Actelsar

Leaflet accompanying the packaging: patient information

Actelsar, 40 mg, tablets
Actelsar, 80 mg, tablets
Telmisartan

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any further doubts, consult your 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Actelsar and what is it used for

Actelsar belongs to a group of medicines called angiotensin II receptor antagonists.
Angiotensin II is a substance produced by the body that causes blood vessels to constrict, leading to an increase in blood pressure. Actelsar blocks the action of angiotensin II, causing blood vessels to relax and blood pressure to decrease.
Actelsar is used totreat essential hypertension (high blood pressure). The term "essential" means that high blood pressure is not caused by another disease.
Untreated high blood pressure can cause damage to blood vessels in various organs, which can lead to heart attack, heart failure, or kidney disease, stroke, or vision loss. Most of the time, before these complications occur, no symptoms of high blood pressure are observed. Therefore, it is essential to regularly measure blood pressure to check if it is within the normal range.
Actelsar is also used toreduce the risk of cardiovascular events (such as heart attack or stroke) in adults at risk, i.e., those with reduced blood flow to the heart or legs, those who have had a stroke, or those with diabetes. The doctor will inform the patient if they are at risk of these disorders.
2.

Important information before taking Actelsar

When not to take Actelsar

• if the patient is allergic to telmisartan or any other ingredient of this medicine (listed in section 6) after the third month of pregnancy (also, Actelsar should be avoided during early pregnancy - see "Pregnancy")
• if the patient has severe liver dysfunction, such as cholestasis or biliary obstruction (problems with bile flow from the liver and gallbladder), or any other severe liver disease.
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to the patient, they should inform their doctor or pharmacist before taking Actelsar.

Warnings and precautions

Before starting Actelsar, the patient should consult their doctor if they have or have had any of the following conditions or diseases:

• kidney disease or kidney transplant
• renal artery stenosis (narrowing of the blood vessels supplying one or both kidneys)
• liver disease
• heart problems
• high aldosterone levels (water and salt retention in the body, accompanied by mineral imbalance)
• low blood pressure (hypotension), which is more likely if the patient is dehydrated (excessive water loss from the body) or has a low salt level due to diuretic use, low-salt diet, diarrhea, or vomiting
• high potassium levels in the blood
• diabetes.

Before starting Actelsar, the patient should discuss the following with their doctor:

• if the patient is taking digoxin
• if the patient is taking any of the following blood pressure-lowering medicines:
• angiotensin-converting enzyme (ACE) inhibitors (e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes
• aliskiren.

The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals.
See also the information under the heading "When not to take Actelsar".
If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Actelsar, they should discuss this with their doctor. The doctor will decide on further treatment. The patient should not stop taking Actelsar on their own.
The patient should inform their doctor if they suspect or plan to become pregnant. Actelsar should not be taken during early pregnancy, and it is contraindicated after the third month of pregnancy, as it may seriously harm the fetus (see "Pregnancy").
In case of planned surgery or anesthesia, the patient should inform their doctor about taking Actelsar.
Actelsar may be less effective in lowering blood pressure in black patients.

Children and adolescents

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

Other medicines and Actelsar

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take. The doctor may need to change the dose and/or take other precautions. In some cases, it may be necessary to stop taking one of the medicines. This is especially true for the following medicines taken with Actelsar:

• lithium preparations used to treat certain types of depression
• medicines that may increase potassium levels in the blood, such as potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, nonsteroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen), heparin, immunosuppressive drugs (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim
• diuretics, especially when taken in high doses with Actelsar, as they may lead to significant water loss and low blood pressure (hypotension)
• if the patient is taking an ACE inhibitor or aliskiren (see also the information under the headings "When not to take Actelsar" and "Warnings and precautions")
• digoxin.

The effect of Actelsar may be reduced when taken with NSAIDs or corticosteroids.
Actelsar may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that may cause a decrease in blood pressure (e.g., baclofen, amifostine).
Additionally, low blood pressure may be further reduced by: alcohol, barbiturates, narcotics, and antidepressant drugs. The symptom is dizziness when standing up. If necessary, the dose of another medicine taken by the patient during Actelsar treatment should be adjusted, and the patient should consult their doctor.

Pregnancy and breastfeeding

Pregnancy
The patient should inform their doctor if they suspect or plan to become pregnant. Usually, the doctor will advise stopping Actelsar before planned pregnancy or immediately after pregnancy is confirmed and will prescribe another medicine instead of Actelsar. Actelsar is not recommended during early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the fetus.
Breastfeeding
The patient should tell their doctor if they are breastfeeding or plan to breastfeed. Actelsar is not recommended during breastfeeding. The doctor may choose another treatment during breastfeeding, especially in the case of newborns and premature infants.

Driving and using machines

Some patients taking Actelsar may experience dizziness or fatigue. If dizziness or fatigue occurs, the patient should consult their doctor before performing these activities.

Actelsar contains sodium

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

3. How to take Actelsar

This medicine should always be taken as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
The recommended dose of Actelsar is one tablet per day. The patient should try to take the tablet at the same time every day. Actelsar can be taken with or without food. The tablets should be swallowed with water or another non-alcoholic liquid.
It is essential to take Actelsar every day, unless the doctor advises otherwise. If the patient feels that the effect of Actelsar is too strong or too weak, they should consult their doctor or pharmacist.
In the treatment of high blood pressure, the usual dose of Actelsar is one 40 mg tablet per day for most patients, which provides blood pressure control for more than 24 hours. However, the doctor may also recommend a lower dose of 20 mg per day or a higher dose of 80 mg. Alternatively, Actelsar may be given in combination with a diuretic, such as hydrochlorothiazide, which enhances the blood pressure-lowering effect of Actelsar.
To reduce the risk of cardiovascular events, the usual dose of Actelsar is one 80 mg tablet per day. At the start of treatment with an 80 mg dose of Actelsar, blood pressure should be frequently monitored.
In patients with liver dysfunction, the usual dose should not exceed 40 mg per day.

Taking a higher dose of Actelsar than recommended

If too many tablets are taken by mistake, the patient should immediately contact their doctor or pharmacist or the nearest hospital emergency department.

Missing a dose of Actelsar

If a dose is missed, the patient should take it as soon as they remember, and then continue taking the medicine as scheduled. If the tablet is not taken within a day, the patient should take the usual dose the next day. Do nottake a double dose to make up for a missed dose.
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

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

If the patient experiences any of the following symptoms, they should immediately contact their doctor:
sepsis* (often referred to as blood poisoning, a severe infection with a systemic inflammatory response), sudden swelling of the skin and mucous membranes (angioedema). These side effects are rare (may occur in less than 1 in 1,000 patients), but they are extremely serious and may require stopping the medicine and immediate medical attention. If left untreated, these symptoms may be fatal.

Possible side effects of Actelsar:

Common side effects (may occur in less than 1 in 10 patients):
low blood pressure (hypotension) in patients treated to reduce the risk of cardiovascular events.
Uncommon side effects (may occur in less than 1 in 100 patients):
urinary tract infections, upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), decreased red blood cell count (anemia), high potassium levels in the blood, insomnia, depression, fainting, dizziness (peripheral vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, dizziness when standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhea, abdominal discomfort, bloating, vomiting, itching, excessive sweating, rash, back pain, muscle spasms, muscle pain, kidney problems, including acute kidney failure, chest pain, feeling of weakness, and increased creatinine levels in the blood.
Rare side effects (may occur in less than 1 in 1,000 patients):
sepsis* (often referred to as blood poisoning, a severe infection with a systemic inflammatory response), increased white blood cell count (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylaxis), allergic reactions (e.g., rash, itching, breathing problems, wheezing, facial swelling, or low blood pressure), low blood sugar levels (in patients with diabetes), feeling of restlessness, drowsiness, vision disturbances, rapid heart rate (tachycardia), dry mouth, gastritis, taste disturbances, liver problems (more common in patients of Japanese origin), sudden swelling of the skin and mucous membranes (angioedema), which may also be fatal, erythema multiforme (a skin disease), skin redness, severe rash, joint pain, limb pain, tendon pain, flu-like symptoms, decreased hemoglobin levels (a protein in the blood), increased uric acid levels, increased liver enzyme activity or creatine phosphokinase in the blood.
Very rare side effects (may occur in less than 1 in 10,000 patients):
progressive scarring of the lung tissue (interstitial lung disease)**
Frequency not known (frequency cannot be estimated from the available data): angioedema of the intestine - after using similar products, intestinal angioedema has been reported with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
* The event may be coincidental or related to an unknown mechanism.
** Cases of interstitial lung disease have been reported in association with telmisartan. However, a causal relationship has not been established.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
By reporting side effects, more information can be collected on the safety of the medicine. Side effects can also be reported to the marketing authorization holder.
5.

How to store Actelsar

Keep the 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.
Store in the original packaging to protect the tablets from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Actelsar contains

• The active substance of Actelsar is telmisartan. Each tablet contains 40 mg or 80 mg of telmisartan.
• The other ingredients are: magnesium stearate, croscarmellose sodium, mannitol (E 421), povidone (K-29/32), potassium hydroxide.

What Actelsar looks like and contents of the pack

Actelsar, 40 mg: white, oval, biconvex tablets with a score line and logo T on one side.
The tablet can be divided into two halves.
Actelsar, 80 mg: white, oval, biconvex tablets with logo T1 on one side.
Actelsar is available in aluminum/aluminum blisters containing 28, 30, or 56 tablets (Actelsar, 40 mg) and 28, 30, 56, or 84 tablets (Actelsar, 80 mg).

Marketing authorization holder

Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer

Actavis Ltd.
BLB015-016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, the patient should contact the representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.
Date of last revision of the leaflet:January 2025