Prospect: Information for the user

Amlodipino Kern Pharma 5 mg tablets EFG

Read this prospect carefully before starting to take the medication.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospect, inform your doctor or pharmacist.

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

2.Before taking Amlodipino Kern Pharma

3.How to take Amlodipino Kern Pharma

4.Possible adverse effects

1. Conservation of Amlodipino Kern Pharma

6.Additional information

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

Amlodipino Kern Pharma is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, which includes 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, Amlodipino Kern Pharma improves blood flow to the heart muscle, which receives more oxygen as a result, and as a consequence, chest pain is prevented. This medicine does not provide immediate relief from chest pain due to angina.

Do not take Amlodipino Kern Pharma

• If you are allergic (hypersensitive) to amlodipine, or to any of the other components of the medication 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 (aortic stenosis) in your heart or cardiogenic shock (a condition in which the heart is unable to pump enough blood to the body).
• If you have heart failure after a heart attack.

Be especially careful with Amlodipino Kern Pharma

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 an elderly person and your dose needs 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 high blood pressure in children and adolescents aged 6 to 17 years. (See section 3).

For more information, consult your doctor.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Amlodipino Kern Pharma may affect or be affected by other medications, such as:

• Ketoconazole, itraconazole (antifungal medications)
• Ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat HIV/AIDS)
• Rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum(St. John's Wort)
• Verapamil, diltiazem (heart medications)
• Dantrolene (for severe body temperature abnormalities)

If you are already taking other medications 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 should not consume grapefruit or grapefruit juice.This is because grapefruit and grapefruit juice may cause an increase in the blood levels of the active ingredient amlodipine, which may lead to an unpredictable increase in the effect of lowering blood pressure 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 Amlodipino Kern Pharma.

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 Amlodipino Kern Pharma.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Amlodipino Kern Pharma 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.

Always take your medicine exactly as your doctor has told you to . Consult your doctor or pharmacist if you have any doubts.

The usual initial dose is 5 mg of Amlodipino Kern Pharma once a day. The dose can be increased to 10 mg of Amlodipino Kern Pharma once a day.

You can take your medicine before or after meals. It should be taken at the same time every day, with a glass of water. Do not take Amlodipino Kern Pharma with grapefruit juice.

Use in children and adolescents

For children and adolescents (between 6-17 years of age), the usual recommended initial dose is 2.5 mg per day. The maximum recommended dose is 5mg per day.

Amlodipino 2.5 mg is currently not available and the 2.5 mg dose cannot be obtained with Amlodipino Kern Pharma 5 mg tablets as 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 until the tablets run out to visit your doctor.

If you take more Amlodipino Kern Pharma than you should

Consuming too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, disoriented, experience postural dizziness when standing up, or weakness. If the drop in blood pressure is severe enough, it can cause shock. You may feel your skin is cold and moist, and you could lose consciousness. If you take too many Amlodipino Kern Pharma tablets, consult your doctor immediately or call the Toxicological Information Service, phone 91 562 04 20.

Excess fluid can accumulate in the lungs (pulmonary edema) causing breathing difficulties that can develop up to 24-48 hours after consumption.

If you forget to take Amlodipino 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 compensate for the missed dose.

If you interrupt treatment with Amlodipino Kern Pharma

Your doctor will tell you for how long you should take this medicine. Your condition may recur if you stop taking this medicine before your doctor tells you to.

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

Like all medicines, Amlodipine can cause side effects, although not everyone will experience them.

Go to your doctor immediately if you experience any of the following severe side effects, which are very rare after taking this medication.

• Sudden hissing sounds while breathing (sibilant breathing), 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, itching, blistering, peeling, inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
• Heart attack, abnormal heart rhythm
• Pancreatitis that can cause severe abdominal pain and back pain accompanied by a great sense of discomfort

The following are the reported frequent side effects.If any of these cause problems or last more than a week, consult your doctor.

Frequent: Affect between 1 and 10 of every 100 patients

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (feeling the heartbeat), shortness of breath
• Abdominal pain, sense of discomfort (nausea)
• Swelling of the ankles (edema), fatigue

The following have been reported or other side effects that are included in the following list.If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this prospectus, report it to your doctor or pharmacist.

Rare: Affect between 1 and 10 of every 1,000 patients

• Mood changes, anxiety, depression, insomnia
• Trembling, alterations in taste, fainting, weakness
• Numbness or tingling sensation in the extremities, loss of sensation of pain
• Visual disturbances, double vision, buzzing in the ears
• Decrease in blood pressure
• Runny nose/secretion caused by inflammation of the nasal mucosa (rhinitis)
• Alteration of bowel habit, diarrhea, constipation, indigestion, dry mouth, vomiting (discomfort)
• Hair loss, increased sweating, itching skin, red spots on the skin, skin discoloration
• Urinary tract disorder, increased need to urinate at night, increased number of times to urinate
• Impotence, discomfort or enlargement of the breasts in men
• Weakness, pain, sense of discomfort
• Muscle or joint pain, muscle cramps, back pain
• Weight gain or loss

Rare: Affect between 1 and 10 of every 10,000 patients

• Confusion

Very rare: Affect less than 1 patient in every 10,000

• Decrease in the number of white blood cells in the blood, decrease in platelets in the blood that can cause easy bleeding or unusual bruises (damage to red blood cells)
• High blood sugar (hyperglycemia)
• A disorder in the nerves that can cause weakness, tingling, or numbness
• Cough, inflammation of the gums
• Abdominal swelling (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellow discoloration of the skin (jaundice), increase in liver enzymes that can affect some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin eruptions

• Sensitivity to light
• Disorders combining stiffness, trembling, 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 prospectus. You can also report them directly through the Spanish System for 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 medication.

Keep out of reach and sight of children.

Do not use this medicine after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way,you will help protect the environment.

Composition of Amlodipino Kern Pharma

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

Appearance of Amlodipino Kern Pharma and content of the container

White, uncoated, scored tablets on one face and with the mark “ 5” on the other face.

The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Amlodipino Kern Pharma 5 mg is available in blister-type containers containing 28 tablets, 30 tablets, 100 tablets (clinical container) or 500 tablets (clinical container).

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

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

Last review date of this leaflet: June 2022

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