20 mg, 40 mg, 80 mg film-coated tablets
telmisartan
What Telmark is and what it is used for
Telmark belongs to a group of medicines called angiotensin II inhibitors. Angiotensin II is a body-specific substance that causes the blood vessels to constrict, leading to a rise in blood pressure. Telmark inhibits this effect of angiotensin II, which leads to the dilation of the blood vessels and lowering of blood pressure et al.
Telmark is used to treat elevated blood pressure, so-called essential hypertension in adults. Essential means that high blood pressure is not caused by any other disease.
High blood pressure that is not treated can cause damage to the blood vessels in several organs. This can lead to heart attacks, heart or kidney failure, stroke, or blindness. Most of the time, high blood pressure causes no symptoms before the damage occurs. It is therefore important to regularly measure blood pressure et to check if it is within normal values.
Telmark is also used to reduce the number of cardiovascular events (such as heart attack or stroke/bleeding in the brain) in adults who are at risk because of reduced or blocked blood supply to the heart or legs, or who have had a stroke or have high-risk diabetes. Your doctor can tell you if you are at high risk of such events.
Telmisartan found in Telmark may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Telmark
Do not use Telmark
- if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
- pregnant women should not use Telmark during the last 6 months of pregnancy. (Even earlier in pregnancy it is good to avoid Telmark, see Pregnancy and breastfeeding).
- if you have severe liver problems such as cholestasis or biliary obstruction (problems with the outflow of bile from the liver and gallbladder) or any other severe liver disease.
- if you have diabetes or impaired kidney function and you are being treated with an antihypertensive medicine containing aliskiren.
If any of the above apply to you, tell your doctor or pharmacist before using Telmark.
Warnings and precautions
Talk to your doctor if you have or have had any of the following diseases or conditions:
- Kidney disease or kidney transplant
- Renal artery stenosis (narrowing of the blood vessels in one or both kidneys).
- Liver disease.
- Heart problems.
- Increased aldosterone levels (water or salt accumulations in the body and altered mineral balance in the blood).
- Low blood pressure ( hypotension ), can occur if you are dehydrated (have lost a lot of body fluid) or have a lack of salt due to diuretic treatment (water-reducing treatment), a diet with low salt intake, diarrhea, or vomiting.
- High level of potassium in the blood.
- Diabetes.
Talk to your doctor before taking Telmark:
- if you are taking any of the following medicines used to treat high blood pressure:- an ACE inhibitor (for example enalapril, lisinopril, ramipril), especially if you have diabetes-related kidney problems.- the aliskiren
Your doctor may need to check kidney function, blood pressure, and the number of electrolytes (e.g. potassium ) in the blood at regular intervals. See also information under the heading “Do not use Telmark”.
- if you take digoxin.
If you think you are pregnant or become pregnant during treatment, contact your doctor. Telmark is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it can then cause birth defects, see Pregnancy and breastfeeding.
During surgery or anesthesia, you must tell your doctor that you are using Telmark.
Telmark may be less effective in treatment to lower blood pressure et in colored patients.
Children and young people
Telmark is not recommended for the treatment of children or adolescents up to the age of 18.
Other medicines and Telmark
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may need to change the dose of other medicines or take other precautions. In some cases, you may need to stop treatment with a medicine. This applies especially if the medicines below are taken at the same time as Telmark.
- Medicines containing lithium treat certain types of depression.
- Medicines that increase the level of potassium in the blood, e.g. potassium-containing salt substitutes, potassium-sparing diuretics (some diuretics), ACE inhibitors, angiotensin II inhibitors, non-steroidal anti-inflammatory drugs ( NSAIDs, e.g. aspirin or ibuprofen), heparin, immunosuppressive drugs (eg ciclosporin or tacrolimus) and trimethoprim ( antibiotics ).
- Diuretics (water tablets), especially if taken in high doses together with Telmark, can lead to excessive fluid loss and low blood pressure ( hypotension ).
- If you are taking an ACE inhibitor or aliskiren (see also information under the headings “Do not use Telmark” and “Warnings and precautions”).
- Digoxin.
The effect of Telmark can be reduced when you take NSAIDs (non-steroidal anti-inflammatory drugs, eg acetylsalicylic acid or ibuprofen ) or corticosteroids.
Telmark may increase the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that can lower blood pressure (eg baclofen, amifostine).
In addition, low blood pressure can be worsened by alcohol, barbiturates, narcotics, and antidepressants. You may notice it as dizziness when you stand up. You should consult a doctor if you need to adjust the dose of one of your other medicines while taking Telmark.
Pregnancy and breastfeeding
Pregnancy
If you think you are pregnant or become pregnant during treatment, contact your doctor. Usually, your doctor will suggest that you stop taking Telmark before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Telmark should not be used at the beginning of pregnancy and should not be used during the last 6 months of pregnancy as it can then cause birth defects.
Breast-feeding
Tell your doctor if you are breastfeeding or intend to start breastfeeding. Telmark is not recommended during breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed your baby, especially if your baby is a newborn or was born prematurely.
Driving ability and use of machinery
Some people feel dizzy and tired when taking Telmark. If you feel dizzy or tired, do not drive or operate machinery.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Telmark contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before using Telmark.
How you use Telmark
Always use Telmark according to your doctor’s instructions. Ask your doctor or pharmacist if you are unsure.
The recommended dose of Telmark is one tablet a day. Try to take the tablet at the same time each day.
You can take Telmark with or without food. You should swallow the tablets with a glass of water or another non-alcoholic drink. It is important to take Telmark every day until the doctor gives other instructions. Contact your doctor or pharmacist if you feel that the effect of Telmark is too strong or too weak.
For the treatment of high blood pressure, the normal dose of Telmark for most patients is one 40 mg tablet once a day to control blood pressure for 24 hours. But sometimes the doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, Telmark can be used together with a diuretic (fluid-reducing medicine), for example, hydrochlorothiazide, which has been shown to have an additional blood pressure-lowering effect together with Telmark.
To reduce the number of cardiovascular events, the usual dose is one Telmark 80 mg tablet once a day. At the beginning of preventive treatment with Telmark 80 mg, the blood pressure should be checked frequently.
If you have impaired liver function, the normal dose should not exceed 40 mg once a day.
If you have used too much Telmark
If you have ingested too much medicine or if, for example, If a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Telmark
If you should forget to take the medicine, do not worry. Take dose one as soon as you remember and continue earlier. If you forget the medicine one day, take the usual dose the next day. You should not take a double dose to compensate.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and require immediate medical treatment.
Contact your doctor immediately if you experience any of the following symptoms:
Sepsis* (which is often called “blood poisoning” is a severe infection with inflammatory reactions throughout the body), rapid swelling of the skin and mucous membranes ( angioedema ). These side effects are rare (may affect up to 1 in 1,000 users) but extremely serious and patients should stop taking the medicine and see a doctor immediately. The conditions can be fatal if left untreated.
Possible side effects of Telmark:
Common side effects ( may affect up to 1 in 10 users):
Low blood pressure ( hypotension ) in users treated to reduce the number of cardiovascular events.
Uncommon side effects ( may affect up to 1 in 100 people): Urinary tract infections, upper respiratory tract infection (eg sore throat, inflamed sinuses, common cold), lack of red blood cells (anemia), high potassium levels, difficulty sleeping, low mood (depression ), fainting ( syncope ), a feeling of dizziness ( vertigo ), slow heartbeat ( bradycardia ), low blood pressure ( hypotension ) in users treated for high blood pressure, dizziness when standing up ( orthostatic hypotension), shortness of breath, cough, stomach pain, diarrhea, discomfort from the gastrointestinal tract, swelling, vomiting, itching, sweating, skin rash due to drugs, back pain, muscle spasm, muscle pain ( myalgia ), reduced kidney function including acute kidney failure, chest pain, weakness and increased levels of creatinine in the blood.
Rare side effects ( may affect up to 1 in 1,000 users):
Sepsis* (which is often called “blood poisoning”, is a severe infection with inflammatory reactions throughout the body, which can lead to death), increased number of certain white blood cells (eosinophilia), low platelet count ( thrombocytopenia ), severe allergic reactions ( anaphylactic reaction ), allergic reactions (e.g. skin rash, itching , difficulty breathing, wheezing, swelling of the face or low blood pressure ), low blood sugar (in patients with diabetes ), restlessness, somnolence , visual disturbances, rapid heartbeat ( tachycardia ), dry mouth, upset stomach, altered sense of taste ( dysgeusia ), abnormal liver function (Japanese patients are at greater risk of this side effect), rapid swelling of the skin and mucous membranes that can lead to death ( angioedema even with a fatal outcome), eczema (a skin disease), skin redness , hives , severe skin rashes due to medicines, joint pain ( arthralgia ), pain in the extremities , pain in the tendons, flu-like illness, reduced levels of hemoglobin (a blood protein), increased levels of uric acid , increased levels of liver enzymes or creatine phosphokinase in the blood.
Very rare side effects (may affect up to 1 in 10,000 people): Progressive scarring of lung tissue (interstitial lung disease) **
* These side effects may be coincidental or related to a mechanism that is currently unknown.
** Cases of progressive scarring of lung tissue have been reported during treatment with telmisartan. However, it is not known whether telmisartan is the cause.
How Telmark should be stored
Keep this medicine out of sight and reach of children.
Use before the expiry date stated on the carton after “EXP”. The expiration date is the last day of the specified month.
No special temperature instructions.
Store in the original packaging. Moisture sensitive. Take the Telmark tablet out of the blister pack just before you are about to take it.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is telmisartan. Each tablet contains 20 mg, 40 mg or 80 mg of telmisartan.
Other ingredients:
sodium hydroxide, povidone (K-25), meglumine, lactose monohydrate, crospovidone, yellow iron oxide (E172), and magnesium stearate.
The film coating contains hypromellose, titanium dioxide (E171), macrogol-400, talc, and yellow iron oxide (E172)
Appearance and package sizes of the medicine
Telmark 20 mg tablets are yellow, round, and debossed with “20” on one side and “T” on the other side.
Telmark 40 mg tablets are yellow, oval, and debossed with “40” on one side and “T” on the other side.
Telmark 80 mg tablets are yellow, oval, and debossed with “80” on one side and “T” on the other side.
Telmark is available in blister packs of 14, 15, 28, 30, 56, 60, 90 or 98 tablets.
Not all pack sizes may be marketed in your country.
Marketing Authorisation Holder
Glenmark Arzneimittel GmbH
Industrystr. 31, 82194 Gröbenzell,
Germany
Manufacturer
Glenmark Pharmaceuticals s.r.o.,
Fibichova 143,
566 17 Vysoké Mýto,
Czech Republic