TELMISARTAN 80 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Telmisartan Bluefish, 40 mg, tablets
3. Telmisartan Bluefish, 80 mg, tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Telmisartan Bluefish and what is it used for
5. Important information before taking Telmisartan Bluefish
   1. When not to take Telmisartan Bluefish
   2. Warnings and precautions
   3. Children and adolescents
   4. Telmisartan Bluefish and other medicines
   5. Telmisartan Bluefish with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
6. How to take Telmisartan Bluefish
   1. Taking a higher dose of Telmisartan Bluefish than recommended
   2. Missing a dose of Telmisartan Bluefish
7. Possible side effects
   1. Reporting side effects
8. How to store Telmisartan Bluefish
9. Contents of the packaging and other information
   1. What Telmisartan Bluefish contains
   2. What Telmisartan Bluefish looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Leaflet accompanying the packaging: patient information

Telmisartan Bluefish, 40 mg, tablets

Telmisartan Bluefish, 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 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 Telmisartan Bluefish and what is it used for
• 2. Important information before taking Telmisartan Bluefish
• 3. How to take Telmisartan Bluefish
• 4. Possible side effects
• 5. How to store Telmisartan Bluefish
• 6. Contents of the packaging and other information

1. What is Telmisartan Bluefish and what is it used for

Telmisartan Bluefish contains the active substance telmisartan. Telmisartan Bluefish 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. Telmisartan Bluefish blocks the action of angiotensin II, causing blood vessels to relax and blood pressure to decrease.
Telmisartan Bluefish is usedto treat essential hypertension (high blood pressure) in adults. 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 often, before the above 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.
Telmisartan Bluefish is also usedto reduce the risk of cardiovascular events (such as heart attack or stroke) in adults at risk, who have been diagnosed with reduced blood flow to the heart or legs, who have had a stroke, or who have been diagnosed with diabetes. The doctor will inform the patient if they are at risk of these disorders.

2. Important information before taking Telmisartan Bluefish

When not to take Telmisartan Bluefish

• if the patient is allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6);
• after the third month of pregnancy (it is also recommended to avoid taking Telmisartan Bluefish in early pregnancy - see section "Pregnancy");
• if the patient has severe liver problems, such as cholestasis or biliary obstruction (disorders of 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.

Inform your doctor or pharmacist before taking Telmisartan Bluefish if any of the above conditions apply to you.

Warnings and precautions

Inform 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 sodium retention in the body, accompanied by electrolyte imbalance).
• Low blood pressure (hypotension), which is more likely if the patient is dehydrated (excessive water loss from the body) or has low sodium levels due to the use of diuretics, a low-sodium diet, diarrhea, or vomiting.
• High potassium levels in the blood.
• Diabetes.

Before starting Telmisartan Bluefish, discuss with your doctor:

• if you are taking any of the following blood pressure-lowering medicines:
• an angiotensin-converting enzyme (ACE) inhibitor, such as enalapril, lisinopril, or ramipril, especially if you have kidney problems related to diabetes,
• aliskiren. Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood. See also section "When not to take Telmisartan Bluefish" and "Warnings and precautions".
• if you are taking digoxin.

Tell your doctor if you think you might be pregnant or plan to have a baby. It is not recommended to take Telmisartan Bluefish in early pregnancy, and it should not be taken after the third month of pregnancy (see section "Pregnancy").
In case of planned surgery or anesthesia, inform your doctor that you are taking Telmisartan Bluefish.
Telmisartan Bluefish may be less effective in lowering blood pressure in black patients.

Children and adolescents

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

Telmisartan Bluefish and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Your doctor may recommend changing the dose or taking 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 Telmisartan Bluefish:

• Lithium preparations used to treat certain types of depression.
• Medicines that may increase potassium levels in the blood, such as potassium-sparing diuretics, certain 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 in high doses, as this may lead to significant water loss from the body and low blood pressure (hypotension).
• ACE inhibitors or aliskiren (see also sections "When not to take Telmisartan Bluefish" and "Warnings and precautions").
• Digoxin.

As with other blood pressure-lowering medicines, the effect of Telmisartan Bluefish may be weakened if taken with non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen) or corticosteroids.
Telmisartan Bluefish may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines with blood pressure-lowering properties (e.g., baclofen, amifostine). Additionally, low blood pressure may be enhanced by alcohol, barbiturates, opioids, or antidepressants. The symptom is dizziness when standing up. If necessary, adjust the dose of another medicine taken with Telmisartan Bluefish, consult your doctor.

Telmisartan Bluefish with food and drink

Telmisartan Bluefish can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy
If you think you might be pregnant or plan to have a baby, consult your doctor. Usually, the doctor will recommend stopping Telmisartan Bluefish before planned pregnancy or as soon as pregnancy is detected and recommend another medicine instead of Telmisartan Bluefish. It is not recommended to take Telmisartan Bluefish in early pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the baby if taken after 3 months of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take Telmisartan Bluefish while breastfeeding. The doctor may recommend taking another medicine if you want to breastfeed, especially if you are breastfeeding a newborn or premature baby.

Driving and using machines

Some patients taking Telmisartan Bluefish may experience dizziness or fatigue.
In such cases, do not drive or operate machinery.
The medicine contains less than 1 mmol (23 mg) of sodium per 40 mg tablet, which means the medicine is considered "sodium-free".
The medicine contains less than 1 mmol (23 mg) of sodium per 80 mg tablet, which means the medicine is considered "sodium-free".

3. How to take Telmisartan Bluefish

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
The recommended dose of Telmisartan Bluefish is one tablet per day. Try to take the tablet at the same time every day.
Telmisartan Bluefish can be taken with or without food. Swallow the tablet with water or another non-alcoholic drink. It is essential to take Telmisartan Bluefish every day, unless your doctor tells you to stop. If you feel that the effect of Telmisartan Bluefish is too strong or too weak, consult your doctor or pharmacist.
In the treatment of high blood pressure, the usual dose of Telmisartan Bluefish is 40 mg once daily for most patients, which provides 24-hour blood pressure control. In some patients, the doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Telmisartan Bluefish can also be given in combination with a diuretic, such as hydrochlorothiazide, which enhances the blood pressure-lowering effect of Telmisartan Bluefish.
To reduce the risk of cardiovascular events, the usual dose of Telmisartan Bluefish is 80 mg once daily. At the beginning of treatment, blood pressure should be frequently monitored.
In patients with liver function disorders, the recommended dose should not exceed 40 mg once daily.

Taking a higher dose of Telmisartan Bluefish than recommended

In case of accidental ingestion of too many tablets, contact your doctor or go to the emergency department of the nearest hospital immediately.

Missing a dose of Telmisartan Bluefish

If you miss a dose, take it as soon as you remember, and then continue taking the medicine as scheduled. If you do not take the tablet within a day, take the usual dose the next day. Do not take a double dose to make up for a missed dose.
If you have any further doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Telmisartan Bluefish can cause side effects, although not everybody gets them.
Some side effects may be serious and may require immediate medical attention:
If you experience any of the following symptoms, contact your doctor immediately:
Septicemia* (often referred to as blood poisoning, a severe infection with an inflammatory reaction throughout the body), sudden swelling of the skin and mucous membranes (angioedema) - these are very serious side effects that occur rarely (may occur in up to 1 in 1,000 patients); in such cases, stop taking the medicine and contact your doctor immediately, as if left untreated, these symptoms may be fatal.
Possible side effects of Telmisartan Bluefish:
Common side effects (may occur in up to 1 in 10 patients):
Low blood pressure (hypotension) in patients treated to reduce the risk of cardiovascular events.
Uncommon side effects (may occur in 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, abdominal pain, diarrhea, discomfort in the abdomen, 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 up to 1 in 1,000 patients):
Septicemia* (often referred to as blood poisoning, a severe infection with an inflammatory reaction throughout the body, which may be fatal), increased white blood cell count (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reactions (e.g., rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in patients with diabetes), feeling of restlessness, drowsiness, vision disturbances, rapid heart rate (tachycardia), dryness of the mucous membranes of the mouth, gastritis, taste disturbances, liver problems (more common in patients of Japanese origin), sudden swelling of the skin and mucous membranes (angioedema, which may be fatal), skin eruption (skin disease), redness of the skin, hives, 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 up to 1 in 10,000 patients):
Progressive scarring of lung tissue (interstitial lung disease)**
*May occur spontaneously or for an unknown reason.
**During treatment with telmisartan, cases of progressive scarring of lung tissue have been reported. However, a causal relationship has not been established.

Reporting side effects

If you experience any side effects, including any side effects not listed in this 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
Al. Jerozolimskie 181 C
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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Telmisartan Bluefish

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. 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 Telmisartan Bluefish contains

The active substance is telmisartan
40 mg: Each tablet contains 40 mg of telmisartan.
80 mg: Each tablet contains 80 mg of telmisartan.
The other ingredients are sodium hydroxide, povidone (K25), meglumine, mannitol (E 421), magnesium stearate, and crospovidone.

What Telmisartan Bluefish looks like and contents of the pack

Telmisartan Bluefish, 40 mg, tablets are white, oblong tablets with debossed letters LC on one side, approximately 12.0 mm x 5.9 mm in size.
Telmisartan Bluefish, 80 mg, tablets are white, oblong tablets with debossed letters LC on one side, approximately 16.0 mm x 8.0 mm in size.
Telmisartan Bluefish is packaged in aluminum/aluminum blisters.
Pack sizes: 28 tablets

Marketing authorization holder

Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden

Manufacturer

Laboratorios Liconsa, S.A.
Avenida Miralcampo 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara
Spain

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

Poland
Telmisartan Bluefish 40 mg & 80 mg tablets
Portugal
Telmisartan Bluefish 40 mg & 80 mg comprimidos
Date of last revision of the leaflet:December 2024