Telmisartan medical valley

Package leaflet: Information for the patient

Telmisartan Medical Valley, 20 mg, tablets
Telmisartan Medical Valley, 40 mg, tablets
Telmisartan Medical Valley, 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Telmisartan Medical Valley is and what it is 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 pack and other information

1. What Telmisartan Medical Valley is and what it is 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 narrow, leading to increased blood pressure. Telmisartan Medical Valley blocks the action of angiotensin II, allowing blood vessels to relax and blood pressure to decrease.

Telmisartan Medical Valley is used for the treatment of 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 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 these complications occur. Therefore, it is important to measure your blood pressure regularly to ensure it remains within normal limits.

Telmisartan Medical Valley is also used to reduce the frequency of cardiovascular events (such as heart attack or stroke) in adults at risk, i.e. those who have reduced blood flow to the heart or legs, have had a stroke, or have been diagnosed with diabetes. Your doctor will inform you if you belong to this risk group.

2. Information before taking Telmisartan Medical Valley

When not to take Telmisartan Medical Valley

• 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 (Telmisartan Medical Valley should also be avoided in early pregnancy – see section “Pregnancy”);
• if the patient has severe liver disease, such as biliary obstruction or cholestasis (impaired 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.

If any of the above conditions apply to the patient, inform the doctor or
pharmacist before taking Telmisartan Medical Valley.
Warnings and precautions
Discuss with the doctor if the patient has or has 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 disease.
• 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 water from the body) or has sodium deficiency due to diuretic (water pill) use, low-sodium diet, diarrhoea, or vomiting.
• Increased blood potassium levels.
• Diabetes.

If the patient experiences abdominal pain, nausea,
vomiting, or diarrhoea after taking Telmisartan Medical Valley, discuss this with the doctor. The doctor will decide on further treatment.
Do not make independent decisions about stopping Telmisartan Medical
Valley.
Before starting Telmisartan Medical Valley, discuss the following with the doctor:

• if the patient is taking any of the following medicines used to treat high blood pressure:
  • angiotensin-converting enzyme (ACE) inhibitors (e.g. enalapril, lisinopril, ramipril), particularly if the patient has kidney problems related to diabetes,
  • aliskiren.

The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also the section “When not to take Telmisartan Medical Valley”.

• if the patient is taking digoxin.

Inform the doctor about pregnancy, suspected (or planned) pregnancy. Use of Telmisartan Medical Valley 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 “Pregn游戏副本

3. How to use Telmisartan Medical Valley

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.
The recommended dose of Telmisartan Medical Valley is one tablet per day. Try to take the tablet at the same time each day. Telmisartan Medical Valley may be taken with or without food. Swallow the tablet with water or another non-alcoholic drink. It is important to take Telmisartan Medical Valley every day unless your doctor advises otherwise. If you feel that the effect of Telmisartan Medical Valley is too strong or too weak, consult your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of Telmisartan Medical Valley is one 40 mg tablet once daily for most patients, providing 24-hour blood pressure control. Your doctor may prescribe a lower dose of 20 mg or a higher dose of 80 mg for some patients. Telmisartan Medical Valley may also be given in combination with a diuretic (water tablet), such as hydrochlorothiazide, which enhances the blood pressure-lowering effect of Telmisartan Medical Valley.

To reduce the risk of cardiovascular events, the usual dose of Telmisartan Medical Valley 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 Medical Valley than prescribed
If you accidentally take too many tablets, contact your doctor or pharmacist immediately, or go to the nearest hospital emergency department.

Missing a dose of Telmisartan Medical Valley
If you miss a dose, do not worry. Take it as soon as you remember, then continue taking the medicine as prescribed. If you do not remember until the next day, take your usual dose on the following day. Do not take a double dose to make up for the missed dose.

If you have any further questions 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 everyone will experience 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 called blood poisoning, a severe infection causing systemic inflammatory response), sudden swelling of the skin and mucous membranes (angioedema) – these adverse reactions are rare (may occur in up to 1 in 1,000 patients), but extremely serious; if they occur, treatment with this medicine must be stopped and immediate medical advice must be sought. If the above symptoms are not treated, they may result in death.

Possible adverse reactions of Telmisartan Medical Valley:
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 rash, back pain, muscle cramps, muscle pain, kidney function disorders, 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 called 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 disorders (occur 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 rash, joint pain, limb pain, tendon pain, influenza-like symptoms, decreased haemoglobin concentration (a protein in the blood), increased uric acid levels, increased activity of liver enzymes or creatine kinase in blood.

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

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

* May occur incidentally or due to a currently unknown mechanism.
** Cases of progressive fibrosis of lung tissue 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 of the 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Telmisartan Medical Valley

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP". The expiry date refers to the last day of the specified month.
Aluminium/Aluminium foil blister: No special storage instructions 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 package 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.
• 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 as tablets.
Telmisartan Medical Valley 20 mg: white, round tablets with bevelled edges, marked with the imprint LC on one side.
Telmisartan Medical Valley 40 mg: white, oblong tablets, marked with the imprint LC on one side.
Telmisartan Medical Valley 80 mg: white, oblong tablets, marked with the imprint LC on one side.
Telmisartan Medical Valley is supplied in blister packs, in pack sizes containing 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Austria: Telmisartan +pharma 20 mg/40 mg/80 mg Tabletten
Belgium: Telmisartan Liconsa 20 mg/40 mg/80 mg comprimés
Germany: Telmisartan AXiromed 20 mg /40 mg /80 mg Tabletten
Netherlands: Telmisartan Xiromed 20 mg/40 mg/80 mg tabletten
Poland: Telmisartan Medical Valley
Portugal: Telmisartan Liconsa 20 mg/40 mg/80 mg Comprimidos
United Kingdom: Telmisartan 20 mg/40 mg/80 mg tablets