Perindopril and indapamide Sandoz

Patient Information Leaflet

Perindopril and Indapamide Sandoz 2 mg/0.625 mg tablets, 4 mg/1.25 mg tablets, 8 mg/2.5 mg tablets

Generic medicine
Please read 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 only. Do not give it to others, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Perindopril and Indapamide Sandoz is and what it is used for

What is Perindopril and Indapamide Sandoz tablets?
Perindopril and Indapamide Sandoz is a combination of two active substances, perindopril and indapamide.
Perindopril and Indapamide Sandoz is an antihypertensive medicine used for the treatment of
high blood pressure (hypertension).

What are Perindopril and Indapamide Sandoz tablets used for?
Perindopril belongs to a class of medicines called angiotensin-converting enzyme (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 is different from other diuretics, as it causes only a slight increase in the amount of urine produced. Each of the two active substances reduces blood pressure, and they act together to control your blood pressure.

Perindopril and Indapamide Sandoz 8 mg/2.5 mg tablets
Perindopril and Indapamide Sandoz is indicated in patients who are already taking perindopril 8 mg and indapamide 2.5 mg tablets separately. These patients may instead take a single tablet of Perindopril and Indapamide Sandoz containing both active substances.

2. What you need to know before taking Perindopril and Indapamide Sandoz

Do not take Perindopril and Indapamide Sandoz

• if you are allergic to perindopril or any other ACE inhibitor, to indapamide or any other sulfonamide, or to any of the other ingredients of this medicine (listed in section 6),
• if you have experienced symptoms such as breathlessness, swelling of the face or tongue, intense itching, or severe skin rashes during previous treatment with ACE inhibitors, or if you or a family member have had these symptoms under other circumstances (a condition called angioedema),
• if you have severe liver disease or suffer from a condition called hepatic encephalopathy (a degenerative brain disorder),
• if you have severe kidney disease or if blood supply to the kidneys is reduced (renal artery stenosis),
• or if you are undergoing dialysis or any other type of blood filtration. Depending on the type of equipment used, Perindopril and Indapamide Sandoz may not be suitable for you,
• if you have high or low levels of potassium in your blood,
• if untreated decompensated heart failure is suspected (symptoms may include severe fluid retention and breathing difficulties),
• if you are more than 3 months pregnant (it is also advisable to avoid Perindopril and Indapamide Sandoz in early pregnancy – see section “Pregnancy and breastfeeding”),
• if you are breastfeeding,
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren,
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat). Only for Perindopril and Indapamide Sandoz 8 mg/2.5 mg tablets,
• if you suffer from moderate kidney disease.

Warnings and precautions
Talk to your doctor or pharmacist before taking Perindopril and Indapamide Sandoz tablets:

• if you suffer from aortic stenosis (narrowing of the main blood vessel 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 have heart failure or any heart problems,
• if you have kidney problems or are undergoing dialysis,
• if you have abnormally high levels of a hormone called aldosterone in your blood (primary hyperaldosteronism),
• if you suffer from liver problems,
• if you have a connective tissue disease (skin disease) such as systemic lupus erythematosus or scleroderma,
• if you suffer from atherosclerosis (hardening of the arteries),
• if you have hyperparathyroidism (overactive parathyroid gland),
• if you suffer from gout,
• if you have diabetes,
• if you are on a low-sodium diet or use salt substitutes containing potassium,
• if you are taking lithium or potassium-sparing diuretics (spironolactone, triamterene), as these should not be taken with Perindopril and Indapamide Sandoz tablets (see “Other medicines and Perindopril and Indapamide Sandoz”),
• if you are elderly,
• if you have experienced photosensitivity reactions while taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (ARB) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), particularly 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 Perindopril and Indapamide Sandoz”.
• if you are of Black origin, 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 dialysis membranes,
• if you are taking any of the following medicines, the risk of angioedema (rapid subcutaneous swelling in areas such as the throat) is increased:
• 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 and in cancer treatment),
• vildagliptin (a medicine used to treat diabetes).

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 Perindopril and Indapamide Sandoz. This may occur at any time during treatment. If you develop such symptoms, stop taking Perindopril and Indapamide Sandoz and contact a doctor immediately. See also section 4.
You must inform your doctor if you think you are (or might become) pregnant. Perindopril and Indapamide Sandoz is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used at this stage (see “Pregnancy and breastfeeding”).
When taking Perindopril and Indapamide Sandoz tablets, you must also inform your doctor or hospital staff:

• if you are scheduled for anaesthesia and/or surgery,
• if you have recently had diarrhoea or vomiting or are dehydrated,
• if you are undergoing dialysis or low-density lipoprotein (LDL) apheresis (removal of cholesterol from your blood via 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 agent (a substance that makes certain organs such as kidneys or stomach visible on X-rays),
• 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 pressure inside the eye and may occur from a few hours to weeks after taking Perindopril and Indapamide Sandoz. This could lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this symptom.
• Stop taking Perindopril and Indapamide Sandoz and consult a doctor.

For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Children and adolescents
Perindopril and Indapamide Sandoz must not be given to children or adolescents.

Other medicines and Perindopril and Indapamide Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Avoid using Perindopril and Indapamide Sandoz tablets with:

• lithium (used to treat depression),
• aliskiren (a medicine used to treat hypertension) if you do not have diabetes or kidney problems,
• potassium-sparing diuretics (such as triamterene, amiloride), potassium salts, or other medicines that may increase potassium levels in the body (including 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 Perindopril and Indapamide Sandoz may be affected by other medicines. Make sure to inform your doctor if you are taking any of the following medicines, as special caution may be required:

• other medicines for treating high blood pressure, including an angiotensin II receptor antagonist (ARB) or aliskiren (see also “Do not take Perindopril and Indapamide Sandoz” 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,
• sacubitril/valsartan (used to treat chronic heart failure). See section “Do not take Perindopril and Indapamide Sandoz” and “Warnings and precautions”,
• anaesthetic medicines,
• procainamide (for treating irregular heartbeat),
• allopurinol (for treating gout),
• terfenadine or astemizole, mizolastine (antihistamines for hay fever or allergies),
• corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis,
• immunosuppressants used to treat autoimmune diseases or to prevent organ transplant rejection (e.g. cyclosporine),
• cancer treatment medicines,
• injectable erythromycin, moxifloxacin, sparfloxacin (antibiotics),
• halofantrine (used to treat certain types of malaria),
• pentamidine (used to treat pneumonia),
• vincamine (used for symptomatic treatment of 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),
• digoxin or other cardiac glycosides (for treating heart problems),
• baclofen (for treating muscle stiffness occurring in diseases such as multiple sclerosis),
• medicines for treating diabetes such as insulin, metformin, or vildagliptin,
• calcium, including calcium supplements,
• stimulant laxatives (e.g. senna),
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high-dose salicylates (e.g. acetylsalicylic acid),
• parenteral amphotericin B (to treat serious fungal infections),
• medicines for treating mental disorders such as depression, anxiety, and schizophrenia (e.g. tricyclic antidepressants and neuroleptics such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol),
• tetracosactide (for treating Crohn’s disease),
• injectable gold preparations (used to treat rheumatoid arthritis),
• medicines mainly used to treat diarrhoea (racecadotril),
• medicines usually used to prevent organ transplant rejection (sirolimus, everolimus, and other mTOR inhibitors). See section “Warnings and precautions”,
• medicines used to treat low blood pressure, shock, or asthma (e.g. ephedrine, noradrenaline, or adrenaline).

Your doctor may consider it necessary to adjust your dose and/or take additional precautions:

• if you are taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also “Do not take Perindopril and Indapamide Sandoz” and “Warnings and precautions”).

Perindopril and Indapamide Sandoz with food and drinks
It is preferable to take Perindopril and Indapamide Sandoz tablets before a meal.

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

Pregnancy
You must inform your doctor if you think you are (or might become) pregnant. Your doctor will usually advise you to stop treatment with Perindopril and Indapamide Sandoz before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Perindopril and Indapamide Sandoz 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 baby if used beyond the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Perindopril and Indapamide Sandoz is contraindicated in breastfeeding mothers. If you wish to breastfeed, your doctor may choose an alternative treatment for you.

Driving and using machines
Perindopril and Indapamide Sandoz tablets usually do not affect reflexes, but in some patients, side effects such as dizziness or weakness related to low blood pressure may occur. If you experience such effects, your ability to drive or operate machinery may be impaired.

Perindopril and Indapamide Sandoz contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. How to take Perindopril and Indapamide Sandoz

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet once daily.
Your doctor may decide to adjust the dose if you have renal impairment.
It is preferable to take the tablet in the morning and before a meal.
Swallow the tablet with a glass of water.
If you take more Perindopril and Indapamide Sandoz than you should
If you take too many tablets, contact your doctor or the nearest
hospital emergency department immediately. The most likely effect of an overdose is low blood
pressure.
If a marked drop in blood pressure occurs (symptoms include dizziness and fainting),
it may help to lie down with your feet raised in the air.
If you forget to take Perindopril and Indapamide Sandoz
It is important to take the medicine every day, as regular treatment is more effective.
However, if you forget to take a dose of Perindopril and Indapamide Sandoz tablets, take the
next dose at your usual time. Do not take a double dose to make up for the forgotten dose.
If you stop taking Perindopril and Indapamide Sandoz
Since treatment for high blood pressure usually lasts a lifetime, you must speak to your
doctor before stopping the treatment.
If you have any questions about how to use 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.
Stop taking the medicine and contact your doctor immediately if you experience any of the following
side effects, which may be serious.

• Severe dizziness or fainting due to low blood pressure (Common – may affect up to 1 in 10 people),
• Bronchospasm (chest tightness, wheezing and shortness of breath) (Uncommon – may affect up to 1 in 100 people),
• Swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema) (See section 2 “Warnings and precautions”) (Uncommon – may affect up to 1 in 100 people),
• Severe skin reactions including erythema multiforme (a skin rash that often starts with itchy red spots on the face, arms and legs) or severe skin reaction, urticaria, redness of the skin all over the body, intense itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson Syndrome) or other allergic reactions (Very rare – may affect up to 1 in 10,000 people),
• Cardiovascular disorders (irregular heartbeat, angina pectoris (chest, jaw and back pain caused by physical exertion), heart attack) (Very rare – may affect up to 1 in 10,000 people),
• Weakness in arms or legs, or speech problems which could be signs of a possible stroke (Very rare – may affect up to 1 in 10,000 people),
• Inflammation of the pancreas which may cause severe abdominal pain and backache accompanied by feeling unwell (Very rare – may affect up to 1 in 10,000 people),
• Yellowing of the skin or eyes (jaundice) which may be a sign of hepatitis (Very rare – may affect up to 1 in 10,000 people),
• Life-threatening irregular heartbeat (Frequency not known),
• Brain disease caused by liver disease (hepatic encephalopathy) (Frequency not known).

The following side effects may occur:
Common (may affect up to 1 in 10 people):

• 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, gastrointestinal disorders (nausea, vomiting, abdominal pain, altered taste, dry mouth, dyspepsia or indigestion, diarrhoea, constipation), allergic reactions (e.g. skin rashes, itching), muscle cramps, feeling of fatigue.

Uncommon (may affect up to 1 in 100 people):

• Mood changes, sleep disturbances, urticaria, purpura (red spots on the skin), blistering rash, kidney problems, 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), hypoglycaemia (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 oedema, fever, increased blood urea, increased blood creatinine, falls.

Rare (may affect up to 1 in 1,000 people):

• Worsening of psoriasis, changes in laboratory parameters: increased liver enzyme levels, elevated serum bilirubin levels, fatigue.

Very rare (may affect up to 1 in 10,000 people):

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

Frequency not known (cannot be estimated from the available data):

• Abnormal electrocardiogram (ECG) readings, changes in laboratory parameters: low potassium levels, elevated uric acid levels and high blood sugar levels, decreased vision (myopia), blurred vision, visual impairment, decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
• If you suffer from systemic lupus erythematosus (a collagen disease), this may worsen.
• Abnormal colour, numbness and pain in fingers or toes (Raynaud's phenomenon).
• Blood, kidney, liver or pancreas disorders and changes in laboratory test parameters (blood tests) may occur. Your doctor may need to carry out blood tests to monitor your condition.

In case of liver impairment (liver problems), there is a possibility that hepatic encephalopathy (a degenerative brain disorder) may develop.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
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 Perindopril and Indapamide Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
Perindopril and Indapamide Sandoz 2 mg/0.625 mg tablets
Perindopril and Indapamide Sandoz 4 mg/1.25 mg tablets
Do not store above 25°C.
Keep in the original packaging to protect the medicine from moisture.
Perindopril and Indapamide Sandoz 8 mg/2.5 mg tablets
Do not store above 30°C.
Keep in the original packaging to protect the medicine from moisture.
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. Contents of the pack and other information

What Perindopril and Indapamide Sandoz contains
The active substances are perindopril tert-butylamine and indapamide.

• Perindopril and Indapamide Sandoz 2 mg/0.625 mg tablets: Each tablet contains 2 mg of perindopril tert-butylamine, equivalent to 1.67 mg of perindopril, and 0.625 mg of indapamide.
• Perindopril and Indapamide Sandoz 4 mg/1.25 mg tablets: Each tablet contains 4 mg of perindopril tert-butylamine, equivalent to 3.34 mg of perindopril, and 1.25 mg of indapamide.
• Perindopril and Indapamide Sandoz 8 mg/2.5 mg tablets: Each tablet contains 8 mg of perindopril tert-butylamine, equivalent to 6.68 mg of perindopril, and 2.5 mg of indapamide.

The other components are: calcium chloride dihydrate, lactose monohydrate, crospovidone, microcrystalline cellulose, sodium hydrogen carbonate, anhydrous colloidal silica, magnesium stearate. See section 2 “Perindopril and Indapamide Sandoz contains lactose and sodium”.

Description of the appearance of Perindopril and Indapamide Sandoz and the contents of the pack
Perindopril and Indapamide Sandoz 2 mg/0.625 mg tablets
This medicine is supplied as white to off-white, round, slightly biconvex tablets with bevelled edges, marked with a short breakline on one side.

Perindopril and Indapamide Sandoz 4 mg/1.25 mg tablets
This medicine is supplied as white to off-white, round, slightly biconvex tablets with bevelled edges and a breakline on one side. The breakline is intended to facilitate breaking the tablet for easier swallowing and does not allow division into equal doses.

Perindopril and Indapamide Sandoz 8 mg/2.5 mg tablets
This medicine is supplied as white to off-white, round, slightly biconvex tablets with a breakline on one side. The breakline on the tablet is intended to facilitate breaking the tablet for easier swallowing and does not allow division into equal doses.

The tablets are available in packs of 14, 20, 28, 30, 50, 56, 60, 90, 100 tablets in blister packs. Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This medicinal product is authorized in the European Economic Area countries under the following names: