Drug Ingredient Information
NEBIVOLOL-5MG+VALSARTAN-80MG
NEBIVOLOL
| Information for
patients
|
| Drug Information |
Nebivolol contains nebivolol which is a selective beta blocker and it dilates blood vessels (vasodilator). It is used for the treatment of raised blood pressure (hypertension). Nebivolol is also used to treat chronic heart failure in patients aged 70 or over. |
| Drug Alert |
| Alert |
|
| Before Consuming
the Medicine
|
| Avoid Drug |
•if you are allergic (hypersensitive) to nebivolol or to any of the other ingredients of Nebivolol.
•if you have low blood pressure (the systolic or “upper” pressure is less than 90 mmHg)
•if you have poor circulation in the arms or legs
•if you have a very slow heartbeat (less than 60 heart beats per minute before having started this medication)
•if you have been diagnosed with conduction disorders in your heart (such as sick sinus syndrome or atrio-ventricular blockade) and you do not have a functioning pacemaker
•if you have acute heart failure, or you are receiving treatment into a vein (by intravenous ‘drip’) to help your heart work
•if you have difficulty in breathing or wheezing (or history of)
•if you have a tumour of the adrenal gland called phaeochromocytoma
•if you have severe liver disease or liver function impairment
•if you have a metabolic acidosis (such as in diabetic patients when the blood sugar has risen too much and blood has become too acidic)
•if you use either floctafenine or sultopride containing medications. |
| Drug Special Care |
-If you have or develop one of the following conditions:
•heart failure (inability of heart to pump enough blood for body´s needs)
•a mild (first degree) atrioventricular blockade in your heart
•chest pain caused by cramping of the coronary arteries (called Prinzmetal´s angina or variant angina)
•poor circulation in the arms or legs, e.g. Raynaud’s disease or syndrome, cramp-like pains on walking
•prolonged breathing problems (or history of)
•diabetes: Nebivolol has no effect on blood sugar, but it could mask the signs of a low sugar level (e.g. trembling, fast heartbeat).
•overactive thyroid gland, as Nebivolol may mask the signs of an abnormally fast heart rate due to this condition
•allergy, as the allergic reactions may become stronger and more medicines may be needed to treat them
•a skin condition known as psoriasis, as Nebivolol\ may aggravate the symptoms
•wear contact lenses, as Nebivolol may reduce lacrimation and make the eyes dryer. Use in children and adolescents below 18 years old is not recommended. In these cases, your doctor may need to adapt your treatment or check you more often. If you need to have an operation and need an anaesthetic, it is important that you tell the surgeon or dentist that you are taking this medicine.
If you have kidney problems, do not take this medicine for heart failure and inform your doctor. |
| Drug Drug Interactions |
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal remedies and strong vitamins and minerals. Always tell your doctor or pharmacist if you are using or receiving any of the following medicines in addition to Nebivolol:
•diltiazem or verapamil (used for high blood pressure and other heart problems). During Nebivolol treatment, verapamil should not be injected into a vein
•other medicinal products known as calcium channel blockers for high blood pressure or other heart problems such as amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, nitrendipine
•other antihypertensive medications or organic nitrates to treat chest pain
•clonidine, guanfacin, moxonidine, methyldopa, rilmenidine used for the treatment of high blood pressure
•medicinal products for cardiac arrhythmias (irregular heartbeat) such as quinidine, hydroquinidine, amiodarone, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone
•tricyclic antidepressants (for depression), phenothiazines (for psychoses), or barbiturates (for epilepsy)
•medicinal products for diabetes mellitus (insulins and oral preparations)
•digoxin or other so called digitalis glycosides (to treat heart failure)
•anti-inflammatory analgesics (NSAIDs) for pain and inflammation- please note that small daily antithrombotic doses of acetylsalicylic acid (e.g., 50 or 100 mg) can be used safely with Nebivolol
•medicinal products for asthma, blocked nose or certain eye disorders such as glaucoma (increased pressure in the eye) or dilation of the pupil
•anaesthetics: always inform your anaesthetist that you are on Nebivolol before being anaesthetized
•cimetidine (to treat excessive stomach acid)- you should take Nebivolol during a meal, and the antacid drug between meals
•medicinal products affecting the metabolism of nebivolol namely terbinafine (for fungal or yeast infections), bupropion (to help in cessation of smoking), chloroquine (for malaria or rheumatoid arthritis), levomepromazine (for psychoses), paroxetine, fluoxetine, thioridiazine (for depression)
•amifostine (a protecting substance during chemo- or radiation therapy)
•baclofen (a muscle relaxant)
•mefloquine (an antimalarial). |
| Drug Pregnancy Interaction |
Nebivolol should not be used during pregnancy unless instructed to do so by a doctor. |
| Drug Breast feeding Interaction |
Breast-feeding is not recommended during administration of Nebivolol. |
| Drug Machinery Interaction |
No studies on the effects on the ability to drive and use machines have been performed. This medicine may cause dizziness or fainting as a result to reduction in blood pressure. If these occur, DO NOT drive or operate machinery. These effects are more likely to occur after initiation of the treatment or after dose increases. |
| Drug More Information |
Nebivolol 5 mg tablets can be taken before, during or after a meal, but also you can take them without food. The tablet or its parts should be swallowed with some water or another liquid. |
| How to take the
Medicine
|
| Consumption Info |
|
| Drug quanitty |
Treatment of raised blood pressure (hypertension)
•The usual dose is 1 tablet per day.
•Elderly patients and patients with a kidney disorder will usually start with 1/2 tablet daily.
•It may take up to 4 weeks for this medicine to have full effect.
Treatment of chronic heart failure
•Your treatment will be started and monitored by an experienced physician.
•Your doctor will start your treatment with 1/4 tablet per day. This may be increased after 1-2 weeks to 1/2 tablet per day, then to 1 tablet per day and then to 2 tablets per day until the correct dose is reached for you.
•The maximum recommended dose is 10 mg (2 tablets a day).
•You will need to be monitored for 2 hours by an experienced physician when you start treatment and every time your dose is increased.
•Your doctor may reduce your dose if necessary, and you should not stop abruptly as this can worsen heart failure.
•Patients with serious kidney problems should not take this medicine. |
| Drug Dose |
Always take Nebivolol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.Take your medicine once daily, preferably at about the same time of day. Your doctor may decide to combine your tablets with
other medicine for your condition. Nebivolol is not recommended in children and adolescents. |
| Excess Drug Consumption |
If you accidentally take too many tablets (overdose), you may experience slow heart beat, low blood pressure or other heart problems, or difficulty in breathing or wheezing. Contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. |
| Forgot Drug Consumption |
If you forget to take your medicine, but remember to take it after a short time, take the next tablet normally, when it is the time to take it. However, if a long delay has occurred (e.g. all day) skip that dose and take the next dose the next day at the usual time and skip the forgotten dose. Do not take a double or a larger dose to make up with a forgotten dose (s). Repeated skipping is to be avoided. |
| Stop Drug Consumption |
Do not stop taking Nebivolol without consulting your doctor first. If the medication is terminated abruptly, the patient may experience dangerous worsening of the symptoms. This concerns especially the patients with angina pectoris. |
| Possible Side
Effects
|
| General Information |
|
| Common Drug Side Effects |
When used for raised blood pressure:
•Headache
•Dizziness
•Tiredness
•An unusual itching or tingling feeling
•Diarrhoea
•Constipation
•Nausea
•Shortness of breath
•Swollen hands or feet |
| Rare Drug Side Effects |
when used for raised blood pressure:
•Slow heartbeat or other heart complaints
•Low blood pressure
•Abnormal vision
•Impotence (difficulty in getting an erection)
•Depressive feelings
•Indigestion, gas in stomach or bowel
•Vomiting
•Skin rash
•Tightening of the chest, difficulty in breathing or wheezing
•Nightmares
•In a clinical study for chronic heart failure, the side effects seen were slow heart beat, dizziness, worsening of heart failure, low blood pressure (such as feeling faint when getting up quickly), inability to tolerate medicine, irregular heart beat, swelling (such as swollen ankles). |
| Very Rare Drug Side Effects |
•Fainting
•Psoriasis aggravated |
| Drug Side Effects Symptoms |
•Angioedema: swelling of the skin of the face or extremities, lips, tongue, mucous membranes of the throat and airway, resulting in shortness of breath or difficulty to swallow – contact a doctor
immediately!
•Hypersensitivity |
| How to Store the
Medicine
|
| How to Store the Medicine |
Keep out of the reach and sight of children. Do not use Nebivolol after the expiry date which is stated on the carton after .
The expiry date refers to the last day of that month. Do not store above 30°C. 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. |
VALSARTAN
| Information for
patients
|
| Drug Information |
Valsartan belongs to a class of medicines known as angiotensin II receptor antagonist, 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. Valsartan 40 mg film-coated tablets can be used for three different conditions:
• to treat high blood pressure in children and adolescents 6 to 18 years of age. High blood pressure increases the workload on the heart and arteries. If not treated it can damage the blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood pressure to normal reduces the risk of developing these disorders.
• to treat adult patients after a recent heart attack (myocardial infarction). “Recent” here means between 12 hours and 10 days.
• to treat symptomatic heart failure in adult patients. Valsartan is used when a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors (a medication to treat heart failure) cannot be used or it may be used in addition to ACE inhibitors when beta blockers (another medication to treat heart failure) cannot be used. Heart failure symptoms include shortness of breath, and swelling of the feet and legs due to fluid build-up. It is caused when the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body. |
| Drug Alert |
| Alert |
|
| Before Consuming
the Medicine
|
| Avoid Drug |
• if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Valsartan listed at the end of this leaflet.
• if you have severe liver disease.
• if you are more than 3 months pregnant (it is also better to avoid Valsartan in early pregnancy - see pregnancy section). |
| Drug Special Care |
• if you have liver disease.
• if you have severe kidney disease or if you are undergoing dialysis.
• if you are suffering from a narrowing of the kidney artery.
• if you have recently undergone kidney transplantation (received a new kidney).
• if you are treated after a heart attack or for heart failure, your doctor may check your kidney function.
• if you have severe heart disease other than heart failure or heart attack.
• if you are taking medicines that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin. It may be necessary to check the amount of potassium in your blood at regular intervals.
• if you are below 18 years of age and you take Valsartan in combination with other medicines that inhibit the renin angiotensin aldosterone system (medicines that lower blood pressure), your doctor may check your kidney function and the amount of potassium in your blood at regular intervals.
• if you suffer from aldosteronism. This is a disease in which your adrenal glands make too much of the hormone aldosterone. If this applies to you, the use of Valsartan is not recommended.
• if you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of water tablets (diuretics).
• you must tell your doctor if you think you are (or might become) pregnant. Valsartan 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. |
| Drug Drug Interactions |
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The effect of the treatment can be influenced if Valsartan is taken together with certain other medicines. It may be necessary to change the dose, to take other precautions, or in some cases to stop taking one of the medicines. This applies to both prescription and non-prescription medicines, especially:
• other medicines that lower blood pressure, especially water tablets (diuretics).
• medicines that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin.
• certain type of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).
• lithium, a medicine used to treat some types of psychiatric illness.
In addition:
• if you are being treated after a heart attack, a combination with ACE inhibitors (a medication to treat heart attack) is not recommended.
• if you are being treated for heart failure, a triple combination with ACE inhibitors and beta blockers (medications to treat heart failure) is not recommended. |
| Drug Pregnancy Interaction |
• You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking Valsartan before you become pregnant or as soon as youknow you are pregnant, and will advise you to take another medicine instead of Valsartan. Valsartan 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 it is used after the third month of pregnancy |
| Drug Breast feeding Interaction |
• Tell your doctor if you are breast-feeding or about to start breast-feeding. Valsartan 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. |
| Drug Machinery Interaction |
Before you drive a vehicle, use tools or operate machines, or carry out other activities that require concentration, make sure you know how Valsartan affects you. Like many other medicines used to treat high blood pressure, Valsartan may in rare cases cause dizziness and affect the ability to concentrate. |
| Drug More Information |
You can take Valsartan with or without food. |
| How to take the
Medicine
|
| Consumption Info |
|
| Drug quanitty |
Children and adolescents (6 to 18 years of age) with high blood pressure
In patients who weigh less than 35 kg the usual dose is 40 mg of valsartan once daily. In patients who weigh 35 kg or more the usual starting dose is 80 mg of valsartan once daily. In some cases your doctor may prescribe higher doses (the dose can be increased to 160 mg and to a maximum of 320 mg).
Adult patients after a recent heart attack: After a heart attack the treatment is generally started as early as after 12 hours, usually at a low dose of 20 mg twice daily. You obtain the 20 mg dose by dividing the 40 mg tablet. Your doctor will increase this dose gradually over several weeks to a maximum of 160 mg twice daily. The final dose depends on what you as an individual patient can tolerate.
Valsartan can be given together with other treatment for heart attack, and your doctor will decide which treatment is suitable for you.
Adult patients with heart failure: Treatment starts generally with 40 mg twice daily. Your doctor will increase the dose gradually over several weeks to a maximum of 160 mg twice daily. The final dose depends on what you as an individual patient can tolerate. Valsartan can be given together with other treatment for heart failure, and your doctor will decide which treatment is suitable for you. You can take Valsartan with or without food. Swallow Valsartan with a glass of water. Take Valsartan at about the same time each day. |
| Drug Dose |
Always take Valsartan exactly as your doctor has told you in order to get the best results and reduce the risk of side effects. You should check with your doctor or pharmacist if you are not sure. People with high blood pressure often do not notice any signs of this problem. Many may feel quite normal. This makes it all the more important for you to keep your appointments with the doctor even if you are feeling well. |
| Excess Drug Consumption |
If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital. |
| Forgot Drug Consumption |
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed. Do not take a double dose to make up for a forgotten dose. |
| Stop Drug Consumption |
Stopping your treatment with Valsartan may cause your disease to get worse. Do not stop taking your medicine unless your doctor tells you to. |
| Possible Side
Effects
|
| General Information |
You may experience symptoms of angioedema (a specific allergic reaction), such as
• swollen face, lips, tongue or throat
• difficulty in breathing or swallowing
• hives, itching |
| Common Drug Side Effects |
• dizziness
• low blood pressure with or without symptoms such as dizziness and fainting when standing up
• decreased kidney function (signs of renal impairment) |
| Rare Drug Side Effects |
• angioedema (see section “Some symptoms need immediate medical attention”)
• sudden loss of consciousness (syncope)
• spinning sensation (vertigo)
• severely decreased kidney function (signs of acute renal failure)
• muscle spasms, abnormal heart rhythm (signs of hyperkalaemia)
• breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of cardiac failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhoea
• tiredness
• weakness |
| Very Rare Drug Side Effects |
|
| Drug Side Effects Symptoms |
• allergic reactions with rash, itching and hives; symptoms of fever, swollen joints and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms may occur (signs of serum sickness)
• purplish-red spots, fever, itching (signs of inflammation of blood vessels also called vasculitis)
• unusual bleeding or bruising (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat or mouth ulcers due to infections (symptoms of low level of white blood cells also called neutropenia)
• decrease of level of haemoglobin and decrease of the percentage of red blood cells in the blood (which can lead to anaemia in severe cases)
• increase of level of potassium in the blood (which can trigger muscle spasms and abnormal heart rhythm in severe cases)
• elevation of liver function values (which can indicate liver damage) including an increase of bilirubin in the blood (which can trigger yellow skin and eyes in severe cases)
• increase of level of blood urea nitrogen and increase of level of serum creatinine (which can indicate abnormal kidney function)
• low level of sodium in the blood (which can trigger tiredness, confusion, muscle twitching and/or convulsions in severe cases)
The frequency of some side effects may vary depending on your condition. For example, side effects such as dizziness, and decreased kidney function, were seen less frequently in adult patients treated with high blood pressure than in adult patients treated for heart failure or after a recent heart attack. Side effects in children and adolescents are similar to those seen in adults. |
| How to Store the
Medicine
|
| How to Store the Medicine |
• Do not store above 30°C. Store in the original package in order to protect from moisture.
• Keep out of the reach and sight of children.
• Do not use Valsartan after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
• Do not use Valsartan if you notice that the pack is damaged or shows signs of tampering.
• 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. |
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