Patient Information Leaflet

Astudal 5 mg Tablets

amlodipino

Read this leaflet carefully before you start taking this medicine, as 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. Do 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, even if they are not listed in this leaflet.

1.What is Astudal and what is it used for

2.What you need to know before you start taking Astudal

3.How to take Astudal

4.Possible side effects

5.Storage of Astudal

6.Contents of the pack and additional information

Astudalcontains the active substance amlodipine whichbelongs to a group of medications known ascalcium antagonists.

Astudalis used to treathigh blood pressure(hypertension)or a certain type of chest pain called angina, which includes a less common type known asPrinzmetal's anginaor 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,Astudalimproves blood flow to the heart muscle, which receives more oxygen as a result, thereby preventing chest pain. This medication does not provide immediate relief from chest pain due to angina.

Do not takeAstudal

• if you are allergic (hypersensitive) to amlodipine, or any of the other ingredients in the medicine listed in section 6, or to any other calcium antagonist. This may cause itching, redness of the skin, or difficulty breathing.
• if you have very low blood pressure (hypotension).
• if you have a narrowing of the aortic valve in your heart (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to pump enough blood to the body).
• if you have had a heart attack.

Warnings and precautions

Consult your doctor before starting to take Astudal.

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

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 more information, consult your doctor.

Other medicines and Astudal

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

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

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (also known as protease inhibitors used to treat HIV/AIDS)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum (St. John's Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (in infusion for severe temperature abnormalities)
• tacrolimus (medicine used to modify the functioning of the immune system)
• ciclosporin (immunosuppressant)
• simvastatin (medicine that reduces 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 cause an increase in the levels of the active ingredient amlodipine in the blood, which may lead to an unpredictable increase in the effect of lowering blood pressure of Astudal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or planning 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 may be pregnant, or are planning to become pregnant, 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 are about to start, you must inform your doctor before taking Astudal.

Driving and operating machinery

Astudal may affect your ability to drive or operate machinery.If the tablets make you feel unwell, 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".

Follow exactly the administration instructions of this medication as 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 medication before or after meals. It should be taken at the same time every 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 usually 2.5 mg per day. The maximum recommended dose is 5 mg per day.

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

It is essential not to interrupt the administration of the tablets. Do not wait for the tablets to run out before consulting your doctor.

If you take moreAstudalthan you should

Consuming too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, dazed, experience postural dizziness when standing up, or weakness.

If the drop in blood pressure is severe, it can cause shock. You may feel your skin is cold and wet, 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 consumption.

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

If you forgot to takeAstudal

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 dose.

If you interrupt treatment withAstudal

Your doctor will indicate for how long you should take this medication. Your disease may reappear if you stop taking this medication before your doctor tells you to.

If you have any other doubts about the use of this medication, consult your doctor or pharmacist.

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.

Go to yourdoctorimmediatelyifyou experience any of thefollowingserious side effects, which areveryrareafter taking thismedicine.

• Sudden hissing sounds when breathing (sudden sibilance), chest pain,shortness of breath, ordifficulty breathing.
• Swelling of the eyelids, face, or lips.
• Swellingofthetongueandthroatthatcausesgreatdifficulty breathing.
• Severe skin reactions that includeintense skin rash, blisters,rednessoftheskinall over the body,itching, blister formation,peeling, and inflammationoftheskin,inflammationofthe mucous membranes(Syndrome of Stevens Johnson, toxic epidermal necrolysis)or other allergic reactions.
• Heart attack, abnormal heart rhythm.
• Inflammation of thepancreasthatcan causesevere abdominal painand back painaccompaniedbygreatdiscomfort.

Thefollowingvery frequent side effecthas been reported.If thiscauses problemsorifit lastsmore thanone week,consult your doctor.

Very frequent: may affect more than 1 in 10 people

• Edema (fluid retention)

Frequent:may affect up to 1 in 10 people

• Headache,dizziness,sleepiness(especially at the beginningof treatment)
• Palpitations(feeling the heartbeats), shortness of breath
• Abdominal pain,discomfort(nausea)
• Alteration of bowel habit, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

Otherside effectshave been reportedthatare included in the following list.If you consider that any of the side effects you are experiencing are severeorif you notice any side effect not mentioned inthisleaflet,inform your doctoror pharmacist.

Frequent:may affect up to 1 in 100 people

• Mood changes,anxiety,depression,insomnia
• Tremor,alterationsof taste,syncope
• Numbnessortingling sensationin the extremities, lossofpain sensation
• Tinnitusin 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 spotson the skin,skin discoloration
• Urinary disorders,increased needto urinate at night,increased frequencyof urination
• Impotence,discomfort orenlargementof the breastsin men
• Pain, discomfort
• Painin the muscles or joints,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

• Decreased number of white blood cells in the blood,decreased platelets in the bloodthat cancauseeasy bleedingor unusual bruising
• High blood sugar (hyperglycemia)
• A disorder of the nerves that can cause muscle weakness, numbness, or tingling
• Inflammation of the gums, gum bleeding
• Abdominal swelling (gastritis)

• Abnormal liver function,inflammation of theliver(hepatitis), yellowing of the skin(jaundice),increasein liver enzymesthatmayaffect some medical tests
• Increased muscle tension
• Inflammationof the blood vessels, oftenwithskin eruptions
• Sensitivity to light
• Disorders combining stiffness, 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 of Pharmacovigilance of Medicines for Human Use:https://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.

Do not store at a temperature above30°C.

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so,you will help protect the environment.

Composition of Astudal

• The active ingredient of Astudal 5 mg tablets is amlodipine (as besilate).
• The other components are microcrystalline cellulose, calcium carbonate, sodium carboxymethylstarch (potato starch) and magnesium stearate.

Appearance of the product and contents of the packaging

This medication 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 boxes with blisters containing 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Almirall, S.A.

General Mitre, 151

08022 - Barcelona (Spain)

Responsible for manufacturing

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

Last review date of this leaflet: June 2022.

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) web site at http://www.aemps.gob.es/