Indix sr

Package leaflet: Information for the patient

INDIX SR
1.5 mg, prolonged-release tablets
Indapamidum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Indix SR is and what it is used for
2. Important information before taking Indix SR
3. How to take Indix SR
4. Possible side effects
5. How to store Indix SR
6. Contents of the pack and other information

1. What Indix SR is and what it is used for

Indix SR is a coated prolonged-release tablet containing indapamide as the active substance. Indapamide is a diuretic. Most diuretics increase the volume of urine produced by the kidneys. However, indapamide differs from other diuretics in that it causes only a slight increase in urine volume. Indix SR is used in the treatment of high blood pressure (hypertension).

2. Important information before using Indix SR

When not to use Indix SR:

• if the patient is allergic to indapamide, sulphonamides, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe kidney disease;
• if the patient has severe liver disease or a brain disorder caused by liver disease, known as hepatic encephalopathy;
• if the patient has low levels of potassium in the blood.

Warnings and precautions
Before starting treatment with Indix SR, discuss this with the doctor or pharmacist:

• if the patient has liver problems;

• if the patient has diabetes;

• if the patient has gout;

• if the patient has any heart rhythm disorders or kidney problems;

• if the patient experiences worsening of vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive accumulation of fluid between choroid and sclera) or increased eye pressure, which may occur within a few hours to a week after starting treatment with Indix SR. Untreated symptoms may lead to complete loss of vision. The risk of such disorders is higher in patients allergic to penicillin or sulphonamides.

• if the patient has muscle disorders, including pain, tenderness, weakness, or muscle cramps;

• if the patient is due to undergo tests assessing parathyroid function.

The patient should inform the doctor if they experience photosensitivity reactions.
The doctor may recommend tests to monitor decreased potassium or sodium levels, or increased calcium levels.
If the patient believes any of the above situations apply, or has questions or doubts about using the medicine, they should contact their doctor or pharmacist.
Athletes should be aware that Indix SR contains an active substance that may result in a positive doping test.

Indix SR and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Do not take Indix SR together with lithium (used to treat depression) due to the risk of increased lithium levels in the blood.
Ensure the doctor is informed about use of the following medicines, as special precautions may be necessary:

• medicines used to treat heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis preparations, bretylium);
• medicines used to treat psychiatric disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotics, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol));
• bepridil (used to treat ischemic heart disease causing chest pain);
• cisapride, difenoxin (used to treat gastrointestinal disorders);
• antibiotics used to treat bacterial infections (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin);
• intravenous vinpocetine (used to treat symptomatic cognitive disorders in the elderly, including memory loss);
• halofantrine (an antiparasitic medicine used to treat certain types of malaria);
• pentamidine (used to treat certain types of pneumonia);
• antihistamines used to treat allergic reactions such as hay fever (e.g. mizolastine, astemizole, terfenadine);
• non-steroidal anti-inflammatory drugs with analgesic effects (e.g. ibuprofen) or high doses of acetylsalicylic acid;
• angiotensin-converting enzyme (ACE) inhibitors (used to treat high blood pressure and heart failure);
• intravenous amphotericin B (a medicine used for fungal infections);
• oral corticosteroids, used to treat various diseases including severe asthma and rheumatoid arthritis;
• stimulant laxatives;
• baclofen (used to treat muscle stiffness occurring in diseases such as multiple sclerosis);
• allopurinol (used to treat gout);
• potassium-sparing diuretics (e.g. amiloride, spironolactone, triamterene);
• metformin (used to treat diabetes);
• iodine-containing contrast agents (used during diagnostic X-ray examinations);
• calcium tablets or other calcium supplements;
• cyclosporine, tacrolimus, or other immunosuppressive medicines used after organ transplantation or to treat autoimmune diseases or severe rheumatic or dermatological diseases;
• tetracosactide (used to treat Crohn's disease);
• methadone (used to treat addiction).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Use of Indix SR during pregnancy is not recommended. When pregnancy is planned or confirmed, alternative treatment should be initiated as soon as possible. Inform the doctor if the patient is pregnant or planning pregnancy.
Indapamide passes into breast milk. Use of this medicine during breastfeeding is not recommended.

Driving and operating machinery
Indix SR may cause adverse effects related to lowered blood pressure, such as dizziness or fatigue (see section 4). These adverse effects occur more frequently at the beginning of treatment or after dose increase.
In such cases, the patient should refrain from driving or performing other activities requiring concentration.
However, these symptoms are rare when treatment is well controlled.

Indix SR contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before starting this medicine.

3. How to use Indix SR

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
The recommended dose is one tablet daily, preferably taken in the morning.
The tablets may be taken independently of meals. The tablet should be swallowed whole with water.
Do not break or chew the tablet.
Treatment of high blood pressure is usually long-term.

Patients with impaired kidney function
Indix SR is not recommended for patients with impaired kidney function.

Patients with impaired liver function
Indix SR is not recommended for patients with impaired liver function.

Elderly patients
Indix SR may be used in elderly patients provided they do not have impaired kidney function.

Children and adolescents (under 18 years of age)
Indix SR is not recommended for use in children and adolescents.

Taking more Indix SR than recommended
If you have taken too many tablets, contact your doctor or pharmacist immediately.
Very high doses of indapamide may cause: nausea, vomiting, low blood pressure, muscle cramps,
dizziness, drowsiness, confusion, and changes in the amount of urine produced by the kidneys.

If you miss a dose of Indix SR
If you miss a dose, take the next dose as scheduled. Do not take a double dose to make up for
the missed dose.

Stopping Indix SR
Since treatment of high blood pressure is usually lifelong, you should consult your doctor before
stopping the medicine.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur in a patient, which may be
severe, stop taking the medicine and contact a doctor immediately:

• Angioedema and (or) urticaria. Angioedema is characterized by swelling of the skin of the limbs or face, lips or tongue, mucous membranes of the throat or airways, causing shortness of breath or difficulty swallowing. If such symptoms occur, seek medical advice immediately (very rare – may occur in up to 1 in 10,000 patients);
• Severe skin reactions, including severe rash, redness of the entire skin surface, intense itching, formation of blisters, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome) or other allergic reactions (very rare – may occur in up to 1 in 10,000 patients);
• Life-threatening heart rhythm disturbances (very rare – may occur in up to 1 in 10,000 patients);
• Pancreatitis, which may cause severe upper abdominal pain radiating to the back and very poor general condition (very rare – may occur in up to 1 in 10,000 patients);
• Liver disease-related brain disorder (hepatic encephalopathy; frequency unknown);
• Hepatitis (frequency unknown);
• Muscle weakness, cramps, tenderness or muscle pain, especially when the patient simultaneously feels unwell or has a high temperature, which may be due to abnormal muscle breakdown (frequency unknown).

Other adverse reactions, grouped by decreasing frequency of occurrence:
Common adverse reactions (may occur in up to 1 in 10 patients):

• Red, raised rash;
• Allergic reactions mainly affecting the skin, in patients with predisposition to allergic and asthmatic reactions;
• Low blood potassium levels.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• Vomiting;
• Red spots on the skin (petechiae);
• Low blood sodium levels, which may cause dehydration and low blood pressure;
• Impotence (inability to achieve or maintain an erection).

Rare adverse reactions (may occur in up to 1 in 1,000 patients):

• Dizziness, feeling excessively tired, tingling (paresthesia), headaches;
• Gastrointestinal disturbances (such as nausea, constipation), dryness of the oral mucosa;
• Low blood chloride levels;
• Low blood magnesium levels.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):

• Changes in blood cell composition, such as thrombocytopenia (reduced platelet count, leading to easy bruising and nosebleeds), leukopenia (reduced white blood cell count, which may cause unexplained fever, sore throat or other flu-like symptoms – if these occur, contact a doctor), agranulocytosis (absence of granulocytes in the blood), aplastic and hemolytic anemia (reduced red blood cell count);
• Heart rhythm disturbances, hypotension;
• Renal failure;
• Liver function disorders;
• Toxic epidermal necrolysis;
• Hypercalcemia (increased calcium levels in the blood).

Frequency not known (frequency cannot be estimated from available data):

• Fainting;
• Possible exacerbation of pre-existing systemic lupus erythematosus;
• Cases of photosensitivity reactions (skin changes) after exposure to sunlight or artificial UVA radiation have also been reported;
• Myopia;
• Blurred vision;
• Visual disturbance;
• Worsening of vision or eye pain due to high pressure (possible symptoms of fluid accumulation in the vascular membrane surrounding the eye – excessive fluid accumulation between choroid and sclera or acute angle-closure glaucoma);
• Changes in laboratory test results (blood tests) may occur, and your doctor may recommend blood testing. The following changes in laboratory results may occur:
• Increased uric acid levels, a substance which may cause or worsen gout (pain in joint or joints, especially in the feet);
• Increased blood glucose levels in patients with diabetes;
• Increased liver enzyme activity;
• Abnormal electrocardiogram (ECG) findings.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions
not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of using the medicine.

5. How to store Indix SR

Do not store this medicine above 30°C.
Keep the medicine in a place that is out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP"
(expiry date). The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Indix SR contains

• The active substance is indapamide. Each prolonged-release tablet contains 1.5 mg of indapamide.
• The other ingredients are: monohydrate lactose, copovidone, hypromellose, magnesium stearate, anhydrous colloidal silicon dioxide.

What Indix SR looks like and contents of the pack
Indix SR is white or almost white, round, biconvex tablets.
The tablets are packed in blisters placed in a cardboard box.
Pack sizes: 30, 60 or 90 tablets.
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
Emilii Plater 53 Street
00-113 Warsaw
tel.: (22) 345 93 00
Manufacturer
Teva Operations Poland Sp. z o.o.
Mogilska 80 Street
31-546 Kraków