Tertens am

Package leaflet: Information for the patient

Tertens-AM, 1.5 mg + 5 mg, modified-release tablets
Tertens-AM, 1.5 mg + 10 mg, modified-release tablets
Indapamide + Amlodipine
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What Tertens-AM is and what it is used for

Tertens-AM is used as replacement therapy for high blood pressure (arterial hypertension) in patients already being treated with indapamide and amlodipine taken as separate tablets at the same dose.
Tertens-AM is a combination medicine containing two active substances: indapamide and amlodipine.
Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics because it causes only a slight increase in urine production. Amlodipine is a calcium antagonist (belonging to a group of medicines known as dihydropyridines) and causes relaxation of blood vessels, thereby improving blood flow. Each of the active substances helps to lower blood pressure.

2. Important information before using Tertens-AM

When not to use Tertens-AM:

• if the patient is allergic to indapamide, any sulfonamide (a group of medicines used to treat high blood pressure), amlodipine or any other calcium antagonists (a group of medicines used to treat high blood pressure), or to any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, redness of the skin, or difficulty breathing;
• if the patient has very low blood pressure (hypotension);
• if the patient has aortic valve stenosis (narrowing of the aortic valve) or cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to meet the body's needs);
• if the patient has heart failure following a heart attack;
• if the patient has severe kidney disease;
• if the patient has severe liver disease or a condition called hepatic encephalopathy (a brain disorder caused by liver disease);
• if the patient has low potassium levels in the blood.

Warnings and precautions
Before starting treatment with Tertens-AM, discuss this with your doctor or pharmacist.
If any of the following apply to the patient, or have applied in the past, inform your doctor:

• recent heart attack;
• if the patient has heart failure, any heart rhythm disorders, or ischemic heart disease (heart disease caused by inadequate blood flow in the coronary arteries);
• if the patient has 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 Tertens-AM. If left untreated, these symptoms may lead to permanent vision loss. If the patient has previously had an allergic reaction to penicillin or sulfonamides, the risk of these disorders is higher.
• if the patient has muscle disorders, including pain, tenderness, weakness, or muscle cramps;
• if the patient has severe high blood pressure (hypertensive crisis);
• if the patient is elderly and the dose of the medicine needs to be increased;
• if the patient is taking other medicines;
• if the patient is malnourished;
• if the patient has liver problems;
• if the patient has diabetes;
• if the patient has gout;
• if the patient is scheduled for parathyroid function testing;
• if the patient has previously experienced photosensitivity reactions. The doctor may recommend blood tests to check for decreased sodium or potassium levels, or increased calcium levels. If the patient believes any of the above conditions apply, or has any questions or concerns about using this medicine, they should contact their doctor or pharmacist.

Athletes should be aware that Tertens-AM contains the active substance (indapamide)
which may lead to a positive result in anti-doping tests.
Children and adolescents
Tertens-AM must not be given to children and adolescents.
Tertens-AM and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to use.
Do not take Tertens-AM:

• with lithium (used to treat psychiatric disorders such as mania, bipolar disorder, and recurrent depression) due to the risk of increased lithium levels in the blood;
• with intravenous dantrolene (used in severe temperature regulation disorders).

Inform your doctor if the patient is taking any of the following medicines, as this may require special precautions:

• other medicines used to treat high blood pressure;
• medicines used to treat heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, 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 angina pectoris, a condition causing chest pain);
• cisapride, difenoxin (used to treat gastrointestinal disorders);
• intravenous vinpocetine (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 drugs with analgesic effect (e.g. ibuprofen) or high doses of acetylsalicylic acid;
• angiotensin-converting enzyme (ACE) inhibitors (used to treat high blood pressure and heart failure);
• oral corticosteroids, used to treat various diseases including severe asthma and rheumatoid arthritis;
• cardiac glycosides (used to treat heart conditions);
• stimulant laxatives;
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis);
• potassium-sparing diuretics (amiloride, spironolactone, triamterene);
• metformin (used to treat diabetes);
• iodine-containing contrast agents (used during diagnostic X-ray procedures);
• calcium tablets or other calcium supplements;
• immunosuppressive medicines (used to control immune system responses) in autoimmune diseases or after organ transplantation (e.g. cyclosporine, tacrolimus);
• sirolimus, temsirolimus, everolimus, and other medicines belonging to the class known as mTOR inhibitors (medicines used to modify immune system function);
• tetracosactide (used to treat Crohn's disease);
• antifungal medicines (e.g. ketoconazole, itraconazole, intravenous amphotericin B);
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV);
• antibiotics used to treat bacterial infections (e.g. rifampicin, intravenous erythromycin, clarithromycin, sparfloxacin, moxifloxacin);
• St John's wort (Hypericum perforatum);
• verapamil, diltiazem (used in heart diseases);
• simvastatin (a medicine that lowers blood cholesterol levels);
• allopurinol (used to treat gout);
• methadone (used to treat addiction).

Tertens-AM with food and drink
Patients taking Tertens-AM should not consume grapefruit juice or grapefruits,
as grapefruit and grapefruit juice may increase blood levels of the active substance - amlodipine, which may lead to an unpredictable intensification of the blood pressure-lowering effect of Tertens-AM.
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. If pregnancy is planned or confirmed, the doctor will recommend alternative treatment as soon as possible.
Tertens-AM is not recommended if the patient is breastfeeding. Inform your doctor immediately if the patient is breastfeeding or intends to breastfeed.
Driving and operating machinery
Tertens-AM may affect the ability to drive or operate machinery. If the tablets cause nausea, dizziness, tiredness, or headache, the patient should not drive or operate machinery and should contact their doctor immediately. If such symptoms occur, avoid driving and performing tasks requiring attention.
Tertens-AM contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.
Tertens-AM contains sodium
Tertens-AM contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to use Tertens-AM

This medicine should always be taken as directed by the physician. In case of doubts, consult your
doctor or pharmacist.
The recommended dose is one tablet taken once daily, preferably in the morning.
The tablet should be swallowed whole, without chewing, with a glass of water.
Taking a higher than recommended dose of Tertens-AM
Taking too many tablets may cause blood pressure to become low or even dangerously low. The patient may experience dizziness, drowsiness, a "blank" feeling in the head, faintness, or weakness. Nausea, vomiting, cramps, disorientation, and changes in the amount of urine produced by the kidneys may occur. If the drop in blood pressure is significant, shock may develop. The patient's skin may become cold and clammy, and loss of consciousness may occur.
Breathing difficulties caused by excess fluid accumulating in the lungs (pulmonary edema) may occur up to 24–48 hours after taking the medicine.
Seek immediate medical attention if an overdose of Tertens-AM has been taken.
Missing a dose of Tertens-AM
Do not be alarmed. If the patient forgets to take a tablet, skip the missed dose. Take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.
Stopping treatment with Tertens-AM
Treatment of high blood pressure is usually long-term; therefore, consult your doctor before discontinuing this medicine.
If you have any further questions 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 will experience them.
If any of the following severe adverse symptoms occur in a patient, the medicine must be discontinued immediately and the doctor should be contacted without delay:

• swelling of the eyelids, face or lips (very rare, may occur in less than 1 in 10,000 patients);
• swelling of the tongue and throat, causing significant breathing difficulties (very rare, may occur in less than 1 in 10,000 patients);
• severe skin reactions, including severe rash, urticaria, redness of the entire body skin, intense itching, blisters, skin peeling and swelling of the skin, mucosal inflammation

(Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions (very rare, may occur in less than 1 in 10,000 patients);

• myocardial infarction (very rare, may occur in less than 1 in 10,000 patients);
• abnormal heart function (uncommon, may occur in less than 1 in 100 patients);
• life-threatening heart rhythm disorders (torsade de pointes) (frequency unknown);
• pancreatitis, which may cause severe abdominal and back pain and very poor general condition (very rare, may occur in less than 1 in 10,000 patients);
• muscle weakness, cramps, tenderness or muscle pain, particularly 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, may include:
Very common adverse reactions – may occur in at least 1 in 10 patients:

• fluid retention (edema).

Common adverse reactions – may occur in less than 1 in 10 patients:

• headache, dizziness, drowsiness (especially at the beginning of treatment);
• visual disturbances, double vision;
• palpitations (awareness of heartbeat), facial flushing;
• shortness of breath;
• abdominal pain, nausea, changes in bowel rhythm, diarrhea, constipation, indigestion;
• swelling around the ankles, fatigue, weakness, muscle cramps;
• low blood potassium levels, which may cause muscle weakness;
• skin rashes.

Uncommon adverse reactions – may occur in less than 1 in 100 patients:

• mood changes, anxiety, depression, insomnia;
• tremor;
• taste disturbances;
• tingling or numbness in the limbs, loss of pain sensation;
• ringing in the ears;
• low blood pressure;
• low blood sodium levels, which may cause dehydration and lowered blood pressure;
• fainting;
• sneezing or nasal congestion due to inflammation of the nasal mucosa;
• cough;
• dryness of the oral mucous membrane, vomiting;
• hair loss, excessive sweating, itchy skin, red skin spots, skin discoloration, urticaria;
• urinary disturbances, nocturia (need to urinate at night), increased frequency of urination;
• impotence (inability to achieve or maintain an erection), discomfort or enlargement of breasts in men;
• pain, malaise;
• muscle or joint pain, back pain;
• increase or decrease in body weight.

Rare adverse reactions – may occur in less than 1 in 1,000 patients:

• disorientation;
• sensation of dizziness;
• low blood chloride levels;
• low blood magnesium levels.

Very rare adverse reactions – may occur in less than 1 in 10,000 patients:

• blood test abnormalities 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 such symptoms occur, contact a doctor), and anemia (reduced red blood cell count);
• excessive blood glucose levels (hyperglycemia);
• increased blood calcium levels;
• nerve disorders, which may cause weakness, tingling or numbness;
• gum swelling;
• abdominal bloating (gastritis);
• liver dysfunction, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity, which may affect results of certain laboratory tests; in cases of liver failure, hepatic encephalopathy (brain dysfunction caused by liver disease) may develop;
• kidney disease;
• increased muscle tone;
• vasculitis, often with skin rash;
• photosensitivity.

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

• changes in laboratory test results may occur, and the doctor may recommend blood tests to monitor the patient's health. The following changes in laboratory test results may occur:
• increased uric acid levels, a substance which may cause or worsen an attack of gout (joint pain, especially in the feet);
• increased blood glucose levels in patients with diabetes;
• abnormal electrocardiogram (ECG) findings;
• myopia;
• blurred vision;
• worsening of vision or eye pain due to high pressure (possible symptoms of fluid accumulation in the choroidal layer of the eye (choroidal effusion) or acute angle-closure glaucoma);
• tremor, rigidity, mask-like facial expression, bradykinesia, shuffling gait.

In patients with systemic lupus erythematosus (a type of collagenosis), symptoms may worsen.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 provide more information on the safety of the medicine.

5. How to store Tertens-AM

Keep the 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. Such practices help protect the environment.

6. Contents of the pack and other information

What Tertens-AM contains

• The active substances in the medicine are: indapamide and amlodipine. One Tertens-AM 1.5 mg + 5 mg tablet contains 1.5 mg of indapamide and 6.935 mg of amlodipine besylate (equivalent to 5 mg of amlodipine). One Tertens-AM 1.5 mg + 10 mg tablet contains 1.5 mg of indapamide and 13.87 mg of amlodipine besylate (equivalent to 10 mg of amlodipine).
• Other ingredients in the tablet are:
• tablet core of Tertens-AM 1.5 mg + 5 mg and Tertens-AM 1.5 mg + 10 mg: monohydrate lactose, hypromellose 4000 mPas, magnesium stearate, povidone K30, colloidal anhydrous silica, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium croscarmellose, pregelatinized corn starch.
• tablet coating of Tertens-AM 1.5 mg + 5 mg: glycerol, hypromellose 6 mPas, macrogol 6000, magnesium stearate, titanium dioxide (E 171).
• tablet coating of Tertens-AM 1.5 mg + 10 mg: glycerol, hypromellose 6 mPas, iron oxide red (E172), macrogol 6000, magnesium stearate, titanium dioxide (E 171).

What Tertens-AM looks like and contents of the pack
Tertens-AM 1.5 mg + 5 mg: white, round, film-coated modified-release tablets
with a diameter of 9 mm, imprinted with a mark on one side.

Tertens-AM 1.5 mg + 10 mg: pink, round, film-coated modified-release tablets
with a diameter of 9 mm, imprinted with a mark on one side.

Tablets are available in blister packs containing 30, 60 or 90 tablets.
Not all pack sizes may be marketed.

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

Manufacturer
Les Laboratoires Servier Industrie (LSI)
905 route de Saran
45520 Gidy
France
Servier (Ireland) Industries Ltd (SII)
Moneylands, Gorey Road
Arklow – Co. Wicklow
Ireland
Anpharm Przedsiębiorstwo Farmaceutyczne S.A.
Annopol 6B
03-236 Warsaw
Poland
Laboratorios Servier S.L.
Avenida de los Madroños, 33
28043 Madrid
Spain
Egis Pharmaceuticals PLC
H-1165 Budapest
Bökényföldi út 118-120
Hungary
Egis Pharmaceuticals PLC
H-9900 Körmend
Mátyás király u. 65
Hungary

For further information about this medicine, please contact the representative of the Marketing Authorisation Holder:
Servier Polska Sp. z o.o.
Telephone number: (22) 594 90 00

This medicinal product is authorised in the European Economic Area countries under the following names:
Bulgaria NATRIXAM, таблетки с изменено освобождаване
Croatia NATRIXAM tablete s prilagođenim oslobađanjem
Estonia NATRIXAM
France NATRIXAM, comprimé à libération modifiée
Germany NATRIXAM, Tabletten mit veränderter Wirkstofffreisetzung
Latvia TERTENSAM, ilgstošās darbības tabletes
Lithuania NATRIXAM, modifikuoto atpalaidavimo tabletės
Luxembourg NADREXAM, comprimé à libération modifiée
Malta NATRIXAM, modified-release tablets
Netherlands NATRIXAM, tabletten met gereguleerde afgifte
Poland Tertens-AM
Romania NATRIXAM, comprimate cu eliberare modificată
Slovakia NATRIXAM, tablety s riadeným uvoľňaním
Slovenia NADEXAM, tablete s prirejenim sproščanjem