AMLODIPINE KERN PHARMA 5 mg TABLETS

2. Before you start taking Amlodipine Kern Pharma

Do not take Amlodipine Kern Pharma

• If you are allergic (hypersensitive) 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, redness of the skin, 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 condition where the heart is unable to pump enough blood to the body).
• If you have heart failure after a heart attack.

Be careful with Amlodipine 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 needs to be increased

Use in children and adolescents

Amlodipine Kern Pharma has not been studied in children under 6 years old. Amlodipine Kern Pharma 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, consult your doctor.

Using other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Amlodipine Kern Pharma 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)
• Hypericum perforatum(St. John's Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (in infusion for severe body temperature abnormalities)

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

Taking Amlodipine Kern Pharma with food and drink

People taking Amlodipine Kern Pharma should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure-lowering effect of Amlodipine 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 should inform your doctor before taking Amlodipine Kern Pharma.

Breastfeeding

Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding or about to start breastfeeding, you should 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 machines. If the tablets make you feel sick, dizzy, or tired, or if they cause you headaches, do not drive or use machinery and consult your doctor immediately.

3. How to take Amlodipine Kern Pharma

Always take your medicine exactly as your doctor has told you. Consult your doctor or pharmacist if you are unsure.

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

You can take your medicine before or after meals. You should 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 (between 6-17 years old), the usual recommended initial dose is 2.5 mg once daily. The maximum recommended dose is 5 mg once daily.

Amlodipine 2.5 mg is not currently available, and a dose of 2.5 mg cannot be obtained with Amlodipine Kern Pharma 5 mg tablets, as these tablets are not designed to be divided into equal parts.

It is important not to interrupt the administration of the tablets. Do not wait until the tablets are finished before going to your doctor.

If you take more Amlodipine Kern Pharma than you should

Taking too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, faint, suffer from 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. If you take too many Amlodipine Kern Pharma tablets, consult your doctor immediately or call the Toxicology Information Service, phone 91 562 04 20.

Excess fluid can accumulate in the lungs (pulmonary edema) causing difficulty breathing, which can develop up to 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 stop taking Amlodipine Kern Pharma

Your doctor will tell you for how long you should take this medicine. Your condition may come back 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.

4. Possible side effects

Like all medicines, Amlodipine can cause side effects, although not everybody gets them.

Go to your doctor immediatelyif you experience any of the following serious side effects, which are very rare when 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, which can cause great difficulty breathing
• Severe skin reactions, including intense skin rash, hives, redness of the skin all over the body, 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, which can cause severe abdominal pain and back pain, accompanied by a great feeling of discomfort

The following common side effectshave been reported. If any of these cause problems or last more than one week, consult your doctor.

Common:affects between 1 and 10 patients in 100

• Headache, dizziness, drowsiness (especially at the start of treatment)
• Palpitations (feeling the heartbeat), flushing
• Abdominal pain, feeling sick (nausea)
• Swelling of the ankles (edema), tiredness

Other side effects have been reported, which are included in the following list. If you think any of the side effects you are experiencing is serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Uncommon:affects between 1 and 10 patients in 1,000

• Mood changes, anxiety, depression, insomnia
• Tremors, taste disturbances, fainting, weakness
• Numbness or tingling in the limbs, loss of pain sensation
• Visual disturbances, double vision, ringing in the ears
• Low blood pressure
• Sneezing/nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• Changes in bowel habits, diarrhea, constipation, indigestion, 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 frequency of urination
• Impotence, discomfort or breast enlargement in men
• Weakness, pain, feeling unwell
• Muscle or joint pain, muscle cramps, back pain
• Weight gain or loss

Rare:affects between 1 and 10 patients in 10,000

• Confusion

Very rare:affects less than 1 patient in 10,000

• Decrease in white blood cell count, decrease in blood platelets, which can cause easy bruising or bleeding (red blood cell damage)
• High blood sugar (hyperglycemia)
• A nerve disorder that can cause weakness, numbness, or tingling
• Cough, gum inflammation
• Abdominal swelling (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes, which can affect some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin rashes

• Sensitivity to light
• Disorders combining stiffness, tremors, and/or movement disorders

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side 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 packaging, after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and additional information

Composition of Amlodipine Kern Pharma

• The active ingredient of Amlodipine Kern Pharma 5 mg is amlodipine (as besylate).
• The other ingredients 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 pack contents

White, uncoated tablets, scored on one side and marked with "5" on the other side.

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

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

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 last revision of this leaflet: June 2022

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