Tenloris 50 mg. / 5 mg. 30 tablets

What is Tenloris and what it is used for
Tenloris contains two active substances called losartan and amlodipine. Both substances help to control high blood pressure.

Losartan belongs to a group of medicines called "angiotensin-II receptor antagonists" that lower blood pressure by relaxing blood vessels;
Amlodipine belongs to a group of substances called "calcium antagonists". Amlodipine stops the passage of calcium into the wall of the blood vessels, which prevents the blood vessels from contracting. It also lowers blood pressure.
The actions of these two substances contribute to stopping the blood vessels. As a result, the blood vessels are relaxed and the blood pressure decreases.
Tenrolis is used to treat high blood pressure (hypertension) in patients who have already taken losartan and amlodipine at the same doses instead of taking these two medicines separately.

2. What you need to know before you take Tenloris
Do not take Tenorris:

If you are allergic to losartan, amlodipine or any of the other ingredients of this medicine (listed in section 6) or to another calcium antagonist. This may appear as itching, reddening of the skin or difficulty in breathing;
If you have very low blood pressure (hypotension);
If you have a narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to deliver enough blood to the body);
If you suffer from heart failure after a heart attack;
If you are pregnant after 3 months. (It is also better to avoid Tenorris in early pregnancy - see Pregnancy);
If your liver function is severely impaired.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tenorris.
You should tell your doctor if you think you are pregnant (or you may become pregnant). TENORRIS is not recommended in early pregnancy and should not be taken if you are pregnant after 3 months because it can cause serious harm to your baby if used during this period (see Pregnancy).

It is important to tell your doctor before taking Tenloris

If you have a history of angioedema (swelling of the face, lips, throat and / or tongue) (see also section 4);
If you suffer from severe vomiting or diarrhea leading to excessive loss of fluid and / or salts from your body;
If you are taking diuretics (medicines that increase the amount of water that is excreted through your kidneys) or are on a low-salt diet leading to excessive fluid and salt loss in your body;
If you are aware that you have narrowing or blockage of your blood vessels to your kidneys or if you have recently had a kidney transplant;
If your liver function is impaired (see section 2 "Do not take Tenorris");
If you suffer from heart failure, with or without renal impairment or with severe, life-threatening cardiac arrhythmias. Take special care when you are treated with a beta-blocker at the same time;
If you have problems with your heart valves or heart muscle;
If you suffer from ischemic heart disease (caused by reduced blood flow in the blood vessels of the heart) or from cerebrovascular disease (caused by reduced blood circulation in the brain);
If you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone from the adrenal gland caused by abnormalities in the glands);
If you have recently suffered a heart attack;
If you have or have had a severe increase in blood pressure (hypertensive crisis);
If you are elderly and the dose should be increased.
Children and adolescents
The use of Tenrolis in children and adolescents under 18 years of age is not recommended.

Other drugs and Tenloris
Tell your doctor or pharmacist if you are taking, have recently taken or may be taking other medicines.

Take special care if you are taking the following medicines while you are treated with Tenorris:

Other medicines to lower your blood pressure as they may further lower your blood pressure. Blood pressure may be decreased by one of the following drugs / class of medicines: tricyclic antidepressants, antipsychotics, baclofen, amyphofine;
Medicines that retain potassium or may raise potassium levels (eg potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines, such as certain diuretics [amiloride, triamterene, spironolactone] or heparin);
Non-steroidal anti-inflammatory drugs such as indomethacin, including COX-2 inhibitors (medicines that reduce inflammation and can be used to relieve pain), as they may weaken the effect of lowering losartan blood pressure.
If your kidney function is impaired, concomitant use of these medicines may lead to deterioration of renal function.

Tenloris may affect or be affected by other medicines, such as:

Ketoconazole, itraconazole
Tenloris may affect or be affected by other medicines, such as:

Ketoconazole, itraconazole (antifungal medicines);
Ritonavir, indinavir, nelfinavir (the so-called protease inhibitors used to treat HIV);
Rifampicin, erythromycin, clarithromycin (antibiotics);
St John's wort (St. John's wort);
Verapamil, diltiazem (heart medicines);
Dantrolene (infusion at a markedly elevated body temperature);
Simvastatin (a cholesterol lowering drug).
Medicines containing lithium should not be taken in combination with Tenrolis without immediate supervision by your doctor. It may be appropriate to apply special precautions (eg blood tests).

Tenorris with food and beverages
Grapefruit and grapefruit juice should not be eaten by people who take Tenorris. This is because grapefruit and grapefruit juice can lead to an increase in the levels of the active substance amlodipine, which may lead to an unpredictable increase in the Tenorris blood pressure lowering effect.

Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You should tell your doctor if you think you are pregnant (or you may become pregnant).
Your doctor will usually advise you to stop taking Tenoris before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Tenorris. TENORRIS is not recommended in early pregnancy and should not be taken when you are pregnant after 3 months because it can cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breast-feeding or intend to breast-feed. Tenorris 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 premature.

Driving and using machines
Tenrolis may affect your ability to drive or use machines. If your tablets make you feel sick, dizzy or tired or cause a headache, do not drive or use machines and contact your doctor immediately.

Tenolis contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Tenloris
Always take this medicine exactly as your doctor or pharmacist has told you. Consult your doctor or pharmacist if you are not sure.
The recommended dose of Tenrolis is one tablet a day.
The tablets should be swallowed with a glass of water, with or without food. You should try to take the daily dose at the same time each day. Do not take Tenorris with grapefruit juice.
It is important that you continue to take Tenoris until your doctor tells you otherwise.

Use in children and adolescents
The use of Tenrolis in children and adolescents is not recommended.

If you take more than the necessary dose of Tenorris
If you accidentally take too many tablets, contact your doctor immediately. Taking too many tablets can cause a fall in blood pressure or even lowering to dangerously low levels. You may experience dizziness, vertigo, pallor, or weakness. If the drop in blood pressure is severe, you may experience severe shock. Your skin can become cool and sticky and lose consciousness.

If you forget to take Tenloris
If you accidentally miss the daily dose, just take the next dose as usual.
Do not take a double dose to make up for the missed dose.

If you stop taking Tenloris
Your doctor will advise you how long to take your medicine. Your condition may get worse if you stop using your medicine before he tells you this.

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 everyone gets them.

Contact your doctor immediately if you experience any of the following serious side effects after taking this medicine.

Sudden wheezing, chest pain, shortness of breath or shortness of breath;
Swelling of the eyelids, face or lips;
Swelling of the tongue and throat, which causes great difficulty in breathing;
Severe skin reactions including intense skin rash, urticaria, redness of the skin throughout the skin, itching of the skin, blistering, scaling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome) or other allergic reactions;
Heart attack, impaired heart rhythm;
Inflammation of the pancreas, which can lead to severe abdominal pain and back pain, accompanied by a feeling that you are very bad.
AMLODIPIN
The following common side effects have been reported. 
Common (may affect up to 1 in 10 people):

Headache, dizziness, drowsiness (especially at the beginning of treatment);
Palpitations (feeling of heart rhythm), redness;
Abdominal pain, malaise (nausea);
Swelling of the ankles (edema), fatigue.
Other side effects that have been reported are listed below. If any of these gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Uncommon (may affect up to 1 in 100 people):

Changes in mood, anxiety, depression, insomnia;
Trembling, taste abnormalities, seizures, weakness;
Stiffness or numbness in limbs; loss of sense of pain;
Vision disorders, double vision, tinnitus;
Low blood pressure;
Sneezing / runny nose caused by inflammation of the lining of the nose (rhinitis);
Changed intestinal peristalsis, diarrhea, constipation, indigestion, dry mouth, vomiting (illness);
Hair loss, increased sweating, itchy skin, red spots on the skin, discoloration of the skin;
Irritation disorder, frequent urination at night, increased number of urination times;
Inability to develop an erection, discomfort or breast enlargement in men;
Weakness, pain, malaise;
Joint or muscle pain, muscle cramps, back pain;
Increase or decrease weight.
Rare (may affect up to 1 in 1,000 people):

Confusion.
Very rare (may affect up to 1 in 10,000 people):

Reduced white blood cell counts, blood platelets decreased, which may lead to abnormal bruising or bleeding (damage to red blood cells);
Increased blood sugar (hyperglycaemia);
Disease of the nerves, which may lead to weakness, tingling or stiffness;
Coughing;
Swelling of gums;
Abdominal swelling (gastritis);
Hepatic dysfunction, liver inflammation (hepatitis), yellowing of the skin (jaundice), elevation of liver enzymes which may affect some medical tests;
Increasing tension in muscles;
Inflammation of the blood vessels, often with rash on the skin;
Sensitivity to light;
Disturbances involving rigidity, tremor, and / or motor impairment.
LOSCARAN
Common (may affect up to 1 in 10 people):

Dizziness;
Decrease in blood pressure (especially after excessive water release from the body and, in particular, reduction in blood volume, for example in patients with severe heart failure or in high dose diuretics);
Dose-related orthostatic effects such as decreasing blood pressure when standing or lying down;
Weakness;
Fatigue;
Too little sugar in the blood (hypoglycaemia);
Too much potassium in the blood (hyperkalaemia);
Changes in renal function, including renal failure;
Reduced red blood cell count (anemia);
Increase in blood urea, serum creatinine and serum potassium in patients with heart failure.
Uncommon (may affect up to 1 in 100 people):

Drowsiness;
Headache;
Sleep disorder;
Feeling of an accelerated heartbeat;
Strong chest pain (angina);
Shortness of breath (shortness of breath);
Abdominal pain;
Constipation;
Diarrhea;
Nausea;
Vomiting;
Hives (urticaria);
Pruritus (pruritus);
Rash;
Localized swelling (swelling);
Cough.
Rare (may affect up to 1 in 1,000 people):

Hypersensitivity;
Angioedema;
Inflammation of the blood vessels (vasculitis including Henoch-Schonlein purpura);
Stiffness or tingling (paraesthesia);
Loss of consciousness (syncope);
Severely accelerated and uneven heartbeat (atrial fibrillation);
Stroke (stroke);
Inflammation of the liver (hepatitis);
Increased alanine aminotransferase (ALT) in the blood, usually at discontinuation of treatment.
Not known (can not be estimated from the available data):

Decreased platelet count;
Migraine;
Liver function abnormalities;
Muscle and joint pain;
Flu-like symptoms;
Back pain and urinary tract infection;
Increased sensitivity to the sun (photosensitivity);
Unexplained muscle pain with dark (tea-colored) urine (rhabdomyolysis);
Impotence;
Inflammation of the pancreas (pancreatitis);
Low levels of sodium in the blood (hyponatraemia);
Depression;
Total malaise (discomfort);
Ringing, buzzing, roar or snapping (tinnitus);
Impaired taste (change of taste).
How to Store Tenloris
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of your unnecessary medicines. These measures will help to protect the environment.

6. Package Contents and Additional Information
What Tenloris contains
The active substances are: losartan potassium and amlodipine besylate.
Tenorris 50 mg / 5 mg film-coated tablets
Each film-coated tablet contains 50 mg of losartan potassium and 6.94 mg of amlodipine besylate equivalent to 5 mg of amlodipine.

Write a review