Telmisartanum Teva B.v.

Leaflet attached to the packaging: information for the user

Telmisartanum Teva B.V., 40 mg, tablets
Telmisartanum Teva B.V., 80 mg, tablets
Telmisartanum

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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 Telmisartanum Teva B.V. and what is it used for
• 2. Important information before taking Telmisartanum Teva B.V.
• 3. How to take Telmisartanum Teva B.V.
• 4. Possible side effects
• 5. How to store Telmisartanum Teva B.V.
• 6. Contents of the pack and other information

1. What is Telmisartanum Teva B.V. and what is it used for

Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists.
Angiotensin II is a substance produced in the body that narrows blood vessels, causing an increase in blood pressure. Telmisartan blocks the action of angiotensin II, causing blood vessels to dilate and blood pressure to decrease.

Telmisartanum Teva B.V. is used

to 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.
2 Important information before taking Telmisartanum Teva B.V.

When not to take Telmisartanum Teva B.V.

• after the third month of pregnancy (You should also avoid taking Telmisartanum Teva B.V. during early pregnancy - see section "Pregnancy");

If any of the above situations apply to you, tell your doctor or pharmacist before taking Telmisartanum Teva B.V..

Warnings and precautions

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 balance disorders in the blood).
• 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 taking Telmisartanum Teva B.V., tell 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 Telmisartanum Teva B.V.".
• if you are taking digoxin.

Tell your doctor if you suspect (or plan) pregnancy. It is not recommended to take Telmisartanum Teva B.V. during early pregnancy and it should not be taken after the third month of pregnancy, as taking the medicine during this period can be very harmful to the baby (see section "Pregnancy").
In case of planned surgery or anesthesia, inform your doctor that you are taking Telmisartanum Teva B.V..
Telmisartanum Teva B.V. may be less effective in lowering blood pressure in black patients.

Children and adolescents

Telmisartanum Teva B.V. should not be used in children and adolescents under 18 years of age.

Other medicines and Telmisartanum Teva B.V.

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Your doctor may decide to change the dose of these medicines or take other precautions.
In some cases, it may be necessary to stop taking one of the medicines. This is especially true when taking the following medicines with Telmisartanum Teva B.V.:

• Lithium preparations used to treat certain types of depression.
• Medicines that can increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics (some diuretics), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non-steroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen), heparin, immunosuppressive drugs (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim.

Medicines that can lower blood pressure (diuretics), especially when taken in high doses with Telmisartanum Teva B.V., as they can lead to significant water loss from the body and decreased blood pressure (hypotension).

• If you are taking an ACE inhibitor or aliskiren (see also the information under the heading "When not to take Telmisartanum Teva B.V." and "Warnings and precautions").
• Digoxin.

The effect of Telmisartanum Teva B.V. may be reduced when taking NSAIDs (non-steroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen) or corticosteroids.
Telmisartanum Teva B.V. may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that can cause a decrease in blood pressure (e.g., baclofen, amifostine).
Additionally, low blood pressure can be further reduced by: alcohol, barbiturates, narcotics, or antidepressants. The symptom is dizziness when standing up. If necessary, adjust the dose of other medicines you are taking while taking Telmisartanum Teva B.V., consult your doctor.

Pregnancy and breastfeeding

Pregnancy
Tell your doctor if you suspect (or plan) pregnancy. Usually, your doctor will advise you to stop taking Telmisartanum Teva B.V. before planned pregnancy or immediately after pregnancy is confirmed and will prescribe another medicine instead of Telmisartanum Teva B.V.. It is not recommended to take Telmisartanum Teva B.V. during early pregnancy and it should not be taken after the third month of pregnancy, as it can seriously harm the baby if taken after 3 months of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or planning to breastfeed. It is not recommended to take Telmisartanum Teva B.V. during breastfeeding. Your doctor may choose another treatment during breastfeeding, especially in the case of breastfeeding a newborn or premature baby.

Driving and using machines

Some patients taking Telmisartanum Teva B.V. may experience dizziness or fatigue. If you experience dizziness or fatigue, do not drive or operate machinery.
Telmisartanum Teva B.V. contains sorbitol.
Telmisartanum Teva B.V. 40 mg contains 19.2 mg of sorbitol in each tablet.
Telmisartanum Teva B.V. 80 mg contains 38.4 mg of sorbitol in each tablet.

Telmisartanum Teva B.V. contains sodium.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Telmisartanum Teva B.V.

Always take Telmisartanum Teva B.V. exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Telmisartanum Teva B.V. is one tablet per day. Try to take the tablet at the same time each day.
Telmisartanum Teva B.V. can be taken with or without food.
Swallow the tablets with water or another non-alcoholic drink. It is important to take Telmisartanum Teva B.V. every day, unless your doctor tells you to stop. If you feel that the effect of Telmisartanum Teva B.V. is too strong or too weak, talk to your doctor or pharmacist.
In the treatment of high blood pressure, the usual dose of Telmisartanum Teva B.V. is 40 mg once daily for most patients, which provides 24-hour blood pressure control. However, in some cases, your doctor may prescribe a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, Telmisartanum Teva B.V. may be given in combination with a diuretic, which has an additive blood pressure-lowering effect with Telmisartanum Teva B.V..

Taking a higher dose of Telmisartanum Teva B.V. than recommended

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

Missing a dose of Telmisartanum Teva B.V.

If you miss a dose, take it as soon as you remember. If you haven't taken the tablet all day, take the next dose the next day. Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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:
Septicemia* (often referred to as blood poisoning, being a severe infection with an inflammatory reaction of the whole body), sudden swelling of the skin and mucous membranes (angioedema).
The above side effects are rare (may affect up to 1 in 1000 patients), but are extremely severe, in which case you should stop taking the medicine and contact your doctor immediately. If the above symptoms are not treated, they can be fatal.

Possible side effects of Telmisartanum Teva B.V.:

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, abdominal pain, diarrhea, discomfort in the abdomen, 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 1000 patients):
Septicemia* (often referred to as blood poisoning, being a severe infection with an inflammatory reaction of the whole body, which can lead to death), 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 anxious, drowsiness, vision disturbances, rapid heart rate (tachycardia), dry mouth, gastritis, liver problems (more common in patients of Japanese origin), sudden swelling of the skin and mucous membranes, which can also lead to death (angioedema), skin eruptions (skin disease), skin redness, hives, severe drug rash, joint pain, limb pain, tendon pain, flu-like symptoms, decreased hemoglobin levels (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 lung tissue (interstitial lung disease)**
*The event may be coincidental or related to an unknown mechanism.
**There have been reports of interstitial lung disease associated 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. You can report side effects 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. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Telmisartanum Teva B.V.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
There are no special storage precautions.
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 pack and other information

What Telmisartanum Teva B.V. contains

The active substance is telmisartan.
Each tablet contains 40 mg or 80 mg of telmisartan.
The other ingredients are: mannitol, meglumine, sorbitol, povidone K-90, sodium hydroxide, hypromellose, magnesium stearate.

What Telmisartanum Teva B.V. looks like and contents of the pack

White or almost white, oblong tablets with a dividing line on one side.
The tablet can be divided into two equal halves.
Pack sizes: 28, 56 tablets in blisters in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V.
Swensweg 5,
2031 GA Haarlem,
Netherlands
Tel: (22) 345 93 00

Manufacturer

Merckle GmbH, Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren, Germany
Teva Pharmaceutical Works Private Limited Company, Pallagi str. 13., H-4042, Debrecen, Hungary
Teva Operations Poland Sp. z o. o. ul. Mogilska 80, 31-546 Kraków, Poland

Date of last revision of the leaflet: July 2021