PACKAGE LEAFLET: INFORMATION FOR THE USER

TELMISARTAN ALTER 20 mg tablets, 40 mg tablets, 80 mg tablets

Telmisartan
Generic Medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT TELMISARTAN ALTER IS AND WHAT IT IS USED FOR

TELMISARTAN ALTER 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 narrow, thereby increasing blood pressure.
TELMISARTAN ALTER blocks the effect of angiotensin II, causing blood vessels to relax and thus reducing blood pressure.
TELMISARTAN ALTER is used for the treatment of essential hypertension (high blood pressure). "Essential" means that the high blood pressure is not caused by other conditions.
If left 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 occurs. Therefore, it is important to have your blood pressure checked regularly to ensure it is within the normal range.
TELMISARTAN ALTER is also used for reducing cardiovascular events (e.g. heart attack or stroke) in patients who are at risk because of reduced or blocked blood flow to the heart or legs, or who have had a stroke or have diabetes with high risk. Your doctor can determine whether you are at high risk for these events.

2. WHAT YOU SHOULD KNOW BEFORE TAKING TELMISARTAN ALTER

Do not take TELMISARTAN ALTER

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 ALTER even in early pregnancy – see Pregnancy section);
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 ALTER.
Warnings and precautions
Talk to 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 body water) 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 ALTER

if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (e.g. 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 (e.g. potassium) in your blood at regular intervals. See also information under “Do not take TELMISARTAN ALTER”;
if you are taking digoxin.

You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). TELMISARTAN ALTER 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 Pregnancy section).
If undergoing surgery or receiving anaesthetics, you must inform the doctor that you are taking TELMISARTAN ALTER.
Talk to your doctor if, after taking TELMISARTAN ALTER, you experience abdominal pain, nausea, vomiting or diarrhoea. The doctor will decide whether treatment should continue. Do not stop taking TELMISARTAN ALTER on your own.
TELMISARTAN ALTER may be less effective in lowering blood pressure in patients of African origin.
Children and adolescents
The use of TELMISARTAN ALTER is not recommended in children and adolescents under 18 years of age.
Other medicines and TELMISARTAN ALTER
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may decide to adjust the dose of these other medicines 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 taken concomitantly with TELMISARTAN ALTER:

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 with TELMISARTAN ALTER, may cause excessive loss of body water and low blood pressure (hypotension).
If you are taking an ACE inhibitor or aliskiren (see also information under “Do not take TELMISARTAN ALTER” and “Warnings and precautions”).
Digoxin.

The effect of TELMISARTAN ALTER may be reduced when taken with NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen) or corticosteroids.
TELMISARTAN ALTER may enhance 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.
Consult your doctor if you need to adjust the dose of your other medicines while taking TELMISARTAN ALTER.
Taking TELMISARTAN ALTER with food and drink
You may take TELMISARTAN ALTER with or without food.
Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking TELMISARTAN ALTER before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of TELMISARTAN ALTER. TELMISARTAN ALTER 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.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. TELMISARTAN ALTER 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 a newborn or was born prematurely.
Driving and using machines
Some patients may experience dizziness or drowsiness when taking TELMISARTAN ALTER. If these effects occur, do not drive or operate machinery.
TELMISARTAN ALTER contains sorbitol (E420).
If you have an intolerance to certain sugars, consult your doctor before taking TELMISARTAN ALTER.

3. HOW TO TAKE TELMISARTAN ALTER

Take TELMISARTAN ALTER exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose of TELMISARTAN ALTER is one tablet daily. Try to take the tablet at the same time
every day. You may take TELMISARTAN ALTER with or without food. Swallow the tablets with a little water or another non-alcoholic drink. It is important to take
TELMISARTAN ALTER every day unless your doctor tells you otherwise.
If you feel that the effect of TELMISARTAN ALTER is too strong or too weak, consult your doctor
or pharmacist.
For the treatment of high blood pressure, the recommended dose of TELMISARTAN ALTER for most patients is one 40 mg tablet once daily to control blood pressure over a 24-hour period. However, sometimes your doctor may prescribe a lower dose of 20 mg or a higher dose of 80 mg. TELMISARTAN ALTER may also be used in combination with diuretics such as hydrochlorothiazide, with which it has demonstrated an additive effect in reducing blood pressure.
For the reduction of cardiovascular events, the usual dose of TELMISARTAN ALTER is one 80 mg tablet once daily. At the beginning of preventive therapy with TELMISARTAN ALTER 80 mg, blood pressure should be monitored frequently.
If your liver is not functioning properly, the usual daily dose of 40 mg must not be exceeded.
If you take more TELMISARTAN ALTER than you should
If you have taken too many tablets by mistake, contact your doctor or pharmacist immediately, or go to the nearest hospital emergency department.
If you forget to take TELMISARTAN ALTER
If you forget to take your 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 take a double dose to make up for a forgotten tablet.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Some adverse 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 adverse effects are rare (may affect up to 1 in 1,000 people), but extremely serious. Patients must stop taking the medicine and consult a doctor immediately. If these effects are not treated, they may be fatal.

Possible adverse effects of TELMISARTAN ALTER:

Common adverse effects (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in patients treated for reduction of cardiovascular events.

Uncommon adverse effects (may affect up to 1 in 100 people):
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), reduced red blood cells (anaemia), high levels of potassium in the blood, difficulty falling asleep, feeling of sadness (depression), fainting (syncope), sensation of dizziness (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, feeling of instability upon standing (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, abdominal discomfort, swelling, vomiting, itching, increased sweating, drug-related skin rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, chest pain, feeling of weakness, increased levels of creatinine in the blood.

Rare adverse 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, difficulty breathing, wheezing, facial swelling or low blood pressure), low blood sugar levels (in diabetic patients), feeling of anxiety, drowsiness, visual disturbances, rapid heartbeat (tachycardia), dry mouth, stomach discomfort, altered taste (dysgeusia), altered liver function (patients of Japanese origin are more likely to experience these side effects), rapid swelling of the skin and mucous membranes which may also be fatal (angioedema, including fatal outcomes), eczema (skin disorder), skin redness (urticaria), severe drug-related skin rash, joint pain (arthralgia), pain in the extremities, tendon pain, influenza-like illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased liver enzymes or creatine phosphokinase in the blood.

Very rare adverse effects (may affect up to 1 in 10,000 people):
Progressive scarring of lung tissue (interstitial lung disease)**.

Not known (frequency cannot be estimated from the available data):
Intestinal angioedema: following the use of similar products, swelling in the intestine has been reported, manifesting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

*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 adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE TELMISARTAN ALTER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after Exp. The expiry date refers to the
last day of the month.
This medicine does not require any special storage conditions. Keep in the original packaging to protect the
medicine from moisture. Remove the TELMISARTAN ALTER tablet from the blister pack only immediately
before taking it.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TELMISARTAN ALTER contains
The active substance is telmisartan.
Each tablet of TELMISARTAN ALTER 20 mg contains 20 mg of telmisartan.
Each tablet of TELMISARTAN ALTER 40 mg contains 40 mg of telmisartan.
Each tablet of TELMISARTAN ALTER 80 mg contains 80 mg of telmisartan.
The other components are: microcrystalline cellulose, sodium hydroxide, meglumine, povidone K30, sodium starch glycolate, sorbitol (E420), magnesium stearate.

Description of the appearance of TELMISARTAN ALTER and the contents of the pack
TELMISARTAN ALTER 20 mg tablets are white or slightly beige, round, biconvex, with a diameter of 8 mm.
TELMISARTAN ALTER 40 mg tablets are white or slightly beige, round, biconvex, with a diameter of 11 mm.
TELMISARTAN ALTER 80 mg tablets are white or slightly beige, oblong, measuring 17 mm x 7.5 mm.
TELMISARTAN ALTER 20 mg is available in blister packs containing 14 or 28 tablets.
TELMISARTAN ALTER 40 mg is available in blister packs containing 14, 28, or 30 tablets.
TELMISARTAN ALTER 80 mg is available in blister packs containing 14, 28, or 30 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder:
LABORATORI ALTER srl
Via Egadi, 7
20144 Milano, Italy

Manufacturer:
Laboratorios Alter S.A.
c/ Mateo Inurria, 30 - 28036 Madrid – Spain

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