Amvasc™ contains the active substance amlodipine which belongs to a group of
medicines called calcium antagonists.
Amvasc™ 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
Amvasc™ 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 Amvasc™
• 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.
Take special care with Amvasc™
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.
Use in children and adolescents
Amvasc™ has not been studied in children under the age of 6 years. Amvasc™
should only be 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
Amvasc™ 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).
Amvasc™ may lower your blood pressure even more if you are already taking
other medicines to treat your high blood pressure.
Taking Amvasc™ with food and drink
Grapefruit juice and grapefruit should not be consumed by people who are
taking Amvasc™. 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 Amvasc™.
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 Amvasc™.
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 Amvasc™.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Amvasc™ may affect your ability to drive or use machines. If the capsules 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 Amvasc™ 5 mg once daily. The dose can be increased
to Amvasc™ 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 Amvasc™ 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. It is
important to keep taking the capsules.
If you take more Amvasc™ than you should
Taking too many capsules 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 Amvasc™ capsules.
If you forget to take Amvasc™
Do not worry. If you forget to take a capsule, 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 Amvasc™
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.

Like all medicines, Amvasc™ 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
discoloration.
• 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
• Confusion.
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.
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.

Keep out of the reach and sight of children.
Do not store above 30 ºC. Protect from light.
Do not use your medicine after the expiry date which is stated on the pack after
‘EXP’.
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.