Amlodipine Kern Pharma 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amlodipine KERN PHARMA 10 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to others, even if they have the same symptoms as you, because it could be harmful to them.
• If you think any of the side effects you experience is serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

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 the 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 taking Amlodipine Kern Pharma

Do not take Amlodipine Kern Pharma

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

Take special care 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 may need adjustment

Use in children and adolescents

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

For further information, consult your doctor.

Use of other medicines

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

Amlodipine Kern Pharma may interact with, 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 (intravenous infusion for serious disturbances in body temperature)

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

Taking Amlodipine Kern Pharma with food and drinks

Patients taking Amlodipine Kern Pharma should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could lead to an unpredictable increase in the blood pressure-lowering effect of Amlodipine Kern Pharma.

Pregnancy

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.

Breast-feeding

It has been shown that amlodipine passes into breast milk in small amounts. If you are breast-feeding or intend to breast-feed, you should inform your doctor before taking Amlodipine Kern Pharma.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Amlodipine Kern Pharma may affect your ability to drive or operate machinery. If the tablets make you feel unwell, dizzy, tired, or cause headache, 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 instructed. Consult your doctor or pharmacist if you have any doubts.

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 your medicine before or after meals. 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 normally 2.5 mg daily. The maximum recommended dose is 5 mg daily.

It is important not to interrupt the administration of the tablets. 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 when standing up, or weakness. If the drop in blood pressure is severe enough, shock may occur. You may feel cold and clammy skin and could lose consciousness. If you have taken too many Amlodipine Kern Pharma tablets, contact your doctor immediately or call the Toxicology Information Service at 91 562 04 20.

Excess fluid may accumulate in the lungs (pulmonary edema), causing breathing difficulties, 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, skip that dose. Take the next dose at the correct time. Do not take a double dose to make up for the missed dose.

If you stop taking Amlodipine Kern Pharma

Your doctor will advise you on how long you should take this medicine. Your condition may recur if you stop taking this medicine before your doctor tells you to do so.

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 Kern Pharma may cause adverse effects, although not everyone experiences 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, chest pain, shortness of breath or difficulty breathing
• Swelling of the eyelids, face or lips
• Swelling of the tongue and throat causing severe breathing difficulty
• Severe skin reactions including severe rash, hives, redness of the skin all over the body, itching, blistering, peeling and skin inflammation, swelling of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
• Heart attack, irregular heartbeat
• Inflammation of the pancreas (pancreatitis) which may cause severe abdominal pain and back pain accompanied by a marked feeling of illness

The following frequent adverse effects have been reported. If any of these cause problems or 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), flushing
• Abdominal pain, feeling unwell (nausea)
• Swelling of the ankles (edema), fatigue

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 mentioned 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
• Decrease in blood pressure
• Sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis)
• Changes in bowel habits, diarrhea, constipation, indigestion, dry mouth, vomiting (nausea)
• 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 unwell
• 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 fewer than 1 in every 10,000 patients

• Decrease in the number of white blood cells, decrease in blood platelets which may cause easy bleeding or unusual bruising (damage to red blood cells)
• High blood sugar (hyperglycemia)
• A nerve disorder that 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
• Light sensitivity
• Disorders combining stiffness, 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 through 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 packaging, following EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

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

6. Package contents and additional information

Composition of Amlodipine Kern Pharma

The active substance in Amlodipine Kern Pharma 10 mg tablets is amlodipine (as besylate).

• 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

White, uncoated tablets, scored on one side and marked “10” on the other side.

The score line is intended only to facilitate breaking the tablet for ease of swallowing and not to divide the tablet into equal doses.

Amlodipine Kern Pharma 10 mg tablets are available in blister packs containing 30 tablets (regular pack) or 100 tablets (clinical pack).

Marketing Authorization Holder

Kern Pharma, S.L.

Polígono Industrial Colón II

Venus 72

08228 Terrassa (Barcelona)

Spain

Manufacturer

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

Date of latest revision of this leaflet: June 2022

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