5 mg, 10 mg tablets
ramipril
What Ramipril Aurobindo is and what it is used for
Ramipril Aurobindo contains a medicine called ramipril. It belongs to a group of medicines called ACE inhibitors ( Angiotensin Converting Enzyme Inhibitors).
Ramipril Aurobindo works by:
- Reduce your body’s production of substances that could increase your blood pressure
- Make your blood vessels dilate and relax
- Make it easier for your heart to pump blood around your body.
Ramipril Aurobindo can be used:
- To treat high blood pressure ( hypertension )
- To reduce the risk of heart attack or stroke
- To reduce or delay the worsening of kidney problems (whether you have diabetes or not)
- For the treatment of the heart when it can not pump around enough blood to the rest of the body ( heart failure )
- As treatment after a heart attack complicated by heart failure
Ramipril contained in Ramipril Aurobindo may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions
What you need to know before you use Ramipril Aurobindo
Do not use Ramipril Aurobindo
- If you are allergic to ramipril or any other ACE inhibitor or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction may include rash, difficulty swallowing or breathing, and swelling of your face, lips, throat, or tongue.
- If you have ever had a severe allergic reaction called “angioedema”. Signs of this include itching, hives ( urticaria ), red marks on the hands, feet, and neck, swelling of the throat and tongue, swelling around the eyes and lips, and difficulty breathing and swallowing.
- If you have been taking or are taking sacubitril/valsartan, a medicine used to treat a type of long-term ( chronic ) heart failure in adults, it increases the risk of angioedema (rapid swelling under the skin in an area such as the throat).
- If you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, Ramipril Aurobindo may not be suitable for you
- If you have kidney problems which means that the blood supply to your kidneys is reduced ( stenosis of the renal artery)
- During the last 6 months of pregnancy (see section “Pregnancy and breast-feeding” below)
- If your blood pressure is abnormally low or unstable. Your doctor will make this assessment
- If you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren
- The risk of angioedema may increase if you take any of the following medicines:
- Racecadotril, a medicine used to treat diarrhea;
- Drugs are used to prevent rejection of transplanted organs and against cancer (eg temsirolimus, sirolimus, everolimus).
- Vildagliptin is a medicine used to treat diabetes.
Do not take Ramipril Aurobindo if any of the above apply to you. If you are not sure, talk to your doctor before taking Ramipril Aurobindo.
Warnings and cautions
Talk to your doctor or pharmacist before taking Ramipril Aurobindo
- If you have heart, liver, or kidney problems
- If you have lost a lot of body salts or body fluids (through vomiting, diarrhea, abnormal sweating, a strictly low-salt diet, treatment with diuretics for a long time, or have undergone dialysis )
- If you are going to undergo a treatment to reduce your allergy to wasp or bee stings ( hyposensitization )
- If you will be given anesthetics. This can be given to you before an operation or dental treatment. You may need to stop taking Ramipril Aurobindo one day before surgery; Ask your doctor for advice
- If you have high levels of potassium in your blood (shown by a blood test)
- If you are taking medicines or have a condition that can reduce the sodium levels in your blood. Your doctor may perform regular blood tests, especially to check your blood sodium levels, especially if you are older
- If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is higher:
- temsirolimus, sirolimus, everolimus, and other medicines belonging to the group mTOR inhibitors (used to prevent rejection of transplanted organs), vildagliptin, neprilysin (NEP) inhibitors (such as racecadotril) or sacubitril/valsartan. For sacubitril / valsartan, see section 2 “Do not take Ramipril Aurobindo”.
- If you have connective tissue diseases such as scleroderma or SLE (systemic lupus erythematosus)
- If you think you may be pregnant or may become pregnant during treatment, contact your doctor. Ramipril Aurobindo is not recommended during the first 3 months of pregnancy and may cause serious birth defects after the first 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 (ARB) (also known as sartans – for example, valsartan, telmisartan, irbesartan), especially if you have diabetes-related kidney problems.
- aliskiren ”
Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.
See also the information under the heading “Do not take Ramipril Aurobindo”.
Children and young people
Ramipril Aurobindo is not recommended for use in children and adolescents below 18 years of age as the safety and efficacy of ramipril in children have not yet been established.
If any of the above applies to you (or you are not sure), talk to your doctor before taking Ramipril Aurobindo.
Other medicines and Ramipril Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ramipril Aurobindo can affect the way other medicines work. Some medicines may also affect the way Ramipril Aurobindo works.
Tell your doctor if you are taking any of the following medicines. They can make Ramipril Aurobindo work worse:
- Drugs used to relieve pain and inflammation (non-steroidal anti-inflammatory drugs such as ibuprofen or indomethacin and acetylsalicylic acid)
- Medicines are used to treat low blood pressure, shock, heart failure, asthma, or allergies such as ephedrine, norepinephrine, or adrenaline. Your doctor will check your blood pressure.
Tell your doctor if you are taking any of the following medicines. They may increase the risk of side effects if you take them with Ramipril Aurobindo:
- Sacubitril/valsartan – used to treat a type of long-term ( chronic ) heart failure in adults (see section 2 “Do not take Ramipril Aurobindo”)
- Drugs used to relieve pain and inflammation (non-steroidal anti-inflammatory drugs such as ibuprofen or indomethacin and acetylsalicylic acid)
- Anti-cancer drugs ( chemotherapy )
- Drugs that prevent the rejection of transplanted organs such as cyclosporine
- Diuretics (diuretics) such as furosemide
- Potassium supplements (including salt replacement), potassium-sparing diuretics (diuretics), and other medicines that can increase the amount of potassium in your blood (eg trimethoprim and cotrimoxazole (trimethoprim/sulfamethoxazole) against bacterial infections; ciclosporin, an immunosuppressant which prevents the rejection of transplanted organs; and heparin, a drug used to thin the blood to prevent blood clots).
- Steroids used in inflammation such as prednisolone
- Allopurinol (used to reduce the amount of uric acid in your blood)
- Procainamide (used for heart rhythm disorders)
- Temsirolimus (for cancer)
- Medicines are commonly used to prevent the rejection of transplanted organs (sirolimus, everolimus, and other medicines belonging to the group mTOR inhibitors). See section “Warnings and Precautions”.
- Vildagliptin (used to treat type 2 diabetes )
- Racecadotril (used for diarrhea)
- Your doctor may need to change your dose and/or take other precautions if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also the information under the headings “Do not take Ramipril Aurobindo” and “Warnings and precautions”).
Tell your doctor if you are taking any of the following medicines. They can be affected by Ramipril Aurobindo:
- Antidiabetic drugs such as oral glucose-lowering drugs and insulin. Ramipril Aurobindo may reduce your blood sugar levels. Check your blood sugar levels carefully while you are taking Ramipril Aurobindo.
- Lithium (used in mental illness). Ramipril Aurobindo may increase the amount of lithium in your blood. Your lithium levels will need to be monitored closely by your doctor.
If any of the above applies to you (or you are not sure), talk to your doctor before taking Ramipril Aurobindo.
Ramipril Aurobindo with food, drink, and alcohol
- If you drink alcohol while taking Ramipril Aurobindo, you may feel dizzy. If you are concerned about how much you can drink while taking Ramipril Aurobindo, talk to your doctor as alcohol may increase the effect of antihypertensive drugs.
- Ramipril Aurobindo can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
If you think you may be pregnant or may become pregnant during treatment, contact your doctor. You should not take Ramipril Aurobindo during the first 12 weeks of pregnancy and you should not take them at all after the 13th week of pregnancy as its use during pregnancy may be harmful to the baby. If you become pregnant while taking Ramipril Aurobindo, tell your doctor immediately. A change to an alternative treatment that is more suitable during pregnancy should take place before the planned pregnancy.
Breast-feeding
You should not take Ramipril Aurobindo if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You may feel dizzy when taking Ramipril Aurobindo. This is more likely to happen when you start taking Ramipril Aurobindo or if you take a higher dose. If this happens, do not drive or use any tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs, due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Ramipril Aurobindo contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to use Ramipril Aurobindo
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Ramipril Aurobindo 5 mg tablets:
This strength is not suitable for doses below 2.5 mg
Ramipril Aurobindo 10 mg tablets:
This strength is not suitable for doses below 5 mg
For doses lower than 2.5 mg per day Ramipril Aurobindo is not suitable. Other ramipril medicines of suitable strength are available. Your doctor will inform you of this.
What does 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 dose one until your blood pressure is under control
- The maximum dose is 10 mg once daily
- If you are already taking diuretics ( diuretics ), your doctor may ask you to stop taking or reduce the dose of one of the diuretics before starting treatment with Ramipril Aurobindo
To reduce the risk of heart attack and stroke
- The usual starting dose is 2.5 mg once daily
- Your doctor may then decide to increase this dose
- The usual dose is 10 mg once a day
To reduce or delay the worsening of kidney problems:
- Your starting dose maybe 1.25 mg or 2.5 mg once daily
- Your doctor will adjust your dose
- The usual dose is 5 mg or 10 mg once a day
Treatment of heart failure
- The usual starting dose is 1.25 mg once daily
- Your doctor will adjust your dose
- The maximum dose is 10 mg daily. Two dosing sessions per day are preferred
Treatment after a heart attack
- The usual starting dose is 1.25 mg once daily or 2.5 mg twice daily
- Your doctor will adjust your dose
- The maximum dose is 10 mg daily. Two dosing sessions per day are preferred
Older
Your doctor will reduce the starting dose and adjust your treatment at a slower pace.
How to take this medicine
- To be swallowed. Taken at the same time each day.
- Swallow the tablets whole with liquid.
Do not crush or chew the tablets.
If you take more Ramipril Aurobindo than you should
Tell your doctor or go to the emergency department at the nearest hospital as soon as possible. Do not drive to the hospital, ask someone else to drive you or call an ambulance. Bring your medicine pack. This is so that the doctor knows what you have taken.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center (tel. 112) for risk assessment and advice.
If you forget to take Ramipril Aurobindo
- If you forget to take a dose, take your normal dose at the next dose
- Do not take a double dose to make up for a forgotten tablet
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Ramipril Aurobindo and see a doctor immediately if you notice any of the following serious side effects – you may need urgent medical attention:
- Swelling of the face, lips, or throat which makes it difficult to swallow or breathe, but also itching and rash. This may be a sign of a severe allergic reaction to Ramipril Aurobindo
- Severe skin reactions including rash, cold sores, worsening of skin conditions, redness, blisters, or skin detachment (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme)
Tell your doctor immediately if you experience:
- Increased heart rate, irregular or severe heartbeat ( palpitation ), chest pain, chest tightness, or more serious problems including heart attack and stroke
- Shortness of breath or cough. This may be a sign of lung problems
- Bruising that occurs more easily than usual, prolonged bleeding time, signs of bleeding (eg bleeding in the gums), purple spots on the skin or increased susceptibility to infection, sore throat and fever, fatigue, weakness, dizziness, or pale skin. This could be a sign of blood or bone marrow problems
- Severe abdominal pain can be felt in the back. This may be a sign of pancreatitis ( inflammation of the pancreas).
- Fever, chills, fatigue, loss of appetite, abdominal pain, nausea, yellowing of the skin or eyes (jaundice). This can be a sign of liver problems such as hepatitis ( inflammation of the liver) or other liver damage.
Other side effects include :
Tell your doctor if any of the following become serious or persist for more than a few days
Common (may affect up to 1 in 10 people):
- Headache or fatigue
- Dizziness. This is more likely to happen when you start taking Ramipril Aurobindo or if you start taking a higher dose.
- Fainting, abnormally low blood pressure ( hypotension ), especially when standing or getting up quickly
- Dry cough, sinusitis or bronchitis, shortness of breath
- Stomach pain, diarrhea, heartburn, nausea, or vomiting
- Skin rash with or without swelling
- Chest pain
- Cramp or muscle pain
- Blood tests that show more potassium than normal
Uncommon (may affect up to 1 in 100 people):
- Balance problem (fraud)
- Itching and abnormal sensations in the skin such as numbness, tingling, burning sensation, or ant crawling ( paresthesia )
- Changed or lost taste experience
- Sleep disorders
- Depression, anxiety, increased nervousness or restlessness
- Nasal congestion, difficulty breathing, or worsening of asthma
- Swelling in the stomach is called “intestinal angioedema” which causes symptoms such as abdominal pain, vomiting, and diarrhea
- Heartburn, constipation, or dry mouth
- Increased urination
- Increased sweating
- Lost or decreased appetite ( anorexia )
- Increased or irregular heartbeat. Swollen arms and legs. This may be a sign that your body is storing more water than usual
- Hemorrhoids
- Dimsyn
- Joint pain
- Fever
- Sexual inability in men decreased sexual desire in men or women
- Increased number of certain white blood cells ( eosinophilia ) detected by blood tests
- Blood tests that show changes in your liver function, pancreas, or kidney function
Rare (may affect up to 1 in 1,000 people):
- Tremors or confusion
- Red and swollen tongue
- Severe skin flaking, itchy lumpy rash
- Nail problems (eg loose nails or the nail coming loose from its bracket)
- Skin rash or bruising
- Stains on the skin and cold limbs
- Red, itchy, swollen, or watery eyes
- Affected hearing and ringing in the ears
- Feeling weak
- Blood tests show a decrease in the number of red blood cells, white blood cells, or platelets or a decrease in the level of hemoglobin
Very rare (may affect up to 1 in 10,000 people):
- Increased sun sensitivity
Other reported side effects:
Tell your doctor if any of the following become serious or persist for more than a few days
- Concentration difficulties
- Swelling of the mouth
- Blood tests that show too few blood cells in your blood
- Blood tests that show less sodium in your blood than normal
- Concentrated urine (dark color), nausea or vomiting, muscle cramps, confusion, and seizures that may be caused by incorrect secretion of ADH ( antidiuretic hormone ). If you get these symptoms, contact your doctor as soon as possible.
- Color change of fingers and toes when cold and then pain and tingling when warmed up (Raynaud’s phenomenon)
- Enlarged breasts in men
- Slow or worsening reactions
- Burned feeling
- Change of the sense of smell
- Hair loss.
How to store Ramipril Aurobindo
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Store in the original package. Moisture sensitive.
Close the HDPE package tightly. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the carton, can and label after “EXP”. The expiration date is the last day of the specified month.
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.
Contents of the package and other information
Content declaration
- The active substance is ramipril. Each tablet contains 5 mg or 10 mg ramipril.
- The other ingredients are pregelatinized starch (maize), lactose monohydrate, sodium bicarbonate (E500), croscarmellose sodium (E468), and red iron oxide [for 5 mg tablets only] (E172), and sodium stearyl fumarate.
What the medicine looks like and the contents of the pack
Ramipril Aurobindo 5 mg tablets:
Light pink flammable colored, uncoated, round [diameters 6.0 mm], flat tablet with beveled edges,
embossed with “H” and “19” separated by notches on one side and smooth on the other side. The tablet can be divided into two equal doses.
Ramipril Aurobindo 10 mg tablets:
White to an off-white color, uncoated, round [diameter 8.0 mm], flat tablet with beveled edges, embossed with “H” and “20” separated by a notch on one side and smooth on the other side. The tablet can be divided into two equal doses.
Ramipril Aurobindo tablets are available in:
Blister pack (Transparent – PVC / Aluminum).
White opaque HDPE jar with PP screw cap
Pack sizes :
Ramipril Aurobindo 5 mg tablets:
Blister pack: 7, 10, 14, 20, 28, 30, 42, 50, 56, 60, 90, 98, 100 and 500 tablets
HDPE jar: 30 and 1000 (hospital packaging) tablets
Ramipril Aurobindo 10 mg tablets :
Blister pack: 20, 28, 30, 50, 56, 60, 90, 98, 100 and 500 tablets
HDPE jar: 30 and 1000 (hospital packaging) tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Aurobindo Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913
Malta
Manufacturer
Milpharm Limited
Ares, Odyssey Business Park, West End Road,
South Ruislip HA4 6QD.
UK
or
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate
Hal Far, Birzebbugia, BBG 3000
Malta
or
Galenicum Health, SL
Avenida Diagonal 538, 4º 1ª
08006, Barcelona,
Spain
or
Generis Pharmacêutica, SA,
Rua João de Deus, no 19,
Venda Nova, 2700-487
Amadora, Portugal.
For any information about this medicine, contact your local pharmacist
| This medicinal product is authorized under the European Economic Area under the names: | |
|---|---|
| Denmark | Ramipril Aurobindo |
| Finland | Ramipril Orion 5 mg / 10 mg tablets |
| France | RAMIPRIL ARROW LAB 5 mg / 10 mg, squeezed compress |
| Greece | RAMISYN 5 mg / 10 mg dose |
| Italy | Ramipril Aurobindo Pharma Limited 5 mg / 10 mg compress |
| Malta | Ramipril Aurobindo 5 mg / 10 mg tablets |
| Netherlands | Ramipril Aurobindo 5 mg / 10 mg, tablets |
| Norway | Ramipril Aurobindo 5 mg / 10 mg tablets |
| Poland | Ramipril Aurobindo |
| Romania | Ramipril Aurobindo 5 mg / 10 mg compress |
| Spain | ramipril cinfa 5 mg / 10 mg compressed |
| Sweden | Ramipril Aurobindo 5 mg / 10 mg tablets |
| UK | Ramipril 5 mg / 10 mg tablets |