Avancardo
Package leaflet: Information for the user
Avancardo 2.5 mg/0.625 mg film‑coated tablets
Perindopril arginine/indapamide hemihydrate
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 Avancardo is and what it is used for
2. What you need to know before you take Avancardo
3. How to take Avancardo
4. Possible side effects
5. How to store Avancardo
6. Contents of the pack and other information
1. What Avancardo is and what it is used for
Avancardo is a combination of two active ingredients, perindopril and indapamide. It is an antihypertensive and is used in the treatment of high blood pressure (hypertension).
Perindopril belongs to a class of medicines called ACE inhibitors. These work by widening the blood vessels, which makes it easier for your heart to pump blood through them. Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics, as it only causes a slight increase in the amount of urine produced. Each of the active ingredients reduces blood pressure and they work together to control your blood pressure.
2. What you need to know before you take Avancardo
Do not take Avancardo
- if you are allergic to perindopril or any other ACE inhibitor, or to indapamide or any other sulphonamides or any of the other ingredients of this medicine (listed in section 6).
- if you have experienced symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rashes with previous ACE inhibitor treatment or if you or a member of your family have had these symptoms in any other circumstances (a condition called angioedema).
- if you are more than 3 months pregnant (It is also better to avoid Avancardo in early pregnancy ‑ see “Pregnancy and breast‑feeding”).
- if you have a severe kidney disease or if you are receiving dialysis.
- if you have severe liver disease or suffer from a condition called hepatic encephalopathy (degenerative disease of the brain).
- if you have low potassium levels in your blood.
- if you are breast‑feeding.
- if you are suspected of having untreated decompensated heart failure (severe water retention, difficulty in breathing).
- if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren
Warnings and precautions
Talk to your doctor before taking Avancardo:
- if you suffer from a collagen disease (skin disease) such as systemic lupus erythematosus or scleroderma,
- if you have liver problems,
- if you have aortic stenosis (narrowing of the main blood vessel leading from the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney with blood),
- if you have any other heart problems or problems with your kidneys,
- if you have atherosclerosis (hardening of the arteries),
- if you suffer from hyperparathyroidism (overactive parathyroid gland),
- if you have diabetes,
- if you suffer from gout,
- if you are on a salt restricted diet or use salt substitutes which contain potassium,
- if you take lithium or potassium‑sparing diuretics (e.g. spironolactone, triamterene) as their use with Avancardo should be avoided (see “Other medicines and Avancardo”).
- 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 Avancardo”
In rare instances some patients have had severe allergic reactions after taking ACE inhibitors such as Avancardo. These reactions are more common in black people, and can result in an itchy rash and/or the swelling of the face, lips, tongue and throat (angioedema). Severe allergic reactions may also affect the gut and cause stomach pain (with or without nausea and vomiting) (intestinal angioedema).
You must tell your doctor if you think that you are (or might become) pregnant. Avancardo is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see “Pregnancy and breast‑feeding”).
If you develop a dry cough which is persistent for a long time, contact your doctor or pharmacist.
Avancardo may be less effective in lowering the blood pressure in black patients.
When you are taking Avancardo, you should also inform your doctor or the medical staff:
- if you are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings,
- if you are to undergo dialysis or LDL apheresis (which is removal of cholesterol from your blood by a machine),
- if you have had photosensitivity reactions,
- if you are to undergo anaesthesia and/or surgery,
- if you have recently suffered from diarrhoea or vomiting, or are dehydrated.
Athletes should be aware that Avancardo contains an active ingredient (indapamide hemihydrate) which may give a positive reaction in drug tests.
Children and adolecents
Avancardo should not be given to children.
Other medicines and Avancardo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You should avoid Avancardo with:
- lithium (used to treat depression),
- potassium‑sparing diuretics (spironolactone, triamterene), potassium salts.
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 Avancardo” and “Warnings and precautions”)
Treatment with Avancardo can be affected by other medicines. Make sure to tell your doctor if you are taking any of the following medicines as special care may be required:
- baclofen (to treat muscle stiffness occurring in diseases such as multiple sclerosis),
- non‑steroidal anti‑inflammatory drugs (e.g. ibuprofen) or high dose salicylates (e.g. aspirin),
- medicines to treat diabetes such as insulin or metformin,
- medicines used for heart rhythm problems (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol),
- medicines to treat mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, neuroleptics),
- sultopride (for the treatment of psychoses),
- bepridil (used to treat angina pectoris),
- cisapride or diphemanil (used for the treatment of gastro‑intestinal problems),
- erythromycin by injection (an antibiotic),
- halofantrine (used to treat certain types of malaria),
- moxifloxacin, pentamidine, sparfloxacin (used to treat infections),
- vincamine (used to treat symptomatic cognitive disorders in elderly including memory loss),
- methadone (used for the treatment of opioid (narcotic) dependence),
- terfenadine, astemizole or mizolastine (antihistamines for hay fever or allergies),
- amphotericin B by injection (to treat severe fungal disease),
- corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis,
- stimulant laxatives (e.g. senna),
- digoxin or other cardiac glycosides (for the treatment of heart problems),
- tetracosactide (to treat Crohn’s disease),
- allopurinol (for the treatment of gout),
- medicines for the treatment of cancer,
- immunosuppressants used for the treatment of auto‑immune disorders or following transplant surgery to prevent rejection (e.g. ciclosporin),
- procainamide (for the treatment of an irregular heart beat),
- other medicines for treating high blood pressure, including diuretics (medicines which increase the amount of urine produced by the kidneys),
- injectable gold (used to treat rhumatoid polyarthritis),
- iodine contrast media (agents used for imaging examinations),
- calcium including calcium supplements.
Avancardo with food and drink
It is preferable to take Avancardo before a meal.
Pregnancy, breast‑feeding and fertility
Pregnancy
You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking Avancardo before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Avancardo. Avancardo is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast‑feeding
Tell your doctor if you are breast‑feeding or about to start breast‑feeding. Avancardo is contraindicated for mothers who are breast‑feeding, and your doctor may choose another treatment for you if you wish to breast‑feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
Avancardo usually does not affect alertness but different reactions such as dizziness or weakness in relation to the decrease in blood pressure may occur in certain patients. If affected, your ability to drive or to operate machinery may be impaired.
Avancardo contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Avancardo
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one tablet once a day.
Your doctor may decide to increase the dose to 2 tablets daily or to modify the dosage regimen if you suffer from renal impairment.
Take your tablet preferably in the morning and before a meal. Swallow the tablet with a glass of water.
If you take more Avancardo than you should
If you take too many tablets, contact your doctor or emergency department immediately. The most likely effect in case of overdose is low blood pressure. If marked low blood pressure occurs (symptoms such as dizziness or faintness), lying down with your legs raised can help.
If you forget to take Avancardo
It is important to take your medicine every day as regular treatment is more effective. However, If you forget to take a dose of Avancardo, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Avancardo
As the treatment for high blood pressure is usually life‑long, you should discuss with your doctor before stopping this medicinal product.
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.
If you experience any of the following, stop taking the medicinal product at once and tell your doctor immediately:
- A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens‑Johnson syndrome), and a more severe form, causing extensive peeling of the skin (toxic epidermal necrolysis)
- Angioedema (symptoms include sudden wheeziness, swelling of the face or tongue)
- Severe dizziness or fainting (due to low blood pressure)
- Unusual fast or irregular heart beat.
In decreasing order of frequency, side effects can include:
Common (may affect up to 1 in 10 people):
- Pins and needles, headache, dizziness, vertigo
- Vision disturbances
- Tinnitus (sensation of noises in the ears)
- Light‑headedness due to low blood pressure
- Cough, shortness of breath
- Gastro‑intestinal disorders (nausea, epigastric pain, anorexia, vomiting, abdominal pain, taste disturbances, dry mouth, dyspepsia or difficulty of digestion, diarrhoea, constipation)
- Allergic reactions (such as skin rashes, itching)
- Muscle cramps
- Feeling of tiredness.
Uncommon (may affect up to 1 in 100 people):
- Mood swings, sleep disturbances
- Bronchospasm (tightening of the chest, wheezing and shortness of breath)
- Urticaria, allergic reactions, mainly dermatological, such as skin rashes, purpura (red pinpoints on skin) in subjects with a predisposition to allergic and asthmatic reactions, purpura (red pinpoints on skin), activation or worsening of systemic lupus erythematosus (a disease where the body´s immune system attacs the body, which causes joint pain, skin rashes and fever)
- Kidney problems
- Impotence
- Sweating.
Rare (may affect up to 1 in 1,000 people):
- High levels of calcium in the blood (hypercalcemia).
Very rare (may affect up to 1 in 10,000 people):
- Disorders of the blood, liver or pancreas
- Confusion
- Cardiovascular disorders (irregular heart beat, angina, heart attack)
- Eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked up or runny nose)
- Severe skin manifestations such as erythema multiforme. Cases of photosensitivity reactions (change in skin appearance) after exposure to the sun or artificial UVA have also been reported
- Kidney failure (symptoms may be lower back pain and reduction in the volume of urine passed).
Not known (frequency cannot be estimated from the available data):
- Fainting, life‑threatening irregular beat (Torsade de Pointes), abnormal ECG heart tracing, increased levels of liver enzymes
- Disorders of the blood and changes in laboratory parameters (blood tests) can occur. Your doctor may need to give you blood tests to monitor your condition
- In cases of hepatic insufficiency (liver problems), there is a possibility of onset of hepatic encephalopathy (degenerative disease in the brain).
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 listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Avancardo
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 label, carton or bottle after “EXP”. The expiry date refers to the last day of that month.
Do not store blister packs above 30° C
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 Avancardo contains
The active substances are
perindopril arginine and indapamide hemihydrate.
Each tablet contains 2.5 mg
perindopril arginine and 0.625 mg indapamide
hemihydrate.
- The other ingredients are:
Tablet core: Magnesium stearate, silica, hydrophobic colloidal, sodium starch glycolate, glycerol dibehenate, maltodextrin, lactose monohydrate
Film‑coating: Poly(vinyl)alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b)
What Avancardo looks like and contents of the pack
Avancardo 2.5 mg/0.625 mg film‑coated tablets are white, 8.5 mm x 4.3 mm oval and biconvex
Blister packs (OPA-Aluminium-PVC/Aluminium): 30, 60, 90 and 100 film‑coated tablets
Tablet container (HDPE): 30, 60, 90 and 100 film‑coated tablets
The tablet container contains two desiccants and is sealed with tamper evident foil and closed with child-resistant closure, do not eat the desiccant.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
<[To be completed nationally]>
<This medicinal product is authorised in the Member States of the EEA under the following names:>
<[To be completed nationally]>
This leaflet was last revised in 2015-11-24
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