TESPADAN 20 mg. / 5 mg. 28 tablets

What TESPADAN is and what it is used
TESPADAN contains two active substances called olmesartan medoxomil and amlodipine (as amlodipine besilate). Both substances help to control high blood pressure.
Olmesartan medoxomil belongs to a group of drugs called "angiotensin-II receptor antagonists", which lowers blood pressure by widening the blood vessels.
Amlodipine belongs to a group of substances called "calcium channel blockers". Amlodipine stops the passage of calcium in the blood vessel wall, which prevents the contraction of blood vessels and thus also lowers blood pressure.
Action of both active substances contribute to the cessation contraction of blood vessels, so that blood vessel relaxes and blood pressure is lowered.

TESPADAN is administered for treatment of hypertension in patients whose blood pressure is not adequately controlled in the self-administration of olmesartan medoxomil and amlodipine.

2. Before sweep TESPADAN
Do not take TESPADAN
if you are allergic to olmesartan medoxomil or to amlodipine or a certain group of calcium channel blockers, dihydropyridines or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, talk to your doctor before taking TESPADAN
if you are pregnant after the third month of pregnancy. (It is advisable to avoid the use of Sevikar and during early pregnancy - see "Pregnancy and breastfeeding");
if you have severe liver problems if production of bile is impaired or the passage of bile in the gallbladder is difficult (eg. gallstones), or if you have jaundice (yellowing of skin and eyes);
if you have very low blood pressure;
if you suffer from insufficient blood supply to the tissues with symptoms such as low blood pressure, weak pulse, fast heartbeat (shock, including cardiogenic shock). Cardiogenic shock means shock due to severe heart disorders;
if blood running down from the heart is impaired (eg. due to a narrowing of the aorta (aortic stenosis);
if you have reduced cardiac output (which leads to shortness of breath or peripheral edema) after a heart attack (acute myocardial infarction).
Warnings and Precautions
Talk to your doctor before taking TESPADAN
Talk to your doctor if you have any of the following health problems:
kidney problems or have a kidney transplant;
liver disease;
heart failure or problems with the heart slaughtering or heart muscle;
severe vomiting, diarrhea, treatment with high doses of "water tablets" (diuretics) or if you follow a diet low in salt;
increased levels of potassium in the blood;
problems with the adrenal glands (glands which form hormones, located above the kidneys).
As with any drug that lowers blood pressure, sudden drop in blood pressure in patients with impaired blood supply to the heart or brain can lead to heart attack or stroke. Therefore your doctor will carefully monitor your blood pressure.
You should tell your doctor if you think you are (or become) pregnant. Sevikar is not recommended in early pregnancy and must not be taken after the third month of pregnancy because it may seriously harm your baby during this period of pregnancy (see section "Pregnancy and lactation").

Children and adolescents (under 18 years)
Sevikar is not recommended in children and adolescents aged under 18 years.

Other medicines and TESPADAN
Tell your doctor or pharmacist if you are taking or have recently taken any of the following medications:
Supplements that contain potassium, salt substitutes containing potassium, "water tablets" (diuretics) or heparin (for thinning the blood and preventing blood clotting). The use of these medicines together with Sevikar can lead to increased levels of potassium in the blood;
Lithium (a medicine for the treatment of disorders in behavior and some types of depression), when co-administered with TESPADAN may increase the toxicity of lithium. If you have to take lithium, your doctor will measure the levels of lithium in your blood;
Nonsteroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis) co-administered with Sevikar may increase the risk of kidney failure. The effect of Sevikar can be decreased by NSAIDs;
Other medicines that lower blood pressure, as it can enhance the effect of TESPADAN
Certain antacids (medicines for indigestion or heartburn), as it may slightly reduce the effect of TESPADAN
Drugs used to treat HIV / AIDS (eg. Ritonavir, indinavir, nelfinavir), or for the treatment of fungal infections (eg. Ketoconazole, itraconazole);
Diltiazem, verapamil (substances applied for heart rhythm problems and high blood pressure);
Rifampicin, erythromycin, clarithromycin (substances that are used for treatment of tuberculosis and other infections);
St. John's wort (Hypericum perforatum), an herb;
Dantrolene (infusion for severe abnormalities in body temperature);
Simvastatin, a substance which is used to reduce cholesterol and fats (triglycerides) in the blood.
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.

TESPADAN with food and drink
TESPADAN can be taken with or without food. Swallow the tablets with a little liquid (eg a glass of water). If possible, take your daily dose at the same time each day, such as breakfast.
Grapefruit juice and grapefruit should not be taken by people who are taking Sevikar. This is because grapefruit and grapefruit juice may lead to increased levels in the body of the active substance amlodipine, which can cause unpredictable amplification of the blood pressure lowering effect of Sevikar.

Elderly
If you are aged over 65, your doctor will regularly monitor your blood pressure at any dose increase, to make sure that your blood pressure falls too much.

Black patients
As with other similar drugs, the blood pressure lowering effect of Sevikar can be somewhat less in black patients.

Pregnancy and lactation
Pregnancy
You should tell your doctor if you think you are (or become) pregnant. Your doctor will advise you to stop taking Sevikar if planning a pregnancy, or as soon as you know you are pregnant and will advise you to take another medicine instead of Sevikar. Sevikar is not recommended in early pregnancy and must not be taken after the third month of pregnancy because it may cause serious harm to your baby if taken after the third month of pregnancy.
If you become pregnant during treatment with Sevikar, please immediately inform and see your doctor.

Breastfeeding
Tell your doctor if you are breast-feeding or breast-feeding. Sevikar is not recommended in women who are breastfeeding. Your doctor may order other treatments if you wish to breastfeed, especially if your baby is newborn, or was born prematurely.

If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.

Driving and using machines
During the treatment of high blood pressure you may feel sleepy, indisposed or dizzy or get a headache. If this happens, do not drive or use machinery until the symptoms subside. Ask your doctor for advice.

3. How to take TESPADAN
Always take this medicine exactly as you have been told your doctor or pharmacist. If you're not sure, ask your doctor or pharmacist.
The recommended dose of TESPADAN is one tablet daily.
The tablets can be taken with or without food. Swallow the tablets with a little liquid (eg a glass of water). The tablet should not be chewed. Do not take the tablet with grapefruit juice.
If possible, take your daily dose at the same time each day, such as breakfast.

If you take more dose TESPADAN
If you take more tablets than necessary may feel that your blood pressure is low, with symptoms such as dizziness, fast or slow heartbeat.
If you take more tablets than necessary or if a child accidentally swallows tablets, see your doctor or the nearest emergency department. Take the medicine pack or this leaflet with you.

If you forget to take TESPADAN
If you forget to take a dose, the next day, take your normal dose. Do not take a double dose to make up the missed dose.

If you stop taking TESPADAN
It is important to continue to take TESPADAN unless your doctor tells you to stop.

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 everybody gets them. If occur, they are usually mild and do not require discontinuation of treatment.

Although it can occur in a few people following two side effects can be serious:
Allergic reactions that can affect the whole body, with swelling of the face, mouth and / or larynx (vocal cords) together with itching and rash may occur during treatment with TESPADAN. If this happens, stop taking TESPADAN and immediately contact your doctor;
TESPADAN can cause severe lowering of blood pressure in susceptible individuals or as a result of an allergic reaction. This can cause severe dizziness or fainting. If this happens, stop taking Sevikar, immediately contact your doctor and go to bed.
Other possible side effects with TESPADAN
Common (affects less than 1 in 10 patients):
Dizziness; headache; swelling of ankles, feet, legs, hands or arms; fatigue.
Uncommon (affects less than 1 in 100 patients):
Dizziness upon standing; lack of energy; tingling or numbness in the hands or feet; dizziness; heart palpitations; fast heartbeat; low blood pressure with symptoms such as dizziness, vertigo; difficulty breathing; cough; nausea; vomiting; indigestion; diarrhea; constipation; dry mouth, pain in the upper abdomen; skin rash; muscular spasms; pain in arms and legs; back pain; need for frequent urination; decreased sexual activity; inability to achieve or maintain an erection; weakness;
Also seen some changes in the results of blood tests that include the following: raising and lowering the levels of potassium in the blood, elevated creatinine levels in the blood, elevated uric acid levels, elevated liver tests (levels of gamma-glutamyl transferase).
Rare (affects less than 1 in 1000 patients):
Drug hypersensitivity; seizures; redness and warm feeling of the face; hives; swelling of the face.
Adverse reactions reported with the use of olmesartan medoxomil and amlodipine separately, but not the use of Sevikar or seen at a higher frequency:
Olmesartan medoxomil
Common (affects less than 1 in 10 patients):
Bronchitis; sore throat; runny or stuffy nose; cough; abdominal pain; indigestion; diarrhea; indigestion; nausea; pain in the joints or bones; back pain; blood in the urine; urinary tract infection; chest pain; flu-like symptoms; pain. Changes in the results of blood tests as elevated lipids (hypertriglyceridemia); elevated levels of urea and uric acid in the blood and increase of liver and muscle function.
Uncommon (affects less than 1 in 100 patients):
Reduced number of types of blood cells, ie. Called. Platelets which can result in easy bruising or prolongation of bleeding time; rapid allergic reactions that can affect the whole body and can lead to difficulty breathing and a rapid drop in blood pressure, which can even lead to fainting (anaphylaxis); angina (pain or discomfort in the chest, known as angina pectoris); itching; skin rash; allergic skin rash; hives; swelling of the face; muscle pain; feeling unwell.
Rare (affects less than 1 in 1000 patients):
Swelling of the face, mouth and / or larynx (vocal cords); acute renal failure and renal failure; drowsiness.
Amlodipine
Common (affects less than 1 in 10 patients):
Abdominal pain; nausea; swelling of the ankles; drowsiness; redness and warm feeling of the face.
Uncommon (affects less than 1 in 100 patients):
Sleep problems; sleep disorders; mood swings, including anxiety; depression; irritability; fever; changes in taste; seizures; visual disturbances, including blurred vision; ringing in the ears (tinnitus); worsening of angina pectoris (pain or discomfort in the chest); runny or stuffy nose; hair loss; purple spots or blotches on the skin due to small haemorrhages (purpura); discoloration of the skin; increased sweating; skin rash; itching; pain in joints and muscles; problems with urination; urgent need to urinate during the night; need for frequent urination (excretion of urine); breast enlargement in men; chest pain; pain; feeling unwell; increase or decrease in body weight.
Rare (affects less than 1 in 1000 patients):
Confusion.
Very rare (affects less than 1 in 10,000 patients):
Decrease the number of white blood cells, which can increase the risk of infection; decreasing the number of one type of blood cell called platelets, leading to easy bruising or increased bleeding time; high blood sugar; increased muscle density and increased resistance to passive movements (hypertension); tingling or numbness in the hands or feet; heart attack or irregular heartbeat; inflammation of blood vessels; inflammation of the liver or pancreas; inflammation of the stomach lining; thickening of gums; elevated liver enzymes; yellowing of the skin and eyes; increased skin sensitivity to light; Allergic reactions (itching, rash, swelling of the face, mouth and / or larynx (vocal cords) together with itching and rash, other allergic conditions with inflammation and peeling of the skin, sometimes life-threatening).