TELMISARTAN 40 mg /12.5 Mg Tabletki Powlekane

Treść ulotki

1. TELMISARTAN e IDROCLOROTIAZIDE DOC Generici 40 mg/12,5 mg tablets, 80 mg/12,5 mg tablets, 80 mg/25 mg tablets
   1. What is TELMISARTAN and IDROCLOROTIAZIDE DOC Generici and what it is used for
   2. What you need to know before taking TELMISARTAN and IDROCLOROTIAZIDE DOC Generici
   3. How to take TELMISARTAN and IDROCLOROTIAZIDE DOC Generici
   4. Possible side effects
   5. How to store TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici
   6. Package Contents and Other Information

TELMISARTAN e IDROCLOROTIAZIDE DOC Generici 40 mg/12,5 mg tablets, 80 mg/12,5 mg tablets, 80 mg/25 mg tablets

Equivalent Medicine

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, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

TELMISARTAN and IDROCLOROTIAZIDE DOC Generici is a combination of two active ingredients, telmisartan and
hydrochlorothiazide in a single tablet. Each of these substances helps to control high
blood pressure.

• telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin II is a substance produced by the body that causes constriction of blood vessels, thereby increasing blood pressure. Telmisartan blocks the effect of angiotensin II, causing a relaxation of blood vessels and thus reducing blood pressure.
• hydrochlorothiazide belongs to a group of medicines called 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 various 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 measure blood pressure regularly to
verify if it is within the normal range.

TELMISARTAN and IDROCLOROTIAZIDE DOC Generici is used totreat high blood pressure
(essential hypertension) in adults in whom blood pressure is not sufficiently controlled by
telmisartan used alone.

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

Do not take TELMISARTAN and IDROCLOROTIAZIDE DOC Generici

• 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 IDROCLOROTIAZIDE 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 have severe kidney disease
• 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
IDROCLOROTIAZIDE DOC Generici.

Warnings and precautions
Talk to your doctor before taking TELMISARTAN and IDROCLOROTIAZIDE DOC Generici if you suffer or have
suffered from any of the following conditions or illnesses:

• 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 hemodialysis.
• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels of one or both kidneys).
• Liver disease.
• Heart problems.
• Diabetes.
• Gout.
• Increased levels of aldosterone (retention of fluids and salt 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 increased pressure in your eye and can occur from hours to weeks after taking TELMISARTAN and IDROCLOROTIAZIDE DOC Generici. This condition can lead to permanent visual impairment if not treated.

Talk to your doctor, pharmacist or nurse before taking TELMISARTAN and IDROCLOROTIAZIDE
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, 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 the section “Do not take TELMISARTAN and IDROCLOROTIAZIDE DOC Generici.”
• if you are taking digoxin.
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with 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 IDROCLOROTIAZIDE DOC Generici;
• If you have decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a period ranging from a few hours to a week after taking TELMISARTAN and IDROCLOROTIAZIDE DOC Generici. If not

treated, this can lead to permanent vision loss. If you have previously had
allergy to penicillins or sulfonamides you may have a higher risk of developing this
disorder.
You should inform your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). TELMISARTAN and IDROCLOROTIAZIDE DOC Generici is not recommended in early
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).
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 a fast heartbeat (more than 100 beats per minute). If you experience any of
these symptoms, tell your doctor.
You should also inform your doctor if you experience increased skin sensitivity to the sun, which manifests
with the earlier onset than normal of sunburn symptoms (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 IDROCLOROTIAZIDE DOC Generici.
TELMISARTAN and IDROCLOROTIAZIDE DOC Generici may be less effective in reducing blood
pressure in patients of color.

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

Other medicines and TELMISARTAN and IDROCLOROTIAZIDE 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 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 IDROCLOROTIAZIDE DOC Generici:

• Medicines containing lithium to treat some types of depression
• Medicines associated with low potassium levels in the blood (hypokalemia) such as other diuretics, (water pills), laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (a hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), sodium penicillin G (an antibiotic), salicylic acid and its derivatives.
• Medicines that can increase potassium levels in the blood such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressant medicine) and other medicinal products such as sodium heparin (an anticoagulant).
• Medicines that are affected by changes in potassium levels in the blood such as heart medicines (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 treating 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 the sections: “Do not take TELMISARTAN and IDROCLOROTIAZIDE DOC Generici” and “Warnings and precautions”).
• Digoxin.

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

TELMISARTAN and IDROCLOROTIAZIDE DOC Generici with food and alcohol
You can take TELMISARTAN and IDROCLOROTIAZIDE DOC Generici 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
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Pregnancy
You should 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 and IDROCLOROTIAZIDE DOC
Generici 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 and IDROCLOROTIAZIDE DOC
Generici. TELMISARTAN and IDROCLOROTIAZIDE DOC Generici is not recommended during 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
Inform your doctor if you are breastfeeding or are about to start breastfeeding. TELMISARTAN and IDROCLOROTIAZIDE
DOC Generici is not recommended for women who are breastfeeding and your doctor may choose another
treatment for you if you wish to breastfeed.

Driving and operating machinery
Some patients may experience dizziness or fatigue when taking TELMISARTAN and
IDROCLOROTIAZIDE DOC Generici. If these effects occur, do not drive or operate machinery.

TELMISARTAN and IDROCLOROTIAZIDE DOC Genericicontains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially
‘sodium-free’.

For athletes
The use of the drug without therapeutic need constitutes doping and may still result in positive
doping tests.

3. How to take TELMISARTAN and IDROCLOROTIAZIDE DOC Generici

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose is one tablet a day. Try to take the tablet every day at the same
time.
You can take TELMISARTAN and IDROCLOROTIAZIDE DOC Generici with or without food. The tablets must
be swallowed with a little water or other non-alcoholic beverage. It is important to take TELMISARTAN and
IDROCLOROTIAZIDE DOC Generici 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/12.5
mg per day.

If you take more TELMISARTAN and IDROCLOROTIAZIDE DOC Generici 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, markedly low blood pressure and low levels of potassium in the blood may also
occur, which can cause nausea, drowsiness and muscle cramps and/or irregular heartbeat associated with the
concomitant use of drugs 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 IDROCLOROTIAZIDE DOC Generici
If you forget to take the medicine, do not worry. Take it as soon as you remember, then continue
as before. If you do not take a dose one day, take your normal dose the next day. Do not take
a double dose to make up for a missed dose.

If you stop taking TELMISARTAN and IDROCLOROTIAZIDE DOC Generici
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 everyone will experience them.

Some side effects may be serious and require immediate medical attention:
You should immediately see a doctor 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), the appearance of blisters and
shedding 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 of unknown frequency (toxic epidermal
necrolysis), but are 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 DOC Generici.

Possible side effects of TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici:
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), sensation of spinning (vertigo), fast heartbeat (tachycardia),
heart rhythm disorders, 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):
Lung inflammation (bronchitis), activation or worsening of systemic lupus erythematosus (a
disease in which the immune system attacks the body itself, causing joint pain, rash, and fever), sore throat, sinusitis, feeling of sadness (depression), difficulty
falling asleep (insomnia), altered 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
effect), skin redness (erythema), allergic reactions such as itching or rash,
increased sweating, hives, joint pain (arthralgia) and pain in the extremities, muscle cramps,
flu-like illness, pain, low sodium levels, 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 DOC Generici, even if not observed in clinical studies with this
product.

Telmisartan
The following additional side effects have been reported in patients treated with telmisartan alone:
Uncommon side effects (may affect up to 1 in 100 people):
Upper respiratory tract infection (e.g. sore throat, sinusitis, common cold), urinary tract infections, reduced red blood cells (anemia), high potassium levels, slow heartbeat
(bradycardia), impaired kidney function including acute renal failure, feeling of weakness, cough.
Rare side effects (may affect up to 1 in 1,000 people):
Low number of platelets (thrombocytopenia), increased levels of some white blood cells (eosinophilia), severe allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in diabetic patients), stomach upset, eczema (skin disorder), osteoarthritis,
inflammation of the tendons, decreased hemoglobin (a blood protein), drowsiness.
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.

Hydrochlorothiazide
The following additional side effects have been found in patients treated with hydrochlorothiazide alone:
Common side effects (may affect up to 1 in 10 people):
Feeling unwell (nausea), low magnesium levels in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
Reduced platelets, which increases the risk of bleeding or bruising (small purple-red
marks on the skin or other tissues caused by bleeding), high calcium levels in the blood, headache.
Very rare side effects (may affect up to 1 in 10,000 people):
Increased pH (altered acid-base balance) due to a low level of chlorine in the blood.
Side effects of unknown frequency (frequency cannot be estimated based on available data):
Inflammation of the salivary glands, decrease in the number (or even absence) of blood cells, including a decrease in the count of red blood cells and white blood cells, severe allergic reactions (e.g.
hypersensitivity, anaphylactic reaction), loss or decrease in appetite, restlessness, dizziness, blurred or yellowish vision, decreased vision and eye pain (possible signs of acute myopia or
acute angle-closure glaucoma), inflammation of blood vessels (necrotizing vasculitis),
inflammation of the pancreas, stomach upset, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition similar to a disease called systemic lupus erythematosus because of
which the immune system attacks the body itself); skin disorders such as inflammation of the blood
vessels in the skin, increased sensitivity to sunlight, rash, redness of the skin,
formation of blisters on lips, eyes or mouth, peeling of the skin, fever (possible signs of
erythema multiforme), feeling of weakness, inflammation of the kidneys or altered kidney function,
glucose present in the urine (glycosuria), fever, electrolyte imbalance, high cholesterol levels in
the blood, reduced blood volume, increased glucose levels in the blood, difficulty controlling glucose levels
in the blood/urine in patients diagnosed with diabetes mellitus, or fats in the blood, skin and lip cancer (non-melanoma skin cancer). -Decreased vision or eye pain
due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye
(choroidal effusion) or acute angle-closure glaucoma).
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor, pharmacist or nurse. 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 and HYDROCHLOROTHIAZIDE DOC Generici

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after SCAD. The expiry date refers to the last day of that month.
[For Al/Al blisters]:
This medicine does not require any special storage conditions.
[For Al/PVC/PVDC blisters]:
Do not store at a temperature above 30°C.
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. Package Contents and Other Information

What TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici contains
TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici 40 mg/12.5: the active ingredients are telmisartan and
hydrochlorothiazide. Each tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici 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.
TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici 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 magnesium stearate (E470b), potassium hydroxide, meglumine, povidone, sodium
starch glycolate (type A), microcrystalline cellulose, mannitol (E421).

Description of the appearance of TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici and contents of the
pack
TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici 40 mg/12.5 mg tablets are white or
off-white, oval and biconvex shaped tablets of 6.55 x 13.6 mm, marked with “TH” on one side.
TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici 80 mg/12.5 mg tablets are white or
off-white, capsule-shaped tablets of 9.0 x 17.0 mm, marked with “TH 12.5” on both sides.
TELMISARTAN and HYDROCHLOROTHIAZIDE DOC Generici 80 mg/25 mg tablets are white or
off-white, oval and biconvex shaped tablets of 9.0 x 17.0 mm, marked with “TH” on one side and “25”
on the other side.

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

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

Manufacturer responsible for batch release
Actavis Ltd., BLB 016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Denmark: Telmisartan/hydrochlortiazid “DOC Generici”
Italy: TELMISARTAN E IDROCLOROTIAZIDE DOC Generici