Patient Information Leaflet

Perindopril/Indapamida Stada 4 mg/1.25 mg Tablets EFG

perindopril terbutilamine/indapamide

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

Perindopril/Indapamida Stada is an association of perindopril and indapamida. They belong to the group of anti-hypertensive medications, used for the treatment of high blood pressure.

Perindopril belongs to the group of medications called ACE inhibitors. They act by widening blood vessels, making it easier for the heart to pump blood through them.

Indapamida belongs to the group of medications called diuretics. They act by allowing the kidney to produce more urine than normal.

Each of the medications acts together with the other to reduce blood pressure and control it.

Do not take Perindopril/Indapamida Stada

• If you are allergic to perindopril, indapamida, or any of the other components of this medication (listed in section 6).
• If you are allergic to any other angiotensin-converting enzyme (ACE) inhibitor or diuretic (sulfonamides).

• If you have experienced swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing, in a previous therapy with an ACE inhibitor. This is a condition called angioneurotic edema (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/Indapamida Stada").

• If you are pregnant more than 3 months (it is also recommended to avoid Perindopril/Indapamida Stada in the early months of pregnancy, see "Pregnancy and lactation").

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

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

• If you have a severe liver disorder or suffer from a condition called hepatic encephalopathy (it is a disorder of the brain and nervous system caused by a severe liver disorder).

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

Warnings and precautions

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

• If you have bilateral renal artery stenosis (narrowing of the main blood vessel that leads to the kidney) or a single functional kidney.
• If you have diabetes.
• If you are following a low-sodium 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 undergoing surgery with general anesthesia, as you will need to stop treatment for a few days beforehand.
• If you have atherosclerosis (a disease of the arteries in which the blood vessels become thick and hardened due to cholesterol deposits).
• If you are undergoing LDL apheresis (removal of cholesterol from your blood using a machine).
• If you are undergoing desensitization treatment to reduce the effects of an allergy (e.g., bee or wasp stings).
• If you are undergoing 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 of your body transport less oxygen, some symptoms of anemia are fatigue, headache, dizziness).
• If you have gout (a disease in which uric acid crystals cause swelling of the joints).
• If you suffer from a collagen disease such as systemic lupus erythematosus or scleroderma.
• You should inform your doctor if you think you (or may be) pregnant. Perindopril/Indapamida Stada is not recommended at the beginning of pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause severe damage 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 "sartanes" - e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• 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:

-racecadotrilo, a medication used to treat diarrhea

• Medications used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).
• vildagliptina, a medication used to treat diabetes

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

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

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

Use in athletes

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

Other medications and Perindopril/Indapamida Stada

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

You should avoid taking Perindopril/Indapamida Stada with:

• Lithium
• Potassium supplements (including salt substitutes), potassium-sparing diuretics (e.g., spironolactone, triamterene), and other medications that may increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medication used to prevent blood clots).
• Alopurinol (for the treatment of gout)
• Procainamide (for the treatment of irregular heart rhythm)
• 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/Indapamida Stada" and "Warnings and precautions").

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

The treatment with Perindopril/Indapamida Stada may be affected by other medications. Inform your doctor if you are taking any of the following medications, as you may need special care:

• Astemizol or terfenadine (antihistamines for seasonal allergic rhinitis or allergies)
• Bepridil (used to treat angina pectoris - a feeling of discomfort in the chest)
• Erythromycin injectable, moxifloxacino, esparfloxacino (antibiotics)
• Halofantrina (used to treat certain types of malaria)
• Pentamidine (used to treat pneumonia, a severe lung infection)
• Vincamine (used to treat brain 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 sulfonamide hypoglycemics
• Nonsteroidal anti-inflammatory drugs (e.g., ibuprofen) or high doses of salicylates (e.g., aspirin)
• Medications that reduce potassium, e.g. amphotericin B (injectable, for the treatment of serious fungal infections), glucocorticoids, and mineralocorticoids (systemic), or laxatives (e.g., senna)
• Potassium-sparing diuretics (amiloride, spironolactone, triamterene)
• Diuretics of the loop or thiazide
• Medications for the treatment of irregular heart rhythm such as quinidine, hydroquinidine, disopyramide, amiodarone, bretylium, dofetilide, ibutilide, and sotalol
• Medications for treating mental disorders such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants and neuroleptics such as chlorpromazine, ciamemazine, levomepromazine, thioridazine, trifluoperazine, amisulpride, tiapride, droperidol, haloperidol, pimozide)
• Cisapride, difemanil, mizolastina
• Methadone
• Sultopride (used in the treatment of psychotic disorders)
• Tetracosactide (for the treatment of Crohn's disease)
• Calcium salts
• The medications most commonly used to treat diarrhea (racecadotrilo) or prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other medications belonging to the class of inhibitors of mTOR). See the section "Warnings and precautions".

Taking Perindopril/Indapamida Stada with food and drinks

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

Pregnancy and lactation

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

Pregnancy

You should inform your doctor if you think you (or may be) pregnant. Your doctor will usually recommend stopping Perindopril/Indapamida Stada before becoming pregnant or as soon as you know you are pregnant and will indicate that you take another medication instead of Perindopril/Indapamida Stada.

Perindopril/Indapamida Stada is not recommended at the beginning of pregnancy, and should not be taken after the first 3 months of pregnancy, as it may cause severe damage to your baby if taken during this period (see "Pregnancy and lactation").

Lactation

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

Driving and operating machines

Perindopril/Indapamida Stada has a minor or moderate effect on the ability to drive or operate machines. This medication does not alter the state of alertness, but reactions related to blood pressure drops may occur in certain patients. It may cause dizziness or weakness. Your ability to drive or operate machines may be affected, so you should be cautious.

Perindopril/Indapamida Stada contains lactose

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

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

The recommended dose is:

High blood pressure:

It is recommended to take one Perindopril/Indapamida 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/Indapamida Stada 4 mg/1.25 mg tablet per day.

In elderly patients with high blood pressure:

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

If you take more Perindopril/Indapamida Stada than you should

If you take more Perindopril/Indapamida 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 include dizziness, drowsiness, or nausea. It may help to lie down with your legs elevated.

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

If you forget to take Perindopril/Indapamida Stada

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

If you interrupt treatment with Perindopril/Indapamida Stada

If you interrupt treatment with Perindopril/Indapamida Stada, inform your doctor as soon as possible. Treatment for high blood pressure is usually long-term.

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

Like all medications, this medication may cause side effects, although not everyone will experience 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

Less frequent (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)
• muscle cramps
• paresthesia (numbness or tingling in hands and feet)
• depression
• low sodium levels in the blood that may cause dehydration and low blood pressure
• impotence (inability to achieve or maintain an erection)

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

• elevated calcium levels in the blood
• worsening of psoriasis
• acute kidney failure
• decreased or absent urine production
• concentrated urine, nausea, vomiting, muscle cramps, confusion, and seizures. These symptoms may be a sign of a condition called SIADH (inappropriate antidiuretic hormone secretion).
• 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 levels in the blood. Symptoms may include easy bruising or bleeding.
• leucopenia or agranulocytosis: low white blood cell count. Symptoms may include frequent infections such as fever, intense chills, sore throat, or mouth ulcers.
• aplastic anemia: a rare type of anemia with reduced red and white blood cells and platelets.
• hemolytic anemia: a disease resulting from the destruction of red blood cells.
• anemia in patients after a kidney transplant or on hemodialysis.
• pancreatitis: inflammation of the pancreas in cases of liver insufficiency.
• hepatic encephalopathy: brain and nervous system damage related to liver complications.

Unknown (frequency cannot be estimated from available data)

• change in color, numbness, and pain in the fingers of the hands or feet (Raynaud's disease).
• vision loss or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma)

If you need to have a blood test, inform your doctor that you are taking Perindopril/Indapamida Stada, as it may cause:

• high potassium levels
• elevated 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 does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of the medication.

Keep this medication out of the sight and reach of children.

PVC/PVdC-Aluminum Blister Packs:

Store in the original packaging to protect it from moisture.

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

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

Aluminum-Aluminum Blister Packs:

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Perindopril/Indapamida Stada

• The active principles are perindopril terbutilamine and indapamida. Each tablet contains 4 mg of perindopril terbutilamine equivalent to 3,338 mg of perindopril and 1.25 mg of indapamida.
• The other components are: lactose monohydrate, magnesium stearate, hydrophobic colloidal silica, and microcrystalline cellulose.

Appearance of the product and contents of the packaging

White tablets, in the shape of a capsule, engraved with “PI” on one side.

PVC/PVdC-Aluminum blisters:

The tablets are presented in PVC/PVdC-Aluminum blisters with an aluminum protective pouch, 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 box.

Packaging sizes: 30, 90, and 100

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer:

STADA Arzneimittel AG

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

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

Bulgaria:Pontea

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

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

Slovak Republic:PerindostadKombi 4 mg/1.25 mg Tablets

Last review date of this leaflet: March 2022

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