Amlodipine 10mg Tablets
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AMLODIPINE 10mg TABLETS (amlodipine besilate)
Patient Information Leaflet
This product is known as the above name, but will be referred to as Amlodipine Tablets. Please note that the leaflet also contains information about another strength of the medicine, Amlodipine 5mg Tablets.
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Amlodipine Tablets are and what they are used for
2. Before you take Amlodipine Tablets
3. How to take Amlodipine Tablets
4. Possible side effects
5. How to store Amlodipine Tablets
6. Further information
1. What Amlodipine Tablets are and what they are used for
Amlodipine Tablets contain the active substance amlodipine which belongs to a group of medicines called calcium antagonists.
Amlodipine Tablets are 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 Amlodipine Tablets work 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 Tablets Do not take Amlodipine Tablets
• 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 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.
Use in children and adolescents
Amlodipine Tablets have not been studied in children under the age of 6 years. Amlodipine Tablets 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.
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 (antibiotics)
• hypericum perforatum (St. John's Wort)
• verapamil, diltiazem (heart medicines)
• 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.
Taking 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
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 Tablets.
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 Tablets.
Ask your doctor or pharmacist for advice before taking any medicine.
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.
Important information about some of the ingredients of Amlodipine Tablets
This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially ‘sodium-free'.
3. How to take Amlodipine Tablets
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 Tablets 5 mg once daily. The dose can be increased to Amlodipine Tablets 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 Tablets with grapefruit juice.
Use in children and adolescents
For children and adolescents (6-17 years old), the recommended usual starting dose is 2.5mg 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.
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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. Do not take a double dose to make up for a missed dose.
If you stop using Amlodipine Tablets
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 Tablets 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 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: 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.
5. How to store Amlodipine Tablets
• Amlodipine Tablets 10mg tablets should not be stored above 25°C.
• Do not use after the expiry date printed on the carton label or blister strip.
• KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
• If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.
• If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist who will advise 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 protect the environment.
6. Further information
Your medicine is called Amlodipine 10mg tablets. It contains 10mg of the active ingredient, Amlodipine (as the besilate salt) in an eight-sided, white, oblong tablet, marked 'AML 10' with a breakline on one side and with Pfizer logo on the other side.
Amlodipine 10mg tablets also contain the following:
dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose and sodium starch glycollate. Amlodipine 10mg tablets are available as blister packs of 14 and 28 tablets.
POM PL No: 6464/0602
This product is manufactured by Pfizer Manufacturing Deutschland GmbH, Heinrich MackStrasse, 35, 89257 Mlertissen, Germany and is procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex, SS14 3FR
Leaflet revision and issue date (Ref.) 22.04.2013
000-0000D
ISTIN®10mg TABLETS/ AMLODIPINE 10mg TABLETS (amlodipine besilate)
Patient Information Leaflet
This product is known as either of the above names, but will be referred to as Istin. Please note that the leaflet also contains information about another strength of the medicine, Istin 5mg Tablets.
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Istin is and what it is used for
2. Before you take Istin
3. How to take Istin
4. Possible side effects
5. How to store Istin
6. Further information
1. What Istin is and what it is used for
Istin contains the active substance amlodipine which belongs to a group of medicines called calcium antagonists. Istin 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 Istin 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 Istin
Do not take Istin
• 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 Istin
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
Istin has not been studied in children under the age of 6 years. Istin 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.
Istin 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).
Istin may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure.
Taking Istin with food and drink
Grapefruit juice and grapefruit should not be consumed by people who are taking Istin. 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 Istin.
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 Istin.
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 Istin.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Istin 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 Istin
This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially ‘sodium-free'.
3. How to take Istin
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 Istin 5 mg once daily. The dose can be increased to Istin 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 Istin with grapefruit juice.
Use in children and adolescents
For children and adolescents (6-17 years old), the recommended usual starting dose is 2.5mg 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 Istin 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 Istin 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 Istin tablets.
If you forget to take Istin
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 Istin
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, Istin 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 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: 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.
5. How to store Istin
• Istin 10mg tablets/Amlodipine 10mg tablets should not be stored above 25°C.
• Do not use after the expiry date printed on the carton label or blister strip.
• KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
• If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.
• If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist who will advise 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 protect the environment.
6. Further information
Your medicine is called Istin 10mg tablets/Amlodipine 10mg tablets. It contains 10mg of the active ingredient, Amlodipine (as the besilate salt) in an eight-sided, white, oblong tablet, marked 'AML 10' with a breakline on one side and with Pfizer logo on the other side.
Istin 10mg tablets/Amlodipine 10mg tablets also contain the following:
dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose and sodium starch glycollate.
Istin 10mg tablets/Amlodipine 10mg tablets are available as blister packs of 14 and 28 tablets.
POM PL No: 6464/0602
This product is manufactured by Pfizer Manufacturing Deutschland GmbH, Heinrich Mack Strasse, 35, 89257 Illertissen, Germany and is procured from within the EU and repackaged by the Product Licence holder: Waymade plc, Miles Gray Road, Basildon, Essex, SS14 3FR
Leaflet revision and issue date (Ref.) 22.04.2013 Istin is a registered trademark of Pfizer Limited
000-0000D
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