Amlodipine Vir-Pharma 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Amlodipine Vir-Pharma 5 mg tablets EFG

Read the entire 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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Amlodipine Vir-Pharma is and what it is used for
2. What you need to know before taking Amlodipine Vir-Pharma
3. How to take Amlodipine Vir-Pharma
4. Possible side effects
5. How to store Amlodipine Vir-Pharma

Pack contents and additional information

1. What Amlodipine Vir-Pharma is and what it is used for

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

Amlodipine Vir-Pharma 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 the blood vessels, allowing blood to flow through them more easily. In patients with angina, Amlodipine Vir-Pharma improves blood flow to the heart muscle, thereby increasing oxygen supply and preventing chest pain. This medicine does not provide immediate relief of chest pain caused by angina.

2. What you need to know before taking Amlodipine Vir-Pharma

Do not take Amlodipine Vir-Pharma

• If you are allergic (hypersensitive) to amlodipine, or to 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 heart valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to pump enough blood to the body).
• If you have heart failure following a heart attack.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Amlodipine Vir-Pharma.

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

• Recent heart attack
• Heart failure
• Severe increase in blood pressure (hypertensive crisis)
• Liver disease
• You are elderly and your dose needs to be increased

Children and adolescents

Amlodipine Vir-Pharma has not been studied in children under 6 years of age. Amlodipine Vir-Pharma should only be used to treat high blood pressure in children and adolescents aged 6 to 17 years. (See section 3).

For further information, consult your doctor.

Taking Amlodipine Vir-Pharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Amlodipine Vir-Pharma may affect or be affected by other medicines, such as:

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (also known as protease inhibitors used to treat AIDS)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum (St. John's Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (administered by infusion for serious body temperature abnormalities)
• tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to modify the immune system function)
• simvastatin (a cholesterol-lowering medicine)
• cyclosporine (an immunosuppressant)

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

Taking Amlodipine Vir-Pharma with food, drinks and alcohol

People taking Amlodipine Vir-Pharma should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could cause an unpredictable increase in the blood pressure-lowering effect of Amlodipine Vir-Pharma.

Pregnancy and breastfeeding

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 Amlodipine Vir-Pharma.

Breastfeeding

It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or about to start breastfeeding, you should inform your doctor before taking Amlodipine Vir-Pharma.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Amlodipine Vir-Pharma may affect your ability to drive or operate machinery. If the tablets make you feel unwell, dizzy or tired, or cause you to have a headache, do not drive or use machinery and consult your doctor immediately.

3. How to take Amlodipino Vir-Pharma

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended starting dose is 5 mg of Amlodipino Vir-Pharma once daily. The dose may be increased to 10 mg of Amlodipino Vir-Pharma once daily.

You may take your medicine before or after meals. Take it at the same time each day with a glass of water. Do not take Amlodipino Vir-Pharma with grapefruit juice.

Use in children and adolescents

For children and adolescents (6–17 years of age), the usual recommended starting dose is 2.5 mg once daily. The recommended maximum dose is 5 mg daily.

Currently, amlodipine 2.5 mg is not available, and the 2.5 mg dose cannot be obtained from Amlodipino Vir-Pharma 5 mg tablets, as these tablets are not manufactured to be divided into equal parts.

It is important not to interrupt treatment with the tablets. Do not wait until you have run out of tablets before seeing your doctor.

If you take more Amlodipino Vir-Pharma than you should

Taking too many tablets may cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, lightheaded, experience postural dizziness when standing up, or weakness. Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop 24–48 hours after ingestion.

If the drop in blood pressure is severe enough, shock may occur. You may feel cold and clammy skin and could lose consciousness. If you take too many Amlodipino Vir-Pharma tablets, contact your doctor immediately or call the Toxicology Information Service at telephone number 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 usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Amlodipino Vir-Pharma

Your doctor will advise you on how long you should take this medicine. Your condition may return if you stop taking this medicine before your doctor tells you to do so.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Seek medical advice immediately if you experience any of the following serious adverse effects, which are very rare after 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 causing severe difficulty in breathing
• Severe skin reactions including intense rash, hives, redness of the skin all over the body, itching, blistering, peeling and skin inflammation, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, irregular heartbeat
• Inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by a marked feeling of malaise

The following very common adverse effect has been reported. If this causes problems or lasts longer than one week, consult your doctor.

Very common: may affect more than 1 in 10 patients

• Edema (fluid retention)

The following common adverse effects have been reported. If any of these cause problems or last longer than one week, consult your doctor.

Common: may affect up to 1 in 10 patients

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of heartbeat), hot flushes
• Abdominal pain, feeling unwell (nausea)
• Changes in bowel habits, diarrhoea, constipation, indigestion
• Tiredness, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of ankles

Other adverse effects have been reported and are listed below. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.

Uncommon: may affect up to 1 in 100 patients

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting
• Numbness or tingling sensation in the limbs, loss of pain sensation
• Ringing in the ears
• Decrease in blood pressure
• Sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting (feeling unwell)
• Hair loss, increased sweating, skin itching, red spots on the skin, skin discoloration
• Urinary disorders, increased need to urinate at night, increased frequency of urination
• Inability to achieve an erection, discomfort or enlargement of the breasts in men
• Weakness, pain, feeling unwell
• Muscle or joint pain, back pain
• Weight gain or weight loss

Rare: may affect up to 1 in 1,000 patients

• Confusion

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

• Decrease in white blood cell count, decrease in blood platelets which may cause easy bleeding or unusual bruising
• High blood sugar (hyperglycaemia)
• A nerve disorder which may cause muscle weakness, tingling or numbness
• Inflammation of the gums
• Abdominal swelling (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect certain medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin rashes
• Light sensitivity
• Disorders combining rigidity, tremor and/or movement disorders

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine Vir-Pharma

Keep out of the sight and reach of children.

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amlodipino Vir-Pharma

The active substance in Amlodipino Vir-Pharma 5 mg tablets is amlodipine (as besilate).

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

Appearance of Amlodipino Vir-Pharma and pack contents

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

Amlodipino Vir-Pharma 5 mg tablets are available in blister packs containing 30 tablets.

Marketing Authorization Holder and Manufacturer

Industria Química y Farmacéutica VIR, S.A.

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

28923 Alcorcón (Madrid)

Spain

Date of the most recent revision of this package leaflet: June 2022

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