ACTELSAR 80 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is Actelsar and what is it used for
   1. Important information before taking Actelsar
   2. When not to take Actelsar
   3. Warnings and precautions
   4. Children and adolescents
   5. Other medicines and Actelsar
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Actelsar contains sodium
3. How to take Actelsar
   1. Taking more than the recommended dose of Actelsar
   2. Missing a dose of Actelsar
4. Possible side effects
   1. Some side effects may be serious and require immediate medical attention:
   2. Possible side effects of Actelsar:
   3. Reporting side effects
   4. How to store Actelsar
5. Contents of the packaging and other information
   1. What Actelsar looks like and contents of the pack
   2. Marketing authorization holder
   3. Manufacturer

Leaflet attached to 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 questions, ask 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 you experience any side effects, including those not listed in this leaflet, tell your 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 packaging 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, allowing blood vessels to relax and lowering blood pressure.
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, there are no symptoms of high blood pressure before these complications occur. 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. Your doctor will tell you if you are at risk of these disorders.
2.

Important information before taking Actelsar

When not to take Actelsar

If any of the above situations apply to you, tell your doctor or pharmacist before taking Actelsar.

Warnings and precautions

Before starting Actelsar, tell your doctor if you 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 disorders)
• low blood pressure (hypotension), which is more likely if you are dehydrated (excessive water loss from the body) or have low salt levels due to taking diuretics, a low-salt diet, diarrhea, or vomiting
• high potassium levels in the blood
• diabetes.

Before starting Actelsar, discuss with your doctor:

• angiotensin-converting enzyme (ACE) inhibitors (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals.
See also the information under the heading "When not to take Actelsar".
If you experience stomach pain, nausea, vomiting, or diarrhea after taking Actelsar, discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Actelsar on your own.
Tell your doctor if you suspect or plan to become pregnant. Actelsar should not be taken in early pregnancy, and it must not be taken after the third month of pregnancy, as it may seriously harm the baby (see "Pregnancy").
If you are scheduled for surgery or anesthesia, inform your doctor that you are taking Actelsar.
Actelsar may be less effective in lowering blood pressure in black patients.

Children and adolescents

Actelsar should not be used in children and adolescents under 18 years of age.

Other medicines and Actelsar

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Your 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 can increase potassium levels in the blood, such as potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal 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 can lead to significant water loss and low blood pressure (hypotension)
• digoxin.

The effect of Actelsar may be reduced when taken with NSAIDs (non-steroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen) or corticosteroids.
Actelsar may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that can cause low blood pressure (e.g., baclofen, amifostine).
Additionally, low blood pressure can be further reduced by: alcohol, barbiturates, narcotics, and antidepressant drugs. The symptom is dizziness when standing up. If you need to adjust the dose of another medicine you are taking while taking Actelsar, consult your doctor.

Pregnancy and breastfeeding

Pregnancy
Tell your doctor if you suspect or plan to become pregnant. Usually, your doctor will advise you to stop taking Actelsar before planned pregnancy or as soon as you become pregnant and will prescribe another medicine instead of Actelsar. Actelsar should not be taken in early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the baby.
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. Actelsar is not recommended during breastfeeding. Your doctor may choose another treatment during breastfeeding, especially for newborns and premature babies.

Driving and using machines

Some patients taking Actelsar may experience dizziness or fatigue. If you experience dizziness or fatigue, consult your 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

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Actelsar is one tablet per day. Try to take the tablet at the same time every day. Actelsar can be taken with or without food. Swallow the tablet with water or another non-alcoholic drink. It is important to take Actelsar every day, unless your doctor tells you to stop. If you feel that the effect of Actelsar is too strong or too weak, talk to your 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 over 24 hours. However, your doctor may also prescribe 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 the 80 mg dose of Actelsar, blood pressure should be frequently monitored.
In patients with liver problems, the usual dose should not exceed 40 mg per day.

Taking more than the recommended dose of Actelsar

If you accidentally take too many tablets, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department.

Missing a dose of Actelsar

If you miss a dose, take it as soon as you remember, and then continue taking your medicine as prescribed. If you do not take a tablet during the entire day, take your usual dose the next day. Do nottake a double dose to make up for a missed dose.
If you have any further questions about taking your medicine, ask your 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 you experience any of the following symptoms, contact your doctor immediately:
sepsis* (often referred to as blood poisoning, a severe infection with inflammation of the whole body), 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 be life-threatening if not treated. If these symptoms are not treated, they may be fatal.

Possible side effects of Actelsar:

Common side effects (may affect up to 1 in 10 patients):
low blood pressure (hypotension) in patients treated to reduce the risk of cardiovascular events.
Uncommon side effects (may affect up to 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, difficulty sleeping, low mood (depression), fainting, spinning sensation (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, stomach pain, diarrhea, abdominal discomfort, bloating, vomiting, itching, excessive sweating, rash, back pain, muscle cramps, muscle pain, kidney problems, including acute kidney failure, chest pain, feeling weak, and increased creatinine levels in the blood.
Rare side effects (may affect up to 1 in 1,000 patients):
sepsis* (often referred to as blood poisoning, a severe infection with inflammation of the whole body, which can be life-threatening), increased white blood cell count (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reactions (e.g., rash, itching, breathing problems, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in patients with diabetes), feeling anxious, drowsiness, vision problems, fast heart rate (tachycardia), dry mouth, stomach upset, taste disorders, liver problems (more common in Japanese patients), sudden swelling of the skin and mucous membranes (angioedema), which can also be life-threatening, skin rash, skin redness, severe drug 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 affect up to 1 in 10,000 patients):
progressive scarring of the lungs (interstitial lung disease)**
Frequency not known (frequency cannot be estimated from the available data): angioedema of the intestine - after taking similar products, intestinal angioedema has occurred with symptoms such as stomach 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 you experience any side effects, including those not listed in this leaflet, tell your 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, you can help provide more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder.
5.

How to store Actelsar

Keep the medicine out of the 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Actelsar contains

• The active substance 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, 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