PATIENT INFORMATION LEAFLET

ZABART 5 mg tablets EFG

Amlodipine

Read this 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Zabart contains the active substance amlodipine, which belongs to a group of medicines known as calcium antagonists.

Zabart 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, Zabart improves blood flow to the heart muscle, which receives more oxygen as a result, and as a consequence, prevents chest pain. This medicine does not provide immediate relief from chest pain due to angina.

Do not take Zabart

• 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 Zabart

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

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

Zabart may affect or be affected by other medications, such as:

• ketoconazole, itraconazole (antifungal medications)
• ritonavir, indinavir, nelfinavir (also called 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, Zabart may lower your blood pressure even further.

Taking Zabart with food and drinks

People taking Zabart 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 Zabart.

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 Zabart.

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 Zabart.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

Zabart 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.

Important information about some of the components of Zabart

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which means 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 Zabart, once a day. The dose can be increased to 10 mg of Zabart, once a day.

You can take your medicine before or after meals. It must be taken at the same time every day, with a glass of water. Do not take Zabart with grapefruit juice.

Use in children and adolescents

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

Currently, amlodipine 2.5 mg is not available and the 2.5 mg dose cannot be obtained with Zabart 5 mg tablets since 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 Zabart 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. Excess fluid can accumulate in the lungs (pulmonary edema) causing breathing difficulties that can develop up to 24-48 hours after consumption. If the drop in blood pressure is severe enough, it can cause shock. You may feel your skin is cold and moist and could lose consciousness. If you take too many Zabart tablets, consult your doctor immediately or call the Toxicological Information Service, phone 91 562 04 20.

If you forgot to take Zabart

Do not worry. If you forgot 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 Zabart

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 medications, Zabart may cause side effects, although not everyone will experience them.

Consult your doctorimmediatelyif you experience any of the following severe side effects, which are very rare after taking this medication.

• Sudden hissing sounds while 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, 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 out of 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 are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Uncommon:affect between 1 and 10 out of every 1,000 patients

• Changes in mood, anxiety, depression, insomnia
• Tremor, taste alterations, fainting, weakness
• Numbness or tingling sensation 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 habits, diarrhea, constipation, indigestion, dry mouth, vomiting (unwellness)
• Hair loss, increased sweating, itching skin, red spots on the skin, skin discoloration
• Urination 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 out of every 10,000 patients

• Confusion

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

• Decreased white blood cell count, decreased platelet count that can cause easy bleeding or unusual bruising (red blood cell damage)
• High blood sugar (hyperglycemia)
• A disorder of the nerves that can cause weakness, numbness, or tingling
• 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 eruptions
• Sensitivity to light
• Movements combining stiffness, tremor, and/or movement disorders

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist

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 at a temperature below 30°C and protected from light

Medicines should not be thrown down the drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Zabart

The active ingredient of Zabart 5 mg tablets is amlodipine (as besilate).

The other components (excipients) are microcrystalline cellulose, calcium phosphate dibasic (dihydrate), sodium carboxymethylcellulose from potato, anhydrous colloidal silica, and magnesium stearate.

Appearance of Zabart and packaging contents

White or almost white, round, flat, and smooth tablets on both sides.

Zabart 5 mg tablets are available in blister packaging containing 28, 30, or 500 tablets.

Marketing authorization holder and responsible manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid) Spain

For more information about this medication, please contact the local representative of the marketing authorization holder:

ABABOR PHARMACEUTICALS, S.L.

C/ Chile 4, building 1, office 1, Las Matas,

28290, Las Rozas, Madrid, Spain.

Tel.: +34 91630 82 75

This prospectus was approved in June 2022

The detailed and updated information about this medication is available on the website of the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)http://www.aemps.gob.es/