TELMISARTAN 20 mg Coated Tablet

Зміст інструкції

1. TELMISARTAN DOC Generici 20 mg tablets
   1. What is TELMISARTAN DOC Generici and what is it used for
   2. What you need to know before taking TELMISARTAN DOC Generici
   3. How to take TELMISARTAN DOC Generici
   4. Possible side effects
   5. How to store TELMISARTAN DOC Generici
   6. Contents of the pack and other information

TELMISARTAN DOC Generici 20 mg tablets

TELMISARTAN DOC Generici 40 mg tablets
TELMISARTAN DOC Generici 80 mg tablets
Generic medicine

Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What TELMISARTAN DOC Generici is and what it is used for
• 2. What you need to know before you take TELMISARTAN DOC Generici
• 3. How to take TELMISARTAN DOC Generici
• 4. Possible side effects
• 5. How to store TELMISARTAN DOC Generici
• 6. Contents of the pack and other information

1. What is TELMISARTAN DOC Generici and what is it used for

TELMISARTAN DOC Generici belongs to a class of medicines known as
angiotensin II receptor antagonists. Angiotensin II is a substance present in the
body that causes constriction of blood vessels, thereby increasing blood pressure.
TELMISARTAN DOC Generici blocks the effect of angiotensin II, causing a
relaxation of blood vessels and thus reducing blood pressure.

TELMISARTAN DOC Generici is used forthe treatment of essential hypertension (high
blood pressure) in adults. “Essential” means that the high blood pressure is not
caused by other conditions.
High blood pressure, if left untreated, can damage blood vessels in many organs,
which can sometimes cause heart attack, heart or kidney failure, stroke or blindness. Normally, the
high blood pressure does not give symptoms before such damage occurs. Therefore, it is important
to have your blood pressure measured regularly to check if it is within the
normal range.

TELMISARTANDOCGenericiisalsousedto reduce cardiovascular
events (heart attacks or stroke) in adults who are at risk because their blood supply to the
heart or legs is reduced or blocked or have had a stroke or have high-risk diabetes. Your doctor can tell you if you are at high risk for these events.

2. What you need to know before taking TELMISARTAN DOC Generici

Do not take TELMISARTAN DOC Generici

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant for more than 3 months (it is best to avoid TELMISARTAN DOC Generici even in the early stages of pregnancy - see the Pregnancy section).
• if you suffer from severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of bile from the liver and gallbladder) or any other serious liver disease. if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren

If any of the above conditions apply to you, tell your doctor or pharmacist
before taking TELMISARTAN DOC Generici.

Warnings and precautions
Consult your doctor if you suffer from or have ever suffered from any of the following conditions or
diseases:

• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels of one or both kidneys).
• Liver diseases.
• Heart problems.
• Increased levels of aldosterone (retention of water and salt in the body with an imbalance of various minerals in the blood).
• Low blood pressure (hypotension), which is more likely to occur if you are dehydrated (excessive water loss from the body) or have a salt deficiency due to diuretic therapy, a low-salt diet, diarrhea or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Consult your doctor before taking TELMISARTAN DOC Generici

• 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 suffer from kidney problems related to diabetes
• aliskiren

The doctor may check your kidney function, blood pressure and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is stated under “Do not take TELMISARTAN DOC Generici”.

• if you are taking digoxin

You must tell your doctor if you think you may be pregnant (or if there is a possibility of
becoming pregnant). TELMISARTAN DOC Generici is not recommended in the early
stages of pregnancy and should not be taken if you are pregnant for more than 3 months, as
it can cause serious harm to the baby if taken during this period (see the Pregnancy
section).
In case of surgery or administration of anesthetics, you must inform your doctor
that you are taking TELMISARTAN DOC Generici.
Like all other angiotensin II receptor antagonists, TELMISARTAN DOC
Generici may be less effective in lowering blood pressure in black patients.

Children and adolescents
The use of TELMISARTAN DOC Generici is not recommended in children and adolescents
under 18 years of age.

Other medicines and TELMISARTAN DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. Your doctor may need to adjust the dose
and/ or take other precautions. In some cases, it may be necessary to stop taking
one of these medicines. This applies especially to the medicines listed below, taken
simultaneously with TELMISARTAN DOC Generici:

• Medicines containing lithium to treat some types of depression.
• Medicines that can increase potassium levels in the blood such as potassium-containing salt substitutes, potassium-sparing diuretics (some “diuretics”), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen), heparin, immunosuppressants (e.g. cyclosporine or tacrolimus) and the antibiotic trimethoprim.
• Diuretics, especially if taken at high doses with TELMISARTAN DOC Generici, can induce excessive water loss from the body and lower blood pressure (hypotension) If you are taking an ACE inhibitor or aliskiren (see also what is stated under: “Do not take TELMISARTAN DOC Generici” and “Warnings and precautions”) Digoxin

As with other medicines that lower blood pressure, the effect of TELMISARTAN
DOC Generici may be reduced when you take NSAIDs (non-steroidal anti-inflammatory drugs
e.g. aspirin or ibuprofen) or corticosteroids.
TELMISARTAN DOC Generici may increase the effect of other medicines used to treat
high blood pressure or medicines that can potentially lower blood pressure (e.g. baclofen, amifostine). Furthermore, the lowering of blood pressure
may be aggravated by alcohol, barbiturates, narcotics or antidepressants. You may experience this
lowering of blood pressure as dizziness when getting up. You should consult your doctor if you need to change the dose of other medicines while taking TELMISARTAN DOC
Generici.

TELMISARTAN DOC Generici with food and drink
You can take TELMISARTAN DOC Generici with or without food.

Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of
becoming pregnant). As a rule, your doctor will advise you to stop taking
TELMISARTAN DOC Generici before becoming pregnant or as soon as you find out you are pregnant and will advise you to take another medicine
instead of TELMISARTAN DOC Generici. TELMISARTAN DOC Generici is not
recommended in the early stages of pregnancy and should not be taken if you are pregnant
for more than 3 months as it can cause serious harm to the baby if taken after the third month of
pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. TELMISARTAN DOC
Generici is not recommended for mothers who are breastfeeding and your doctor may choose a
different treatment if you wish to breastfeed, especially if the baby is newly born or was
born prematurely.

Driving and operating machinery
Some patients may experience dizziness or feel tired when taking
TELMISARTAN DOC Generici. If you experience dizziness or feel tired, do not drive or
operate machinery

3. How to take TELMISARTAN DOC Generici

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.
The recommended dose of TELMISARTAN DOC Generici is one tablet a day. Try to
take the tablet at the same time each day. You can take TELMISARTAN DOC
Generici with or without food. The tablets must be swallowed with some water or other
non-alcoholic beverage. It is important to take TELMISARTAN DOC Generici every day until
your doctor tells you otherwise. If you feel that the effect of
TELMISARTAN DOC Generici is too strong or too weak, talk to your doctor or
pharmacist.
For the treatment of high blood pressure, the usual dose of TELMISARTAN DOC
Generici for most patients is one 40 mg tablet once a day to
control blood pressure over the 24-hour period. However, in some cases your doctor may
recommend a lower dose of 20 mg per day or a higher dose of 80 mg. Alternatively,
TELMISARTAN DOC Generici can be taken in association with diuretics, such as
hydrochlorothiazide, which has been shown to have an additive blood pressure lowering effect when combined with TELMISARTAN DOC Generici.
To reduce cardiovascular events, the usual dose is one tablet of TELMISARTAN
DOC Generici 80 mg once a day. At the beginning of preventive therapy with
TELMISARTAN DOC Generici 80 mg, blood pressure should be checked
frequently.
If your liver is not functioning properly, the usual dose of 40 mg per
day should not be exceeded.

If you take more TELMISARTAN DOC Generici than you should
If you have accidentally taken too many tablets, contact your doctor or
pharmacist, or the emergency room of the nearest hospital immediately.

If you forget to take TELMISARTAN DOC Generici
If you forget to take a dose, do not worry. Take it as soon as you remember, then
continue as before. If you miss a dose for one day, take your normal dose the next day.

Do nottake a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. 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:
You should seek immediate medical attention if you experience any of the following symptoms:
Sepsis* (often called "blood infection" is a serious infection with inflammatory response of the entire organism), rapid swelling of the skin and mucous membranes (angioedema);
these side effects are rare (may affect up to 1 in 1,000 people), but
extremely serious and patients should stop taking the medicine and consult
a doctor immediately. If these effects are not treated they can be fatal.

Possible side effects of TELMISARTAN DOC Generici:
Common side effects (may affect up to 1 in 10 people)::
Low blood pressure (hypotension) in patients treated to reduce cardiovascular events.
Uncommon side effects (may affect up to 1 in 100 people):
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis,
cold), decreased red blood cells (anemia), high potassium levels in the blood, difficulty
falling asleep, feeling sad (depression), fainting (syncope), feeling of
dizziness (vertigo), slowed heartbeat (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, dizziness upon standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhea, abdominal discomfort, bloating, vomiting, itching, increased sweating, drug-related skin rash, back pain, muscle cramps, muscle pain (myalgia), impaired kidney function
including acute renal failure, chest pain, feeling of weakness and increased
creatinine levels in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
Sepsis* (often called “blood infection” is a serious infection with inflammatory response of the entire organism that can lead to death), increased white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction
(anaphylactic reaction), allergic reaction (e.g. rash (skin eruption), itching, difficulty
breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling of anxiety, drowsiness, vision changes, fast heart rate (tachycardia), dry mouth, stomach upset, altered taste
(dysgeusia), altered liver function (of the liver), (Japanese patients are more likely
to experience this side effect), rapid swelling of the skin and mucous membranes which can
also lead to death (angioedema, even with fatal outcome), eczema (skin disorder),
redness of the skin (urticaria), severe drug-related skin rash, joint pain (arthralgia), limb pain, tendon pain, flu-like illness,
decreased hemoglobin (a blood protein), increased uric acid levels,
increased 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)**.
* The event may have occurred by chance or may be related to a currently unknown mechanism.
** Cases of progressive scarring of lung tissue have been reported during
the intake of telmisartan. However, it is not known whether telmisartan was the cause.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store TELMISARTAN DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
Aluminum/aluminum blister: This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TELMISARTAN DOC Generici contains

• The active ingredient is telmisartan: one 20 mg tablet of TELMISARTAN DOC Generici contains 20 mg of telmisartan; one 40 mg tablet of TELMISARTAN DOC Generici contains 40 mg of telmisartan; one 80 mg tablet of TELMISARTAN DOC Generici contains 80 mg of telmisartan
• The other ingredients are: povidone, meglumine, sodium hydroxide, mannitol, crospovidone and magnesium stearate.

Description of the appearance of TELMISARTAN DOC Generici and contents of the pack
TELMISARTAN DOC Generici are tablets.
TELMISARTAN DOC Generici 20 mg: white, rounded tablets with LC imprinted on one
side.
TELMISARTAN DOC Generici 40 mg: white, oblong tablets with LC imprinted on one
side.
TELMISARTAN DOC Generici 80 mg: white, oblong tablets with LC imprinted on one
side.
TELMISARTAN DOC Generici is supplied in blisters containing 28 tablets.
Not all pack sizes or strengths may be marketed.

Marketing Authorisation Holder:
DOC Generici S.r.l
Via Turati 40
20121 Milano
Italy

Manufacturer responsible for batch release:
Laboratorios Liconsa, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Portugal: Meldoc 20/40/80 mg Comprimidos
Italy: TELMISARTAN DOC Generici 20, 40 and 80 mg tablets