20 mg/ 40 mg/ 80 mg film-coated tablets
telmisartan
What Telmisartan STADA is and what it is used for
Telmisartan Stada 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. Telmisartan Stada inhibits this effect of angiotensin II, which leads to the dilation of the blood vessels and lowering of blood pressure et al.
Telmisartan Stada is used to treat elevated blood pressure, so-called essential hypertension. 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.
Telmisartan Stada is also used to reduce cardiovascular disease (such as heart attack or stroke ) in patients who are at risk due to 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.
The telmisartan contained in Telmisartan Stada may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Telmisartan STADA
Do not use Telmisartan STADA
- if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
- during the last six months of pregnancy (Even earlier during pregnancy it is good to avoid Telmisartan Stada – see Pregnancy and breast-feeding).
- 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 serious liver disease.
- if you have diabetes or impaired kidney function and are being treated with an antihypertensive medicine containing aliskiren.
If any of the above apply to you, talk to your doctor or pharmacist before taking Telmisartan Stada.
Warnings and precautions
Tell 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 ), which 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), low-salt diet, diarrhea, or vomiting.
- increased level of potassium in the blood.
- diabetes.
Talk to your doctor, pharmacist, or nurse before taking Telmisartan Stada
- if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (eg enalapril, lisinopril, ramipril), especially if you have diabetes-related kidney problems.
- the aliskiren.
Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.
See also the information under the heading “Do not take Telmisartan Stada”.
If you think you are pregnant ( or become pregnant ) during treatment, you should contact your doctor. Telmisartan Stada is not recommended at the beginning of pregnancy and should not be used during the last 6 months of pregnancy as it may then cause birth defects (see section Pregnancy and breastfeeding).
During surgery or anesthesia, you must tell your doctor that you are using Telmisartan Stada.
Like another angiotensin -II inhibitors, Telmisartan Stada may be less effective when used to lower blood pressure in colored patients.
Children and young people
Telmisartan Stada is not recommended for the treatment of children or adolescents up to the age of 18.
Other medicines and Telmisartan STADA
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 Telmisartan Stada:
- medicines containing lithium to treat certain types of depression.
- medicines that increase the level of potassium in the blood, e.g. salt substitutes containing potassium, potassium-sparing diuretics (some diuretics), ACE inhibitors, angiotensin II inhibitors, non-steroidal anti-inflammatory drugs ( NSAIDs, such as aspirin or ibuprofen ), heparin, drugs that suppress the body’s immune system (e.g. eg ciclosporin or tacrolimus) and trimethoprim ( antibiotics ).
- diuretics (water tablets), especially if taken in high doses, together with Telmisartan Stada can lead to excessive fluid loss and low blood pressure ( hypotension ).
- if you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Telmisartan Stada” and “Warnings and precautions”).
As with other antihypertensive medicines, the effect of Telmisartan Stada can be reduced when you take NSAIDs (non-steroidal anti-inflammatory medicines, eg aspirin or ibuprofen ) or corticosteroids.
Telmisartan Stada can increase the blood pressure-lowering effect of other medicines used to treat high blood pressure.
Telmisartan STADA with food, drink, and alcohol
You can take Telmisartan Stada with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Usually, your doctor will suggest that you stop taking Telmisartan Stada before you become pregnant or as soon as you know you are pregnant and will recommend another medicine for you instead. Telmisartan Stada is not recommended for use in early pregnancy and must not be used when the pregnancy has continued for more than three months as it may cause serious harm to your baby.
Breast-feeding
Telmisartan Stada is not recommended if you are breastfeeding and your doctor may choose another treatment for you if you want to breastfeed your baby, especially if your baby is a newborn or was born prematurely.
Driving ability and use of machinery
There is no information on how Telmisartan Stada affects the ability to drive and use machines. Some people feel dizzy and tired when treating high blood pressure. 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.
Telmisartan STADA contains lactose and sodium
Telmisartan Stada contains lactose. If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. is almost “sodium-free”.
How to use Telmisartan STADA
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The recommended dose of Telmisartan Stada is one tablet daily. Try to take the tablet at the same time each day. You can take Telmisartan Stada with or without food. You should swallow the tablets with a little water or another non-alcoholic drink. It is important to take Telmisartan Stada every day until your doctor tells you otherwise. Contact your doctor or pharmacist if you feel that the effect of Telmisartan Stada is too strong or too weak.
For the treatment of high blood pressure, the recommended dose of Telmisartan Stada for most patients is one 40 mg tablet once daily to control blood pressure it for 24 hours. In some cases, the doctor may recommend a lower dose, 20 mg, or a higher dose, 80 mg. Telmisartan Stada can also be used together with a diuretic (water-reducing medicine), e.g. hydrochlorothiazide, which has been shown to provide an additional blood pressure-lowering effect together with Telmisartan Stada.
To reduce cardiovascular diseases, the recommended dose is one Telmisartan Stada 80 mg tablet once a day. At the beginning of the preventive treatment with Telmisartan Stada 80 mg, 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 Telmisartan STADA
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Telmisartan STADA
If you should forget to take the medicine, do not worry. Take dose one as soon as you remember and then continue as before. If you forget the medicine one day, take the usual dose the next day. You should not take a double dose to make up for a missed dose.
If you stop using Telmisartan STADA
Do not stop using Telmisartan Stada without consulting your doctor.
Medicines for the high blood pressure may need to be taken for life. If you stop taking Telmisartan Stada, your blood pressure will return to the level it was before treatment after a few days.
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* (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 Telmisartan Stada:
Common (may affect up to 1 in 10 users):
- low blood pressure ( hypotension ) in users who are treated reduces the risk of cardiovascular diseases.
Uncommon (may affect up to 1 in 100 users):
- urinary tract infections
- upper respiratory infections (eg sore throat, inflamed sinuses, common cold)
- lack of red blood cells ( anemia )
- high potassium levels
- difficulty falling asleep
- low mood (depression)
- fainting ( syncope )
- a feeling of dizziness ( vertigo )
- slow heart rate ( bradycardia )
- low blood pressure ( hypotension ) in users treated for high blood pressure
- dizziness when standing up ( orthostatic hypotension )
- shortness of breath
- cough
- stomach pains
- diarrhea
- discomfort from the gastrointestinal tract
- bloating
- vomiting
- itching
- sweating
- drug-induced skin rash
- back pain
- muscle cramp
- muscle pain ( myalgia )
- impaired renal function including acute renal failure
- chest pain
- feeling of weakness
- increased levels of creatinine in the blood.
Rare (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)
- increased number of certain white blood cells (eosinophilia)
- low platelet count ( thrombocytopenia )
- severe allergic reaction ( anaphylactic reaction )
- allergic reactions (eg skin rash, itching, difficulty breathing, wheezing, facial swelling, or low blood pressure )
- low blood sugar (in patients with diabetes )
- concern
- somnolence
- visual disturbances
- fast heart rate ( tachycardia )
- dry mouth
- upset stomach
- abnormal liver function (Japanese patients are at greater risk of this side effect)
- rapid swelling of the skin and mucous membranes, which can also lead to death ( angioedema also with a fatal outcome)
- eczema (a skin disease)
- skin redness
- hives
- severe skin rashes due to drug
- joint pain ( arthralgia )
- pain in the extremities
- pain in tendons
- flu-like illness
- decreased levels of hemoglobin (a blood protein)
- increased levels of uric acid
- increased levels of liver enzymes or creatine phosphokinase in the blood.
Very rare (may affect up to 1 in 10,000 users):
- 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 with telmisartan treatment. However, it is not known whether telmisartan is the cause.
How to store Telmisartan STADA
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 storage instructions.
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 are:
Sodium hydroxide
Povidone (K-25)
Meglumine
Lactose monohydrate
Crospovidone
Yellow iron oxide (E172)
Magnesium stearate
Film coating
Hypromellose
Titanium dioxide (E171)
Macrogol-400
Talc
Appearance and package sizes of the medicine
Telmisartan Stada 20 mg film-coated tablets are yellow, round, and marked with ’20’ on one side and ‘T’ on the other.
Telmisartan Stada 40 mg film-coated tablets are yellow, capsule-shaped, and marked with ’40’ on one side and ‘T’ on the other side.
Telmisartan Stada 80 mg film-coated tablets are yellow, capsule-shaped, and marked with ’80’ on one side and ‘T’ on the other.
Telmisartan Stada 20 mg is available in blister packs of 7, 10, 14, 15, 28, 30, 56, 60, 84, 90, 98, 112, 126, 140, 154, 168 or 182 tablets.
Telmisartan Stada 40 mg is available in blister packs of 7, 10, 14, 15, 28, 30, 50, 56, 60, 84, 90, 98, 112, 126, 140, 154, 168 or 182 tablets.
Telmisartan Stada 80 mg is available in blister packs of 7, 10, 14, 15, 28, 30, 50, 56, 60, 84, 90, 98, 112, 126, 140, 154, 168 or 182 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer
Glenmark Pharmaceuticals s.r.o
Fibíchova 143
566 17 Vysoké Mýto
Czech Republic
Tillomed Laboratories Ltd
3 Howard Road
Eaton Socon, St Neots
Cambridgeshire PE19 3ET
Great Britain and Northern Ireland
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria
Clonmel Healthcare Ltd.
Waterford Road, Clonmel
Co. Tipperary
Ireland
Local Representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark