Package leaflet: Information for the patient

Indapamide SR Genoptim, 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, as you may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Indapamide SR Genoptim is and what it is used for
What you need to know before taking Indapamide SR Genoptim
How to take Indapamide SR Genoptim
Possible side effects
How to store Indapamide SR Genoptim
Contents of the pack and other information

1. What Indapamide SR Genoptim is and what it is used for

Indapamide SR Genoptim is a prolonged-release tablet containing indapamide as the active substance. This medicine is used to lower high blood pressure (hypertension) in adults. Indapamide is a diuretic medicine. Most diuretics increase urine production by the kidneys. However, indapamide differs from other diuretics in that it causes only a slight increase in the amount of urine produced.
In addition, indapamide widens blood vessels, thereby improving blood flow. This helps to lower blood pressure.

2. Information before using Indapamide SR Genoptim

When not to use Indapamide SR Genoptim

if the patient is allergic to indapamide, sulfonamides, 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 brain disorder caused by liver disease, known as hepatic encephalopathy;
if the patient has low blood potassium levels.

Warnings and precautions
Before starting treatment with Indapamide SR Genoptim, discuss with your doctor or
pharmacist:

if the patient has liver problems;
if the patient has been diagnosed with diabetes;
if the patient has been diagnosed with gout;
if the patient has any heart rhythm disorders or kidney problems;
if the patient experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular membrane surrounding the eye (excessive fluid buildup between
the choroid and sclera) or increased pressure inside the eye – these may occur within
hours to weeks after taking Indapamide SR Genoptim. If left untreated, they may lead to permanent vision loss. The risk of these symptoms is higher in patients who previously had an allergic reaction to penicillin or
sulfonamides.
if the patient has muscle-related disorders, including pain, tenderness, weakness, or muscle cramps;
if the patient is scheduled for a test assessing parathyroid function.

Inform the doctor if the patient has a photosensitivity reaction.
The doctor may order blood tests to monitor decreased blood sodium or potassium levels, or
elevated blood calcium levels.
If the patient believes any of the above situations apply, or has any questions or
doubts about using this medicine, they should consult their doctor or
pharmacist.
Athletes should be aware that this medicine contains an active substance that may cause positive results in doping tests.

Indapamide SR Genoptim and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Do not use Indapamide SR Genoptim in combination with lithium (used to treat depression) due to the risk of increased lithium blood levels.
Ensure that the doctor has been informed about the use of any 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 (e.g. amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol));
bepridil (used to treat ischemic heart disease causing chest pain);
cisapride, difemanil (used to treat gastrointestinal disorders);
antibiotics used to treat bacterial infections (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin);
intravenous vinpocetine (used to treat cognitive symptoms in elderly patients, including memory loss);
halofantrine (an antiparasitic medicine used to treat various 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 (NSAIDs) used to relieve pain (e.g. ibuprofen) and high-dose acetylsalicylic acid;
angiotensin-converting enzyme (ACE) inhibitors (used to treat hypertension and heart failure);
intravenous amphotericin B (used to treat 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 in X-ray examinations);
calcium-containing medicines or other calcium-containing agents;
cyclosporine, tacrolimus, or other immunosuppressive medicines used after organ transplantation, or to treat autoimmune diseases, severe rheumatic or dermatological conditions;
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 this medicine during pregnancy is not recommended. When pregnancy is planned or confirmed, alternative treatment should be initiated as soon as possible. Inform the doctor
that the patient is pregnant or planning pregnancy.
The active substance is excreted in breast milk. Use of this medicine during breastfeeding is not recommended.

Driving and operating machinery
This medicine may cause adverse effects related to lowering blood pressure, such as
dizziness or fatigue (see section 4). These adverse effects may occur especially at the
beginning of treatment and after dose increase. If these effects occur, the patient should refrain from
driving and performing other activities requiring concentration.
However, with proper blood pressure control, the occurrence of these adverse effects is unlikely.

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

3. How to use Indapamide SR Genoptim

This medicine should always be taken according to the instructions provided by your doctor or pharmacist. In case of
doubt, consult your doctor or pharmacist.
The recommended dose is one tablet daily, preferably taken in the morning.
The tablets may be taken regardless of meals. The tablet should be swallowed whole with water. Do not break or chew it.
Treatment of high blood pressure is usually long-term.
Taking more Indapamide SR Genoptim than recommended
If too many tablets have been taken, contact your doctor or pharmacist immediately.
Very high doses of Indapamide SR Genoptim may cause nausea, vomiting, low blood pressure, muscle cramps,
dizziness, drowsiness, confusion, and changes in the amount of urine produced by the kidneys.
Missing a dose of Indapamide SR Genoptim
If a dose has been missed, take the next dose at the usual time.
Do not take a double dose to make up for the missed dose.
Stopping the use of Indapamide SR Genoptim
Treatment for high blood pressure usually lasts for the patient's entire life, therefore consult your doctor before
discontinuing the use of this medicine.
If you have any further doubts regarding 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 experiences them.
If the patient experiences any of the following adverse reactions, which may be
severe, treatment must be discontinued and immediate medical advice sought:

angioedema and (or) urticaria. Angioedema is characterised by swelling of the skin of the limbs or face, lips or tongue, or mucous membranes of the throat or airways, causing breathlessness or difficulty swallowing. If such symptoms occur, immediate medical attention must be sought (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, blistering, peeling and swelling of the skin, 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 (frequency not known);
pancreatitis, which may cause severe abdominal and back pain accompanied by a very poor general condition (very rare - may occur in up to 1 in 10,000 patients);
liver disease-related brain disorder (hepatic encephalopathy) (frequency not known);
hepatitis (frequency not known);
muscle weakness, cramps, tenderness or pain, particularly when the patient also feels unwell or has a high temperature, which may be due to abnormal muscle breakdown (frequency not known).

In decreasing order of frequency, other adverse reactions may include:
Common (may occur in up to 1 in 10 patients):

red, raised rash;
allergic reactions, mainly affecting the skin, in patients with a history of allergies and asthmatic reactions;
low blood potassium levels.

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

vomiting;
small 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 (may occur in up to 1 in 1,000 patients):

feeling of fatigue, headache; tingling or numbness (paresthesia), dizziness;
gastrointestinal disturbances (such as nausea, constipation), dry mouth;
low blood chloride levels;
low blood magnesium levels.

Very rare (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, medical advice should be sought), and anaemia (reduced red blood cell count);
increased blood calcium levels;
heart rhythm disturbances, low blood pressure;
kidney failure;
liver function disturbances.

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

fainting;
in patients with acute systemic lupus erythematosus (a rare inflammatory disease), symptoms of the disease may worsen during treatment;
photosensitivity reactions (skin changes) following exposure to sunlight or artificial UVA radiation;
myopia;
blurred vision;
visual disturbances;
reduced vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer 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 the doctor may order blood tests. The following changes in laboratory results may occur:
increased uric acid levels, a substance which may cause onset or worsening of gout (pain in joint or joints, particularly feet);
increased blood glucose levels in patients with diabetes;
high blood calcium levels;
increased activity of liver enzymes.
abnormal electrocardiogram (ECG) findings.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Adverse
reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Indapamide SR Genoptim

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the specified month.
No special precautions for storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Indapamide SR Genoptim contains

The active substance is indapamide. Each tablet of Indapamide SR Genoptim contains 1.5 mg of indapamide.
The other ingredients are: monohydrate lactose, hypromellose (Methocel K4M Premium), colloidal anhydrous silica, and magnesium stearate.
The tablet coating (Opadry II white 33G28707) contains: hypromellose 6cP (E464), titanium dioxide (E171), monohydrate lactose, macrogol 3000, and triacetin.

What Indapamide SR Genoptim looks like and contents of the pack
Indapamide SR Genoptim is white, round, biconvex tablets with an embossed "1.5" on one side and smooth on the other side.
Indapamide SR Genoptim is available in packs containing: 10, 14, 15, 20, 28, 30, 60, 90, 98 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw, Poland
Manufacturer
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary