AMLODIPINE 10 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 delivered, 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

Warnings and precautions

Before starting to take Amlodipine Bluefish, discuss it with your doctor or pharmacist.
Tell your doctor if you have or have had:

• Recently had a heart attack
• Heart failure
• Significantly increased blood pressure (hypertensive crisis)
• Liver disease
• A need 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, consult your doctor.

Amlodipine Bluefish and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you 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 (an 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 if you are also taking other blood pressure-lowering medicines.

Amlodipine Bluefish with food and drink

Do not consume grapefruit juice or grapefruits while taking Amlodipine Bluefish, as they may cause an increase in the level of the active substance, amlodipine, in the blood, which may result in an unexpected increase in the effect of Amlodipine Bluefish in lowering blood pressure.

Pregnancy and breastfeeding

The safety of amlodipine in pregnancy has not been established. If you are pregnant, think you may be pregnant, or plan to have a baby, consult your doctor before taking this medicine.
It has been shown that small amounts of amlodipine pass into breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking this medicine.

Driving and using machines

Amlodipine Bluefish may affect your ability to drive or use machines. If the tablets cause nausea, dizziness, fatigue, or headache, do not drive or use machines; consult your 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

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
The recommended initial dose of Amlodipine Bluefish is 5 mg once a day. Your doctor may increase the dose to 10 mg once a day.
This medicine can be taken with or without food and drinks. Take this medicine every day at the same time, with a glass of water. Do 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 manufactured in a form that prevents them from being broken into two equal halves.
It is essential to take the tablets continuously. Do not wait until you have used all the tablets before visiting your 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. Dizziness, feeling of emptiness in the head, fainting, or weakness may occur. If the blood pressure drop is too large, shock may occur. The skin may become cool and moist, and the patient may lose consciousness. If you have taken too many Amlodipine Bluefish tablets, 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

Do not worry. If you forget to take a tablet, skip it.
Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Amlodipine Bluefish

Your doctor will tell you how long to take the medicine. If you stop taking this medicine before your doctor tells you to, your condition may get worse.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following very rare, serious side effects, contact your 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 can cause severe abdominal pain, radiating to the back, with very poor general condition

The following very common side effecthas been reported. If this side effect is troublesome for you or lasts for more than a week, you should consult your 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 you or last for more than a week, you should consult your doctor.

Common: may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the start of treatment)
• Palpitations (awareness of heartbeat), sudden flushing (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 you experience any side effects not listed in the leaflet, you should tell your doctor or pharmacist.

Uncommon: may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting
• Numbness or tingling of limbs, lack of pain sensation
• Ringing in the ears
• Low blood pressure
• Sneezing/runny nose caused by inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting
• Hair loss, increased sweating, itching of the skin, red spots on the skin, changes in skin color
• Urinary disorders, increased need to urinate at night, increased frequency of urination
• Impotence, discomfort, or enlargement of the breasts in men
• Pain, poor general condition
• Pain in the joints or muscles, 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 the occurrence of unusual bruising or easier bleeding
• Increased blood sugar levels (hyperglycemia)
• Nerve disorders that can 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 tone
• Vasculitis, often with skin rash
• Sensitivity to light

Unknown:frequency cannot be estimated from the available data

• Tremor, stiffness, mask-like face, slow movements, and shuffling gait

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store 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 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. Ask your pharmacist how to dispose of medicines no longer required. 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, with the marking "C" on one side and "58" on the other side.
Amlodipine Bluefish, 10 mg
White or almost white, flat, round tablets with beveled edges, with the marking "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
phone: +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: