Telmisartan and hydrochlorothiazide Teva Italia: detailed information

Patient Information Leaflet

Telmisartan and Hydrochlorothiazide Teva Italia 40 mg/12.5 mg tablets, 80 mg/12.5 mg tablets, 80 mg/25 mg tablets

Generic medicine
Please read all of 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 give it to other people, 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Telmisartan and Hydrochlorothiazide Teva Italia is and what it is used for

Telmisartan and Hydrochlorothiazide Teva Italia is a combination of two active substances, telmisartan and hydrochlorothiazide, in a single tablet. Each of these substances helps control high blood pressure.

Telmisartan belongs to a group 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 blocks this effect of angiotensin II, causing blood vessels to relax and thus reducing blood pressure.
Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics, which increase urine flow, helping to reduce blood pressure.

If left untreated, high blood pressure can damage blood vessels in many organs, sometimes leading 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 regularly check your blood pressure to ensure it is within the normal range.

[ For 40 mg/12.5 mg and 80 mg/12.5 mg: ]
Telmisartan and Hydrochlorothiazide Teva Italia is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not sufficiently controlled with telmisartan alone.

[ For 80 mg/25 mg: ]
Telmisartan and Hydrochlorothiazide Teva Italia is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled with Telmisartan and Hydrochlorothiazide Teva Italia 80/12.5 mg, or in patients whose blood pressure has previously been stabilized with telmisartan and hydrochlorothiazide given separately.

2. What you should know before taking Telmisartan and Hydrochlorothiazide Teva Italia

Do not take Telmisartan and Hydrochlorothiazide Teva Italia

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 sulfonamide-derived medicine.
if you are more than 3 months pregnant. (It is best to avoid taking Telmisartan and Hydrochlorothiazide Teva Italia even in the early stages of pregnancy – see the 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 serious liver disease.
if you have severe kidney disease.
if your doctor finds that your blood potassium levels are low or your calcium levels are high and do not improve with treatment.
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of these conditions apply to you, inform your doctor or pharmacist before taking
Telmisartan and Hydrochlorothiazide Teva Italia.
Warnings and precautions
Talk to your doctor before taking Telmisartan and Hydrochlorothiazide Teva Italia if you have or
have had any of the following conditions or diseases:

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), a low-salt diet, diarrhoea, vomiting, or haemodialysis.
Kidney disease or kidney transplant.
Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
Liver disease.
Heart problems.
Diabetes.
Gout.
Increased levels of aldosterone (water and salt retention in the body with imbalance of various minerals 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 may cause an uncommon reaction leading to vision loss and eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur from hours to weeks after taking Telmisartan and Hydrochlorothiazide Teva Italia. This condition may lead to permanent vision impairment if not treated.
If you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun and UV exposure while taking Telmisartan and Hydrochlorothiazide Teva Italia.

Talk to your doctor before taking Telmisartan and Hydrochlorothiazide Teva Italia:

if you are taking any of the following medicines used to treat high blood pressure:
an "ACE inhibitor" (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading "Do not take Telmisartan and Hydrochlorothiazide
Teva Italia"

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 and Hydrochlorothiazide Teva Italia is not recommended
in 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 the pregnancy section).
Treatment with hydrochlorothiazide may 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 unwell), vomiting, muscle fatigue, and abnormally fast heartbeat (over 100 beats per minute). If you experience any of these symptoms,
inform your doctor.
You should also inform your doctor if you have noticed increased skin sensitivity to sunlight,
manifesting as unusually rapid onset of sunburn symptoms (such as redness, itching, swelling, or blistering).
If you undergo surgery or are administered anaesthetics, you must inform the doctor
that you are
taking Telmisartan and Hydrochlorothiazide Teva Italia.
Telmisartan and Hydrochlorothiazide Teva Italia may be less effective in lowering blood
pressure in patients of African origin.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
The use of Telmisartan and Hydrochlorothiazide Teva Italia is not recommended in children and
adolescents under 18 years of age.
Other medicines and Telmisartan and Hydrochlorothiazide Teva Italia
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 discontinue one of these medicines. This particularly applies to the following
medicines when taken concurrently with Telmisartan and Hydrochlorothiazide Teva
Italia:

Medicines containing lithium used to treat certain types of depression.
Medicines associated with low blood potassium levels (hypokalaemia), such as other diuretics, 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 may increase blood potassium levels, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressant), and other medicines such as sodium heparin (an anticoagulant).
Medicines that are affected by changes in blood potassium levels, 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 certain antibiotics (e.g., sparfloxacin, pentamidine) or certain 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 used to lower blood fat levels.
Medicines to increase blood pressure, such as noradrenaline.
Muscle relaxants, such as tubocurarine.
Calcium supplements and/or vitamin D supplements.
Anticholinergic medicines (used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid in anaesthesia), such as atropine and biperiden.
Amantadine (a medicine used to treat Parkinson's disease and also used to treat or prevent certain viral infections).
Other substances used to treat high blood pressure, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), cancer medicines, gout or arthritis medicines.
If you are taking an ACE inhibitor or aliskiren (see also the sections: "Do not take Telmisartan and Hydrochlorothiazide Teva Italia" and "Warnings and precautions").
Digoxin.

Telmisartan and Hydrochlorothiazide Teva Italia may enhance the effect of other medicines used to
lower blood pressure or medicines that may potentially lower blood
pressure (e.g., baclofen, amifostine). In addition, low blood
pressure may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may experience this drop in blood pressure as dizziness upon standing. Consult your doctor if you need to adjust the dose of other medicines while taking Telmisartan and
Hydrochlorothiazide Teva Italia.
The effect of Telmisartan and Hydrochlorothiazide Teva Italia may be reduced when taking
NSAIDs (non-steroidal anti-inflammatory drugs, e.g., aspirin and ibuprofen).
Telmisartan and Hydrochlorothiazide Teva Italia with food and alcohol
You may take Telmisartan and Hydrochlorothiazide Teva Italia with or without food.
Avoid alcohol consumption until you have spoken with your doctor. Alcohol may
further lower your blood pressure and/or increase the risk of dizziness or fainting.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a
baby, consult your doctor or pharmacist before taking this medicine.
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 and Hydrochlorothiazide Teva Italia before becoming pregnant or as soon as you
find out you are pregnant and will recommend an alternative medicine instead of Telmisartan and Hydrochlorothiazide Teva Italia.
Telmisartan and Hydrochlorothiazide Teva Italia is not recommended during 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 about to start breastfeeding. Telmisartan and
Hydrochlorothiazide Teva Italia is not recommended for women who are breastfeeding, and your
doctor may choose an alternative treatment if you wish to breastfeed.
Driving and using machines
Some patients may experience dizziness or fatigue when taking Telmisartan and
Hydrochlorothiazide Teva Italia. If you experience these effects, do not drive or operate machinery.

3. How to take Telmisartan and Hydrochlorothiazide Teva Italia

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of Telmisartan and Hydrochlorothiazide Teva Italia is one tablet daily. Try to take the tablet at the same time every day. You may take Telmisartan and Hydrochlorothiazide Teva Italia with or without food. Swallow the tablets with a glass of water or another non-alcoholic drink. It is important to take Telmisartan and Hydrochlorothiazide Teva Italia every day unless your doctor tells you otherwise.
If your liver is not functioning properly, the usual dose of 40 mg/12.5 mg once daily should not be exceeded.

If you take more Telmisartan and Hydrochlorothiazide Teva Italia than you should
If you accidentally take too many tablets, you may experience symptoms such as low blood pressure and a fast heartbeat. Slow heartbeat, dizziness, vomiting, reduced kidney function including kidney failure have also been reported. Due to the hydrochlorothiazide component, markedly low blood pressure and low levels of potassium in the blood may also occur, which can cause nausea, drowsiness, muscle cramps and/or irregular heartbeat, especially when used concomitantly with medications such as digitalis or certain anti-arrhythmic treatments. Contact your doctor, pharmacist, or the nearest hospital emergency department immediately.

If you forget to take Telmisartan and Hydrochlorothiazide Teva Italia
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 day's dose, take your normal dose the next day. Do not take a double dose to make up for a forgotten dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Some side effects can be serious and require immediate medical treatment:
You must go to the doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood infection") is a severe infection with an inflammatory response
throughout the whole body, rapid swelling of the skin and mucous membranes (angioedema), blisters and
peeling of the top 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 must
stop taking the medicine and consult a doctor immediately. If
these effects are not treated, they can be fatal. An increased incidence of sepsis has been
observed with telmisartan alone; however, it cannot be excluded for Telmisartan and
Hydrochlorothiazide Teva Italia.
Possible side effects of Telmisartan and Hydrochlorothiazide Teva Italia:
Common side effects (may affect up to 1 in 10 people):
Dizziness
Uncommon side effects (may affect up to 1 in 100 people):
Low blood potassium levels, anxiety, fainting (syncope), numbness sensation, tingling sensation (paraesthesia), spinning sensation (dizziness),
rapid heartbeat (tachycardia), heart rhythm disorders, low blood pressure, sudden drop in blood pressure when standing up, shortness of breath (dyspnoea),
diarrhoea, dry mouth, flatulence, back pain, muscle spasm, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, increased blood uric acid levels.
Rare side effects (may affect up to 1 in 1,000 people):
Inflammation of the lungs (bronchitis), activation or worsening of systemic lupus erythematosus (a disease in which the immune system attacks the body itself, causing joint pain, skin rash and fever), sore throat, sinusitis,
feeling of sadness (depression), difficulty falling asleep (insomnia), altered vision, breathing difficulties, abdominal pain, constipation, swelling (dyspepsia), feeling of discomfort (nausea), inflammation of the stomach (gastritis), abnormal liver function (this side effect is more likely to occur in Japanese patients),
skin redness (erythema), allergic reactions such as itching or skin rash,
increased sweating, urticaria, joint pain (arthralgia) and pain in the extremities, muscle cramps, influenza-like illness, pain, low sodium levels, increased creatinine levels, elevated liver enzymes or creatine phosphokinase in the blood.
Adverse reactions reported with one of the individual components may be potential adverse reactions with Telmisartan and Hydrochlorothiazide Teva Italia, even if not observed in clinical studies with this product.
Telmisartan
In patients treated with telmisartan alone, the following additional side effects have been observed:
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 (anaemia), high potassium levels, slow heart rate (bradycardia), kidney impairment including acute kidney failure, feeling of weakness, cough.
Rare side effects (may affect up to 1 in 1,000 people):
Low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), severe allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in diabetic patients), stomach disorder, skin disorders (including eczema, drug rash, toxic epidermal rash), osteoarthritis, inflammation of tendons, decreased haemoglobin (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 could be related to a currently unknown mechanism.
**Cases of progressive scarring of lung tissue have been reported during telmisartan treatment. However, it is not known whether telmisartan was the cause.
Hydrochlorothiazide
In patients treated with hydrochlorothiazide alone, the following additional side effects have been observed:
Common side effects (may affect up to 1 in 10 people):
Feeling of discomfort (nausea), low blood magnesium levels.
Rare side effects (may affect up to 1 in 1,000 people):
Reduced platelets in the blood, increasing the risk of bleeding or bruising (small red-purple spots on the skin or other tissues caused by bleeding), high blood calcium levels, headache.
Very rare side effects (may affect up to 1 in 10,000 people):
Increased pH (disturbed acid-base balance) due to low blood chloride levels.
Side effects with unknown frequency (frequency cannot be determined from available data):
Inflammation of the salivary glands, skin and lip cancer (non-melanoma skin cancer), decreased number of blood cells, including reduced red and white blood cell counts, severe allergic reactions (e.g. hypersensitivity, anaphylactic reaction), irregular blood sugar levels if you have diabetes, decreased or loss of appetite, restlessness, dizziness, blurred or yellowish vision, decreased vision and eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or of acute myopia or acute angle-closure glaucoma), inflammation of blood vessels (necrotizing vasculitis), inflammation of the pancreas, stomach disorder, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition mimicking a disease called systemic lupus erythematosus, in which the immune system attacks the body itself); skin disorders such as inflammation of skin blood vessels, increased sensitivity to sunlight, rash, skin redness, appearance of blisters on the lips, eyes or mouth, skin peeling, fever (possible sign of erythema multiforme), feeling of weakness, kidney inflammation or altered kidney function, glucose in urine (glucosuria), fever, electrolyte imbalance, elevated blood cholesterol levels, reduced blood volume, increased blood glucose levels, difficulty controlling blood/urine glucose levels in patients diagnosed with diabetes mellitus, or blood fats.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
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 Teva Italia

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 packaging after
"Exp.". The expiry date refers to the last day of that month.
[ For Al/Al blisters and HDPE tablet containers: ]
This medicine does not require any special storage conditions.
[ For Tristar Al/PVDC blisters: ]
Do not store above 30 °C.
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. Pack contents and other information

What Telmisartan and Hydrochlorothiazide Teva Italia contains

The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
The other components 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 Teva Italia
Telmisartan and Hydrochlorothiazide Teva Italia 40 mg/12.5 mg tablets are white or almost white, oval-shaped, 6.55 x 13.6 mm, biconvex, marked with "TH" on one side.
Telmisartan and Hydrochlorothiazide Teva Italia 80 mg/12.5 mg tablets are white or almost white, capsule-shaped, 9.0 x 17.0 mm, marked with "TH 12.5" on both sides.
Telmisartan and Hydrochlorothiazide Teva Italia 80 mg/25 mg tablets are white or almost white, oval-shaped, 9.0 x 17.0 mm, biconvex, marked with "TH" on one side and "25" on the other side.
Pack sizes
Blister packs: 14, 28, 56, 84 and 98 tablets
Bottle packs: 30, 90 and 250 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 - 20123 Milano, Italy

Manufacturer
Merckle GmbH Ludwig-Merckle-Str. 3, 89143 Blaubeuren, Germany
Actavis Ltd. BLB 016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta
Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

This medicinal product is authorized in the European Economic Area countries under the following names:
Denmark Mogilarta
Germany Telmisartan comp. ratiopharm
Italy Telmisartan and Hydrochlorothiazide Teva Italia
Hungary Telmisartan/HCT-Teva
Czech Republic Telmisartan/hydrochlorotiazid Teva

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