Ramipril Medis

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Package leaflet: Information for the patient

Ramipril Medis 2.5 mg, tablets

Ramipril Medis 5 mg tablets

Ramipril Medis 10 mg tablets

ramipril

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. See section 4.

What is in this leaflet

1. What Ramipril Medis is and what it is used for

2. What you need to know before you take Ramipril Medis

3. How to take Ramipril Medis

4. Possible side effects

5. How to store Ramipril Medis

6. Contents of the pack and other information

1. What Ramipril Medis is and what it is used for

Ramipril Mediscontains a medicine called ramipril. This belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).

Ramipril Medisworks 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 Medis 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. What you need to know before you takeRamipril Medis

Do not take Ramipril Medis:

If you are allergic to ramipril, other ACE inhibitors 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 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 Medis 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 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 Medis if any of the above applies to you. If you are not sure, talk to your doctor before taking Ramipril Medis.

Warnings and precautions

Talk to 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 Medis 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 Medis 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 to treat high blood pressure:

- an angiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems.

- aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading “Do not take Ramipril Medis”

Children and adolescents

Ramipril Medisis not recommended for use in children and adolescents below 18 years of age because there is no information available in this population.

If any of the above apply to you (or you are not sure), talk to your doctor before taking Ramipril Medis.

Other medicines and Ramipril Medis

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Ramipril Mediscan affect the way some other medicines work. Also some medicines can affect the way Ramipril Medisworks.

Please tell your doctor if you are taking any of the following medicines. They can make Ramipril Mediswork 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.

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 Medis:

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 Medis:

Medicines for diabetes such as oral glucose lowering medicines and insulin. Ramipril Medis may lower your blood sugar amounts. Check your blood sugar amounts closely while taking Ramipril Medis
Lithium (for mental health problems). Ramipril Medis may increase the amount of lithium in your blood. Your lithium amount will need to be closely checked by your doctor.

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 Medis” and “Warnings and precautions”).

If any of the above apply to you (or you are not sure), talk to your doctor before taking RAMIPRIL MEDIS.

Ramipril Medis with food, drink and alcohol

Drinking alcohol with Ramipril Medis may make you feel dizzy or light-headed. If you are concerned about how much you can drink while you are taking Ramipril Medis, discuss this with your doctor as medicines used to reduce blood pressure and alcohol can have additive effects.
Ramipril Medis may be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you 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 Medis 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 Medis, 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 Medis if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You may feel dizzy, while taking Ramipril Medis. This is more likely to happen when you start taking Ramipril Medis or start taking a higher dose. If this happens, do not drive or use any tools or machines.

Ramipril Mediscontains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Ramipril Medis

Always take Ramipril Medis exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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 Medis.

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 Medis 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 Medis

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 dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Ramipril Medisand 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 Medis
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 (may affect up to 1 in 10 people)

Headache or feeling tired
Feeling dizzy. This is more likely to happen when you start taking Ramipril Medis 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 (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 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 change 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 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 (may affect up to 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.

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 national reporting system.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ramipril Medis

Store below 30C.

Blisters: Store in the original package in order to protect from moisture.

Bottles: Keep the bottle tightly closed in order to protect from moisture.

Keep this medicine out of the sight and reach of children.

Do not use Ramipril Medisafter the expiry date stated on the carton. The expiry date refers to the last day of that month.

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 Mediscontains

The active substance is ramipril 2.5 mg, 5 mg or 10 mg.
The other ingredients are sodium hydrogen carbonate, lactose monohydrate , croscarmellose sodium, pregelatinised starch(maize), and sodium stearyl fumarate.
In addition the 2.5 mg tablets contain yellow iron oxide (E 172) and the 5 mg tablets contain yellow iron oxide (E172) and red iron oxide (E 172).

What Ramipril Medislooks like and contents of the pack

2.5 mg tablet: capsule-shaped, flat, yellow tablet, scored on one side and on the edges, printed with R2.
5 mg tablet: capsule-shaped, flat, pink tablet, scored on one side and on the edges, printed with R3.
10 mg tablet: capsule-shaped, flat, white tablet, scored on one side and on the edges, printed with R4.

Blister packs (Al/Al/Polyamide/PVC): 10, 14, 20, 28, 30, 42, 50, 98 and 100 tablets.

Plastic polypropene bottle with white LD-polyethylene cap and dessicant: 100 and 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Medochemie Ltd.

1-10 Constantinoupoleos Str.

3011 Limassol

Cyprus

This medicinal product is authorised in the Member States of the EEA under the following names:

Bulgaria	Ramimed 5mg and 10mg tablets
Cyprus	Ramimed 2.5mg, 5mg and 10mg tablets
Czech Republic	Medoram 2,5mg, 5mg & 10mg tablets
Lithuania	Ramimed 2.5mg 5mg and 10mg tabletės
Latvia	Ramimed 2.5mg 5mg and 10mg tabletes
Sweden	Ramipril Medis tablett 2.5mg, 5mg and 10mg
Slovak Republic	Ramimed 2.5mg 5mg and 10mg tablets

This leaflet was last revised in 2015-01-22