Amlodipine BD-Mabo 10 mg orodispersible tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Amlodipino BD-MABO 10 mg orodispersible 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 and should not be given to other people, even if they have the same symptoms as you, because it may harm them.
- If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What Amlodipino BD-MABO is and what it is used for
- Before you take Amlodipino BD-MABO
- How to take Amlodipino BD-MABO
- Possible side effects
- How to store Amlodipino BD-MABO
- Further information
1. What AMLODIPINE BD-MABO is and what it is used for
Amlodipine BD-Mabo contains the active substance amlodipine, which belongs to a group of medicines known as calcium antagonists.
Amlodipine BD-Mabo 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 blood vessels, allowing blood to flow through them more easily. In patients with angina, Amlodipine BD-Mabo improves blood supply to the heart muscle, thereby increasing oxygen delivery to the heart and preventing chest pain. This medicine does not provide immediate relief of angina-related chest pain.
2. BEFORE TAKING AMLODIPINE BD-MABO
Do not take Amlodipine BD-MABO
- 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 aortic valve narrowing (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to pump enough blood to the body).
- If you suffer from heart failure following a heart attack.
Take special care with Amlodipine BD-MABO
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
Use in children and adolescents
Amlodipine BD-MABO has not been studied in children under 6 years of age. Amlodipine BD-MABO 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
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
Amlodipine BD-MABO 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 (by infusion for serious body temperature abnormalities)
If you are already taking other medicines to treat high blood pressure, Amlodipine BD-MABO may lower your blood pressure even further.
Taking Amlodipine BD-MABO with food and drink
People taking Amlodipine BD-MABO 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 lead to an unpredictable increase in the blood pressure-lowering effect of Amlodipine BD-MABO.
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 BD-MABO.
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 must inform your doctor before taking Amlodipine BD-MABO.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Amlodipine BD-MABO may affect your ability to drive or operate machinery. If the tablets make you feel unwell, dizzy, tired, or cause headache, do not drive or use machinery and consult your doctor immediately.
Amlodipine BD-MABO contains aspartame
This medicine contains 8 mg of aspartame per tablet.
Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
Amlodipine BD-MABO contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially "sodium-free".
3. HOW TO TAKE AMLODIPINE BD-MABO
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 Amlodipine BD-Mabo once daily. The dose may be increased to 10 mg of Amlodipine BD-Mabo once daily.
You may take your medicine before or after meals. Take it at the same time each day by placing the orodispersible tablet on the tongue, where it will dissolve in saliva. Swallow afterwards. Do not take Amlodipine BD-Mabo with grapefruit juice.
Use in children and adolescents
For children and adolescents (aged 6–17 years), the recommended starting dose is usually 2.5 mg once 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 from Amlodipine BD-Mabo 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 run out of tablets before seeing your doctor.
If you take more Amlodipine BD-MABO 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 when standing up, or weakness. If the drop in blood pressure is severe enough, shock may occur. You may feel your skin cold and moist and could lose consciousness.
Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop within 24–48 hours after ingestion.
If you have taken too many Amlodipine BD-Mabo tablets, contact your doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20.
If you forget to take Amlodipine BD-MABO
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 a forgotten dose.
If you stop taking Amlodipine BD-MABO
Your doctor will advise you on how long you should take this medicine. Your condition may recur 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, Amlodipino BD-Mabo may produce adverse effects, although not everyone experiences 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, 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, abnormal heartbeat
- Inflammation of the pancreas that 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 ankles (oedema), tiredness
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 (infrequent): 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, ringing in the ears (tinnitus)
- 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, itching of the skin, 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, malaise
- 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 less than 1 patient in every 10,000
- Decrease in white blood cell count, decrease in blood platelets which may cause easy bleeding or unusual bruising (damage to red blood cells)
- High blood sugar (hyperglycaemia)
- A nerve disorder that may cause weakness, tingling or numbness
- Cough, swelling 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 stiffness, 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of AMLODIPINE BD-MABO
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.
Store below 30°C.
Keep in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. ADDITIONAL INFORMATION
Composition of Amlodipine BD-MABO
- The active substance in Amlodipine BD-Mabo 10 mg tablets is amlodipine (as besylate).
- The other components are D-mannitol (E-421), microcrystalline cellulose (E-460), aspartame (E-951), orange flavour (containing glucose in maltodextrin derived from maize), magnesium stearate, sodium carboxymethyl potato starch (potato starch).
Appearance of Amlodipine BD-MABO and contents of the pack
White, round, scored, buccodispersible tablets.
Amlodipine BD-Mabo 10 mg tablets are available in blister packs containing 30 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
MABO-FARMA S.A.
Calle Vía de los Poblados, 3, Edificio 6
28033 Madrid,
Spain.
Manufacturer
MEIJI PHARMA SPAIN, S.A.
Avda. de Madrid, 94,
28802 Alcalá de Henares, Madrid
Spain
or
MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham, TW13 7HF, United Kingdom
Date of the most recent review of this leaflet: July 2022
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/