Amlodipine Tablets 10mg
Out of date information, search anotherS1449-50 LEAFLET Istin 20130227
PACKAGE LEAFLET: INFORMATION FOR USER ISTIN 5mg TABLETS ISTIN 10mg TABLETS (amlodipine besilate)
Your medicine is known as above but will be referred to as Istin 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.
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 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.
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)
• simvastatin (a cholesterol lowering medicine)
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 2.5 mg a day.
The maximum recommended dose is 5 mg a day. Amlodipine 5 mg tablets can be divided into halves to provide a 2.5 mg dose.
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.
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 taking 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
• 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
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Istin should be stored below 30°C.
• 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.
6. FURTHER INFORMATION
What Istin contains
• Istin tablets come in two strengths, 5mg and 10mg. The 5mg tablets contain 5mg of active substance amlodipine (as besilate) and 10mg tablets contain 10mg of active substance amlodipine (as besilate).
• Istin also contain anhydrous dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate
What Istin looks like and contents of the pack
The 5mg tablet is octagonal and white with ‘AML' and ‘5' and a breakline imprinted on one side.
The 10mg tablet is octagonal and white with ‘AML' and ‘10' and a breakline imprinted on one side.
Istin Tablets 5mg are available as blister packs of 28 tablets.
Istin Tablets 10mg are available as blister packs of 14 & 28 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 Heinrich Mack Nachf. GmbH & Co. KG, Heinrich-Mack-Strasse 35, D-89257 Illertissen, Germany.
|POM| PL No. 19488/1449 Istin 5mg Tablets
PL No. 19488/1450 Istin 10mg Tablets
Leaflet revision date: 27 February 2013
Istin is a registered trade mark of Pfizer Ltd, UK.
S1449-50 LEAFLET Istin 20130227
S1449-50 LEAFLET Amlodipine 20130227
PACKAGE LEAFLET: INFORMATION FOR USER 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 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 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 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 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.
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 Use in children and adolescents
Amlodipine has not been studied in children under the age of 6 years. Amlodipine 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 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)
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
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. Amlodipine 5 mg tablets can be divided into halves to provide a 2.5 mg dose.
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
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.
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 taking 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
• 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
• 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 SIGHT AND REACH OF CHILDREN.
• Amlodipine should be stored below 30°C.
• 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.
6. FURTHER INFORMATION
What Amlodipine contains
• Amlodipine tablets come in two strengths, 5mg and 10mg. The 5mg tablets contain 5mg of active substance amlodipine (as besilate) and 10mg tablets contain 10mg of active substance amlodipine (as besilate).
• Amlodipine also contain 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 octagonal and white with ‘AML' and ‘5' and a breakline imprinted on one side.
The 10mg tablet is octagonal and white with ‘AML' and ‘10' and a breakline imprinted on one side.
Amlodipine 5mg Tablets are available as blister packs of 28 tablets. Amlodipine 10mg Tablets are available as blister packs of 14 & 28 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 Heinrich Mack Nachf. GmbH & Co. KG, Heinrich-Mack-Strasse 35, D-89257 Illertissen, Germany.
|POM| PL No. 19488/1449 Amlodipine 5mg Tablets
PL No. 19488/1450 Amlodipine 10mg Tablets
Leaflet revision date: 27 February 2013
S1449-50 LEAFLET Amlodipine 20130227