TELAM 80 mg/10 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Telam, 40 mg+5 mg, tablets
3. Telam, 40 mg+10 mg, tablets
4. Telam, 80 mg+5 mg, tablets
5. Telam, 80 mg+10 mg, tablets
   1. You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
6. What is Telam and what is it used for
7. Important information before taking Telam
   1. When not to take Telam
   2. Warnings and precautions
   3. Children and adolescents
   4. Telam and other medicines
   5. Telam with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Telam contains sodium
8. How to take Telam
   1. Taking a higher dose of Telam than recommended
   2. Missing a dose of Telam
   3. Stopping treatment with Telam
9. Possible side effects
   1. Some side effects may be serious and require immediate medical attention:
   2. Reporting side effects
10. How to store Telam
11. Contents of the packaging and other information
    1. What Telam contains
    2. What Telam looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Telam, 40 mg+5 mg, tablets

Telam, 40 mg+10 mg, tablets

Telam, 80 mg+5 mg, tablets

Telam, 80 mg+10 mg, tablets

Telmisartan+Amlodipine

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• -You should keep this leaflet, so that you can read it again if you need to.
• -If you have 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 as yours.
• -If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Telam and what is it 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 packaging and other information

1. What is Telam and what is it used for

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

• Telmisartan belongs to a group of angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to constrict, which increases blood pressure. Telmisartan works by blocking the action of angiotensin II.
• Amlodipine belongs to a group of calcium antagonists. Amlodipine prevents calcium from entering the blood vessel walls, which prevents the blood vessels from constricting. This means that both active substances prevent the blood vessels from constricting. As a result, the medicine causes blood vessels to relax and lowers blood pressure.

Telam is used to treathigh blood pressure:

• in adult patients whose blood pressure is not adequately controlled with amlodipine alone,
• in adult patients already taking telmisartan and amlodipine in the same doses as in Telam, who for convenience wish to take telmisartan and amlodipine in one tablet.

Untreated high blood pressure can lead to damage to blood vessels in several organs, which can increase the risk of serious complications such as heart attack, heart failure or kidney failure, stroke or blindness. Usually, there are no symptoms of high blood pressure before organ damage occurs. Therefore, regular blood pressure checks are important to confirm whether the values are normal.

2. Important information before taking Telam

When not to take Telam

• if you are allergic to telmisartan or amlodipine or any of the other ingredients of this medicine (listed in section 6);
• if you have been diagnosed with an allergy to other dihydropyridine derivatives (a type of calcium antagonist);
• after the third month of pregnancy (you should also avoid taking Telam in early pregnancy, see section Pregnancy);
• if you have severe liver disease or bile duct obstruction (disorders of bile flow from the liver or gallbladder);
• if you have a narrowing of the aortic valve in the heart (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply enough blood to the body);
• if you have heart failure after a heart attack;
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are in any of the above situations, you should discuss this with your doctor before taking Telam.

Warnings and precautions

Before starting to take Telam, you should consult a doctor if you have or have had any of the following disorders or diseases:

• kidney disease or a kidney transplant;
• narrowing of the blood vessels of one or both kidneys (renal artery stenosis);
• liver disease;
• heart disease;
• increased aldosterone levels (which can lead to water and salt retention in the body, including electrolyte disturbances in the blood);
• low blood pressure (hypotension), which occurs especially in patients who are dehydrated (with excessive fluid loss from the body) or have a low sodium level due to the use of diuretics, a low-salt diet, diarrhea, or vomiting;
• high potassium levels in the blood;
• diabetes;
• aortic narrowing;
• chest pain related to the heart, also at rest or with minimal exertion (unstable angina);
• heart attack within the last four weeks.

Before starting to take Telam, you should discuss this with your doctor:

• if you are taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme inhibitors (ACE inhibitors) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren. Your doctor may prescribe regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the information under the heading "When not to take Telam" and "Warnings and precautions".
• if you are elderly and the dose of the medicine needs to be increased.

In the event of planned surgery (surgical procedure) or anesthesia, you should inform your doctor that you are taking Telam.
If you experience abdominal pain, nausea, vomiting, or diarrhea after taking Telam, you should discuss this with your doctor. Your doctor will decide on further treatment. You should not stop taking Telam on your own.

Children and adolescents

Telam should not be used in children and adolescents under the age of 18.

Telam and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Your doctor may recommend changing the dose of these medicines or taking other precautions. In some cases, it may be necessary to stop taking one of these medicines.
This applies in particular to the simultaneous use of Telam with the following medicines:

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

As with other blood pressure-lowering medicines, the effect of Telam may be reduced when taken 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 can be felt as dizziness when standing up.
While taking Telam, you should not drink grapefruit juice or eat grapefruits, as grapefruit and grapefruit juice may lead to increased levels of the active substance amlodipine in the blood and enhance the blood pressure-lowering effect of Telam.

Pregnancy and breastfeeding

Pregnancy
You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will usually recommend stopping Telam before planned pregnancy or as soon as possible after confirming pregnancy, and will recommend taking a different medicine instead of Telam. Telam should not be used in early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the baby.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk.
You should inform your doctor if you are breastfeeding or plan to breastfeed. Telam should not be used during breastfeeding, especially in the case of breastfeeding a newborn or premature baby. Your doctor may recommend a different medicine.
Before taking any medicine, you should consult a doctor or pharmacist.

Driving and using machines

Some patients treated for high blood pressure may experience side effects such as fainting, drowsiness, dizziness, or a feeling of spinning. If you experience such side effects, you should not drive or operate machinery.

Telam contains sodium

Telam contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is essentially "sodium-free".

3. How to take Telam

This medicine should always be taken exactly as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
The recommended dose is one tablet per day.
The maximum recommended dose is one tablet of 80 mg telmisartan + 10 mg amlodipine per day.
You should try to take the tablet at the same time every day.
The tablet of Telam should be removed from the blister pack immediately before taking.
Telam can be taken with or without food. The tablets should be swallowed with a small amount of water or another non-alcoholic drink (except grapefruit juice).
If you have liver problems, the usual dose should not exceed one tablet of 40 mg+5 mg or one tablet of 40 mg+10 mg per day.

Taking a higher dose of Telam than recommended

If you have taken too many tablets, you should immediately contact a doctor, pharmacist, or go to the emergency department of the nearest hospital. You may experience low blood pressure and a rapid heart rate. Slow heart rate, dizziness, worsening of kidney function, including kidney failure, significant and prolonged low blood pressure, including shock and death, have also been reported.
Even up to 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Telam

If you miss a dose, you should take it as soon as possible and continue taking the medicine as directed by your doctor. If you miss a tablet one day, you should take the usual dose of Telam the next day at the usual time.
You should not take a double dose to make up for the missed dose.

Stopping treatment with Telam

It is important to take Telam every day, unless your doctor tells you to stop. If you feel that the effect of Telam is too strong or too weak, you should consult your doctor or pharmacist.
If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects may be serious and require immediate medical attention:

If you experience any of the following symptoms, you should contact your doctor immediately:
Septicemia (often referred to as blood poisoning, being an infection of the entire body, with high fever and very poor general condition), sudden swelling of the skin and mucous membranes (angioedema).
These side effects are rare (may occur in less than 1 in 1000 patients), but are very serious, and in such cases, you should stop taking the medicine and contact your doctor immediately. If left untreated, these side effects can be fatal. An increased incidence of septicemia has been observed in patients taking telmisartan monotherapy; however, it cannot be ruled out in the case of Telam therapy.
Common(may occur in less than 1 in 10 patients):
Dizziness, swelling of the ankles.
Uncommon(may occur in less than 1 in 100 patients):
Drowsiness, migraine, headache, tingling or numbness of the hands or feet, feeling of spinning, slow heart rate, palpitations (awareness of heartbeat), low blood pressure (hypotension), dizziness when standing up (orthostatic hypotension), sudden flushing (especially of the face), cough, stomach pain (abdominal pain), diarrhea, nausea, itching, joint pain, muscle cramps, muscle pain, erectile dysfunction, weakness, chest pain, swelling (edema), increased liver enzyme activity.
Rare(may occur in less than 1 in 1000 patients):
Urinary tract infections, feeling of sadness (depression), anxiety, insomnia, fainting, nerve damage in the hands or feet, decreased sensitivity to touch, taste disturbances, tremors, vomiting, gum hypertrophy, abdominal complaints, dryness of the mucous membranes of the mouth, rash (skin disorder), redness of the skin, rash, back pain, leg pain, nocturia, malaise, increased uric acid levels in the blood.
Very rare(may occur in less than 1 in 10,000 patients):
Progressive scarring of lung tissue (interstitial lung disease [mainly interstitial pneumonia and eosinophilic pneumonia]).
The following side effects have been reported with telmisartan or amlodipine; these side effects may also occur with Telam:
Telmisartan
Patients taking telmisartan alone have reported the following additional side effects:
Uncommon(may occur in less than 1 in 100 patients):
Urinary tract infections, upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), anemia, high potassium levels in the blood, shortness of breath, bloating, increased sweating, kidney damage, including sudden kidney failure, increased creatinine levels.
Rare(may occur in less than 1 in 1000 patients):
Increased white blood cell count of a certain type (eosinophilia), low platelet count (thrombocytopenia), allergic reaction (e.g., rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), vision disturbances, rapid heart rate, gastritis, abnormal liver function, hives, drug rash, tendonitis, flu-like syndrome (e.g., muscle pain, general poor condition), decreased hemoglobin levels (a protein in the blood), increased phosphocreatine kinase activity in the blood, low sodium levels.
Most cases of abnormal liver function or liver damage after the introduction of telmisartan to the market occurred in Japanese patients. The likelihood of this side effect is higher in Japanese patients.
Unknown(frequency cannot be estimated from the available data):
Angioedema of the intestine - after the use of similar products, angioedema of the intestine has been reported with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
Amlodipine
Patients taking amlodipine alone have reported the following additional side effects:
Common(may occur in less than 1 in 10 patients):
Changes in bowel habits, diarrhea, constipation, vision disturbances, double vision, swelling of the ankles.
Uncommon(may occur in less than 1 in 100 patients):
Mood changes, vision disturbances, ringing in the ears, shortness of breath, 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 less than 1 in 1000 patients):
Confusional state.
Very rare(may occur in less than 1 in 10,000 patients):
Decreased white blood cell count (leukopenia), low platelet count (thrombocytopenia), allergic reaction (e.g., rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), high blood sugar levels, uncontrolled muscle twitching or cramps, heart attack, arrhythmias, vasculitis, pancreatitis, gastritis, liver disease, jaundice, increased liver enzyme activity with jaundice, sudden swelling of the skin and mucous membranes (angioedema), severe skin reactions, hives, severe allergic reactions with blisters on the skin and mucous membranes (Stevens-Johnson syndrome), increased sensitivity of the skin to sunlight, increased muscle tension.
Unknown(frequency cannot be estimated from the available data):
Severe allergic reactions with blisters on the skin and mucous membranes (toxic epidermal necrolysis).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should 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
Al. Jerozolimskie 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 Telam

The medicine should be stored 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.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT, it indicates the batch number.
Store in the original packaging to protect from light. The tablet of Telam should be removed from the blister pack immediately before taking.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Telam contains

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

What Telam looks like and contents of the pack

Telam 40 mg+5 mg tablets: two-layer tablets, white or almost white on one side, pink on the other side, with slight speckling allowed on the pink side, oblong, (12.2 - 12.8 mm x 5.7 - 6.3 mm), biconvex.
Telam 40 mg+10 mg tablets: two-layer tablets, white or almost white on one side, yellow on the other side, with slight speckling allowed on the yellow side, oblong, (12.2 - 12.8 mm x 5.7 - 6.3 mm), biconvex.
Telam 80 mg+5 mg tablets: two-layer tablets, white or almost white on one side, pink on the other side, with slight speckling allowed on the pink side, oblong, (14.7 - 15.3 mm x 7.0 - 7.6 mm), biconvex.
Telam 80 mg+10 mg tablets: two-layer tablets, white or almost white on one side, yellow on the other side, with slight speckling allowed on the yellow side, oblong, (14.7 - 15.3 mm x 7.0 - 7.6 mm), biconvex.
Telam is available in a carton containing 14, 28, 30, 56, 90, 98 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19
83-200 Starogard Gdański
Phone: +48 22 364 61 01

Date of last revision of the leaflet: