Ramipril 5 Mg Capsules
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PACKAGE LEAFLET: INFORMATION FORTHE USER
Ramipril 1.25 mg Capsules
Ramipril 2.5 mg Capsules
Ramipril 5mg Capsules
Ramipril 10 mg Capsules
Ramipril
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 toothers. It may harm them even if their symptoms are thesame 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 doctoror pharmacist.
In this leaflet:
1. What Ramipril Capsules are and what they are used for
2. Before you take Ramipril Capsules
3. Howto take Ramipril Capsules
4. Possible side effects
5. Howtostore Ramipril Capsules
6. Further information
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BROWN & BURK
Ramipril Capsules contain a medicine called ramipril. This belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).
Ramipril Capsules work by:
• Decreasing your body's production of substances that could raise your blood pressure
• Making your blood vessels relax and widen
• Making it easier for your heart to pump blood around your body.
Ramipril Capsules can be used:
• To treat high blood pressure (hypertension)
• To reduce the riskof you having a heart attack or stroke
• To reduce the risk or delay the worsening of kidney problems (whetheror notyou have diabetes)
• To treat your heart when it cannot pump enough blood to the rest of your body (heart failure)
Pharmacode • As treatment following heart llllllllll attack (myocardial infarction) complicated with heartfallure.
Do nottake Ramipril Capsules:
• If you are allergic (hypersensitive) to ramipril, any other ACE inhibitor medicine or any of the ingredients of Ramipril Capsules listed in section 6.
• Signs of an allergic reaction may include a rash, swallowing or breathing problems, swelling of your lips,face, throat or tongue
• 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 Capsules may not be suitable for you
• If you have kidney problems where the blood supply to your kidney is reduced (renal arterystenosis)
• During the last 6 months of pregnancy (see section below on “Pregnancy and breastfeeding")
• If your blood pressure is abnormally low or unstable. Your doctor will need to make this assessment.
Do not take Ramipril Capsules if any of the above apply to you. If you are not sure, talk to your doctor before taking Ramipril Capsules.
Take special care with Ramipril Capsules
Check with your doctor or pharmacist before taking your medicine:
• Ifyou have heart, liver or kidney problems
• If you have lost a lot of body salts or fluids (through being sick (vomiting), having diarrhoea, sweating more than usual, being on a low salt diet, taking diuretics (watertablets)for a long timeor having had dialysis)
• If you are going to have treatment to reduce your allergy to bee or wasp stings (desensitisation)
• If you are going to receive an anaesthetic. This may be given for an operation or any dental work. You may need to stop your Ramipril Capsules treatment one day beforehand; askyour doctor for advice
• If you have high amounts of potassium in your blood (shown in blood test results)
• If you have collagen vascular disease such as sclerodermaorsystemiclupus erythematosus
• You must tell your doctor if you think that you are (or might become) pregnant. Ramipril Capsules are not recommended in the first 3 months of pregnancy and may cause serious harm to your baby after 3 months of pregnancy,seesection “Pregnancyand breastfeeding".
Children
Ramipril Capsules are not recommended for use in children and adolescents below 18 years of age because safety and efficacy of Ramipril Capsules in children has not yet been established.
If any of the above apply to you (or you are not sure), talk to your doctor before taking Ramipril Capsules.
Taking Ramipril Capsules with 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 (including herbal medicines). This is because Ramipril Capsules can affect the way some other medicines work. Also some medicines can affect the way Ramipril Capsules work.
Please tell your doctor ifyou are taking any of the following medicines. They can make Ramipril Capsules work less well:
• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such asibuprofen or indometacin and aspirin)
• Medicines used forthe treatment of low blood pressure, shock, cardiac failure, asthma or allergies such as ephedrine, noradrenaline or adrenaline. Your doctor will needtocheckyour blood pressure.
Please tell your doctor if you are taking any of the following medicines. They can increase the chance of getting side effects if you take them with Ramipril Capsules:
• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such asibuprofen or indometacin and aspirin)
• Medicines for cancer (chemotherapy)
• Medicines to stop the rejection of organs after a transplant such as ciclosporin
• Diuretics (water tablets) 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 ifyou are taking any of the following medicines. They may be affected by Ramipril Capsules:
• Medicines for diabetes such as oral glucose lowering medicines and insulin. Ramipril Capsules may lower your blood sugar amounts. Check your blood sugar amounts closely while taking Ramipril Capsules.
• Lithium (for mental health problems). Ramipril Capsules may increase the amount of lithium in your blood. Your lithium amount will need to be closely checked byyour doctor.
If any of the above apply to you (or you are not sure), talk to your doctor before taking Ramipril Capsules.
Taking Ramipril Capsules with food and alcohol
• Drinking alcohol with Ramipril Capsules may make you feel dizzy or light-headed. If you are concerned about how much you can drink while you are taking Ramipril Capsules, discuss this with your doctor as medicines used to reduce blood pressure and alcohol can have additive effects.
• Ramipril Capsules may be taken with or withoutfood. Pregnancy and breast-feeding
You must tell your doctor if you think that you are (or might become) pregnant
You should nottake Ramipril Capsules in the first 12 weeks of pregnancy, and you must not take them at all after the 13th weekas their use during pregnancy may possibly be harmful to the baby.
Ifyou become pregnant while on Ramipril Capsules, tell your doctor immediately. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy.
You should not take Ramipril Capsules if you are breastfeeding.
Askyour doctoror pharmacist for advice before taking any medicine.
Driving and using machines
You may feel dizzy while taking Ramipril Capsules. This is more likely to happen when you start taking Ramipril Capsules or start taking a higher dose. If this happens, do not drive or use any tools or machines.
Always take Ramipril Capsules exactly as your doctor has
told you. You should checkwith your doctoror pharmacist if
you are notsure.
Taking this medicine
• Take this medicine by mouth at the same time of the day each day.
• Swallow the capsules with liquid.
• Donotcrushorchewthecapsules.
How much totake
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 your blood pressure is controlled.
• ThemaximumdoseislOmgoncedaily.
• If you are already taking diuretics (water tablets), your doctor may stop or reduce the amount of the diureticyou take before beginning treatment with Ramipril Capsules.
To reduce the risk of you having a heart attack or stroke
• The usual starting dose is2.5 mg once daily.
• Your doctor may then decide to increase the amount you take.
• TheusualdoseislOmgoncedaily.
Treatment to reduce or delay the worsening of kidney problems
• You may be started on a dose of 1.25 mg or 2.5 mg once daily.
• Your doctor will adjustthe amount you are taking.
• The usual dose is 5 mg or 10 mg once daily.
Treatment of heart failure
• The usual starting dose is 1.25 mg once daily.
• Your doctor will adjustthe amount you take.
• The maximum dose is 10 mg daily. Two administrations perdayare preferable.
Treatment after you have had a heart attack
• The usual starting dose is 1.25 mg once daily to 2.5 mg twice daily.
• Your doctor will adjustthe amount you take.
• The usual dose is 10 mg daily. Two administrations per dayare preferable.
Elderly
Your doctor will reduce the initial dose and adjust your treatment moreslowly.
If you take more Ramipril Capsules than you should
Tell a doctor or go to the nearest hospital casualty department straight away. Do not drive to the hospital, get somebody else to take you or call for an ambulance. Take the medicine packwith you. This is so the doctor knows what youhavetaken.
Ifyou forget to take Ramipril Capsules
• Ifyou miss a dose, take your normal dose when it is next due.
• Do not take a double dose to make up for a forgotten tablet.
Ifyou have any further questions on the use of this product, askyour doctor or pharmacist.
Like all medicines, Ramipril Capsules can cause side effects, although not everybodygetsthem.
Stop taking Ramipril Capsules and see a doctor straight away, if you notice any of the following serious side effects-you may need urgent medical 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 Capsules.
• 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 erythema multiform).
Tell your doctor immediately if you experience:
• Faster heart rate, uneven or forceful heartbeat (palpitations), chest pain, tightness in your chest or more serious problems including heart attack and stroke
• Shortnessofbreath oracough. These could besignsof 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 ofthepancreas).
• Fever, chills, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of your skin or eyes (jaundice). These can besignsof liver problems such as hepatitis (inflammation of the liver) or liver damage.
Other side effects include:
Please tell your doctor if any of the following gets serious or lasts longer than a few days.
Common (affects less than 1 in 10 people)
• Headacheorfeeling tired
• Feeling dizzy. This is more likely to happen when you start taking Ramipril Capsules 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, shortnessofbreath
• Stomach or gut pain, diarrhoea, indigestion, feeling or being sick
• Skin rash with or without raised area
• Chestpain
• Crampsorpaininyourmuscles
• Blood tests showing more potassium than usual in your blood.
Uncommon (affects less than 1 in 100 people)
• Balance problems (vertigo)
• Itching and unusual skin sensations such as numbness, tingling, pricking, burning or creeping on your skin (paraesthesia)
• Lossorchangeinthewaythingstaste
• 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 over the day
• Sweating morethan usual
Pharmacode • Loss or decrease of appetite llll II llll (anorexia)
• Increased or irregular heartbeats, swollen arms and legs. This maybeasign ofyour body holding onto more water than usual
• Flushing
• Blurred vision
• Paininyourjoints
• Fever
• Sexual inability in men, reduced sexual desire in men or women
• 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 (affects I ess than 1 in 1,000 people)
• Feeling shaky or confused
• Redandswollentongue
• Severe flaking or peeling oftheskin, itchy, lumpy rash
• Nail problem (e.g. loosening or separation of a nail from its bed)
• Skin rash or bruising
• Blotcheson your skin and cold extremities
• Red,itchy,swollenorwateryeyes
• Disturbed hearing and ringing in your ears
• Feeling weak
• Blood tests showing a decrease in the number of red blood cells, white blood cells or platelets or in the amount of haemoglobin.
Very rare (affects less than 1 in 10,000 people)
• Being more sensitive to thesun than usual.
Other side effects reported:
Please tell your doctor if any of the following gets serious or lasts longer than a few 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)
• Breastenlargementinmen
• Slowedorimpairedreactions
• Burning sensation
• Change i n the way things smell
• Hair loss.
Ifyou notice any side effects not listed in this leaflet, please tell your doctoror pharmacist.
Reporting ofsideeffects
Ifyou 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.
Keepoutofthe reach and sightof children.
Do not store above 25°C. Store in the original packaging.
Do not use Ramipril Capsules after the expiry date which is stated on the carton and the blister or the tablet container. The expiry date refers to the last day of that month.
Medicines should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect theenvironment.
What Ramipril Capsules contain
• The active substance is ramipril.
The other ingredients are: starch (pregelatinised), gelatin and the colourings, black iron oxide (E172) and titanium dioxide (E171). The 2.5mg, 5mg and 10mg capsules also contain the colourings indigo carmine (E132) and yellow iron oxide (E172). The printing ink on the capsules contains the following additional ingredients: shellac, soya leicithin and antifoam.
What Ramipril Capsules looks like and contents of the pack
Ramipril 1.25 mg Capsules: light grey in colour, with “R" marked on the capsule cap and 1.25 on the capsule body. Ramipril 2.5 mg Capsules: lightgreen cap marked “R" and a light grey capsule body marked 2.5.
Ramipril 5 mg Capsules: green cap marked “R" and a light grey capsule body marked 5.
Ramipril 10 mg Capsules: dark green cap marked “R"and a lightgrey capsule body marked 10.
Pack sizes:
The capsules aresupplied in blister packsof 7,21,28,30,50 and 100 capsules.
Not all packsizes maybe marketed.
Marketing Authorisation Holder:
Brown&BurkUKLtd 5 Marryat Close Hounslow West Middlesex TW4 5DQ United Kingdom Manufacturer:
Morningside Pharmaceutical Ltd.
5 Pavilion Way, Loughborough
LE115GW
UK
This leaflet was last updated in October2014
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, askyour doctor or pharmacist.
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