SYMAPAMID 1.5 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Symapamid SR, 1.5 mg, prolonged-release tablets
   1. Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Symapamid SR and what is it used for
4. Important information before taking Symapamid SR
   1. When not to take Symapamid SR
   2. Warnings and precautions
   3. Symapamid SR and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Symapamid SR contains lactose monohydrate
5. How to take Symapamid SR
   1. Taking a higher dose of Symapamid SR than recommended
   2. Missing a dose of Symapamid SR
   3. Stopping treatment with Symapamid SR
6. Possible side effects
   1. If the patient experiences any of the following serious side effects, they should stop taking the medicine and contact their doctor immediately:
   2. Reporting side effects
7. How to store Symapamid SR
8. Contents of the pack and other information
   1. What Symapamid SR contains
   2. What Symapamid SR looks like and contents of the pack
   3. Marketing authorization holder
   4. Importer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: patient information

Symapamid SR, 1.5 mg, prolonged-release tablets

Indapamide

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Symapamid SR is a prolonged-release tablet containing indapamide as the active substance. Indapamide is a diuretic. Most diuretics increase the volume of urine excreted by the kidneys. However, indapamide differs from other diuretics in that it causes only a slight increase in urine volume.

Symapamid SR is used to treat high blood pressure (hypertension).

2. Important information before taking Symapamid SR

When not to take Symapamid SR

• 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 liver dysfunction-related brain disorders, known as hepatic encephalopathy;
• if the patient has low potassium levels in the blood.

Warnings and precautions

Before starting to take Symapamid SR, the patient should discuss it with their 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 vision disturbances or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased eye pressure, which may occur within a few hours or weeks of taking Symapamid SR. Untreated symptoms may lead to permanent vision loss. If the patient has previously been allergic to penicillin or sulfonamides, there is a higher risk of these disorders.
• if the patient has muscle disorders, including pain, tenderness, weakness, or cramps,
• if the patient is to undergo a test to assess parathyroid function.

The patient should inform their doctor if they experience a light-sensitive reaction.

The doctor may recommend tests to assess decreased potassium or sodium levels, or increased calcium levels.

If the patient thinks they may be affected by any of the above situations, or has questions or doubts about taking the medicine, they should contact their doctor or pharmacist.

Athletes should be aware that Symapamid SR contains an active substance that may cause a positive result in anti-doping tests.

Symapamid SR and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, or have recently taken, and about any medicines they plan to take.

Symapamid SR should not be taken at the same time as lithium (used to treat depression) due to the risk of increased lithium levels in the blood.

The doctor should be informed about the patient's use of the following medicines, as special caution may be necessary:

• medicines used to treat heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, digitalis preparations, bretylium);
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia [e.g., tricyclic antidepressants, antipsychotics, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol)];
• bepridil (used to treat coronary heart disease, which causes chest pain);
• cisapride, difemanil (used to treat gastrointestinal disorders);
• antibiotics used to treat bacterial infections (e.g., sparfloxacin, moxifloxacin, erythromycin given by injection);
• vincamine given by injection (used to treat symptomatic cognitive disorders in elderly patients, 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 medicines 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);
• amphotericin B given by injection (a medicine used to treat fungal infections);
• orally administered corticosteroids, used to treat various diseases, including severe asthma and rheumatoid arthritis;
• laxatives that stimulate peristalsis;
• baclofen (used to treat muscle stiffness, which occurs in diseases such as multiple sclerosis);
• allopurinol (used to treat gout);
• potassium-sparing diuretics (e.g., amiloride, spironolactone, triamterene);
• metformin (used to treat diabetes);
• contrast agents containing iodine (used during diagnostic tests using X-rays);
• calcium supplements or other calcium deficiency supplements;
• cyclosporine, tacrolimus, or other medicines that suppress the immune system after organ transplantation or used 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

This medicine is not recommended during pregnancy. When pregnancy is planned or confirmed, alternative treatment should be started as soon as possible. The patient should tell their doctor that they are pregnant or plan to become pregnant.

The active substance passes into human milk. This medicine is not recommended during breastfeeding.

Driving and using machines

Symapamid SR may cause side effects related to lowering blood pressure, such as dizziness or fatigue (see section 4). These side effects are more common at the beginning of treatment and after dose increases.

In such cases, the patient should avoid driving or performing other activities that require concentration.

However, these symptoms are rare if treatment is well controlled.

Symapamid SR contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Symapamid SR

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

The recommended dose is one tablet per day, taken preferably in the morning.

The tablets can be taken with or without food. The tablet should be swallowed whole with water. It should not be broken or chewed.

Treatment of hypertension is usually long-term.

Patients with kidney function disorders

Symapamid SR is not recommended for patients with kidney function disorders.

Patients with liver function disorders

Symapamid SR is not recommended for patients with liver function disorders.

Elderly patients

Symapamid SR can be used in elderly patients, provided they do not have kidney function disorders.

Children and adolescents (up to 18 years old)

Symapamid SR is not recommended for children and adolescents.

Taking a higher dose of Symapamid SR than recommended

In case of taking too many tablets, the patient should immediately consult their doctor or pharmacist.

Very high doses of indapamide may cause nausea, vomiting, low blood pressure, muscle cramps, dizziness, drowsiness, disorientation, and changes in urine production in the kidneys.

Missing a dose of Symapamid SR

If a dose is missed, the next dose should be taken as usual. A double dose should not be taken to make up for the missed tablet.

Stopping treatment with Symapamid SR

Since treatment of high blood pressure usually lasts for life, the patient should consult their doctor before stopping treatment with Symapamid SR.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Symapamid SR can cause side effects, although not everybody gets them.

If the patient experiences any of the following serious side effects, they should stop taking the medicine and contact their 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 respiratory tract, which can cause difficulty breathing or swallowing. If such symptoms occur, the patient should immediately consult their doctor (very rare - may occur in up to 1 in 10,000 patients);
• severe skin reactions, including severe rash, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, mucous membrane inflammation (Stevens-Johnson syndrome) or other allergic reactions (very rare - may occur in up to 1 in 10,000 patients);
• life-threatening heart rhythm disorders (frequency not known);
• pancreatitis, which can cause severe 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 caused by liver disease (hepatic encephalopathy; frequency not known);
• liver inflammation (frequency not known);
• muscle weakness, cramps, tenderness, or pain, especially if the patient feels unwell or has a high temperature, which may be caused by abnormal muscle breakdown (frequency not known).

Other side effects, grouped by decreasing frequency:

Common side effects (may occur in up to 1 in 10 patients):

• red, raised rash;
• allergic reactions, mainly affecting the skin, in people prone to allergies and asthmatic reactions;
• low potassium levels in the blood.

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

• vomiting;
• red spots on the skin (petechiae);
• low sodium levels in the blood, which can cause dehydration and low blood pressure;
• impotence (inability to achieve or maintain an erection).

Rare side effects (may occur in up to 1 in 1,000 patients):

• feeling tired, headache, tingling (paresthesia), dizziness;
• gastrointestinal disorders (such as nausea, constipation), dry mouth;
• low chloride levels in the blood;
• low magnesium levels in the blood.

Very rare side effects (may occur in up to 1 in 10,000 patients):

• changes in blood cell counts, such as low platelet count (thrombocytopenia, which can cause easy bruising and nosebleeds), low white blood cell count (leukopenia, which can cause unexplained fever, sore throat, or other flu-like symptoms - if these occur, the patient should consult their doctor) and anemia (reduced red blood cell count);
• heart rhythm disorders, low blood pressure;
• kidney disease;
• abnormal liver function.

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

• fainting;
• in case of systemic lupus erythematosus (a type of collagenosis), symptoms may worsen;
• there have also been reports of light-sensitive reactions (skin discoloration) after exposure to sunlight or artificial UVA radiation;
• myopia;
• blurred vision;
• vision disturbances;
• worsening vision or eye pain due to high pressure [possible symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or acute angle-closure glaucoma];
• changes in laboratory test results (blood tests) and the doctor may recommend a blood test. The following changes in laboratory test results may occur:
• increased uric acid levels, which can cause gout (joint pain or stiffness, especially in the feet);
• increased blood glucose levels in patients with diabetes;
• high calcium levels in the blood;
• increased liver enzyme activity;
• abnormal electrocardiogram (ECG) tracing.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products

Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych

Al. Jerozolimskie 181C

02-222 Warszawa

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Symapamid SR

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.

There are no special precautions for storing the medicine.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Symapamid SR contains

• The active substance of the medicine is indapamide. Each prolonged-release tablet contains 1.5 mg of indapamide.
• The other ingredients are: lactose monohydrate, cornstarch, hypromellose, colloidal anhydrous silica, magnesium stearate, macrogol 6000, titanium dioxide (E171).

What Symapamid SR looks like and contents of the pack

White, round, prolonged-release tablets.

30, 60, 90 prolonged-release tablets in blister packs (PVC/aluminum).

Marketing authorization holder

Farmak International Sp. z o.o.

ul. Koszykowa 65

00-667 Warszawa

tel.: +48 22 822 93 06

Importer

Farmak International Sp. z o.o.

ul. Chełmżyńska 249

04-458 Warszawa

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

PL: Symapamid SR

Date of last revision of the leaflet:July 2025