Label: information for the user

Amlodipino TecniGen 10 mg tablets EFG

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication 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 experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Amlodipino TecniGen contains the active ingredient amlodipine which belongs to a group of medicines called calcium antagonists.

Amlodipine 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 the walls of blood vessels so that blood flows more easily. In patients with angina, Amlodipino TecniGen improves the delivery of blood 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 TecniGen:

• If you are allergic (hypersensitive) to amlodipine or 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.
• 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 the body).

body).

• If you suffer from heart failure after a heart attack

Warnings and precautions

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

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 TecniGen 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 TecniGen with other medications

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

Amlodipino TecniGen may affect or be affected by othermedications, 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 (in infusion for severe body temperature abnormalities)

• tacrolimus (medication used to alter the way your immune system works)

?simvastatin (medication that reduces cholesterol)

?ciclosporin (immunosuppressant)

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

Useof Amlodipino TecniGen with food, drinks, or alcohol

People taking Amlodipino TecniGen 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 lead to unpredictable lowering of blood pressure by Amlodipino TecniGen.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

The safety of amlodipine in pregnant women has not been established yet.

Breastfeeding

Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding or want to start breastfeeding, talk to your doctor before taking amlodipine.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Information on sodium content

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

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

The recommended initial dose is 5 mg of Amlodipino TecniGen, once a day. The dose can be increased to 10 mg of Amlodipino TecniGen, 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 TecniGen with grapefruit juice.

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

Use in children and adolescents

The usual starting dose recommended for children and adolescents (6 to 17 years old) is 2.5 mg per day. The maximum daily recommended dose is 5 mg. Amlodipino TecniGen 5 mg tablets can be divided into two equal doses to provide 2.5 mg doses.

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 TecniGen 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 you could lose consciousness. If you take too many Amlodipino TecniGen tablets, consult your doctor immediately or call the Toxicological Information Service, phone 91 562 04 20.

If you forgot to take Amlodipino TecniGen:

Do not worry. If you forgot to take a tablet, forget about that dose completely. Take your next dose at the recommended time. Do not take a double dose to compensate for the missed doses.

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

Go to your doctorimmediatelyif you experience any of the following side effects after taking this medicine:

?Wheezing or sudden hissing sounds when breathing (sibilant breathing), 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, 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 great discomfort

The followingvery common side effecthas been reported. If this causes problems or if it lasts more than a week,consult your doctor.

Very common: may affect more than 1 in 10 people

?Swelling of the ankles (edema)

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

Common: 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 unwell (nausea)

?Alteration of bowel habit, diarrhea, constipation, indigestion

?Fatigue, weakness

?Visual disturbances, double vision

?Muscle cramps

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

Uncommon: may affect up to 1 in 100 people

?Changes in mood, anxiety, depression, insomnia

?Tremor, taste disturbances, fainting, weakness

?Numbness or tingling in the extremities, loss of pain sensation

?Tinnitus (ringing in the ears)

?Decreased blood pressure

?Nasal congestion and 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

?Urination disorders, increased need to urinate at night, increased frequency of urination

?Impotence, discomfort or breast tenderness in men

?Pain, discomfort

?Muscle or joint pain, 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 white blood cell count, decreased platelet count that can cause easy bleeding or unusual bruising (damage to red blood cells)

?Hyperglycemia (excess sugar in the blood)

?A disorder of the nerves that can cause weakness, numbness, or tingling

?Gingivitis (inflammation of the gums)

?Abdominal swelling (gastritis)

?Abnormal liver function, hepatitis (inflammation of the liver), yellowing of the skin (jaundice), increased liver enzymes that can affect some medical tests

?Increased muscle tension

?Inflammation of blood vessels, often with skin eruptions

?Sensitivity to light

?Movement disorders combining stiffness, tremor, and/or movement disorders

Reporting of 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 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 store at a temperature above25°C.

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.

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

Composition of Amlodipino TecniGen 10 mg tablets

• The active ingredient is amlodipine (as besilate).
• The other components are:

potato starch sodium glycolate,

microcrystalline cellulose,

lactose monohydrate,

magnesium stearate.

Appearance of the product and content of the packaging

Amlodipino TecniGen 10 mg are white, round, flat, and marked on one side.

Each package contains 10, 14, 20, 28, 30, 60, 100, or 500 tablets.

Only some package sizes may be commercially marketed.

Other presentations

Amlodipino TecniGen 5 mg tablets EFG

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica S.A.

Avda. de Bruselas, 13, 3rd floor. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) SPAIN

Responsible manufacturer

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande nº 2, Abrunheira. 2710 – 089 Sintra (Portugal).

This leaflet does not contain all the information about the medicine. If you have any questions or are unsure about something, consult your doctor or pharmacist.

This medicine is authorized in the Member States of the EEA under the following names:

Portugal: Amlodipina Tecnimede 5 mg/10 mg tablets

Spain: Amlodipino Tecnigen 5 mg/10 mg tablets EFG

Last review date of this leaflet: March 2023

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