Package Leaflet: Information for the User

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

Equivalent medicine
Please read this leaflet carefully before 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Telmisartan Almus is and what it is used for
What you need to know before taking Telmisartan Almus
How to take Telmisartan Almus
Possible side effects
How to store Telmisartan Almus
Contents of the pack and other information

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

Telmisartan Almus belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance in the body that causes blood vessels to constrict, thereby increasing blood pressure. Telmisartan Almus blocks this effect of angiotensin II, causing blood vessels to relax and thereby reducing blood pressure.
Telmisartan Almus is used for the treatment of essential hypertension (high blood pressure) in adults. "Essential" means that the high blood pressure is not caused by other conditions.
Untreated high blood pressure can damage blood vessels in many organs, which may sometimes lead to heart attack, heart or kidney failure, stroke or blindness. High blood pressure usually does not cause symptoms until such damage has occurred. Therefore, it is important to have your blood pressure checked regularly to ensure it is within the normal range.
Telmisartan Almus is also used for reducing cardiovascular events (heart attacks or strokes) in adults who are at risk due to reduced or blocked blood flow to the heart or legs, who have had a stroke, or who have high-risk diabetes. Your doctor can advise you whether you are at high risk for such events.

2. What you should 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 more than 3 months pregnant (it is better to avoid taking Telmisartan Almus even in the early stages of pregnancy – see section Pregnancy).
if you have severe liver problems such as cholestasis or biliary obstruction (problems with bile drainage from the liver and gallbladder) or any other severe liver disease.
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are in any of the above conditions, inform your doctor or pharmacist before taking
Telmisartan Almus.
Warnings and precautions
Tell your doctor if you have or have ever had any of the following conditions or diseases:

Kidney disease or kidney transplant.
Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
Liver diseases.
Heart problems.
Elevated levels of aldosterone (water and salt retention in the body with imbalance of various minerals in the blood).
Low blood pressure (hypotension), which is more likely if you are dehydrated (excessive loss of water from the body) or have salt deficiency due to diuretic therapy (“diuretics”), low-salt diet, diarrhoea 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), particularly if you have kidney problems related to diabetes.
aliskiren

Your doctor may check your kidney function, blood pressure and the amount of
electrolytes (for example potassium) in your blood at regular intervals.
See also the information under the heading “Do not take Telmisartan Almus”.

If you are taking digoxin.

You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Telmisartan Almus is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see section Pregnancy).
If you are undergoing surgery or receiving anaesthetics, you must inform your doctor that you are taking Telmisartan Almus.
Like all other angiotensin II receptor antagonists, Telmisartan Almus may be less effective in reducing 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 medicines. 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 particularly applies to the following medicines when taken at the same time as
Telmisartan Almus:

Medicines containing lithium used to treat certain types of depression.
Medicines that may 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 when taken at high doses together with Telmisartan Almus, may 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 may increase the effect of other medicines used to lower blood pressure or of medicines that may potentially lower blood pressure (e.g. baclofen,
amifostine).
In addition, the lowering of blood pressure may be worsened by alcohol, barbiturates, narcotics
or antidepressants. You may experience this drop in blood pressure as dizziness when standing up.
You should consult your doctor if you need to adjust the dose of your other medicines while
taking Telmisartan Almus.
Telmisartan Almus with food and drink
You may take Telmisartan Almus with or without food.
Pregnancy and breast-feeding
Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking
Telmisartan Almus before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Telmisartan Almus.
Telmisartan Almus is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Telmisartan Almus is not
recommended for women who are breast-feeding, and your doctor may choose another
treatment for you if you wish to breast-feed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
Some patients may experience dizziness or fatigue while taking Telmisartan Almus. If you experience these effects, do not drive or operate machinery.

3. How to take Telmisartan Almus

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
The recommended dose of Telmisartan Almus is one tablet per day. Try to take the tablet at the same time each day. You may take Telmisartan Almus with or without food. Swallow the tablets with a little water or other non-alcoholic drink. It is important to take Telmisartan Almus every day unless your doctor tells you otherwise. If you think that the effect of Telmisartan Almus is too strong or too weak, talk to your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of Telmisartan Almus for most patients is one 40 mg tablet once daily to control blood pressure over 24 hours. 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 combination with diuretics such as hydrochlorothiazide, which has been shown to provide an additional blood pressure-lowering effect when used together with Telmisartan Almus.

To reduce cardiovascular events, the usual dose is one 80 mg tablet of Telmisartan Almus once daily. During the initial phase of preventive treatment with Telmisartan Almus 80 mg, blood pressure should be monitored 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 taken too many tablets by mistake, contact your doctor, pharmacist, or the nearest hospital emergency department immediately.

If you forget to take Telmisartan Almus
If you forget to take your medicine, don't worry. Take it as soon as you remember, then continue as before. If you miss a day's dose, take your normal dose the next day. Do not take a double dose to make up for the forgotten dose.

If you have any doubts about how to use 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 treatment:
You must immediately contact your doctor if you experience any of the following symptoms:
Sepsis* (often called "blood infection" – a severe infection causing a systemic inflammatory response), 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 must stop taking the medicine and consult their doctor immediately. If these effects are not treated, they may 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), red blood cell deficiency (anaemia), elevated potassium levels, difficulty falling asleep, feeling of sadness (depression), fainting (syncope), dizziness (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, dizziness when standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, abdominal discomfort, bloating, vomiting, itching, increased sweating, drug-related skin rashes, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute renal failure, chest pain, feeling of fatigue, and increased blood creatinine levels.
Rare side effects (may affect up to 1 in 1,000 people):
Sepsis* (often called “blood infection” – a severe infection with systemic inflammatory response that may lead to death), increased levels of certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, breathing difficulties, wheezing, facial swelling or drop in blood pressure), low blood sugar levels (in diabetic patients), anxiety, drowsiness, visual disturbances, fast heartbeat (tachycardia), dry mouth, stomach discomfort, altered taste (dysgeusia), altered liver function (Japanese patients are more predisposed to these side effects), rapid swelling of the skin and mucous membranes which may also be fatal (angioedema, including fatal outcomes), eczema (a skin disorder), skin redness, urticaria, severe drug-induced skin rash, joint pain (arthralgia), limb pain, tendon pain, influenza-like illness, decreased haemoglobin (a blood protein), increased uric acid levels, increased liver enzymes or increased creatine phosphokinase in 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 could be related to a currently unknown mechanism.
** Cases of progressive scarring of lung tissue have been reported during treatment with telmisartan. However, it is not known whether telmisartan was the cause.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website
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 stated on the carton and blister after "Exp." The expiry date refers to the last day of that month.
Aluminium/aluminium blisters: This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Telmisartan Almus contains

The active substance is telmisartan: one 20 mg tablet of Telmisartan Almus contains 20 mg of telmisartan; one 40 mg tablet of Telmisartan Almus contains 40 mg of telmisartan; one 80 mg tablet of Telmisartan Almus contains 80 mg of telmisartan.
The other components 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 available as tablets.
Telmisartan Almus 20 mg: white, round tablets, engraved with "LC" on one side.
Telmisartan Almus 40 mg: white, oval tablets, engraved with "LC" on one side.
Telmisartan Almus 80 mg: white, oval tablets, engraved with "LC" on one side.
Telmisartan Almus is supplied in blisters containing 28 tablets.
It is possible that not all pack sizes or tablet strengths are marketed.

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

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 EEA Member States under the following names:
Portugal: Terfedel 20, 40 and 80 mg tablets
Italy: Telmisartan Almus 20, 40 and 80 mg tablets