TELMISARTAN 20 mg Tabletka

Treść ulotki

1. Telmisartan Almus 20 mg tablets, 40 mg tablets, 80 mg tablets
   1. What is Telmisartan Almus and what is it used for
   2. What you need to know before taking Telmisartan Almus
   3. How to take Telmisartan Almus
   4. Possible side effects
   5. How to store Telmisartan Almus
   6. Contents of the pack and other information

Telmisartan Almus 20 mg tablets, 40 mg tablets, 80 mg tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 Almus is and what it is used for
• 2. What you need to know before you take Telmisartan Almus
• 3. How to take Telmisartan Almus
• 4. Possible side effects
• 5. How to store Telmisartan Almus
• 6. Contents of the pack and other information

1. What is Telmisartan Almus and what is it used for

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

Telmisartan Almus 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, 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.

Telmisartan Almus is also used toreduce cardiovascular events (heart attacks or strokes) in adults who are at risk because they have a reduction or blockage of blood flow to the heart or legs, have had a stroke, or have diabetes at high risk. Your doctor can tell you if you are at high risk for such events.

2. What you need to know before taking Telmisartan Almus

Do not take Telmisartan Almus

• if you are allergic to telmisartan or to 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 taking Telmisartan Almus 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 you are in any of the conditions listed above, tell your doctor or pharmacist before taking
Telmisartan Almus.

Warnings and precautions
Tell your doctor if you suffer from 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 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 (“diuretics”), a low-salt diet, diarrhea or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Talk to your doctor before taking Telmisartan Almus:

• 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 (for example potassium) in your blood at regular intervals.
See also what is stated in the section “Do not take Telmisartan Almus”.

• If you are taking digoxin.

You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting a
pregnancy). Telmisartan Almus 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
child 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 Almus.
Like all other angiotensin II receptor blockers, Telmisartan Almus may be less
effective in lowering blood pressure in black patients.

Children and adolescents
The use of Telmisartan Almus is not recommended in children and adolescents under 18 years of age.

Other medicines and Telmisartan Almus
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine. Your doctor may decide to change your 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 at the same time as
Telmisartan Almus:

• 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 blockers, 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 Almus, can cause excessive loss of body water and low blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also the sections “Do not take Telmisartan Almus” and “Warnings and precautions”).
• Digoxin As with other medicines that lower blood pressure, the effect of Telmisartan Almus may be reduced when taking NSAIDs (non-steroidal anti-inflammatory drugs e.g. aspirin or ibuprofen) or corticosteroids.

Telmisartan Almus can increase the effect of other medicines used to lower blood
pressure or of 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 Almus.

Telmisartan Almus with food and drink
You can take Telmisartan Almus 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 starting a
pregnancy). As a rule, your doctor will advise you to stop taking
Telmisartan Almus before starting a pregnancy or as soon as you find out you are
pregnant and will advise you to take another medicine instead of Telmisartan Almus.
Telmisartan Almus 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 child if taken after the
third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Telmisartan Almus is not
recommended for women who are breastfeeding and your doctor may choose another
treatment for you if you wish to breastfeed, especially if the baby is newborn or premature.

Driving and using machines
Some patients may experience dizziness or fatigue while taking Telmisartan Almus. If this
happens, do not drive or use machines.

3. How to take Telmisartan Almus

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

If you take more Telmisartan Almus 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 Almus
If you forget to take the medicine, 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 not
takea double dose to make up for a missed dose.
If you have any questions about 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 may 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 an inflammatory response
throughout the body), rapid swelling of the skin and mucous membranes (angioedema); these 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 Almus:
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), low red blood cell count (anemia), high potassium levels, difficulty
falling asleep, feeling sad (depression), fainting (syncope), dizziness (vertigo),
slow heartbeat (bradycardia), low blood pressure (hypotension) in patients treated
for high blood pressure, lightheadedness when standing up (orthostatic hypotension), shortness of
breath, cough, abdominal pain, diarrhea, abdominal discomfort, bloating, vomiting, itching,
increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment
including acute renal failure, chest pain, feeling tired 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 an inflammatory response
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
reaction (e.g., rash, itching, difficulty breathing, wheezing, swelling of the
face or lowering of blood pressure), low blood sugar levels (in diabetic patients),
anxiety, drowsiness, impaired vision, fast heartbeat (tachycardia), dry mouth,
stomach discomfort, altered taste (dysgeusia), altered liver function (Japanese patients are more
prone to experience these side effects), rapid swelling of the skin and mucous membranes that can also
lead to death (angioedema, including fatal outcome), eczema (a skin disorder), skin redness, hives,
severe drug rash, joint pain (arthralgia), limb pain, tendon pain, flu-like malaise, 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 Almus

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 package and on the 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 Almus contains

• The active ingredient is telmisartan: a 20 mg tablet of Telmisartan Almus contains 20 mg of telmisartan; a 40 mg tablet of Telmisartan Almus contains 40 mg of telmisartan; an 80 mg tablet of Telmisartan Almus contains 80 mg of telmisartan
• The other ingredients are: povidone, meglumine, sodium hydroxide, mannitol, crospovidone and magnesium stearate.

Description of the appearance of Telmisartan Almus and contents of the pack
Telmisartan Almus is in tablet form.
Telmisartan Almus 20 mg: is formulated as white, rounded tablets with LC inscribed on one side.
Telmisartan Almus 40 mg: is formulated as white, oblong tablets with LC inscribed on one side.
Telmisartan Almus 80 mg: is formulated as white, oblong tablets with LC inscribed on one side.
Telmisartan Almus is supplied in blisters containing 28 tablets.
Not all pack sizes or strengths may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Almus S.r.l.
Via Cesarea, 11/10
16121 Genova

Manufacturer:
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 EEA with the following names:
Portugal: Terfedel tablets 20, 40 and 80 mg
Italy: Telmisartan Almus 20, 40 and 80 mg tablets