Leaflet: information for the user

Amlodipino Almus 10 mg tablets EFG

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What isAmlodipino Almusand what it is used for

2.What you need to know before you start takingAmlodipino Almus

3.How to takeAmlodipino Almus

4.Possible side effects

5.Storage ofAmlodipino Almus

6. Contents of the pack and additional information

Amlodipino Almuscontains the active substance amlodipine whichbelongs to a group of medicines known ascalcium antagonists.

Amlodipino Almusisusedto treathigh blood pressure(hypertension)or a certain typeofchest pain called angina, including a less common type known asPrinzmetal's anginaor 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 Almus improves blood flow to the heart muscle, which receives more oxygen as a result, and this helps to prevent chest pain. This medicine does not provide immediate relief from chest pain due to angina.

Do not take Amlodipino Almus

• If you are allergic (hypersensitive) to amlodipino, or to any of the other components of this medication (listed in section 6), or to any other calcium antagonist. This may cause itching, redness of the skin, 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 condition in which the heart is unable to pump enough blood to the body).
• If you have heart failure after a heart attack.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amlodipino Almus.

You must 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 an elderly person and your dose needs to be increased

Children and adolescents

Amlodipino Almus has not been studied in children under 6 years of age.Amlodipino Almus should only be used to treat high blood pressure in children and adolescents aged 6 to 17 years (see section 3).

For more information, consult your doctor.

Use of Amlodipino Almus with other medications

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

Amlodipino Almus may affect or be affected by other medications, such as:

• ketoconazole, itraconazole (antifungal medications)
• ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat HIV/AIDS)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum (St. John's Wort)
• verapamil, diltiazem (heart medications)
• dantrolene (intravenous for severe temperature anomalies)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medications used to modify the functioning of the immune system)
• simvastatin (cholesterol-lowering medication)
• ciclosporin (immunosuppressant)

If you are already taking other medications to treat high blood pressure, Amlodipino Almus may lower your blood pressure even further.

Taking Amlodipino Almus with food and drinks

People taking Amlodipino Almus should not consume grapefruit or grapefruit juice.This is because grapefruit and grapefruit juice may cause an increase in the blood levels of the active ingredient amlodipino, which may cause an unpredictable increase in the effect of lowering blood pressure of Amlodipino Almus.

Pregnancy and breastfeeding

Pregnancy

The safety of amlodipino 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 Almus.

Breastfeeding

Amlodipino 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 Almus.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

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

Amlodipino Almus 10 mg tablets contain lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual initial dose is 5 mg of amlodipino, once a day. The dose can be increased to 10 mg of amlodipino, once a day.

You can take your medication before or after meals. It should be taken at the same time every day, with a glass of water. Do not take amlodipino 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 5 mg per day.

A 5 mg Amlodipino Almus tablet is available that can be divided into equal doses to provide 2.5 mg doses.

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 Almus than you should

Consuming too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, dazed, experience postural dizziness when standing up, or weakness.

If the drop in blood pressure is severe, it can cause shock. You may feel your skin is cold and wet, and you could lose consciousness.

If you take too many amlodipino tablets, consult your doctor immediately or call the Toxicological Information Service, phone 91 562 04 20.

Excess fluid can accumulate in the lungs (pulmonary edema) causing breathing difficulties that can develop up to 24-48 hours after consumption.

If you forget to take Amlodipino Almus

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 Almus

Your doctor will indicate for how long you should take this medication. Your condition may reappear if you stop taking this medication before your doctor tells you to.

If you have any other doubts about the use of this medication, consult your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Consult your doctor immediately if you experience any of the following severe 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 great difficulty breathing
• Severe skin reactions that include intense skin rash, hives, redness of the skin all over the body, intense itching, blister formation, peeling, and inflammation of the skin, inflammation of the mucous membranes (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 a great sense of discomfort

The following very frequent side effect has been reported. If this causes problems or lasts more than a week, consult your doctor.

Very frequent (may affect more than 1 in 10 people)

• Edema (fluid retention)

The following frequent side effects have been reported.If any of these cause problems or last more than a week, consult your doctor.

Frequent (may affect up to 1 in 10 people)

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (feeling the heartbeat), shortness of breath
• Abdominal pain, feeling of discomfort (nausea)
• Alteration of bowel habit, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

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

Rare (may affect up to 1 in 100 people)

• Mood changes, anxiety, depression, insomnia
• Tremor, alterations of taste, fainting
• Numbness or tingling sensation in the extremities, loss of pain sensation
• Tinnitus in the ears
• Decreased blood pressure
• Runny nose/ nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• Cough
• 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 number of times to urinate
• Impotence, discomfort or increased breast size in men
• Bad smell, feeling of discomfort
• Pain in the muscles or joints, back pain
• Weight gain or loss

Rare (may affect up to 1 in 1,000 people)

• Confusion

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

• Decreased number of white blood cells in the blood, decreased platelets in the blood that can cause easy bleeding or unusual bruises
• High blood sugar (hyperglycemia)
• A disorder of the nerves that can cause muscle weakness, numbness, or tingling
• Inflammation of the gums, bleeding gums
• Abdominal swelling (gastritis)

• Abnormal liver function, inflammation of the liver (hepatitis), yellow discoloration of the skin (jaundice), increased liver enzymes that can affect some medical tests
• Increased muscle tension
• Inflammation of the blood vessels, often with skin eruptions
• Sensitivity to light
• Movements combining rigidity, tremor, and/or movement disorders

Frequency unknown (cannot be estimated from available data)

• Tremors, stiff posture, face with a mask-like appearance, slow movements, and a dragging and unbalanced gait

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect not mentioned in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use. Website:www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach 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.

Do not store at a temperature above 25 °C.

Medications should not be disposed of through drains or trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so,you will help protect the environment.

Composition ofAmlodipino Almus

The active ingredient of Amlodipino Almus 10 mg tablets is amlodipine (as besilate).

• The other components are:carboxymethylcellulose sodium (from potato), microcrystalline cellulose E 460i, lactose monohydrate, magnesium stearate E 470b.See section 2Amlodipino Almus 10 mg tabletscontains lactose and sodium.

Appearance of Amlodipino Almus and contents of the packaging

White, round, flat, and marked on one face tablets.

The tablet can be divided into equal doses.

Amlodipino Almus10mg tabletsareavailablein blister packs containing30tablets.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Manufacturer responsible

West Pharma - Producções de Especialidades Farmacêuticas, S.A.

Rua João de Deus, nº 11, Venda Nova.

2700 Amadora, Portugal

Atlantic Pharma - Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2, Abrunheira

2710-089 Sintra

Portugal

Last review date of this leaflet: May 2024

The detailed and updated informationof this medicine is available on thewebsiteoftheSpanish Agency of Medicines and Medical Devices(AEMPS)http://www.aemps.gob.es/