Kinzalkomb 80 mg/12.5 mg tablets

Kinzalkomb is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet. Both substances help to control high blood pressure.

• Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin-II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which cause your urine output to increase leading to a lowering of your blood pressure.

High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. , Thus it is important to regularly measure blood pressure to verify if it is within the normal range.

Kinzalkomb is used to treat high blood pressure (essential hypertension) in patients whose blood pressure is not controlled enough when either telmisartan or hydrochlorothiazide is used alone.

Do not take Kinzalkomb

• if you are allergic (hypersensitive) to telmisartan or any other ingredients included in Kinzalkomb tablets (see "Further Information" for a list of other ingredients).
• if you are allergic (hypersensitive) to hydrochlorothiazide or to any other sulfonamide-derived medicines.
• if you are more than 3 months pregnant. (It is also better to avoid Kinzalkomb in early pregnancy ? see pregnancy section.)
• if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the gall bladder) or any other severe liver disease.
• if you have severe kidney disease.
• if your doctor determines that you have low potassium levels or high calcium levels in your blood that do not get better with treatment.

If any of the above applies to you, tell your doctor or pharmacist before taking Kinzalkomb.

Take special care with Kinzalkomb

Please tell your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses:

• Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (water tablets), 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 trouble.
• Diabetes.
• Gout.
• Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals).
• Lupus erythematosus (also called ?lupus? or ?SLE?) a disease where the body?s immune system attacks the body.

You must tell your doctor if you think you are ( or might become) pregnant. Kinzalkomb 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 your baby if used at that stage (see pregnancy section).

Treatment with hydrochlorothiazide may cause electrolyte imbalance in your body. Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea (feeling sick), vomiting, tired muscles, and an abnormally fast heart rate (faster than 100 beats per minute). If you experience any of these you should tell your doctor.

You should also tell your doctor, if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal.

In case of surgery or anaesthetics, you should tell your doctor that you are taking Kinzalkomb.

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

As with all other angiotensin II receptor antagonists, telmisartan may be less effective in lowering the blood pressure in black patients.

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Your doctor may need to change the dose of these other medications or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below taken at the same time with Kinzalkomb:

• Lithium containing medicines to treat some types of depression.
• Medicines associated with low blood potassium (hypokalaemia) such as other diuretics, ('water tablets'), laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (a hormone),

amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin G sodium (an antibiotic), and salicylic acid and derivatives.

• Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors that may increase blood potassium levels.
• Heart medicines (e.g. digoxin) or medicines to control the rhythm of your heart (e.g. quinidine, disopyramide).
• Medicines used for mental disorders (e.g. thioridazine, chlorpromazine, levomepromazine).
• Other medicines used to treat high blood pressure, steroids, painkillers, medicines to treat cancer, gout, or arthritis, and vitamin D supplements.

Kinzalkomb may increase the blood pressure lowering effect of other medicines and you should consult with your doctor if you need to adjust the dose of your other medicine while taking Kinzalkomb.

As with other blood pressure lowering medicines, the effect of Kinzalkomb may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen).

Taking Kinzalkomb with food and drink

You can take Kinzalkomb tablets with or without food.

Pregnancy and breast-feeding

Pregnancy
You must tell your doctor if you think you are ( or might become) pregnant. Your doctor will normally advise you to stop taking Kinzalkomb before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Kinzalkomb. Kinzalkomb is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Kinzalkomb is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines

No information is available on the effect of Kinzalkomb on the ability to drive or operate machinery. Some people feel dizzy or tired when they are treated for high blood pressure. If you feel dizzy or tired, do not drive or operate machinery.

Important information about some of the ingredients of Kinzalkomb

Kinzalkomb contains milk sugar (lactose) and sorbitol.
If you are intolerant to some sugars, consult your doctor before taking Kinzalkomb.

Always take Kinzalkomb exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose of Kinzalkomb is one tablet a day. Try to take the tablet at the same time each day. You can take Kinzalkomb with or without food. The tablets should be swallowed with some water or other non-alcoholic drink. It is important that you take Kinzalkomb every day until your doctor tells you otherwise.

If your liver is not working properly, the usual dose should not exceed 40 mg/12.5 mg once a day.

If you take more Kinzalkomb than you should

If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.

If you forget to take Kinzalkomb

If you forget to take a dose, do not worry. Take it as soon as you remember then carry on as before. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.

If you have further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Kinzalkomb can cause side effects, although not everybody gets them. These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data.

Common side effects may include:
Dizziness

Uncommon side effects may include:
Decreased blood potassium levels; anxiety; fainting (syncope); sensation of tingling, pins and needles (paraesthesia); feeling of spinning (vertigo); fast heart beat (tachycardia), heart rhythm disorders, low blood pressure, a sudden fall in blood pressure when you stand up; shortness of breath (dyspnoea); symptoms of an upset stomach such as diarrhoea; dry mouth, flatulence; back pain, muscle spasm, muscle pain; erectile dysfunction (inability to get or keep an erection); chest pain; and increased blood uric acid levels.

Rare side effects may include:
Inflammation of the lung (bronchitis); feeling sad (depression); difficulty falling asleep (insomnia); impaired vision; difficulty breathing; abdominal pain, constipation, bloating (dyspepsia), feeling sick; abnormal liver function; rapid swelling of the skin and mucosa (angioedema), redness of the skin (erythema); allergic reactions such as itching or rash; increased sweating, hives (urticaria); joint pain (arthralgia) and pain in extremities, muscle cramps; flu-like-illness; pain; increased levels of uric acid, low levels of sodium, increased levels of creatinine, hepatic enzymes or creatine phosphokinase in the blood.

Side effects of unknown frequency may include:
Sore throat, inflamed sinuses; inflammation of the stomach (gastritis)

Telmisartan

In patients taking telmisartan alone the following additional side effects have been reported:

Side effects of unknown frequency may include:
Upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), urinary tract infections; increase in certain white blood cells (eosinophilia), deficiency in red blood cells (anaemia), low platelet count (thrombocytopenia); serious allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash); high potassium levels; slow heart rate (bradycardia); upset stomach; eczema (a skin disorder); inflammation of the tendons; kidney impairment including acute kidney failure;

weakness; decreased haemoglobin (a blood protein), sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death).

*In a long-term study involving more than 20,000 patients, more patients treated with telmisartan experienced sepsis compared with patients who received no telmisartan. The event may have happened by chance or could be related to a mechanism currently not known.

Hydrochlorothiazide

In patients taking hydrochlorothiazide alone the following additional side effects have been reported:

Side effects of unknown frequency may include:
Inflammation of the salivary gland; decreases in the number of cells in the blood, including low red and white blood cell count , low platelet count (thrombocytopenia); serious allergic reactions; (e.g. hypersensitivity, anaphylactic reaction), inflammation of blood vessels (vasculitis necrotising), decreased or loss of appetite; restlessness, weakness, light-headedness, blurred or yellowing of vision; inflamed pancreas, upset stomach; yellowing of the skin or eyes (jaundice); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, or blistering and peeling of the top layer of skin (toxic epidermal necrolysis); kidney inflammation or impaired kidney function; fever; impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, glucose in the urine (glycosuria), increased levels of glucose, or fat in the blood.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Kinzalkomb after the expiry date which is stated on the carton after ?EXP?. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions. You should store your medicine in the original package in order to protect the tablets from moisture.

Occasionally, the outer layer of the blister pack separates from the inner layer between the blister pockets. You do not need to take any action if this happens.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Kinzalkomb contains

The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
The other ingredients are lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, red iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420)

What Kinzalkomb looks like and contents of the pack

Kinzalkomb 80 mg/12.5 mg tablets are red and white, oval-shaped, two-layer tablets engraved with the code number 'H8'.

Kinzalkomb is available in blisters packs containing 14, 28, 56, or 98 tablets, or unit dose blister packs containing 28 x 1 tablets.

Not all pack sizes may be available in your country.

Marketing Authorisation Holder

Bayer Schering Pharma AG
13342 Berlin
Germany

Manufacturer

Bayer Schering Pharma AG
51368 Leverkusen
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Luxembourg Luxemburg Bayer SA-NV TélTel 32-02-535 63 11 Magyarország Bayer Hungária Kft. Tel.36-14 87-41 00 Malta Alfred Gera and Sons Ltd. Tel 356-21 44 62 05 Nederland Bayer B.V., Bayer Schering Pharma Tel 31-0297-28 06 66 Norge Bayer AS Tlf. 47 24 11 18 00 Österreich Bayer Austria Ges. m. b. H. Tel 43-01-711 46-0 Polska Bayer Sp. z o.o. Tel. 48-22-572 35 00 Portugal Bayer Portugal S.A Tel 351-21-416 42 00 România SC Bayer SRL Tel. 40 21 528 59 00 Slovenija Bayer d. o. o. Tel. 386-1-58 14 400 Slovenská republika Bayer, spol. s r.o. Tel 421 2 59 21 31 11 SuomiFinland Bayer Oy, Bayer Schering Pharma PuhTel. 358-20 785 21 Sverige Bayer AB Tel 46-08-580 223 00 United Kingdom Bayer plc Tel 44-01 635-56 30 00 België Belgique Belgien Bayer SA-NV TélTel 32-02-535 63 11 . 359 02 81 401 01 eská republika Bayer s.r.o. Tel 420 271 730 661 Danmark Bayer AS Tlf 45-45 23 50 00 Deutschland Bayer Vital GmbH Tel 49-0214-30 513 48 Eesti Bayer OÜ Tel 372 655 85 65 Bayer 30 210 618 75 00 España Química Farmacéutica Bayer S.L. Tel 34-93-495 65 00 France Bayer Santé Tél 33-03 28 16 34 00 Ireland Bayer Limited Tel 353 1 299 93 13 Ísland Icepharma Sími 354 540 8000 Italia Bayer S.p.A. Tel 39-02-397 81 NOVAGEM Limited 357 22 74 77 47 Latvija SIA Bayer Tel 371 67 84 55 63 Lietuva UAB Bayer Tel. 37 05 23 36 868

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