Amlodipine Normon 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amlodipino Normon 5 mg tablets EFG

amlodipine

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Amlodipino Normon is and what it is used for
2. What you need to know before taking Amlodipino Normon
3. How to take Amlodipino Normon
4. Possible adverse effects
5. How to store Amlodipino Normon
6. Contents of the pack and other information

1. What Amlodipine Normon is and what it is used for

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

Amlodipine Normon is 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 medicine works by relaxing the blood vessels, allowing blood to flow through them more easily. In patients with angina, Amlodipine Normon improves blood flow to the heart muscle, thereby increasing oxygen supply to the heart and preventing chest pain. This medicine does not provide immediate relief of angina-related chest pain.

2. What you need to know before taking Amlodipine Normon

Do not take Amlodipine Normon

• If you are allergic (hypersensitive) to amlodipine or to 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 aortic valve stenosis (narrowing of the aortic valve in the heart) or cardiogenic shock (a condition in which the heart is unable to pump enough blood to the body).
• If you suffer from heart failure following a heart attack.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Amlodipine Normon.

You should inform your doctor if you have or have had any of the following conditions:

• Recent heart attack
• Heart failure
• Severe increase in blood pressure (hypertensive crisis)
• Liver disease
• You are elderly and your dose may need adjustment

Children and adolescents

Amlodipine Normon has not been studied in children under 6 years of age. Amlodipine Normon should only be used to treat high blood pressure in children and adolescents aged 6 to 17 years. (See section 3).

For further information, consult your doctor.

Use of Amlodipine Normon with other medicines

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

Amlodipine Normon may affect or may 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 (by infusion for serious disturbances in body temperature)
• tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to modify the function of the immune system)
• simvastatin (a cholesterol-lowering medicine)
• ciclosporin (an immunosuppressant)

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

Taking Amlodipine Normon with food and drinks

People taking Amlodipine Normon should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could cause an unpredictable increase in the blood pressure-lowering effect of Amlodipine Normon.

Pregnancy and breastfeeding

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 Normon.

Breastfeeding

It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or about to start breastfeeding, you must inform your doctor before taking Amlodipine Normon.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Amlodipine Normon may affect your ability to drive or use machinery. If the tablets make you feel unwell, dizzy, tired, or cause you to have headaches, do not drive or operate machinery and consult your doctor immediately.

Amlodipine Normon contains sodium

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

3. How to take Amlodipine Normon

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended starting dose is 5 mg of Amlodipine Normon once daily. The dose may be increased to 10 mg of Amlodipine Normon once daily.

You may take this medicine before or after meals. Take it at the same time each day with a glass of water. Do not take Amlodipine Normon with grapefruit juice.

Use in children and adolescents

For children and adolescents (aged 6–17 years), the usual recommended starting dose is 2.5 mg daily. The maximum recommended dose is 5 mg daily.

Currently, amlodipine 2.5 mg is not available, and the 2.5 mg dose cannot be obtained with Amlodipine Normon 5 mg tablets, as these tablets are not manufactured to be divided into equal parts.

It is important not to interrupt the administration of the tablets. Do not wait until you run out of tablets before seeing your doctor.

If you take more Amlodipine Normon than you should

Taking too many tablets may cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, lightheaded, experience postural dizziness upon standing, or weakness. If the drop in blood pressure is severe enough, shock may occur. You may feel cold and clammy and could lose consciousness. If you have taken too many Amlodipine Normon tablets, consult your doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20.

Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop 24–48 hours after ingestion.

If you forget to take Amlodipine Normon

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 the missed dose.

If you stop taking Amlodipine Normon

Your doctor will advise you on how long you should take this medicine. Your condition may return if you stop taking this medicine before your doctor tells you to do so.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Seek immediate medical attention if you experience any of the following adverse 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 severe difficulty breathing
• Severe skin reactions including severe rash, hives, redness of the skin all over the body, severe itching, blistering, peeling and inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
• Heart attack, abnormal heartbeat
• Inflammation of the pancreas that may cause severe abdominal pain and back pain accompanied by a marked feeling of malaise

The following very common adverse effect has been reported. If this causes problems or lasts longer than one week, consult your doctor.

Very common: may affect more than 1 in 10 people

• Edema (fluid retention)

The following common adverse effects have been reported. If any of these cause problems or last longer than one week, consult your doctor.

Common: may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of heartbeat), hot flush
• Abdominal pain, feeling of discomfort (nausea)
• Changes in bowel habits, diarrhoea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps

Swelling of ankles

Other adverse effects that have been reported are included in the following list. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform 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 sensation in the limbs, loss of pain sensation
• Tinnitus (ringing in the ears)
• Decrease in blood pressure
• Sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting (feeling unwell)
• Hair loss, increased sweating, skin itching, red spots on the skin, skin discoloration
• Urinary disorders, increased need to urinate at night, increased frequency of urination
• Inability to achieve an erection, discomfort or enlargement of the breasts in men
• Pain, feeling of discomfort
• Muscle or joint pain, back pain
• Weight gain or weight 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 platelets which may cause easy bleeding or unusual bruising
• High blood sugar (hyperglycaemia)
• A nerve disorder that may cause muscle weakness, tingling or numbness
• Inflammation of the gums, bleeding gums
• Abdominal swelling (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect certain medical tests
• Increased muscle tension
• Inflammation of blood vessels, often associated with skin rashes
• Light sensitivity
• Disorders combining rigidity, tremor and/or movement disorders

Frequency not known: cannot be estimated from available data

• Tremor, rigid posture, mask-like facial expression, slow movements, and shuffling, unbalanced gait

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine Normon

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

Do not use this medicine after the expiry date stated on the packaging, following EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amlodipine Normon

The active substance in Amlodipine Normon 5 mg tablets is amlodipine (as besilate).

The other components are: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium carboxymethyl potato starch (potato starch), and magnesium stearate.

Appearance of the medicine and contents of the pack

White or almost white, round, flat tablets marked with "A5" on one side. The packs available contain 28 and 30 tablets.

Amlodipine Normon 5 mg tablets are available in blister packs containing 28 or 30 tablets, and in unit-dose blisters containing 500 tablets (hospital pack).

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent review of this leaflet: May 2024

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/68310/P_68310.html