Amlodipine 5 G Tablets

AMLODIPINE GDC contains the active substance amlodipine which belongs to a group of medicines called calcium antagonists. AMLODIPINE GDC is used to treat high blood pressure (hypertension) and a type of chest pain called angina pectoris, a rare form of which is Prinzmetal’s or variant angina. AMLODIPINE GDC is also used to reduce the risk of fatal and non-fatal heart disease or stroke. AMLODIPINE GDC can be used alone or in combination with other medicines to treat these conditions.

Do not take AMLODIPINE GDC tablets:

• if you are sensitive (allergic) or ever had a harmful reaction to amlodipine, dihydropyridine (used to lower blood pressure), or any of the other ingredients of AMLODIPINE GDC (see section 6)
• if you suffer from severe hypotension (severe low blood pressure, symptoms include light headedness or dizziness)
• if you have previously experienced shock which could include cardiogenic shock (this is the term used when blood pressure becomes so low that your heart stops working properly and medical treatment is required)
• if you recently (within the past 28 days) suffered a heart attack
• if the blood flow from the left side of your heart is obstructed (e.g. aortic valve narrowing)
• if you have unstable angina (chest pain which may occur when you are resting)
• in combination with grapefruit juice (see “Take special care with AMLODIPINE GDC”)
• if you are pregnant or breastfeeding your baby
• if you are younger than 6 years of age.

Do not share medicines prescribed for you with others. Always take AMLODIPINE GDC exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults

The usual dose is initially 5 mg once daily taken at the same time every day with or without food. If no improvement is seen after 10 – 14 days, your doctor may increase the dose to the maximum of 10 mg AMLODIPINE GDC per day (taken as a single dose).

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. The effect of AMLODIPINE GDC on blood pressure in patients less than 6 years of age is not known.

AMLODIPINE GDC can have side effects. Not all side effects reported for AMLODIPINE GDC are included in this leaflet. Should your general health worsen while taking AMLODIPINE GDC, please consult your doctor, pharmacist or other health care professional for advice.

If any of the following happens, stop taking AMLODIPINE GDC and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or severe itching
• fainting
• severe and serious skin reactions which can include:
• reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes, forming very painful raw areas, called erosions that resemble severe hot-water burns. These intense and serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN))
• severe and potentially life-threatening inflammation and scaling and extreme loss of skin over most of the body's skin surface (exfoliative or bullous dermatitis)
• heart failure (when the heart cannot pump adequate amounts of blood to body tissues). You may experience chest pain, shortness of breath, fatigue, swollen legs and rapid heartbeat
• severe liver problems (hepatitis) which can cause symptoms such as fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, light-coloured stools, joint pain, and jaundice (yellowing of the eyes and skin).

These are all very serious side effects. If you have them, you may have had a serious reaction to AMLODIPINE GDC. You may need urgent medical attention or hospitalisation.

Store all medicines out of reach of children.

• Store at or below 25 °C in a cool, dry place.
• Protect from light and moisture.
• Keep container tightly closed.
• Do not remove tablets from container/blister until required for use.
• Return all unused or expired medicines to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).