Telam

Package leaflet: Information for the patient

Telam, 40 mg+5 mg, tablets
Telam, 40 mg+10 mg, tablets
Telam, 80 mg+5 mg, tablets
Telam, 80 mg+10 mg, tablets
Telmisartanum+Amlodipinum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, 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.

Table of contents of the leaflet

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

1. What Telam is and what it is used for

Telam contains two active substances – telmisartan and amlodipine. Both substances work by lowering arterial blood pressure.

• Telmisartan belongs to the group of angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that causes narrowing of blood vessels, thereby increasing blood pressure. Telmisartan works by blocking the action of angiotensin II.
• Amlodipine belongs to the group of calcium antagonists. Amlodipine prevents calcium from entering the walls of blood vessels, thus preventing their constriction. As a result, both active substances prevent blood vessels from narrowing. Therefore, this medicine causes vasodilation and reduces arterial blood pressure.

Telam is used for the treatment of arterial hypertension:

• in adult patients whose blood pressure is not sufficiently controlled with amlodipine alone,
• in adult patients already taking telmisartan and amlodipine at the same doses as in Telam, who wish for convenience to take both substances in a single tablet.

Untreated arterial hypertension may lead to damage of blood vessels in several organs, increasing the risk of serious complications such as heart attack, heart or kidney failure, stroke, or blindness. Usually, there are no symptoms of hypertension before organ damage occurs. Therefore, regular blood pressure measurements are essential to confirm whether blood pressure values are within the normal range.

2. Important information before taking Telam

When not to take Telam

• if the patient is allergic to telmisartan or amlodipine or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has had an allergic reaction to other medicines from the dihydropyridine derivatives group (calcium channel antagonists);
• after the third month of pregnancy (Telam should also be avoided during earlier stages of pregnancy; see Pregnancy section);
• if the patient has severe liver disease or biliary obstruction (impaired bile flow from the liver or gallbladder);
• if the patient has aortic valve stenosis (narrowing of the heart's aortic valve) or cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body);
• if the patient has heart failure following a heart attack;
• if the patient has diabetes or kidney function impairment and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above conditions apply, the patient should consult a doctor before taking Telam.

Warnings and precautions

Before starting Telam, consult a doctor if the patient has or has previously had any of the following conditions or diseases:

• kidney disease or status post kidney transplant;
• narrowing of the blood vessels to one or both kidneys (renal artery stenosis);
• liver disease;
• heart disease;
• elevated aldosterone levels (leading to fluid and salt retention in the body, including disturbances in blood levels of various electrolytes);
• low blood pressure (hypotension), particularly in dehydrated patients (excessive loss of body water) or those with sodium deficiency due to diuretic (water pill) use, low-salt diet, diarrhoea, or vomiting;
• increased potassium levels in the blood;
• diabetes;
• aortic stenosis;
• chest pain related to the heart, including at rest or after minimal exertion (unstable angina);
• myocardial infarction (heart attack) within the last four weeks.

Before starting Telam, discuss with the doctor:

• if the patient is taking any of the following medicines for high blood pressure:
  • angiotensin-converting enzyme (ACE) inhibitors (e.g., enalapril, lisinopril, ramipril), particularly if the patient has kidney problems related to diabetes;
  • aliskiren. The treating doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g., potassium). See also information under the heading "When not to take Telam".
• if the patient is elderly and a dose increase is required.

If a surgical procedure or anaesthesia is planned, inform the doctor about taking Telam.

If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Telam, discuss this with the doctor. The doctor will decide on further treatment. Do not stop taking Telam on your own.

Children and adolescents

Telam is not recommended for use in children and adolescents under 18 years of age.

Telam and other medicines

Tell your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.

The doctor may recommend adjusting the dose of these medicines or taking other precautions. In some cases, discontinuation of one of these medicines may be necessary.

This especially applies to concomitant use of Telam with the following medicines:

• lithium-containing medicines, used in the treatment of certain forms of depression;
• medicines that may increase blood potassium levels, such as potassium-containing salt substitutes, potassium-sparing diuretics;
• angiotensin II receptor antagonists;
• ACE inhibitors or aliskiren (see also sections "When not to take Telam" and "Warnings and precautions");
• NSAIDs (non-steroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen), heparin, immunosuppressive medicines (e.g., cyclosporine or tacrolimus), and the antibacterial medicine trimethoprim;
• rifampicin, erythromycin, clarithromycin (antibiotics);
• St. John's wort (Hypericum perforatum);
• dantrolene (used intravenously in severe temperature regulation disorders);
• medicines used to modify immune system function (e.g., sirolimus, temsirolimus, everolimus);
• medicines used to treat HIV/AIDS infection (e.g., ritonavir) or fungal infections (e.g., ketoconazole);
• diltiazem (a heart medicine);
• simvastatin used to treat high cholesterol;
• digoxin.

As with other antihypertensive medicines, the effect of Telam may be reduced when taken concomitantly with NSAIDs (non-steroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen) or corticosteroids.

Telam may enhance the blood pressure-lowering effect of other antihypertensive medicines or medicines that may lower blood pressure (e.g., baclofen, amifostine, neuroleptics, and antidepressants).

Telam with food and drink

The blood pressure-lowering effect may be enhanced by alcohol. This may be felt as dizziness upon standing.

While taking Telam, do not drink grapefruit juice or eat grapefruits, as grapefruit and grapefruit juice may in some patients increase blood levels of the active substance amlodipine and enhance the blood pressure-lowering effect of Telam.

Pregnancy and breastfeeding

Pregnancy

Inform the doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. The doctor will usually recommend stopping Telam before a planned pregnancy or immediately after pregnancy is confirmed, and will advise taking another medicine instead of Telam. Telam is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may cause serious harm to the unborn child.

Breastfeeding

It has been shown that small amounts of amlodipine pass into human milk.

Inform the doctor if you are breastfeeding or intend to breastfeed. Telam is not recommended during breastfeeding, especially when breastfeeding a newborn or premature infant. The doctor may recommend using another medicine.

Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines

In some patients treated for hypertension, adverse effects such as fainting, drowsiness, dizziness, or vertigo may occur. If such adverse effects occur, driving or operating machinery must not be undertaken.

Telam contains sodium

Telam contains less than 1 mmol of sodium (23 mg) per tablet; i.e., the medicine is considered "sodium-free".

3. How to take Telam

This medicine should always be taken exactly as prescribed by your doctor. In case of doubt,
consult your doctor or pharmacist.
The recommended dose is one tablet per day.
The maximum recommended dose is one tablet containing 80 mg of telmisartan and 10 mg of amlodipine per day.
Try to take the tablet at the same time every day.
The Telam tablet should be removed from the blister pack only immediately before taking.
Telam may be taken during meals or independently of meals. Tablets should be swallowed
with a small amount of water or another non-alcoholic drink (except grapefruit juice).
If the patient has impaired liver function, the usual dose should not exceed one tablet of 40 mg + 5 mg or one tablet of 40 mg + 10 mg per day.
Taking more than the recommended dose of Telam
If too many tablets have been taken, contact your doctor, pharmacist, or go immediately to the emergency department of the nearest hospital. Low blood pressure and rapid heartbeat may occur. Slow heartbeat, dizziness, worsening of kidney function including renal failure, severe and prolonged hypotension, shock, and death have also been reported.
Breathing difficulty due to excess fluid accumulating in the lungs (pulmonary edema) may occur up to 24–48 hours after taking the medicine.
Missing a dose of Telam
If a dose of Telam is missed, take it as soon as possible and continue taking the medicine as prescribed by your doctor. If one day's tablet is missed, take the usual dose of Telam the next day at the usual time.
Do not take a double dose to make up for a missed dose.
Stopping Telam
It is important to take Telam every day unless otherwise instructed by your doctor. If you feel that the effect of Telam is too strong or too weak, consult your doctor or pharmacist.
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.
Some adverse reactions may be serious and require immediate medical attention:
If any of the following symptoms occur, contact your doctor immediately:
Sepsis (often called blood poisoning, a systemic infection with high fever and severe malaise), sudden swelling of the skin and mucous membranes (angioedema).
The above adverse reactions are rare (may occur in no more than 1 in 1,000 patients), but are very serious. In such cases, treatment with this medicine must be discontinued immediately and medical advice sought without delay. If left untreated, these symptoms may result in death. An increased incidence of sepsis has been observed in patients receiving telmisartan monotherapy; however, it cannot be excluded in patients treated with Telam.

Common (may occur in no more than 1 in 10 patients):
Dizziness, ankle swelling.

Uncommon (may occur in no more than 1 in 100 patients):
Drowsiness, migraine, headache, tingling or numbness of hands or feet, sensation of spinning, slow heart rate, palpitations (awareness of heartbeat), low blood pressure (hypotension), dizziness upon standing (orthostatic hypotension), sudden flushing (especially of the face), cough, stomach pain (abdominal pain), diarrhoea, nausea, itching, joint pain, muscle cramps, muscle pain, erectile dysfunction, weakness, chest pain, fatigue, swelling (oedema), increased liver enzyme activity.

Rare (may occur in no more than 1 in 1,000 patients):
Urinary tract infections, feeling of sadness (depression), anxiety, insomnia, fainting, nerve damage in hands or feet, reduced sensitivity to touch, taste disturbances, tremor, vomiting, gum enlargement, abdominal discomfort, dryness of oral mucous membranes, rash (skin disorder), redness of the skin, skin eruptions, back pain, leg pain, nocturia (urinating at night), malaise, increased blood uric acid levels.

Very rare (may occur in no more than 1 in 10,000 patients):
Progressive lung tissue scarring (interstitial lung disease [mainly interstitial pneumonia and eosinophilic pneumonia]).

The following adverse reactions have been observed during treatment with telmisartan or amlodipine and may also occur with Telam:

Telmisartan
In patients receiving telmisartan alone, the following additional adverse reactions have been reported:

Uncommon (may occur in no more than 1 in 100 patients):
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), deficiency of red blood cells (anaemia), high potassium levels in blood, shortness of breath, bloating, increased sweating, kidney damage including acute impairment of kidney function, increased creatinine levels.

Rare (may occur in no more than 1 in 1,000 patients):
Increased number of a certain type of white blood cells (eosinophilia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, breathing difficulties, wheezing, facial swelling or low blood pressure), low blood sugar levels (in diabetic patients), visual disturbances, rapid heartbeat, gastritis, abnormal liver function, urticaria, drug eruption, tendonitis, influenza-like illness (e.g. muscle pain, general malaise), decreased haemoglobin concentration (blood protein), increased blood creatine phosphokinase activity, low sodium levels.

Most cases of abnormal liver function or liver-related adverse reactions reported after marketing of telmisartan occurred in Japanese patients. The likelihood of this adverse reaction is higher in Japanese patients.

Unknown (frequency cannot be estimated from available data):
Intestinal angioedema – after administration of similar products, intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea has occurred.

Amlodipine
In patients receiving amlodipine alone, the following additional adverse reactions have been reported:

Common (may occur in no more than 1 in 10 patients):
Change in bowel habits, diarrhoea, constipation, visual disturbances, double vision, ankle swelling.

Uncommon (may occur in no more than 1 in 100 patients):
Mood changes, visual disturbances, tinnitus, dyspnoea, sneezing or runny nose, hair loss, unusual bruising and bleeding (platelet dysfunction), skin discoloration, increased sweating, difficulty urinating, increased frequency of urination, especially at night, breast enlargement in men, pain, weight gain, weight loss.

Rare (may occur in no more than 1 in 1,000 patients):
Confusion.

Very rare (may occur in no more than 1 in 10,000 patients):
Reduced number of white blood cells (leukopenia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, breathing difficulties, wheezing, facial swelling or low blood pressure), elevated blood glucose levels, uncontrolled muscle twitching or spasms, myocardial infarction, cardiac arrhythmias, vasculitis, pancreatitis, inflammation of the stomach lining (gastritis), hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity with jaundice, sudden swelling of the skin and mucous membranes (angioedema), severe skin reactions, urticaria, severe allergic reactions with blister formation on the skin and mucous membranes (exfoliative dermatitis, Stevens-Johnson syndrome), increased skin sensitivity to sunlight, increased muscle tension.

Unknown (frequency cannot be estimated from available data):
Severe allergic reactions with blister formation on the skin and mucous membranes (toxic epidermal necrolysis).

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 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
Adverse reactions may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Telam

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after:
EXP. The expiry date refers to the last day of the month indicated.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot/LOT indicates the batch number.
Store in the original packaging to protect from light. A Telam tablet should be removed from the blister pack only immediately before administration.
Medicines must 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 Telam contains

• The active substances are telmisartan and amlodipine. Each tablet contains 40 mg of telmisartan and 5 mg of amlodipine (as amlodipine besilate). Each tablet contains 40 mg of telmisartan and 10 mg of amlodipine (as amlodipine besilate). Each tablet contains 80 mg of telmisartan and 5 mg of amlodipine (as amlodipine besilate). Each tablet contains 80 mg of telmisartan and 10 mg of amlodipine (as amlodipine besilate).
• Other ingredients are: sodium hydroxide; meglumine; povidone K-25; red iron oxide (E172) (for the Telam 40 mg+5 mg dose and for the Telam 80 mg+5 mg dose); yellow iron oxide (E172) (for the Telam 40 mg+10 mg dose and for the Telam 80 mg+10 mg dose); mannitol; microcrystalline cellulose; crospovidone; magnesium stearate; pregelatinized corn starch; corn starch; colloidal anhydrous silica.

What Telam looks like and contents of the pack
Telam 40 mg+5 mg tablets: two-layered tablets, white or almost white on one side,
pink on the other side, slight speckling on the pink side acceptable, elongated,
(12.2 - 12.8 mm x 5.7 - 6.3 mm), biconvex.
Telam 40 mg+10 mg tablets: two-layered tablets, white or almost white on one side,
yellow on the other side, slight speckling on the yellow side acceptable, elongated,
(12.2 - 12.8 mm x 5.7 - 6.3 mm), biconvex.
Telam 80 mg+5 mg tablets: two-layered tablets, white or almost white on one side,
pink on the other side, slight speckling on the pink side acceptable, elongated,
(14.7 - 15.3 mm x 7.0 - 7.6 mm), biconvex.
Telam 80 mg+10 mg tablets: two-layered tablets, white or almost white on one side,
yellow on the other side, slight speckling on the yellow side acceptable, elongated,
(14.7 - 15.3 mm x 7.0 - 7.6 mm), biconvex.
Telam is available in cardboard packs containing 14, 28, 30, 56, 90, or 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
tel. + 48 22 364 61 01