Patient Information Leaflet: Package Insert

Amlodipine Bluefish 5 mg Tablets EFG

amlodipine

Read this entire leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only; do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Amlodipine Bluefish is and what it is used for
2. What you need to know before you start taking Amlodipine Bluefish
3. How to take Amlodipine Bluefish
4. Possible side effects
5. Storage of Amlodipine Bluefish
6. Contents of the pack and additional information

Amlodipino Bluefish contains the active substance amlodipine, which belongs to a group of medicines called calcium antagonists.

Amlodipino Bluefish is used for the treatment of high blood pressure (hypertension) or a certain type of chest pain (angina pectoris), or a rare form of angina (Prinzmetal's variant angina).

In patients with high blood pressure, this medicine acts by relaxing blood vessels, allowing blood to flow through them more easily. In patients with angina, Amlodipino Bluefish acts by improving blood supply to the heart muscle, allowing it to receive more oxygen and as a result, preventing chest pain. This medicine does not provide immediate relief from chest pain due to angina.

Do not take Amlodipino Bluefish

• If you are allergic to amlodipine or any of the other ingredients listed in section 6, or to similar calcium channel blockers. This may cause itching, skin redness, or difficulty breathing.
• If you have severe hypotension (very low blood pressure)
• If you have aortic stenosis (narrowing of the aortic valve of the heart) or cardiogenic shock (a condition where the heart is unable to supply enough blood to the body)
• If you have heart failure as a result of a heart attack

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amlodipino Bluefish.

Inform your doctor if you have or have had any of the following conditions:

• Recent heart attack
• Heart failure
• Severe hypertension (hypertensive crisis)
• Liver disease
• If you are an elderly person and your dose needs to be increased

Children and adolescents

Amlodipino Bluefish has not been evaluated in children under 6 years of age. Amlodipino Bluefish should only be used in children and adolescents 6-17 years of age with hypertension (see section 3).

For more information, consult your doctor.

Other medications and Amlodipino Bluefish

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Some medications interact or may interact with Amlodipino Bluefish.

• ketoconazole, itraconazole (antifungal medications)
• ritonavir, indinavir, nelfinavir (also called protease inhibitors used in HIV treatment)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum (St. John's Wort)
• verapamil, diltiazem (heart medications)
• dantrolene (intravenous infusion for treating severe body temperature abnormalities)
• simvastatin (medication to lower blood cholesterol)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medications used to modify the functioning of the immune system)
• ciclosporin (an immunosuppressant)

Amlodipino Bluefish may lower blood pressure even more if you are already taking other medications to treat high blood pressure.

Taking Amlodipino Bluefish with food and drinks

People taking amlodipino Bluefish should not take grapefruit or grapefruit juice.

This is because grapefruit and grapefruit juice may increase the amount of amlodipine in the blood and may cause unpredictable lowering of blood pressure.

Pregnancy and breastfeeding

The safety of amlodipine in human 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 Bluefish.

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 Bluefish.

Driving and operating machinery

Amlodipino Bluefish may affect your ability to drive or operate machinery. If the tablets make you feel sick, dizzy, or tired, or give you a headache, do not drive or operate machinery and contact your doctor immediately.

Amlodipino Bluefish contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The usual initial dose is Amlodipino Bluefish 5 mg once a day. The dose may be increased to 10 mg of Amlodipino Bluefish once a day.

Take the tablets with a little water. You can take them with meals or between them.

You must take this medication at the same time every day. Do not take Amlodipino Bluefish with grapefruit juice.

Use in children and adolescents

For children and adolescents (6-17 years), the recommended dose is to start treatment with 2.5 mg daily. The maximum recommended dose is 5 mg daily.

The 2.5 mg dose is not currently available and the 2.5 mg dose cannot be obtained from Amlodipino Bluefish 5 mg since the tablets have not been designed to be split in half.

It is essential to continue treatment. Do not wait for the tablets to run out before seeing your doctor.

If you take more Amlodipino Bluefish than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

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 wet, and you could lose consciousness. Seek immediate medical attention if you take too many Amlodipino Bluefish tablets.

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 Amlodipino Bluefish

Do not worry. If you forget to take a tablet, leave that dose completely. 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 Bluefish

Your doctor has indicated for how long you should take this medication. If you suddenly stop treatment, your symptoms may reappear.

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

Like all medicines, this medicine may cause side effects, although not everyone experiences them.

Seek medical attention immediately if you experience any of the following side effects after taking this medicine.

• Sudden hissing sound while breathing, 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, including intense skin rash, urticaria, skin redness 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, abnormal heart rhythm
• Pancreatitis that can cause severe abdominal and back pain accompanied by a feeling of discomfort

The followingcommon side effectshave been reported. If you suffer from any of these problems orif they last more than a week, you shouldconsult your doctor.

Very common: may affect more than 1 in 10 people.

• Edema (fluid retention).

Common: may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (note the heartbeats), flushing
• Abdominal pain, feeling of discomfort (nausea)
• Alteration of bowel habits, diarrhea, constipation, indigestion.
• Fatigue, weakness

• Visual disturbances, double vision.

• Muscle cramps
• Swelling of the ankles

Other side effects that have been reported are included in the following list. If any of them are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Uncommon: may affect up to 1 in 100 people

• Changes in mood, anxiety, depression, insomnia
• Tremors, alterations in taste, fainting
• Numbness or tingling in the extremities, loss of pain sensation
• Ringing in the ears
• Low blood pressure
• Runny nose / nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting (feeling sick)
• Loss of hair, increased sweating, itching skin, red spots on the skin, skin discoloration
• Urination disorders, increased need to urinate at night, increased frequency of urination
• Inability to achieve an erection, breast tenderness or enlargement in men
• Pain, feeling of discomfort
• Joint or muscle pain, back pain
• Weight gain or loss

Rare: may affect up to 1 in 1,000 people

• Confusion

Very rare: may affect up to 1 in 10,000 people

• Decreased white blood cell count, decreased platelet count in the blood that may cause unusual bleeding or petechiae
• High blood glucose (hyperglycemia)
• A disorder of the nerves that may cause weakness, numbness, or tingling
• Gingivitis
• Abdominal distension (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that may affect some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin eruptions
• Sensitivity to light

Frequency not known: the frequency cannot be estimated from the available data

• Tremors, rigid posture, "mask-like" face, slow movements, and unsteady gait with dragging of the feet.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach 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.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at your local SIGRE collection point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Amlodipino Bluefish

• The active ingredient is Amlodipino as besilate.

Each tablet contains 5 mg of Amlodipino as besilate

• The other components (excipients) are: microcrystalline cellulose, calcium hydrogen phosphate, sodium starch glycolate (Type A), magnesium stearate.

Appearance of the product and contents of the package

5 mg: white or almost white, flat, bisected, cylindrical in shape, and engraved with “C” on one face and “58” on the other.

PVC-PVdC aluminum blister pack with: 14, 20, 28, 30, 50, and 100 tablets.

It is possible that not all package sizes are available.

Marketing Authorization Holder

Bluefish Pharmaceuticals AB;

P.O. Box 49013

100 28 Stockholm;

Sweden

Responsible for manufacturing

Bluefish Pharmaceuticals AB;

Gavlegatan 22

113 30Stockholm;

Sweden

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Bluefish Pharma S.L.U.,

AP 36007

2832094 Madrid, Branch 36

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:September 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/