Document: Amlodipin Bluefish tablet ENG PL change

• Amlodipin Bluefish tablet PL
• Amlodipin Bluefish tablet ENG PL

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Package leaflet: Information for the user

Amlodipin Bluefish 5 mg tablets

Amlodipin Bluefish 10 mg tablets

Amlodipine.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you..

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Amlodipin Bluefishis and what it is used for

2. What you need to know before you take Amlodipin Bluefish

3. How to take Amlodipin Bluefish

4. Possible side effects

6. Contents of the pack and other information

Amlodipin Bluefish contains the active substance amlodipine which belongs to a group of medicines called calcium antagonists.

Amlodipin Bluefish is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, a rare form of which is Prinzmetal’s or variant angina.

In patients with high blood pressure your medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina Amlodipin Bluefish works by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. Your medicine does not provide immediate relief of chest pain from angina.

Do not take Amlodipin Bluefish

• If you are allergic (hypersensitive) to amlodipine, or any of the other ingredients of your medicine listed in section 6, or to any other calcium antagonists. This may be itching, reddening of the skin or difficulty in breathing.

• If you have severe low blood pressure (hypotension)

• If you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body).

• If you suffer from heart failure after a heart attack

Warnings and precautions

You should 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

• You are elderly and your dose needs to be increased

Children and adolescents

Amlodipin Bluefish has not been studied in children under the age of 6 years. Amlodipin Bluefish should only used for hypertension in children and adolescents from 6 years to 17 years of age (see section 3).

For more information, talk to your doctor.

Other medicines and Amlodipin Bluefish

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription..

Amlodipin Bluefish may affect or be affected by other medicines, such as:

• ketoconazole, itraconazole (anti-fungal medicines)

• ritonavir, indinavir, nelfinavir (so called protease inhibitors used to treat HIV)

• rifampicin, erythromycin, clarithromycin (antibiotics)

• hypericum perforatum (St. John’s Wort)

• verapamil, diltiazem (heart medicines)

• dantrolene (infusion for severe body temperature abnormalities)

• simvastatin (a cholesterol lowering medicine)

Amlodipin Bluefish may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure.

Amlodipin Bluefishwith food and drink

Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipin Bluefish. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Amlodipin Bluefish.

Pregnancy

The safety of amlodipine in human pregnancy has not been established. If you think you might be pregnant, or are planning to get pregnant, you must tell your doctor before you take Amlodipin Bluefish.

Breast-feeding

It is not known whether amlodipine is passed into breast milk. If you are breast-feeding or about to start breast-feeding you must tell your doctor before taking Amlodipin Bluefish.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Amlodipin Bluefish may affect your ability to drive or use machines. If the tablets make you feel sick, dizzy or tired, or give you a headache, do not drive or use machines and contact your doctor immediately.

Always take your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual initial dose is Amlodipin Bluefish 5 mg once daily. The dose can be increased to Amlodipin Bluefish 10 mg once daily.

Your medicine can be used before or after food and drinks. You should take your medicine at the same time each day with a drink of water. Do not take Amlodipin Bluefish with grapefruit juice.

Use in children and adolescents

For children and adolescents (6 -17 years old), the recommended usual starting dose is 2.5 mg a day. The maximum recommended dose is 5 mg a day.

Amlodipine 2.5 mg is not currently available and the 2.5 mg dose cannot be obtained with Amlodipin Bluefish 5mg tablets as these tablets are not manufactured to break into two equal halves.

It is important to keep taking the tablets. Do not wait until your tablets are finished before seeing your doctor.

If you take more Amlodipin Bluefish than you should

Taking too many tablets may cause your blood pressure to become low or even dangerously low. You may feel dizzy, lightheaded, faint or weak. If blood pressure drop is severe enough shock can occur. Your skin could feel cool and clammy and you could lose consciousness. Seek immediate medical attention if you take too many Amlodipin Bluefish tablets

If you forget to take Amlodipin Bluefish

Do not worry. If you forget to take a tablet, leave out that dose completely. Take your next dose at the right time. Do not take a double dose to make up for a missed dose.

If you stop taking Amlodipin Bluefish

Your doctor will advise you how long to take your medicine. Your condition may return if you stop using your medicine before you are advised.

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

4. Possible side effects

Like all medicines, Amlodipin Bluefish can cause side effects, although not everybody gets them.

Visit your doctor immediately if you experience any of the following very rare, severe side effects after taking this medicine.

• Sudden wheeziness, chest pain, shortness of breath or difficulty in breathing

• Swelling of eyelids, face or lips

• Swelling of the tongue and throat which causes great difficulty breathing

• Severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome) or other allergic reactions

• Heart attack, abnormal heart beat

• Inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell

The following common side-effects have been reported. If any of these cause you problems or if they last for more than one week, you should contact your doctor.

Common: affects 1 to 10 users in 100

• Headache, dizziness, sleepiness (especially at the beginning of treatment)

• Palpitations (awareness of your heart beat), flushing

• Abdominal pain, feeling sick (nausea)

• Ankle swelling (oedema), tiredness

Other side-effects that have been reported include the following list. If any of these get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.

Uncommon: affects 1 to 10 users in 1,000

• Mood changes, anxiety, depression, sleeplessness

• Trembling, taste abnormalities, fainting, weakness

• Numbness or tingling sensation in your limbs; loss of pain sensation

• Visual disturbances, double vision, ringing in the ears

• Low blood pressure

• Sneezing/running nose caused by inflammation of the lining of the nose (rhinitis)

• Altered bowel habits, diarrhoea, constipation, indigestion, dry mouth, vomiting (being sick)

• Hair loss, increased sweating, itchy skin, red patches on skin, skin discolouration

• Disorder in passing urine, increased need to urinate at night, increased number of times of passing urine

• Inability to obtain an erection; discomfort or enlargement of the breasts in men

• Weakness, pain, feeling unwell

• Joint or muscle pain, muscle cramps, back pain

• Weight increase or decrease

Rare: affects 1 to 10 users in 10,000

Very rare: affects less than 1 user in 10,000

• Decreased numbers of white blood cells, decrease in blood platelets which may result in unusual bruising or easy bleeding (red blood cell damage)

• Excess sugar in blood (hyperglycaemia)

• A disorder of the nerves which can cause weakness, tingling or numbness

• Cough, swelling of the gums

• Abdominal bloating (gastritis)

• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), liver enzyme increase which may have an effect on some medical tests

• Increased muscle tension

• Inflammation of blood vessels, often with skin rash

• Sensitivity to light

• Disorders combining rigidity, tremor, and/or movement disorders

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

[To be completed nationally]

5. How to store Amlodipin Bluefish

Keep out of the reach and sight of children.

Do not use Amlodipin Bluefish after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

No special storage conditions.

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. Content of the pack and other information

What Amlodipin Bluefish contains

Each tablet contains 5 mg amlodipine as amlodipine besylate

Each tablet contains 10 mg amlodipine as amlodipine besylate

What Amlodipin Bluefish looks like and contents of the pack

5 mg: white or almost white, flat, bevelled edges, cylinder shaped tablet imprinted with “C” on one side and “58” on the other side.

10 mg: white or almost white, flat, bevelled edges, round tablet imprinted with “C” on one side and “59” on the other side.

PVC/PVdC - aluminium blister

14, 20, 28, 30, 50 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Bluefish Pharmaceuticals AB

Torsgatan 11

111 23 Stockholm

Sweden

This medicinal product is authorized in the Member States of the EEA under the following names:

This leaflet was last approved in 2014-02-28