Naviod Co 80 mg/12,5 mg/25 mg Film-Coated Tablets

NAVIOD CO film - coated tablets contain two active substances called valsartan and hydrochlorothiazide. Both of these substances help to control high blood pressure (hypertension).

• Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists”, which help to control high blood pressure. Angiotensin II is a substance in the body that causes vessels to tighten, thus causing your blood pressure to increase. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax, and blood pressure is lowered.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as “water tablets”). Hydrochlorothiazide increases urine output, which also lowers blood pressure.

NAVIOD CO is used to treat high blood pressure, which is not adequately controlled by a single substance alone.

Do not take NAVIOD CO:

• if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide or any of the other ingredients of NAVIOD CO (listed in section 6).
• if you have developed swelling of the face, lips, mouth, tongue or throat and giant wheals on your skin when previously taking medicines called angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) – you should never take these medicines again.
• if you suffer from obstruction of blood vessels to your heart or kidneys.
• if you suffer from severe kidney function impairment.
• if you suffer from porphyria.
• if you are currently taking lithium.
• if you are currently taking potassium sparing water tablets containing spironolactone, triamterene or amiloride.
• if you are taking fluoroquinolones (antibiotics to treat infections).
• if you are currently taking aliskiren-containing medicines.
• if you are pregnant or breast-feeding.
• if the level of potassium or sodium in your blood is lower than normal, or if the level of calcium in your blood is higher than normal despite treatment.

Warnings and precautions

Take special care with NAVIOD CO:

• if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium or other medicines that increase the amount of potassium in your blood such as heparin. Your doctor may need to check the amount of potassium in your blood regularly.
• if you have low levels of potassium in your blood.
• if you have diarrhoea or severe vomiting.
• if you are taking high doses of water tablets (diuretics).
• if you have severe heart disease.
• if you are suffering from heart failure or have experienced a heart attack. Follow your doctor’s instruction for the starting dose carefully. Your doctor may also check your kidney function.
• if you suffer from a narrowing of the kidney artery.
• if you have recently received a new kidney.
• if you suffer from hyperaldosteronism. This is a disease in which your adrenal glands make too much of the hormone aldosterone. If this applies to you, the use of NAVIOD CO is not recommended.
• if you have liver or kidney disease.
• if you have ever experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking another drug (including ACE inhibitors), tell your doctor. If these symptoms occur when you are taking NAVIOD CO, stop taking NAVIOD CO immediately and never take it again. See also section 4, “Possible side effects”.
• if you have fever, rash and joint pain, which may be signs of systemic lupus erythematosus (SLE, a so-called autoimmune disease).
• if you have diabetes, gout, high levels of cholesterol or triglycerides in your blood.
• if you have had allergic reactions with the use of other blood pressure-lowering medicines of this class (angiotensin II receptor antagonists) or if you have allergy or asthma.
• if you experience a decrease in vision or eye pain. These could be symptoms of an increase of pressure in your eye and can happen within hours to a week of taking NAVIOD CO. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulphonamide allergy you can be at higher risk of developing this.
• if you are taking any of the following medicines used to treat high blood pressure: an ACE inhibitors (for example enalapril, lisinopril, Ramipril), in particular if you have diabetes-related kidney problems.
• aliskiren.
• if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.

Do not share medicines prescribed for you with any other person. Always take NAVIOD CO exactly as your doctor has told you. Check with your doctor if you are not sure. Your doctor will tell you exactly how many tablets of NAVIOD CO to take. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.

• The recommended dose of NAVIOD CO is one tablet per day.
• Do not change the dose or stop taking the tablets without consulting your doctor.
• NAVIOD CO should be taken at the same time each day, usually in the morning.
• You can take NAVIOD CO with or without food.
• Swallow the tablet with a glass of water. NAVIOD CO tablets are only for adults and should not be taken by children and adolescents up to 18 years.

If you have the impression that NAVIOD CO is too strong or too weak, talk to your doctor or pharmacist.

If you take more NAVIOD CO than you should

If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take NAVIOD CO

NAVIOD CO can have side effects. Not all side effects reported for NAVIOD CO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking NAVIOD CO, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking NAVIOD CO and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching. These are all very serious side effects. If you have them, you may have had a serious reaction to NAVIOD CO. 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:

• severe skin disease that causes rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis),
• decrease in vision or pain in your eyes due to high pressure (possible signs of acute angle-closure glaucoma),
• fever, sore throat, more frequent infections (agranulocytosis). These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent:
• low level of potassium in the blood,
• increase of lipids in the blood,
• low level of sodium in the blood,
• low level of magnesium in the blood
• high level of uric acid in the blood,
• itchy rash and other types of rash,
• reduced appetite,
• mild nausea and vomiting,
• dizziness, fainting on standing up,
• inability to achieve or maintain erection

- Keep out of the sight and reach of children.

- Store at or below 25 °C.

- Store in the original package in order to protect from light and moisture.

- Do not use NAVIOD CO after the expiry date, which is stated on the package. The expiry date refers to the last day of that month.

- If your tablets become discoloured or show any other signs of deterioration, consult your doctor or pharmacist who will tell you what to do.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).