Package Leaflet: Information for the user

Amlodipino Mabo 10 mg tablets EFG

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• 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, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Amlodipino Mabo contains amlodipine (as besilate) as its active ingredient, which belongs to a group of medications known as calcium antagonists.

Amlodipine 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 medication acts by relaxing blood vessels, allowing blood to flow through them more easily. In patients with angina, Amlodipino acts by improving blood flow to the heart muscle, which then receives more oxygen and as a result, chest pain is prevented. This medication does not provide immediate relief from chest pain due to angina.

Do not take Amlodipino Mabo

• If you are allergic to amlodipino or any of the other components of this medication (listed in section 6), or to other calcium antagonists. 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 of the heart (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to supply enough blood to the body).
• If you have heart failure after a heart attack.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amlodipino Mabo. You must inform your doctor if you have or have had any of the following conditions:

• Recent heart attack.
• Heart failure.
• High blood pressure crisis.
• Liver disease.
• You are an elderly person and need to increase the dose.

Children and adolescents

Amlodipino has not been studied in children under 6 years of age. Amlodipino 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.

Other medications and Amlodipino Mabo

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

• Ketoconazole and itraconazole (antifungal medications).
• Ritonavir, indinavir, nelfinavir (called protease inhibitors used to treat HIV).
• Rifampicin, erythromycin, clarithromycin (antibiotics: for bacterial infections).
• Hypericum perforatum (St. John's Wort).
• Verapamil, diltiazem (heart medications).
• Dantrolene (in infusion for severe body temperature abnormalities).
• Tacrolimus, sirolimus, temsirolimus, and everolimus (medications used to modify the functioning of your immune system).
• Simvastatin (medication to lower cholesterol).
• Ciclosporin(an immunosuppressant).

Amlodipino Mabo may lower your blood pressure even further if you are already taking other medications to treat high blood pressure.

Taking Amlodipino Mabo with food and drinks

People taking Amlodipino should not take grapefruit juice or grapefruit. This is because grapefruit and grapefruit juice may lead to an increase in blood levels of amlodipino, which may cause unpredictable lowering of blood pressure.

Pregnancy and breastfeeding

Pregnancy

The safety of amlodipino during pregnancy has not been established. If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor before using Amlodipino.

Breastfeeding

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Amlodipino 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.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended initial dose is one 5 mg Amlodipino tablet once a day. The dose can be increased to one 10 mg Amlodipino tablet once a day.

This medication can be taken before or after meals and beverages. You must take your medication every day at the same time with a glass of water.Swallow the tablet immediately with a glass of water. Do not take Amlodipino with grapefruit juice.

Use in children and adolescents

For children and adolescents (6-17 years), the usual recommended initial dose is 2.5 mg per day.

The maximum recommended dose is 5 mg per day.

It is essential to continue taking the tablets. Do not wait for the tablets to run out before consulting your doctor.

If you take more Amlodipino Mabo than you should

Taking too many tablets can cause your blood pressure to be low or even dangerously low. You may feel dizzy, disoriented, experience postural hypotension when standing up, or weakness. Severe drops in blood pressure can lead to shock. You may feel your skin is cold and moist and lose consciousness. Seek immediate medical attention if you take too much Amlodipino.

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

If you have taken too much Amlodipino Mabo, contact your doctor, an emergency service, or the Toxicological Information Service (phone: 91.562.04.20), indicating the medication and the amount ingested.

If you forget to take Amlodipino Mabo

Do not worry. If you forget to take a tablet, let the missed dose pass completely. Take the next dose at the correct time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Amlodipino Mabo

Your doctor will tell you for how long you should take this medication. If you stop taking this medication before, your symptoms may return.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience any of the following side effects after taking this medicine, consult your doctorimmediately.

• Sudden hissing sounds when breathing, 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 including intense skin rash, urticaria, skin redness all over the body, intense itching, blisters, peeling and skin swelling, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis or other allergic reactions.
• Heart attack, abnormal heartbeats.
• Pancreatitis that can cause severe abdominal and back pain accompanied by a feeling of discomfort.

The followingvery common side effectshave been reported. If any of these cause problems or ifthey last more than a week,you shouldconsult your doctor.

Very common: may affect more than 1 in 10 people

• Edema (fluid retention).

The followingcommon side effectshave been reported. If any of them cause problems or ifthey last more than a week,you shouldconsult your doctor.

Common: may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the start of treatment).
• Palpitations (note the heartbeats), flushing.
• Abdominal pain, discomfort (nausea).
• Alteration of bowel habit, diarrhea, constipation, indigestion.
• Fatigue, weakness.
• Visual disturbances, double vision.
• Muscle cramps.
• Swelling of the ankles.

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

Uncommon: may affect up to 1 in 100 people

• Changes in mood, anxiety, depression, insomnia.
• Tremors, taste disturbances, fainting.
• Numbness or tingling in the extremities; loss of pain sensation.
• Ringing in the ears.
• Low blood pressure.
• Runny nose / nasal congestion caused by inflammation of the nasal mucosa (rhinitis).
• Cough.
• Dry mouth, vomiting (dizziness).
• Hair loss, increased sweating, itching 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, breast tenderness or enlargement in men.
• Pain, discomfort.
• Joint or muscle pain, back pain.
• Weight gain or loss.

Rare: may affect up to 1 in 1,000 people

• Confusion.

Very rare: may affect up to 1 in 10,000 people

• Decreased white blood cell count, decreased platelet count in the blood that may cause unusual bleeding or bruising.
• High blood sugar (hyperglycemia).
• Nerve disorder that may cause muscle weakness, tingling or numbness.
• Gum inflammation.
• Abdominal distension (gastritis).
• Abnormal liver function, inflammation of the liver (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 that combine stiffness, tremor and / or movement disorders.

Reporting of side effects

If you experience any type of side effect,consult your doctor or pharmacist,evenifit is a side effect thatdoes not appear in this leaflet. You can also report them directly through the Spanish System for the 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 this medication out of the sight and reach of children.

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

Store below 25 C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

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Composition of Amlodipino Mabo

• The active ingredient is amlodipine (as besilate). Each tablet contains amlodipine besilateequivalent to 10 mg of amlodipine
• The other components arecalcium dihydrogen phosphate, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silica, and sodium carboxymethyl starch (Type A).

Appearance of the product and contents of the packaging

White to off-white, round (10.5 mm – 10.7 mm), biconvex tablets, marked with “10” on one face.

Amlodipino Mabo 10 mg tablets are available in PVC-PVDC/Aluminum blisters containing 30 tablets.

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Rejas 2, 1st floor

28821 Coslada (Madrid)

Spain

Responsible for Manufacturing

PharmaS d.o.o.

Industrijska cesta 5

44317 Potok, Popovaca

Croatia

Last review date of this leaflet: July 2022

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

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