Amlodipine Vir 10 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Amlodipine VIR 10 mg tablets EFG
Read the entire leaflet carefully before you start taking this 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 give it to other people, even if they have the same symptoms as you, because it may harm them.
?????????????If you think that any of the side effects you experience is serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What Amlodipine VIR is and what it is used for
- Before you take Amlodipine VIR
- How to take Amlodipine VIR
- Possible side effects
- How to store Amlodipine VIR
- Further information
1. What Amlodipino Vir is and what it is used for
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 the blood vessels, allowing blood to flow through them more easily. In patients with angina, Amlodipino Vir improves blood flow to the heart muscle, thereby increasing oxygen supply to the heart and preventing chest pain. This medicine does not provide immediate relief of angina-related chest pain.
2. Before taking amlodipine Vir
Do not take Amlodipine Vir
?????????????????If you are allergic (hypersensitive) to amlodipine or to any of the other ingredients of the 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 in the heart (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.
Take special care with Amlodipine Vir
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 may need adjustment
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 aged 6 to 17 years. (See section 3).
For further 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 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 disturbances in body temperature)
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 may increase blood levels of the active ingredient amlodipine, which could 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 must inform your doctor before taking Amlodipine Vir.
Breast-feeding
It has been shown that amlodipine passes 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 operate machinery. If the tablets make you feel unwell, dizzy, 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
Always take your medicine exactly as your doctor has instructed. Consult your doctor or
pharmacist if you have any doubts.
The usual starting dose is 5 mg of Amlodipino Vir once daily. The dose may be increased to
10 mg of Amlodipino Vir 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 with grapefruit juice.
Use in children and adolescents
For children and adolescents (aged 6–17 years), the usual recommended starting dose is
2.5 mg daily. The maximum recommended dose is 5 mg daily.
Currently, amlodipine 2.5 mg is not available, and the 2.5 mg dose cannot be obtained with Amlodipino Vir 5 mg tablets, as these tablets are not manufactured to be divided into equal parts.
It is important not to interrupt the administration of the tablets. Do not wait until you run out of tablets before seeing your doctor.
If you take more Amlodipino Vir than you should
Taking too many tablets may cause a drop in blood pressure or even a dangerous decrease. You may feel dizzy, lightheaded, experience postural dizziness upon standing, or weakness. Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty 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, clammy skin and could lose consciousness. If you take too many Amlodipino Vir 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
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 stop taking Amlodipino Vir
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 stop.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Amlodipine Vir may produce adverse effects, although not all people experience them.
Contact your doctor immediately if you experience any of the following serious adverse effects, which are very rare after taking this medicine:
- Sudden wheezing (sudden whistling sounds when breathing), 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 severe 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 strong feeling of malaise
The following frequent adverse effects have been reported. If any of these cause problems or if they last longer than one week, consult your doctor.
Frequent: affect between 1 and 10 out of every 100 patients
- Headache, dizziness, drowsiness (especially at the beginning of treatment)
- Palpitations (awareness of heartbeat), hot flush
- Abdominal pain, feeling unwell (nausea)
- Swelling of the ankles (oedema), fatigue
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: affect between 1 and 10 out of every 1,000 patients
- Mood changes, anxiety, depression, insomnia
- Tremor, taste disturbances, fainting, weakness
- Numbness or tingling sensation in the limbs, loss of pain sensation
- Visual disturbances, double vision, tinnitus (ringing in the ears)
- Decrease in blood pressure
- Sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis)
- Changes in bowel habits, diarrhoea, constipation, indigestion, dry mouth, vomiting (nausea)
- 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, muscle cramps, back pain
- Weight gain or weight loss
Rare: affect between 1 and 10 out of every 10,000 patients
- Confusion
Very rare: affect fewer than 1 in 10,000 patients
- Decrease in white blood cells, decrease in blood platelets which may cause easy bleeding or unusual bruising (damage to red blood cells)
- High blood sugar levels (hyperglycaemia)
- A nerve disorder which may cause weakness, tingling or numbness
- Cough, 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 associated with skin rashes
- Light sensitivity
- Disorders combining rigidity, tremor and/or movement disorders
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 packaging, following
EXP. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.
6. Additional information
Composition of Amlodipino Vir
The active substance in Amlodipino Vir 10 mg tablets is amlodipine (as besylate).
The other components (excipients) are microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.
Appearance of Amlodipino Vir and contents of the pack
White or slightly yellowish, round tablets with smooth surfaces and bevelled edges, marked with “AM 10” on one side and scored on the other. The score line is intended only to facilitate breaking the tablet for ease of swallowing and is not intended to divide the tablet into equal doses.
Amlodipino Vir 10 mg tablets are available in blister packs containing 14, 28 and 30 tablets.
Marketing Authorization Holder and Manufacturer
Industria Química y Farmacéutica VIR, S.A.
C/ Laguna 66-68-70, Polígono Industrial Urtinsa II, 28923 Alcorcón (Madrid)
This summary of product characteristics was last approved in May 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/