PATIENT INFORMATION LEAFLET

Amlodipino KERN PHARMA 10 mg tablets EFG

Read 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 should not be given to others, even if they have the same symptoms, as it may harm them.
• If you think you are having a serious side effect or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

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, prevents chest pain. 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 amlodipino, 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.
• If you have a narrowing of the aortic valve (aortic stenosis) in your heart or cardiogenic shock (a disease in which the heart is unable to pump enough blood to the body).
• If you suffer from 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 high 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 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 (in infusion 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 beverages

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 levels of the active ingredient amlodipino in the blood, which may cause an unpredictable increase in the effect of lowering blood pressure of Amlodipino Kern Pharma.

Pregnancy

The safety of amlodipino 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

Amlodipino 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 taking any medication.

Driving and operating machinery

Amlodipino Kern Pharma may affect your ability to drive or operate machinery. If the tablets make you feel sick, dizzy, or tired, or cause headaches, do not drive or operate machinery and consult your doctor immediately.

Always take your medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.

The usual initial dose is 5 mg of Amlodipino Kern Pharma, once a day. The dose may increase 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 5 mg per day.

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 reappear if you stop taking this medicine before your doctor tells you to.

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

Like all medicines, Amlodipino Kern Pharma can cause side effects, although not everyone will experience them.

See your doctorimmediatelyif you experience any of the following serious side effects, which are very rare after taking this medicine.

• Sudden hissing sounds while breathing (sudden sibilance), chest pain, shortness of breath, or difficulty breathing
• Swelling of the eyelids, face, or lips
• Swelling of the tongue and throat that causes severe difficulty breathing
• Severe skin reactions that include intense skin rash, blisters, skin redness all over the body, itching, blister formation, skin peeling, and skin inflammation, mucous membrane inflammation (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 strong feeling of discomfort

The followingcommon side effectshave been reported. If any of these cause problems or if they last more than a week, consult your doctor.

Common: affect between 1 and 10 in every 100 patients

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

The following side effects have also been reported. If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Uncommon:affect between 1 and 10 in every 1,000 patients

• Changes in mood, anxiety, depression, insomnia
• Tremor, taste alterations, fainting, weakness
• Numbness or tingling sensation in the extremities, loss of pain sensation
• Visual disturbances, double vision, ringing in the ears
• Decreased blood pressure
• Runny nose/ nasal 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 patches on the skin, skin discoloration
• Urinary disorders, increased need to urinate at night, increased frequency of urination
• Impotence, discomfort or breast tenderness in men
• Weakness, pain, feeling of discomfort
• Muscle or joint pain, muscle cramps, back pain
• Weight gain or loss

Rare:affect between 1 and 10 in every 10,000 patients

• Confusion

Very rare:affect fewer than 1 in 10,000 patients

• Decreased white blood cell count, decreased platelet count that can cause easy bleeding or unusual bruising (red blood cell damage)
• High blood sugar (hyperglycemia)
• A disorder of the nerves that can cause weakness, tingling, or numbness
• Cough, inflammation of the gums
• 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 eruptions
• Sensitivity to light
• Movements combining stiffness, tremor, 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 leaflet. 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 medicine.

Keep out of reach and sight of children.

Do not use this medication 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. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Amlodipino Kern Pharma

The active ingredient of Amlodipino Kern Pharma 10 mg tablets is amlodipine (as besilate).

• The other components are: microcrystalline cellulose (E-460i), anhydrous calcium hydrogen phosphate, sodium carboxymethylstarch (potato starch) and magnesium stearate (E-470b).

Appearance of Amlodipino Kern Pharma and content of the packaging

White, uncoated tablets, scored on one face and with the mark “10” on the other face.

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

Amlodipino Kern Pharma 10 mg tablets are available in blister packs of 30 tablets (standard pack) or 100 tablets (clinical pack).

Holder of the marketing authorization

Kern Pharma, S.L

Polígono Industrial Colón II

Venus 72

08228 Terrassa (Barcelona)

Spain

Responsible for manufacturing

Kern Pharma, S.L

Polígono Industrial Colón II

Venus 72

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

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