Lacidipine 4mg Tablets
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Assessed against UK PIL dated June 2009 |
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By potrickn at 2:08 pm, Sep 14, 2009 |
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MOTENS® 4MG TABLETS
(lacidipine)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Motens 4mg Tablets but will be referred to as Motens throughout the 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 troublesome or serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Motens is and what it is used for
2. Before you take Motens
3. How to take Motens
4. Possible side effects
5. How to store Motens
6. Further information
1. What Motens is and what it is used for
Motens contains a medicine called lacidipine. This belongs to a group of medicines called 'calcium channel blockers'. Motens helps to relax your blood vessels so that they get wider. This helps the blood to flow more easily and lowers the blood pressure.
Motens tablets taken regularly as prescribed by your doctor will help to lower your blood pressure (to treat hypertension).
2. Before you take Motens
Do not take Motens if:
■ You are pregnant, likely to get pregnant or are breast -feeding
■ You are allergic (hypersensitive) to lacidipine, other calcium channel blocker medicines or any of the other ingredients of Motens (See section 6: Further information)
■ You have the heart problem 'aortic stenosis'. This is a narrowing of a valve on your heart, which restricts blood flow
■ You have had a heart attack within the last month
Do not take if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Motens.
■ You should stop taking Motens if you get chest pain (angina) or a fast, weak pulse, rapid shallow breathing, low blood pressure, cold clammy skin, blue lips or feel dizzy, faint, weak or sick
Take special care with Motens
Check with your doctor or pharmacist before taking Motens if:
■ You have an uneven heart beat or any other heart problems
■ You have or have ever had any liver problems
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. This includes herbal medicines. This is because Motens can affect the way some other medicines work. Also some other medicines can affect the way Motens works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
■ Medicines for high blood pressure
■ Medicines to control your heart beat (called 'anti-arrhythmics')
■ Medicines for depression called 'tricyclic antidepressants'
■ Sleeping tablets or sedatives
■ Antibiotics
■ Antihistamines - used for hayfever and other allergies
■ Cimetidine - used for stomach problems
Tests
If you are having any blood tests, tell the person giving the test that you are taking this medicine. This is because Motens can affect results relating to your liver.
Taking Motens with food and drink
Do not take this medicine with grapefruit juice.
Pregnancy and breast-feeding
Do not take Motens if you are pregnant, likely to get pregnant or are breast-feeding.
Driving and using machines
You may feel dizzy while taking Motens. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of Motens
Motens contains lactose. If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
3. How to take Motens
Always take Motens exactly as your doctor has told you. You should check with your doctor if you are not sure.
It is important to take the right number of tablets at the right time of day.
■ The usual starting dose is 2mg every morning.
■ After 3-4 weeks this may be increased to 4mg every morning.
■ If necessary the dose may be increased again to 6mg every morning which is the maximum daily dose.
■ Swallow the tablets whole with a drink of water.
■ Do not take with grapefruit juice.
If you take more Motens than you should
If you take more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you, even if there are no tablets left.
If you forget to take Motens
If you forget a dose in the morning, take it as soon as you remember it on the same day. However, if you remember the next day, take your normal dose on that morning. Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, Motens can cause side effects, although not everybody gets them.
The side effects described below have been experienced by people taking Motens. They are listed as either common, uncommon, rare or very rare.
Common (affects less than 1 in 10 people, more than 1 in 100 people)
■ dizziness, headache, fast or uneven heart beat (also called palpitations), flushing, swelling particularly of the ankles. These side effects usually go away as treatment continues.
■ upset stomach, feeling sick (nausea)
■ rash, redness of the skin, itching
■ an increase in the amount of water (urine) that you pass
■ feeling weak
■ changes in results of blood tests relating to your liver
Uncommon (affects less than 1 in 100 people, more than 1 in 1,000 people)
■ chest pain (angina) including chest pain that is getting worse. Tell your doctor straight away if you have this serious side effect as you may need urgent medical treatment
■ swelling of the gums
Rare (affects less than 1 in 1,000 people, more than 1 in 10,000 people)
■ rapid swelling of the face, mouth and throat which may cause difficulty breathing. Tell your doctor straight away if you have this serious side effect as you may need urgent medical treatment
■ nettle rash (urticaria)
Very rare (affects less than 1 in 10,000 people)
■ tremor
Muscle cramps and mood changes have also been reported.
If any of the side effects gets troublesome or serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
■ Do not store above 30°C.
■ Keep in the original package.
■ Protect from light.
■ Do not remove any tablets from the foil until you are ready to take them.
■ Keep out of the reach and sight of children.
■ Do not use the tablets after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month
If the tablets become discoloured or show signs of deterioration, you should seek the advice of your pharmacist.
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.
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 Motens contains
The active substance is lacidipine.
Each film-coated tablet contains 4mg of lacidipine.
The tablets also contain the following inactive ingredients: lactose, povidone K30 and magnesium stearate.
The film coating contains hypromellose, titanium dioxide (E171), Polysorbate 80 and polyethylene glycol 400.
What Motens looks like and contents of the pack
The tablets are white, oval, film-coated tablets with a scoreline on one side and a breakline on the other.
Your tablets are available in blister packs of 28 tablets.
Manufacturer
Manufactured by: GlaxoSmithKline Pharmaceuticals S.A., ul. Grunwaldzka 189, 60-322 Poznan, Poland.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: TESTERWORLD Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
iPOMl PL No: 19280/0119
Leaflet revision and issue date (Ref): 04.09.09
Motens® is a registered trademark of GlaxoSmithKline Group of Companies.
Page 2 of 2
APPROVED
Assessed against UK PIL dated June 2009
By potrickn at 2:09 pm, Sep 14, 2009
LACIDIPINE 4MG TABLETS
PATIENT LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Lacidipine 4mg Tablets but will be referred to as Lacidipine throughout the 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 troublesome or serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Lacidipine is and what it is used for
2. Before you take Lacidipine
3. How to take Lacidipine
4. Possible side effects
5. How to store Lacidipine
6. Further information
1. What Lacidipine is and what it is used for
Lacidipine contains a medicine called lacidipine. This belongs to a group of medicines called 'calcium channel blockers'. Lacidipine helps to relax your blood vessels so that they get wider. This helps the blood to flow more easily and lowers the blood pressure.
Lacidipine tablets taken regularly as prescribed by your doctor will help to lower your blood pressure (to treat hypertension).
2. Before you take Lacidipine
Do not take Lacidipine if:
■ You are pregnant, likely to get pregnant or are breast -feeding
■ You are allergic (hypersensitive) to lacidipine, other calcium channel blocker medicines or any of the other ingredients of Lacidipine (See section 6: Further information)
■ You have the heart problem 'aortic stenosis'.
This is a narrowing of a valve on your heart, which restricts blood flow
■ You have had a heart attack within the last month
Do not take if any of the above apply to you. If you are not sure,
talk to your doctor or pharmacist before taking Lacidipine.
■ You should stop taking Lacidipine if you get chest pain (angina) or a fast, weak pulse, rapid shallow breathing, low blood pressure, cold clammy skin, blue lips or feel dizzy, faint, weak or sick
Take special care with Lacidipine
Check with your doctor or pharmacist before taking Lacidipine if:
■ You have an uneven heart beat or any other heart problems
■ You have or have ever had any liver problems
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. This includes herbal medicines. This is because Lacidipine can affect the way some other medicines work. Also some other medicines can affect the way Lacidipine works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
■ Medicines for high blood pressure
■ Medicines to control your heart beat (called 'anti-arrhythmics')
■ Medicines for depression called 'tricyclic antidepressants'
■ Sleeping tablets or sedatives
■ Antibiotics
■ Antihistamines - used for hayfever and other allergies
■ Cimetidine - used for stomach problems
Tests
If you are having any blood tests, tell the person giving the test that you are taking this medicine. This is because Lacidipine can affect results relating to your liver.
Taking Lacidipine with food and drink
Do not take this medicine with grapefruit juice.
Pregnancy and breast-feeding
Do not take Lacidipine if you are pregnant, likely to get pregnant or are breast-feeding.
Driving and using machines
You may feel dizzy while taking Lacidipine. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of Lacidipine
Lacidipine contains lactose. If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
3. How to take Lacidipine
Always take Lacidipine exactly as your doctor has told you. You should check with your doctor if you are not sure.
It is important to take the right number of tablets at the right time of day.
■ The usual starting dose is 2mg every morning.
■ After 3-4 weeks this may be increased to 4mg every morning.
■ If necessary the dose may be increased again to 6mg every morning which is the maximum daily dose.
■ Swallow the tablets whole with a drink of water.
■ Do not take with grapefruit juice.
If you take more Lacidipine than you should
If you take more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you, even if there are no tablets left.
If you forget to take Lacidipine
If you forget a dose in the morning, take it as soon as you remember it on the same day. However, if you remember the next day, take your normal dose on that morning. Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, Lacidipine can cause side effects, although not everybody gets them.
The side effects described below have been experienced by people taking Lacidipine. They are listed as either common, uncommon, rare or very rare.
Common (affects less than 1 in 10 people, more than 1 in 100 people)
■ dizziness, headache, fast or uneven heart beat (also called palpitations), flushing, swelling particularly of the ankles. These side effects usually go away as treatment continues.
■ upset stomach, feeling sick (nausea)
■ rash, redness of the skin, itching
■ an increase in the amount of water (urine) that you pass
■ feeling weak
■ changes in results of blood tests relating to your liver
Uncommon (affects less than 1 in 100 people, more than 1 in 1,000 people)
■ chest pain (angina) including chest pain that is getting worse. Tell your doctor straight away if you have this serious side effect as you may need urgent medical treatment
■ swelling of the gums
Rare (affects less than 1 in 1,000 people, more than 1 in 10,000 people)
■ rapid swelling of the face, mouth and throat which may cause difficulty breathing. Tell your doctor straight away if you have this serious side effect as you may need urgent medical treatment
■ nettle rash (urticaria)
Very rare (affects less than 1 in 10,000 people)
■ tremor
Muscle cramps and mood changes have also been reported.
If any of the side effects gets troublesome or serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
■ Do not store above 30°C.
■ Keep in the original package.
■ Protect from light.
■ Do not remove any tablets from the foil until you are ready
to take them.
■ Keep out of the reach and sight of children.
■ Do not use the tablets after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month.
If the tablets become discoloured or show signs of deterioration, you should seek the advice of your pharmacist.
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.
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 Lacidipine contains
The active substance is lacidipine.
Each film-coated tablet contains 4mg of lacidipine.
The tablets also contain the following inactive ingredients: lactose, povidone K30 and magnesium stearate.
The film coating contains hypromellose, titanium dioxide (E171), Polysorbate 80 and polyethylene glycol 400.
What Lacidipine looks like and contents of the pack
The tablets are white, oval, film-coated tablets with a scoreline on one side and a breakline on the other.
Your tablets are available in blister packs of 28 tablets.
Manufacturer
Manufactured by: GlaxoSmithKline Pharmaceuticals S.A., ul. Grunwaldzka 189, 60-322 Poznan, Poland.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: TESTERWORLD Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
iPOMl PL No: 19280/0119
Leaflet revision and issue date (Ref): 04.09.09
Page 2 of 2