PERINDOPRIL/INDAPAMIDE STADA 4 mg/1.25 mg TABLETS

2. What you need to know before taking Perindopril/Indapamide Stada

Do not take Perindopril/Indapamide Stada

• if you are allergic to perindopril, indapamide, or any of the other components of this medication (listed in section 6).
• if you are allergic to any other ACE inhibitor or diuretic (sulfonamides).

• if you have experienced swelling of the face, lips, mouth, tongue, or throat that can cause difficulty swallowing or breathing, in previous therapy with an ACE inhibitor. This is a condition called angioedema (Quincke's edema).

• Alternatively, if you or any member of your family has had these symptoms, inform your doctor as soon as possible.

• if you have heart problems or are taking medications (see "Other medications and Perindopril/Indapamide Stada").

• if you are pregnant for more than 3 months (it is also preferable to avoid Perindopril/Indapamide Stada in the first months of pregnancy, see "Pregnancy and lactation").

• if you are breastfeeding (see "Pregnancy and lactation").

• if you have kidney failure or are undergoing dialysis treatment.
• if you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.

• if you have severe liver damage or suffer from a condition called hepatic encephalopathy (a brain and nervous system disorder caused by severe liver damage).

• if your doctor has told you that you have low or high potassium levels in your blood.
• if you have taken or are currently taking sacubitril/valsartan, a medication used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in areas such as the throat) is high.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Perindopril/Indapamide Stada:

• if you have bilateral renal artery stenosis (narrowing of the main blood vessel that leads to the kidney) or a single functioning kidney.
• if you have diabetes.
• if you are following a low-salt diet or using salt substitutes that contain potassium.
• if you are taking lithium or potassium-sparing diuretics (e.g., spironolactone, triamterene).
• if you are taking a medication that is a combination with a potassium-sparing diuretic.
• if you are going to undergo surgery with general anesthesia, as you will need to stop treatment a few days before.
• if you have atherosclerosis (a disease of the arteries in which the blood vessels become thick and hard due to cholesterol deposits).
• if you are undergoing LDL apheresis (removal of cholesterol from your blood using a machine).
• if you are going to receive desensitization treatment to reduce the effects of an allergy (e.g., bee or wasp stings).
• if you are going to undergo a medical test that requires injecting a substance that allows organs such as the kidney or stomach to be visible with X-rays (iodinated contrast agent).
• if you have anemia (a condition in which the red blood cells in your body carry less oxygen, some symptoms of anemia are fatigue, headache, dizziness).
• if you have gout (a disease in which uric acid crystals cause joint swelling).
• if you suffer from a collagen disease such as systemic lupus erythematosus or scleroderma.
• you should inform your doctor if you think you are (or may be) pregnant. Perindopril/Indapamide Stada is not recommended at the start of pregnancy, and should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if taken during this period (see "Pregnancy and lactation").

• if you are taking any of the following medications used to treat high blood pressure (hypertension):

• an angiotensin II receptor antagonist (ARA) (also known as "sartans" - e.g., valsartan, telmisartan, irbesartan), particularly if you have diabetes-related kidney problems.
• aliskiren.

• if you are taking any of the following medications, the risk of angioedema (rapid swelling under the skin in areas such as the throat) may increase:

• racecadotril, a medication used to treat diarrhea
• medications used to prevent organ transplant rejection and cancer (e.g., temsirolimus, sirolimus, everolimus)
• vildagliptin, a medication used to treat diabetes

• if you experience a decrease in vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure, and can occur within a few hours to a few weeks after taking perindopril/indapamide. This can lead to permanent vision loss if not treated. You may be more likely to develop this if you have previously had an allergy to penicillin or sulfonamides.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading "Do not take Perindopril/Indapamide Stada".

Use in athletes

This medication contains indapamide, which may produce a positive result in doping tests.

Other medications and Perindopril/Indapamide Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

You should avoid taking Perindopril/Indapamide Stada with:

• lithium
• potassium supplements (including salt substitutes), potassium-sparing diuretics (e.g., spironolactone, triamterene, alone or in combination), and other medications that can increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medication used to thin blood to prevent clots).
• allopurinol (for the treatment of gout)
• procainamide (for the treatment of irregular heart rhythm)
• systemic corticosteroids (used to treat various disorders, including severe asthma and rheumatoid arthritis)
• other medications used to treat high blood pressure

Your doctor may need to adjust your dose and/or take precautions:

If you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings "Do not take Perindopril/Indapamide Stada" and "Warnings and precautions").

• immunosuppressants used to treat autoimmune disorders or after a transplant to prevent rejection (e.g., cyclosporine)

Treatment with Perindopril/Indapamide Stada may be affected by other medications. Tell your doctor if you are taking any of the following medications, as you may need special care:

• astemizole or terfenadine (antihistamines for spring allergic rhinitis or allergies)
• bepridil (used to treat angina pectoris - a feeling of discomfort in the chest)
• erythromycin injection, moxifloxacin, esparfloxacino (antibiotics)
• halofantrine (used to treat some types of malaria)
• pentamidine (used to treat pneumonia, a serious lung infection)
• vincamine (used to treat cerebral disorders in the elderly)
• baclofen (for the treatment of muscle stiffness that occurs in diseases such as multiple sclerosis)
• medications for the treatment of diabetes, such as insulin or metformin, or sulfonylureas
• non-steroidal anti-inflammatory drugs (e.g., ibuprofen) or high doses of salicylates (e.g., acetylsalicylic acid)
• medications that reduce potassium, e.g., amphotericin B (injectable, for the treatment of serious fungal infections), systemic glucocorticoids and mineralocorticoids, or laxative stimulants (e.g., senna)
• potassium-sparing diuretics (amiloride, spironolactone, triamterene)
• loop or thiazide diuretics
• medications for the treatment of irregular heart rhythm, such as quinidine, hydroquinidine, disopyramide, amiodarone, bretylium, dofetilide, ibutilide, and sotalol
• medications for the treatment of mental problems, such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants and neuroleptics, such as chlorpromazine, ciamemazine, levomepromazine, thioridazine, trifluoperazine, amisulpride, tiaprida, droperidol, haloperidol, pimozide)
• cisapride, difemanil, mizolastine
• methadone
• sultopride (used in the treatment of psychotic disorders)
• tetracosactide (for the treatment of Crohn's disease)
• calcium salts
• medications that are most often used to treat diarrhea (racecadotril) or prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other medications that belong to the class of mTOR inhibitors). See the "Warnings and precautions" section.

Taking Perindopril/Indapamide Stada with food and drinks

It is recommended to take Perindopril/Indapamide Stada in the morning on an empty stomach. Swallow the tablets with a glass of water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Pregnancy

You should inform your doctor if you think you are (or may be) pregnant. Your doctor will normally advise you to stop taking Perindopril/Indapamide Stada before becoming pregnant or as soon as you know you are pregnant, and will indicate that you take another medication instead of Perindopril/Indapamide Stada.

Perindopril/Indapamide Stada is not recommended at the start of pregnancy, and should not be taken after the first 3 months of pregnancy, as it may cause serious harm to your baby if taken during this period.

Breastfeeding

Tell your doctor if you are about to start or are breastfeeding. Perindopril/Indapamide Stada is not recommended in breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

Perindopril/Indapamide Stada has a minor or moderate influence on the ability to drive or use machines. This medication does not alter alertness, but reactions related to blood pressure lowering may occur in certain patients. It can cause dizziness or weakness. Your ability to drive or use machines may be affected, so caution is advised.

Perindopril/Indapamide Stada contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Perindopril/Indapamide Stada

Follow the administration instructions of this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. The dose may be increased based on your condition or other medications you are taking. Take Perindopril/Indapamide Stada orally only.

The recommended dose is:

High blood pressure:

It is recommended to take one Perindopril/Indapamide Stada 2 mg/0.625 mg tablet in the morning before breakfast. If your blood pressure is not controlled, your doctor may increase the dose to one Perindopril/Indapamide Stada 4 mg/1.25 mg tablet per day.

In elderly patients with high blood pressure:

It is recommended to take one Perindopril/Indapamide Stada 2 mg/0.625 mg tablet in the morning before breakfast.

If you take more Perindopril/Indapamide Stada than you should

If you take more Perindopril/Indapamide Stada than you should, or someone has taken your medication, contact your doctor or pharmacist immediately. The most common symptom in case of overdose is a decrease in blood pressure, symptoms may be dizziness, drowsiness, or nausea. It may help to lie down with your legs raised.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Perindopril/Indapamide Stada

Take the next dose at the usual time, unless it is the time for the next dose. Take your next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Perindopril/Indapamide Stada

If you stop taking Perindopril/Indapamide Stada, inform your doctor as soon as possible. Normally, treatment for high blood pressure is long-term.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Frequent (may affect up to 1 in 10 people)

• dry cough
• dry mouth
• constipation
• nausea
• stomach pain or discomfort
• loss of appetite
• loss of taste
• low potassium levels in the blood

Infrequent (may affect up to 1 in 100 people)

• low blood pressure
• headache
• dizziness when standing up
• dizziness
• mood changes
• sleep disturbances
• hypersensitivity reaction (allergic reaction)
• cramps
• paresthesia (hypersensitivity or tingling in hands and feet)
• depression
• low sodium levels in the blood that can cause dehydration and low blood pressure
• impotence (inability to have or maintain an erection)

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

• high calcium levels in the blood
• worsening of psoriasis
• acute kidney failure
• decreased or absent diuresis
• concentrated urine, feeling of discomfort (nausea) or being sick (vomiting), muscle cramps, confusion, and convulsions. These symptoms may be due to a disease called SIADH (inadequate secretion of antidiuretic hormone).
• facial flushing
• low chloride levels in the blood
• low magnesium levels in the blood

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

• thrombocytopenia: low platelet count in the blood. Symptoms may include bleeding or bruising more easily than normal.
• leukopenia or agranulocytosis: lack of white blood cells. Symptoms may include frequent infections such as fever, chills, sore throat, or mouth ulcers.
• aplastic anemia: a rare type of anemia with reduced red, white, and platelet count.
• hemolytic anemia: disease resulting from the destruction of red blood cells.
• anemia in patients after kidney transplant or on hemodialysis.
• pancreatitis: inflammation of the pancreas in case of liver failure.
• hepatic encephalopathy: brain and nervous system damage related to liver disease complications.

Unknown frequency (cannot be estimated from available data)

• color change, numbness, and pain in the fingers of the hands or feet (Raynaud's disease).
• decreased 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).

If a blood test needs to be performed, inform your doctor that you are taking Perindopril/Indapamida Stada, as the following may appear:

• high potassium levels
• high uric acid and glucose levels
• slightly elevated creatinine and urea levels

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of the medicine.

5. Conservation of Perindopril/Indapamida Stada

Keep this medicine out of sight and reach of children.

PVC/PVdC-Aluminum blisters:

Store in the original package to protect it from moisture.

When closed, this medicine does not require any special storage temperature.

Once the protective bag is opened, the blisters must be stored in the case at a temperature below 30°C. All unused tablets must be discarded 2 months after opening the protective bag.

Aluminum-Aluminum blisters:

Store in the original package to protect it from moisture. Store below 30°C.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Perindopril/Indapamida Stada

• The active ingredients are perindopril terbutylamine and indapamide. Each tablet contains 4 mg of perindopril terbutylamine equivalent to 3.338 mg of perindopril and 1.25 mg of indapamide.
• The other components are: lactose monohydrate, magnesium stearate, colloidal hydrophobic silica, and microcrystalline cellulose.

Appearance of the product and package contents

White capsules, with a capsule shape, engraved with "PI" on one side.

PVC/PVdC-Aluminum blisters:

The tablets are presented in PVC/PVdC-Aluminum blisters with an aluminum protective bag, including a desiccant to protect the tablets from moisture. Do not ingest the desiccant.

Aluminum/Aluminum blisters:

The tablets are presented in Aluminum/Aluminum blisters packaged in a cardboard case.

Package sizes: 30, 90, and 100

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

STADA Arzneimittel AG

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

This medicine is authorized in the EEE member states with the following names:

Bulgaria: Pontea

Spain: Perindopril/Indapamida Stada 4 mg/1.25 mg EFG tablets

Netherlands: Perindopril/Indapamide STADA 4/1.25 mg, tablets

Slovak Republic: PerindostadKombi 4 mg/1.25 mg tablets

Date of the last revision of this prospectus: March 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es