What Telmisartan Sandoz is and what it is used for
Telmisartan Sandoz 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 Sandoz inhibits this effect of angiotensin II, which leads to the dilation of blood vessels and lowering of blood pressure et al.
Telmisartan Sandoz is used to treating 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.
Telmisartan Sandoz is also used to reduce the number of cardiovascular events (such as heart attack or stroke ) 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 contained in Telmisartan Sandoz 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 Sandoz
Do not use Telmisartan Sandoz
- if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
- pregnant women should not use Telmisartan Sandoz after 3 months of pregnancy, i.e. during the last 6 months of pregnancy. (Even earlier in pregnancy it is good to avoid Telmisartan Sandoz – 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 severe 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, tell your doctor or pharmacist before using Telmisartan Sandoz.
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
- elevated aldosterone levels (water and 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
- high level of potassium in the blood
- diabetes .
Talk to your doctor before taking Telmisartan Sandoz:
- 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
- if you take digoxin .
Your doctor may need to check your kidney function, blood pressure and the amount of electrolytes (eg potassium ) in your blood at regular intervals.
See also the information under the heading “Do not use Telmisartan Sandoz”.
If you think you are pregnant (or may become pregnant) during treatment, contact your doctor. Telmisartan Sandoz is not recommended during early pregnancy and should not be used during the last 6 months of pregnancy as it may cause serious birth defects (see Pregnancy and breast-feeding).
During surgery or anesthesia , you must tell your doctor in advance that you are using Telmisartan Sandoz.
Telmisartan Sandoz may be less effective when used to lower blood pressure in patients of color .
Children and young people
Telmisartan Sandoz is not recommended for the treatment of children and adolescents up to the age of 18.
Other medicines and Telmisartan Sandoz
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 Sandoz:
- medicines containing lithium to 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 , eg aspirin or ibuprofen ), heparin , drugs that suppress the body’s immune system (eg ciclosporin or tacrolimus) and trimethoprim ( antibiotics )
- diuretics (water tablets), especially if taken in high doses together with Telmisartan Sandoz, can lead to excessive fluid loss and low blood pressure ( hypotension )
- ACE inhibitors or aliskiren (see also the information under the headings “Do not use Telmisartan Sandoz” and “Warnings and precautions”).
- digoxin .
The effect of Telmisartan Sandoz can be reduced when you take NSAIDs (non-steroidal anti-inflammatory drugs, such as acetylsalicylic acid or ibuprofen ) or corticosteroids .
Telmisartan Sandoz may increase the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that may lower blood pressure et (e.g. baclofen, amifostine). Low blood pressure can also be worsened by alcohol, barbiturates , narcotics or antidepressants. You may notice it as dizziness when you stand up. Consult your doctor if you need to adjust the dose of one of your other medicines while taking Telmisartan Sandoz.
Telmisartan Sandoz with food and drink
You can take Telmisartan Sandoz with or without food.
Pregnancy and breastfeeding
Pregnancy
If you think you are pregnant (or may become pregnant) during treatment, contact your doctor. Your doctor will usually suggest that you stop taking Telmisartan Sandoz before pregnancy or as soon as you know you are pregnant and will recommend another medicine for you instead. Telmisartan Sandoz should not be used in early pregnancy and should not be used during the last 6 months of pregnancy as it may cause serious birth defects.
Breast-feeding
Tell your doctor if you are breast-feeding or intend to start breast-feeding. Telmisartan Sandoz is not recommended during breast-feeding and your doctor may choose another treatment for you if you wish to breast-feed your baby, especially if your baby is newborn or was born prematurely.
Driving ability and use of machinery
Some people feel dizzy and tired when taking Telmisartan Sandoz. If you feel dizzy or tired, do not drive or operate machinery.
You yourself 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 . 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 Sandoz contains excipients
Telmisartan Sandoz contains lactose
If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
Telmisartan Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to use Telmisartan Sandoz
Always use Telmisartan Sandoz as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The recommended dose of Telmisartan Sandoz is one tablet a day.
- Try to take the tablet at the same time each day.
- You can take Telmisartan Sandoz with or without food.
- You should swallow the tablets with a glass of water or another non-alcoholic drink.
- It is important to take Telmisartan Sandoz every day until your doctor tells you otherwise.
- Contact your doctor or pharmacist if you feel that the effect of Telmisartan Sandoz is too strong or too weak.
- Tablet with a break notch can be divided into two equal parts.
For the treatment of high blood pressure , the normal dose of Telmisartan Sandoz for most patients is one 40 mg tablet once a day to control blood pressure et for 24 hours. In some cases, the doctor may recommend a lower dose , 20 mg daily, or a higher dose , 80 mg daily.
Alternatively, Telmisartan Sandoz can be used in combination with diuretics (water-reducing drugs), e.g. hydrochlorothiazide , which has been shown to have an additional blood pressure-lowering effect together with Telmisartan Sandoz.
To reduce the number of cardiovascular events, the usual dose is 80 mg telmisartan once a day. At the beginning of preventive treatment with 80 mg telmisartan, blood pressure should be checked frequently.
Use for children
Telmisartan Sandoz is not recommended for children and adolescents under 18 years of age.
Patients with impaired liver function
If you have impaired liver function, the normal dose should not exceed 40 mg once a day.
Patients with impaired renal function
No dose adjustment is required for patients with impaired renal function.
If your kidney function is severely impaired or if you are on hemodialysis , your doctor may prescribe a lower starting dose of 20 mg.
If you have used too much Telmisartan Sandoz
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor, pharmacist or hospital for an assessment of the risk and advice.
If you forget to take Telmisartan Sandoz
If you should forget to take the medicine, do not worry. Take dose one as soon as you remember and continue as before. If you forget the medicine one day, take the usual dose the next day. Do not take a double dose to make up for missed individual doses .
If you stop using Telmisartan Sandoz
Always consult your doctor if you want to stop using this medicine. It may be important that you continue to use this medicine even if you feel well.
If you have any further questions about this medicine, ask 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 attention:
Seek medical attention immediately if you experience any of the following symptoms:
Sepsis* (often called “blood poisoning”, a severe infection with inflammatory reactions throughout the body) and rapid swelling of the skin and mucous membranes ( angioedema ) are rare side effects (may affect up to 1 in 1,000 users) but extremely serious. Patients should stop taking the medicine and see a doctor immediately. The conditions can be fatal if left untreated.
Possible side effects:
Common (may affect up to 1 in 10 users):
• low blood pressure ( hypotension ) in users treated to reduce the number of cardiovascular events
Uncommon (may affect up to 1 in 100 users):
- urinary tract infections
- upper respiratory infection (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
- stomach upset
- bloating
- vomiting
- itching
- increased sweating
- drug rash
- back pain
- muscle cramp
- muscle pain ( myalgia )
- impaired renal function including acute renal failure
- chest pain
- weakness
- increased levels of creatinine in the blood
Rare (may affect up to 1 in 1,000 users):
- sepsis* (often called “blood poisoning”, a severe infection with inflammatory reactions throughout the body that can lead to death)
- 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 diabetics)
- concern
- somnolence
- visual disturbances
- fast heart rate ( tachycardia )
- dry mouth
- upset stomach
- altered taste sensation ( 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
- serious drug rash
- 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)**
* Side effect one may be coincidental or related to a mechanism that is currently not known.
**Cases of progressive scarring of the lung tissue during treatment with telmisartan have been reported.
However, it is not known whether telmisartan is the cause.
How to store Telmisartan Sandoz
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and blister after Ex.Date. or EXP. The expiration date is the last day of the specified month.
Store in the original packaging. Moisture sensitive.
Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to deal with 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 40 mg of telmisartan.
- Other ingredients are sodium hydroxide, meglumine, povidone K25, lactose monohydrate , povidone, crospovidone, anhydrous lactose and magnesium stearate.
Appearance and package sizes of the medicine
White, oblong, smooth tablets with a score on one side and marking “40” on the other side.
The tablets are 11.5-11.8 mm long and 6.4-6.8 mm wide.
Alu/Alu blisters with 10, 14, 20, 21, 28, 30, 50, 56, 60, 84, 90, 98, 100 tablets
Alu/Alu single-dose blister with 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, D-39179 Barleben, Germany
or
LEK SA, Ul. Domaniewska 50 C, 02-672 Warsaw, Poland
or
LEK SA, Ul. Podlipie 16, 95-010 Stryków, Poland
or
Lek Pharmaceuticals dd, Trimlini 2D, 9220 Lendava, Slovenia
or
Lek Pharmaceuticals dd, Verovskova 57, 1526 Ljubljana, Slovenia
or
SC Sandoz, SRL, Str. Livezeni No. 7A, 540472, Targu Mures, Romania