Prospect: information for the patient

Amlodipino STADA 10 mg tablets EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-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 only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Amlodipino Stada and for what it is used

2.What you need to know before starting to take Amlodipino Stada

3.How to take Amlodipino Stada

4.Possible adverse effects

5.Storage ofAmlodipino Stada

6.Contents of the package and additional information

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

Amlodipino Stadais 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 Stadaimproves blood flow to the heart muscle, which receives more oxygen as a result, and thus prevents chest pain. This medicine does not provide immediate relief from chest pain due to angina.

Do not takeAmlodipino Stada

• If you are allergic to amlodipine, or any of the other ingredients in 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) in your heart 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 Stada. 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

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

Other medicines and Amlodipino Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

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

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat HIV/AIDS)

• rifampicin, erythromycin, clarithromycin (antibiotics - for bacterial infections)

• Hypericum perforatum (St. John's Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (for severe body temperature abnormalities)
• simvastatin (medicine that reduces high blood cholesterol levels)

• tacrolimus (used to control the body's immune response allowing it to accept the transplanted organ)
• ciclosporin (immunosuppressant)

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

Taking Amlodipino Stada with food and drinks

People taking Amlodipino Stada 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 amlodipine, which may cause an unpredictable increase in the blood pressure-lowering effect of Amlodipino Stada.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

The safety of amlodipine during pregnancy has not been established.

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 amlodipine.

Driving and operating machinery

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

Amlodipino Stada contains sodium

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

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

The recommended initial dose is 5 mg of Amlodipino Stada, once a day. The dose can be increased to 10 mg of Amlodipino Stada, once a day.

The 10 mg Amlodipino Stada tablet can be divided into equal doses.

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 Stada 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. The maximum recommended dose is 5 mg per day.

Amlodipino 2.5 mg is not currently available and the 2.5 mg dose cannot be obtained with Amlodipino Stada 5 mg since the tablets cannot be divided into equal 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 Stada than you should

Consuming too many tablets can 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 can cause shock. You may feel your skin is cold and moist and could lose consciousness.

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

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 Stada

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 Stada

Your doctor will indicate for how long you should take this medication. Your condition may recur 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 doctorimmediatelyif you experience any of the following serious side effects 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 severe 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, 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 strong feeling of discomfort.

The following side effect has been reported as very frequent. 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)

Frequent (may affect up to 1 in 10 people)

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (feeling heartbeats), 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. If you consider that any of the side effects you experience 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 people):

• Changes in mood, anxiety, depression, insomnia
• Tremors, taste disturbances, fainting
• Numbness or tingling in the extremities, loss of pain sensation
• Ringing in the ears
• Decreased blood pressure
• Nasal discharge and sneezing 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 people):

• Confusion

Very rare (affects fewer than 1 in 10,000 people):

• Decreased white blood cell count, decreased platelet count that may cause easy bleeding or unusual bruising (damage to red blood cells)
• High blood sugar (hyperglycemia)
• A disorder of the nerves that may cause muscle weakness, numbness, or tingling
• 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
• Movements combining rigidity, tremors, and/or movement disorders

Frequency unknown(cannot be estimated from available data):

• Tremors, rigid posture, "mask-like" face, slow movements, and unsteady gait with dragging feet.

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 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 this medication out of the 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.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need 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 Stada

-The active ingredient is amlodipine (as besilate). Each tablet contains 10 mg of amlodipine (as besilate).

-The other components are microcrystalline cellulose (E460), calcium hydrogen phosphate (E341), sodium starch glycolate from potato, and magnesium stearate (E470b).

Appearance of the product and contents of the package

Amlodipino Stada 10 mg are white, circular tablets with a notch on one side. The tablet can be divided into equal doses.

The packages contain 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 100, or 120 tablets or 7x1, 10x1, 14x1, 15x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 100x1, or 120x1 tablets in perforated unit-dose blisters.

Only some package sizes may be marketed.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Manufacturer responsible

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel (Germany)

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary (Ireland)

or

Specifar S.A.

1, 28 Octovriou Str.

Ag. Varvara 123 51,

Athens (Greece)

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna (Austria)

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medicinal product is authorized in the Member States of the EEA with the following names:

Austria:Amlodipin besilat STADA10 mg Tabletten

Denmark:Amlodistad

Germany:Amlodipin AL10 mg Tabletten

Spain:Amlodipino STADA10 mg comprimidos EFG

Ireland:Amlodipine Clonmel10 mg tablets

Portugal:Pineam

Sweden:Amlodistad

Date of the last review of this leaflet:August 2022

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