AMLODIPINE COMBIX 10 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amlodipine Combix 10 mg tablets EFG

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

• Keep this leaflet, as 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. See section 4.

Contents of the pack:

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

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

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

Amlodipine Combix is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, including a rare type 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, Amlodipine Combix 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 Amlodipine Combix

Do not take Amlodipine Combix

• 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.

Be careful with Amlodipine Combix

You should inform your doctor if you have or have had any of the following diseases:

• 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

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

Amlodipine Combix 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 perfusion for severe body temperature abnormalities)

If you are already taking other medicines to treat high blood pressure, Amlodipine Combix may lower your blood pressure even more.

Taking Amlodipine Combix with food and drinks

People taking Amlodipine Combix 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 Amlodipine Combix.

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 should inform your doctor before taking Amlodipine Combix.

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 Amlodipine Combix.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Amlodipine Combix 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.

3. How to take Amlodipine Combix

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 Amlodipine Combix, once a day. The dose can be increased to 10 mg of Amlodipine Combix, 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 Amlodipine Combix with grapefruit juice.

Use in children and adolescents

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

Amlodipine 2.5 mg is not currently available, and a dose of 2.5 mg cannot be obtained with Amlodipine Combix 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 Amlodipine Combix than you should

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing, which can develop up to 24-48 hours after ingestion.

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. If the drop in blood pressure is severe, it can cause shock. You may feel your skin cold and sweaty, and you could lose consciousness. If you take too many Amlodipine Combix tablets, consult your doctor immediately or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Amlodipine Combix

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 Amlodipine Combix

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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Amlodipine Combix 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 patients in 100

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

Other side effects have been reported, which are included in the following list. If you think you are suffering from any of the side effects that are not listed in this leaflet, inform your doctor or pharmacist.

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

• Mood changes, anxiety, depression, insomnia
• Tremors, taste disturbances, fainting, weakness
• Numbness or tingling in the limbs, loss of pain sensation
• Visual disturbances, double vision, ringing in the ears
• Decrease in 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 breast enlargement in men
• Weakness, pain, feeling unwell
• Muscle or joint pain, muscle cramps, back pain
• Weight gain or loss

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

• Confusion

Very rare:affects less than 1 patient in 10,000

• Decrease in white blood cell count, decrease in blood platelets, which can cause easy bleeding or unusual bruising (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, tremors, and/or movement disorders

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that the side effects are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine Combix

Keep out of the reach and sight of children.

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place the cartons and any remaining medicines in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the cartons and any remaining medicines. This will help protect the environment.

6. Further information

Composition of Amlodipine Combix

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

• The other ingredients are microcrystalline cellulose (E460i), sodium starch glycolate (potato starch), anhydrous colloidal silica (E551), and magnesium stearate (E470b).

Appearance of Amlodipine Combix and pack contents

White or almost white, round tablets, marked with "AM10" on one side and smooth on the other.

Amlodipine Combix 10 mg tablets are available in blister packs containing 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Pharmex Advanced Laboratories, S.L.

Ctra. A-431 Km. 19

14720 Almodóvar del Río (Córdoba)

Spain

This leaflet was approved in July 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/