Indapamide Mylan Generics Italia

Package leaflet: Information for the patient

Indapamide Mylan Generics Italia

1.5 mg prolonged-release film-coated tablets
Generic Medicine
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 other people, even if their symptoms are the same as yours, as 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 Indapamide Mylan Generics Italia is and what it is used for
2. What you need to know before taking Indapamide Mylan Generics Italia
3. How to take Indapamide Mylan Generics Italia
4. Possible side effects
5. How to store Indapamide Mylan Generics Italia
6. Contents of the pack and other information

1. What Indapamide Mylan Generics Italia is and what it is used for

This medicine is used to reduce high blood pressure (hypertension) in adults.
It is a prolonged-release film-coated tablet containing indapamide as the active substance.
Indapamide is a diuretic. Most diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics because it causes only a slight increase in the amount of urine produced.

2. What you need to know before taking Indapamide Mylan Generics Italia

Do not take Indapamide Mylan Generics Italia:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Indapamide Mylan Generics Italia:

• If you have liver problems.
• If you have diabetes.
• If you suffer from gout.
• If you have heart rhythm disorders or kidney problems.

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• If you need a test to assess the function of your parathyroid glands.
• If you experience decreased vision 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, which may occur from a few hours to weeks after taking Indapamide Mylan Generics Italia. This may lead to permanent loss of vision if not treated. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition.

You must inform your doctor if you have ever experienced sensitivity to sunlight.
Your doctor may prescribe blood tests to monitor whether you have low levels of sodium or potassium, or high levels of calcium.
If you think any of these conditions apply to you, or if you have any questions or doubts about taking this medicine, you should consult your doctor or pharmacist.
For individuals engaged in sports: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.
Athletes should be aware that this medicine contains an active substance that may lead to positive results in anti-doping tests.

Other medicines and Indapamide Mylan Generics Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
You must not take Indapamide Mylan Generics Italia with lithium (used to treat depression) due to the risk of increased lithium levels in the blood.
Remember to tell your doctor if you are taking any of the following medicines, as special care may be needed:

• Medicines used to treat heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis)
• Medicines used to treat mental disorders such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, antipsychotic drugs, neuroleptics)
• Bepridil (used to treat angina pectoris, a condition causing chest pain)
• Cisapride, difemanil (used to treat gastrointestinal problems)
• Sparfloxacin, moxifloxacin, injectable erythromycin (antibiotics used to treat infections)
• Injectable vincamine (used to treat symptomatic cognitive disorders in the elderly, including memory loss)
• Halofantrine (an antiparasitic used to treat certain types of malaria)
• Pentamidine (used to treat certain types of pneumonia)
• Mizolastine (used to treat allergic reactions, such as hay fever)
• Non-steroidal anti-inflammatory drugs (NSAIDs) used to relieve pain (e.g., ibuprofen) or high doses of acetylsalicylic acid
• Angiotensin-converting enzyme (ACE) inhibitors (used to treat high blood pressure and heart failure)
• Injectable amphotericin B (antifungal medicines) Page 2 of 6
• Oral corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis
• Stimulant laxatives
• Baclofen (to treat muscle stiffness occurring in diseases such as multiple sclerosis)
• Allopurinol (for the treatment of gout)
• Potassium-sparing diuretics (amiloride, spironolactone, triamterene)
• Metformin (for treating diabetes)
• Iodinated contrast media (used in X-ray tests)
• Calcium tablets or other calcium supplements
• Cyclosporine, tacrolimus, or other medicines used to suppress the immune system after organ transplantation, or to treat autoimmune diseases or severe rheumatic or dermatological conditions
• Tetracosactide (for treating Crohn’s disease)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking any medicine.
This medicine is not recommended during pregnancy. When pregnancy is planned or confirmed, switching to an alternative treatment should begin as soon as possible.
Inform your doctor if you are pregnant or intend to become pregnant.
The active substance is excreted in breast milk. Breastfeeding is not recommended while taking this medicine.

Driving and using machines
This medicine may cause side effects related to low blood pressure, such as dizziness or fatigue (see section 4). These side effects are more likely when starting treatment for the first time or after dose increases. If they occur, you must refrain from driving or operating machinery. However, once these effects are under control, it is unlikely they will interfere with such activities.

Indapamide Mylan Generics Italia contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Indapamide Mylan Generics Italia

Take this medicine exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is one tablet per day, preferably in the morning.
The tablets can be taken with or without food. They must be swallowed whole with water. Do not break or chew them.
Treatment for high blood pressure is usually lifelong.
If you take more Indapamide Mylan Generics Italia than you should
If you have taken too many tablets, contact your doctor or pharmacist immediately.
A very high dose of Indapamide Mylan Generics Italia may cause nausea, vomiting,
hypotension, cramps, dizziness, drowsiness, confusion, and changes in the amount of urine
produced by the kidneys.
If you forget to take Indapamide Mylan Generics Italia
If you forget to take a dose of the medicine, take the next dose at your usual time.
Never take a double dose to make up for a forgotten dose.
If you stop taking Indapamide Mylan Generics Italia
Since treatment for high blood pressure is usually lifelong, you must talk to your doctor before stopping
this medicine.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

  • Angioedema and/or urticaria, severe skin reactions. Angioedema is characterised 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 airways leading to difficulty breathing or swallowing. Severe skin reactions, including intense rashes, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome).
  • Inflamed pancreas which may cause severe abdominal and back pain accompanied by a strong feeling of illness.

• Not known (frequency cannot be estimated from the available data)

  • Inflammation of the liver (hepatitis)
  • Brain disorder caused by liver problems (hepatic encephalopathy)
  • Life-threatening irregular heartbeat (Torsade de Pointes)
  • Decreased vision or eye pain may be possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma

Other side effects include:

• Common (may affect up to 1 in 10 people):

  • Reddish, raised skin rashes,
  • Allergic reactions, mainly dermatological, in subjects predisposed to allergic and asthmatic reactions.

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

  • Vomiting
  • Red spots on the skin (purpura)

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

  • Feeling of tiredness, dizziness, vertigo, headache, tingling sensations (paresthesia)
  • Gastrointestinal disorders (such as nausea and constipation), dry mouth

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

  • Changes in blood cells, such as thrombocytopenia (reduced platelet count causing easy bruising and nosebleeds), leucopenia and agranulocytosis (reduced white blood cells which may cause unexplained fever, sore throat and other flu-like symptoms – if this occurs, contact your doctor), and anaemia (reduced red blood cells)

  • High levels of calcium in the blood

  • Irregular heart rhythm (which may cause palpitations and sensation of a pounding heartbeat), low blood pressure

  • Kidney disease (causing symptoms such as fatigue, increased need to urinate, skin itching, feeling unwell, swelling of the extremities)

  • Altered liver function

  • Not known (frequency cannot be estimated from the available data)

  • Fainting

  • If you suffer from systemic lupus erythematosus (an immune system disorder causing inflammation and damage to joints, tendons and organs, with symptoms including skin rashes, fatigue, loss of appetite, weight gain and joint pain), this condition may worsen

  • Cases of photosensitivity reactions (changes in skin appearance) after exposure to sunlight or artificial ultraviolet (UVA) radiation have also been reported

  • Difficulty seeing distant objects (myopia), blurred or reduced vision

  • Blood changes may occur and your doctor may carry out blood tests to monitor your condition. The following laboratory test changes may occur:

    • low potassium levels in the blood,
    • low sodium levels in the blood which may lead to dehydration and low blood pressure,
    • increased uric acid levels, a substance that may cause or worsen gout (joint pain, particularly in the feet),
    • increased blood glucose levels in diabetic patients,
    • increased levels of liver enzymes.

  • Changes in the electrocardiogram (ECG) trace.

Reporting of side effects
If you experience any side effect, 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 the following website:
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 Indapamide Mylan Generics Italia

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Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp”. The
expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Indapamide Mylan Generics Italia contains
The active substance is indapamide.
The other components are: monohydrate lactose, hypromellose, anhydrous colloidal silica, magnesium stearate, titanium dioxide (E171), macrogol 6000, pregelatinized maize starch. See section 2 “Indapamide Mylan Generics Italia contains lactose”.
Description of the appearance of Indapamide Mylan Generics Italia and pack sizes
Indapamide Mylan Generics Italia 1.5 mg prolonged-release film-coated tablets are white, round, film-coated tablets. They are available in blister packs containing 10, 30, 90 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder:
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan, Italy
Manufacturer:
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 - Ireland
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary.
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
France – Indapamide Mylan LP 1.5 mg comprimé pelliculé à libération prolongée
Italy – Indapamide Mylan Generics Italia
United Kingdom – Tensaid XL 1.5 mg prolonged-release film-coated tablet
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