AMLODIPINE STADA 5 mg TABLETS

2. What you need to know before you take Amlodipine Stada

Do not takeAmlodipine Stada

• If you are allergic to amlodipine or any other ingredients of this medicine (listed in section 6) or to other calcium antagonists. This may cause itching, skin rash, 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 have heart failure after a heart attack.

Warnings and precautions

Talk to your doctor or pharmacist before taking Amlodipine Stada. 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 needs to be increased

Children and adolescents

Amlodipine has not been studied in children under 6 years old. Amlodipine Stada should only be used to treat high blood pressure in children and adolescents from 6 to 17 years old (see section 3). For more information, talk to your doctor.

Other medicines and Amlodipine Stada

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

Amlodipine Stada 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 - for infections caused by bacteria)

• Hypericum perforatum (St. John's Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (in infusion for severe 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 for high blood pressure, Amlodipine Stada may lower your blood pressure even further.

Taking Amlodipine Stada with food and drinks

People taking Amlodipine Stada should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in the levels of the active ingredient amlodipine in the blood, which can 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 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.

Breastfeeding

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

Driving and using machines

Amlodipine Stada 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 machines and talk to 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

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The recommended initial dose is 5 mg of Amlodipine Stada, once daily. The dose can be increased to 10 mg of Amlodipine Stada, once daily.

You can take this medicine before or after food. You should 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 (from 6 to 17 years old), the recommended initial dose is 2.5 mg daily. The maximum recommended dose is 5 mg daily.

Amlodipine 2.5 mg is not currently available and a dose of 2.5 mg cannot be obtained with Amlodipine Stada 5 mg since the tablets cannot be divided into equal doses.

It is important not to interrupt the administration of the tablets. Do not wait until the tablets run out to see your doctor.

If you take more Amlodipine Stada than you should

Taking too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, faint, or experience 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 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 forgotten dose.

If you stop taking Amlodipine Stada

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 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 that causes great difficulty breathing.
• Severe skin reactions that include intense skin rash, hives, redness of the skin all over the body, severe 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 that can cause severe abdominal pain and back pain accompanied by a great feeling of discomfort.

The following side effect has been reported very frequently. If it causes problems or lasts more than a week, talk to 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, somnolence (especially at the start of treatment)
• Palpitations (feeling the heartbeat), flushing
• Abdominal pain, feeling unwell (nausea)
• Change in bowel habit, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

Other side effects have been reported that are included in the following list. If you think any side effect is serious or if you notice any side effects not mentioned in this leaflet, tell 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 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 disorders, increased need to urinate at night, increased number of times urinating
• Impotence, discomfort or enlargement of the breasts in men
• Pain, feeling unwell
• Pain in the muscles or joints, back pain
• Weight gain or weight loss

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

• Confusion

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

• Decrease in the number of white blood cells, decrease in blood platelets that can cause easy bleeding or unusual bruising (red blood cell damage)
• High blood sugar (hyperglycemia)
• A disorder of the nerves that can cause muscle weakness, tingling, or numbness
• Gingivitis
• Abdominal swelling (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that 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

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

• Tremors, rigid posture, "mask-like" face, slow and unsteady gait.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

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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 which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amlodipine Stada

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

Appearance and packaging of the product

Amlodipine Stada 5 mg are white and circular tablets.

The 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 unit dose blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratory 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 medicine is authorized in the EEA member states with 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 last revision of this leaflet:August 2022

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