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AMLODIPINE 5MG TABLETS
Active substance(s): AMLODIPINE BESILATE / AMLODIPINE BESYLATE / AMLODIPINE MALEATE / AMLODIPINE MESILATE MONOHYDRATE / AMLODIPINE BESILATE / AMLODIPINE BESYLATE / AMLODIPINE MALEATE / AMLODIPINE MESILATE MONOHYDRATE / AMLODIPINE BESILATE / AMLODIPINE BESYLATE / AMLODIPINE MALEATE / AML
Amlodipine 5 mg tablets
Amlodipine 10 mg tablets
Amlodipine (as besilate)
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, pharmacist or nurse.
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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4
What is in this leaflet:
What Amlodipine Tablet is and what it is used for
What you need to know before you take Amlodipine Tablets
How to take Amlodipine Tablets
Possible side effects
How to store Amlodipine Tablets
Contents of the pack and other information.
1. WHAT AMLODIPINE TABLET IS AND WHAT IT IS USED FOR
Amlodipine tablets contains the active substance amlodipine which belongs to a group of medicines called calcium antagonists.
Amlodipine tablet 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
In patients with high blood pressure this medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina,
amlodipine tablets works by improving blood supply to the heart muscle, which then receives more oxygen and, as a result, chest pain is prevented. This
medicine does not provide immediate relief of chest pain from angina.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMLODIPINE TABLETS
Do not take Amlodipine Tablet
- if you are allergic to amlodipine, or any of the other ingredients of this medicine, or 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
- if you suffer from heart failure after a heart attack.
Warning and precautions
Talk to your doctor or pharmacist before taking Amlodipine tablets
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
Amlodipine tablet has not been studied in children under the age of 6 years. Amlodipine tablet 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.
Other medicines and Amlodipine tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Amlodipine tablets 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 (for infections caused by bacteria)
- hypericumperforatum (St. John’s Wort)
- verapamil, diltiazem (heart medicines)
- dantrolene (infusion for severe body temperature abnormalities)
- simvastatin (a cholesterol lowering medicine)
- cyclosporine (an immunosuppressant)
Amlodipine tablets may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure.
Amlodipine tablets with food and drink
Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipine tablets. 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 Amlodipine tablets.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this
The safety of amlodipine in human pregnancy has not been established.
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 Amlodipine tablets.
Driving and using machines
Amlodipine tablets 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.
3. HOW TO TAKE AMLODIPINE TABLETS
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended initial dose is Amlodipine tablet 5 mg once daily. The dose can be increased to Amlodipine tablet 10 mg once daily.
This 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
Amlodipine tablets 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.
For tablets without a break-line: Amlodipine 2.5 mg is not currently available and the 2.5 mg dose cannot be obtained with Amlodipine 5 mg tablet as these
tablets are not manufactured to break into two equal doses.
It is important to keep taking the tablets. Do not wait until your tablets are finished before seeing your doctor.
If you take more Amlodipine tablets than you should
Taking too many tablets may cause your blood pressure to become low or even dangerously low. You may feel dizzy, light headed, 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 Amlodipine tablets.
If you forget to take Amlodipine tablets
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 forgotten dose.
If you stop taking Amlodipine tablets
Your doctor will advise you how long to take this medicine. Your condition may return if you stop using this medicine before you are advised.
5 mg and 10 mg
5 mg and 10 mg
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects although not everybody gets them.
Visit your doctor immediately if you experience any of the following 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 very 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.
Very common: may affect more than 1 in 10 people
- Oedema (fluid retention)
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
Common: may affect up to 1 to 10 people
- Headache, dizziness, sleepiness (especially at the beginning of treatment)
- Palpitations (awareness of your heart beat), flushing
- Abdominal pain, feeling sick (nausea)
- Altered bowel habit, diarrhoea, constipation, indigestion
- Weakness, tiredness
- Visual disturbances, double vision
- Shortness of breath
- Muscle cramps
- Ankle swelling
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: may affect up to 1 to 100 people
- Mood changes, anxiety, depression, sleeplessness
- Trembling, taste abnormalities, fainting, weakness
- Numbness or tingling sensation in your limbs; loss of pain sensation
- Visual disturbances, ringing in the ears
- Irregular heat beat
- Low blood pressure
- Sneezing/running nose caused by inflammation of the lining of the nose (rhinitis)
- 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
- Pain, feeling unwell
- Joint or muscle pain, back pain
- Weight increase or decrease
Rare: may affect up to 1 to 1,000 people
Very rare: may affect up to 1 in 10,000 people
- 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
- Heart attack
- Inflammation of the pancreas causing pain in the upper abdomen
- 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
- Increased muscle tension
- Inflammation of blood vessels, often with skin rash
- Sensitivity to light
- Disorders combining rigidity, tremor, and/or movement disorders
Not known (frequency cannot be estimated from the available data)
- Trembling, rigid posture, mash-like face, slow movements and a shuffling, unbalanced walk.
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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE AMLODIPINE TABLETS
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 after “EXP”. The expiry date refers to the last day of that month.
Store below 25°C. Keep the blister in the outer carton in order to protect from light. Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Amlodipine tablets contain
- The active substance is amlodipine.
◦ 5 mg: Each tablet contains 6.94 mg amlodipine besilate equivalent to 5 mg amlodipine.
◦ 10 mg: Each tablet contains 13.87 mg amlodipine besilate equivalent to 10 mg amlodipine.
- The other ingredients of the tablet are microcrystalline cellulose, dibasic calcium phosphate (dehydrate), sodium starch glycolate Type A,
colloidal anhydrous silica and magnesium stearate.
What Amlodipine tablets look like and contents of the pack
- Amlodipine 5 mg tablets are white to off white, round, tablets with “5” debossed on one side and plain on the other side.
- Amlodipine 10 mg tablets are white to off white, round, tablets with “10” debossed on one side and plain on the other side.
Amlodipine tablets are available in clear PVC /aluminium blister. Available in pack of 28 tablets, 14 tablets/strip, 2 strips in a carton box.
Marketing Authorisation Holder: Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom.
Manufacturer: Cipla (EU) Limited, 4th Floor, 1 Kingdom Street, London, W2 6BY, United Kingdom
Distributor: Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, United Kingdom.
This leaflet was last revised 10/2016.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.