AMLODIPINE 5 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Amlodipine Bluefish, 5 mg, tablets
3. Amlodipine Bluefish, 10 mg, tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Amlodipine Bluefish and what is it used for
5. Important information before taking Amlodipine Bluefish
   1. When not to take Amlodipine Bluefish
   2. Warnings and precautions
   3. Children and adolescents
   4. Amlodipine Bluefish and other medicines
   5. Amlodipine Bluefish with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Amlodipine Bluefish contains sodium
6. How to take Amlodipine Bluefish
   1. Use in children and adolescents
   2. Taking a higher dose of Amlodipine Bluefish than recommended
   3. Missing a dose of Amlodipine Bluefish
   4. Stopping treatment with Amlodipine Bluefish
7. Possible side effects
   1. Very common: may affect more than 1 in 10 people
   2. Common: may affect up to 1 in 10 people
   3. Uncommon: may affect up to 1 in 100 people
   4. Rare: may affect up to 1 in 1,000 people
   5. Very rare: may affect up to 1 in 10,000 people
   6. Reporting side effects
8. How to store Amlodipine Bluefish
9. Contents of the pack and other information
   1. What Amlodipine Bluefish contains
   2. What Amlodipine Bluefish looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet:

Leaflet accompanying the packaging: information for the user

Amlodipine Bluefish, 5 mg, tablets

Amlodipine Bluefish, 10 mg, tablets

Amlodipine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Amlodipine Bluefish and what is it used for
• 2. Important information 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 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 chest pain, known as angina pectoris, a rare form of which is Prinzmetal's angina (vasospastic angina).
In patients with high blood pressure, this medicine widens the blood vessels, making it easier for blood to flow through them. In patients with angina, Amlodipine Bluefish makes it easier for blood to reach the heart muscle, increasing the amount of oxygen supplied, which in turn prevents chest pain. This medicine does not provide immediate relief from chest pain caused by angina.

2. Important information before taking Amlodipine Bluefish

When not to take Amlodipine Bluefish

• if the patient is allergic to amlodipine or any other ingredient of this medicine (listed in section 6), or to any other calcium antagonist - symptoms may include itching, redness of the skin, or difficulty breathing,
• if the patient has severely low blood pressure (hypotension),
• if the patient has narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where the heart cannot supply enough blood to the body),
• if the patient has heart failure after a heart attack.

Warnings and precautions

Before starting to take Amlodipine Bluefish, the patient should discuss it with their doctor or pharmacist.
The patient should inform their doctor if they have or have had:

• Recently had a heart attack
• Heart failure
• Severe increase in blood pressure (hypertensive crisis)
• Liver disease
• Necessity to increase the dose in elderly patients

Children and adolescents

No studies have been conducted on the use of Amlodipine Bluefish in children under 6 years of age. In children and adolescents aged 6-17 years, Amlodipine Bluefish can only be used to treat high blood pressure (see section 3).
To obtain further information, the patient should consult their doctor.

Amlodipine Bluefish and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
Amlodipine Bluefish may affect the action of other medicines, and other medicines may affect the action of Amlodipine Bluefish, e.g.:

• ketokonazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• St. John's Wort
• verapamil, diltiazem (medicines used to treat heart conditions)
• dantrolene (infusion used to treat severe body temperature disorders)
• simvastatin (a medicine that lowers cholesterol levels)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to change the way the patient's immune system works)
• cyclosporin (an immunosuppressive medicine)

Amlodipine Bluefish may lower blood pressure more when the patient is also taking other blood pressure-lowering medicines.

Amlodipine Bluefish with food and drink

The patient should not drink grapefruit juice or eat grapefruits while taking Amlodipine Bluefish, as they may increase the levels of the active substance, amlodipine, in the blood, which may lead to an unpredictable increase in the blood pressure-lowering effect of Amlodipine Bluefish.

Pregnancy and breastfeeding

The safety of amlodipine in pregnancy has not been established. If the patient is pregnant, thinks she may be pregnant, or plans to have a baby, she should consult her doctor before taking this medicine.
It has been shown that small amounts of amlodipine pass into breast milk. If the patient is breastfeeding or plans to breastfeed, she should consult her doctor before taking this medicine.

Driving and using machines

Amlodipine Bluefish may affect the patient's ability to drive or use machines. If the tablets cause nausea, dizziness, fatigue, or headache, the patient should not drive or use machines; they should contact their doctor immediately.

Amlodipine Bluefish contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Amlodipine Bluefish

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended initial dose of Amlodipine Bluefish is 5 mg once a day. The doctor may increase the dose to 10 mg once a day.
This medicine can be taken with or without food and drinks. The patient should take this medicine every day at the same time, with a glass of water. The patient should not take Amlodipine Bluefish with grapefruit juice.

Use in children and adolescents

The recommended initial dose in children and adolescents (aged 6-17 years) is 2.5 mg once a day. The maximum recommended dose is 5 mg once a day.
A 2.5 mg dose is not currently available and cannot be obtained using Amlodipine Bluefish 5 mg tablets, as the tablets are produced in a form that does not allow them to be broken into two equal halves.
It is essential to take the tablets continuously. The patient should not wait until they have used up all the tablets before visiting their doctor.

Taking a higher dose of Amlodipine Bluefish than recommended

Taking too many tablets may cause a decrease or even a dangerous decrease in blood pressure. The patient may experience dizziness, a feeling of emptiness in the head, fainting, or weakness. If the blood pressure drop is too large, it may lead to shock. The skin may become cool and moist, and the patient may lose consciousness. If the patient has taken too many Amlodipine Bluefish tablets, they should seek medical attention immediately.
Even 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema) may occur.

Missing a dose of Amlodipine Bluefish

The patient should not worry. If they forget to take a tablet, they should skip it and take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Amlodipine Bluefish

The doctor will advise the patient on how long to take the medicine. If the patient stops taking this medicine before their doctor advises them to, their condition may worsen.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Amlodipine Bluefish can cause side effects, although not everybody gets them.
If any of the following very rare, serious side effects occur, the patient should contact their doctor immediately.

• 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 breathing
• Severe skin reactions, including severe rash, hives, redness of the skin all over the body, severe itching, blisters, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, irregular heartbeat
• Pancreatitis, which may cause severe abdominal pain radiating to the back, with very severe illness

The following very common side effecthas been reported. If this side effect is troublesome for the patient or lasts for more than a week, they should contact their doctor.

Very common: may affect more than 1 in 10 people

• Swelling (fluid retention)

The following common side effectshave been reported. If any of these side effects are troublesome for the patient or last for more than a week, they should contact their doctor.

Common: may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the start of treatment)
• Pounding heart (awareness of heartbeat), sudden reddening (especially of the face)
• Abdominal pain, nausea
• Changes in bowel movements, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

Other reported side effects are listed below. If any of the side effects get worse or if the patient experiences any side effects not listed in the leaflet, they should tell their doctor or pharmacist.

Uncommon: may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia
• Trembling, taste disturbances, fainting
• Numbness or tingling of the limbs, lack of pain sensation
• Ringing in the ears
• Low blood pressure
• Sneezing/runny nose caused by inflammation of the nasal mucous membrane (rhinitis)
• Cough
• Dry mouth, vomiting
• Hair loss, increased sweating, itching of the skin, red spots on the skin, changes in skin color
• Urination disorders, increased need to urinate at night, increased frequency of urination
• Impotence, discomfort or enlargement of the breasts in men
• Pain, malaise
• Joint or muscle pain, back pain
• Weight increase or decrease

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

• Disorientation

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

• Decrease in white blood cell count, decrease in platelet count, which may lead to unusual bruising or easier bleeding
• Increased blood sugar levels (hyperglycemia)
• Nerve disorders, which may cause weakness, numbness, or tingling
• Gingival swelling
• Abdominal bloating (gastritis)
• Abnormal liver function, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme activity, as shown in blood tests
• Increased muscle tension
• Vasculitis, often with skin rash
• Sensitivity to light

Unknown:frequency cannot be estimated from the available data

• Trembling, stiffness of posture, mask-like face, slow movements, and dragging of the feet when walking, unsteady gait

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, the patient can help provide more information on the safety of the medicine.

5. How to store Amlodipine Bluefish

The medicine should be stored out of sight and reach of children.
The patient should not take this medicine after the expiry date stated on the carton and blister after "EXP".
The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Amlodipine Bluefish contains

• The active substance of the medicine is amlodipine in the form of amlodipine besylate.

Amlodipine Bluefish, 5 mg, tablets
Each tablet contains 5 mg of amlodipine in the form of amlodipine besylate.
Amlodipine Bluefish, 10 mg, tablets
Each tablet contains 10 mg of amlodipine in the form of amlodipine besylate.

• Other ingredients of the medicine are: microcrystalline cellulose, calcium hydrogen phosphate, sodium carboxymethylcellulose (type A), magnesium stearate.

What Amlodipine Bluefish looks like and contents of the pack

Amlodipine Bluefish, 5 mg
White or almost white, flat, cylindrical tablets with beveled edges, marked with "C" on one side and "58" on the other side.
Amlodipine Bluefish, 10 mg
White or almost white, flat, round tablets with beveled edges, marked with "C" on one side and "59" on the other side.
PVC/PVDC/Aluminum blister pack.
Pack sizes: 14, 20, 28, 30, 50, and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bluefish Pharmaceuticals AB, P.O. Box 49013, 100 28 Stockholm, Sweden
tel. +46851911600

Manufacturer

Bluefish Pharmaceuticals AB, Gävlegatan 22, 113 30 Stockholm, Sweden

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

Date of last revision of the leaflet: