Tertensif Sr

Leaflet accompanying the packaging: patient information

TERTENSIF SR

1.5 mg, prolonged-release tablets

Indapamide

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

• Please keep this leaflet, so that you can read it again if necessary.
• In case of 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 those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

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

2. Important information before taking Tertensif SR

When not to take Tertensif 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, known as hepatic encephalopathy;
• if the patient has low potassium levels in the blood.

Warnings and precautions

Before starting treatment with Tertensif 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 of the eye (choroidal effusion) or increased eye pressure,

which may occur within a few hours or weeks after taking Tertensif 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 muscle 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 low potassium or sodium levels, or high 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 consult their doctor or pharmacist. Athletes should be aware that Tertensif SR contains an active substance that may cause a positive result in anti-doping tests.

Tertensif SR and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient should not take Tertensif SR with lithium (used to treat depression) due to the risk of increased lithium levels in the blood. The patient should ensure that their doctor is informed about the 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, ibutilide, dofetilide, 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 injection);
• vinkamine injection (used to treat 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 medicines with analgesic properties (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 injection (a medicine used to treat fungal infections);
• oral 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);
• iodine-containing contrast agents (used during diagnostic tests with X-rays);
• calcium supplements or other calcium supplements;
• cyclosporine, tacrolimus, or other immunosuppressive medicines used after organ transplantation or to treat autoimmune diseases, severe rheumatic diseases, 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. The use of 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 inform their doctor that they are pregnant or plan to become pregnant. The active substance passes into human milk. The use of this medicine is not recommended during breastfeeding.

Driving and using machines

Tertensif SR may cause side effects related to low blood pressure, such as dizziness or fatigue (see section 4). These side effects occur more frequently 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.

Tertensif SR contains lactose monohydrate

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

3. How to take Tertensif SR

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult their doctor or pharmacist. The recommended dose is one tablet per day, preferably taken 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 high blood pressure is usually long-term. Patients with kidney function disorders The use of Tertensif SR is not recommended in patients with kidney function disorders. Patients with liver function disorders The use of Tertensif SR is not recommended in patients with liver function disorders. Elderly patients Tertensif SR may be used in elderly patients, provided they do not have kidney function disorders. Children and adolescents (up to 18 years old) The use of Tertensif SR is not recommended in children and adolescents.

Taking a higher dose of Tertensif 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 Tertensif SR

In case of missing a dose, the next dose should be taken as usual. A double dose should not be taken to make up for the missed dose.

Stopping treatment with Tertensif SR

Since treatment of high blood pressure usually lasts for life, the patient should consult their doctor before stopping treatment with Tertensif SR. In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Tertensif 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 immediately consult their doctor:

• 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 shortness of breath or difficulty 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);
• hepatitis (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 thrombocytopenia (decreased platelet count, which can cause easy bruising and nosebleeds), leukopenia (decreased white blood cell count, which can cause unexplained fever, sore throat, or flu-like symptoms - if these occur, the patient should consult their doctor) and anemia (decreased 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 collagen disease), 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 of the eye (choroidal effusion) or acute angle-closure glaucoma);
• changes in laboratory test results (blood tests) may occur, 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 or worsen its symptoms (joint pain or stiffness, especially in the feet);
• increased glucose levels in the blood 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 those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Tertensif SR

The medicine should be stored out of sight and reach of children. This medicine should not be used after the expiry date stated on the packaging after the abbreviation "EXP" (used to describe the expiry date). The expiry date refers to the last day of the month stated. The word "Lot" on the packaging means the batch number of the medicine. Store in a temperature below 30°C. 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 packaging and other information

What Tertensif SR contains

• The active substance of the medicine is indapamide. Each tablet contains 1.5 mg of indapamide.
• The other ingredients are:
• tablet core:hypromellose, lactose monohydrate, magnesium stearate, povidone, colloidal silica anhydrous.
• coating:glycerol, hypromellose, macrogol 6000, magnesium stearate, titanium dioxide (E 171).

What Tertensif SR looks like and contents of the packaging

Tertensif SR is a round, white, prolonged-release tablet. The tablets are available in packs of 30 tablets (1 blister of 30 or 2 blisters of 15), 60 tablets (2 blisters of 30), 90 tablets (5 blisters of 18), or 108 tablets (6 blisters of 18), packaged in a cardboard box.

Marketing authorization holder

Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France

Manufacturer

ANPHARM Pharmaceutical Company S.A., ul. Annopol 6 B, 03-236 Warsaw, Les Laboratoires Servier Industrie, 905 route de Saran, 45520 Gidy, France. For more detailed information, please contact the representative of the marketing authorization holder: Servier Polska Sp. z o.o., phone number: (22) 594-90-00

Date of last revision of the leaflet: 10/2021