INDAPAMIDE 1.5 MG Tabletki o przedłużonym uwalnianiu

Treść ulotki

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

Indapamide Mylan Generics Italia

1.5 mg film-coated tablets with prolonged release
Generic Medicine
Read this leaflet carefully before taking this medicine as 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 pass it on to others even if they have the same symptoms as you, as it could be harmful. If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Indapamide Mylan Generics Italia and what is it used for

This medicine is used to reduce high blood pressure (hypertension) in adults.
It is a film-coated, prolonged-release tablet that contains 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 as 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 (brain disease)
• 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 problems or kidney problems

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• If you need a test to assess the functioning of the parathyroid glands
• If you have decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and can occur within a period ranging from a few hours to weeks after taking Indapamide Mylan Generics Italia. This can lead to permanent vision loss if left untreated. If you have previously had an allergy to penicillin or sulfonamides, you may be at greater risk of developing this.

You should inform your doctor if you have suffered from sensitivity to sunlight.
The doctor may prescribe blood tests to check if you have low levels of sodium or
potassium or high levels of calcium.
If you think that any of these situations apply to you or if you have any questions or doubts
regarding taking this medicine, you should consult your doctor or pharmacist.
For those who play sports: the use of the drug without a therapeutic need constitutes doping and may
still result in positive doping tests.
Athletes should be aware that this medicine contains an active ingredient that can give positive
results in doping tests.

Other medicines and Indapamide Mylan Generics Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
You should not take Indapamide Mylan Generics Italia with lithium (used to treat depression)
due to the risk of increasing 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 problems (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, neuroleptic drugs)
• Bepridil (used to treat angina pectoris, a condition that causes chest pain)
• Cisapride, difemanil (used to treat gastrointestinal problems)
• Sparfloxacin, moxifloxacin, erythromycin for injection (antibiotics used to treat infections)
• Vincamine for injection (used to treat symptomatic cognitive disorders in the elderly including memory loss)
• Alofantrine (antimalarial 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 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) Amphotericin B for injection (antifungal medicines) Page 2 of 6
• Oral corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis
• Stimulant laxatives
• Baclofen (for treating muscle stiffness that occurs in diseases such as multiple sclerosis)
• Allopurinol (for the treatment of gout)
• Potassium-sparing diuretics (amiloride, spironolactone, triamterene)
• Metformin (for treating diabetes)
• Iodinated contrast agents (used for X-ray tests),
• Calcium tablets or other calcium supplements
• Cyclosporine, tacrolimus or other medicines to suppress the immune system after organ transplantation, to treat autoimmune diseases or severe rheumatic or dermatological diseases
• Tetracosactide (for treating Crohn's disease)

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking any
medicine.
This medicine is not recommended during pregnancy. When a pregnancy is planned
or confirmed, you should start an alternative treatment as soon as possible.
Tell your doctor if you are pregnant or if you wish to become pregnant.
The active ingredient is excreted in breast milk. Breastfeeding is not recommended while taking
this medicine.

Driving and operating machinery
This medicine can cause side effects due to lowering blood pressure
such as dizziness or fatigue (see section 4). These side effects are more
likely if treatment is started for the first time or after dose increases. If
they occur, you should refrain from driving vehicles or operating machinery. However, if kept under
control, these side effects are unlikely to occur.

Indapamide Mylan Generics Italiacontains lactose monohydrate. If your
doctor has diagnosed you with intolerance to some sugars, contact him before taking this medicine.

3. How to take Indapamide Mylan Generics Italia

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.
The recommended dose is one tablet a 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 for life.

If you take more Indapamide Mylan Generics Italia than you should
If you have taken too many tablets, contact your doctor or pharmacist immediately.
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A very high dose of Indapamide Mylan Generics Italia can 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 have forgotten to take a dose of the medicine, take the next dose at the usual time.
Never take a double dose to make up for a missed dose.

If you stop taking Indapamide Mylan Generics Italia
Since treatment for high blood pressure usually lasts for life, before stopping
this medicine you must talk to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• Very rare (may affect up to 1 in 10,000 people)
• Angioedema and/or urticaria, severe skin manifestations. 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 airways resulting in difficulty breathing or swallowing. Severe skin reactions, including intense skin rashes, redness of the skin all over the body, severe itching, blisters, scaling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome).
• Inflamed pancreas which can cause severe abdominal and back pain accompanied by a feeling of severe malaise.
• Not known (frequency cannot be estimated based on available data)
• Inflammation of the liver (hepatitis)
• Brain pathology caused by liver problems (hepatic encephalopathy)
• Dangerous life-threatening irregular heartbeat (Torsade de Pointes - Torsades 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 and raised skin rashes,
• allergic reactions, mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions.
• Not common (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).
• Feeling of fatigue, dizziness, vertigo, headache, tingling (paresthesia)
• Gastrointestinal disorders (such as nausea and constipation), dry mouth
• Very rare (may affect up to 1 in 10,000):
• Changes in blood cells, such as thrombocytopenia (decrease in the number of platelets causing easy bruising and nosebleeds), leukopenia and agranulocytosis (decrease in white blood cells which can cause unexplained fever, sore throat and other flu-like symptoms - if this happens contact your doctor) and anemia (decrease in red blood cells)
• Elevated levels of calcium in the blood
• Irregular heartbeat (which can cause palpitations and the sensation of a racing heart), low blood pressure
• Kidney diseases (causing symptoms of fatigue, increased need to urinate, itchy skin, feeling unwell, swelling of the extremities)
• Altered liver function.
• Not known (frequency cannot be estimated based on available data)
• Fainting
• If you suffer from systemic lupus erythematosus (an autoimmune disorder that leads to inflammation and damage to joints, tendons and organs with symptoms including skin rashes, fatigue, loss of appetite, weight gain and joint pain), this could worsen
• Cases of photosensitivity reactions (change in skin appearance) have also been reported after exposure to sunlight or artificial ultraviolet (UVA) rays
• Disturbance of distant vision, blurred or reduced vision
• Changes in blood may occur and your doctor may subject you to blood tests to check your condition. The following changes in laboratory parameters may occur:
• low potassium levels in the blood,
• low sodium levels in the blood which can lead to dehydration and low blood pressure,
• 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,
• increased levels of enzymes produced by the liver.
• Changes in the electrocardiogram (ECG).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
consult your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
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 any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Indapamide Mylan Generics Italia contains
The active ingredient is indapamide.
The other ingredients are: lactose monohydrate, hypromellose, anhydrous colloidal silica, magnesium
stearate, titanium dioxide (E171), macrogol 6000, pregelatinized starch. See
section 2 “Indapamide Mylan Generics Italia contains lactose”

Description of the appearance of Indapamide Mylan Generics Italia and contents of the pack
Indapamide Mylan Generics Italia 1.5 mg film-coated prolonged-release
tabletsare white, round, film-coated tablets. They are available in blister packs of 10, 30, 90 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan

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 authorised in the Member States of the European Economic Area under the
following denominations:
France – Indapamide Mylan LP 1.5 mg film-coated prolonged-release tablet
Italy – Indapamide Mylan Generics Italia
United Kingdom – Tensaid XL 1.5 mg prolonged-release film-coated tablet
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