Amlodipine Stada 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Amlodipine STADA 5 mg tablets EFG

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 you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Amlodipino Stada is and what it is used for

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

Amlodipino Stada 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, Amlodipino Stada improves blood flow to the heart muscle, thereby increasing oxygen supply and preventing chest pain. This medicine does not provide immediate relief of chest pain caused by angina.

2. What you need to know before taking Amlodipino Stada

Do not take Amlodipino Stada

• If you are allergic 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 a narrowing of the aortic valve in the heart (aortic stenosis) 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 you start taking Amlodipino Stada. You must 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 to be increased

Children and adolescents

Amlodipine has not been studied in children under 6 years of age. Amlodipino Stada 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 Amlodipino Stada

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

Amlodipino Stada 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 AIDS)

• rifampicin, erythromycin, clarithromycin (antibiotics – for infections caused by bacteria)

• Hypericum perforatum (St. John's wort)

• verapamil, diltiazem (medicines for the heart)

• dantrolene (administered by infusion for serious disturbances in body temperature)

• simvastatin (a medicine that lowers high blood cholesterol levels)

• tacrolimus (used to control the body's immune response, allowing acceptance of a transplanted organ)

• ciclosporin (immunosuppressant)

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

Taking Amlodipino Stada with food and drink

People taking Amlodipino Stada must 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 Amlodipino Stada.

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.

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.

Driving and using machines

Amlodipino Stada may affect your ability to drive or operate 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.

Amlodipino Stada contains sodium

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

3. How to take Amlodipine Stada

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

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

Amlodipine 2.5 mg is currently not available, and the 2.5 mg dose cannot be achieved with Amlodipine Stada 5 mg tablets, as the tablets cannot be divided into equal doses.

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 Stada 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 within 24–48 hours after ingestion.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Amlodipine Stada

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 Stada

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 may cause adverse effects, although not everyone will experience them.

Seek medical help immediately if you experience any of the following serious 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, irregular heartbeat.
• Inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by a general feeling of severe illness.

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)

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 listed 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 unwell
• Muscle or joint pain, back pain
• Weight gain or weight loss

Rare (may affect up to 1 in 1,000 people):

• Confusion

Very rare (affects less than 1 in 10,000 people):

• Decrease in white blood cells, decrease in blood platelets which may cause easy bleeding or unusual bruising (damage to red blood cells)
• High blood sugar (hyperglycaemia)
• A nerve disorder which may cause muscle weakness, tingling or numbness
• Swelling of the 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

Frequency not known (cannot be estimated from the available data):

• Tremors, rigid posture, "mask-like" face, slow movements and unbalanced gait with shuffling steps.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, 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 Amlodipine Stada

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

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

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amlodipino Stada

• The active substance is amlodipine (as besilate). Each tablet contains 5 mg of amlodipine (as besilate).
• The other components are microcrystalline cellulose (E460), calcium hydrogen phosphate (E341), sodium starch glycolate from potato, magnesium stearate (E470b).

Nature of the product and pack contents

Amlodipino Stada 5 mg are white, circular tablets.

Packs contain 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 100 or 120 tablets or 7x1, 10x1, 14x1, 15x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 100x1 or 120x1 tablets in perforated unit-dose blisters.

HDPE container (85 ml) with polypropylene closure and integrated silica gel containing 250 tablets, for pharmacy dispensing only.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel (Germany)

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary (Ireland)

or

PharmaPath S.A.

1, 28 Octovriou Str.

Ag. Varvara 123 51,

Athens (Greece)

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna (Austria)

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medicinal product is authorized in EEA member states under the following names:

Austria: Amlodipin besilat STADA 5 mg Tabletten

Denmark: Amlodistad

Germany: Amlodipin AL 5 mg Tabletten

Spain: Amlodipino STADA 5 mg comprimidos EFG

Ireland: Amlodipine Clonmel 5 mg tablets

Portugal: Pineam

Sweden: Amlodistad

Date of the most recent review of this leaflet: August 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/