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

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Contents of the package 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 to treat high blood pressure in patients who are already taking indapamide and amlodipine in separate tablets at the same dose.
Tertens-AM is a combination medicine that contains 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 only causes a slight increase in urine production. Amlodipine is a calcium antagonist (belonging to a group of medicines called dihydropyridines) and causes relaxation of blood vessels, making it easier for blood to flow through them. Each of the active substances lowers blood pressure.

2. Important information before taking Tertens-AM

When not to take Tertens-AM:

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

Warnings and precautions

Before taking Tertens-AM, discuss it with your doctor or pharmacist.
If you are concerned about or have experienced any of the following, tell your doctor:

• recent heart attack;
• if you have heart failure, any heart rhythm disorders, if you have coronary heart disease (a heart condition caused by reduced blood flow in the blood vessels of the heart);
• if you have kidney problems;
• if you experience vision changes 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 Tertens-AM. Untreated symptoms can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamides, you are at greater risk of developing these disorders.
• if you have muscle disorders, including pain, tenderness, weakness, or muscle cramps;
• if you experience a significant increase in blood pressure (hypertensive crisis);
• if you are elderly and your dose needs to be increased;
• if you are taking other medicines;
• if you are malnourished;
• if you have liver problems;
• if you have diabetes;
• if you have gout;
• if you are to undergo a parathyroid function test;
• if you have had allergic reactions to light. Your doctor may recommend blood tests to check if you have decreased sodium or potassium levels or increased calcium levels. If you think any of the above applies to you, or if you have any questions or concerns about taking this medicine, you should consult your doctor or pharmacist.

Athletes should be aware that Tertens-AM contains an active substance (indapamide) that may cause a positive result in anti-doping tests.

Children and adolescents

Tertens-AM should not be given to children and adolescents.

Tertens-AM and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Do not take Tertens-AM:

• with lithium (used to treat mental disorders such as mania, manic-depressive illness, and recurring depression) due to the risk of increased lithium levels in the blood;
• with dantrolene (given by infusion), used to treat severe body temperature disorders.

Tell your doctor if you are taking any of the following medicines, as they may require special caution:

• 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 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 angina pectoris, a condition that causes chest pain);
• cisapride, difemanil (used to treat gastrointestinal disorders);
• vincamine given intravenously (used to treat symptomatic 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);
• orally administered corticosteroids, used to treat various diseases, including severe asthma and rheumatoid arthritis;
• foxglove preparations (used to treat heart conditions);
• laxatives that stimulate peristalsis;
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis);
• potassium-sparing diuretics (amiloride, spironolactone, triamterene);
• metformin (used to treat diabetes);
• contrast agents containing iodine (used during diagnostic tests with X-rays);
• calcium supplements or other calcium preparations;
• immunosuppressive medicines (given to control the immune system's response) used to treat autoimmune diseases or after organ transplantation (e.g., cyclosporine, tacrolimus);
• sirolimus, temsirolimus, everolimus, and other medicines belonging to the group of medicines called mTOR inhibitors (medicines used to modify the immune system's function);
• tetracosactide (used to treat Crohn's disease);
• antifungal medicines (e.g., ketoconazole, itraconazole, amphotericin B given by infusion);
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV);
• antibiotics used to treat bacterial infections (e.g., rifampicin, erythromycin given by infusion, clarithromycin, sparfloxacin, moxifloxacin);
• St. John's Wort (Hypericum perforatum);
• verapamil, diltiazem (used to treat heart conditions);
• simvastatin (a medicine that lowers cholesterol levels in the blood);
• 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 grapefruits and grapefruit juice may lead to increased levels of the active substance amlodipine in the blood, which may cause unexpected intensification of the blood pressure-lowering effect of Tertens-AM.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Tertens-AM is not recommended during pregnancy. If you become pregnant or plan to become pregnant, your doctor will promptly recommend alternative treatment.
Tertens-AM is not recommended if you are breastfeeding. If you are breastfeeding or plan to breastfeed, tell your doctor immediately.

Driving and using machines

Tertens-AM may affect your ability to drive or use machines. If the tablets make you feel nauseous, dizzy, tired, or give you headaches, do not drive or use machines, and contact your doctor immediately. If you experience such symptoms, avoid driving and performing tasks that require attention.

Tertens-AM contains lactose

If you have been told that you have an intolerance to some sugars, contact your 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 essentially 'sodium-free'.

3. How to take Tertens-AM

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one tablet per day, preferably in the morning.
Swallow the tablet whole with water, without chewing.

If you take more Tertens-AM than you should

Taking too many tablets may cause your blood pressure to be too low or even dangerously low. You may feel dizzy, sleepy, "empty" in your head, or experience fainting or weakness. You may experience nausea, vomiting, cramps, disorientation, and changes in the amount of urine produced by your kidneys. If the blood pressure drop is significant, it may lead to shock. Your skin may become cold, wet, and you may lose consciousness.
Even 24-48 hours after taking the medicine, you may experience shortness of breath caused by excess fluid accumulating in the lungs (pulmonary edema).
Immediately contact your doctor if you have taken too many Tertens-AM tablets.

If you forget to take Tertens-AM

Do not worry. If you forget to take a tablet, skip that dose. Take your next dose at the usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Tertens-AM

Treatment of high blood pressure is usually long-term, so before stopping this medicine, consult your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tertens-AM can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop taking the medicine and contact your doctor immediately:

• swelling of the eyelids, face, or lips (very rare, may affect less than 1 in 10,000 people);
• swelling of the tongue and throat, causing severe breathing difficulties (very rare, may affect less than 1 in 10,000 people);
• severe skin reactions, including severe rash, hives, redness of the skin, severe itching, blisters, peeling, and swelling of the skin, mucous membrane inflammation

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

• heart attack (very rare, may affect less than 1 in 10,000 people);
• abnormal heart function (uncommon, may affect less than 1 in 100 people);
• life-threatening heart rhythm disorders (torsades de pointes)(frequency not known);
• pancreatitis, which can cause severe abdominal and back pain and very poor general health (very rare, may affect less than 1 in 10,000 people);
• muscle weakness, cramps, tenderness, or pain, especially if you feel unwell or have a high temperature, which may be caused by abnormal muscle breakdown (frequency not known).

Other side effects, grouped by decreasing frequency, may include:
Very common side effects - may affect more than 1 in 10 people:

• swelling (fluid retention).

Common side effects – may affect less than 1 in 10 people:

• headache, dizziness, sleepiness (especially at the start of treatment);
• vision disturbances, double vision;
• palpitations (feeling of heartbeat), flushing of the face;
• shortness of breath;
• abdominal pain, nausea, changes in bowel movements, diarrhea, constipation, indigestion;
• swelling of the ankles, fatigue, weakness, muscle cramps;
• low potassium levels in the blood, which may cause muscle weakness;
• skin rashes.

Uncommon side effects – may affect less than 1 in 100 people:

• mood changes, anxiety, depression, insomnia;
• tremors;
• taste disturbances;
• numbness, tingling, or prickling sensations in the limbs, loss of pain sensation;
• ringing in the ears;
• low blood pressure;
• low sodium levels in the blood, which may cause dehydration and low blood pressure;
• fainting;
• coughing or runny nose due to nasal mucosa inflammation;
• dryness of the mucous membranes in the mouth, vomiting;
• hair loss, excessive sweating, itchy skin, red spots on the skin, skin discoloration, hives;
• urination disorders, frequent urination at night, increased urination frequency;
• impotence (inability to achieve or maintain an erection), discomfort or breast enlargement in men;
• pain, poor general health;
• muscle or joint pain, back pain;
• weight gain or loss.

Rare side effects – may affect less than 1 in 1,000 people:

• disorientation;
• dizziness;
• low chloride levels in the blood;
• low magnesium levels in the blood.

Very rare side effects – may affect less than 1 in 10,000 people:

• blood test changes, such as low platelet count (thrombocytopenia, which can cause easy bruising and bleeding from the nose), low white blood cell count (leukopenia, which can cause unexplained fever, sore throat, or other flu-like symptoms - if you experience such symptoms, contact your doctor), and anemia (reduced red blood cell count);
• high blood sugar levels (hyperglycemia);
• high calcium levels in the blood;
• nerve disorders, which can cause weakness, numbness, or tingling;
• gum swelling;
• abdominal bloating (gastritis);
• abnormal liver function, liver inflammation, jaundice, increased liver enzyme activity, which may affect the results of some laboratory tests; in case of liver failure, there is a possibility of developing hepatic encephalopathy (a brain disorder caused by liver disease);
• kidney disease;
• increased muscle tension;
• blood vessel inflammation, often with skin rash;
• photosensitivity.

Unknown frequency (frequency cannot be estimated from available data):

• changes in laboratory test results, and your doctor may recommend blood tests to monitor your health. The following changes in laboratory test results may occur:
• increased uric acid levels, a substance that can cause or worsen gout (pain in the joint, especially the feet);
• increased blood sugar levels in diabetic patients;
• abnormal electrocardiogram (ECG) tracing;
• myopia;
• blurred vision;
• 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);
• tremors, stiffness, mask-like face, slow movements, and shuffling gait.

In the case of systemic lupus erythematosus (a type of collagen disease), symptoms may worsen.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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, you can help provide more information on the safety of this medicine.

5. How to store Tertens-AM

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

6. Contents of the pack and other information

What Tertens-AM contains

• The active substances of Tertens-AM 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 of the tablet are:
• Tertens-AM, 1.5 mg + 5 mg and Tertens-AM, 1.5 mg + 10 mg core: lactose monohydrate, hypromellose 4000 mPas, magnesium stearate, povidone K30, colloidal anhydrous silica, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium croscarmellose, pregelatinized starch, cornstarch.
• Tertens-AM, 1.5 mg + 5 mg coating: glycerol, hypromellose 6 mPas, macrogol 6000, magnesium stearate, titanium dioxide (E 171).
• Tertens-AM, 1.5 mg + 10 mg coating: 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, modified-release tablets with a diameter of 9 mm, with an embossed mark on one side.
Tertens-AM, 1.5 mg + 10 mg: pink, round, modified-release tablets with a diameter of 9 mm, with an embossed mark on one side.
Tablets are available in blisters containing 30, 60, and 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Servier Laboratories
50, rue Carnot
92284 Suresnes cedex
France

Manufacturer

Servier Industrial Laboratories (LSI)
905 route de Saran
45520 Gidy
France
Servier (Ireland) Industries Ltd (SII)
Moneylands, Gorey Road
Arklow – Co. Wicklow
Ireland
Anpharm Pharmaceutical Company S.A.
Annopol 6B
03-236 Warsaw
Poland
Servier Laboratories 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
To obtain detailed information about this medicine, contact the representative of the marketing authorization holder:
Servier Poland Ltd.
Phone: (22) 594 90 00

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

Bulgaria
NATRIXAM, tablets with modified release
Croatia
NATRIXAM tablets with modified release
Estonia
NATRIXAM
France
NATRIXAM, modified-release tablets
Germany
NATRIXAM, tablets with modified active substance release
Latvia
TERTENSAM, tablets with prolonged action
Lithuania
NATRIXAM, tablets with modified release
Luxembourg
NADREXAM, modified-release tablets
Malta
NATRIXAM, modified-release tablets
Netherlands
NATRIXAM, tablets with regulated release
Poland
Tertens-AM
Romania
NATRIXAM, tablets with modified release
Slovakia
NATRIXAM, tablets with controlled release
Slovenia
NADEXAM, tablets with modified release

Date of last revision of the package leaflet: 10/2024