, feeling unwell

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

?? Weight gain or loss

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

?? Confusion

Very rare:affects less than 1 in every 10,000 patients

?? Decrease in white blood cell count, decrease in blood platelets, which can cause easy bruising or bleeding (damage to red blood cells)

?? High blood sugar (hyperglycemia)

?? A nerve disorder that can cause weakness, numbness, or tingling

?? Cough, gum inflammation

?? Abdominal swelling (gastritis)

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

?? Increased muscle tension

?? Inflammation of blood vessels, often with skin rash

?? Sensitivity to light

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine VIR

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date stated on the pack, after EXP. The expiry date is the last day of the month stated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Further information

Composition of Amlodipine VIR

The active substance of Amlodipine VIR 5 mg tablets is amlodipine (as besylate).

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

Appearance of Amlodipine VIR and pack contents

White or slightly yellowish tablets, round with smooth surfaces, beveled edges, marked with "AM 5" on one side and scored on the other. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Amlodipine VIR 5 mg tablets are available in blister packs containing 14 and 28 tablets.

Marketing authorization holder and manufacturer

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

Detailed and up-to-date information on this medicine is available on the website of the Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.aemps.gob.es/