PATIENT INFORMATION LEAFLET

Amlodipino BD-MABO 10 mg buccal tablets EFG

Read this leaflet carefully before you start taking the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you are experiencing to be serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

1. What Amlodipino BD-MABO is and for what it is used

2. Before taking Amlodipino BD-MABO

3. How to take Amlodipino BD-MABO

4. Possible side effects

5. Storage of Amlodipino BD-MABO

6. Additional information

Amlodipino BD- Mabo contains the active substance amlodipine which belongs to a group of medicines known as calcium antagonists.

Amlodipino BD- Mabo is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, which includes 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, Amlodipino BD- Mabo improves blood flow to the heart muscle, which receives more oxygen as a result, and as a consequence, chest pain is prevented. This medicine does not provide immediate relief from chest pain due to angina.

Do not take Amlodipino BD- MABO

• If you are allergic (hypersensitive) to amlodipine, or any of the other components of the medication 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) in your heart or cardiogenic shock (a disease in which the heart is unable to pump enough blood to the body).
• If you suffer from heart failure after a heart attack.

Be especially careful with Amlodipino BD- MABO

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

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

Use in children and adolescents

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

For more information, consult your doctor.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Amlodipino BD- Mabo may affect or be affected by other medications, such as:

• ketoconazole, itraconazole (antifungal medications)
• ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat HIV/AIDS)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum(St. John's Wort)
• verapamil, diltiazem (heart medications)
• dantrolene (in infusion for severe body temperature abnormalities)

If you are already taking other medications to treat high blood pressure, Amlodipino BD- Mabo may lower your blood pressure even further.

Taking Amlodipino BD-MABO with food and drinks

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

Breastfeeding

Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding, or are about to start, you must inform your doctor before taking Amlodipino BD- Mabo.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

Amlodipino BD- Mabo may affect your ability to drive or operate machinery. If the tablets make you feel sick, dizzy, or tired, or cause headaches, do not drive or operate machinery and consult your doctor immediately.

Amlodipino BD-MABO contains aspartame

This medication contains 8 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Amlodipino BD-MABO contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Always take your medicine exactly as your doctor has told you. Consult your doctor or pharmacist if you have any doubts.

The usual initial dose is 5 mg of Amlodipino BD-Mabo, once a day. The dose can be increased to 10 mg of Amlodipino BD-Mabo, once a day.

You can take your medicine before or after meals. It should be taken at the same time every day, placing the buccodispersable tablet on the tongue, where it dissolves with saliva. Swallow afterwards. Do not take Amlodipino BD-Mabo 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 per day. The maximum recommended dose is 5 mg per day.

Amlodipino 2.5 mg is currently not available and the 2.5 mg dose cannot be obtained with the Amlodipino BD-Mabo 5 mg tablets as these tablets are not manufactured to be divided into equal parts.

It is essential not to interrupt the administration of the tablets. Do not wait until the tablets run out to visit your doctor.

If you take more Amlodipino BD-MABO than you should

Consuming too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, disoriented, experience postural dizziness when standing up, or weakness. If the drop in blood pressure is severe enough, it can cause shock. You may feel your skin is cold and wet and could lose consciousness.

Excess fluid can accumulate in the lungs (pulmonary edema) causing difficulty breathing that can develop up to 24-48 hours after consumption.

If you take too many Amlodipino BD-Mabo tablets, consult your doctor immediately or call the Toxicological Information Service, phone 91 562 04 20.

If you forget to take Amlodipino 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 compensate for the missed dose.

If you interrupt treatment with Amlodipino BD-MABO

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

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

Like all medicines, Amlodipino BD-Mabo may cause side effects, although not everyone will experience them.

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

• Sudden hissing sounds when breathing (sudden sibilance), chest pain, shortness of breath, or difficulty breathing
• Swelling of the eyelids, face, or lips
• Swelling of the tongue and throat that causes severe difficulty breathing
• Severe skin reactions that include intense skin rash, blisters, skin redness all over the body, itching, blister formation, skin peeling, and skin inflammation, mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, abnormal heart rhythm
• Pancreatitis that can cause severe abdominal pain and back pain accompanied by a strong feeling of discomfort

The followingcommon side effectshave been reported. If any of these cause problems or if theylast more than a week,consult your doctor.

Common:affect between 1 and 10 in every 100 patients

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (feeling the heartbeat), shortness of breath
• Abdominal pain, feeling unwell (nausea)
• Swelling of the ankles (edema), fatigue

The following side effects have also been reported. If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

• Mood changes, anxiety, depression, insomnia
• Tremors, taste alterations, fainting, weakness
• Numbness or tingling in the extremities, loss of pain sensation
• Visual disturbances, double vision, ringing in the ears
• Decreased blood pressure
• Runny nose/ nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• Alteration of bowel habit, diarrhea, constipation, indigestion, dry mouth, vomiting (unwellness)
• Hair loss, increased sweating, itching skin, red patches on the skin, skin discoloration
• Urinary disorders, increased need to urinate at night, increased frequency of urination
• Impotence, discomfort or breast tenderness in men
• Weakness, pain, feeling unwell
• Muscle or joint pain, muscle cramps, back pain
• Weight gain or loss

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

• Confusion

Very rare:affect fewer than 1 in 10,000 patients

• Decreased white blood cell count, decreased platelet count that may cause easy bleeding or unusual bruising (damage to red blood cells)
• High blood sugar (hyperglycemia)
• A disorder of the nerves that may cause weakness, tingling, or numbness
• Cough, inflammation of the gums
• Abdominal swelling (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that may affect some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin eruptions
• Sensitivity to light
• Movements combining stiffness, tremors, and/or movement disorders

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of reach and sight of children.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Amlodipine BD-MABO

- The active ingredient of Amlodipine BD-Mabo 10 mg tablets is amlodipine (as besilate).

- The other components are D-mannitol (E-421), microcrystalline cellulose (E-460), aspartame (E-951), orange essence (which contains glucose in maltodextrin derived from corn), magnesium stearate, sodium carboxymethyl starch from potato (potato starch).

Appearance of Amlodipine BD-MABO and packaging contents

White, round, scored, and biconvex buccal dispersible tablets.

Amlodipine BD-Mabo 10 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, Alcala de Henares, Madrid

Spain

or

MEDREICH PLC

Warwick House, Plane Tree Crescent,

Feltham, TW13 7HF, United Kingdom

Last review date of this leaflet: July 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/