AMLODIPINE BLUEFISH 5 mg TABLETS

Contents of the pack:

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

1. What is Amlodipine Bluefish and what is it used for

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

Amlodipine Bluefish is used to treat high blood pressure (hypertension) or a certain type of chest pain (angina pectoris), or a rare form of angina (Prinzmetal's angina).

In patients with high blood pressure, this medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina, Amlodipine Bluefish works by improving blood supply to the heart muscle, which receives more oxygen and as a result, chest pain is prevented. This medicine does not provide immediate relief of chest pain due to angina.

2. What you need to know before you take Amlodipine Bluefish

Do not take Amlodipine Bluefish

• If you are allergic to amlodipine or any of the other ingredients of this medicine 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 narrowing of the aortic valve in the heart (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to supply enough blood to the body).
• If you suffer from heart failure following a heart attack.

Warnings and precautions

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

Tell 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
• If you are elderly and the dose needs to be increased

Children and adolescents

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

For more information, consult your doctor.

Other medicines and Amlodipine Bluefish

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines interact or may interact with Amlodipine Bluefish.

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

Amlodipine Bluefish may lower blood pressure even further if you are already taking other medicines to treat high blood pressure.

Taking Amlodipine Bluefish with food and drinks

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

This is because grapefruit and grapefruit juice can cause an increase in the blood of amlodipine and this can cause an unpredictable increase in the blood pressure lowering effect of Amlodipine Bluefish.

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 Amlodipine Bluefish.

Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding, or are about to start breastfeeding, you must inform your doctor before taking Amlodipine Bluefish.

Driving and using machines

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

Amlodipine Bluefish contains sodium

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

3. How to take Amlodipine Bluefish

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Take the tablets with a little water. They can be taken with or without food.

You should take this medicine at the same time each day. Do not take Amlodipine 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 Amlodipine Bluefish 5 mg because the tablets have not been designed to be split in half.

It is important to continue treatment. Do not wait until you have run out of tablets before seeing your doctor.

If you take more Amlodipine Bluefish than you should

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

Taking too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, faint, suffer from postural dizziness when getting up or weakness. If the drop in blood pressure is severe enough, it can cause shock. You may feel your skin cold and wet and you could lose consciousness. Seek immediate medical attention if you take too many Amlodipine Bluefish tablets.

Excess fluid may 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 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 make up for the forgotten dose.

If you stop taking Amlodipine Bluefish

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

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

4. Possible side effects

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

Go to your doctor immediately if you experience any of the following side effects 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 that causes great difficulty breathing
• Severe skin reactions, including intense skin rash, hives, skin redness 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 heart rhythm
• Pancreatitis that can cause severe abdominal and back pain accompanied by a feeling of discomfort

The following common side effectshave been reported. If you suffer from any of these problems or if they last more than a week, you should consult 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 start of treatment)
• Palpitations (noticing heartbeats), flushing
• Abdominal pain, feeling sick (nausea)
• Changes in 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 effects not mentioned in this leaflet, inform your doctor or pharmacist.

Uncommon: may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia
• Tremors, taste disturbances, fainting
• Numbness or tingling in the limbs, loss of pain sensation
• Ringing in the ears
• Low blood pressure
• Sneezing/nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting (being sick)
• Hair loss, increased sweating, itching, red spots on the skin, skin discoloration
• Urination disorder, increased need to urinate at night, increased number of times urinating
• Impotence, discomfort or enlargement of the breasts in men
• Pain, feeling unwell
• 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

• Decrease in the number of white blood cells, decrease in platelets in the blood that can cause unusual bleeding or bruising
• Excess glucose in the blood (hyperglycemia)
• A nerve disorder that can cause weakness, tingling, or numbness
• Gingivitis
• Abdominal distension (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 rashes
• Sensitivity to light

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

• Tremors, rigid posture, "mask-like" face, slow movements, and unsteady gait.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine Bluefish

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pack after "EXP". The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your usual pharmacy. 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 other information

Composition of Amlodipine Bluefish

• The active substance is Amlodipine as besylate.

Each tablet contains 5 mg of Amlodipine as besylate

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

Appearance of the product and packaging

5 mg: white or almost white, flat, beveled, cylindrical in shape, and engraved with "C" on one side and "58" on the other.

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

Not all pack sizes may be available.

Marketing authorization holder

Bluefish Pharmaceuticals AB;

P.O. Box 49013

100 28 Stockholm;

Sweden

Manufacturer

Bluefish Pharmaceuticals AB;

Gavlegatan 22

113 30 Stockholm;

Sweden

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

Bluefish Pharma S.L.U.,

AP 36007

2832094 Madrid, Branch 36

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:September 2022

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