AMLODIPINE 10 MG TABLETS
Active substance: AMLODIPINE BESILATE
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AMLODIPINE 5 mg and 10 mg TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
suffer from heart failures have a hypertensive crisis (very high blood pressure). 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 Amlodipine with food and drink Amlodipine Tablets are for oral use and should be swallowed with a drink of water. Pregnancy and breast-feeding Do not take Amlodipine if you are pregnant, trying to become pregnant, or breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.
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
Amlodipine and tell your doctor immediately Pancreatitis (inflammation of the or go to the casualty department at your pancreas) nearest hospital: Gastritis (inflammation of the stomach lining) causing abdominal pain. Difficulty breathing and swelling of the lips, face and neck. If any of the side effects get serious, or if you notice any side effects not listed in this This is a very serious but very rare side leaflet, please tell your doctor or effect, which affects fewer than one person pharmacist. in 10,000. You may need urgent medical attention or hospitalisation. HOW TO STORE AMLODIPINE
5
The following side effects have been reported at the approximate frequencies shown: Common (affecting fewer than one person in 10 but more than one person in 100): Headache Water retention causing swelling Sleepiness, tiredness Abdominal pain, nausea Flushing Dizziness Palpitations. Uncommon (affecting fewer than one person in 100 but more than one person in 1,000): Shortness of breath, fainting Indigestion, vomiting, dry mouth, altered bowel habit Difficulty sleeping, mood changes Impotence, breast enlargement in men Problems with urination including an increased need to urinate Changes to taste perception Low blood pressure Blocked or runny nose, sneezing Back, muscle or joint pain Rash, skin discoloration, increased sweating, itching Visual disturbances Ringing in the ears Loss of sensation, muscle cramps Shaking, generally feeling unwell, feeling of weakness Hair loss Weight increase or decrease Chest pain. Very rare (affecting fewer than one person in 10,000): Unusual bleeding or unexplained bruising High level of blood sugar Inflammation of the blood vessels Coughing Enlarged gums Numbness or tingling in the hands and feet Abnormal liver function test results Hepatitis Jaundice (yellowing of the skin and whites of the eyes) Severe, red, itchy skin rash Heart attack, irregular heartbeat
1. 2. 3. 4. 5. 6.
What Amlodipine is and what it is used for Before you take Amlodipine 3 HOW TO TAKE AMLODIPINE How to take Amlodipine Possible side effects Always take Amlodipine exactly as your How to store Amlodipine doctor has told you. You should check with Further information your doctor or pharmacist if you are not sure. The usual dosage instructions are given below: 1 WHAT AMLODIPINE IS AND
Keep out of the reach and sight of children. Do not store above 25C. Store in the original packaging. Keep the blister in the outer carton. Do not use Amlodipine after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. Do not take these tablets if there are any signs of discolouration or deterioration of the tablets. 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.
WHAT IT IS USED FOR
Amlodipine belongs to a group of drugs called calcium-channel blockers. It relieves heart problems by widening blood vessels to allow more blood to flow through. This helps to reduce blood pressure and relieve the strain on the heart muscle. Amlodipine is used in the treatment of high blood pressure and angina, including the rare form, Prinzmetal's angina. Amlodipine does not provide immediate relief of chest pain from angina.
Adults (including the elderly) The starting dose is one 5 mg tablet, once a day. This may be increased to a maximum of 10 mg (two 5 mg tablets or one 10 mg tablet) once a day. Children Not recommended.
6
FURTHER INFORMATION
What Amlodipine contains: The active ingredient is amlodipine (as besilate). The other ingredients are microcrystalline cellulose, calcium hydrogen phosphate, sodium starch glycolate and magnesium stearate. What Amlodipine looks like and contents of the pack: Amlodipine 5 mg Tablets are white, round, slightly arched tablets debossed AB 5 on one side, plain on the other side and are available in pack sizes of 15, 20, 28, 30, 50, 56, 84, 90, 98, 100, 112 and 300 tablets Amlodipine 10 mg Tablets are white, round, slightly arched tablets, debossed AB 10 and breakline on one side, plain on the other side and are available in pack sizes of 14, 15, 20, 28, 30, 50, 56, 84, 90, 98, 100 and 112 tablets Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG. This leaflet was last revised: March 2007. PL00289/0487-88
If you take more Amlodipine than you should If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your 2 BEFORE YOU TAKE AMLODIPINE doctor immediately. An overdose is likely to Do NOT take Amlodipine: cause redness of the skin and low blood if you are allergic (hypersensitive) to pressure (dizziness and fainting). Please take Amlodipine besilate or any of the other this leaflet, any remaining tablets and the ingredients of this medicine container with you to the hospital or doctor if you are sensitive to any other calcium so that they know which tablets were channel blockers e.g. nifedipine, felodipine consumed. if you are pregnant, trying to become pregnant, or breast-feeding If you forget to take Amlodipine if you suffer from unstable angina If you forget to take a tablet, take one as (excluding Prinzmetal's angina) or aortic soon as you remember, unless it is nearly stenosis (a narrowing of the main artery time to take the next one. Do not take a leading from the heart) double dose to make up for a forgotten if you have suffered a collapse of your tablet. Take your next dose at the usual time. blood circulation system (cardiogenic shock). 4 POSSIBLE SIDE EFFECTS Take special care with Amlodipine Tell your doctor before you start to take this medicine if you: have problems with your liver have had a heart attack within the last month Like all medicines, Amlodipine can cause side effects, although not everybody gets them. If you experience the following, stop taking
86270-T
PACKAGE LEAFLET: INFORMATION FOR THE USER
suffer from heart failures have a hypertensive crisis (very high blood pressure). 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 Amlodipine with food and drink Amlodipine Tablets are for oral use and should be swallowed with a drink of water. Pregnancy and breast-feeding Do not take Amlodipine if you are pregnant, trying to become pregnant, or breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.
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
Amlodipine and tell your doctor immediately Pancreatitis (inflammation of the or go to the casualty department at your pancreas) nearest hospital: Gastritis (inflammation of the stomach lining) causing abdominal pain. Difficulty breathing and swelling of the lips, face and neck. If any of the side effects get serious, or if you notice any side effects not listed in this This is a very serious but very rare side leaflet, please tell your doctor or effect, which affects fewer than one person pharmacist. in 10,000. You may need urgent medical attention or hospitalisation. HOW TO STORE AMLODIPINE
5
The following side effects have been reported at the approximate frequencies shown: Common (affecting fewer than one person in 10 but more than one person in 100): Headache Water retention causing swelling Sleepiness, tiredness Abdominal pain, nausea Flushing Dizziness Palpitations. Uncommon (affecting fewer than one person in 100 but more than one person in 1,000): Shortness of breath, fainting Indigestion, vomiting, dry mouth, altered bowel habit Difficulty sleeping, mood changes Impotence, breast enlargement in men Problems with urination including an increased need to urinate Changes to taste perception Low blood pressure Blocked or runny nose, sneezing Back, muscle or joint pain Rash, skin discoloration, increased sweating, itching Visual disturbances Ringing in the ears Loss of sensation, muscle cramps Shaking, generally feeling unwell, feeling of weakness Hair loss Weight increase or decrease Chest pain. Very rare (affecting fewer than one person in 10,000): Unusual bleeding or unexplained bruising High level of blood sugar Inflammation of the blood vessels Coughing Enlarged gums Numbness or tingling in the hands and feet Abnormal liver function test results Hepatitis Jaundice (yellowing of the skin and whites of the eyes) Severe, red, itchy skin rash Heart attack, irregular heartbeat
1. 2. 3. 4. 5. 6.
What Amlodipine is and what it is used for Before you take Amlodipine 3 HOW TO TAKE AMLODIPINE How to take Amlodipine Possible side effects Always take Amlodipine exactly as your How to store Amlodipine doctor has told you. You should check with Further information your doctor or pharmacist if you are not sure. The usual dosage instructions are given below: 1 WHAT AMLODIPINE IS AND
Keep out of the reach and sight of children. Do not store above 25C. Store in the original packaging. Keep the blister in the outer carton. Do not use Amlodipine after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. Do not take these tablets if there are any signs of discolouration or deterioration of the tablets. 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.
WHAT IT IS USED FOR
Amlodipine belongs to a group of drugs called calcium-channel blockers. It relieves heart problems by widening blood vessels to allow more blood to flow through. This helps to reduce blood pressure and relieve the strain on the heart muscle. Amlodipine is used in the treatment of high blood pressure and angina, including the rare form, Prinzmetal's angina. Amlodipine does not provide immediate relief of chest pain from angina.
Adults (including the elderly) The starting dose is one 5 mg tablet, once a day. This may be increased to a maximum of 10 mg (two 5 mg tablets or one 10 mg tablet) once a day. Children Not recommended.
6
FURTHER INFORMATION
What Amlodipine contains: The active ingredient is amlodipine (as besilate). The other ingredients are microcrystalline cellulose, calcium hydrogen phosphate, sodium starch glycolate and magnesium stearate. What Amlodipine looks like and contents of the pack: Amlodipine 5 mg Tablets are white, round, slightly arched tablets debossed AB 5 on one side, plain on the other side and are available in pack sizes of 15, 20, 28, 30, 50, 56, 84, 90, 98, 100, 112 and 300 tablets Amlodipine 10 mg Tablets are white, round, slightly arched tablets, debossed AB 10 and breakline on one side, plain on the other side and are available in pack sizes of 14, 15, 20, 28, 30, 50, 56, 84, 90, 98, 100 and 112 tablets Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG. This leaflet was last revised: March 2007. PL00289/0487-88
If you take more Amlodipine than you should If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your 2 BEFORE YOU TAKE AMLODIPINE doctor immediately. An overdose is likely to Do NOT take Amlodipine: cause redness of the skin and low blood if you are allergic (hypersensitive) to pressure (dizziness and fainting). Please take Amlodipine besilate or any of the other this leaflet, any remaining tablets and the ingredients of this medicine container with you to the hospital or doctor if you are sensitive to any other calcium so that they know which tablets were channel blockers e.g. nifedipine, felodipine consumed. if you are pregnant, trying to become pregnant, or breast-feeding If you forget to take Amlodipine if you suffer from unstable angina If you forget to take a tablet, take one as (excluding Prinzmetal's angina) or aortic soon as you remember, unless it is nearly stenosis (a narrowing of the main artery time to take the next one. Do not take a leading from the heart) double dose to make up for a forgotten if you have suffered a collapse of your tablet. Take your next dose at the usual time. blood circulation system (cardiogenic shock). 4 POSSIBLE SIDE EFFECTS Take special care with Amlodipine Tell your doctor before you start to take this medicine if you: have problems with your liver have had a heart attack within the last month Like all medicines, Amlodipine can cause side effects, although not everybody gets them. If you experience the following, stop taking
86270-T
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.
