Amlodipine bluefish

Package leaflet: Information for the user

Amlodipine Bluefish, 5 mg, tablets
Amlodipine Bluefish, 10 mg, tablets
Amlodipine
Please read all of this leaflet carefully before 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents:

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 channel blockers.
Amlodipine Bluefish is used to treat high blood pressure (hypertension) or chest pain known as angina, including a less common type called Prinzmetal's angina (vasospastic angina).
In patients with high blood pressure, this medicine relaxes blood vessels, making it easier for blood to flow through them. In patients with angina, Amlodipine Bluefish improves blood flow to the heart muscle, increasing the oxygen supply, thereby helping to prevent chest pain. This medicine does not provide immediate relief of chest pain caused by angina.

2. Information before using Amlodipine Bluefish

When not to use Amlodipine Bluefish

• if the patient is allergic to amlodipine or any of the other ingredients of this medicine (listed in section 6), or to any other calcium antagonist – symptoms may include itching, redness of the skin or difficulty in breathing,
• if the patient has significant hypotension (low blood pressure),
• if the patient has aortic valve stenosis (narrowing of the aortic valve) or cardiogenic shock (a condition in which the heart is unable to deliver sufficient blood to the body),
• if the patient has heart failure following a previous heart attack.

Warnings and precautions
Before starting treatment with Amlodipine Bluefish, please consult your doctor or
pharmacist.
Inform your doctor if the patient has or has previously had:

• Recent heart attack
• Heart failure
• Severe high blood pressure (hypertensive crisis)
• Liver disease
• Need for dose adjustment in elderly patients

Children and adolescents
Studies on the use of Amlodipine Bluefish in children under 6 years of age have not been conducted. Amlodipine Bluefish may be used in children and adolescents aged 6 to 17 years only for the treatment of hypertension (see section 3).
For further information, please consult your doctor.
Amlodipine Bluefish with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends to take.
Amlodipine Bluefish may affect the action of other medicines, and other medicines may affect the action of Amlodipine Bluefish, for example:

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (protease inhibitors used in the treatment of HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• St John's wort (herbal remedy)
• verapamil, diltiazem (medicines used for heart conditions)
• dantrolene (an intravenous infusion used in severe disturbances of body temperature)
• simvastatin (a medicine used to lower cholesterol levels)
• tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to modify the patient's immune system function)
• cyclosporine (an immunosuppressant medicine)

Amlodipine Bluefish may lower blood pressure to a greater extent if the patient is also taking other antihypertensive medicines.
Amlodipine Bluefish with food and drink
Do not consume grapefruit juice or grapefruits during treatment with Amlodipine Bluefish, as they may increase the concentration of the active substance, amlodipine, in the blood, which could result in an unpredictable intensification of the blood pressure-lowering effect of Amlodipine Bluefish.
Pregnancy and breastfeeding
The safety of amlodipine during pregnancy has not been established. If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
It has been shown that small amounts of amlodipine pass into human breast milk. If the patient is breastfeeding or intends to breastfeed, she should consult her doctor before using this medicine.
Driving and using machines
Amlodipine Bluefish may affect the ability to drive or operate machinery. If the tablets cause nausea, dizziness, fatigue or headache, the patient should not drive or operate machinery and should contact their doctor immediately.
Amlodipine Bluefish contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to use Amlodipine Bluefish

This medicine should always be taken exactly as your doctor has instructed. If in doubt, consult
your doctor or pharmacist.
The usual recommended starting dose of Amlodipine Bluefish is 5 mg once daily. Your doctor may
increase the dose to 10 mg once daily.
This medicine can be taken with or without food or drink. It should be taken every day at the same
time, with water. Do not take Amlodipine Bluefish with grapefruit juice.
Use in children and adolescents
The usual recommended starting dose in children and adolescents (aged 6–17 years) is 2.5 mg once
daily. The maximum recommended dose is 5 mg once daily.
The 2.5 mg dose is currently not available and cannot be obtained by splitting the 5 mg Amlodipine
Bluefish tablets, as the tablets are manufactured in a form that does not allow them to be divided
into two equal halves.
It is important to take the tablets continuously. Do not wait until all tablets are used before visiting
your doctor.
Taking more Amlodipine Bluefish than prescribed
Taking too many tablets may cause a reduction or even dangerous lowering of blood pressure.
Dizziness, a feeling of emptiness in the head, fainting, or weakness may occur. If blood pressure
drops too low, shock may develop. The skin may become cold and clammy, and the patient may
lose consciousness. If too many Amlodipine Bluefish tablets have been taken, seek immediate
medical help.
Breathlessness caused by excess fluid accumulating in the lungs (pulmonary oedema) may occur
even 24–48 hours after taking the medicine.
If you miss a dose of Amlodipine Bluefish
Do not worry. If you forget to take a tablet, simply skip that dose. Take the next dose at your usual
time. Do not take a double dose to make up for a missed dose.
Stopping Amlodipine Bluefish treatment
Your doctor will advise you on how long to take this medicine. If you stop taking this medicine
before your doctor advises, your condition may return.
If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following very rare, serious adverse effects occur after taking the medicine, you should seek immediate medical advice.

• Sudden wheezing, chest pain, shortness of breath or difficulty breathing
• Swelling of the eyelids, face or lips
• Swelling of the tongue and throat causing significant breathing difficulties
• Severe skin reactions, including severe rash, urticaria, redness of the entire skin surface, intense itching, blisters, skin peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, cardiac arrhythmias
• Pancreatitis, which may cause severe upper abdominal pain radiating to the back, accompanied by a very poor general condition

The following very common adverse effect has been reported. If this adverse effect is troublesome for the patient or if it lasts longer than one week, you should consult a doctor.
Very common: may affect more than 1 in 10 people

• Swelling (fluid retention)

The following common adverse effects have been reported. If any of these adverse effects are troublesome for the patient or if they last longer than one week, you should consult a doctor.
Common: may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of heartbeat), sudden flushing (especially of the face)
• Abdominal pain, nausea
• Changes in bowel habits, diarrhoea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Ankle swelling

Other reported adverse effects are listed below. If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform 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
• Tinnitus
• Low blood pressure
• Sneezing/nasal congestion due to inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting
• Hair loss, increased sweating, skin itching, red skin spots, skin discoloration
• Urinary disorders, increased need to urinate at night, increased frequency of urination
• Inability to achieve erection, discomfort or enlargement of breasts in men
• Pain, malaise
• Joint or muscle pain, back pain
• Increased or decreased body weight

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

• Disorientation

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

• Decreased number of white blood cells, decreased number of platelets, which may lead to unusual bruising or easier bleeding
• Increased blood glucose levels (hyperglycaemia)
• Nerve disorders which may cause weakness, tingling or numbness
• Gum swelling
• Abdominal bloating (dyspepsia)
• Liver function abnormalities, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity detected in blood tests
• Increased muscle tone
• Inflammation of blood vessels, often with skin rash
• Light sensitivity

Not known: frequency cannot be estimated from the available data

• Tremor, muscle rigidity, facial expressionlessness, slowed movements and dragging of the legs when walking, unsteady gait

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the 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 pack following "EXP".
The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Amlodipine Bluefish contains

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

Amlodipine Bluefish 5 mg tablets
Each tablet contains 5 mg of amlodipine as amlodipine besylate.
Amlodipine Bluefish 10 mg tablets
Each tablet contains 10 mg of amlodipine as amlodipine besylate.

• Other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate, sodium carboxymethyl starch (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 bevelled 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 bevelled edges, marked with "C" on one side and "59" on the other side.
Blister pack made of PVC/PVDC/Aluminium.
Pack sizes: 14, 20, 28, 30, 50 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area under the following names: