Package Insert: Information for the User

Amlodipino TAD 5 mg Tablets EFG

Amlodipino TAD 10 mg Tablets EFG

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should 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 package insert. See section 4.

Amlodipinocontains the active substance amlodipino thatbelongs to a group of medications known ascalcium antagonists.

Amlodipinoisusedto treathigh blood pressure(hypertension)in adults, adolescents, and children over 6 years old,ora certain typeofchest pain called angina in adults, which includes a less common type calledPrinzmetal's anginaorvariant angina.

In patients with high blood pressure, this medication works by relaxing blood vessels, allowing blood to flow through them more easily. In patients with angina, amlodipino improves blood flow to the heart muscle, which receives more oxygen as a result, and as a result, chest pain is prevented. This medication does not provide immediate relief from chest pain due to angina.

Do not take Amlodipino TAD if:

• You are allergic 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, skin redness, or difficulty breathing.
• You have very low blood pressure (severe hypotension).
• 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).
• You suffer from heart failure after a heart attack.

Warnings and precautions

Consult your doctor or pharmacist before starting to take amlodipino.

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

Other medications and Amlodipino TAD

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, even those purchased without a prescription.

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

• ketoconazol, itraconazol (antifungal medications)
• ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat AIDS)
• rifampicina, eritromicina, claritromicina (antibiotics)
• Hypericum perforatum(St. John's Wort)
• verapamilo, diltiazem (heart medications)
• dantroleno (in perfusion for severe body temperature abnormalities)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medications used to modify the functioning of the immune system)
• simvastatina (cholesterol-lowering medication)
• ciclosporina (immunosuppressant)

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

Taking Amlodipino TAD with food and drinks

People taking amlodipino 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.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

The safety of amlodipino during pregnancy has not been established. If you think you may be pregnant or intend to become pregnant, you must inform your doctor before taking this medication.

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 this medication.

Driving and operating machinery

This medication 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 TAD contains sodium

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 recommended 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 this 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 recommended initial dose is usually 2.5 mg per day only for hypertension indication. The maximum recommended dose is 5 mg per day. The 5 mg tablet can be divided into equal halves.

It is essential not to interrupt the administration of the tablets. Do not wait for the tablets to run out before consulting your doctor.

If you take more Amlodipino TAD 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. Seek immediate medical attention if you have taken too many tablets of this medication.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Amlodipino TAD

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 doses.

If you interrupt treatment with Amlodipino TAD

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, ask your doctor or pharmacist.

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

Go to your doctor immediately if you experience any of the following side effects 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, blisters, skin redness all over the body, severe itching, blister formation, skin peeling, and skin inflammation, inflammation of 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 great discomfort.

The following side effects have also been reported.

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 patients

• Edema (fluid retention)

The following 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 patients

• 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, 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.

Frequent: may affect up to 1 in 100 patients

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting
• Numbness or tingling 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
• Urination disorders, increased need to urinate at night, increased frequency of urination
• Impotence, discomfort or breast tenderness in men
• Pain, feeling of discomfort
• Muscle or joint pain, back pain
• Weight gain or loss

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

• Confusion

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

• Decreased white blood cell count, decreased platelet count that may cause easy bleeding or unusual bruising
• High blood sugar (hyperglycemia)
• A disorder of the nerves that may cause muscle weakness, numbness, or tingling (peripheral neuropathy)
• Gingivitis, bleeding gums
• Abdominal swelling (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that may affect some medical tests
• Increased muscle tension (hypertonia)
• Inflammation of blood vessels, often with skin eruptions (vasculitis)
• Sensitivity to light

Frequency not known: cannot be estimated from available data

• Tremor, stiff posture, mask-like face, slow movements, and a dragging and unsteady gait

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible 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:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

This medication does not require any special storage temperature

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGREpointofyour pharmacy. If in 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 of Amlodipine TAD

• The active ingredient is amlodipine.

Amlodipine TAD 5 mg tablets EFG

Each tablet contains 5 mg of amlodipine (as amlodipine besilate).

Amlodipine TAD 10 mg tablets EFG

Each tablet contains 10 mg of amlodipine (as amlodipine besilate).

• The other components (excipients) are: microcrystalline cellulose (E460), pregelatinized maize starch, carboxymethylstarch sodium (type A) (potato), anhydrous colloidal silica and magnesium stearate (E470b).

See section 2 “Amlodipine TAD contains sodium”.

Appearance of Amlodipine TAD and packaging contents

Amlodipine TAD 5 mg tablets EFG:

The tablets are white, round (diameter 8 mm), slightly biconvex with bisected edges, scored on one face.

The tablet can be divided into equal doses.

Amlodipine TAD 10 mg tablets EFG:

The tablets are white, round (diameter 11 mm), slightly biconvex with bisected edges.

The tablets are available in carton boxes in:

• Unscored blisters of 28, 30 and 90 tablets
• Single-dose perforated blisters of 28 x 1, 30 x 1 and 90 x 1 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

TAD Pharma GmbH

Heinz-Lohmann-Straße 5

27472 Cuxhaven

Germany

Manufacturers

TAD Pharma GmbH

Heinz-Lohmann-Straße 5

27472 Cuxhaven

Germany

or

KRKA, d. d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the member states of the European Economic Area and the United Kingdom (Northern Ireland) with the following names:

Last review date of this leaflet:March 2023

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