Leaflet: information for the patient

IndapamidaNormon2,5mg coated tabletsEFG

indapamida

Read this leaflet carefully before you start taking this medicine because 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 should not be given 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 informationadditional

Indapamida NORMON is presented in the form of a coated tablet containing indapamida as the active ingredient.

Indapamida is a diuretic. Most diuretics increase the amount of urine produced by the kidneys. However, indapamida is different from other diuretics, as it only produces a slight increase in the amount of urine formed.

This medicationis used to lower high blood pressure (hypertension) in adults.

Do not take Indapamida NORMON

• if you are allergic to indapamida or any other sulfonamide, or to any of the other components of this medication (listed in section 6),
• if you have a severe kidney disease,
• if you have a severe liver disease or suffer from a condition called hepatic encephalopathy (a degenerative brain disease),
• if you have low blood potassium levels.

Warnings and precautions

Consult your doctor or pharmacist before taking Indapamida NORMON

• if you have liver problems,
• if you have diabetes,
• if you have gout,
• if you have any heart rhythm problems or kidney problems,
• if you are undergoing a test to check if your parathyroid gland is functioning correctly.
• if you experience a decrease in vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur within a few hours to a week after taking Indapamida. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at a higher risk of developing it

You should inform your doctor if you have had photosensitivity reactions.

Your doctor may prescribe blood tests to check if you have low sodium or potassium levels, or high calcium levels.

Use in athletes

Athletes should be aware that this medication contains an active ingredient that can produce a positive result in doping control tests.

Use of Indapamida NORMON with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

You should not take Indapamida NORMON with lithium (used to treat depression) due to the risk of increased lithium levels in the blood.

Make sure to inform your doctor if you are using any of the following medications, as special care may be required:

• medications for heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitals),
• medications used to treat mental disorders such as depression, anxiety, schizophrenia… (e.g. tricyclic antidepressants, antipsychotics, neuroleptics),
• bepridil (used to treat angina pectoris, a disorder that causes chest pain),
• cisapride, difemanil (used to treat gastrointestinal problems),
• esparfloxacine, moxifloxacine, intravenous erythromycin (antibiotics used to treat infections),
• intravenous vincamine (used to treat cognitive disorders in elderly patients, including memory loss),
• halofantrine (antiparasitic used to treat certain types of malaria),
• pentamidine (used to treat certain types of pneumonia),
• mizolastine (used to treat allergic reactions, such as pollen allergy),
• nonsteroidal anti-inflammatory drugs for pain relief (e.g. ibuprofen) or high doses of acetylsalicylic acid,
• angiotensin-converting enzyme inhibitors (ACE inhibitors) (used to treat high blood pressure and heart failure),
• intravenous amphotericin B (antifungal medications),
• oral corticosteroids used in various treatments, including severe asthma and rheumatoid arthritis,
• stimulant laxatives,
• baclofen (used to treat muscle stiffness that occurs in diseases such as multiple sclerosis),
• potassium-sparing diuretics (amiodarone, spironolactone, triamterene),
• metformin (used to treat diabetes),
• iodinated contrast agents (used in X-ray tests),
• calcium tablets or other calcium supplements,
• ciclosporin, tacrolimus, or other immunosuppressive medications used after a transplant, to treat autoimmune diseases, or severe dermatological or rheumatological diseases,
• tetracosactide (used to treat Crohn's disease),
• allopurinol (used to treat gout).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using any medication.

This medication is not recommended during pregnancy. When pregnancy is planned or confirmed, the switch to an alternative treatment should be made as soon as possible. Inform your doctor if you are pregnant or plan to become pregnant.

The active ingredient is excreted in breast milk. If you are taking this medication, breastfeeding is not recommended.

Driving and operating machinery

This medication may cause adverse effects due to low blood pressure, such as dizziness or fatigue (see section 4). These adverse effects are more likely to occur after starting treatment and after dose increases. If this happens, you should refrain from driving or performing other activities that require alertness. However, when control is good, these effects are unlikely.

Indapamida NORMON contains lactose and sodium.

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day, preferably in the mornings.

Tablets should be swallowed whole with a glass of water. Do not break or chew them.

The treatment for high blood pressure is usually lifelong.

If you take moreIndapamida NORMON than you should

A very high dose of Indapamida NORMON could cause nausea, vomiting, low blood pressure, muscle cramps, dizziness, drowsiness, confusion, and changes in the amount of urine produced by the kidneys.

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

If you forgot to take Indapamida NORMON

If you forgot to take a dose of this medication, take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Indapamida NORMON

Since the treatment for high blood pressure is usually lifelong, you should talk to your doctor before stopping this medication.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking this medicine and seek immediate medical attentionif you experience any of the following side effects:

• Angioedema and/or urticaria. Angioedema is characterized by swelling of the skin on the extremities or face, swelling of the lips or tongue, swelling of the mucous membranes of the throat or respiratory tract causing difficulty breathing or difficulty swallowing. If this occurs, contact your doctor immediately. (Very rare) (may affect up to 1 in 10,000 people).
• Severe skin reactions including intense skin rash, body-wide skin redness, intense itching, blisters, peeling, and skin swelling, mucous membrane inflammation (Stevens-Johnson syndrome) or other allergic reactions, (Very rare) (may affect up to 1 in 10,000 people).
• Irregular heartbeat with life-threatening risk (Unknown frequency).
• Pancreatitis that can cause severe abdominal and back pain accompanied by intense discomfort (Very rare) (may affect up to 1 in 10,000 people).
• Brain disease caused by liver disease (Hepatic Encephalopathy) (Unknown frequency).
• Liver inflammation (Hepatitis) (Unknown frequency).

In decreasing order of frequency, other side effects may be:

Frequent(may affect up to 1 in 10 people):

• Skin rash with redness.
• Allergic reactions, mainly dermatological in individuals with a predisposition to allergic and asthmatic reactions.
• Low potassium levels in the blood.

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

• Vomiting.
• Red spots on the skin (Purpura).
• Low sodium levels in the blood that can cause dehydration and low blood pressure.
• Impotence (inability to achieve or maintain an erection).

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

• Feeling tired, headache, tingling (paresthesia), dizziness.
• Gastrointestinal disorders (such as nausea, constipation), dry mouth.
• Low chloride levels in the blood.
• Low magnesium levels in the blood.

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

• Changes in blood cells, such as thrombocytopenia (decreased platelet count, which favors the appearance of bruises and nasal bleeding), leucopenia (decreased white blood cell count, which can cause fever without apparent cause, sore throat, or other symptoms similar to the flu – if this occurs, contact your doctor) and anemia (decreased red blood cell count).
• Irregular heart rhythm, low blood pressure.
• Kidney disease.
• Abnormal liver function.

Unknown frequency:

• Loss of consciousness.
• If you have systemic lupus erythematosus (a type of collagen disease), it may worsen.
• Phototoxicity reactions (skin changes) have also been described after exposure to sunlight or artificial UVA radiation.
• Myopia (nearsightedness).
• Blurred vision.
• Decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma].
• Visual disturbance.
• You may observe changes in your laboratory tests (blood analysis), so your doctor may prescribe blood tests to monitor your condition. The following changes may be observed in your laboratory tests:
• • Increased uric acid levels, a substance that can cause or worsen gout (joint pain, especially in the feet).
  • Increased blood glucose levels in diabetic patients.
  • High calcium levels in the blood.
  • High liver enzyme levels.
• Abnormal electrocardiogram.

Reporting of side effects

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

Do not store at a temperature above 25°C.

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

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Composition of Indapamida NORMON

The active ingredient is indapamida. Each tablet contains 2.5mg of indapamida.

The other components are:

- tablet core: Lactose, cornstarch, magnesium stearate (E470B), polividone, talc.

- coating film: Titanium dioxide, beeswax, glycerol, sodium lauryl sulfate, macrogol 6000, methylhydroxypropylcellulose, magnesium stearate.

Appearance of the product and content of the packaging

This medication is a coated tablet with a white color and lenticular shape.

The tablets are available in blisters of 30 tablets packaged in a cardboard box.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

or

Les Laboratoires Servier Industrie

905 Route de Saran - 45520 Gidy (FRANCE)

Last review date of this leaflet: October 2021

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