5 mg and 10 mg tablets
amlodipine
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 a special type of chest pain called angina. A rare form of this is Prinzmetal’s angina or variant angina.
In patients with high blood pressure, the drug reduces the resistance in the blood vessels, so that the blood can pass more easily. In patients with angina, Amlodipine Bluefish works by increasing blood flow to the heart muscle, which then receives more oxygen. That way, chest pain is prevented. The drug does not provide immediate relief of chest pain in angina.
Amlodipine contained in Amlodipine Bluefish may also be approved for the treatment of other
diseases not mentioned in this product information. Ask your doctor, pharmacist, or other personal
healthcare professionals if you have further questions and always follow their instructions.
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 any other calcium channel blocker. Symptoms may include itching, redness of the skin, or difficulty breathing.
- if you have very low blood pressure ( hypotension ).
- if you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition that means that the heart is unable to supply the body with sufficient amounts of blood).
- if you have heart failure after a heart attack.
Warnings and cautions
Talk to your doctor or pharmacist before using Amlodipine Bluefish.
Tell your doctor if you have or have had any of the following:
- recent heart attack
- heart failure
- very high blood pressure (hypertensive crisis)
- liver disease
- if you are older and your dose needs to be increased
Children and young people
Amlodipine Bluefish has not been studied in children under 6 years of age. Amlodipine Bluefish should only be used to treat hypertension in children and adolescents between 6 and 17 years of age (see section 3).
For more information, talk to 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.
Amlodipine Bluefish may affect or be affected by other medicines, such as:
- ketoconazole, itraconazole ( antifungal )
- ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV)
- rifampicin, erythromycin, clarithromycin ( antibiotics )
- Hypericum perforatum ( St. John’s wort )
- verapamil, diltiazem (heart medicine)
- dantrolene (infusion for severe body temperature disturbances)
- simvastatin (a cholesterol-lowering drug)
- tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to change the way the immune system works)
- ciclosporin (medicines that suppress the immune system)
Amlodipine Bluefish may lower your blood pressure further if you are already taking other medicines for high blood pressure.
Amlodipine Bluefish with food and drink
If you are taking Amlodipine Bluefish, do not eat grapefruit or drink grapefruit juice. Grapefruit and grapefruit juice can lead to an increase in the amount of the active substance amlodipine in the blood, which can lead to an unpredictable increase in the blood pressure-lowering effect of Amlodipine Bluefish.
Pregnancy and breastfeeding
The safety of amlodipine during pregnancy has not been established. If you think you are pregnant or planning to become pregnant, tell your doctor before taking Amlodipine Bluefish.
Amlodipine passes into breast milk in small amounts. If you are breast-feeding or about to start breast-feeding, tell your doctor before taking Amlodipine Bluefish.
Driving and using machines
Amlodipine Bluefish may affect your ability to drive or use machines. If you feel unwell, dizzy, or tired, or have headaches from the tablets, do not drive or use machines. Contact your doctor immediately.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects.
Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Amlodipine Bluefish contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to take Amlodipine Bluefish
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended starting dose is 5 mg Amlodipine Bluefish once daily. The dose can be increased to 10 mg Amlodipine Bluefish once daily.
You can take the medicine before or after food or drink. You should take the medicine at the same time each day with a glass of water. Do not take Amlodipine Bluefish with grapefruit juice.
Use for children and adolescents
The recommended starting dose for children and adolescents (6-17 years) is 2.5 mg daily. The maximum recommended dose is 5 mg daily. Amlodipine Bluefish 2.5 mg is currently not available and a 2.5 mg dose can not be obtained with Amlodipine Bluefish 5 mg, as these tablets are not manufactured in such a way that they can be divided into two equal parts.
It is important that you take the tablets at all times. Do not wait until the tablets run out before going to the doctor.
If you take too many tablets, your blood pressure may be low or even dangerously low. You may feel dizzy, unsteady, faint, or weak. If the blood pressure drops low enough, you can experience shock. The skin then feels cold and moist and you can become unconscious. Seek immediate care if you have taken too many Amlodipine Bluefish tablets.
If you forget to take Amlodipine Bluefish
Do not worry. If you forget to take a tablet, just ignore that dose. Take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Amlodipine Bluefish
Your doctor will tell you how long to take the medicine. Your illness may return if you stop taking the medicine earlier.
If you have any further questions on 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.
See your doctor immediately if you get any of the following very rare and serious 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 makes it very difficult to breathe
- severe skin reactions such as severe rash, hives, redness all over the body, severe itching, blistering, skin flaking and swelling, inflamed mucous membranes ( Stevens-Johnson syndrome, toxic epidermal necrolysis ), or other allergic reactions
- heart attack, abnormal heart rate ( pulse )
- inflammation of the pancreas, which can cause severe abdominal and back pain and a strong feeling of illness.
The following very common side effects have been reported. If it causes you problems or if it lasts for more than a week, contact your doctor.
Very common: may affect more than 1 user in 10
- edema (swelling due to fluid)
The following common side effects are reported. If any of these cause you problems or if they last for more than a week, consult your doctor.
Common: may affect up to 1 in 10 users
- headache, dizziness, drowsiness (especially at the beginning of treatment)
- palpitations (you feel the heartbeat), hot flashes
- abdominal pain, nausea
- altered bowel habits, diarrhea, constipation, indigestion
- fatigue, weakness
- visual disturbances, double vision
- muscle cramps
- swollen ankles
Other side effects reported are listed below. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Uncommon: may affect up to 1 in 100 people
- mood swings, anxiety, depression, insomnia
- tremors, taste change, fainting
- numbness or tingling in the arms and legs, inability to feel pain
- earrings
- low blood pressure
- sneezing / runny nose due to inflammation of the nasal mucosa ( rhinitis )
- cough
- dry mouth, vomiting
- hair loss, increased sweating, itchy skin, red spots on the skin, skin discoloration
- urination problems, increased need to urinate at night, increased urination frequency
- impotence, discomfort from or enlarged breasts in men
- pain, feeling sick
- joint or muscle pain, back pain
- weight gain or weight loss
Rare: may affect up to 1 in 1,000 users
- confusion.
Very rare: may affect up to 1 in 10,000 people
- decreased number of white blood cells, decreased number of platelets that can lead to bruising or bleeding easily
- elevated blood sugar (hyperglycemia)
- a nerve disorder that can cause weakness, tingling, or numbness
- swollen gums
- swollen abdomen ( gastritis )
- abnormal liver function, inflammation of the liver ( hepatitis ), yellowing of the skin (jaundice), elevated liver enzymes that may affect certain medical tests
- increased muscle tone (muscle tension)
- inflammation of the blood vessels, often with a rash
- photosensitivity
Has been reported: (occurs in an unknown number of users)
- tremors, stiff posture, worm-like face, slow movements, and sluggish, unbalanced gait.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
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 which is stated on the carton and blister after “EXP”: “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is amlodipine as amlodipine besylate. Each tablet contains 5 mg of amlodipine as amlodipine besilateEach tablet contains 10 mg of amlodipine as amlodipine besylate
- The other ingredients are microcrystalline cellulose, calcium hydrogen phosphate, sodium starch glycolate (Type A), magnesium stearate.
What the medicine looks like and the contents of the pack
5 mg: white or almost white, flat, beveled edges, cylindrical tablet marked with “C” on one side and “58” on the other side.
10 mg: white or almost white, flat, beveled edges, round tablet marked with “C” on one side and “59” on the other side.
PVC / PVdC-aluminum blister
14, 20, 28, 30, 50 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm
This medicinal product is authorized under the European Economic Area under the names:
| Member State | Name of the medicine |
| Denmark | Amlodipine Bluefish |
| Finland | Amlodipine Bluefish 5 mg / 10 mg tablets / tablets |
| Ireland | Amlodipine Bluefish 5 mg / 10 mg tablets |
| Iceland | Amlodipine Bluefish 5 mg tablets |
| Italy | Amlodipine Bluefish 5 mg / 10 mg compress |
| Poland | Amlodipine Bluefish |
| Spain | Amlodipine Bluefish 5 mg / 10 mg compressed |
| Austria | Amlodipine Bluefish 5 mg / 10 mg tablets |