Amlodipine Bluefish 5 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Amlodipine Bluefish 5 mg tablets EFG

amlodipine

Read the 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet:

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

1. What Amlodipine Bluefish is and what it is 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), 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 works by relaxing the blood vessels, allowing blood to flow through them more easily. In patients with angina, Amlodipine Bluefish improves blood supply to the heart muscle, thereby increasing oxygen delivery 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 Bluefish

Do not take Amlodipine Bluefish

• If you are allergic to amlodipine or to 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 heart's aortic valve (aortic stenosis) or cardiogenic shock (a condition in which 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.

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
• If you are elderly and require a dose increase

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 aged 6–17 years with hypertension (see section 3).

For further information, consult your doctor.

Other medicines and Amlodipine Bluefish

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

Some medicines interact or may interact with Amlodipine Bluefish.

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

Amlodipine Bluefish may lower blood pressure even more if you are already taking other medicines for high blood pressure.

Taking Amlodipine Bluefish with food and drink

People taking Amlodipine Bluefish should not eat grapefruit or drink grapefruit juice.

This is because grapefruit and grapefruit juice may cause an increase in amlodipine levels in the blood, which could lead to 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.

It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or 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 unwell, dizzy, 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 instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The usual starting dose is Amlodipine Bluefish 5 mg once daily. The dose may be increased to Amlodipine Bluefish 10 mg once daily.

Take the tablets with a little water. They may 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 currently not available, and the 2.5 mg dose cannot be obtained from Amlodipine Bluefish 5 mg tablets, as the tablets are not designed to be split in half.

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

If you take more Amlodipine Bluefish than you should

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

Taking too many tablets may cause a drop in blood pressure or even a dangerous drop. 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 your skin is cold and clammy, 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 breathing difficulties, which may develop within 24–48 hours after ingestion.

If you forget to take Amlodipine Bluefish

Do not worry. If you forget to take a tablet, simply 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 Bluefish

Your doctor has advised you on how long you should take this medicine. If you stop treatment suddenly, your symptoms may return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Seek medical advice immediately if you experience any of the following adverse 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 causing severe difficulty in breathing
• Severe skin reactions, including intense rash, urticaria, redness of the skin all over the body, itching, blistering, peeling and inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
• Heart attack, irregular heartbeat
• Inflammation of the pancreas which may cause severe abdominal and back pain accompanied by malaise

The following common side effects have been reported. If you experience any of these problems or if they last longer than one 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 beginning of treatment)
• Palpitations (awareness of heartbeat), flushing
• Abdominal pain, malaise (nausea)
• Changes in bowel habits, diarrhoea, 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 these are severe, or if you notice any side effects not listed 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 sensation in the limbs, loss of pain sensation
• Ringing in the ears
• Low blood pressure
• Sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting (feeling sick)
• 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
• Pain, malaise
• Joint or muscle pain, back pain
• Weight gain or weight 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 white blood cell count, decrease in platelets in the blood which may cause unusual bleeding or bruising
• Excess glucose in the blood (hyperglycaemia)
• A nerve disorder which may cause weakness, tingling, or numbness
• Inflammation of the gums
• Abdominal distension (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

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

• Tremors, rigid posture, "mask-like" face, slow movements and unbalanced gait with shuffling steps.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE Point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Amlodipine Bluefish

• The active substance is Amlodipine as besylate.

Each tablet contains 5 mg of amlodipine as besylate.

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

Appearance of the medicinal product and content of the container

5 mg: white or almost white, flat, bevelled, cylindrical tablets, engraved with “C” on one side and “58” on the other.

Aluminum PVC-PVdC blister pack containing: 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

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Bluefish Pharma S.L.U.,
P.O. Box 36007
28320 Madrid, Branch 36
Spain

This medicinal product is authorized in the European Economic Area member states with the following names:

Date of the last revision of this leaflet: September 2022

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