RAMIPRIL 5 MG TABLETS

Active substance: RAMIPRIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Ramipril 5 and 10 mg Tablets
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 get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

IN THIS LEAFLET:
1. What Ramipril is and what it is used for
2. Before you take Ramipril
3. How to take Ramipril
4. Possible side effects
5. How to store Ramipril
6. Further information

1.

What Ramipril is and what it is used for

Ramipril belongs to a group of drugs called angiotensin-converting enzyme (ACE) inhibitors.
Ramipril works 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 can be used:
• To treat 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 not you have
diabetes)
• To treat your heart when it cannot pump enough blood to the rest of your body (heart
failure)
• As treatment following heart attack (myocardial infarction) complicated with heart failure.

2. Before you take Ramipril
Do NOT take Ramipril:
• If you are allergic (hypersensitive) to ramipril, any other ACE inhibitor medicine or any of
the ingredients of Ramipril 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

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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 suitable for you
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 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 if any of the above apply to you. If you are not sure, talk to your doctor before
taking Ramipril.
Take special care with Ramipril
Check with your doctor or pharmacist before taking your medicine:
• If you 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 (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)
• 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 treatment one day beforehand; ask your 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 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”.
Children
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 to your doctor before taking Ramipril.

Taking Ramipril 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 can affect the way some other medicines work. Also some medicines can affect the way
Ramipril works.
Please tell your doctor if you are taking any of the following medicines. They can make Ramipril
work less well:
• 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.

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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:









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 (water tablets) such as furosemide
Medicines which can increase the amount of potassium in your blood such as
spironolactone, triamterene, amiloride, potassium salts and heparin (for thinning 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
lower your blood sugar amounts. Check your blood sugar amounts closely 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 by your doctor.

If any of the above apply to you (or you are not sure), talk to your doctor before taking Ramipril.
Taking 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 be taken with or without food.

Pregnancy and breast-feeding
You must tell your doctor if you think you are (or might become) pregnant. 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 be harmful to the baby.
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 planned pregnancy.
You should not take Ramipril if you are breast-feeding.
Ask your doctor for advice before taking any medicine.
Driving and using machines
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 any tools or machines.

3. How to take Ramipril
Always take Ramipril exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.

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Taking this medicine
• Take this medicine by mouth at the same time of the day each day.
• Swallow the tablets/capsules whole with liquid.
• Do not crush or chew the tablets/capsules.
How much to take
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.
• The maximum dose is 10 mg once 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 amount you take.
• 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 2.5 mg once daily.
• Your doctor will adjust the 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 adjust the amount you take.
• The maximum dose is 10 mg daily. Two administrations per day are 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 adjust the amount you take.
• The usual dose is 10 mg daily. Two administrations per day are preferable.
Elderly
Your doctor will reduce the initial dose and adjust your treatment more slowly.
If you take more Ramipril 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 pack with you.
This is so the doctor knows what you have taken.
If you forget to take Ramipril
• If you 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/capsule.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Ramipril can cause side effects, although not everybody gets them.
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Stop taking Ramipril 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
• 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
• Shortness of breath or a cough. These could be signs of 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.
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)
• Headache or feeling tired
• 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
• Cramps or pain in your muscles
• 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)
• 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
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Passing more water (urine) than usual over the day
Sweating more than 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 water than usual
Flushing
Blurred vision
Pain in your joints
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 less than 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 or watery eyes
• 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 the sun 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)
• Breast enlargement in men
• Slowed or impaired reactions
• Burning sensation
• Change in the way things smell
• Hair loss.

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Ramipril
Keep out of the reach and sight of children. Do not store above 25°C. Store in the original package.
Do not use Ramipril after the expiry date that is stated on the outer packaging.
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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 Ramipril contains:
• The active ingredient is ramipril. Each tablet contains 5 or 10 mg of ramipril
• The other ingredients are microcrystalline cellulose, sodium stearyl fumarate and magnesium
hydroxide. The 5 mg tablets also contain the colour, iron oxide (E172).
What Ramipril looks like and contents of the pack:
• Ramipril 5 mg Tablets are pink, round tablets, scored on both sides and debossed with “5” on
one side of the score and with “RL” on the other side of the score
• Ramipril 10 mg Tablets are white to off-white, round tablets, scored on both sides and
debossed with “10” on one side of the score and with “RL” on the other side of the score.
• The 5 mg tablets are available in pack sizes of 14, 20, 28, 30, 50, 56, 98, 100, 200 & 500 tablets.
Hospital packs of 50, 300 (10x30) & 500 tablets.
• The 10 mg tablets are available in pack sizes of 20, 28, 30, 50, 56, 98, 100, 200 & 500 tablets.
Hospital packs of 50, 300 (10x30) & 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited,
Eastbourne, BN22 9AG.
This leaflet was last revised: May 2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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