ASTUDAL 5 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Astudal 5 mg Tablets

amlodipine

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.

Contents of the pack and other information:

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

1. What is Astudal and what is it used for

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

Astudal is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, including a rare type called Prinzmetal 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, Astudal improves blood supply to the heart muscle, which receives more oxygen and as a result, the pain in the chest is prevented. This medicine does not provide immediate relief of chest pain due to angina.

2. What you need to know before you take Astudal

Do not takeAstudal

• if you are allergic (hypersensitive) to amlodipine or any of the other ingredients of this medicine (listed in section 6), or to other calcium antagonists. 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 suffer from heart failure after a heart attack.

Warnings and precautions

Talk to your doctor before taking Astudal.

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 an elderly person and your dose needs to be increased

Children and adolescents

Astudal has not been studied in children under 6 years of age. Astudal 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, talk to your doctor.

Other medicines and Astudal

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Astudal 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 abnormalities)
• tacrolimus (a medicine used to modify the functioning of the immune system)
• ciclosporin (immunosuppressant)
• simvastatin (a medicine that lowers cholesterol)

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

TakingAstudalwith food and drinks

People taking Astudal 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 Astudal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The safety of amlodipine during pregnancy has not been established. If you think you may be pregnant, or are planning to have a baby, you must inform your doctor before taking Astudal.

Breastfeeding

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

Driving and using machines

Astudal 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.

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

3. How to take Astudal

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

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

You can take your medicine before or after meals. You should take it at the same time each day, with a glass of water. Do not take Astudal with grapefruit juice.

Use in children and adolescents

For children and adolescents (between 6-17 years of age), the recommended initial dose is normally 2.5 mg per day. The maximum recommended dose is 5mg per day.

Amlodipine 2.5 mg is not currently available and a dose of 2.5 mg cannot be obtained with Astudal 5 mg tablets as these tablets are not designed to be divided into equal parts.

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

If you take moreAstudalthan 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 can accumulate in the lungs (pulmonary edema) causing difficulty breathing that can develop up to 24-48 hours after ingestion.

If you take too many Astudal tablets, consult your doctor immediately or call the Toxicology Information Service, telephone 91 562 04 20.

If you forget to takeAstudal

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 forgotten dose.

If you stop takingAstudal

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 further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

See your doctor immediatelyif you experience any of the following serious side effects, which are very rare when 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, which can cause great difficulty in breathing.
• Severe skin reactions, including intense skin rash, hives, skin redness all over the body, 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 very common side effecthas been reported. If this causes problems or lasts more thanone week, consult yourdoctor.

Very common: may affect more than 1 in 10 people

• Edema (fluid retention)

Common:may affect up to 1 in 10 people

• Headache, dizziness, somnolence (especially at the beginning of treatment)
• Palpitations (feeling the heartbeat), flushing
• Abdominal pain, feeling unwell (nausea)
• Altered bowel habit, diarrhea, constipation, indigestion
• Visual disturbances, double vision
• Muscle cramps
• Swelling of ankles

Other side effects have been reported, which are included in the following list. If you think you are suffering from any of these side effects, or if you think any of the side effects 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

• Mood changes, anxiety, depression, insomnia
• Tremor, altered taste, 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 of urination
• Impotence, discomfort or breast enlargement in men
• Pain, feeling unwell
• Pain in muscles or joints, 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 the number of white blood cells, decrease in blood platelets which can cause easy bleeding or unusual bruising
• High blood sugar (hyperglycemia)
• A disorder of the nerves that can cause muscle weakness, tingling, or numbness
• Inflammation of the gums, bleeding gums
• 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) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Astudal

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 refers to the last day of that month.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition ofAstudal

• The active substance of Astudal 5 mg tablets is amlodipine (as besylate).
• The other ingredients are microcrystalline cellulose, calcium carbonate, sodium starch glycollate (potato starch), and magnesium stearate.

Appearance of the product and contents of the pack

This medicine is presented in the form of tablets. The tablets are circular, white, and marked with a “5” on one face.

Astudal 5 mg tablets are available in blister packs containing 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Almirall, S.A.

General Mitre, 151

08022 - Barcelona (Spain)

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

Date of last revision of this leaflet:June 2022.

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