Zabart 5 mg tablets EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZABART 5 mg tablets EFG
Amlodipine
Read the entire 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 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 experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What ZABART is and what it is used for
- Before you take ZABART
- How to take ZABART
- Possible side effects
- How to store ZABART
- Further information
1. What ZABART is and what it is 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 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, thereby increasing oxygen supply and preventing chest pain. This medicine does not provide immediate relief of angina-related chest pain.
2. BEFORE TAKING ZABART
Do not take Zabart
- If you are allergic (hypersensitive) to amlodipine, or to any of the other components of the 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 heart's aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to pump enough blood to the body).
- If you suffer from heart failure following a heart attack.
Take special care with Zabart
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 may need adjustment
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 aged 6 to 17 years. (See section 3).
For further information, consult your doctor.
Use of other medicines
Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
Zabart may affect, or may 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 (intravenous infusion for severe body temperature abnormalities)
If you are already taking other medicines 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 increase blood levels of the active ingredient amlodipine, which could 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 think you may be pregnant, or are planning to become pregnant, you must inform your doctor before taking Zabart.
Breast-feeding
It has been shown that amlodipine passes into breast milk in small amounts. If you are breast-feeding or about to start breast-feeding, you must 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 unwell, dizzy, tired, or cause you to have headaches, do not drive or operate machinery and consult your doctor immediately.
Important information about some of the components of Zabart
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning it is essentially "sodium-free".
3. HOW TO TAKE ZABART
Always take your medicine exactly as your doctor has instructed. Consult your doctor or pharmacist if you have any doubts.
The usual starting dose is 5 mg of Zabart once daily. The dose may be increased to 10 mg of Zabart once daily.
You may take your medicine before or after meals. 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 recommended starting dose is usually 2.5 mg once daily. The maximum recommended dose is 5 mg daily.
Currently, amlodipine 2.5 mg is not available, and the 2.5 mg dose cannot be obtained with Zabart 5 mg tablets, as these tablets are not manufactured to be divided into equal parts.
It is important not to interrupt the administration of the tablets. Do not wait until you run out of tablets before seeing your doctor.
If you take more Zabart than you should
Taking too many tablets may cause a drop in blood pressure or even a dangerous decrease. You may feel dizzy, lightheaded, experience postural dizziness upon standing, or weakness. Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty breathing, which may develop within 24–48 hours after ingestion. If the drop in blood pressure is severe enough, shock may occur. You may feel cold and clammy skin and could lose consciousness. If you have taken too many Zabart tablets, contact your doctor immediately or call the Toxicology Information Service at telephone number 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 a missed dose.
If you stop taking Zabart
Your doctor will advise you on how long you should take this medicine. Your condition may return if you stop taking this medicine before your doctor tells you to do so.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Zabart may produce adverse effects, although not everyone experiences them.
Seek medical attention immediately if you experience any of the following serious adverse effects, which are very rare after 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 severe breathing difficulty
- Severe skin reactions including severe rash, hives, redness of the skin all over the body, itching, blistering, peeling and inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome; toxic epidermal necrolysis), or other allergic reactions
- Heart attack, irregular heartbeat
- Inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by a marked feeling of malaise
The following frequent adverse effects have been reported. If any of these cause problems or if they last longer than one week, consult your doctor.
Frequent: affect between 1 and 10 out of every 100 patients
- Headache, dizziness, drowsiness (especially at the beginning of treatment)
- Palpitations (awareness of heartbeat), hot flushes
- Abdominal pain, feeling unwell (nausea)
- Swelling of the ankles (edema), fatigue
Other adverse effects have been reported and are listed below. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Uncommon: affect between 1 and 10 out of every 1,000 patients
- Mood changes, anxiety, depression, insomnia
- Tremor, taste disturbances, fainting, weakness
- Numbness or tingling sensation in the limbs, loss of pain sensation
- Visual disturbances, double vision, ringing in the ears
- Decrease in blood pressure
- Sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis)
- Changes in bowel habits, diarrhoea, constipation, indigestion, dry mouth, vomiting (feeling unwell)
- Hair loss, increased sweating, skin itching, red spots on the skin, skin discoloration
- Urinary disorders, increased need to urinate at night, increased frequency of urination
- Inability to achieve an erection, discomfort or enlargement of the breasts in men
- Weakness, pain, feeling unwell
- Muscle or joint pain, muscle cramps, back pain
- Weight gain or weight 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 number of white blood cells, decreased blood platelets which may cause easy bleeding or unusual bruising (damage to red blood cells)
- High blood sugar (hyperglycemia)
- A nerve disorder which may cause weakness, tingling, or numbness
- Cough, swelling of the gums
- Abdominal swelling (gastritis)
- Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect certain medical tests
- Increased muscle tension
- Inflammation of blood vessels, often with skin rashes
- Light sensitivity
- Disorders combining stiffness, tremor, and/or movement disturbances
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform 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 stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.
Store below 30°C and protect from light.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. ADDITIONAL INFORMATION
Composition of Zabart
The active substance in Zabart 5 mg tablets is amlodipine (as besilate).
The other components (excipients) are microcrystalline cellulose, calcium phosphate dibasic (dihydrate), sodium carboxymethyl starch from potato, colloidal anhydrous silica, and magnesium stearate.
Appearance of Zabart and contents of the pack
White or almost white, round, flat, smooth tablets on both sides.
Zabart 5 mg tablets are available in blister packs containing 28, 30, or 500 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
Further information on this medicinal product can be requested from 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 leaflet was approved in June 2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/