Telmisartan Medical Vallei

Leaflet accompanying the packaging: patient information

Telmisartan Medical Valley, 20 mg, tablets

Telmisartan Medical Valley, 40 mg, tablets

Telmisartan Medical Valley, 80 mg, tablets

Telmisartan

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 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 those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Telmisartan Medical Valley and what is it used for

Telmisartan Medical Valley 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 Medical Valley blocks the action of angiotensin II, causing blood vessels to relax and blood pressure to decrease.
Telmisartan Medical Valley 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 failure, 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 Medical Valley is also usedto reduce the frequency 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. The doctor will inform the patient if they belong to the risk group for these disorders.

2. Important information before taking Telmisartan Medical Valley

When not to take Telmisartan Medical Valley

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

If any of the above conditions apply to the patient, they should inform their doctor or pharmacist before taking Telmisartan Medical Valley.

Warnings and precautions

The patient should discuss with their doctor if they 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 disease.
• 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 diuretic use, low-sodium diet, diarrhea, or vomiting.
• High potassium levels in the blood.
• Diabetes.

If the patient experiences abdominal pain, nausea, vomiting, or diarrhea after taking Telmisartan Medical Valley, they should discuss it with their doctor. The doctor will decide on further treatment.
Do not stop taking Telmisartan Medical Valley without consulting a doctor or pharmacist.

Before taking Telmisartan Medical Valley, the patient should discuss with their doctor:

• if the patient is taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitor (e.g., enalapril, lisinopril, 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 (e.g., potassium) in the blood.
See also the section "When not to take Telmisartan Medical Valley".

• if the patient is taking digoxin.

The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. It is not recommended to take Telmisartan Medical Valley in early pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus (see "Pregnancy").
In case of planned surgery or anesthesia, the patient should inform their doctor about taking Telmisartan Medical Valley.
Telmisartan Medical Valley may be less effective in lowering blood pressure in black patients.

Children and adolescents

Telmisartan Medical Valley is not recommended for children and adolescents under 18 years of age.

Telmisartan Medical Valley and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The 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 Medical Valley:

• Lithium preparations used to treat certain types of depression.
• Medicines that may 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 Telmisartan Medical Valley, as they may lead to significant water loss and low blood pressure (hypotension).
• ACE inhibitors or aliskiren (see also sections "When not to take Telmisartan Medical Valley" and "Warnings and precautions").
• Digoxin.

The effect of Telmisartan Medical Valley may be weakened when taken with NSAIDs (e.g., acetylsalicylic acid or ibuprofen) or corticosteroids.
Telmisartan Medical Valley may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that may lower blood pressure (e.g., baclofen, amifostine). Additionally, low blood pressure may be further decreased by: alcohol, barbiturates, opioids, or antidepressants. The symptom is dizziness when standing up. If necessary, the patient should consult their doctor about adjusting the dose of another medicine taken with Telmisartan Medical Valley.

Telmisartan Medical Valley with food and drink

Telmisartan Medical Valley can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy
The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Telmisartan Medical Valley before planned pregnancy or immediately after pregnancy is confirmed and prescribe another medicine instead of Telmisartan Medical Valley. It is not recommended to take Telmisartan Medical Valley in early pregnancy, and it 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 patient should tell their doctor about breastfeeding or intending to breastfeed. It is not recommended to take Telmisartan Medical Valley 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 Medical Valley may experience dizziness or fatigue. In such cases, they should not drive or operate machines.

Telmisartan Medical Valley contains sodium

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

3. How to take Telmisartan Medical Valley

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose of Telmisartan Medical Valley is one tablet per day. The patient should try to take the tablet at the same time every day. Telmisartan Medical Valley 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 Medical Valley every day, unless the doctor recommends otherwise. If the patient feels that the effect of Telmisartan Medical Valley 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 Medical Valley 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 Medical Valley can also be given in combination with a diuretic, such as hydrochlorothiazide, which enhances the blood pressure-lowering effect of Telmisartan Medical Valley.
To reduce the frequency of cardiovascular events, the usual dose of Telmisartan Medical Valley is 80 mg once daily. Blood pressure should be frequently monitored at the beginning of treatment.

Taking a higher dose of Telmisartan Medical Valley than recommended

If too many tablets are taken by mistake, the patient should immediately contact their doctor or pharmacist or go to the emergency department of the nearest hospital.

Missing a dose of Telmisartan Medical Valley

If a dose is missed, the patient should not worry. They should take it as soon as they remember, and then continue taking the medicine as scheduled. If the tablet is not taken within a day, the patient should take the usual dose the next day.
Do nottake a double dose to make up for a missed dose.
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Telmisartan Medical Valley can cause side effects, although not everybody gets them.

Some side effects may be serious and may require immediate medical attention:

If the patient experiences any of the following symptoms, they should immediately contact their doctor:
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 side effects are rare (may occur in up to 1 in 1,000 patients), but are extremely severe;
if they occur, the patient should stop taking the medicine and immediately contact their doctor. If these symptoms are not treated, they may be fatal.

Possible side effects of Telmisartan Medical Valley:

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, 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 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 can 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, facial swelling, or low blood pressure), low blood sugar levels (in patients with diabetes), feeling anxious, drowsiness, vision disturbances, fast heart rate (tachycardia), dry mouth, gastritis, liver problems (more common in patients of Japanese origin), sudden swelling of the skin and mucous membranes (angioedema, which can be fatal), skin rash, facial redness, hives, severe skin 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)**
Frequency not known (frequency cannot be estimated from the available data):
Angioedema of the intestine - after taking similar products, angioedema of the intestine has occurred with symptoms such as abdominal pain, nausea, vomiting, and diarrhea
*
May occur by chance or due to an unknown mechanism.
**
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 the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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 gather more information on the safety of this medicine.

5. How to store Telmisartan Medical Valley

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.
Aluminum/Aluminum blister: No special storage precautions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Medical Valley contains

• The active substance is telmisartan: a 20 mg tablet contains 20 mg of telmisartan; a 40 mg tablet contains 40 mg of telmisartan; an 80 mg tablet contains 80 mg of telmisartan
• The other ingredients are: povidone (K 25), meglumine, sodium hydroxide, mannitol, crospovidone, and magnesium stearate.

What Telmisartan Medical Valley looks like and contents of the pack

Telmisartan Medical Valley is available in tablet form.
Telmisartan Medical Valley, 20 mg: white, round tablets with beveled edges, with the imprint "LC" on one side.
Telmisartan Medical Valley, 40 mg: white, oval tablets, with the imprint "LC" on one side.
Telmisartan Medical Valley, 80 mg: white, oval tablets, with the imprint "LC" on one side.
Telmisartan Medical Valley is supplied in blisters, in packs containing 28 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Medical Valley Invest AB, Brädgårdsvägen 28, 236 32 Höllviken, Sweden

Manufacturer

Laboratorios Liconsa, S.A., Avda. Miralcampo No 7, Polígono Industrial Miralcampo, 19200 Azuqueca de Henares (Guadalajara), Spain
Medical Valley Invest AB, Brädgårdsvägen 28, 236 32 Höllviken, Sweden

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria:
Telmisartan +pharma 20 mg/40 mg/80 mg Tablets
Belgium:
Telmisartan Liconsa 20 mg/40 mg/80 mg tablets
Germany:
Telmisartan AXiromed 20 mg /40 mg /80 mg Tablets
Netherlands:
Telmisartan Xiromed 20 mg/40 mg/80 mg tablets
Poland:
Telmisartan Medical Valley
Portugal:
Telmisartan Liconsa 20 mg/40 mg/80 mg tablets
United Kingdom:
Telmisartan 20 mg/40 mg/80 mg tablets
Date of last revision of the leaflet:01/2025