Amlodipine Kern Pharma 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Amlodipine Kern Pharma 5 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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 and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects you experience are serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

Contents of the leaflet:

1. What Amlodipine Kern Pharma is and what it is used for
2. Before you take Amlodipine Kern Pharma
3. How to take Amlodipine Kern Pharma
4. Possible side effects
5. How to store Amlodipine Kern Pharma
6. Further information

1. What Amlodipine Kern Pharma is and what it is used for

Amlodipine Kern Pharma contains the active substance amlodipine, which belongs to a group of medicines known as calcium antagonists.

Amlodipine Kern Pharma 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 blood vessels, allowing blood to flow through them more easily. In patients with angina, Amlodipine Kern Pharma 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 you start taking Amlodipine Kern Pharma

Do not take Amlodipino Kern Pharma

• If you are allergic (hypersensitive) to amlodipine, or to any of the other components 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 sufficient blood to the body).
• If you suffer from heart failure following a heart attack.

Take special care with Amlodipino Kern Pharma

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 to be increased

Use in children and adolescents

Amlodipino Kern Pharma has not been studied in children under 6 years of age. Amlodipino Kern Pharma should only be used to treat arterial hypertension in children and adolescents aged 6 to 17 years. (See section 3).

For more information, consult your doctor.

Use of other medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Amlodipino Kern Pharma 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)
• Hypericum perforatum (St. John's Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (administered by infusion for serious body temperature abnormalities)

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

Taking Amlodipino Kern Pharma with food and drinks

People taking Amlodipino Kern Pharma must not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to increased blood levels of the active ingredient amlodipine, which may cause an unpredictable increase in the blood pressure-lowering effect of Amlodipino Kern Pharma.

Pregnancy and breastfeeding

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 Amlodipine Kern Pharma.

Breastfeeding

It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or are about to breastfeed, you must inform your doctor before taking Amlodipine Kern Pharma.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

3. How to take Amlodipine Kern Pharma

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

The usual starting dose is 5 mg of Amlodipine Kern Pharma once daily. The dose may be increased to 10 mg of Amlodipine Kern Pharma once daily.

You may take this medicine before or after food. Take it at the same time each day, with a glass of water. Do not take Amlodipine Kern Pharma 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 once 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 achieved with Amlodipine Kern Pharma 5 mg tablets, as these tablets are not manufactured to be divided into equal parts.

It is important not to interrupt the treatment. Do not wait until you run out of tablets before seeing your doctor.

If you take more Amlodipine Kern Pharma than you should

Taking too many tablets may cause a drop in blood pressure, or even a dangerous decrease. You may feel dizzy, lightheaded, experience postural dizziness upon standing, or weakness. If the drop in blood pressure is severe enough, shock may occur. You may feel your skin is cold and clammy, and you could lose consciousness. If you have taken an excessive amount of Amlodipine Kern Pharma tablets, consult your doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20.

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

If you forget to take Amlodipine Kern Pharma

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 interrupt treatment with Amlodipine Kern Pharma

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 product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Amlodipine may cause adverse effects, although not everyone gets them.

Contact your doctor immediately if you experience any of the following serious adverse effects, which are very rare after taking this medicine.

• Sudden wheezing (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, peeling and skin 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 marked feeling of malaise

The following frequent adverse effects have been reported. If any of these cause problems or if they last longer than one week, consult your doctor.

Frequent: affect between 1 and 10 out of every 100 patients

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of heartbeat), hot flush
• Abdominal pain, feeling of discomfort (nausea)
• Swelling of ankles (oedema), tiredness

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: affect between 1 and 10 out of every 1,000 patients

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting, weakness
• Numbness or tingling sensation in the limbs, loss of pain sensation
• Visual disturbances, double vision, ringing in the ears (tinnitus)
• Decrease in blood pressure
• Sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis)
• Changes in bowel habits, diarrhoea, constipation, indigestion, 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
• Weakness, pain, feeling of discomfort
• Muscle or joint pain, muscle cramps, back pain
• Weight gain or weight loss

Rare: affect between 1 and 10 out of every 10,000 patients

• Confusion

Very rare: affect less than 1 in every 10,000 patients

• 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 weakness, tingling or numbness
• Cough, 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
• Sensitivity to light
• Disorders combining rigidity, tremor and/or movement disorders

Reporting of adverse effects

If you experience any type of adverse effect, talk to 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 Amlodipine Kern Pharma

Keep out of the reach and sight of children.

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and additional information

Composition of Amlodipino Kern Pharma

• The active substance of Amlodipino Kern Pharma 5 mg is amlodipine (as besylate).
• The other components are: microcrystalline cellulose (E-460i), anhydrous calcium hydrogen phosphate, sodium carboxymethyl starch (potato starch), and magnesium stearate (E-470b).

Appearance of Amlodipine Kern Pharma and contents of the pack

Tablets are white, uncoated, with a notch on one side and marked "5" on the other side.

The notch is intended only for ease of splitting and swallowing, and does not ensure equal dose division.

Amlodipine Kern Pharma 5 mg is available in blister packs containing 28 tablets, 30 tablets, 100 tablets (hospital pack), or 500 tablets (hospital pack).

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

or

Adamed Pharma S.A.

Ul. Marszalka J. Pilsudskiego, 5

95-200 Pabianice, Poland

Date of the most recent review of this leaflet: June 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/