Amlodipine Stada 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Amlodipine STADA 10 mg tablets EFG

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 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. It may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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 angina-related chest pain.

2. What you need to know before taking Amlodipine Stada

Do not take Amlodipine Stada

• If you are allergic to amlodipine, or 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 heart valve (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 Amlodipine 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. Amlodipine Stada 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 Amlodipine Stada

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

Amlodipine 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 (given by infusion for serious body temperature abnormalities)

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

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

• ciclosporin (immunosuppressant)

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

Taking Amlodipine Stada with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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

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

Amlodipine 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 using 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.

The Amlodipine Stada 10 mg tablet may be divided into equal doses.

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 recommended starting dose is usually 2.5 mg once daily. The maximum recommended dose is 5 mg once daily.

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

It is important not to interrupt treatment with 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 fall in blood pressure. 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 moist and could lose consciousness.

Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop 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

Don't 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 taking Amlodipine Stada

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 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.

Contact your doctor 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 in breathing.
• Severe skin reactions including severe rash, hives, widespread redness of the skin, 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 strong 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)

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 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 (tinnitus)
• 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 fewer 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
• Inflammation of the gums
• Abdominal swelling (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increase in 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 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 effects, talk to your doctor or pharmacist, even if they are adverse effects that are 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 is the last day of the month indicated.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in 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 10 mg of amlodipine (as besilate).
• The other components are microcrystalline cellulose (E460), calcium hydrogen phosphate (E341), sodium starch glycolate from potato, magnesium stearate (E470b).

Appearance of the product and contents of the pack

Amlodipino Stada 10 mg are white, round tablets with a score line on one side. The tablet can be divided into equal doses.

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.

Only some 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 10 mg Tabletten

Denmark: Amlodistad

Germany: Amlodipin AL 10 mg Tabletten

Spain: Amlodipino STADA 10 mg comprimidos EFG

Ireland: Amlodipine Clonmel 10 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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/