1.25 mg; 2.5 mg; 5 mg; 10 mg tablets
ramipril
What Ramipril Hexal is and what it is used for
Ramipril Hexal contains a medicine called ramipril. It belongs to a group of medicines called ACE inhibitors ( Angiotensin Converting Enzyme Inhibitors).
Ramipril Hexal 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 Hexal 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 Hexal may also be approved for the treatment of other conditions not mentioned in this product information. 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 Hexal
Do not use Ramipril Hexal
- 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 are undergoing dialysis or any other type of blood filtration. Depending on the machine used, Ramipril Hexal may not be suitable for you.
- if you have kidney problems it 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 breastfeeding” below).
- if your blood pressure is abnormally low or unstable. Your doctor will make this assessment.
- if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
- if you have taken 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).
Do not take Ramipril Hexal if any of the above applies to you. If you are not sure, talk to your doctor before taking Ramipril Hexal.
Warnings and cautions
Talk to your doctor or pharmacist before using Ramipril Hexal:
- 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 or anesthetics. This can be given to you before an operation or dental treatment. You may need to stop taking Ramipril Hexal 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
- The risk of angioedema may increase if you take any of the following medicines:
- racecadotril, a medicine used to treat diarrhea
- drugs used to prevent rejection of transplanted organs and against cancer (eg temsirolimus, sirolimus, everolimus)
- vildagliptin, a medicine used to treat diabetes
- If you have connective tissue diseases such as scleroderma or SLE (systemic lupus erythematosus)
- 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 Hexal”.
If you think you may be pregnant (or may become pregnant), consult your doctor. Ramipril Hexal is not recommended during the first three months of pregnancy and may cause serious birth defects after three months of pregnancy (see section “Pregnancy and breastfeeding” below).
Children and young people
Ramipril Hexal 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 apply to you (or you are not sure), talk to your doctor before taking Ramipril Hexal.
Other medicines and Ramipril Hexal
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ramipril Hexal can affect the way other medicines work. Some medicines may also affect the way Ramipril Hexal works.
Tell your doctor if you are taking any of the following medicines. They can make Ramipril Hexal 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 Hexal:
- Drugs used to relieve pain and inflammation (non-steroidal anti-inflammatory drugs such as ibuprofen or indomethacin and acetylsalicylic acid )
- Anti-cancer drugs ( chemotherapy )
- Diuretics (diuretics) such as furosemide
- Potassium supplements (including salt substitutes), potassium-sparing diuretics (diuretics), and other medicines that can increase the amount of potassium in your blood (eg spironolactone, triamterene, amiloride, trimethoprim, and cotrimoxazole against infections caused by bacteria; cyclosporine, 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)
- Sirolimus, everolimus (for the prevention of transplant rejection)
- 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 Hexal” and “Warnings and precautions”).
Tell your doctor if you are taking any of the following medicines. They can be affected by Ramipril Hexal:
- Antidiabetic drugs such as oral glucose-lowering drugs and insulin. Ramipril Hexal may lower your blood sugar levels. Check your blood sugar levels carefully while you are taking Ramipril Hexal.
- Lithium (used in mental illness). Ramipril Hexal 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 apply to you (or you are not sure), talk to your doctor before taking Ramipril Hexal.
Ramipril Hexal with food and alcohol
- If you drink alcohol while taking Ramipril Hexal, you may feel dizzy. If you are worried about how much you can drink while taking Ramipril Hexal, talk to your doctor as alcohol may increase the effect of antihypertensive drugs.
- Ramipril Hexal can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
Tell your doctor if you think you may be pregnant (or may become pregnant).
You should not take Ramipril Hexal during the first 12 weeks of pregnancy and you should especially not take Ramipril Hexal after the 13th week of pregnancy as this may harm the fetus.
If you become pregnant while taking Ramipril Hexal, tell your doctor immediately. Switching to the appropriate alternative treatment should take place before a planned pregnancy.
Breast-feeding
You should not take Ramipril Hexal 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 Hexal. This is more likely to happen when you start taking Ramipril Hexal 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 attention. 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 Hexal contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to use Ramipril Hexal
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dosage
- To be swallowed. Taken at the same time each day.
- Swallow the tablets whole with liquid.
- Do not crush or chew the tablets.
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 Hexal
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 postpone 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 usual 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.
If you take more Ramipril Hexal than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Tell your doctor or see 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 will know what you have taken.
If you forget to take Ramipril Hexal
- 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 this medicine 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 this medicine.
- Severe skin reactions include rash, cold sores, worsening of skin conditions, redness, blistering, or skin rash (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 may 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 this medicine 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 or intestinal pain, diarrhea, indigestion, 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, 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, pancreatic function, 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 loosening of the nail from its attachment)
- 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 side effects get serious or persist for more than a couple of days.
Has been reported (occurs in an unknown number of users):
- 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
- Burning sensation
- Change of the sense of smell
- Hair loss
How to store Ramipril Hexal
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, carton or jar after EXP. or EXP. The expiration date is the last day of the specified month.
Do not store above 25 oC. Store in the original package. Sensitive to light. Moisture sensitive.
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.
Ramipril Hexal 1.25 mg: Each tablet contains 1.25 mg of ramipril.
Ramipril Hexal 2.5 mg: Each tablet contains 2.5 mg of ramipril.
Ramipril Hexal 5 mg: Each tablet contains 5 mg ramipril.
Ramipril Hexal 10 mg: Each tablet contains 10 mg ramipril.
The other ingredients are hypromellose, microcrystalline cellulose, pregelatinised starch , sodium bicarbonate, and sodium stearyl fumarate.
What the medicine looks like and the contents of the pack
1.25 mg tablets:
The tablets are white, oblong, smooth, and oblique, with a notched edge on both sides. One side of the tablets is marked “R 1.25”.
The breaker is not there to divide the tablet into equal doses, but only to facilitate swallowing.
2.5 mg tablets:
The tablets are white, oblong, smooth, and oblique, with a notched edge on both sides. One side of the tablets is marked “R 2.5”.
The tablet can be divided into two equal doses.
5 mg tablets:
The tablets are white, oblong, smooth, and oblique, with a notched edge on both sides. One side of the tablets is marked “R 5”.
The tablet can be divided into two equal doses.
10 mg tablets:
The tablets are white, oblong, smooth, and oblique, with a notched edge on both sides. One side of the tablets is marked “R 10”.
The tablet can be divided into two equal doses.
The tablets are packed in aluminum/aluminum blisters and cardboard or packed in an HDPE jar with desiccant in the lid.
Pack sizes:
Blister: 14, 20, 28, 30, 50, 98, 100, 100×1, 250 tablets
HDPE can: 14, 20, 28, 30, 50, 98, 100, 250, 500 tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Hexal A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, D-39179, Barleben, Germany
or
LEK SA, Ul. Podlipie 16, 95-010 Strykow, Poland
or
LEK SA, Ul. Domaniewska 50 C, 02-672, Warsaw, Poland
or
Lek Pharmaceuticals dd, Verovskova 57, 1526 Ljubljana, Slovenia