INDAPAMIDE NORMON 2.5 mg FILM-COATED TABLETS

2. What you need to know before taking Indapamide Normon

Do not take Indapamide Normon

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

Warnings and precautions

Consult your doctor or pharmacist before taking Indapamide 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 need to undergo a test to check if your parathyroid gland is working properly.
• 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 increased pressure in the eye and can occur within a few hours to a week after taking Indapamida. This can lead to permanent vision loss if left untreated. If you have previously had an allergy to penicillin or sulfonamide, you may be at 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 tests.

Use of Indapamide Normon with other medications

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

Do not take Indapamide 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, digitalis),
• 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),
• esparfloxacin, moxifloxacin, 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 some types of malaria),
• pentamidine (used to treat certain types of pneumonia),
• mizolastine (used to treat allergic reactions, such as pollen allergy),
• non-steroidal 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 (for the treatment of muscle stiffness that occurs in diseases such as multiple sclerosis),
• potassium-sparing diuretics (amiodarone, spironolactone, triamterene),
• metformin (for the treatment of diabetes),
• iodinated contrast agent (used for X-ray tests),
• calcium tablets or other calcium supplements,
• cyclosporin, tacrolimus, or other immunosuppressive medications used after a transplant, for the treatment of autoimmune diseases, or severe dermatological or rheumatological diseases,
• tetracosactide (for the treatment of Crohn's disease),
• allopurinol (for the treatment of gout).

Pregnancy and breastfeeding

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

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

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

Driving and using machines

This medication may cause side effects due to low blood pressure, such as dizziness or fatigue (see section 4). The occurrence of these side effects is more likely after starting treatment and after dose increases. If this happens, you should avoid driving or performing other activities that require alertness. However, when well-controlled, these effects are unlikely.

Indapamide Normoncontains lactose and sodium.

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, 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".

3. How to take Indapamide Normon

Follow the administration instructions for this medication exactly 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 morning.

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

Treatment for high blood pressure is usually for life.

If you take moreIndapamide Normon than you should

A very high dose of Indapamide Normon could cause nausea, vomiting, low blood pressure, 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Indapamide Normon

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

If you stop taking Indapamide Normon

Since treatment for high blood pressure is usually for life, 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.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Stop treatment with this medication and consult your doctor immediatelyif you experience any of the following side effects:

• Angioedema and/or urticaria. Angioedema is characterized by swelling of the skin of 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 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, redness of the skin all over the body, intense itching, blisters, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome) or other allergic reactions, (Very rare) (may affect up to 1 in 10,000 people).
• Life-threatening irregular heartbeat (Frequency not known).
• Pancreatitis, which 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) (Frequency not known).
• Hepatitis (inflammation of the liver) (Frequency not known).

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

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

• Redness of the skin.
• Allergic reactions, mainly dermatological in individuals with a predisposition to allergic and asthmatic reactions.
• Low blood potassium levels.

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

• Vomiting.
• Red spots on the skin (Purpura).
• Low blood sodium levels, which 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):

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

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

• Changes in blood cells, such as thrombocytopenia (decrease in platelet count, which favors the appearance of hematomas and nosebleeds), leukopenia (decrease in white blood cells, which can produce fever without apparent cause, sore throat, or other flu-like symptoms - if this occurs, contact your doctor) and anemia (decrease in red blood cells).
• Irregular heartbeat, low blood pressure.
• Kidney disease.
• Abnormal liver function.

Frequency not known:

• Fainting.
• If you have systemic lupus erythematosus (a type of collagen disease), it may worsen.
• Photosensitivity reactions (change in skin appearance) after sun exposure or artificial UVA radiation have also been described.
• Short-sightedness (myopia).
• Blurred vision.
• 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].
• Visual disturbance.
• Changes may be observed in your laboratory tests (blood tests), so your doctor may prescribe blood tests to monitor your condition. The following changes may be observed in your laboratory tests:
• • increased uric acid, a substance that can cause or worsen gout (joint pain, especially in the feet).
  • increased glucose levels in the blood in diabetic patients.
  • high calcium levels in the blood.
  • increased liver enzyme levels.
• Abnormal electrocardiogram.

Reporting side effects

If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Indapamide Normon

Do not store above 25°C.

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

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Indapamide Normon

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

The other ingredients are:

• tablet core: lactose, cornstarch, magnesium stearate (E470B), povidone, talc.
• film coating: titanium dioxide, white beeswax, glycerol, sodium lauryl sulfate, macrogol 6000, methylhydroxypropylcellulose, magnesium stearate.

Appearance of the product and package contents

This medication is a white, lenticular-shaped film-coated tablet.

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

Marketing authorization holder and manufacturer

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)

Date of last revision of this leaflet: October 2021

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

You can access detailed information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63368/P_63368.html