Teraxans

Patient Information Leaflet

TERAXANS 10 mg/2.5 mg film-coated tablets

perindopril arginine/indapamide
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What TERAXANS is and what it is used for
2. What you need to know before taking TERAXANS
3. How to take TERAXANS
4. Possible side effects
5. How to store TERAXANS
6. Contents of the pack and other information

1. What TERAXANS is and what it is used for

TERAXANS is a combination of two active substances, perindopril and indapamide. It is an antihypertensive used in the treatment of high blood pressure (hypertension). TERAXANS is indicated for patients who are already taking perindopril 10 mg and indapamide 2.5 mg separately, and who may instead take one tablet of TERAXANS containing both active substances.
Perindopril belongs to a class of medicines called ACE inhibitors. These medicines work by dilating blood vessels, making it easier for the heart to pump blood through them. Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics in that it causes only a slight increase in urine output. Each active substance reduces blood pressure, and together they act to control blood pressure.

2. What you need to know before taking TERAXANS

Do not take TERAXANS

• if you are allergic (hypersensitive) to perindopril or to any other ACE inhibitor, or to indapamide or to any other sulfonamide, or to any of the excipients of this medicine (listed in section 6),
• if you have experienced symptoms such as shortness of breath, facial or tongue swelling, intense itching or severe skin rashes related to previous treatment with ACE inhibitors, or if you or a family member has ever experienced such symptoms under any circumstances (a condition called angioedema),
• if you have diabetes or impaired renal function and are being treated with a blood pressure-lowering medicine containing aliskiren,
• if you have severe liver disease or suffer from a condition called hepatic encephalopathy (a degenerative brain disorder),
• if you have a kidney disease causing reduced blood flow to the kidneys (renal artery stenosis),
• if you are undergoing dialysis or any type of blood filtration. Depending on the equipment used, treatment with TERAXANS may not be suitable for you,
• if you have low plasma potassium levels,
• if you suspect you have untreated decompensated heart failure (severe fluid retention, breathing difficulties),
• if you are more than three months pregnant. (TERAXANS should also be avoided during early pregnancy – see section “Pregnancy”),
• if you are being treated with sacubitril/valsartan, a medicine used to treat heart failure (see information under “Warnings and precautions” and “Other medicines and TERAXANS”).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking TERAXANS:

• if you have aortic stenosis (narrowing of the main artery leaving the heart) or hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the artery supplying blood to the kidneys),
• if you suffer from heart failure or other heart problems,
• if you have kidney problems or are on dialysis,
• if you experience vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours or weeks of taking TERAXANS. If untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk,
• if you suffer from muscle disorders including muscle pain, tenderness, weakness, or cramps,
• if you have abnormally high levels of a hormone called aldosterone in your blood (primary hyperaldosteronism),
• if you have liver problems,
• if you have a collagen disease (a skin disorder) such as systemic lupus erythematosus or scleroderma,
• if you suffer from atherosclerosis (hardening of the arteries),
• if you suffer from hyperparathyroidism (overactivity of the parathyroid glands),
• if you suffer from gout,
• if you have diabetes,
• if you are on a low-salt diet or use salt substitutes containing potassium,
• if you are taking lithium or potassium-sparing medicines (spironolactone, triamterene) or potassium supplements; their use with TERAXANS should be avoided (see “Taking with other medicines”),
• if you are elderly,
• if you have experienced photosensitivity reactions,
• if you suffer from severe allergic reactions with swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema). This may occur at any time during treatment. If such symptoms develop, stop treatment and contact a doctor immediately,
• if you are taking any of the following medicines for high blood pressure:
• an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren. Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g. potassium) at regular intervals. See also section "Do not take TERAXANS".
• if you are of African descent, as you may have a higher risk of angioedema and this medicine may be less effective in lowering your blood pressure compared to non-black patients,
• if you are a patient undergoing hemodialysis with high-flux membranes,
• if you are taking any of the following medicines, which increase the risk of angioedema:
• racecadotril (used to treat diarrhoea),
• sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors (used to prevent organ transplant rejection),
• sacubitril (available as a fixed-dose combination with valsartan), used for long-term treatment of heart failure.

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat, causing difficulty swallowing or breathing) has been reported in patients treated with ACE inhibitors, including TERAXANS. This may occur at any time during treatment. If such symptoms develop, stop treatment with TERAXANS and contact a doctor immediately. See also section 4.
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). TERAXANS is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken during this period (see “Pregnancy and breastfeeding”).
If you are taking TERAXANS, inform your doctor or medical staff:

• if you are scheduled for anaesthesia and/or surgery,
• if you have recently had diarrhoea or vomiting, or if you are dehydrated,
• if you are scheduled for dialysis or LDL apheresis (blood purification to remove cholesterol using a machine),
• if you are undergoing desensitisation treatment to reduce the effects of allergy to bee or wasp stings,
• if you are scheduled for a medical examination requiring injection of an iodinated contrast medium (a substance that makes organs such as kidneys or stomach visible on X-rays),
• if you experience vision changes or pain in one or both eyes while taking TERAXANS. This could be a sign of developing glaucoma, increased pressure in one or both eyes. Stop treatment with TERAXANS and consult a doctor.

Athletes should be aware that TERAXANS contains an active substance (indapamide) that may lead to a positive result in anti-doping tests.
For athletes: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

Children and adolescents
TERAXANS must not be administered to children or adolescents.

Other medicines and TERAXANS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must not take TERAXANS with:

• lithium (used to treat manic disorder and depression),
• aliskiren (a medicine used to treat hypertension) if you have diabetes or kidney problems,
• potassium-sparing diuretics (triamterene, amiloride), potassium salts, or other medicines that may increase potassium levels in the blood (such as heparin and co-trimoxazole, also known as trimethoprim/sulfamethoxazole),
• estramustine (used in cancer therapy),
• other medicines used to treat high blood pressure: angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers.

Treatment with TERAXANS may be affected by other medicines. Your doctor may need to adjust your dose and/or take other precautions. Make sure to inform your doctor if you are taking any of the following medicines, as special monitoring may be required:

• other medicines for treating high blood pressure, including an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "Do not take TERAXANS" and "Warnings and precautions") or diuretics (medicines that increase urine production by the kidneys),
• potassium-sparing diuretics used in heart failure treatment: eplerenone and spironolactone at doses between 12.5 mg and 50 mg daily,
• medicines used mainly for treating diarrhoea (racecadotril) or for preventing organ transplant rejection (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors). See section “Warnings and precautions”,
• sacubitril/valsartan (used for long-term treatment of heart failure). See section "Do not take TERAXANS" and “Warnings and precautions”,
• anaesthetics,
• iodinated contrast agents,
• antibiotics used to treat bacterial infections (e.g. moxifloxacin, sparfloxacin, injectable erythromycin),
• methadone (used for addiction treatment),
• procainamide (for treating irregular heartbeat),
• allopurinol (for treating gout),
• antihistamines used to treat allergic reactions such as hay fever (e.g. mizolastine, terfenadine, astemizole),
• corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis,
• immunosuppressants used to treat autoimmune diseases or to prevent transplant rejection (e.g. cyclosporine, tacrolimus),
• halofantrine (used to treat certain types of malaria),
• pentamidine (used to treat pneumonia),
• injectable gold (used to treat rheumatoid arthritis),
• vincamine (used to treat symptomatic cognitive disorders in the elderly, including memory loss),
• bepridil (used to treat angina pectoris),
• medicines used to treat heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis, bretylium),
• cisapride, difenamizine (used to treat gastrointestinal and digestive problems),
• digoxin or other digitalis glycosides (for treating heart problems),
• baclofen (to treat muscle stiffness in conditions such as multiple sclerosis),
• medicines used to treat diabetes such as insulin, metformin or gliptins,
• calcium, including calcium supplements,
• stimulant laxatives (e.g. senna),
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high-dose salicylates (e.g. aspirin),
• injectable amphotericin B (for treating severe fungal infections),
• medicines used to treat mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, neuroleptics (e.g. amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol)),
• tetracosactide (for treating Crohn's disease),
• trimethoprim (for treating infections),
• vasodilators including nitrates (substances that widen blood vessels),
• medicines used to treat low blood pressure, shock, or asthma (e.g. ephedrine, noradrenaline or adrenaline).

TERAXANS with food and drinks
It is preferable to take TERAXANS before a meal.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking any medicine.

Pregnancy
Your doctor will normally advise you to stop taking TERAXANS before planning a pregnancy or as soon as you know you are pregnant, and will recommend an alternative medicine.
TERAXANS is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if taken beyond the third month.

Breastfeeding
TERAXANS is not recommended for breastfeeding mothers. Your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or was born prematurely.
Inform your doctor immediately.

Driving and using machines
TERAXANS does not affect alertness, but in some patients, side effects such as dizziness or fatigue may occur due to blood pressure reduction. If you experience such symptoms, your ability to drive or operate machinery may be impaired.

TERAXANS contains lactose (a type of sugar).
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

TERAXANS contains sodium
TERAXANS contains less than 1 mmol of sodium (23 mg) per tablet and is therefore essentially "sodium-free".

3. How to take TERAXANS

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet daily. Take the tablet preferably in the morning and before a meal. Swallow the tablet with a glass of water.
If you take more TERAXANS than you should
If you have taken an excessive amount of tablets, consult your doctor immediately or go immediately to the nearest emergency room. The most likely effect in case of overdose is a lowering of blood pressure. If a marked drop in blood pressure occurs (associated with nausea, vomiting, cramps, dizziness, drowsiness, confusion, changes in the amount of urine produced by the kidneys), it may help to lie down with your legs raised.
If you forget to take TERAXANS
It is important to take the medicine every day, as regular treatment is more effective. However, if you forget to take a dose of TERAXANS, take the next dose at your usual time. Do not take a double dose to make up for the missed dose.
If you stop taking TERAXANS
Since treatment for hypertension is usually lifelong, you must speak with your doctor before stopping this medicine.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, TERAXANS may cause side effects, although not everybody will experience them.
Stop taking the medicine immediately and contact your doctor straight away if you experience any of the following side effects, which may be serious:

• Severe dizziness or fainting due to low blood pressure (common) (up to 1 in 10),
• Bronchospasm (tightness of the chest, wheezing and breathlessness) (uncommon) (up to 1 in 100),
• Swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema) (see section 2 “Warnings and precautions”) (uncommon) (up to 1 in 100),
• Severe skin reactions including intense rash, hives, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome) or other allergic reactions (very rare) (up to 1 in 10,000),
• Cardiovascular disorders (irregular heartbeat, angina pectoris (chest, jaw and back pain caused by physical exertion)) (very rare) (up to 1 in 10,000),
• Weakness in arms or legs, or speech problems which could be signs of a possible stroke (very rare) (up to 1 in 10,000),
• Inflammation of the pancreas which may cause severe abdominal pain and backache accompanied by a general feeling of illness (very rare) (up to 1 in 10,000),
• Yellowing of the skin or eyes (jaundice) which may be a sign of hepatitis (very rare) (up to 1 in 10,000),
• Life-threatening irregular heartbeat (frequency not known),
• Brain disease caused by liver disease (hepatic encephalopathy) (frequency not known),
• Muscle weakness, cramps, tenderness or pain, particularly if at the same time you feel unwell or have a high fever, which may be due to abnormal muscle breakdown (frequency not known).

In decreasing order of frequency, the possible side effects include:

• Common (up to 1 in 10): Skin reactions in people predisposed to allergies and asthmatic reactions, headache, dizziness, vertigo, tingling, visual disturbances, tinnitus (ringing in the ears), cough, shortness of breath (dyspnea), gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, indigestion or difficulty digesting, diarrhea, constipation), allergic reactions (such as skin rashes, itching), cramps, feeling of fatigue,
• Uncommon (up to 1 in 100): Mood changes, sleep disorders, urticaria, purpura (small red spots on the skin), blistering rash, kidney disorders, impotence, sweating, increased eosinophils (a type of white blood cells), changes in laboratory parameters: high blood potassium levels (reversible upon discontinuation), low blood sodium levels, drowsiness, fainting, palpitations (awareness of heartbeat), tachycardia (rapid heartbeat), hypoglycemia (low blood sugar levels) in diabetic patients, vasculitis (inflammation of blood vessels), dry mouth, photosensitivity reactions (increased skin sensitivity to sunlight), arthralgia (joint pain), myalgia (muscle pain), chest pain, malaise, peripheral edema, fever, increased blood urea, increased blood creatinine, falls.
• Rare (up to 1 in 1,000): Worsening of psoriasis, changes in laboratory parameters: increased liver enzyme levels, elevated serum bilirubin levels, fatigue.
• Very rare (up to 1 in 10,000):

Confusion, eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked or runny nose),
severe kidney problems, changes in blood parameters such as reduced numbers of white and red blood cells, lower hemoglobin, reduced platelet count, elevated blood calcium levels, abnormal liver function.

• Not known (frequency cannot be estimated from the available data): Abnormal ECG pattern, changes in laboratory parameters: low potassium levels, high uric acid levels and high blood sugar levels, decreased vision (myopia), blurred vision, impaired vision, reduced vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), abnormal color, numbness and pain in fingers or toes (Raynaud's phenomenon). If you suffer from systemic lupus erythematosus (a connective tissue disease), this may worsen.

Hematological, renal, hepatic or pancreatic disorders and changes in laboratory parameters (blood tests) may occur. Your doctor may prescribe laboratory tests to monitor your condition.
With the use of ACE inhibitors, very concentrated (dark-colored) urine, sensation or state of malaise, muscle cramps, confusion and seizures may occur, probably due to inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor immediately.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE TERAXANS

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton and container.
The expiry date refers to the last day of the month.
Store the container tightly closed to protect the product from moisture.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TERAXANS contains

• The active substances are perindopril arginine and indapamide. One film-coated tablet contains 10 mg of perindopril arginine (equivalent to 6.79 mg of perindopril) and 2.5 mg of indapamide.
• The excipients contained in the tablet core are: monohydrate lactose, magnesium stearate (E470B), maltodextrin, anhydrous colloidal silica (E551), sodium starch glycolate (type A). The film coating contains: glycerol (E422), hypromellose (E464), macrogol 6000, magnesium stearate (E470B), titanium dioxide (E171).

Description of the appearance of TERAXANS and package contents
TERAXANS tablets are white, round, film-coated tablets with a diameter of 8 mm and a curvature radius of 11 mm. Each film-coated tablet contains 10 mg of perindopril arginine and 2.5 mg of indapamide.
Tablets are available in packages containing 14, 20, 28, 30, 50, 56, 60, 90, 100 or 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
I.F.B Stroder S.r.l
Via Luca Passi, 85
00166 Rome - Italy

Manufacturers
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy - France
and
Servier (Ireland) Industries Ltd
Gorey Road
Arklow - Co. Wicklow – Ireland
and
ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
ul. Annopol 6B
03-236 Warszawa – Poland

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium COVERSYL PLUS 10mg/2.5mg
Bulgaria TERTENSIF COMBI 10mg/2.5mg
France Perindopril arginine/Indapamide Servier 10mg/2.5mg film-coated tablet
Hungary Coverex-AS Komb Forte
Italy TERAXANS (10/2.5)
Latvia Perindopril arginine /Indapamide Servier 10 mg / 2.5 mg
Luxembourg COVERSYL PLUS 10mg/2.5mg
Poland TERTENSIF BI-KOMBI
Romania NORIPLEX 10mg/2.5mg
Slovakia PRESTARIUM FORTE COMBI A
Slovenia TertensifKomb 10mg/2.5mg film-coated tablets