Package Leaflet: Information for the User

Amlodipino Tarbis Farma 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isAmlodipino Tarbis Farmaand what it is used for

2. What you need to know before you start takingAmlodipino Tarbis Farma

3. How to takeAmlodipino Tarbis Farma

4. Possible side effects

5. Storage ofAmlodipino Tarbis Farma

6. Contents of the pack and additional information

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

AmlodipinoTarbis Farmais 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, amlodipine improves blood flow to the heart muscle, which receives more oxygen as a result, and this prevents chest pain. This medicine does not provide immediate relief from chest pain due to angina.

Do not take AmlodipinoTarbis Farma

• 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.
• 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 disease in which the heart is unable to pump enough blood to the body).
• If you suffer from heart failure after a heart attack.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication. You must inform your doctor if you have or have had any of the following diseases:

• 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 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 aged 6 to 17 years (see section 3).

For more information, consult your doctor.

Use of Amlodipino Tarbis Farmawith other medications

Inform your doctor or pharmacist if you are using or have used recently or may take other medications.

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 infusion 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, amlodipino may lower your blood pressure even further.

Taking Amlodipino Tarbis Farmawith food and drinks

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

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.

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.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

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

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

*Amlodipino Tarbis Farma is not suitable when a dose of 2.5 mg is needed. For this dose, other alternative products are available.

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 Tarbis Farmathan 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 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, indicating the medication and the amount ingested.

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

If you forgot to take Amlodipino Tarbis Farma

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 Tarbis Farma

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 questions 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.

See your doctorimmediatelyif 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 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 great sense of discomfort

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

Very common: may affect more than 1 in 10 people

• Edema (fluid retention)

The followingcommon side effectshave been reported. If any of these cause problems orlast 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 of discomfort (nausea)
• Alteration of bowel habit, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

The following other side effects 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.

Uncommon: may affect up to 1 in 100 people

• Changes in mood, anxiety, depression, insomnia
• Tremor, alterations in taste, fainting
• Numbness or tingling sensation in the extremities, loss of pain sensation
• Ringing 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 frequency of urination
• Impotence, discomfort or breast tenderness in men
• Pain, 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 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
• Gingivitis
• Abdominal swelling (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that may affect some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin eruptions
• Sensitivity to light
• Movement disorders combining rigidity, 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 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 the 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 the packaging and medications you no longer need. This will help protect the environment.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from light.

Composition of Amlodipino Tarbis Farma

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

The other components are microcrystalline cellulose (E460), anhydrous colloidal silica (E551), and magnesium stearate (E470b).

Appearance of the product and content of the container

10 mg tablets: white to off-white colored, round, biconvex tablets, engraved with a “J” on one face, and with a “10” on the other.

This medication is available in aluminum – PVC/PVDC blisters in boxes of 14, 20, 28, 30, 50, 90, 100, 105 tablets

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

PLA 3000 Paola

Malta

Amarox Pharma B.V.

Rounoslaan 32

Voorschoten, 2252TR

Netherlands

This medication is authorized in the member states of the European Economic Area with the following names:

NetherlandsAmlodipine ARX 5mg, 10mg tabletten

GermanyAmlodipin Amarox 5mg, 10mg Tabletten

ItalyAmlodipina Amarox

SpainAmlodipino Tarbis Farma 5mg, 10 mg comprimidos EFG

SwedenAmlodipin Amarox 5mg, 10mg Tablett

Last review date of this leaflet: FEBRUARY 2023

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