2.5 mg, 5 mg, 10 mg tablets
Ramipril
What Ramipril STADA is and what it is used for
Ramipril Stada contains a medicine called ramipril. It belongs to a group of medicines called ACE inhibitors ( Angiotensin Converting Enzyme Inhibitors).
Ramipril Stada works by:
- Reduce the 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 Stada 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 (regardless of 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 Stada 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 using Ramipril STADA
Do not take Ramipril Stada
- 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 Stada 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 breast-feeding” 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 Stada if any of the above apply to you. If you are not sure, talk to your doctor before taking Ramipril Stada.
Warnings and cautions
Talk to your doctor or pharmacist before taking Ramipril Stada:
- 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 Stada one day before surgery; Ask your doctor for advice.
- If you have high levels of potassium in your blood (shown by blood tests).
- If you are taking medicines or have a condition that can lower 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 (rapid swelling under the skin in areas such as the throat) 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.
- 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 – eg 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 Stada”.
You must tell your doctor if you think you are ( or will become ) pregnant. Ramipril Stada is not recommended during the first 3 months of pregnancy and may cause serious harm to your baby after the first three months of pregnancy (see section “Pregnancy and breastfeeding” below).
Children and young people
Ramipril Stada 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 Stada.
Other medicines and Ramipril STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ramipril Stada can affect the way other medicines work. Some medicines may also affect the way Ramipril Stada works.
Tell your doctor if you are taking any of the following medicines. They can make Ramipril Stada work worse:
- Drugs used to relieve pain and inflammation (non-steroidal anti-inflammatory drugs ( NSAIDs ) 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 Stada:
- Drugs used to relieve pain and inflammation (non-steroidal anti-inflammatory drugs ( NSAIDs ) 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 .
- Drugs that can increase the amount of potassium in your blood such as spironolactone, triamterene, amiloride, potassium salts, and heparin (blood thinners).
- Steroids are used in inflammation such as prednisolone.
- Allopurinol (used to reduce the amount of uric acid in your blood).
- Procainamide (used for heart rhythm disorders).
- An mTOR inhibitor (eg temsirolimus for the treatment of cancer, everolimus, or sirolimus to prevent rejection of transplanted organs), see section “Warnings and precautions”.
- Vildagliptin (used to treat type 2 diabetes ), see section “Warnings and precautions”.
- 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).
Tell your doctor if you are taking any of the following medicines. They may be affected by Ramipril Stada:
- Antidiabetic drugs such as oral glucose-lowering drugs and insulin. Ramipril Stada may reduce your blood sugar levels. Check your blood sugar levels carefully while you are taking Ramipril Stada.
- Lithium (used in mental illness). Ramipril Stada may increase the amount of lithium in your blood. Your lithium levels will need to be monitored closely by your doctor.
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 Stada” and “Warnings and precautions”).
Ramipril STADA with food, drink, and alcohol
- If you drink alcohol while taking Ramipril Stada, you may feel dizzy. If you are worried about how much you can drink while taking Ramipril Stada, talk to your doctor as alcohol may increase the effect of blood pressure-lowering medicines.
- Ramipril Stada can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you think you may be pregnant or become pregnant during treatment, consult your doctor.
You should not take Ramipril Stada 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 Stada, 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 Stada if you are breastfeeding.
Driving and using machines
You may feel dizzy when taking Ramipril Stada. This is more likely to happen when you start taking Ramipril Stada or if you start taking 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 STADA contains lactose and sodium
Ramipril Stada contains lactose and sodium
If you are hypersensitive to certain sugars, talk to your doctor before taking this medicine.
2.5 mg: This medicine contains 0.8 mg sodium (less than 1 mmol sodium (23 mg)) per tablet, ie essentially ‘sodium-free’. is next to “sodium free”.
5 mg: This medicine contains 1.44 mg sodium (less than 1 mmol sodium (23 mg)) per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.
10 mg: This medicine contains 2.89 mg sodium (less than 1 mmol sodium (23 mg)) per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Ramipril STADA
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
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.
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 Stada.
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 daily.
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.
If you take more Ramipril STADA than you should
If you have ingested too much medicine or if e.g. a child ingested the medicine accidentally 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 STADA
- 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/capsule
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 Stada 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 Stada.
- Severe skin reactions include 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 Stada 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
- abdominal 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 )
- altered or lost taste experience
- sleep disorders
- depression, anxiety, increased nervousness or restlessness
- nasal congestion, difficulty breathing, or worsening of asthma
- swelling in the stomach 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
- hot flashes
- 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 loosening of the nail from its attachment)
- skin rash or bruising
- blemishes 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
Has been reported (occurs in an unknown number of users):
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
- color change of fingers and toes in cold and then pain and creeps when warmed up (Raynaud’s phenomenon)
- enlarged breasts in men
- slowed or worsened reactions
- burning sensation
- change of sense of smell
- hair loss
- concentrated urine (dark color), nausea or vomiting, muscle cramps, confusion, and seizures that may be caused by insufficient secretion of ADH ( antidiuretic hormone ). If you get these symptoms, contact your doctor as soon as possible.
How to store Ramipril STADA
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 pack, jar, and carton after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Blister pack: Store in the original package.
Plastic jar: Close the jar tightly.
Keep the jar tightly closed.
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 pack and other information
Content declaration
- The active substance is ramipril 2.5 mg, 5 mg, or 10 mg.
- The other ingredients are sodium bicarbonate, lactose monohydrate, croscarmellose sodium, pregelatinized starch (maize), and sodium stearyl fumarate.
- The 2.5 mg tablets also contain yellow iron oxide (E 172). The 5 mg tablets also contain yellow iron oxide (E 172) and red iron oxide (E 172).
What the medicine looks like and the contents of the pack
- 2.5 mg tablet: a capsule-shaped, flat, yellow tablet with a scoreline on one side, marked R2.
- 5 mg tablet: a capsule-shaped, flat, pink tablet with a scoreline on one side, marked R3.
- 10 mg tablet: a capsule-shaped, flat, white tablet with a scoreline on one side, marked R4.
Pack sizes
Blister packs: 10, 14, 20, 28, 30, 42, 50, 56, 98, 100 and 105 tablets.
Plastic jars: 100 and 500 tablets (hospital packaging).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Actavis Ltd., BLB016, Bulebel Industrial Estate Zejtun ZTN 3000, Malta
Sanico NV, Industrial Zone IV, Veejijk 59, 2300 Turnhout, Belgium
Clonmel Healthcare Ltd., Waterford Road, Clonmel, Co. Tipperary, Ireland
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark