Amlodipine BD-Mabo 5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amlodipine BD-MABO 5 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 only; do not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you think 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:

1. What Amlodipine BD-MABO is and what it is used for
2. Before you take Amlodipine BD-MABO
3. How to take Amlodipine BD-MABO
4. Possible side effects
5. How to store Amlodipine BD-MABO
6. 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 the blood vessels, allowing blood to pass through them more easily. In patients with angina, Amlodipine BD-Mabo 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. BEFORE TAKING AMLODIPINE BD-MABO

Do not take Amlodipine BD-MABO

• If you are allergic (hypersensitive) to amlodipine or 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 stenosis (narrowing of the aortic valve in the heart) 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 may need adjustment

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 may 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 (intravenous infusion for severe 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 drinks

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 4 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; 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 initial 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 this medicine before or after meals. Take it at the same time each day, 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 usual recommended initial dose is 2.5 mg once daily. The maximum recommended dose is 5 mg once daily.

Currently, amlodipine 2.5 mg is not available, and the 2.5 mg dose cannot be achieved with Amlodipine BD-Mabo 5 mg tablets, since 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 Amlodipine BD-MABO 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. If the drop in blood pressure is severe enough, shock may occur. You may feel cold and clammy skin and could lose consciousness.

Excess fluid may accumulate in the lungs (pulmonary edema), causing breathing difficulties, 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 the missed 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 advises 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.

Seek medical attention 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 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 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 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), flushing
• Abdominal pain, feeling unwell (nausea)
• Swelling of ankles (edema), 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 listed 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, ringing in the ears (tinnitus)
• Decrease in blood pressure
• Sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis)
• Changes in bowel habits, diarrhea, constipation, indigestion, 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, 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 out of every 10,000 patients

• 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 (hyperglycemia)
• A nerve disorder which may cause weakness, tingling or numbness
• Cough, gum inflammation
• 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 disturbances

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through 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 or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, 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 5 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, biconvex orodispersible tablets.

Amlodipine BD-Mabo 5 mg tablets are available in blister packs containing 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 latest revision of this package leaflet: July 2022

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/