Telmisartan bluefish

Package leaflet: Information for the patient

Telmisartan Bluefish, 40 mg, tablets
Telmisartan Bluefish, 80 mg, tablets
Telmisartanum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Telmisartan Bluefish is and what it is used for
2. What you need to know before taking Telmisartan Bluefish
3. How to take Telmisartan Bluefish
4. Possible side effects
5. How to store Telmisartan Bluefish
6. Contents of the pack and other information

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

Telmisartan Bluefish contains the active substance telmisartan. Telmisartan Bluefish belongs to a group of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced by the body that causes blood vessels to narrow, 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 used to treat essential (primary) hypertension (high blood pressure) in adults. The term "essential" means that high blood pressure is not caused by another disease.

Untreated high blood pressure may damage blood vessels in various organs and, in some cases, may lead to heart attack, heart or kidney failure, stroke, or loss of vision. Often, there are no symptoms of high blood pressure before such complications occur. Therefore, it is important to measure blood pressure regularly to ensure it remains within normal limits.

Telmisartan Bluefish is also used to reduce the frequency of cardiovascular events (such as heart attack or stroke) in adult patients at risk, who have had reduced blood flow to the heart or legs, who have had a stroke, or who have diabetes. Your doctor will inform you if you belong to this high-risk group.

2. Important information before using Telmisartan Bluefish

When not to use 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 (use of Telmisartan Bluefish should also be avoided during early pregnancy – see section "Pregnancy");
• if the patient has severe liver disorders such as cholestasis or biliary obstruction (impaired bile flow from the liver and gallbladder) or any other severe liver disease;
• if the patient has diabetes or kidney dysfunction 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 status post kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels supplying one or both kidneys).
• Liver disease.
• Heart disorders.
• Elevated aldosterone levels (retention of water and sodium in the body accompanied by electrolyte imbalance).
• Low blood pressure (hypotension), which is more likely if the patient is dehydrated (excessive loss of body water) or has sodium deficiency due to diuretic (water pill) use, low-sodium diet, diarrhoea, or vomiting.
• Increased potassium levels in the blood.
• Diabetes.
• If abdominal pain, nausea, vomiting, or diarrhoea occur after taking Telmisartan Bluefish, discuss this with your doctor. Your doctor will decide whether treatment should continue. Do not stop taking Telmisartan Bluefish on your own.

Before starting Telmisartan Bluefish, discuss with your doctor:

• if you are taking any of the following medicines used to treat high blood pressure:
  • angiotensin-converting enzyme (ACE) inhibitors, such as enalapril, lisinopril, ramipril, particularly if you have kidney problems related to diabetes,
  • aliskiren. Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also section "When not to use Telmisartan Bluefish".
• if you are taking digoxin.

Tell your doctor if you think you may be pregnant or are planning to become pregnant. Telmisartan Bluefish is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy").

If you are scheduled for surgery or anaesthesia, 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 is not recommended for use in children and adolescents under 18 years of age.

Telmisartan Bluefish and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. Your doctor may need to adjust your dose or take other precautions. In some cases, one of the medicines may need to be discontinued. This particularly applies when taking the following medicines together with Telmisartan Bluefish:

• Lithium preparations used to treat certain types of depression.
• Medicines that may increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics (certain diuretics), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen), heparin, immunosuppressive medicines (e.g. cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics (water pills), especially in high doses, as this may lead to significant fluid loss and low blood pressure (hypotension).
• ACE inhibitors or aliskiren (see also sections "When not to use Telmisartan Bluefish" and "Warnings and precautions").
• Digoxin.

As with other blood pressure-lowering medicines, the effect of Telmisartan Bluefish may be reduced when taken together 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 antihypertensive medicines or medicines with blood pressure-lowering properties (e.g. baclofen, amifostine). In addition, low blood pressure may be intensified by alcohol, barbiturates, opioids, or antidepressants. Dizziness upon standing may occur. If dose adjustment of any other medicine taken during Telmisartan Bluefish therapy is needed, consult your doctor.

Telmisartan Bluefish with food and drink

Telmisartan Bluefish may be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

If you think you may be pregnant or are planning to become pregnant, consult your doctor. Your doctor will usually recommend stopping Telmisartan Bluefish before planned pregnancy or immediately after pregnancy is confirmed, and will prescribe an alternative medicine. Telmisartan Bluefish is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child if used beyond 3 months of gestation.

Breastfeeding

Inform your doctor if you are breastfeeding or intend to breastfeed. Telmisartan Bluefish is not recommended during breastfeeding. Your doctor may recommend an alternative medicine if you wish to breastfeed, especially if the infant is a newborn or premature.

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, meaning the medicine is considered "sodium-free".

The medicine contains less than 1 mmol (23 mg) of sodium per 80 mg tablet, meaning the medicine is considered "sodium-free".

3. How to use Telmisartan Bluefish

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, 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 each day.
Telmisartan Bluefish may be taken with or without food. Swallow the tablet with water or another non-alcoholic drink. It is important to take Telmisartan Bluefish every day unless your doctor advises otherwise. If you feel that the effect of Telmisartan Bluefish is too strong or too weak, consult your doctor or pharmacist.
For the treatment of high blood pressure, the usual dose of Telmisartan Bluefish is one 40 mg tablet once daily for most patients, providing 24-hour blood pressure control. For some patients, your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Telmisartan Bluefish may also be used in combination with a diuretic (water tablet), 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 one 80 mg tablet once daily. Blood pressure should be monitored frequently at the beginning of treatment.
In patients with impaired liver function, the usual dose must not exceed 40 mg once daily.
Taking more Telmisartan Bluefish than prescribed
If you accidentally take too many tablets, contact your doctor immediately or go to the nearest hospital emergency department.
Missing a dose of Telmisartan Bluefish
If you miss a dose, take it as soon as you remember, then continue taking the medicine according to your regular schedule. If the missed tablet is not taken within the same day, take your 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
Some adverse reactions may be serious and may require immediate medical attention:
If any of the following symptoms occur, contact your doctor immediately:
Sepsis* (often referred to as blood poisoning, a severe infection causing systemic inflammatory response) and sudden swelling of the skin and mucous membranes (angioedema) – these are very serious adverse reactions which are rare (may occur in up to 1 in 1,000 patients). In such cases, treatment with this medicine must be discontinued immediately and medical advice sought urgently, because if left untreated, these symptoms may result in death.

Possible adverse reactions of Telmisartan Bluefish:
Common adverse reactions (may occur in up to 1 in 10 patients):
Low blood pressure (hypotension) in patients treated to reduce the frequency of cardiovascular events.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), reduced number of red blood cells (anaemia), high potassium levels in plasma, difficulty falling asleep, low mood (depression), fainting, sensation of spinning (peripheral vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for hypertension, dizziness upon standing (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, abdominal discomfort, bloating, vomiting, itching, excessive sweating, drug eruption, back pain, muscle cramps, muscle pain, renal dysfunction including acute renal failure, chest pain, feeling of weakness, and increased blood creatinine levels.

Rare adverse reactions (may occur in up to 1 in 1,000 patients):
Sepsis* (often referred to as blood poisoning, a severe infection causing systemic inflammatory response which may lead to death), increased number of certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reactions (e.g. rash, itching, breathing difficulties, wheezing, facial swelling or low blood pressure), low blood sugar levels (in patients with diabetes), feeling of restlessness, drowsiness, visual disturbances, rapid heart rate (tachycardia), dryness of the oral mucosa, gastritis, taste disturbances, liver function abnormalities (occurring more frequently in patients of Japanese origin), sudden swelling of the skin and mucous membranes (angioedema, including fatal cases), skin eruption (skin disease), redness of the skin, urticaria, severe drug eruption, joint pain, limb pain, tendon pain, influenza-like symptoms, decreased haemoglobin concentration (a protein in the blood), increased uric acid levels, increased liver enzyme activity or increased creatine kinase levels in blood.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):
Progressive lung tissue fibrosis (interstitial lung disease)**

Frequency not known (frequency cannot be estimated from the available data):
Angioedema of the intestine – with similar medicinal products, intestinal angioedema has been reported, presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

*May occur incidentally or due to an unknown mechanism.
**Cases of progressive lung tissue fibrosis have been reported during treatment with telmisartan. However, a causal relationship has not been established.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions may also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Telmisartan Bluefish

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after:
"EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack 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 the engraved 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 the engraved letters LC on one side, approximately 16.0 mm x 8.0 mm in size.
Telmisartan Bluefish is packed in aluminium/aluminium foil blisters.
Pack sizes: 28 tablets

Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Poland: Telmisartan Bluefish 40 mg & 80 mg tablets
Portugal: Telmisartan Bluefish 40 mg & 80 mg comprimidos