AMLODIPINE PENSA PHARMA 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Amlodipine Pensa Pharma5 mgtablets EFG

Amlodipine besylate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Amlodipine Pensa Pharma and what is it used for
2. What you need to know before you take Amlodipine Pensa Pharma
3. How to take Amlodipine Pensa Pharma
4. Possible side effects
5. Storage of Amlodipine Pensa Pharma
6. Contents of the pack and other information

1. What is Amlodipine Pensa Pharma and what is it used for

This medicine contains the active substance amlodipine, which belongs to a group of medicines known as calcium antagonists.

Amlodipine is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, including a rare type called Prinzmetal's or variant angina.

In patients with high blood pressure, this medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina, amlodipine improves blood supply to the heart muscle, which receives more oxygen and as a result, chest pain is prevented. This medicine does not provide immediate relief of chest pain due to angina.

2. What you need to know before you take Amlodipine Pensa Pharma

Do not take Amlodipine Pensa Pharma

• If you are allergic to amlodipine or any of the other ingredients of 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) or cardiogenic shock (a disease 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 amlodipine.

You should 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 elderly 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 from 6 to 17 years of age (see section 3).

For more information, consult your doctor.

Using Amlodipine Pensa Pharma with other medicines

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

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

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat AIDS)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum(St. John's Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (in infusion for severe body temperature anomalies)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the immune system)
• simvastatin (cholesterol-lowering medicine)
• ciclosporin (immunosuppressant)

If you are already taking other medicines for high blood pressure, amlodipine may lower your blood pressure even further.

Taking Amlodipine Pensa Pharma with food and drinks

People taking amlodipine should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure-lowering effect 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 should inform your doctor before taking amlodipine.

Breastfeeding

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

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

Amlodipine Pensa Pharma contains sodium

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

3. How to take Amlodipine Pensa Pharma

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

You can take this medicine before or after meals. You should take it at the same time each day, with a glass of water. Do not take amlodipine 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. The 5 mg amlodipine tablets can be divided into two equal parts to provide a 2.5 mg dose.

It is important not to interrupt the administration of the tablets. Do not wait until the tablets are finished to go to your doctor.

If you take more Amlodipine Pensa Pharma than you should

Taking too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, faint, suffer from dizziness when standing up, or weakness. If the drop in blood pressure is severe, it can cause shock. You may feel your skin cold and sweaty, and you could lose consciousness. Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing, which can develop up to 24-48 hours after ingestion. If you take too many amlodipine tablets, consult your doctor immediately or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Amlodipine Pensa Pharma

Do not worry. If you forget to take a tablet, do not take that dose. Take the next dose at the correct time. Do not take a double dose to make up for forgotten doses.

If you stop taking Amlodipine Pensa Pharma

Your doctor will tell you for how long you should take this medicine. Your illness may come back if you stop taking this medicine before your doctor tells you to.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Go to your doctor immediately if you experience any of the following side effects after taking this medicine.

• Sudden wheezing, chest pain, shortness of breath, or difficulty breathing
• Swelling of the eyelids, face, or lips
• Swelling of the tongue and throat, causing great difficulty breathing
• Severe skin reactions, including intense skin rash, hives, skin redness all over the body, severe itching, blistering, peeling, and inflammation of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, abnormal heartbeat
• Pancreatitis, which can cause severe abdominal pain and back pain, accompanied by a great feeling of discomfort

The following side effect has been reported very frequently. If this causes problems or lasts more than a week, consult your doctor.

Very common: may affect more than 1 in 10 people

• Edema (fluid retention)

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

Common: may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the start of treatment)
• Palpitations (feeling the heartbeat), flushing
• Abdominal pain, feeling unwell (nausea)
• Change in 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 also included in the following list. If you think any of the side effects you are suffering from is serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Uncommon: may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting
• Numbness or tingling in the limbs, loss of pain sensation
• Ringing in the ears
• Decrease in blood pressure
• Sneezing/nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting (nausea)
• Hair loss, increased sweating, itching, red spots on the skin, skin discoloration
• Urination disorder, increased need to urinate at night, increased number of times urinating
• Impotence, discomfort or breast enlargement in men
• Pain, feeling unwell
• 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

• Decrease in white blood cell count, decrease in blood platelet count, which can cause easy bruising or bleeding
• High blood sugar (hyperglycemia)
• A disorder of the nerves that can cause muscle weakness, tingling, or numbness
• Gingivitis
• Abdominal swelling (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes, which can affect some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin rashes
• Sensitivity to light
• Disorders combining stiffness, tremor, and/or movement disorders

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine Pensa Pharma

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

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

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicinal products in the pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the packaging and unused medicinal products. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amlodipine Pensa Pharma 5 mg tablets EFG

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

The other ingredients are microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium carboxymethylcellulose Type A, and magnesium stearate.

Appearance and packaging

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

Amlodipine Pensa Pharma 5 mg tablets EFG are available in blisters containing 30 tablets.

Marketing authorization holder, manufacturer

Marketing authorization holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

Bluepharma - Indústria Farmacêutica, S. A.

• Martinho do Bispo,

3045-016 Coimbra

Portugal

Date of last revision of this leaflet:June 2022

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