Amlodipine Mabo 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Amlodipine Mabo 5 mg tablets EFG

Read the entire leaflet carefully before you start taking 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Amlodipine Mabo is and what it is used for
2. What you need to know before taking Amlodipine Mabo
3. How to take Amlodipine Mabo
4. Possible side effects
5. How to store Amlodipine Mabo
6. Contents of the pack and other information

1. What Amlodipine Mabo is and what it is used for

Amlodipine Mabo contains as its active substance amlodipine (as besylate), which belongs to a group of medicines called calcium antagonists.

Amlodipine 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 pass through them more easily. In patients with angina, amlodipine 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. What you need to know before starting to take Amlodipine Mabo

Do not take Amlodipine Mabo

• If you are allergic to amlodipine or to any of the other components of this medicine (listed in section 6), or to other calcium antagonists. This may include symptoms such as itching, skin redness, or difficulty breathing.
• If you have very low blood pressure (hypotension).
• If you have narrowing of the heart's aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body).
• If you suffer from heart failure following a heart attack.

Warnings and precautions

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

• Recent heart attack.
• Heart failure.
• Increased blood pressure (hypertensive crisis).
• Liver disease.
• You are elderly and require an increase in dose.

Children and adolescents

Amlodipine has not been studied in children under 6 years of age. Amlodipine Mabo should only be used to treat hypertension in children and adolescents aged 6 to 17 years (see section 3). For further information, consult your doctor.

Other medicines and Amlodipine Mabo

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

Amlodipine Mabo may interact with or be affected by other medicines such as:

• Ketoconazole and itraconazole (antifungal medicines).
• Ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV).
• Rifampicin, erythromycin, clarithromycin (antibiotics: for infections caused by bacteria).
• Hypericum perforatum (St. John's wort).
• Verapamil, diltiazem (medicines for the heart).
• Dantrolene (intravenous infusion for serious disturbances in body temperature).
• Tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the function of your immune system).
• Simvastatin (a medicine to lower cholesterol).
• Cyclosporine (an immunosuppressant).

Amlodipine Mabo may further lower your blood pressure if you are already taking other medicines to treat high blood pressure.

Taking Amlodipine Mabo with food and drink

People taking Amlodipine must not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of amlodipine, which could lead to an unpredictable increase in the blood pressure-lowering effect of Amlodipine.

Pregnancy and breastfeeding

Pregnancy

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

Breastfeeding

It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or about to start breastfeeding, you must inform your doctor before taking Amlodipine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Amlodipine Mabo may affect your ability to drive or operate machinery. If the tablets make you feel unwell, dizzy or tired, or cause you to have headaches, do not drive or operate machinery and consult your doctor immediately.

3. How to take Amlodipine Mabo

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended starting dose is one 5 mg amlodipine tablet once daily. The dose may be increased to one 10 mg amlodipine tablet once daily.

This medicine may be taken before or after food and drinks. You should take your medicine every day at the same time with a glass of water. Swallow the tablet immediately with a glass of water. Do not take amlodipine with grapefruit juice.

Use in children and adolescents

For children and adolescents (6–17 years), the usual recommended starting dose is 2.5 mg daily.

The recommended maximum dose is 5 mg daily.

It is important to continue taking the tablets. Do not wait until you run out of tablets before seeing your doctor.

If you take more Amlodipine Mabo than you should

Taking too many tablets may cause your blood pressure to become low or even dangerously low. You may feel dizzy, lightheaded, experience postural hypotension when standing up, or weakness. Shock may occur if the drop in blood pressure is severe enough. You may feel your skin cold and clammy and lose consciousness. Seek immediate medical attention if you have taken too much amlodipine.

Excess fluid may accumulate in the lungs (pulmonary edema), causing breathing difficulties, which may develop within 24–48 hours after ingestion.

If you have taken too much Amlodipine Mabo, contact your doctor, an emergency service, or the Toxicology Information Service (telephone: 91.562.04.20), indicating the medicine and the amount ingested.

If you forget to take Amlodipine Mabo

Do not worry. If you forget to take a tablet, simply skip the missed dose. Take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Amlodipine Mabo

Your doctor will tell you how long you should take this medicine. If you stop taking this medicine too early, your symptoms may return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you experience any of the following adverse effects after taking this medicine, consult your doctor immediately.

• 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 difficulty breathing.
• Severe skin reactions including intense skin rash, hives, redness of the skin all over the body, severe itching, blisters, skin peeling and swelling, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, or other allergic reactions).
• Heart attack, abnormal heartbeats.
• Inflammation of the pancreas which may cause severe abdominal and back pain accompanied by a general feeling of discomfort.

The following very common adverse effects have been reported. If any of these cause you problems or if they last longer than one week, you should consult your doctor.

Very common: may affect more than 1 in 10 people

• Edema (fluid retention).

The following common adverse effects have been reported. If any of them cause you problems or if they last longer than one week, you should consult your doctor.

Common: may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the beginning of treatment).
• Palpitations (awareness of heartbeat), flushing.
• Abdominal pain, discomfort (nausea).
• Changes in bowel habits, diarrhea, constipation, indigestion.
• Tiredness, weakness.
• Visual disturbances, double vision.
• Muscle cramps.
• Swelling of ankles.

Other adverse effects listed below have also been reported. If any of them are severe, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.

Uncommon: may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia.
• Tremors, taste disturbances, fainting.
• Numbness or tingling sensation in the limbs; loss of pain sensation.
• Ringing in the ears.
• Low blood pressure.
• Sneezing/nasal congestion due to inflammation of the nasal mucosa (rhinitis).
• Cough.
• Dry mouth, vomiting (nausea).
• 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, breast discomfort or breast enlargement in men.
• Pain, feeling of discomfort.
• Joint or muscle pain, back pain.
• Weight gain or weight loss.

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

• Confusion.

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

• Decrease in white blood cell count, decrease in platelets in blood which may cause unusual bleeding or bruising.
• High blood sugar (hyperglycemia).
• Nerve disorders which 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 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.

Reporting of adverse effects

If you experience any type of adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine Mabo

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack and container after the abbreviation EXP. The expiry date is the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Amlodipine Mabo

• The active substance is amlodipine (as besylate). Each tablet contains amlodipine besylate equivalent to 5 mg of amlodipine.
• The other components are calcium hydrogen phosphate dihydrate, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silicon dioxide, and sodium carboxymethyl starch from potato (Type A).

Appearance of the medicinal product and contents of the container

White to off-white, round (8.73–8.93 mm), biconvex tablets, marked with "5" on one side.

Amlodipine Mabo 5 mg tablets are available in PVC-PVDC/Aluminum blisters containing 30 tablets.

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Vía de los Poblados, 3,

Edificio 6, 28033 Madrid,

Spain.

Manufacturer

PharmaS d.o.o.

Industrijska cesta 5

44317 Potok, Popovaca

Croatia

Date of the most recent revision of this leaflet: July 2022

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