AMLODIPINE TABLETS 5MG
Active substance: AMLODIPINE BESYLATE
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S1442-43 LEAFLET Amlodipine 20120419
Amlodipine 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. Johns Wort) verapamil, diltiazem (heart medicines) dantrolene (infusion for severe body temperature abnormalities)
PATIENT INFORMATION LEAFLET
AMLODIPINE 5mg TABLETS AMLODIPINE 10mg TABLETS (amlodipine besilate)
Your medicine is known as above but will be referred to as Amlodipine throughout the following patient information leaflet. Read all of this leaflet carefully before you start taking this medicine. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Amlodipine may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure. Taking Amlodipine with food and drink Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipine. 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. 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 Amlodipine. 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 Amlodipine. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Amlodipine 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. Important information about some of the ingredients of Amlodipine This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially sodium-free. 3. HOW TO TAKE AMLODIPINE 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 Amlodipine 5 mg once daily. The dose can be increased to Amlodipine 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 Amlodipine with grapefruit juice. Use in children and adolescents
In this leaflet: 1. What Amlodipine is and what it is used for 2. Before you take Amlodipine 3. How to take Amlodipine 4. Possible side effects 5. How to store Amlodipine 6. Further information 1. WHAT AMLODIPINE IS AND WHAT IT IS USED FOR Amlodipine contains the active substance amlodipine which belongs to a group of medicines called calcium antagonists. Amlodipine is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, a rare form of which is Prinzmetals 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 Amlodipine 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. BEFORE YOU TAKE AMLODIPINE Do not take Amlodipine 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. For children and adolescents (617 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 Amlodipine 5 mg 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 Amlodipine than you should Use in children and adolescents Amlodipine has not been studied in children under the age of 6 years. Amlodipine 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. 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. 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.
Take special care with Amlodipine 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
If you forget to take Amlodipine 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 using Amlodipine 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, Amlodipine 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
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. 5. HOW TO STORE AMLODIPINE KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. Amlodipine Tablets should be stored below 30C. Do not use after the expiry date printed on the carton label or blister strip. If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to. If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do. 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.
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
6. FURTHER INFORMATION What Amlodipine contains Amlodipine tablets come in two strengths, 5mg and 10mg. The 5mg tablets contains active substance is 5 mg amlodipine (as amlodipine besilate) and 10mg tablets contains 10 mg amlodipine (as amlodipine besilate)
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
Amlodipine Tablets also contain the following: anhydrous dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate What Amlodipine looks like and contents of the pack The 5mg tablet is white and coded 'AML-5' on one side and has the Pfizer logo on the reverse. The 10mg tablet is white and coded 'AML breakline 10' on one side and has the Pfizer logo on the reverse. Amlodipine comes in blister packs of 30 tablets. Product Licence holder Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX. Manufacturer This product is manufactured by Farmasierra SA Ctra. N-1 Km 26200, 28700 S. Sebastian de los Reyes, Madrid, Spain. POM PL No. 19488/1442 PL No. 19488/1443 Leaflet revision date: 19 April 2012
S1442-43 LEAFLET Amlodipine 20120419
Amlodipine 10mg Tablets Amlodipine 5mg Tablets
Rare: affects 1 to 10 users in 10,000 Confusion
Amlodipine 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. Johns Wort) verapamil, diltiazem (heart medicines) dantrolene (infusion for severe body temperature abnormalities)
PATIENT INFORMATION LEAFLET
AMLODIPINE 5mg TABLETS AMLODIPINE 10mg TABLETS (amlodipine besilate)
Your medicine is known as above but will be referred to as Amlodipine throughout the following patient information leaflet. Read all of this leaflet carefully before you start taking this medicine. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Amlodipine may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure. Taking Amlodipine with food and drink Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipine. 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. 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 Amlodipine. 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 Amlodipine. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Amlodipine 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. Important information about some of the ingredients of Amlodipine This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially sodium-free. 3. HOW TO TAKE AMLODIPINE 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 Amlodipine 5 mg once daily. The dose can be increased to Amlodipine 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 Amlodipine with grapefruit juice. Use in children and adolescents
In this leaflet: 1. What Amlodipine is and what it is used for 2. Before you take Amlodipine 3. How to take Amlodipine 4. Possible side effects 5. How to store Amlodipine 6. Further information 1. WHAT AMLODIPINE IS AND WHAT IT IS USED FOR Amlodipine contains the active substance amlodipine which belongs to a group of medicines called calcium antagonists. Amlodipine is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, a rare form of which is Prinzmetals 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 Amlodipine 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. BEFORE YOU TAKE AMLODIPINE Do not take Amlodipine 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. For children and adolescents (617 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 Amlodipine 5 mg 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 Amlodipine than you should Use in children and adolescents Amlodipine has not been studied in children under the age of 6 years. Amlodipine 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. 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. 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.
Take special care with Amlodipine 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
If you forget to take Amlodipine 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 using Amlodipine 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, Amlodipine 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
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. 5. HOW TO STORE AMLODIPINE KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. Amlodipine Tablets should be stored below 30C. Do not use after the expiry date printed on the carton label or blister strip. If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to. If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do. 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.
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
6. FURTHER INFORMATION What Amlodipine contains Amlodipine tablets come in two strengths, 5mg and 10mg. The 5mg tablets contains active substance is 5 mg amlodipine (as amlodipine besilate) and 10mg tablets contains 10 mg amlodipine (as amlodipine besilate)
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
Amlodipine Tablets also contain the following: anhydrous dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate What Amlodipine looks like and contents of the pack The 5mg tablet is white and coded 'AML-5' on one side and has the Pfizer logo on the reverse. The 10mg tablet is white and coded 'AML breakline 10' on one side and has the Pfizer logo on the reverse. Amlodipine comes in blister packs of 30 tablets. Product Licence holder Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX. Manufacturer This product is manufactured by Farmasierra SA Ctra. N-1 Km 26200, 28700 S. Sebastian de los Reyes, Madrid, Spain. POM PL No. 19488/1442 PL No. 19488/1443 Leaflet revision date: 19 April 2012
S1442-43 LEAFLET Amlodipine 20120419
Amlodipine 10mg Tablets Amlodipine 5mg Tablets
Rare: affects 1 to 10 users in 10,000 Confusion
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
