ZABART 10 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

ZABART 10 mg tablets EFG

Amlodipine

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack and other information:

1. What is ZABART and what is it used for
2. Before taking ZABART
3. How to take ZABART
4. Possible side effects
5. Storage of ZABART
6. Further information

1. What is ZABART and what is it used for

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, including a rare form called Prinzmetal's or variant angina.

In patients with high blood pressure, this medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina, Zabart improves blood supply to the heart muscle, which receives more oxygen and as a result, chest pain is prevented. This medicine does not provide immediate relief of chest pain due to angina.

2. Before taking ZABART

Do not take Zabart

• If you are allergic (hypersensitive) to amlodipine or any of the other ingredients of this 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 a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a disease in which the heart is unable to pump enough blood to the body).
• If you have heart failure after a heart attack.

Special warnings and precautions

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 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 medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

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

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

If you are already taking other medicines for 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 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 Zabart.

Pregnancy

The safety of amlodipine during pregnancy has not been established. If you are pregnant or planning to become pregnant, you should inform your doctor before taking Zabart.

Breast-feeding

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

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Zabart may affect your ability to drive or use machines. If the tablets make you feel sick, dizzy, or tired, or give you a headache, do not drive or use machinery and consult your doctor immediately.

Important information about some of the ingredients of Zabart

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take ZABART

Always take your medicine exactly as your doctor has told you. Consult your doctor or pharmacist if you are unsure.

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. You should take it at the same time each 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 of age), the usual recommended initial dose is 2.5 mg once daily. The maximum recommended dose is 5 mg once daily.

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

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

If you take more Zabart 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 dizziness when standing up, or weakness. Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing, which can develop up to 24-48 hours after ingestion. 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. If you take too many Zabart tablets, consult your doctor immediately or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Zabart

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 taking Zabart

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zabart can cause side effects, although not everybody gets them.

See your doctor immediatelyif you experience any of the following serious side effects, which are very rare when 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 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 in every 100 patients

• Headache, dizziness, drowsiness (especially at the start of treatment)
• Palpitations (feeling your heartbeat), flushing
• Abdominal pain, feeling sick (nausea)
• Swelling of the ankles (edema), tiredness

Other side effects have been reported, which are listed below. If you think any of the side effects you are suffering from is serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

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

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

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

• Confusion

Very rare:affects less than 1 in every 10,000 patients

• Decrease in the number of white blood cells, decrease in blood platelets, which can cause easy bruising or bleeding (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, which can affect some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin rashes
• Sensitivity to light
• Disorders combining stiffness, tremor, and/or movement disorders

If you think any of the side effects you are suffering from is serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

5. Storage of ZABART

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month stated.

Store at a temperature below 30°C, protected from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. FURTHER INFORMATION

Composition of Zabart

The active substance of Zabart 10 mg tablets is amlodipine (as besylate).

The other ingredients (excipients) are microcrystalline cellulose, calcium phosphate dibasic (dihydrate), potato starch, colloidal anhydrous silica, and magnesium stearate.

Appearance of Zabart and packaging

White or almost white, round tablets, marked with "10" on one face and smooth on the other face.

Zabart 10 mg tablets are available in blister packs containing 30 tablets.

Marketing authorization holder and manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid) Spain

You can request more information about this medicine by contacting 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.

Phone: +34 91630 82 75

This leaflet was approved in June 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/