TELMISARTAN 40 mg Tablets

Contents of the leaflet

1. Leaflet attached to 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 attached to 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 increased 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 in some cases can lead to heart attack, heart failure, or kidney disease, stroke, or vision loss. Most often, before the above complications appear, 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 frequency 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 "Pregnancy");
• if the patient has severe liver problems, such as cholestasis or biliary obstruction (obstruction 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.

The doctor or pharmacist should be informed before taking Telmisartan Bluefish if any of the above conditions apply to the patient.

Warnings and precautions

The doctor should be informed if the patient has or has 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.
• Increased 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, the patient should discuss the following with their doctor:

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

The doctor should be informed if the patient is pregnant or planning to become pregnant. Telmisartan Bluefish is not recommended during early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the fetus (see "Pregnancy").
In the event of planned surgery or anesthesia, the doctor should be informed about the use of Telmisartan Bluefish.
Telmisartan Bluefish may be less effective in lowering blood pressure in black patients.

Children and adolescents

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

Telmisartan Bluefish and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. The doctor may recommend a dose change or take other precautions. In some cases, it may be necessary to discontinue 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 and low blood pressure (hypotension).
• ACE inhibitors or aliskiren (see also "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 exacerbated by alcohol, barbiturates, opioids, or antidepressants. The symptom is dizziness when standing up. If necessary, the dose of another medicine taken with Telmisartan Bluefish should be adjusted, and the doctor should be consulted.

Telmisartan Bluefish with food and drink

Telmisartan Bluefish can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy
If the patient is pregnant or planning to become pregnant, they should consult their doctor. The doctor will usually recommend stopping Telmisartan Bluefish before planned pregnancy or as soon as pregnancy is detected and recommend another medicine instead of Telmisartan Bluefish. Telmisartan Bluefish is not recommended during early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the fetus if taken after 3 months of pregnancy.
Breastfeeding
The doctor should be informed about breastfeeding or the intention to breastfeed. Telmisartan Bluefish is not recommended during breastfeeding. The doctor may recommend taking another medicine if the patient wants to breastfeed, especially in the case of breastfeeding a newborn or premature baby.

Driving and using machines

Some patients taking Telmisartan Bluefish may experience dizziness or fatigue.
In such cases, driving or operating machines should be avoided.
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

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
The recommended dose of Telmisartan Bluefish is one tablet per day. The patient should try to take the tablet at the same time every day.
Telmisartan Bluefish can be taken with or without food. The tablets should be swallowed with water or another non-alcoholic liquid. It is essential to take Telmisartan Bluefish every day, unless the doctor recommends otherwise. If the patient feels that the effect of Telmisartan Bluefish is too strong or too weak, they should consult their 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 frequency of cardiovascular events, the usual dose of Telmisartan Bluefish is 80 mg once daily. Blood pressure should be frequently monitored at the beginning of treatment.
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, the doctor or the emergency department of the nearest hospital should be contacted immediately.

Missing a dose of Telmisartan Bluefish

If a dose is missed, it should be taken as soon as remembered, and then the patient should continue taking the medicine as scheduled. If the tablet is not taken within a day, the usual dose should be taken the next day. A double dose should not be taken to make up for a missed dose.
In case of further doubts about taking the medicine, the doctor or pharmacist should be consulted.

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 any of the following symptoms occur, the doctor should be contacted 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, the medicine should be stopped, and the doctor should be contacted 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 frequency 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, insomnia, depression, fainting, peripheral vertigo (dizziness), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, orthostatic hypotension (dizziness when standing up), shortness of breath, cough, abdominal pain, diarrhea, abdominal discomfort, bloating, vomiting, itching, excessive sweating, rash, back pain, muscle spasms, muscle pain, renal disorders, including acute renal 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 eosinophil count (a type of white blood cell), low platelet count (thrombocytopenia), severe allergic reaction (anaphylaxis), allergic reactions (e.g., rash, itching, difficulty breathing, wheezing, facial swelling, or low blood pressure), low blood sugar levels (in patients with diabetes), restlessness, drowsiness, vision disturbances, rapid heart rate (tachycardia), dry mouth, gastritis, taste disorders, liver function disorders (more common in patients of Japanese origin), sudden swelling of the skin and mucous membranes (angioedema, which may be fatal), erythema (skin disease), skin redness, urticaria, 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 fibrosis of lung tissue (interstitial lung disease)**
*May occur spontaneously or due to an unknown mechanism.
**During treatment with telmisartan, cases of progressive fibrosis of lung tissue have been reported. However, a causal relationship has not been established.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +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 the medicine.

5. How to store Telmisartan Bluefish

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 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. The pharmacist should be asked 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, elongated 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, elongated 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