Symapamid sr

Package leaflet: Information for the patient

Symapamid 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 the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

Symapamid SR is a prolonged-release tablet containing indapamide as the active substance. Indapamide is a diuretic medicine. 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.
Symapamid SR is used in the treatment of high blood pressure (hypertension).

2. Important information before using Symapamid SR

When not to use 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 brain disorders caused by liver disease, known as hepatic encephalopathy;
• if the patient has low blood potassium levels.

Warnings and precautions
Before starting treatment with Symapamid SR, discuss with a doctor or pharmacist:

• if the patient has any 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 fluid accumulation between choroid and sclera) or increased intraocular pressure, which may occur within hours or weeks after taking Symapamid SR. If untreated, these symptoms may lead to permanent vision loss. If the patient previously had an allergy to penicillin or sulfonamides, the risk of developing these conditions is higher;
• if the patient has muscle disorders, including pain, tenderness, weakness, or muscle cramps;
• if the patient is scheduled for 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 conditions apply, or has questions or doubts about using this 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
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not use Symapamid SR together with lithium (used to treat depression) due to the risk of increased lithium blood levels.
Ensure the doctor is informed if the patient is taking any of the following medicines, as special caution may be required:

• medicines used to treat heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, 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 cognitive symptoms in elderly patients, including memory loss);
• halofantrine (an antiparasitic drug 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 drug 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 procedures);
• calcium tablets or other calcium supplements;
• cyclosporine, tacrolimus, or other immunosuppressive drugs 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 become pregnant, 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 if the patient is pregnant or planning pregnancy.
The active substance passes into human milk. Use of this medicine during breastfeeding is not recommended.

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

Symapamid SR contains monohydrate 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 Symapamid SR

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose is one tablet per day, 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 the tablet.
Treatment of hypertension is usually long-term.

Patients with impaired kidney function
Use of Symapamid SR is not recommended in patients with impaired kidney function.

Patients with impaired liver function
Use of Symapamid SR is not recommended in patients with impaired liver function.

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

Children and adolescents (under 18 years of age)
Use of Symapamid SR is not recommended in children and adolescents.

Taking more Symapamid SR than recommended
If too many tablets have been taken, consult a doctor or pharmacist immediately.
Very high doses of indapamide may cause nausea, vomiting, low blood pressure, muscle cramps,
dizziness, drowsiness, disorientation, and changes in the amount of urine produced by the kidneys.

Missing a dose of Symapamid SR
If a dose is missed, take the next dose as usual. Do not take a double dose to make up for the missed tablet.

Stopping Symapamid SR
Since treatment of high blood pressure usually lasts for life, contact your doctor before stopping the medicine.
If you have any further doubts 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 the patient experiences any of the following adverse reactions, which may be
severe, treatment must be discontinued immediately and the doctor should be contacted without delay:

• 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, causing shortness of breath or difficulty swallowing. If such symptoms occur, medical advice must be sought immediately (very rare – may occur in up to 1 in 10,000 patients);
• Severe skin reactions, including severe rash, redness of the entire body surface, intense itching, formation of blisters, 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 unknown);
• Pancreatitis, which may cause severe upper abdominal pain radiating to the back and general malaise (very rare – may occur in up to 1 in 10,000 patients);
• Brain disease caused by liver disorder (hepatic encephalopathy; frequency unknown);
• Hepatitis (frequency unknown);
• 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 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 individuals prone to allergies 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 (purpura);
• 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):

• Feeling of fatigue, headache, tingling (paresthesia), dizziness;
• Gastrointestinal disturbances (such as nausea, constipation), dryness of the mouth;
• 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 counts, 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), and anemia (reduced red blood cell count);
• Heart rhythm disturbances, low blood pressure;
• Kidney disease;
• Abnormal liver function.

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

• Fainting;
• In patients with systemic lupus erythematosus (a type of collagenosis), symptoms may worsen;
• Cases of photosensitivity reactions (skin changes) following 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 choroidal layer of 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 recommend blood testing. The following changes in laboratory results may occur:
• Increased serum uric acid levels, a substance which may cause or exacerbate gout (pain in joints, particularly in the feet);
• Increased blood glucose levels in patients with diabetes;
• High blood calcium levels;
• Increased liver enzyme activity;
• Abnormal electrocardiogram (ECG) findings.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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
Faks: + 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 to provide more information on the safety of the medicine.

5. How to store Symapamid SR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following
the abbreviation EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
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 packaging and other information

What Symapamid SR contains

• The active substance is indapamide. Each prolonged-release tablet contains 1.5 mg of indapamide.
• The other ingredients are: monohydrate lactose, gelatinized starch, corn starch, 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/aluminium).
Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel.: +48 22 822 93 06
Importer
Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
This medicinal product is authorised in the European Economic Area countries under the following names:
PL: Symapamid SR