Ramipril 10 Mg Tablets
50 mm
£
~k
1st Fold : 126 mm
Ramipril Tablets
V_y
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ramipril 1.25 mg tablets Ramipril 2.5 mg tablets Ramipril 5 mg tablets Ramipril 10 mg tablets Ramipril
Read all of this leaflet carefully before you start taking this medicine because it contains important informationforyou.
• 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 theirsignsof 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 inthis leaflet. See section 4.
What is in this leaflet:
1. What Ramipril is and what it is used for
2. Whatyou need to knowbeforeyou take Ramipril
3. Howtotake Ramipril
4. Possible side effects
5. Howto store Ramipril
6. Contents of the packand other information
1. What Ramipril is and what it is used for
Ramipril contains a medicine called ramipril. This belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).
Ramipril works by:
• Decreasing your body's production of substances that could raiseyourbloodpressure
• Making yourblood vessels relaxand widen
• Making it easier for your heart to pump blood around yourbody.
Ramipril can be used:
• Totreat high blood pressure (hypertension)
• To reduce the risk of you having a heart attack or stroke
• To reduce the risk or delay the worsening of kidney problems (whether or notyou havediabetes)
• To treat your heart when it cannot pump enough blood to therest of your body (heart failure)
• As treatment following heart attack (myocardial infarction) complicated with heartfailure.
2. What you need to know before you take Ramipril Do not take Ramipril:
• If you are allergic to ramipril, any other ACE inhibitor medicine or any of the other ingredients of this medicine (listed in section 6).
Signs of an allergic reaction may include a rash, swallowing or breathing problems, swelling of your lips, face, throat ortongue
• If you have ever had a serious allergic reaction called “angioedema”. The signs include itching, hives (urticaria), red marks on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing
• If you are having dialysis or any other type of blood filtration. Depending on the machine that is used,
Ramipril may not be suitableforyou
• If you have kidney problems where the blood supply to your kidney is reduced (renal artery stenosis)
• During the last 6 months of pregnancy (see section belowon“Pregnancyand breast-feeding”)
• If your blood pressure is abnormally low or unstable. Your doctor will need to make this assessment.
• If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Do not take Ramipril if any of the above apply to you. If you are not sure, talk to your doctor before taking Ramipril.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ramipril:
• If you have heart, liver or kidneyproblems
• Ifyou have losta lot of body salts orfluids (through being sick (vomiting), having diarrhoea, sweating more than usual, being on a low salt diet, taking diuretics (water tablets) for a long time or having had dialysis)
• If you are going to have treatment to reduce your allergy to bee or wasp stings (desensitization)
• Ifyou are going to receive an anaesthetic. This may be given for an operation or any dental work. You may need to stop your Ramipril treatment one day beforehand; askyourdoctorforadvice
• If you have high amounts of potassium in your blood (shown in blood test results)
• If you have collagen vascular disease such as scleroderma or systemic lupus erythematosus
• You must tell your doctor if you think that you are (or might become) pregnant. Ramipril is not recommended in the first 3 months of pregnancy and may cause serious harm to your baby after 3 months of pregnancy, see section “Pregnancy and breast-feeding”.
• “If you are taking any of the following medicines used totreat high blood pressure:
- an angiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular ifyou have diabetes-related kidneyproblems
- aliskiren”
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regularintervals.
See also information under the heading “Do not take Ramipril Tablets””.
Children and adolescents
Ramipril is not recommended for use in children and adolescents below 18 years of age because safety and efficacy of Ramipril in children has not yet been established.
If any of the above apply to you (or you are not sure), talk toyour doctor before taking Ramipril.
Other medicines and Ramipril
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Ramipril can affect the way some other medicines work. Also some medicines can affect the wayRamipril works.
Please tell your doctor if you are taking any of the following medicines. They can make Ramipril work lesswell:
• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indometacin and aspirin)
• Medicines used for the treatment of low blood pressure, shock, cardiac failure, asthma or allergies such as ephedrine, noradrenaline or adrenaline. Your doctor will need to check your blood pressure.
Please tell your doctor if you are taking any of the following medicines. They can increase the chance of getting side effects ifyou take them with Ramipril:
• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indometacin and aspirin)
• Medicines for cancer(chemotherapy)
• Medicines to stop the rejection of organs after a transplant such as ciclosporin
• Diuretics (watertablets) such asfurosemide
• Medicines which can increase the amount of potassium in your blood such as spironolactone, triamterene, amiloride, potassium salts and heparin (forthinning blood)
• Steroid medicines for inflammation such as prednisolone
• Allopurinol (used to lower the uric acid in your blood)
• Procainamide (for heart rhythm problems).
Please tell your doctor if you are taking any of the following medicines. They may be affected by Ramipril:
• Medicines for diabetes such as oral glucose lowering medicines and insulin. Ramipril may loweryour blood sugar amounts. Checkyour blood sugar amountsclosely while taking Ramipril.
• Lithium (for mental health problems). Ramipril may increase the amount of lithium in your blood. Your lithium amount will need to be closely checked byyourdoctor.
If any of the above apply to you (or you are not sure), talkto yourdoctor before taking Ramipril.
Your doctor may need to change your dose and/or to take other precautions:
• If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings "Do not take Ramipril Tablets” and Warning and precautions").
Ramipril with food and alcohol
• Drinking alcohol with Ramipril may make you feel dizzy or light-headed. If you are concerned about how much you can drink while you are taking Ramipril, discuss this with your doctor as medicines used to reduce blood pressure and alcohol can have additive effects.
• Ramipril may betaken with orwithoutfood.
Pregnancy and breast-feeding
Ifyou are pregnant or breast-feeding, thinkyou may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not take Ramipril in the first 12 weeks of pregnancy, and you must not take them at all after the 13th week as their use during pregnancy may possibly beharmfultothebaby.
If you become pregnant while on Ramipril, tell your doctor immediately. A switch to a suitable alternative treatment should be carried out in advance of a plannedpregnancy.
You should not take Ramipril ifyou are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
You may feel dizzy, while taking Ramipril. This is more likely to happen when you start taking Ramipril or start taking a higher dose. If this happens, do not drive or use anytools or machines.
Ramipril contains lactose
Ramipril contains lactose (see section 6 for further information). Ifyou have been told by your doctor that you have an intolerance to some sugars, contact your doctorbeforetakingthis medicine.
3. How to take Ramipril
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist ifyouare notsure.
Taking this medicine
• Take this medicine by mouth at the same time of the day each day.
• Swallow the tablets wholewith liquid.
• Donotcrushorchewthetablets.
Howmuchtotake
Treatment of high blood pressure
• The usual starting dose is 1.25 mg or 2.5 mg once daily.
• Your doctor will adjust the amount you take until yourblood pressure is controlled.
• Themaximumdoseis 10 mgonce daily.
• If you are already taking diuretics (water tablets), your doctor may stop or reduce the amount of the diuretic you take before beginning treatment with Ramipril.
To reduce the risk of you having a heart attack or stroke
• The usual starting dose is 2.5 mg once daily.
• Your doctor may then decide to increase the amountyoutake.
• The usual dose is 10 mg once daily.
Treatment to reduce or delay the worsening of kidney problems
• You may be started on a dose of 1.25 mg or 2.5mgoncedaily.
• Your doctorwill adjustthe amountyou are taking.
• The usual dose is 5mg or 10 mg once daily. Treatment of heartfailure
• The usual starting dose is 1.25mg once daily.
1460
SAP Code: 40100004557
230763 Ramipril Tabiets_Outsert v_6.pdf
|
Issued For Final Production | ||||
|
Issued For Re-Approval :- | ||||
|
Issued For Approval :- |
13-FEB-15 11:47:41 | |||
|
TEMPLE Packaging Pvt. Ltd. Tel:- 28476601, Email:-info@templepackaging.co.in | ||||
|
Customer :- |
LUPIN LTD. |
SAP Code :- |
40100004557 | |
|
Location :- |
Goa |
File No. :- |
29260 | |
|
Product Name :- |
Ramipril Tabs Lit(UK)-AE |
ArtworkSr.No. :- |
64/09/12 | |
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ProductCode :- |
230763 |
Customer A/W No. :- |
NA | |
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Version No. :- |
06 |
OldFileNo. :- |
NA | |
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Date :- |
13-FEB-15 |
Old Product Code :- |
NA | |
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Artwork Status :- |
In Process |
Barcode :- |
NA | |
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Open Size :- |
235 x 340 mm |
Pharmacode :- |
1460 | |
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Folding Size :- |
40 x 50 mm |
Perforation :- |
NA | |
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Substrate :- |
40 Gsm Bible Paper |
Gluing :- |
YES | |
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Cover Page (PAD) :- |
NA |
Font Name :- |
Helvetica Condensed | |
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Cover Pg Substrate :- |
NA |
Font Size :- |
9pt. | |
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NA | |||
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Remark :- | ||||
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Printing Colours | ||||
K
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Note - This approval will be considered for final printing. Please recheck for corrections indicated earlier, in this proof also. | |||||||
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Prepared by: 13-FEB-15 |
Checked by: |
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Approved by: | ||||
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sanjay | |||||||
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CUSTOMER APPROVAL | |||||||
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Checked By |
Approved By | ||||||
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Packaging Development |
Production |
Regulatory Affairs |
Quality Assurance | ||||
• Yourdoctorwill adjustthe amountyou take.
• The maximum dose is 10 mg daily. Two administrations per dayare preferable.
Treatment afteryou have had a heart attack
• The usual starting dose is 1.25 mg once daily to 2.5 mgtwice daily.
• Yourdoctor will adjustthe amountyou take.
• The usual dose is 10 mg daily. Two administrations per dayare preferable.
Elderly
Your doctor will reduce the initial dose and adjust your treatmentmoreslowly.
Ifyou take more Ramipril thanyou should
Tell a doctor or go to the nearest hospital casualty department straightaway. Do not drive to the hospital, get somebody else to take you or call for an ambulance. Take the medicine pack with you. This is sothe doctor knowswhatyou have taken.
Ifyou forget to take Ramipril
• Ifyou miss a dose, take your normal dose when it is nextdue.
• Do not take a double dose to make up for a forgotten tablet/capsule.
If you have any further questions on the use of this medicine,askyourdoctoror pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Ramipril and see a doctor straight away, ifyou notice any of the following serious side effects -you mayneedurgentmedical treatment:
• Swelling of the face, lips or throat which make it difficult to swallow or breathe, as well as itching and rashes. This could be a sign of a severe allergic reaction to Ramipril.
• Severe skin reactions including rash, ulcers in your mouth, worsening of a pre-existing skin disease, reddening, blistering or detachment of skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythemamultiform).
Tell your doctor immediately ifyou experience:
• Faster heart rate, uneven or forceful heartbeat (palpitations), chest pain, tightness inyour chest or more serious problems including heart attack and stroke
• Shortness of breath or a cough. These could be signsof lung problems.
• Bruising more easily, bleeding for longer than normal, any sign of bleeding (e.g. bleeding from the gums), purple spots blotching on the skin or getting infections more easily than usual, sore throat and fever, feeling tired, faint, dizzy or having pale skin. These can be signs of blood or bone marrow problems.
• Severe stomach pain which may reach through to your back. This could be a sign of pancreatitis (inflammation of the pancreas).
• Fever, chills, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of your skin or eyes (jaundice). These can be signs of liver problems such as hepatitis (inflammation of the liver) or liver
damage.
Otherside effects include:
Please tell your doctor if any of the following gets
serious or lasts longerthanafew days.
Common (may affect up to 1 in 10 people)
• Headache orfeelingtired
• Feeling dizzy. This is more likely to happen when you start taking Ramipril or start taking a higher dose
• Fainting, hypotension (abnormally low blood pressure), especially when you stand or sit up quickly
• Dry tickly cough, inflammation of your sinuses (sinusitis) or bronchitis, shortness of breath
• Stomach or gut pain, diarrhoea, indigestion, feeling or being sick
• Skin rash with or without raised area
• Chest pain
• Crampsorpain inyourmuscles
• Blood tests showing more potassium than usual in your blood.
Uncommon (may affect up to 1 in 100 people)
• Balance problems (vertigo)
• Itching and unusual skin sensations such as numbness, tingling, pricking, burning or creeping on your skin (paraesthesia)
• Loss or change in the way things taste
• Sleep problems
• Feeling depressed, anxious, more nervous than usual or restless
• Blocked nose, difficulty breathing or worsening of asthma
• A swelling in your gut called “intestinal angioedema” presenting with symptoms like abdominal pain, vomiting and diarrhoea
• Heartburn, constipation or dry mouth
• Passing more water (urine) than usual overthe day
• Sweating morethan usual
• Loss or decrease of appetite (anorexia)
• Increased or irregular heartbeats
• Swollen arms and legs. This may be a sign of your body holding onto more waterthan usual
• Flushing
• Blurredvision
• Pain inyourjoints
• Fever
• Sexual inability in men, reduced sexual desire in menorwomen
• An increased number of certain white blood cells (eosinophilia) found during a blood test
• Blood tests showing changes in the way your liver, pancreas or kidneys are working.
Rare (may affect up to 1 in 1,000 people)
• Feeling shaky or confused
• Red and swollen tongue
• Severe flaking or peeling of the skin, itchy, lumpy rash
• Nail problem (e.g. loosening or separation of a nail from its bed)
• Skin rash or bruising
• Blotches on your skin and cold extremities
• Red, itchy, swollen orwatery eyes
• Disturbed hearingand ringing inyourears
• Feeling weak
• Blood tests showing a decrease in the number of red blood cells, white blood cells or platelets or in the amountofhaemoglobin.
Very rare (may affect up to 1 in 10,000 people)
• Being moresensitivetothesunthan usual.
Otherside effects reported:
Please tell your doctor if any of the following gets serious or lasts longerthan afew days.
• Difficulty concentrating
• Swollen mouth
• Blood tests showing too few blood cells in your blood
• Blood tests showing less sodium than usual in your blood
• Fingers and toes changing colour when you are cold and then tingling or feeling painful when you warm up (Raynaud's phenomenon)
• Breast enlargement in men
• Slowed or impaired reactions
• Burning sensation
• Changeinthewaythingssmell
• Hair loss.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Ramipril
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the blister The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What Ramipril 1.25 mg contains
The active substance is ramipril 1.25 mg.
The other ingredients are lactose monohydrate, lactic acid, heavy magnesium oxide, pregelatinised maize starch and sodium stearylfumarate.
What Ramipril 2.5 mg contains The active substance is ramipril 2.5 mg.
The other ingredients are lactose monohydrate, lactic acid, heavy magnesium oxide, pregelatinised maize starch, sodium stearyl fumarate, yellow and red iron oxide (E172).
What Ramipril 5 mg contains
The active substance is ramipril 5 mg.
The other ingredients are lactose monohydrate, lactic acid, heavy magnesium oxide, pregelatinised maize starch, sodium stearyl fumarate and red iron oxide (E172).
What Ramipril 10 mg contains
The active substance is ramipril 10 mg.
The other ingredients are lactose monohydrate, lactic acid, heavy magnesium oxide, pregelatinised maize starch, sodium stearyl fumarate and red iron oxide (E172).
What Ramipril 1.25 mg looks like and contents of the pack
Tablets
White to off-white oblong shaped tablet debossed with “1.25” on one side.
Blister packs (Aluminium/PE/Aluminium foil):
20.28.30.50.60.90 and 100 tablets.
What Ramipril 2.5 mg looks like and contents of the pack
Tablets
Light orange oblong shaped tablet debossed with “2.5” on one side.
Blister packs (Aluminium/PE/Aluminium foil):
20.28.30.50.60.90 and 100 tablets.
What Ramipril 5 mg looks like and contents of the pack
Tablets
Pink capsule shaped tablet debossed with “5” on one side.
Blister packs (Aluminium/PE/Aluminium foil):
14.20.28.30.50.60.90 and 100tablets.
What Ramipril 10 mg looks like and contents of the pack
Tablets
Pink capsule shaped tablet debossed with “10” on one side.
Blister packs (Aluminium/PE/Aluminium foil): 20, 28, 30,50,60,90and 100tablets.
Notall pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Limited Victoria Court,
Bexton Road, Knutsford,
Cheshire, WA160PF,
United Kingdom.
This medicinal product is authorised in the Member States of the EEAunder the following names:
Czech Republic: Ramipriltablety Germany: Ramipril-Hormosan Tabletten Poland: Ramipril tabletki Spain: Ramipril comprimidos United Kingdom: Ramipril tablets
This leaflet was last revised in February 2015
Code No.GO/DRUGS/654 ID#: 230763
SAP Code: 40100004557
230763 Ramipril Tabiets_Outsert v_6.pdf
|
Issued For Final Production | ||||
|
Issued For Re-Approval :- | ||||
|
Issued For Approval :- |
13-FEB-15 11:47:41 | |||
|
TEMPLE Packaging Pvt. Ltd. Tel:- 28476601, Email:-info@templepackaging.co.in | ||||
|
Customer :- |
LUPIN LTD. |
SAP Code :- |
40100004557 | |
|
Location :- |
Goa |
File No. :- |
29260 | |
|
Product Name :- |
Ramipril Tabs Lit(UK)-AE |
ArtworkSr.No. :- |
64/09/12 | |
|
ProductCode :- |
230763 |
Customer A/W No. :- |
NA | |
|
Version No. :- |
06 |
OldFileNo. :- |
NA | |
|
Date :- |
13-FEB-15 |
Old Product Code :- |
NA | |
|
Artwork Status :- |
In Process |
Barcode :- |
NA | |
|
Open Size :- |
235 x 340 mm |
Pharmacode :- |
1460 | |
|
Folding Size :- |
40 x 50 mm |
Perforation :- |
NA | |
|
Substrate :- |
40 Gsm Bible Paper |
Gluing :- |
YES | |
|
Cover Page (PAD) :- |
NA |
Font Name :- |
Helvetica Condensed | |
|
Cover Pg Substrate :- |
NA |
Font Size :- |
9pt. | |
|
No.ofPages/PAD :- |
NA | |||
|
Remark :- | ||||
|
Printing Colours | ||||
K
|
Note - This approval will be considered for final printing. Please recheck for corrections indicated earlier, in this proof also. | |||||||
|
Prepared by: 13-FEB-15 |
Checked by: |
Q.A. Checked: |
Approved by: | ||||
|
sanjay | |||||||
|
CUSTOMER APPROVAL | |||||||
|
Checked By |
Approved By | ||||||
|
Packaging Development |
Production |
Regulatory Affairs |
Quality Assurance | ||||