Astudal 5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Astudal 5 mg tablets

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 may harm them.
• If you experience any adverse effects, consult your doctor, even if they are adverse effects not listed in this leaflet.

Leaflet contents:

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

1. What Astudal is and what it is 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 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, Astudal improves blood flow to the heart muscle, thereby increasing oxygen supply and preventing chest pain. This medicine does not provide immediate relief of angina-related chest pain.

2. What you need to know before taking Astudal

Do not take Astudal

• if you are allergic (hypersensitive) to amlodipine, or to any of the other ingredients of the 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 before starting to take Astudal

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

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 aged 6 to 17 years. (See section 3).

For further information, consult your doctor.

Other medicines and Astudal

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

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

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (also known as protease inhibitors used to treat AIDS)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum (St. John's Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (intravenous infusion for serious body temperature abnormalities)
• tacrolimus (a medicine used to modify the immune system function)
• 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.

Taking Astudal with food and drink

People taking Astudal 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 lead to an unpredictable increase in the blood pressure-lowering effect of Astudal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

The safety of amlodipine during pregnancy has not been established. If you think you might be pregnant, or are planning to become pregnant, you should inform your doctor before taking Astudal.

Breastfeeding

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

Driving and using machines

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

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

3. How to take Astudal

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

The recommended starting dose is 5 mg of Astudal once daily. The dose may be increased to 10 mg of Astudal 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 Astudal 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 Astudal 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 Astudal 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 when standing up, or weakness. If the drop in blood pressure is severe enough, shock may occur. You may feel your skin cold and clammy and you could lose consciousness.

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

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

If you forget to take Astudal

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 Astudal

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

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 medical advice immediately if you experience any of the following serious adverse effects, which are very rare 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, itching, blistering, skin peeling and inflammation, inflammation of mucous membranes (Stevens-Johnson Syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Heart attack, irregular heartbeat.
• Inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by a strong feeling of malaise.

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

Very common: may affect more than 1 in 10 people

• Edema (fluid retention)

Common: may affect up to 1 in 10 people

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

Other adverse effects have been reported and are listed below. 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
• 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 cells, decrease in blood platelets which may cause easy bleeding or unusual bruising

• High blood sugar (hyperglycaemia)

• A nerve disorder which may cause muscle weakness, tingling or numbness

• Gum inflammation, 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 with skin rashes

• Light sensitivity

• Disorders combining rigidity, tremor and/or movement disorders

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via 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 Astudal

Keep this medicine out of sight and reach of children.

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

Do not store above 30°C.

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

6. Contents of the pack and other information

Composition of Astudal

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

Appearance of the medicine and contents of the pack

This medicine is presented as tablets. The tablets are round, white, and marked with a "5" on one side.

Astudal 5 mg tablets are available in blister packs contained in cartons, with 30 tablets per carton.

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 the most recent revision of this leaflet: June 2022.

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