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01-23-2016, 06:28 PM
AMLODIPINE 5 MG + BENAZEPRIL HCL 10 MG
2805



1 What Amlodipine tablets are and what they are used for
Amlodipine tablets contain the active substance amlodipine mesilate monohydrate. Amlodipine belongs to a group of medicines called calcium antagonists. It is used to treat:
high blood pressure (hypertension).
angina pectoris (pain in the chest caused by blockages in the arteries leading to the heart) or chest pain classed as vasospastic angina pectoris (or Prinzmetal’s 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, Amlodipine tablets 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.

2 What you need to know before you take Amlodipine Tablets
Do not take Amlodipine tablets if you:
are allergic to amlodipine, dihydropyridine derivatives or any of the other ingredients of this medicine (listed section 6) or to any other calcium antagonists. This may be itching, reddening of the skin or difficulty in breathing.
are in shock including shock caused by heart problems (a condition where your heart is unable to supply enough blood to the body)
suffer from an obstruction in the heart caused by an extreme narrowing of the heart valves (aortic stenosis)
suffer from heart failure after a heart attack
have severe low blood pressure (hypotension).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Amlodipine tablets if you:
have liver problems
have recent heart attack
have heart failure
are elderly, your doctor may monitor you closely.
have/suffer from severe increase in blood pressure (hypertensive crisis)

Children and adolescents
Safety and effectiveness have been studied in 6-17 year old boys and in girls. Amlodipine should only used for hypertension in children and adolescents from 6 years to 17 years of age. Amlodipine has not been studied in children under the age of 6 years. 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, including:
ketoconazole or itraconazole (antifungal drugs)
ritonavir, indinavir, nelfinavir (so called protease inhibitors used to treat HIV)
rifampicin, erythromycin, clarithromycin (antibiotic drug)
hypericum perforatum (St. John’s wort -used for depression)
diltiazem, verapamil (to treat heart diseases)
dantrolene (infusion for severe body temperature abnormalities)
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
Pregnancy The safety of Amlodipine in human pregnancy has not been established. If you are pregnant, think you might be pregnant, or are planning to get pregnant, you must tell your doctor before you take Amlodipine tablets.
Breast-feeding It is not known whether amlodipine is passed in to 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 cause dizziness, headaches, tiredness or feeling sick. Any of these side effects would reduce your ability to react, do not drive or use machinery if you are affected.

3 How to take Amlodipine Tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:
Adults (including the elderly and children 18 years or over): 5mg once a day, up to a maximum of 10mg a day as a single dose depending on your response. If you are elderly, your doctor will closely monitor your response to any dose increase.
Use in Children and adolescents (6 -17 years old): the recommended usual starting dose is 2.5mg a day. The maximum recommended dose is 5mg a day. Amlodipine 2.5mg is not currently available and the 2.5mg dose cannot be obtained with Amlodipine tablets 5mg as these tablets are not manufactured to break into two equal halves.
Patients with impaired liver function: your doctor may prescribe you a different dose.
Your medicine can be used before or after food and drinks. You should take your medicine at the same time each day with a glass of water. Do not take Amlodipine tablets with grapefruit juice.
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, 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 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. Then go on as before. Do not take a double dose to make up for a forgotten dose.

If you stop taking Amlodipine tablets
Do not interrupt or stop treatment with Amlodipine tablets without consulting your doctor, as your symptoms could return or ‘flare-up’.
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 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 (severe chest pain) 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 (may affect up to 1 in 10 people)
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 (may affect up to 1 in 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, double vision, ringing in the ears (tinnitus)
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 (may affect up to 1 in 1,000 people)
Confusion
Very rare (may affect up to 1 in 10,000 people)
Decreased numbers of white blood cells (Leukocytopenia, thrombocytopenia) which increases the risk of infections, sore throats, nosebleeds, decrease in blood platelets which may result in unusual bruising or easy bleeding (red blood cell damage)
Excess sugar in blood (thirst, excessive urinating. tiredness, hyperglycaemia)
A disorder of the nerves which can cause weakness, tingling or numbness (peripheral neuropathy)
Cough, swelling of the gums
Abdominal bloating (gastritis)
Abnormal liver function, inflammation of the liver (hepatitis causing tiredness, pain in abdomen, joints or muscles), yellowing of the skin or whites of the eyes (jaundice), liver enzyme increase (detected in blood test) which may have an effect on some medical tests
Increased muscle tension
Inflammation of blood vessels (vasculitis), often with skin rash
Sensitivity to light
Disorders combining rigidity, tremor, and/or movement disorders
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References
Amlodipine 5mg and 10mg tablets - X-PIL
http://www.srdrugs.in/amlodipine-base.html
Trends in Drug Patenting - Case Studies: THE CASES: 2. AMLODIPINE/AMLODIPINE BESYLATE