TELMISARTAN 40 mg /12,5 Mg Tabletka Powlekana

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1. Telmisartan and Hydrochlorothiazide Alter 40 mg/12.5 mg tablets, 80 mg/12.5 mg tablets, 80 mg/25 mg tablets
   1. What is Telmisartan and Idroclorotiazide Alter and what it is used for
   2. What you need to know before taking Telmisartan and Hydrochlorothiazide Alter
   3. How to take Telmisartan and Hydrochlorothiazide Alter
   4. Possible side effects
   5. How to store Telmisartan e Idroclorotiazide Alter
   6. Contents of the pack and other information

Telmisartan and Hydrochlorothiazide Alter 40 mg/12.5 mg tablets, 80 mg/12.5 mg tablets, 80 mg/25 mg tablets

telmisartan/hydrochlorothiazide
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 and Hydrochlorothiazide Alter is and what it is used for
• 2. What you need to know before you take Telmisartan and Hydrochlorothiazide Alter
• 3. How to take Telmisartan and Hydrochlorothiazide Alter
• 4. Possible side effects
• 5. How to store Telmisartan and Hydrochlorothiazide Alter
• 6. Contents of the pack and other information

1. What is Telmisartan and Idroclorotiazide Alter and what it is used for

Telmisartan and Idroclorotiazide Alter is a combination of the two active ingredients, telmisartan and idroclorotiazide,
in a single tablet. Each of these substances facilitates the control of high blood pressure.

• telmisartan belongs to a class of medicines known as angiotensin II receptor blockers. Angiotensin II is a substance present in the body that causes constriction of blood vessels, thereby increasing blood pressure. Telmisartan blocks this effect of angiotensin II, causing the relaxation of blood vessels and thus reducing blood pressure.
• Idroclorotiazide belongs to a class of medicines known as thiazide diuretics which cause an increase in urine flow, thus contributing to the reduction of blood pressure.

Hypertension, if left untreated, can damage blood vessels in many organs; this can sometimes cause
heart attack, heart or kidney failure, stroke or blindness. Normally hypertension does not give symptoms before
such damage occurs. Therefore, it is important to regularly check blood
pressure to verify if it is within the normal range.
Telmisartan and Idroclorotiazide Alter is used to treat high blood pressure (essential hypertension
) in adults in whom blood pressure is not sufficiently controlled by telmisartan and
idroclorotiazide administered separately.

2. What you need to know before taking Telmisartan and Hydrochlorothiazide Alter

Do not take Telmisartan and Hydrochlorothiazide Alter:

• if you are allergic to telmisartan or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to hydrochlorothiazide or to any other medicine derived from sulfonamide.
• if you are pregnant for more than 3 months (it is best to avoid taking Telmisartan and Hydrochlorothiazide Alter 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 have severe kidney disease or anuria (less than 100 ml of urine per day).
• if your doctor determines that the levels of potassium in your blood are low or the levels of calcium are high and do not improve following treatment.
• 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 these conditions, tell your doctor or pharmacist before taking Telmisartan and
Hydrochlorothiazide Alter.

Warnings and precautions
Talk to your doctor before taking Telmisartan and Hydrochlorothiazide Alter if you suffer or have suffered from any of the
following conditions or diseases:

• Low blood pressure (hypotension), which is more likely to occur if you are dehydrated (excessive fluid loss) or have a salt deficiency due to diuretic therapy (diuretics), a low-salt diet, diarrhea, vomiting, or hemofiltration.
• Kidney disease or kidney transplant.
• Stenosis of the renal artery (narrowing of the blood vessels of one or both kidneys);
• Liver disease.
• Heart problems.
• Diabetes.
• Gout.
• Increased levels of aldosterone (fluid and salt retention in the body with an imbalance of various electrolytes in the blood).
• Systemic lupus erythematosus (also called “lupus” or “SLE”) a disease in which the body's immune system attacks the body itself.
• The active ingredient hydrochlorothiazide can cause an uncommon reaction, resulting in decreased vision and eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in your eye and can occur from hours to weeks after taking Telmisartan and Hydrochlorothiazide Alter. This condition can lead to permanent visual impairment if left untreated.
• If you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Long-term use of hydrochlorothiazide, especially at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Telmisartan and Hydrochlorothiazide Alter.

Talk to your doctor before taking Telmisartan and Hydrochlorothiazide Alter

• if you are taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (for example enalapril, lisinopril, ramipril angiotensin converting enzyme inhibitors), especially 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 what is stated under “Do not take Telmisartan and Hydrochlorothiazide Alter”.
• if you are taking digoxin.
• if you have had breathing or lung problems (including inflammation or fluid in the lungs) following the use of hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Telmisartan and Hydrochlorothiazide Alter, consult a doctor immediately.

You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). Telmisartan and Hydrochlorothiazide Alter is not recommended in the early stages of pregnancy and must not
be taken if you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken in
this period (see the pregnancy section).
Treatment with hydrochlorothiazide can cause an electrolyte imbalance in the body. Typical symptoms of
fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness,
restlessness, muscle pain or cramps, nausea (feeling sick), vomiting, muscle fatigue and
abnormally fast heartbeat (more than 100 beats per minute). If you experience any of
these symptoms, tell your doctor.
You should also tell your doctor if you have noticed an increased sensitivity of the skin to the sun, which
manifests with the onset of sunburn symptoms more quickly than normal (such as redness, itching,
swelling, blistering).
In case of surgery or administration of anesthetics, you must inform the doctor that you are
taking Telmisartan and Hydrochlorothiazide Alter.
Telmisartan and Hydrochlorothiazide Alter may be less effective in reducing blood pressure in patients
of African ethnicity.
Talk to your doctor if, after taking Telmisartan and Hydrochlorothiazide Alter, you experience abdominal pain,
nausea, vomiting or diarrhea. The doctor will decide on the continuation of treatment. Do not stop
taking Telmisartan and Hydrochlorothiazide Alter on your own.

Children and adolescents
The use of Telmisartan and Hydrochlorothiazide Alter is not recommended in children and adolescents up to 18
years of age.

Other medicines and Telmisartan and Hydrochlorothiazide Alter
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. The doctor may decide to change 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 applies especially to the medicines listed below, taken at the same time as
Telmisartan and Hydrochlorothiazide Alter:

• Medicines containing lithium to treat certain types of depression.
• Medicines associated with low potassium levels in the blood (hypokalemia) such as other diuretics, laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), adrenocorticotropic hormone (ACTH), amphotericin (antifungal medicine), carbenoxolone (used for the treatment of mouth ulcers), sodium penicillin G (antibiotic), salicylic acid and its derivatives.
• Iodinated contrast agents used during an imaging examination.
• Medicines that can increase potassium levels in the blood such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (immunosuppressant medicine) and other medicines such as sodium heparin (anticoagulant).Medicines that are affected by changes in potassium levels in the blood such as medicines for the heart (e.g. digoxin) or medicines to control heart rhythm (e.g. quinidine, disopyramide, amiodarone, sotalol), medicines used for mental disorders (e.g. thioridazine, chlorpromazine, levomepromazine) and other medicines such as some antibiotics (e.g. sparfloxacin, pentamidine) or some medicines for the treatment of allergic reactions (e.g. terfenadine).Medicines for the treatment of diabetes (insulin or oral agents such as metformin).
• Cholestyramine and colestipol, medicines to lower blood fat levels
• Medicines to increase blood pressure, such as norepinephrine
• Medicines that relax the muscles, such as tubocurarine.
• Calcium and/or vitamin D supplements
• Anticholinergic medicines (drugs used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease and as an aid to anesthesia), such as atropine and biperiden
• Amantadine (medicine used to treat Parkinson's disease and also used to treat or prevent diseases caused by viruses)
• Other substances used to treat high blood pressure, corticosteroids, pain relievers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), medicines for cancer, gout or arthritis.
• If you are taking an ACE inhibitor or aliskiren (see also “Do not take Telmisartan and Hydrochlorothiazide Alter” and “Warnings and precautions”);
• Digoxin.

Telmisartan and Hydrochlorothiazide Alter can increase the effect of other medicines used to reduce high blood
pressure or medicines that can potentially lower blood pressure (e.g. baclofen,
amifostine). In addition, 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
on your feet. Consult your doctor if you need to change the dose of other medicines while taking
Telmisartan and Hydrochlorothiazide Alter.
The effect of Telmisartan and Hydrochlorothiazide Alter may be reduced when you take NSAIDs (non-steroidal
anti-inflammatory drugs, e.g. aspirin and ibuprofen).

Telmisartan and Hydrochlorothiazide Alter with food and alcohol
tiazide Alter with food and alcohol
You can take Telmisartan and Hydrochlorothiazide Alter with or without food.
Avoid drinking alcohol before talking to your doctor. Alcohol can further lower blood
pressure and/or increase the risk of dizziness or fainting.

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 and
Hydrochlorothiazide Alter before becoming pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Telmisartan and Hydrochlorothiazide Alter.
Telmisartan and Hydrochlorothiazide Alter is not recommended during pregnancy and must 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 about to start breastfeeding. Telmisartan and Hydrochlorothiazide
Alter is not recommended for women who are breastfeeding and your doctor may choose another treatment
for you if you wish to breastfeed.

Driving and using machines
Some patients may experience dizziness, fainting or a feeling of the surrounding environment moving
when taking Telmisartan and Hydrochlorothiazide Alter.
If these effects occur, do not drive or use machines.

Telmisartan and Hydrochlorothiazide Alter contains sorbitol
This medicine contains 21.47 mg of sorbitol per tablet of Telmisartan and Hydrochlorothiazide Alter from
40 mg/12.5 mg and 42.95 mg of sorbitol per tablet of Telmisartan and Hydrochlorothiazide ALTER from 80
mg/12.5 mg and from 80 mg/25 mg. Sorbitol is a source of fructose. If your doctor has told you that you are
intolerant to certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic
disease in which patients cannot metabolize fructose, talk to your doctor before taking
this medicine.

Telmisartan and Hydrochlorothiazide Alter contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Telmisartan and Hydrochlorothiazide Alter

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 and Hydrochlorothiazide Alter is one tablet a day. Try to
take the tablet at the same time each day.
You can take Telmisartan and Hydrochlorothiazide Alter with or without food. The tablets must be swallowed
whole with a little water or other non-alcoholic beverage. It is important to take Telmisartan and Hydrochlorothiazide
Alter every day until your doctor tells you otherwise.
If your liver is not functioning properly, you should not exceed the usual dose of 40 mg of
telmisartan once a day.

If you take more Telmisartan and Hydrochlorothiazide Alter than you should
If you have accidentally taken too many tablets, you may experience symptoms such as low blood
pressure and a fast heartbeat. Slow heartbeat, dizziness, vomiting, and reduced
kidney function including kidney failure have also been reported. Due to the presence of hydrochlorothiazide, you may
also experience markedly low blood pressure and low levels of potassium in the blood, which can
cause nausea, drowsiness and muscle cramps and/or irregular heartbeat associated with the use
of concomitant medicines such as digoxin or certain antiarrhythmic treatments. Contact your
doctor or pharmacist immediately, or the emergency room of the nearest hospital.

If you forget to take Telmisartan and Hydrochlorothiazide Alter
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 take a double dose to make up for missed doses.
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 everyone gets them.
manifest them.

Some side effects may be serious and require immediate medical attention:
You should see a doctor immediately 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, which can be fatal), appearance of
blisters and peeling of the outermost layer of the skin (toxic epidermal necrolysis; these side
effects are rare (may affect up to 1 in 1,000 people), or very rare (toxic epidermal necrolysis; may affect up to 1 in 10,000 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. An increase in the incidence of sepsis has been observed with telmisartan alone, however it cannot be excluded for Telmisartan and Hydrochlorothiazide Alter.

Possible side effects of Telmisartan and Hydrochlorothiazide Alter
Common side effects (may affect up to 1 in 10 people):
Dizziness.
Uncommon side effects (may affect up to 1 in 100 people):
Reduced potassium levels in the blood, anxiety, fainting (syncope), sensation of numbness, sensation
of tingling (paresthesia), vertigo, fast heartbeat (tachycardia), irregular heartbeat,
low blood pressure, sudden drop in blood pressure when standing up, shortness of breath (dyspnea), diarrhea, dry mouth, flatulence (presence of intestinal gas), back pain, muscle spasm, muscle pain, erectile dysfunction (inability to achieve or maintain
an erection), chest pain, increased uric acid levels in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
Inflammation of the lungs (bronchitis), sore throat, sinusitis, increased uric acid levels in the blood,
low levels of sodium, feeling sad (depression), difficulty falling asleep (insomnia), sleep disorders, impaired
vision, blurred vision, difficulty breathing, abdominal pain, constipation,
abdominal bloating (dyspepsia), feeling unwell (vomiting), inflammation of the stomach (gastritis),
abnormal liver function (Japanese patients are more likely to experience this side
effect), rapid swelling of the skin and mucous membranes that can also lead to death (angioedema
which can be fatal)redness of the skin (erythema), allergic reactions such as itching or rash,
increased sweating, hives, joint pain (arthralgia) and pain in the extremities (leg pain),
muscle cramps, activation or worsening of systemic lupus erythematosus (a disease due to
which the immune system attacks the body itself, causing joint pain, rash and
fever), flu-like illness, pain, increased levels in the blood of creatinine, liver enzymes or
creatine phosphokinase.
Adverse reactions reported with one of the individual components may be potential adverse reactions with
Telmisartan and Hydrochlorothiazide Alter, even if not observed in clinical studies with this product.

Telmisartan
The following additional side effects have been found in patients treated with telmisartan alone:
Uncommon side effects (may affect up to 1 in 100)
Upper respiratory tract infection (e.g. sore throat, sinusitis, common cold), urinary tract infections, bladder infection, red blood cell deficiency (anemia), high levels of potassium, slow heartbeat (bradycardia), cough, impaired kidney function including acute renal failure, feeling
of weakness.
Rare side effects (may affect up to 1 in 1,000):
Low number of platelets (thrombocytopenia), increase in some white blood cells (eosinophilia), severe allergic reaction (e.g. hypersensitivity, anaphylactic reaction), low blood sugar levels (in diabetic patients),
drowsiness, stomach upset, eczema (skin disease), drug rash, toxic skin rash,, arthro pain in the tendons (symptoms similar to tendinitis), decreased hemoglobin (a
blood protein).
Very rare side effects (may affect up to 1 in 10,000)
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.
Not known (frequency cannot be estimated on the basis of available data):Intestinal angioedema: after
use of similar products, swelling in the intestine has been reported, which manifests with symptoms such as abdominal pain, nausea, vomiting and diarrhea.

Hydrochlorothiazide
The following additional side effects have been found in patients treated with hydrochlorothiazide alone:
Very common side effects (may affect more than 1 in 10)
u 10)
High levels of fats in the blood.
Common side effects (may affect up to 1 in 10)
Feeling unwell (nausea), low magnesium levels in the blood, reduced appetite.
Uncommon side effects (may affect up to 1 in 100)
Acute renal failure.
Rare side effects (may affect up to 1 in 1,000)
Low number of platelets (thrombocytopenia), which increases the risk of bleeding or bruising
(small purple-red spots on the skin or other tissues caused by bleeding), high calcium levels in
the blood, high blood sugar levels, headache, abdominal discomfort, yellowing of the skin or eyes
(jaundice), excess bile substances in the blood (cholestasis), photosensitivity reaction, uncontrolled glucose levels
in patients diagnosed with diabetes mellitus, sugar in the urine (glycosuria).
Very rare side effects (may affect up to 1 in 10,000)
Abnormal destruction of red blood cells (hemolytic anemia), inability of the bone marrow to function in
adequately, decreased white blood cells (leukopenia, agranulocytosis), severe allergic reactions (e.g. hypersensitivity), increased pH due to low chlorine levels in the blood (altered acid-base
balance, hypochloremic alkalosis), acute respiratory distress (signs include severe shortness of breath,
fever, weakness and confusion), inflammation of the pancreas, lupus-like syndrome (a condition
similar to a disease called systemic lupus erythematosus, due to which the immune system
attacks the body itself), inflammation of blood vessels (necrotizing vasculitis).
Not known (frequency cannot be estimated on the basis of available data):
Inflammation of the salivary glands, skin cancer and lip cancer (non-melanoma skin cancer),
deficiency of blood cells(aplastic anemia), restlessness, dizziness, rapid onset of distance vision reduction (acute myopia), decreased vision and eye pain (possible signs
of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)stomach upset, skin disorders such as inflammation of the blood vessels of the skin,
increased sensitivity to sunlight rash, redness of the skin, blisters on
lips, eyes or mouth, peeling of the skin, fever (possible signs of erythema multiforme), feeling
of weakness, high cholesterol levels in the blood, reduced blood volume, increased fat levels in
the blood, impaired kidney function.
Low sodium levels accompanied by symptoms related to the brain or nerves (malaise, progressive disorientation, lack of interest or energy) occur in isolated cases.

Reporting side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Telmisartan e Idroclorotiazide Alter

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 pack after Exp. The expiry date refers to the last day of that month.
Keep the tablets in the sealed blister pack to protect them from moisture. This medicine does not require
any particular storage temperature.
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 and Hydrochlorothiazide Alter contains
Telmisartan and Hydrochlorothiazide Alter 40 mg/12.5 mg

• The active ingredients are telmisartan and hydrochlorothiazide. Each tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
• The other ingredients are: microcrystalline cellulose, sodium hydroxide, meglumine, povidone K30, polyvinyl alcohol-polyethylene glycol copolymer, sodium glycolate starch, sorbitol, magnesium stearate, yellow iron oxide (E172).

Telmisartan and Hydrochlorothiazide Alter 80 mg/12.5 mg

• The active ingredients are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
• The other ingredients are: microcrystalline cellulose, sodium hydroxide, meglumine, povidone K30, polyvinyl alcohol-polyethylene glycol copolymer, sodium glycolate starch, sorbitol, magnesium stearate, red iron oxide (E172).

Telmisartan and Hydrochlorothiazide Alter 80 mg/25 mg

• The active ingredients are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.
• The other ingredients are: microcrystalline cellulose, sodium hydroxide, meglumine, povidone K30, polyvinyl alcohol-polyethylene glycol copolymer, sodium glycolate starch, sorbitol, magnesium stearate, yellow iron oxide (E172).

Description of the appearance of Telmisartan and Hydrochlorothiazide Alter and contents of the pack
The tablets of Telmisartan and Hydrochlorothiazide Alter 40 mg/12.5 mg are light yellow in color, round in shape
with no groove, approximately 11 mm in diameter..
The tablets of Telmisartan and Hydrochlorothiazide Alter 80 mg/12.5 mg are reddish in color, oblong in shape
with no groove, 17 mm x 7.5 mm.
The tablets of Telmisartan and Hydrochlorothiazide Alter 80 mg/25 mg are light yellow in color, oblong in shape
with no groove, 17 mm x 7.5 mm.

Packs
28 tablets in blisters
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Laboratori Alter S.r.l., Via Egadi, 7 – 20144 Milan

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