Leaflet: information for the user

Amlodipino Almus 5 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 is Amlodipino Almus and what is it used for

2.What you need to know before you start taking Amlodipino Almus

3.How to take Amlodipino Almus

4.Possible side effects

5.Storage of Amlodipino 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 type of chest pain called angina, which includes 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 pass 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 prevents 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 thismedication(including those listed in section6),or to any other calcium antagonist.This may causehives,redness of the skin, or difficulty breathing
• If you have very low blood pressure (hypotension)
• If you have a narrowing of the aortic valve in your heart (aortic stenosis) or cardiogenic shock (a condition in which your heart is unable to pump enough blood to your 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 high 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 from6 to 17 years of age (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 over the counter.

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

• ketoconazole, itraconazole (antifungal medications)
• ritonavir, indinavir, nelfinavir(also known as 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 abnormalities)
• 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 levels of the active ingredient amlodipino in the blood,which may lead to 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,or dizzy,or tired,or give you a headache,do not drive or use machinery and consult your doctor immediately

Amlodipino Almus 5 mg tabletscontainlactose and sodium

If your doctor has told you that you have a certain sugar intolerance,consult with them before taking this medication

This medication contains less than 1 mmolof sodium (23 mg) per tablet;essentially "sodium-free"

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of 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 this medication 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. The tablet can be divided into equal doses to provide a dose of 2.5 mg.

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 tablets of this medication, 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 forgot to take Amlodipino Almus

Do not worry. If you forgot 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 disease 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 can cause side effects, although not everyone will experience them..

Seek medical attention immediately if you experience any of the following severe side effects, which are very rare after taking this medicine.

• Sudden hissing sounds while 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, blisters, widespread redness of the skin, intense itching, blister formation, peeling, and skin inflammation, or inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
• Heart attack, abnormal heart rhythm
• Inflammation of the pancreas 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 (can 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 (can 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, sense 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, which 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 leaflet, inform your doctor or pharmacist.

Rare (can affect up to 1 in 100 people)

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting
• Numbness or tingling sensation in the extremities, loss of pain sensation
• Ringing in the ears
• Decreased blood pressure
• Nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting (discomfort)
• Hair loss, increased sweating, skin itching, red spots on the skin, skin discoloration
• Urinary tract disorder, increased need to urinate at night, increased frequency of urination
• Impotence, discomfort or breast tenderness in men
• Bad taste, sense of discomfort
• Muscle or joint pain, back pain
• Weight gain or loss

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

• Confusion

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

• Decreased number of white blood cells, decreased platelets in the blood that can cause easy bleeding or unusual bruising
• High blood sugar (hyperglycemia)
• A disorder of the nerves that can cause muscle weakness, numbness, or tingling
• Inflammation of the gums, gum bleeding
• 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
• Movement disorders combining rigidity, tremor, and/or movement disorders

Frequency unknown (cannot be estimated from available data)

• Tremors, rigid posture, mask-like face, 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 leaflet.You can also report them directly through the Spanish System for the 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.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medicines at the SIGRE collection point of the pharmacy.Ask your pharmacist if you are unsure how to dispose of unused packaging and medicines. By doing so,you will help protect the environment.

Composition ofAmlodipino Almus

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

• The other components are: carboxymethylstarch sodium (from potato), microcrystalline cellulose E 460i, lactose monohydrate, magnesium stearate E 470b.See section 2Amlodipino Almus 5 mg tablets containlactose and sodium.

Appearance of Amlodipino Almus and content of the container

White, round, flat, and marked on one side.

Amlodipino Almus5mg tabletsare availablein blister packscontaining30tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Responsible manufacturer

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 detailedand updatedinformation of this medicine is available on the websiteofthe Spanish Agency of Medicines and Medical Devices(AEMPS)http://www.aemps.gob.es/