ZANACODAR 80MG TABLETS
Active substance(s): TELMISARTAN
Zanacodar 20 mg tablets
Zanacodar 40 mg tablets
Zanacodar 80 mg tablets
Read all of this leaflet carefully before you start taking this medicine.
− Keep this leaflet. You may need to read it again.
− If you have any further questions, ask your doctor or pharmacist.
− This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
− If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Zanacodar 20/40/80 mg tablets are and what they are used for
2. Before you take Zanacodar 20/40/80 mg tablets
3. How to take Zanacodar 20/40/80 mg tablets
4. Possible side effects
5. How to store Zanacodar 20/40/80 mg tablets
6. Further information
1. WHAT Zanacodar 20/40/80 mg tablets ARE AND WHAT THEY ARE USED FOR
Zanacodar belongs to a class of medicines known as angiotensin II receptor antagonists.
Angiotensin II is a substance produced in your body which causes your blood vessels to narrow,
thus increasing your blood pressure. Zanacodar blocks the effect of angiotensin II so that the blood
vessels relax, and your blood pressure is lowered.
Zanacodar is used to treat essential hypertension (high blood pressure). ‘Essential’ means that the
high blood pressure is not caused by any other condition.
High blood pressure, if not treated, can damage blood vessels in several organs, which could lead
sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no
symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure
blood pressure to verify if it is within the normal range.
Zanacodar is also used to reduce cardiovascular events (i.e. heart attack or stroke) in patients who
are at risk because they have a reduced or blocked blood supply to the heart or legs, or have had a
stroke or have high risk diabetes. Your doctor can tell you if you are at high risk for such event.
2. BEFORE YOU TAKE Zanacodar 20/40/80 mg tablets
Do not take Zanacodar
• if you are allergic (hypersensitive) to telmisartan or any other ingredients included in Zanacodar
tablets (see section Further information for a list of other ingredients).
• if you are more than 3 months pregnant. (It is also better to avoid Zanacodar in early pregnancy –
see pregnancy section
• if you have severe liver problems such as cholestasis or biliary obstruction (problems with the
drainage of the bile from the liver and gall bladder) or any other severe liver disease.
If any of the above applies to you, tell your doctor or pharmacist before taking Zanacodar.
Take special care with Zanacodar
Please tell your doctor if you are suffering or have ever suffered from any of the following
conditions or illnesses:
• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
• Liver disease.
• Heart trouble.
• Raised aldosterone levels (water and salt retention in the body along with imbalance of various
• Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body
water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or
• Elevated potassium levels in your blood.
You must tell your doctor if you think that you are (or might become) pregnant. Zanacodar is not
recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant,
as it may cause serious harm to your bay if uses at that stage (see pregnancy section)
In case of surgery or anaesthesia, you should tell your doctor that you are taking Zanacodar.
The use of Zanacodar in children and adolescents up to the age of 18 years is not recommended.
As with all other angiotensin II receptor antagonists, Zanacodar may be less effective in lowering
the blood pressure in black patients.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription. Your doctor may need to change the dose of
these other medicines or take other precautions. In some cases you may have to stop taking one of
the medicines. This applies especially to the medicines listed below taken at the same time with
• Lithium containing medicines to treat some types of depression.
• Medicines that may increase blood potassium levels such as salt substitutes containing potassium,
potassium-sparing diuretics (certain 'water tablets'), ACE inhibitors, angiotensin II receptor
antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen),
heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
• Diuretics ('water tablets'), especially if taken in high doses together with Zanacodar, may lead to
excessive loss of body water and low blood pressure (hypotension).
As with other blood pressure lowering medicines, the effect of Zanacodar may be reduced when
you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or
Zanacodar may increase the blood pressure lowering effect of other medicines used to treat high
Taking Zanacodar with food and drink
You can take Zanacodar with or without food.
Pregnancy and breast-feeding
You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will
normally advise you to stop taking Zanacodar before you become pregnant or as soon as you are
pregnant and will advise you to take another medicine instead of Zanacodar. Zanacodar is not
recommended in early pregnancy, and must not be taken when more that 3 months pregnant, as it
may cause serious harm to your baby if used after the third month of pregnancy.
Tell your doctor if you are breast-feeding or about to start breast-feeding. Zanacodar is not
recommended for mother who are breast-feeding, and your doctor may choose another treatment for
you if you wish to breast-feed, especially if your baby is newborn or was born prematurely.
Driving and using machines
No information is available on the effect of Zanacodar on the ability to drive or operate machinery.
Some people feel dizzy or tired when they are treated for high blood pressure. If you feel dizzy or
tired, do not drive or operate machinery.
3. HOW TO TAKE Zanacodar 20/40/80 mg tablets
Always take Zanacodar exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
To obtain the tablet follow the steps:
1.- Separate one individual blister cell from the rest of the strip by gently tearing along the
2.- Carefully peel off the backing
3.- Push the tablet out.
The usual dose of Zanacodar is one tablet a day. Try to take the tablet at the same time each day.
You can take Zanacodar with or without food. The tablets should be swallowed with some water or
other non-alcoholic drink. It is important that you take Zanacodar every day until your doctor tells
you otherwise. If you have the impression that the effect of Zanacodar is too strong or too weak,
talk to your doctor or pharmacist.
For treatment of high blood pressure, the usual dose of Zanacodar for most patients is one 40 mg
tablet once a day to control blood pressure over the 24-hour period. Your doctor has recommended
a lower dose of one 20 mg tablet daily. Zanacodar may also be used in combination with diuretics
('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood
pressure lowering effect with Zanacodar.
For reduction of cardiovascular events, the usual dose of Zanacodar is one 80 mg tablet once a day.
At the beginning of the preventive therapy with Zanacodar, blood pressure should be frequently
If your liver is not working properly, the usual dose should not exceed 40 mg once daily.
If you take more Zanacodar than you should
If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital
emergency department immediately.
If you forget to take Zanacodar
If you forget to take a dose, do not worry. Take it as soon as you remember then carry on as before.
If you do not take your tablet on one day, take your normal dose on the next day. Do not take a
double dose to make up for forgotten individual doses.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Zanacodar can cause side effects, although not everybody gets them.
These side effects may occur with certain frequencies, which are defined as follows:
very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data.
Common side effects may include:
Low blood pressure (hypotension) in users treated for reduction of cardiovascular events.
Uncommon side effects may include:
Upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), urinary tract
infections, deficiency in red blood cells (anaemia),high potassium levels, feeling sad (depression)
fainting (syncope), difficulty falling asleep, feeling of spinning (vertigo), slow heart rate
(bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness
on standing up ( orthostatic hypotension) shortness of breath, abdominal pain, diarrhoea, discomfort
in the abdomen, bloating, vomiting, increased sweating, itching, drug rash, muscle pain (myalgia),
back pain, kidney impairment including acute kidney failure, and pain in the chest, feeling of
weakness, and increased level of creatinine in the blood
Rare side effects may include:
Low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty breathing,
wheezing, swelling of the face or low blood pressured), feeling anxious, impaired vision, fast heart
beat (tachycardia), upset stomach, dry mouth, , abnormal liver function, severe drug rash,redness of
skin, rapid swelling of the skin and mucosa (angioedema), eczema ( a skin disorder) joint pain
(arthralgia), , , pain in extremity, symptoms of weakness, flu-like-illness, increased levels of uric
acid, creatinine, hepatic enzymes or creatine phosphokinase in the blood, and decreased
haemoglobin ( a blood protein)
Side effects of unknown frequency may include:
Increase in certain white blood cells (eosinophilia), severe allergic reaction (e.g. rash, itching,
difficulty breathing, wheezing, swelling of the face or low blood pressure), hives (urticaria),
inflammation of the tendons, and sepsis* (often called “blood poisoning”, is a severe infection with
whole body inflammatory response which can lead to death)
*In a long term-study involving more than 20,000 patients, more patients with telmisartan
experienced sepsis compared with patients who received no telmisartan. The event may have
happened by chance or could be related to a mechanism not know.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
5. HOW TO STORE Zanacodar 20/40/80 mg tablets
Keep out of the reach and sight of children.
Do not use Zanacodar after the expiry date which is stated on the carton and blister after “EXP”.
The expiry date refers to the last day of that month.
Aluminium/aluminium blisters: This medicinal product does not require any special storage
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Zanacodar contains
• The active substance is telmisartan: a tablet of 20 mg of Zanacodar contains 20 mg of Telmisartan;
a tablet of 40 mg of Zanacodar contains 40 mg of Telmisartan; a tablet of 80 mg of Zanacodar
contains 80 mg of Telmisartan
• The other ingredients are povidone, meglumine, sodium hydroxide, mannitol, crospovidone and
What Zanacodar looks like and contents of the pack
Zanacodar are tablets.
Zanacodar 20 mg: are white, round bevelled tablets.
Zanacodar 40 mg: are white or slightly yellowish, oblong tablets.
Zanacodar 80 mg: are white or slightly yellowish, oblong tablets.
Not all pack sizes or tablet strengths may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Laboratorios Liconsa, S.A.
Gran Vía Carlos III, 98, 7th floor
Laboratorios Liconsa, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), Spain
1236 Trzin, Ljubljana
ICN Polfa Rzeszów S.A.
2 Przemysłowa Street
Valeant sp. z o.o. sp. j.
ul. Przemysłowa 2
This medicinal product is authorised in the Member States of the EEA under the following
Portugal, Czech Republic, Germany, Denmark, Spain, France, Luxembourg, Poland, United Kingdom:
Zanacodar 20, 40 and 80 mg tablets
This leaflet was last approved in: 01/2015