Drug Ingredient Information
NEBIVOLOL-5MG+AMLODIPINE-5MG
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. |
AMLODIPINE
| Information for
patients
|
| Drug Information |
Amlodipine is one of a group of medicines called calcium antagonists.
Your medicine is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, a rare form of which is Prinzmetal’s or variant angina.
In patients with high blood pressure your medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina Amlodipine works by
improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. Your medicine does not provide immediate relief of chest
pain from angina |
| Drug Alert |
| Alert |
•if you are allergic (hypersensitive) to Amlodipine, or any of the other ingredients of your medicine, or to any other calcium antagonists. This may be itching, reddening of the skin or difficulty in breathing;
•if you have narrowing of the aortic heart valve (aortic stenosis), unstable angina or cardiogenic shock |
| Before Consuming
the Medicine
|
| Avoid Drug |
Do not take Amlodipine:
•if you are allergic (hypersensitive) to Amlodipine, or any of the other ingredients of your medicine , or to any other calcium antagonists. This may be itching, reddening of the skin or difficulty in breathing;
•if you have narrowing of the aortic heart valve (aortic stenosis), unstable angina or cardiogenic shock;
•if you are pregnant or breast feeding |
| Drug Special Care |
You should inform your Doctor if you have or have had any of the following conditions:
•Recent heart attack (within the last month).
•Severe increase in blood pressure (Hypertensive crisis).
•Liver disease |
| 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 |
| Drug Pregnancy Interaction |
If you think you might be pregnant, or are planning to get pregnant, tell your doctor before you take Amlodipine
Women of child bearing potential should ensure that they use effective contraception |
| Drug Breast feeding Interaction |
You should not take Amlodipine if you are breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine |
| Drug Machinery Interaction |
Amlodipine is unlikely to affect your ability to drive or use machines. |
| Drug More Information |
Your medicine can be used before or after food. Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipine. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Amlodipine.
Children
Safety and effectiveness have been studied in 6-17 year old boys and in girls. Amlodipine has not been
studied in children under the age of 6 years. For more information, talk to your doctor. |
| How to take the
Medicine
|
| Consumption Info |
|
| Drug quanitty |
The usual dose of Amlodipine is one tablet daily. |
| Drug Dose |
The usual dose of Amlodipine is one tablet daily. |
| Excess Drug Consumption |
Taking too may tablets at once may make you unwell. If you take too may Amlodipine tablets contact your doctor at once or go to the nearest hospital casualty department |
| Forgot Drug Consumption |
Do not worry. If you forget to take a tablet, leave out that dose completely. Take your next dose at the right time. Do not take a double dose to make up for a missed dose |
| Stop Drug Consumption |
Your doctor will advise you how long to take your medicine. Your condition may return if you stop using your medicine before you are advised.
If you have any further questions on how to take this product, ask your doctor or pharmacist |
| Possible Side
Effects
|
| General Information |
|
| Common Drug Side Effects |
•Headache, dizziness, sleepiness.
•Palpitations (awareness of your heart beat), flushing.
•Abdominal pain, feeling sick (nausea).
•Ankle swelling (oedema), tiredness.
Other side-effects that have been reported include the following list. If any of these get serious, or
if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist |
| Rare Drug Side Effects |
•Unusual bruising and bleeding (red blood cell damage).
•Severe skin reactions.
•Excess sugar in blood (diabetes).
•Increased sensitivity of the skin, pins and needles, loss of pain sensation.
•Heart attack.
•Hives.
•Abdominal bloating (gastritis).
•Cough.
•Inflamed pancreas.
•Abnormal liver function, inflammation of the liver, yellowing of the skin (jaundice), liver enzyme increases.
If any of the side effects gets serious, or if you notice any side effects not listed in this , please tell your doctor or pharmacist |
| Very Rare Drug Side Effects |
•Mood changes, sleeplessness.
•Trembling, taste abnormalities, fainting, weakness.
•Visual disturbances, ringing in the ears.
•Low blood pressure.
•Shortness of breath, sneezing/running nose.
•Altered bowel habit, indigestion, dry mouth, vomiting (being sick).
•Hair loss, increased sweating, itchy skin, red patches on skin.
•Increased need to urinate especially at night, inability to obtain an erection.
•Chest pain, weakness, pain, feeling unwell.
•Joint or muscle pain, muscle cramps, back pain.
•Weight increase or decrease.
•Enlargening of male breasts |
| Drug Side Effects Symptoms |
Like all medicines, Amlodipine can cause side effects, although not everybody gets them. Tell your doctor immediately if you experience any of the following symptoms after taking this medicine.
Although they are very rare, the symptoms can be severe.
•Sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).
The following Common side-effects have been reported. If any of these cause you problems or if they last for more than one week, you should contact your doctor |
| How to Store the
Medicine
|
| How to Store the Medicine |
Keep out of the reach and sight of children.
Do not store above 25oC.
Do not use your medicine after the expiry date which is stamped on the pack. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via wastewater of 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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