PROSPECTO : INFORMATION FOR THE USER

Amlodipino Combix 5 mg tablets EFG

Read this prospect carefully before starting to take the medicine.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult 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 that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this prospect, inform your doctor or pharmacist. See section 4.

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

Amlodipino Combix 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, Amlodipino Combix 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 Amlodipino Combix

• 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 Amlodipino Combix

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

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

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Amlodipino Combix 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, Amlodipino Combix may lower your blood pressure even further.

Taking Amlodipino Combix with food and drinks

People taking Amlodipino Combix 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 Amlodipino 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 must inform your doctor before taking Amlodipino Combix.

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 Amlodipino Combix.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

Amlodipino Combix 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.

Always take your medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.

The usual initial dose is 5 mg of Amlodipino Combix, once a day. The dose may be increased to 10 mg of Amlodipino Combix, once a day.

You can take your medicine before or after meals. It should be taken at the same time every day, with a glass of water. Do not take Amlodipino Combix 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 per day. The maximum recommended dose is 5mg per day.

Amlodipino 2.5 mg is currently not available and the 2.5 mg dose cannot be obtained with the Amlodipino Combix 5 mg tablets as 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 Amlodipino Combix than you should

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing that may develop within 24-48 hours after ingestion.

Consuming too many tablets may cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, disoriented, experience postural dizziness when standing up, or weakness. If the drop in blood pressure is severe enough, it may cause shock. You may feel your skin is cold and moist, and you could lose consciousness. If you take too many Amlodipino Combix tablets, consult your doctor immediately or call the Toxicological Information Service, phone 91 562 04 20.

If you forget to take Amlodipino 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 compensate for the missed dose.

If you interrupt treatment with Amlodipino Combix

Your doctor will instruct you for how long you should take this medicine. Your condition may recur 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 medicines, Amlodipino Combix may cause side effects, although not everyone will experience them.

See your doctorimmediatelyif you experience any of the following serious side effects, which are very rare after taking this medicine.

• Sudden hissing sounds when 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, skin inflammation, mucous membrane 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 severe discomfort

The followingcommon side effectshave been reported. If any of these cause problems or last more than a week, consult your doctor.

Common:affect between 1 and 10 in 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 ofankles (edema), fatigue

The following side effects have also been reported. If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

• Changes in mood, anxiety, depression, insomnia
• Trembling, 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 habit, diarrhea, constipation, indigestion, dry mouth, vomiting (discomfort)
• Hair loss, increased sweating, itching skin, red spots on the skin, skin discoloration
• Urinary 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 in every 10,000 patients

• Confusion

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

• Decreased white blood cell count, decreased platelet count that may cause easy bleeding or unusual bruising (red blood cell damage)
• High blood sugar (hyperglycemia)
• A disorder of the nerves that may cause weakness, tingling, or numbness
• Cough, gum inflammation
• Abdominal swelling (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellow skin discoloration (jaundice), increased liver enzymes that may affect some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin eruptions
• Sensitivity to light
• Movementscombining stiffness, trembling, and/or movement disorders

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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.

No special storage conditions are required.

Do not dispose of medications through drains or trash. Deposit empty packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Amlodipino Combix

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

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

Appearance of Amlodipino Combix and packaging contents

White or almost white, round, marked with “AM5” on one side and smooth on the other.

Amlodipino Combix 5 mg tablets are available in blister packaging containing 30 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible manufacturer

Pharmex Advanced Laboratories, S.L.

Ctra. A-431 Km. 19

14720 Almodóvar del Río (Córdoba)

Spain

This leaflet was approved in July 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/