Tertensif sr

Package leaflet: Information for the patient

TERTENSIF SR
1.5 mg, prolonged-release coated 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
• 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 Tertensif SR is and what it is used for
2. What you need to know before taking Tertensif SR
3. How to take Tertensif SR
4. Possible side effects
5. How to store Tertensif SR
6. Contents of the pack and other information

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

Tertensif SR is a prolonged-release coated 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. Tertensif SR is used in the treatment of high blood pressure (hypertension).

2. Important information before using Tertensif SR

When not to use Tertensif 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, called hepatic encephalopathy;
• if the patient has low blood potassium levels.

Warnings and precautions
Before starting treatment with Tertensif SR, discuss with a 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 choroid layer of the eye (choroidal effusion) or increased intraocular pressure,

which may occur within hours or weeks after taking Tertensif SR. Untreated
symptoms may lead to permanent vision loss. If the patient previously had an allergic reaction to
penicillin or sulphonamides, there is a higher risk of developing these disorders.

• 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.

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 this medicine, they should contact their doctor or pharmacist.
Athletes should be aware that Tertensif SR contains an active substance that may
lead to a positive result in anti-doping tests.

Tertensif SR and other medicines
Tell the doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Do not take Tertensif 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, 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, difenamid (used to treat gastrointestinal disorders);
• antibiotics used to treat bacterial infections (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin);
• vinpocetine administered 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 painkillers (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 administered by injection (a medicine used for fungal infections);
• oral corticosteroids used to treat various diseases, including severe asthma and rheumatoid arthritis;
• stimulant laxatives that increase peristalsis;
• baclofen (used to treat muscle stiffness occurring in conditions 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 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 become pregnant, she should consult a 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
Tertensif 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.

Tertensif 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 Tertensif SR

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in 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. Swallow the tablet whole with water. Do not break or chew it.
Treatment of hypertension is usually long-term.

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

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

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

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

Taking more Tertensif SR than recommended
If you take too many tablets, seek immediate advice from your doctor or pharmacist.
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.

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

Stopping Tertensif 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 the patient experiences any of the following adverse symptoms, which may be
severe, treatment must be discontinued and immediate contact with a doctor is required:

• 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, immediate medical attention must be sought (very rare – may occur in up to 1 in 10,000 patients);
• Severe skin reactions, including intense rash, generalized redness of the skin, severe 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 disturbances in heart rhythm (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 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 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 (petechiae);
• Low blood sodium levels, which may cause dehydration and lowered 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), dry 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 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), and anemia (reduced red blood cell count);
• Heart rhythm disturbances, decreased 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 choroid 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 blood testing. The following changes in laboratory results may occur:
• Increased uric acid levels, a substance which may cause or exacerbate gout (pain in one or more 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 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
Phone: +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 to provide more information on the safety of the medicine.

5. How to store Tertensif SR

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation
"EXP" (the abbreviation used to describe the expiry date). The expiry date refers to the last day
of the stated month. The word "Lot" on the packaging indicates the batch number of the medicine.
Store below 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This practice helps protect the environment.

6. Contents of the pack and other information

What Tertensif SR contains

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

What Tertensif SR looks like and contents of the pack
Tertensif SR is a round, white, coated tablet with prolonged release.
The tablets are available in packs containing 30 tablets (1 blister of 30 tablets or 2 blisters of 15 tablets), 60 tablets (2 blisters of 30 tablets), 90 tablets (5 blisters of 18 tablets) or 108 tablets (6 blisters of 18 tablets), packed in a cardboard box.

Marketing Authorisation Holder
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex
France

Manufacturer
ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
Annopol 6 B
03–236 Warsaw
Poland
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy
France

For further information, contact the marketing authorisation holder's representative:
Servier Polska Sp. z o.o.
Telephone number: (22)\–594-90-00