Ramipril 10mg Tablets
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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 side effects not listed in this leaflet.
What is in this leaflet:
1. What Ramipril Tablets are and what they are used for
2. What you need to know before you take Ramipril Tablets
3. How to take Ramipril Tablets
4. Possible side effects
5. How to store Ramipril Tablets
6. Contents of the pack and other Information
Ramipril belongs to the class of medicines called Angiotensin Converting Enzyme (ACE) inhibitors that act on the heart and blood vessels.
ACE inhibitors lower blood pressure by widening blood vessels, making it easier for the heart to pump blood around the body.
Ramipril Tablets are used for one or more of the following:
• Reduce the risk of a heart attack, stroke or your chances of requiring a surgical procedure to increase the blood flow to your heart if you are a diabetic (suffer from sugar diabetes) and older than 55 years and you have, or have had one or more of the following:
- high blood pressure
- high levels of cholesterol in your blood
- small amounts of protein (albumin) detected in your urine
- blood vessel problems with poor blood circulation
- low HDL blood vessel (high density lipoprotein)
- you are a current smoker
• To lower your blood pressure if it is high (hypertension)
Do not take Ramipril if any of the following apply to you:
• You have previously had an allergic reaction to ramipril or any of the other ingredients in Ramipril Tablets (see Section 6 Further Information)
An allergic reaction may include rash, itching, swelling of the face, lips, tongue or hands/feet, or breathing difficulties
• You are more than 3 months pregnant. (It is also better to avoid Ramipril in early pregnancy - see pregnancy section.)
• You have a condition known as angioneurotic oedema that manifests with swelling of the face, lips, hands/feet, or breathing difficulties without knowing the cause or as a result of taking an ACE inhibitor in the past
• There is a family history of swelling of the face, lips, hands/feet, or breathing problems (oedema)
• You have been diagnosed to have a condition known as renal artery stenosis (narrow blood vessels in one or both kidneys)
• You have low or very variable blood pressure (hypotension)
Children and adolescents
Ramipril Tablets 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.
• You are taking insulin or oral anti-diabetic medicines (e.g. glibenclamide, metformin) for sugar diabetes
• You are taking pain relievers know as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (e.g. aspirin, indomethacin)
• You are taking lithium (used in the treatment of certain mental illnesses)
• You are taking allopurinol (used for the treatment of gout) or corticosteroids or other medicines that depress the immune system (e.g. ciclosporin)
• You are taking procainamide a treatment for irregular heart rhythms
• You are taking antidepressants used for depression such as amitriptyline and lofepramine.
• You are taking medicines for mental disorders such as schizophrenia, including chlorpromazine and flupentixol
• You are taking etoposide, cyclophosphamide, chlorambucil or aldesleukin to treat cancer
• You are taking medicines known as sympathomimetics such as ephedrine, pseudoephedrine and phenylephrine, found in many cold and flu remedies, and salbutamol that is used to treat asthma
• You are taking trimethoprim or co-trimoxazole medicines to treat urinary tract infections or bronchitis.
• If you need to undergo an operation or need an anaesthetic, tell the doctor or dentist about your medicine.
Your doctor may order blood tests during the course of your treatment to check your kidney and liver function.
Please consult your doctor, even if these statements were applicable to you at any time in the past.
Taking Ramipril Tablets with food and drink
Ramipril Tablets can be taken at any time of the day without regard to food intake.
An increase in salt in your diet may reduce the effect of Ramipril.
Do not drink alcohol whist taking these tablets.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Ramipril before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Ramipril. Ramipril is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Ramipril is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Warnings and precautions
Talk to your doctor before taking Ramipril Tablets if the following conditions apply to you:
• You have problems with your heart, kidneys and/or liver. Your doctor may reduce the dose of the tablets
• You are undergoing haemodialysis [blood from an artery (blood vessel) in the arm or leg is drawn into a dialysis machine and the purified blood is fed into a vein] using a certain high-flux membranes
• You are undergoing a form of blood transfusion called apheresis
• You have been diagnosed to have a certain type of autoimmune conditions known as lupus erthematosus or scleroderma
• You have a blood vessel problem known as ‘collagen vascular disease’.
• You are taking diuretics (water tablets e.g. spironolactone, amiloride, triamterene) and/or are) and/or are on a low salt diet, or have had diarrhoea and/or vomiting recently
• You have been diagnosed to have a condition known as primary hyperaldosteronism (a condition which can lead to lowered levels of potassium in the blood)
• You have diabetes
• You are black - ACE inhibitors may be less effective in black patients
• You are having or have had desensitisation treatment with wasp or bee venom
• You have been diagnosed to have heart valve problems affecting the flow of blood in and out of your heart
• You must tell your doctor if you think you are (or might become) pregnant. Ramipril is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as if may cause serious harm to your baby if used at that stage (see pregnancy section).
Other medicines and Ramipril Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines even those not prescribed but bought/obtained without a prescription.
Care is needed if:
• You are taking water tablets (diuretics), especially the ones that prevent loss of potassium in the urine (e.g. spironolactone, amiloride, triamterene)
• You are taking other medicines to treat high blood pressure (e.g. felodipine, lisinopril, methyldopa, losartan)
• You are taking potassium supplements or potassium containing salt substitutes
Driving and using machine
Ramipril may affect the ability to drive or operate machinery in some people as it may cause dizziness or lightheadedness and rarely, affect your vision. This occurs especially after the first dose, or after the dose is increased and during concomitant use of alcohol. Make sure you know how you react to Ramipril before you drive, use machines, or engage in any other activity that could be dangerous if you are not alert.
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Take Ramipril Tablets with a glass of water. Do not chew or crush the tablets. They can be taken at any time of the day either with or without food. To help you remember to take your medicine, try to get into the habit of taking it at the same time each day.
• For treatment of high blood pressure the usual starting dose is 1.25 mg of Ramipril taken once a day. It is possible that your doctor may have to increase the dose, depending on your response to the treatment. Most people will respond to a daily dose of
2.5 mg to 5 mg. The maximum daily dose should not exceed 10 mg. If you are taking water tablets (diuretics) already, your doctor may advise you to stop taking water tablets for 2-3 days prior to starting treatment with this medicine. Your doctor may restart treatment with water tablets later if required. If you have heart failure associated with high blood pressure with or without kidney problems then your doctor will start treatment with Ramipril in hospital.
• For treatment of heart failure the usual starting dose is 1.25 mg of Ramipril taken once a day. It is possible that your doctor may have to increase the dose depending on your response to the treatment. Daily dose of
2.5 mg or more can be taken either as a single dose or in two divided doses. The maximum daily dose should not exceed
10 mg. If you are taking a high dose of water tables (diuretics) already, your doctor may advise you to reduce the dose of water tablets prior to starting treatment with Ramipril.
• To reduce the risk of heart attack, cardiovascular death, stroke, or your chances of requiring surgery to improve the blood flow to your heart, the usual starting dose is
1.25 mg given once daily. In case you tolerate the medicine well the dose will be increased to 2.5 or 5 mg once daily after 1 week and to 10 mg once daily after another 3 weeks. The maximum daily dose should not exceed 10 mg.
• if you are elderly and taking water tablets, or have heart failure, or liver or kidney problems, your doctor may start your treatment with a low dose and increase it if needed.
Take your tablets as directed and for as long as directed, do not stop them, even if you feel better, as otherwise the symptoms may return.
If you have the impression that the effect of Ramipril Tablets is too strong or too weak, talk to your doctor or pharmacist.
anxiety
• Tiredness, weakness, fever
• Pain in your joints and/or muscles, muscle cramps
• Tingling or numbness in your hands or toes
• Temporary changes in skin colour (white to blue to red) and temperature (feels colder) of hands and/or feet (known as Raynaud’s Phenomenon)
• Runny or stuffy nose
• Nausea (feeling sick), indigestion, pain in the belly, loss of appetite
• Change or loss of taste
• Reduced sexual desire or problems maintaining an erection in men (impotence)
• Swelling of face, ankles or other parts of the body, with sudden increase or decrease in the amount of urine passed
• Redness of skin with itching and hives, rashes, bumps, bruises, or small areas of bleeding under the skin (tiny red dots or larger reddish purple spots)
If you have taken more Ramipril Tablets than you should, consult your doctor or got to the nearest hospital casualty department immediately. Take this leaflet or the medicine pack with you so that your doctor will know what you have taken.
If you forget to take Ramipril Tablets at the
right time, take them as soon as you remember. However if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose for a forgotten individual dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects observed with Ramipril Tablets are generally mild and transient and do not require discontinuation of therapy.
Adverse reactions have been reported under heading of frequency using the following convention:
|
Common: |
Affects less than one out of 10 people |
|
Uncommon: |
Affects less than one out of 100 people |
|
Rare: |
Affects less than one out of 1,000 people |
|
Very Rare: |
Affects less than one out of 10,000 people |
Rare
• Dry or sore mouth
• Loss of hair and/or nails
• Sensitivity of the skin to light
• Eye pain, redness, swelling, itching of the eye (manifestations of conjunctivitis)
• Enlargement of the breasts in men
• Confusion
Very rare
• Excessive sweating
• Inflammation of the sinuses (sinusitis)
There may be changes in the results of certain laboratory tests.
Uncommon
• Abnormal liver or kidney function tests
• Increase in blood urea nitrogen and serum creatine
• Increased levels of pancreatic enzymes
• Lower sodium content of blood
• High potassium content of blood
Rare
• Decreased red blood cell count, reduction in the haemoglobin content,
Very rare
• Agranulocytosis and bone marrow depression
• Decreased white blood cell count, reduced platelet count
• Low blood sugar levels
• Increased number of a type of blood cell called eosinophil
• Raised titres of antinuclear antibodies
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
Very serious side effects If any of the following happens, stop taking Ramipril Tablets and tell your doctor immediately or go to the casualty department of your nearest hospital.
• Serious rash, hives, itching, chest constriction, shortness of breath or swelling of face, lips, tongue, hands/feet, fainting, high temperature
• Puffiness and swelling of face, tongue or throat which may cause difficulty in swallowing or breathing.
These are very serious side effects. If you have any of them you may have had a serious allergic reaction or other type of reaction to Ramipril. You may need urgent medical attention or hospitalisation.
Serious side effects
Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
Common
• Feeling of tightness, heaviness, dull discomfort, or crushing pain that is felt behind the breastbone and may spread to the arms, neck and jaw. It is often brought on by exercise, eating, or stress; or may occur at rest. These may be manifestations of angina
• Fast heart beat with light headedness and/or black out associated with weakness and feeling sick (nausea) (especially after the first dose or after the dose is increased)
Uncommon
• Severe and prolonged chest pain, fast or irregular heart beat, and may be associated with nausea (feeling sick), vomiting (being sick), and excessive sweating. These maybe manifestations of a heart attack.
• Sudden onset of a severe headache, dizziness, numbness/weakness in the face, arm, or leg, especially on one side of the body (or) altered speech and mental ability to understand, disturbed vision in one or both eyes, and loss of balance or coordination. These symptoms may occur for a short time and are reversible (transient ischemic attack) or may last for longer period of time (stroke)
• Too slow, or too fast a heart beat (irregular heart beat & palpitations)
• Sudden shortness of breath or tightness in chest, difficulty breathing
Very rare
• Severe abdominal pain associated with nausea and vomiting (manifestations of pancreatatitis)
• Yellowing of skin and whites of eyes, with decreased appetite, abdominal pain (these may be manifestations of a liver problem)
• Cough, fever, increasing breathlessness and night sweats (these may be manifestations of a type of pneumonia)
• General feeling of being unwell, along with fever, weight loss and diffuse pains and aches (due to inflammation of blood vessels)
• Unusual bleeding or increased tendency to bleed, persistent sore throat and frequent infections, and/or anemia
• Sudden fever, rigors, sore throat, and a sharp drop in circulating granular white blood cells (agranulocyctosis)
• Pink or red itchy spots on the skin which may blister and form raised, red pale-centered marks
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 blister and carton after “EXP”. The expiry date refers to the last day of that month.
Medicines should not be disposed via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measure will help to protect the environment.
What Ramipril Tablets contain
Each tablet contains 1.25 mg, 2.5 mg, 5 mg or 10 mg of Ramipril. The other ingredients are microcrystalline cellulose, pregelatinised starch, silicum dioxide precipitated, glycine hydrochloride and glycerol dibehenate. The
2.5 mg tablets also contains yellow iron oxide (E172), 5 mg tablets contain red iron oxide (E172).
What Ramipril Tablets look like and contents of the pack
Ramipril 1.25 mg are white, oblong shaped tablets with a scoreline on both sides Ramipril
2.5 mg are light yellow, speckled, oblong shaped tablets with a scoreline on one side Ramipril 5 mg are light pink, speckled, oblong shaped tablets with a scoreline on side Ramipril 10 mg are white, oblong shaped tablets with a scoreline on one side
Ramipril Tablets are available in blister packs of 14, 20, 28, 30, 50, 56, 98 and 100 x 1 and 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
LEK S.A.,
UI. Podlipie 16,
95-010 Strykow,
Poland
or
Salutas Pharma GmbH,
Dieselstrasse 5,
D - 70839 Gerlingen,
Germany
or
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,
39179 Barleben, Germany
or
LEK S.A.,
UI. Domaniewska 50 C,
02-672 Warsaw, Poland
Other side effects
Tell your doctor if you notice any of the
following:
Common
• Dizziness, headache
• Dry cough
• Vomiting (being sick)
• Diarrhoea (loose stools)
Uncommon
• Disturbances of balance, restlessness, tremors (uncontrolled shaking), sleep disorders (difficulty sleeping or excessive sleep), nervousness, feeling depressed,
or
Sandoz GmbH,
Biochemiestrasse 10,
6250 Kundl, Austria.
This leaflet was last revised in 07/2012.
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