Leaflet: information for the user

Amlodipine pensa pharma5 mg tablets EFG

Amlodipine besilate

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, 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 isAmlodipine Pensa Pharmaand for what it is used

2. What you need to know before starting to takeAmlodipine Pensa Pharma

3. How to takeAmlodipine Pensa Pharma

4. Possible side effects

5. Storage ofAmlodipine Pensa Pharma

6. Contents of the pack and additional information

This medicationcontains the active substance amlodipino which belongs to a group of medicines known as calcium antagonists.

Amlodipinois used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, including a less common type known as Prinzmetal's angina or variant 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 consequence, prevents chest pain. This medication does not provide immediate relief from chest pain due to angina.

Do not take Amlodipino Pensa Pharma

• If you are allergic to amlodipine, or to any of the other ingredients 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 amlodipine.

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. Amlodipine 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 Pensa Pharma with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

Amlodipine may affect or be affected by other medications, 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 (intravenous for severe body 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, amlodipine may lower your blood pressure even further.

Taking Amlodipino Pensa Pharma with food and drinks

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

Pregnancy and breastfeeding

Pregnancy

The safety of amlodipine 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 amlodipine.

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.

Consult your doctor or pharmacist before taking 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 Pensa Pharma contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which means it is 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 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 5 mg tablets can be divided into equal parts 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 Pensa Pharma than you should

Consuming too many tablets can cause a drop in blood pressure or even a severe 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 clammy 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. If you take too many amlodipino tablets, consult your doctor immediately or call the Toxicological Information Service, phone 91 562 04 20.

If you forgot to take Amlodipino Pensa Pharma

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 Pensa Pharma

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 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.

Seek medical attention immediately if you experience any of the following side effects after taking this medicine.

• Sudden wheezing while breathing (sudden onset of wheezing), 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 feeling of severe 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)

The following side effects have been reported as frequent. If any of these cause problems or last more than a week, consult your doctor.

Frequent: 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 habits, 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.

Rare: 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
• Urination 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

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

Store below 25 °C, store in the original packaging to protect it from light.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Amlodipino Pensa Pharma 5 mg tablets EFG

The active ingredient is amlodipine (as besilate). Each tablet contains besilate of amlodipine equivalent to 5 mg of amlodipine.

The other components aremicrocrystalline cellulose, dihydrate calcium hydrogen phosphate, sodium carboxymethyl cellulose Type A and magnesium stearate.

Appearance of the product and content of the packaging

White or almost white, oblong tablets with a notch on one face.

Amlodipino Pensa Pharma 5 mg Tablets EFG is available in blisters containing 30 tablets.

Holder of the marketing authorization, manufacturer

Holder of the marketing authorization:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

Bluepharma - Indústria Farmacêutica, S. A.

S. Martinho do Bispo,

3045-016 Coimbra

Portugal

Last review date of this leaflet:June 2022

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