Motens 2mg Tablets
RSCA/W
Version:
GlaxoSmithKline Artwork Information Panel
2
GlaxoSmithKline
Motens® 2 mg and 4 mg Tablets
lacidipine
Technical Reference No(s).: 02-01-XX-273-02
(do NOT kidude the technical reference docfj] version no{s].)
Artwork copyright Is tho proparty of the GlaxoSmithKline Group of Companies
All suppliers providing a service to GSK for printed components of any description must ensure that they have a licence for all fonts / software used in conjunction with GSK artwork.
The distribution and use of fonts / software without a licence constitutes an intellectual property infringement. GSK will not accept any liability for the breach of third party intellectual property rights by printed component suppliers.
The GSK certification / audit process requires suppliers to declare that they do not use unlicensed fonts/ software and may require the supplier to produce evidence of such licence to GSK.
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1 What Motens is and what it is used for
2 What you need to know before you take Motens
3 How to take Motens
4 Possible side effects
5 How to store Motens
6 Contents of the pack and other information
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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).
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
• Tetracosactide and corticosteroids
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.
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.
FRONT PAGE
TYPE SIZE: 9/10 HORIZONTAL SCALE: 100%
IMPORTANT
GSK Market is responsible for this product, its design and content.
Ensure the artwork is thoroughly checked, all the text proof-read and approved.
RSC GSK is responsible for site technical requirements and pre-press suitability.
GSK Market
is responsible to advise RSC in case changes required impact the followings:
Formulation Tablet embossing Storage conditions Snelf Life
2. What you need to know 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 this medicine (listed in section 6)
• You have the heart problem 'aortic stenosis'. This is a narrowing of a valve in 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
Other medicines and Motens
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.
Always take this medicine 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 2 mg every morning.
• After 3-4 weeks this may be increased to 4 mg every morning.
• If necessary the dose may be increased again to 6 mg every morning which is the maximum daily dose.
• Swallow the tablets whole with a drink of water.
• Do not take with grapefruit juice.
This medicine comes in a calendar pack marked with the days of the week. This means you can easily check that you have taken the dose on each day.
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.
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GlaxoSmithKline Artwork Information Panel
Item Number: 10000000117410
Manufacturing Site: GSK-ESP-Aranda-ESARA
Market or Pack Owner:
United Kingdom-GBR
Market Trade Name: Motens
No. of Colours: 1
(doos NOT Include Varnish, If applicable)
List Colours:
K
Technical Reference No(s).: 02-01-XX-273-02
(do NOT kidude the technical reference docfi] version no{s].)
Artwork copyright Is tho proparty of the GlaxoSmithKline Group of Companies
All suppliers providing a service to GSK for printed components of any description must ensure that they have a licence for all fonts / software used in conjunction with GSK artwork.
The distribution and use of fonts / software without a licence constitutes an intellectual property infringement. GSK will not accept any liability for the breach of third party intellectual property rights by printed component suppliers.
The GSK certification / audit process requires suppliers to declare that they do not use unlicensed fonts/ software and may require the supplier to produce evidence of such licence to GSK.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
• angina, this is a type of chest pain. This is uncommon in people taking Motens and is more likely to occur when you start taking this medicine.
• allergic reactions, the signs may include: rapid swelling of the face, mouth and throat which may cause difficulty breathing.
The side effects described below have been experienced by people taking Motens. They are listed as either common, uncommon, rare or very rare.
Common side effects
These may affect up to 1 in 10 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.
• fast heart beat
• 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
What Motens looks like and contents of the pack
The 2 mg tablets are film-coated, round and white in colour. They have "2" on one side and are plain on the other.
The 4 mg tablets are film-coated, oval and white in colour. They have a break line engraved on both sides of the tablet, and tablets may have "GS" on one side and "3MS" on the other.
Motens tablets are available in blister packs of 28 tablets.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisations for MOTENS are held by:
GlaxoSmithKline UK Limited
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
and the tablets are manufactured at:
Glaxo Wellcome S.A.
Avendia de Extremadura 3 09400 Aranda de Duero Burgos Spain
This leaflet was revised in July 2013.
© 2013 GlaxoSmithKline Group of companies. All rights reserved
Uncommon side effects
These may affect up to 1 in 100 people:
• chest pain (angina) including chest pain that is getting worse.
• low blood pressure for example feeling faint, fainting
• swelling of the gums
GlaxoSmithKline
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BACK PAGE
TYPE SIZE: 9/10 HORIZONTAL SCALE: 100%
IMPORTANT
GSK Market is responsible for this product, its design and content.
Ensure the artwork is thoroughly checked, all the text proof-read and approved.
RSC GSK is responsible for site technical requirements and pre-press suitability.
GSK Market
is responsible to advise RSC in case changes required impact the followings:
Formulation Tablet embossing Storage conditions Snelf Life
Page 2 of 2
Rare side effects
These may affect up to 1 in 1000 people:
• rapid swelling of the face, mouth and throat which may cause difficulty breathing.
• nettle rash (urticaria)
• muscle cramps
Very rare side effects
These may affect up to 1 in 10,000 people:
• tremor
• depression
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children. The tablets should not be stored above 30°C and they should be kept in the original container to protect them from light. Do not remove any tablets from the foil until you are ready to take them.
Do not use this medicine after the expiry date which is stated on the carton and blister pack. The expiry date refers to the last day of that month.
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 Motens contains
The active substance is lacidipine. Each tablet contains either 2 mg or 4 mg. The other ingredients are lactose, povidone and magnesium stearate. The film coating contains hydroxypropylmethylcellulose, PEG 400, polysorbate 80 and titanium dioxide.
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