TOLUCOMBI 40 mg /12.5 Mg Таблетки

Содержание инструкции

1. Tolucombi 40 mg/12.5 mg tablets, 80 mg/12.5 mg tablets, 80 mg/25 mg tablets
   1. What is Tolucombi and what it is used for
   2. What you need to know before taking Tolucombi
   3. How to take Tolucombi
   4. Possible side effects
   5. How to store Tolucombi
   6. Package contents and other information

Tolucombi 40 mg/12.5 mg tablets, 80 mg/12.5 mg tablets, 80 mg/25 mg tablets

telmisartan/hydrochlorothiazide

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 they have the same symptoms as you, 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 Tolucombi is and what it is used for
• 2. What you need to know before you take Tolucombi
• 3. How to take Tolucombi
• 4. Possible side effects
• 5. How to store Tolucombi
• 6. Contents of the pack and other information

1. What is Tolucombi and what it is used for

Tolucombi 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 known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to constrict, 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 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, which can sometimes cause heart attack, heart failure or kidney failure, stroke or blindness. Normally hypertension does not give symptoms before such damage occurs. Therefore, it is important to have blood pressure measured regularly to check if it is within the normal range. Tolucombi (40 mg/12,5 mg, 80 mg/12,5 mg) is used fortreating high blood pressure (essential hypertension) in adults where blood pressure is not sufficiently controlled by telmisartan alone. Tolucombi (80 mg/25 mg) is used fortreating high blood pressure (essential hypertension) in adults where blood pressure is not sufficiently controlled by Tolucombi 80 mg/12,5 mg or in patients who have previously been stabilized by telmisartan and hydrochlorothiazide administered separately.

2. What you need to know before taking Tolucombi

Do not take Tolucombi

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to hydrochlorothiazide or any other medicine derived from sulfonamide.
• if you are pregnant for more than 3 months (it is best to avoid taking Tolucombi even in the early stages of pregnancy - see the pregnancy section).
• if you suffer from severe liver problems such as cholestasis or bile duct obstruction (problems with draining bile from the liver and gallbladder) or other serious liver diseases.
• 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 impaired kidney function and 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 Tolucombi. Warnings and precautionsTalk to your doctor before taking Tolucombi 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 water loss from the body) 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 water and salt in the body with an 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 can cause an unusual reaction, leading to 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 the eye and may occur from hours to weeks after taking Tolucombi. If left untreated, this can lead to permanent vision loss.
• 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 Tolucombi.
• If you have had breathing or lung problems (including inflammation or fluid in the lungs) following the use of hydrochlorothiazide in the past. If shortness of breath or severe difficulty breathing occurs after taking Tolucombi, consult a doctor immediately. Talk to your doctor before taking Tolucombi if you are taking:
• digoxin.
• one of the following medicines used to treat high blood pressure:
• an “ACE inhibitor” (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• aliskiren. You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Tolucombi 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 unusually 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 faster than normal onset of sunburn symptoms (such as redness, itching,
swelling, blisters).
In case of surgery or administration of anesthetics, you must inform your doctor that you are
taking Tolucombi.
Tolucombi may be less effective in lowering blood pressure in patients of African descent.
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 Tolucombi”.

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

Other medicines and Tolucombi
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Your 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 in particular to the medicines listed below, taken
simultaneously with Tolucombi:

• Medicines containing lithium to treat certain types of depression.
• Medicines associated with low levels of potassium 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.
• Medicines that can increase potassium levels in the blood such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors, cyclosporine (immunosuppressant medicine) and other medicines such as sodium heparin (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 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 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 what is stated under “Do not take Tolucombi” and “Warnings and precautions”).
• Digoxin. Tolucombi can increase the effect of other medicines used to lower blood pressure or of medicines that potentially can lower blood pressure (e.g. baclofen, amifostine). Also, 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. Consult your doctor if you need to change the dose of other medicines while taking Tolucombi. The effect of Tolucombi may be reduced when you take NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen). Tolucombi with food and alcoholYou can take Tolucombi 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 breastfeedingPregnancy 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 Tolucombi before starting pregnancy or as soon as you become aware of being pregnant and will advise you to take another medicine instead of Tolucombi. Tolucombi 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 (see the pregnancy section). Breastfeeding Tell your doctor if you are breastfeeding or are about to start breastfeeding. Tolucombi 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 machinesSome patients may experience dizziness or drowsiness when taking Tolucombi. If these effects occur, do not drive or use machines. Tolucombi contains lactose, sorbitol and sodiumIf your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine. Tolucombi 40 mg/12.5 contains 147.04 mg of sorbitol per tablet, equivalent to 5 mg/kg/day, if the body weight is 29.8 kg. Tolucombi 80 mg/12.5 and Tolucombi 80 mg/25 contain 294.08 mg of sorbitol per tablet, equivalent to 5 mg/kg/day, if the body weight is 58.8 kg. Patients weighing 58.8 kg or less should consider that sorbitol is a source of fructose and if your doctor has told you that you (or your child) are intolerant to certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot transform fructose, talk to your doctor before you (or your child) take this medicine.

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

3. How to take Tolucombi

Take this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is one tablet a day. Try to take the tablet at the same time each
day. You can take Tolucombi with or without food. The tablets should be swallowed with a little
water or other non-alcoholic beverage. It is important to take Tolucombi every day until your
doctor tells you otherwise.
If your liver is not functioning properly, the usual dose of
40 mg/12.5 mg per day should not be exceeded.

If you take more Tolucombi 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 renal 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 Tolucombi
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 the normal dose the next day. Do not
take a double dose to make up for a missed dose.
If you have any doubts about using 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 inflammatory response
throughout the body, rapid swelling of the skin and mucous membranes (angioedema), appearance of blisters and
shedding of the outermost layer of skin (toxic epidermal necrolysis); these effects
are rare (may affect up to 1 in 1,000 people) or of unknown frequency (toxic epidermal necrolysis), 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 Tolucombi.

Possible side effects of Tolucombi:
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,
tingling sensation (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, 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), 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, bloating (dyspepsia), feeling unwell (vomiting), inflammation of the stomach
(gastritis), abnormal liver function (Japanese patients are more likely to experience
this side 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 blood levels of
creatinine, liver enzymes or creatine phosphokinase.
Adverse reactions reported with either of the individual components may be potential adverse reactions
with Tolucombi, 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 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 weak, cough.
Rare side effects (may affect up to 1 in 1,000 people):
Low platelet count (thrombocytopenia), increase in 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 low chlorine levels in the blood,
acute respiratory distress (signs include severe shortness of breath, fever, weakness and
confusion).
Side effects of unknown frequency (frequency cannot be estimated based on available data):
Inflammation of the salivary glands, skin and lip cancer (non-melanoma skin cancer), decreased number (or even absence) of blood cells, including decreased
count of red blood cells and white blood cells, severe allergic reactions (e.g. hypersensitivity, anaphylactic reaction), decreased or loss of appetite, restlessness, dizziness, blurred or yellowish vision, loss of vision and eye pain (possible signs of fluid accumulation in the vascular layer of the eye
(choroidal effusion) or acute myopia or 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 that mimics a disease called systemic lupus erythematosus because 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 weak, inflammation of the kidneys or
altered kidney function, glucose in the urine (glycosuria), fever, electrolyte imbalance, elevated cholesterol levels in the blood, reduced blood volume, elevated glucose levels, difficulty
controlling blood glucose/urine glucose levels in patients diagnosed with diabetes mellitus, or of
fats in the blood.

Reporting of 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 reported in Annex V .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Tolucombi

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 package and on the blister after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store in the original package to protect the medicine from light.
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 Tolucombi contains

• The active ingredients are telmisartan and hydrochlorothiazide. Each tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.
• The excipients are: hypromellose, lactose monohydrate, magnesium stearate, mannitol, meglumine, povidone (K30), red iron oxide (E172) - only in the 40 mg/12.5 mg and 80 mg/12.5 mg tablets, anhydrous colloidal silica, sodium hydroxide (E524), sodium stearyl fumarate, sorbitol (E420) and yellow iron oxide (E172) - only in the 80 mg/25 mg tablets. See section 2

“Tolucombi contains lactose, sorbitol and sodium”.

Description of the appearance of Tolucombi and package contents
40 mg/12.5 mg tablets: white, off-white or tending to pink on one side and marbled pink on the
opposite side of a two-layer, biconvex, oval tablet; tablet size 15 mm x
7 mm.
80 mg/12.5 mg tablets: white, off-white or tending to pink on one side and marbled pink on the
opposite side of a two-layer, biconvex, oval tablet; tablet size 18 mm x
9 mm.
80 mg/25 mg tablets: white tending to yellow on one side and marbled yellow on the opposite side of
a two-layer, biconvex, oval tablet; tablet size 18 mm x 9 mm.
Blisters (OPA/Al/PVC foil//Al foil): 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x
1 and 100 x 1 tablet in a box.
Blisters (OPA/Al/PE foil with desiccant//Al foil): 14 x 1 and 98 x 1 tablet in a box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warszawa, Poland
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
For further information on this medicinal product, please contact the local representative of the marketing
authorisation holder:

Lietuva
UAB KRKA Lietuva
Tel: + 370 5 236 27 40

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: +32 (0) 487 50 73 62

България
КРКА България ЕООД
Тел.: +359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: +32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Malta

• E. J. Busuttil Ltd. Tel: + 356 21 445 885 DeutschlandTAD Pharma GmbH Tel: + 49 (0) 4721 606-0 NederlandKRKA Belgium, SA. Tel: + 32 (0) 487 50 73 62 (BE) EestiKRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 658 NorgeKRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE) ΕλλάδαKRKA ΕΛΛΑΣ ΕΠΕ Τηλ: + 30 2100101613 ÖsterreichKRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 300

España
KRKA Farmacéutica, S.L.
Tel: + 34 911 61 03 80

Polska
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650

Hrvatska
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 100

România
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710

Slovenija
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100

Ísland
LYFIS ehf.
Sími: + 354 5343500

Slovenská republika
KRKA Slovensko, s.r.o.
Tel: + 421 (0) 2 571 04 501

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: +358 20 754 5330

Κύπρος
KI.PA. (PHARMACAL) LIMITED
Τηλ: + 357 24 651 882

Sverige
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)

Latvija
KRKA Latvija SIA
Tel: + 371 6 733 86 10

United Kingdom (Northern Ireland)
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .