Tensitev Tablets

TENSITEV tablets contain two active substances called telmisartan and amlodipine. TENSITEV is used to treat high blood pressure (also known as essential hypertension) in patients using the same components as individual components, or when treatment with amlodipine alone did not lower your blood pressure enough.

Do not take TENSITEV if you are pregnant, are considering becoming pregnant or are breastfeeding. A switch to a suitable alternative treatment should be carried out in advance of planned pregnancy.

Do not take TENSITEV:

• if you are hypersensitive (allergic) to telmisartan or amlodipine or to any of the other ingredients of TENSITEV (listed in section 6)
• if you are allergic to other medicines of the dihydropyridine type (one type of calcium channel blocker)
• if you have developed swelling and giant wheals on your skin when having previously taken medicines called angiotensin converting enzyme inhibitors (ACE inhibitors) or angiotensin receptor blockers (ARBs)
• if you have an inherited disorder or of unknown origin you suffer from recurrent episodes of the accumulation of fluids outside of the blood vessels, blocking the normal flow of blood or lymphatic fluid and causing rapid swelling of tissues in the hands, feet, limbs, face, intestinal tract, or airway (hereditary or idiopathic angioedema)
• if you have a heart condition called hypertrophic obstructive cardiomyopathy
• if you suffer from severe renal impairment
• if both blood vessels to the kidneys are narrowed or if you have a single kidney and the blood vessel to the kidney is narrowed
• if you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body)
• if you are currently taking lithium or potassium sparing water tablets containing spironolactone, triamterene or amiloride
• if you suffer from porphyria
• if you are currently taking aliskiren - containing medicines
• if you suffer from biliary obstruction (a problem with the drainage of the bile from the liver and gall bladder)
• if you suffer from severe liver problems
• if you suffer from severe low blood pressure (hypotension)
• if the blood circulation to your heart has not fully recovered following a recent heart attack
• if you have to use fluoroquinolones (antibiotic) concomitantly with TENSITEV and you have moderate to severe renal impairment or if you are elderly.

Warnings and precautions:

Take special care with TENSITEV:

• if you suffer from liver problems
• if you suffer from kidney disease or have ever had a kidney transplant
• if you have low blood pressure (hypotension), which is 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, or vomiting
• if you have heart failure and kidney problems affecting the renin-angiotensin-aldosterone system
• if you are treated with TENSITEV and a fluoroquinolone antibiotic (see section 4.3)
• if you have been told that you have raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals)
• if the valve of your heart is narrowed (aortic and mitral valve stenosis) or your heart muscle is enlarged (hypertrophic obstructive cardiomyopathy)
• if you have heart-associated chest pain also at rest or with minimal effort (unstable angina pectoris)
• if you have high potassium levels in your blood or use salt substitutes that contain potassium
• if you have diabetes
• if you are elderly and your dose needs to be increased.

Children and adolescents:

Do not give TENSITEV to children under the age of 18 years.

Other medicines and TENSITEV:

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Tell your doctor if you are taking:

• Other antihypertensive medicines
• Medicines with the potential to lower blood pressure (baclofen, amifostine, barbiturates, narcotics or antidepressants or alcohol)
• Corticosteroids
• Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain ‘water tablets’)
• Lithium-containing medicines to treat some types of depression
• Digitalis glycosides (digoxin) which is a heart medication
• Anticonvulsant medicines (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone)
• ACE-inhibitors, angiotensin II receptor antagonists or aliskiren (see Do not take TENSITEV and Take special care with TENSITEV)
• NSAIDs (non-steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid or ibuprofen), heparin, immunosuppressives (e.g. ciclosporin or tacrolimus)
• Fluoroquinolones (an antibiotic)
• Grapefruit and grapefruit juice
• Strong or moderate CPY3A4 inhibitors (ketoconazole, erythromycin, clarithromycin, verapamil or diltiazem)
• Rifampicin
• St. John’s wort (Hypericum perforatum)
• Dantrolene infusion used to treat an anaesthetic complication called malignant hyperthermia
• Ciclosporin, tacrolimus, sirolimus, temsirolimus or everolimus used to suppress your immune system or to treat certain types of cancer

Do not share medicines prescribed for you with any other person. Always take TENSITEV exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is one tablet a day. Your doctor will start you on the lowest dose, 40/5 mg and will increase the dose if necessary. Try to take the tablet at the same time each day. You can take TENSITEV with or without food. The tablets should be swallowed with some water or other non-alcoholic drink. If your liver is not working properly, the usual dose should not exceed one 40 mg/5 mg tablet or one 40 mg/10 mg tablet per day. Your doctor will tell you how long your treatment with TENSITEV will last. If you have the impression that the effect of TENSITEV is too strong or too weak, talk to your doctor or pharmacist.

If you take more TENSITEV than you should:

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. You might experience low blood pressure and rapid heartbeat. Slow heartbeat, dizziness, marked and prolonged low blood pressure including shock and death have also been reported. Excess fluid may accumulate in your lungs (pulmonary oedema) causing shortness of breath that may develop up to 24 to 48 hours after intake.

If you forget to take TENSITEV:

If you forget to take a dose, take it as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for forgotten individual doses.

TENSITEV can have side effects. Not all side effects reported for TENSITEV are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TENSITEV, please consult your healthcare provider for advice. If any of the following symptoms occur, stop taking the TENSITEV and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting
• yellowing of the skin and eyes, also called jaundice.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to TENSITEV. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• sepsis (often called ‘blood poisoning’, is a severe infection of the whole-body with high fever and the feeling of being severely ill)
• severe allergic reactions with blistering eruptions of the skin and mucous membranes (exfoliative dermatitis, Stevens-Johnson-Syndrome).

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Fixed dose combination:

Frequent side effects:

• dizziness
• swelling in your lower legs and hands.

Less frequent side effects:

• bladder inflammation
• depression, feeling anxious, sleeplessness
• fainting, sleepiness, migraine, headache
• tingling or numbness of the hands or feet
• weakness, numbness from nerve damage in the hands or feet

Store all medicines out of reach of children. Store at or below 25 °C. Store in the original package to protect from light. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).