Pritor 40 mg tablets

 

What is it and how is it used?

Pritor belongs to a group of medicines known as 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. Pritor blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.

Pritor is used to treat essential hypertension (high blood pressure). ‘Essential’ means that the high blood pressure is not caused by any other condition.

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.

Pritor is also used to reduce cardiovascular events (i.e. heart attack or stroke) in patients who are at risk because they have a reduced or blocked blood supply to the heart or legs, or have had a stroke or have high risk diabetes. Your doctor can tell you if you are at high risk for such events.

What do you have to consider before using it?

Do not take Pritor

  • if you are allergic (hypersensitive) to telmisartan or any other ingredients included in Pritor tablets (see section Further information for a list of other ingredients).
  • if you are more than 3 months pregnant. (It is also better to avoid Pritor 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 liver and gall bladder) or any other severe liver disease.

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

Take special care with Pritor

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

  • Kidney disease or kidney transplant.
  • Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
  • Liver disease.
  • Heart trouble.
  • Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals).
  • 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, or vomiting.
  • Elevated potassium levels in your blood.
  • Diabetes.

You must tell your doctor if you think you are ( or might become) pregnant. Pritor 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).

In case of surgery or anaesthesia, you should tell your doctor that you are taking Pritor.

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

As with all other angiotensin II receptor antagonists, Pritor 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 Pritor:

  • Lithium containing medicines to treat some types of depression.
  • Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain 'water tablets'), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
  • Diuretics ('water tablets'), especially if taken in high doses together with Pritor, may lead to excessive loss of body water and low blood pressure (hypotension).

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

Pritor may increase the blood pressure lowering effect of other medicines used to treat high blood pressure.

Taking Pritor with food and drink

You can take Pritor 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 Pritor before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Pritor. Pritor 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. Pritor 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 Pritor 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 Pritor

Pritor contains sorbitol.
If you are intolerant to some sugars, consult your doctor before taking Pritor.

How is it used?

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

The usual dose of Pritor is one tablet a day. Try to take the tablet at the same time each day. You can take Pritor with or without food. The tablets should be swallowed with some water or other non-alcoholic drink. It is important that you take Pritor every day until your doctor tells you otherwise. If you have the impression that the effect of Pritor is too strong or too weak, talk to your doctor or pharmacist.

For treatment of high blood pressure, the usual dose of Pritor for most patients is one 40 mg tablet once a day to control blood pressure over the 24-hour period. However, sometimes your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, Pritor may be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Pritor.

For reduction of cardiovascular events, the usual dose of Pritor is one 80 mg tablet once a day. At the beginning of the preventive therapy with Pritor 80 mg, blood pressure should be frequently monitored.

If your liver is not working properly, the usual dose should not exceed 40 mg once daily.

If you take more Pritor 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 Pritor

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 any further questions on the use of this product, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, Pritor 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:
Low blood pressure (hypotension) in users treated for reduction of cardiovascular events.

Uncommon side effects may include:
Upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), urinary tract infections, deficiency in red blood cells (anaemia), high potassium levels, feeling sad (depression), fainting (syncope), difficulty falling asleep, feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, increased sweating, itching, drug rash, muscle pain (myalgia), back pain, muscle cramps, kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.

Rare side effects may include:
Low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), feeling anxious, impaired vision, fast heart beat (tachycardia), upset stomach, dry mouth, abnormal liver function, severe drug rash, redness of skin, rapid swelling of the skin and mucosa (angioedema), eczema (a skin disorder), joint pain (arthralgia), pain in extremity, flu-like-illness, increased levels of uric acid, hepatic enzymes or creatine phosphokinase in the blood, and decreased haemoglobin (a blood protein).

Side effects of unknown frequency may include:
Increase in certain white blood cells (eosinophilia), severe allergic reaction (anaphylactic reaction), hives (urticaria), tendon pain, and 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.

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

How should it be stored?

Keep out of the reach and sight of children.

Do not use Pritor 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.

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 is it?

Pritor is a medicine that contains the active substance telmisartan. It is available as white tablets (round: 20 mg; oblong: 40 and 80 mg).

What is it used for?

Pritor is used in adults who have essential hypertension (high blood pressure). ‘Essential’ means that the hypertension has no obvious cause.
The medicine can only be obtained with a prescription.

How is it used?

Pritor is taken by mouth, with or without food. The recommended dose is 40 mg once a day, but some patients may benefit from using a 20-mg dose. If the target blood pressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.

How does it work?

The active substance in Pritor, telmisartan, is an ‘angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a stroke.

How has it been studied?

Pritor has been studied in 1,647 patients who were treated with telmisartan either alone or in combination with hydrochlorothiazide. Pritor was compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine). The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).

What benefits has it shown during the studies?

Pritor was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.

What is the risk associated?

Side effects with Pritor are not common. However, the following side effects are seen in between 1 and 10 patients in 1,000: hyperkalaemia (high blood potassium levels), syncope (fainting), insomnia (difficulty sleeping), vertigo (a spinning sensation), hypotension (low blood pressure), dyspnoea (difficulty breathing), abdominal (tummy) pain, diarrhoea, dry mouth, dyspepsia (heartburn), flatulence (gas), hyperhidrosis (excessive sweating), pruritus (itching), myalgia (muscle pain), renal impairment (kidney problems) including renal failure (kidney failure), and chest pain. For the full list of all side effects reported with Pritor, see the Package Leaflet.
Pritor should not be used in people who may be hypersensitive (allergic) to telmisartan or any of the other ingredients. It must not be used in women who are more than three months pregnant. Its use during the first three months of pregnancy is not recommended. Pritor must not be used in people who have severe liver problems or bile problems.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Pritor’s benefits are greater than its risks for the treatment of essential hypertension in adults. The Committee recommended that Pritor be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Pritor on 11 December 1998. The marketing authorisation was renewed on 11 December 2003 and on 11 December 2008. The marketing authorisation holder is Bayer Schering Pharma AG.