AMLODIPINE BD-MABO 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

PATIENT INFORMATION: SUMMARY OF PRODUCT CHARACTERISTICS

Amlodipine BD-MABO 5 mg orodispersible tablets EFG

Read the entire patient information carefully before starting to take the medication.

• Keep this patient information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to 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 effect not mentioned in this patient information, inform your doctor or pharmacist.

Contents of the patient information:

1. What Amlodipine BD-MABO is and what it is used for
2. Before taking Amlodipine BD-MABO
3. How to take Amlodipine BD-MABO
4. Possible side effects
5. Storage of Amlodipine BD-MABO
6. Additional information

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

Amlodipine BD-MABO contains the active substance amlodipine, which belongs to a group of medicines known as calcium channel blockers.

Amlodipine BD-MABO is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, including a rare type called Prinzmetal's angina or variant angina.

In patients with high blood pressure, this medication works by relaxing blood vessels, allowing blood to pass through them more easily. In patients with angina, Amlodipine BD-MABO improves blood flow to the heart muscle, which receives more oxygen and as a result, prevents chest pain. This medication does not provide immediate relief from chest pain due to 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 medication listed in section 6, or to any other calcium channel blocker. This can 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) or cardiogenic shock (a condition in which the heart is unable to pump enough blood to the body) in your heart.
• If you have heart failure after a heart attack.

Be cautious 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 an elderly person 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 from 6 to 17 years of age. (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.

Amlodipine BD-MABO may affect or be affected by other medications, such as:

• ketoconazole, itraconazole (antifungal medications)
• 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 medications)
• dantrolene (in infusion for severe body temperature abnormalities)

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

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 can lead to an increase in blood levels of the active ingredient amlodipine, which can cause 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 should inform your doctor before taking Amlodipine BD-MABO.

Breastfeeding

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

Consult your doctor or pharmacist before taking any medication.

Driving and using machines

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

Amlodipine BD-MABO contains aspartame

This medication contains 4 mg of aspartame in each tablet.

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

.

Amlodipine BD-MABO contains sodium

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

3. How to take Amlodipine BD-MABO

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

The initial normal dose is 5 mg of Amlodipine BD-MABO, once a day. The dose can be increased to 10 mg of Amlodipine BD-MABO, once a day.

You can take your medication before or after meals. You should take it at the same time each day, placing the orodispersible tablet on the tongue, where it dissolves with saliva. Swallow afterwards. Do not take Amlodipine BD-MABO with grapefruit juice.

Use in children and adolescents

For children and adolescents (between 6-17 years of age), the recommended initial dose is normally 2.5 mg per day. The maximum recommended dose is 5 mg per day.

Amlodipine 2.5 mg is not currently available, and a dose of 2.5 mg cannot be obtained with Amlodipine BD-MABO 5 mg tablets, as these tablets are not designed to be divided into equal parts.

It is essential not to interrupt the administration of the tablets. Do not wait until the tablets are finished before consulting your doctor.

If you take more Amlodipine BD-MABO than you should

Taking too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, faint, suffer from postural dizziness when getting up, or weakness. If the drop in blood pressure is severe enough, it can cause shock. You may feel your skin cold and sweaty, and you could lose consciousness.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing, which can develop up to 24-48 hours after ingestion.

If you take too many Amlodipine BD-MABO tablets, consult your doctor immediately or call the Toxicology Information Service, phone 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 forgotten dose.

If you stop treatment with Amlodipine BD-MABO

Your doctor will indicate how long you should take this medication. Your condition may recur if you stop taking this medication before your doctor indicates.

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

4. Possible side effects

Like all medications, Amlodipine BD-MABO can cause side effects, although not everyone will experience them.

Go to your doctor immediatelyif you experience any of the following serious side effects, which are very rare after taking this medication.

• Sudden wheezing, chest pain, shortness of breath, or difficulty breathing
• Swelling of the eyelids, face, or lips
• Swelling of the tongue and throat, causing great difficulty breathing
• Severe skin reactions, including intense skin rash, hives, skin redness all over the body, itching, blistering, peeling, and inflammation of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, abnormal heartbeat
• Pancreatitis, which can cause severe abdominal pain and back pain accompanied by a great feeling of discomfort

The following common side effectshave been reported. If any of these cause problems or last more than a week, consult your doctor.

Common:affects between 1 and 10 out of 100 patients

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

Other side effects have been reported, which are included in the following list. If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this patient information, inform your doctor or pharmacist.

Uncommon:affects between 1 and 10 out of 1,000 patients

• Mood changes, anxiety, depression, insomnia
• Tremors, taste disturbances, fainting, weakness
• Numbness or tingling in the limbs, loss of pain sensation
• Visual disturbances, double vision, ringing in the ears
• Decrease in blood pressure
• Sneezing/nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• Alteration of bowel habits, diarrhea, constipation, indigestion, dry mouth, vomiting (discomfort)
• Hair loss, increased sweating, itching, red spots on the skin, skin discoloration
• Urination disorder, increased need to urinate at night, increased number of times urinating
• Impotence, discomfort or breast enlargement in men
• Weakness, pain, feeling unwell
• Muscle or joint pain, muscle cramps, back pain
• Weight gain or loss

Rare:affects between 1 and 10 out of 10,000 patients

• Confusion

Very rare:affects less than 1 patient out of 10,000

• Decrease in the number of white blood cells, decrease in blood platelets, which can cause easy bleeding or unusual bruising (red blood cell damage)
• High blood sugar (hyperglycemia)
• A disorder of the nerves that can cause weakness, tingling, or numbness
• Cough, gum inflammation
• Abdominal swelling (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that can affect some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin rashes
• Sensitivity to light
• Disorders combining stiffness, tremors, and/or movement disorders

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that is not listed in this patient information. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) online system: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Amlodipine BD-MABO

Keep out of the reach and sight of children.

Do not use this medication after the expiration date stated on the packaging, after EXP. 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.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Additional information

Composition of Amlodipine BD-MABO

• The active ingredient of Amlodipine BD-MABO 5 mg orodispersible tablets is amlodipine (as besylate).
• The other ingredients are D-mannitol (E-421), microcrystalline cellulose (E-460), aspartame (E-951), orange flavor (containing glucose in maltodextrin from corn), magnesium stearate, sodium carboxymethyl starch potato (potato starch).

Appearance of Amlodipine BD-MABO and packaging contents

White, round, and biconvex orodispersible tablets

Amlodipine BD-MABO 5 mg orodispersible 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

Date of the last revision of this patient information: July 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/