Ramipril Amlodipin 5 mg/5 mg 28 capsules
Ramipril / Amlodipine Zentiva contains two active ingredients: ramipril and amlodipine. Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin converting enzyme). Amlodipine belongs to a group of medicines called calcium channel blockers.
Ramipril works by:
decreases production of substances in the body, which can increase blood pressure;
causing expansion and relaxation of blood vessels;
facilitates pumping of blood from the heart to your whole body.
Amlodipine acts as:
It relaxes and dilates blood vessels so that blood flow is facilitated.
Ramipril / Zentiva Amlodipine is used to treat hypertension (high blood pressure) in patients whose blood pressure is well controlled with amlodipine, ramipril and implemented simultaneously in the same doses as in the ramipril / Amlodipine Zentiva, but as separate medicines.
2. What you need to know before taking Ramipril / Amlodipine Zentiva
Do not take Ramipril / Amlodipine Zentiva:
if you are allergic to ramipril, amlodipine (active substances), other drugs ACE inhibitors or other calcium antagonists, or any of the other ingredients of this medicine (listed in section 6). This may be itching, reddening of the skin and difficulty breathing;
if you have ever had a serious allergic reaction called "angioedema." The signs include itching, hives (urticaria), redness of the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing;
if you are on dialysis or any other type of blood filtration Ramipril / Amlodipine Zentiva is not suitable for the used equipment;
If you have kidney problems due to reduced blood flow to the kidneys (renal artery stenosis);
during the last six months of pregnancy (see. section "Pregnancy and breast-feeding 'below);
if have diabetes or impaired kidney function and you are treated for high blood pressure with aliskiren;
if your blood pressure is abnormally low or unstable. An assessment of your doctor;
if you have narrowing of the heart aortic valve (aortic stenosis) or cardiogenic shock (a condition in which your heart can not supply enough blood to the body);
if you suffer from heart failure after a heart attack.
Do not take Ramipril / Amlodipine Zentiva if something from above apply to you. If you are not sure, talk to your doctor before taking Ramipril / Amlodipine Zentiva.
Warnings and Precautions
Talk to your doctor before taking Ramipril / Amlodipine Zentiva. Inform your doctor if any of the following apply to you:
if you have heart problems, liver or kidney;
If you have lost a lot of body salts or fluids (through vomiting, diarrhea, sweating more profusely than usual, if you are on a diet low in salt; if you are taking diuretics (water tablets) for a long time or having had dialysis);
if forthcoming treatment of allergy to stings from bees or wasps (desensitization);
if it stands anesthesia in operating or dental procedure. It may need to stop treatment with Ramipril / Amlodipine Zentiva one day earlier, ask your doctor for advice;
if you have increased blood potassium (in blood tests);
if you're sick of collagen (scleroderma or systemic lupus);
if you are taking aliskiren to treat high blood pressure;
if you had a hypertensive crisis (fast serious increase in blood pressure);
if you are elderly and your dose needs to be increased;
if you have a dry cough that lasts a long time;
if your blood pressure is not reduced enough. These drugs are less effective in black patients.
At any time during the treatment may occur a severe allergic reaction that occurs with acute swelling of the lips and face, tongue and throat, neck, possibly also hands and feet, difficulty swallowing or breathing, hives or hoarseness ( 'angioedema "). Black people may have a higher risk of this condition. If you get these symptoms, you should inform your doctor immediately.
Children and adolescents
Ramipril / Amlodipine Zentiva is not recommended for use in children and adolescents below 18 years since there is no information available in this population.
Other medicines and Ramipril / Amlodipine Zentiva
Tell your doctor or pharmacist if you are using, have recently used or might use other drugs.
Tell your doctor if you are taking any of these drugs. They can disrupt the operation of Ramipril / Amlodipine Zentiva:
drugs used to relieve pain and inflammation (e.g., nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indomethacin, aspirin);
drugs used for the treatment of low blood pressure, shock, heart failure, asthma or allergies such as ephedrine, noradrenaline or adrenaline. It will be necessary for your doctor to check your blood pressure;
rifampicin (an antibiotic used to treat tuberculosis);
St. John's Wort (used to treat depression).
Tell your doctor if you are taking any of these drugs. They can increase the chance of getting side effects if you take them with Ramipril / Amlodipine Zentiva:
drugs used to relieve pain and inflammation (eg. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indomethacin, acetylsalicylic acid);
drugs for the treatment of cancer (chemotherapy);
drugs used to prevent organ rejection after transplantation as ciclosporin;
diuretics (water tablets), e.g., furosemide and other drugs which may lower blood pressure, such as aliskiren;
drugs which can increase potassium levels in the blood such as spironolactone, triamterene, amiloride, potassium salts and heparin (blood thinning);
steroidal anti-inflammatory drugs such as prednisolone;
allopurinol (used to lower the uric acid in the blood);
procainamide (for heart rhythm disorders);
ketoconazole, itraconazole (antifungal medicines);
ritonavir, indinavir, nelfinavir (m. called. protease inhibitors for the treatment of HIV / AIDS);
erythromycin, clarithromycin (antibiotics);
verapamil, diltiazem (medicines for the treatment of heart disease or high blood pressure);
dantrolene (infusion for serious abnormal body temperature).
Tell your doctor if you are taking any of these drugs, whose action can be changed by Ramipril / Amlodipine Zentiva:
diabetes drugs, such as oral glucose-lowering medications and insulin. Ramipril / Amlodipine Zentiva can reduce the amount of your blood sugar. Check your blood sugar carefully while taking Ramipril / Amlodipine Zentiva;
lithium (for mental health problems). Ramipril / Amlodipine Zentiva may increase the amount of lithium in your blood. The amount of lithium must be closely monitored by your doctor;
simvastatin (a medicine for lowering cholesterol). Ramipril / Amlodipine Zentiva may increase the amount of simvastatin in your blood.
If any of the above applies to you (or you are not sure), talk to your doctor before taking Ramipril / Amlodipine Zentiva.
Ramipril / Amlodipine Zentiva with food, drinks and alcohol
Ramipril / Amlodipine Zentiva can be taken with or without food.
Drinking alcohol with Ramipril / Amlodipine Zentiva can cause you to feel dizzy or primaleli. Discuss with your doctor how much you should drink while you are taking Ramipril / Amlodipine Zentiva as drugs used to lower blood pressure and alcohol can have complementary effects.
Grapefruit juice or grapefruit should not be consumed by people taking Ramipril / Amlodipine Zentiva, because they lead to an increase in the blood of the active ingredient amlodipine, which can cause unpredictable lowering of blood pressure.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
You should not take Ramipril / Amlodipine Zentiva during pregnancy.
If you become pregnant while taking Ramipril / Amlodipine Zentiva, tell your doctor immediately. A planned pregnancy therapy should be replaced by a suitable alternative.
You should not take Ramipril / Amlodipine Zentiva if you are breastfeeding.
You should talk to your doctor before taking any medicine.
There are no adequate data on the potential effect on fertility.
Driving and using machines
Ramipril / Amlodipine Zentiva can affect your ability to drive and use machines. If Ramipril / Amlodipine Zentiva makes you feel sick, dizzy or tired, or cause you headaches, do not drive or operate machinery and contact your doctor immediately. This can occur especially at the beginning of the treatment, or after switching to the other preparations.
3. How to take Ramipril / Amlodipine Zentiva
Always take this medicine exactly as your doctor has told you. If you're not sure, ask your doctor or pharmacist.
If you feel that the effect of Ramipril / Amlodipine Zentiva is too strong or too weak, talk to your doctor or pharmacist.
Take this medicine by mouth at the same time each day, before or after meals.
Swallow the capsules whole with liquid.
Do not take Ramipril / Amlodipine Zentiva with grapefruit juice. Ramipril / Amlodipine Zentiva should not be administered once daily. The physician may adjust the dose, depending on the effect of the drug. The maximum daily dose is one capsule of 10 mg / 10 mg.
Your doctor will recommend a small initial dose and a slow correction of the treatment.
Use in children and adolescents
Ramipril / Amlodipine Zentiva is not recommended in children and adolescents under the age of 18 as there is no information available in this population.
If you take more dose of Ramipril / Amlodipine Zentiva
Taking too many capsules may cause a reduction in blood pressure. It may feel dizziness, vertigo, fatigue or weakness. If the drop in blood pressure is very severe, may occur shock. It may feel your skin cold and damp and lose consciousness. Talk to your doctor or go immediately to the nearest emergency medical care. Do not drive to the hospital, ask someone else to take you or call for an ambulance. Take the medicine pack with you to the doctor to understand what you have taken.
If you forget to take Ramipril / Amlodipine Zentiva
If you forget to take medication, take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
If you stop taking Ramipril / Amlodipine Zentiva
Your doctor will advise you how long to take your medicine. Your condition may return if you stop taking your medicine before you are advised to do so.
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 everybody gets them.
Stop taking Ramipril / Amlodipine Zentiva and contact your physician immediately if you notice any of the following serious side effects - you may need urgent medical treatment:
Swelling of the face, lips or throat which make it difficult to swallow or breathe, as well as itching and rash. This may be a sign of a severe allergic reaction to Ramipril / Amlodipine Zentiva;
Severe skin reactions including rash, mouth ulcers, worsening of pre-existing skin disease, reddening, blistering or peeling of the skin (eg. Syndrome Stevens-Johnson, toxic epidermal necrolysis and erythema multiforme) or other allergic reactions.
The frequency of the above noted side effects is classified as unknown (can not be estimated from the available data).
Immediately contact your doctor if you experience:
Increased heart rate, uneven or forceful heartbeat (palpitations), chest pain, tightness in the chest or more serious problems including heart attack and stroke. The incidence of these adverse reactions were common (chest pain, tightness in the chest, palpitations) or uncommon (rapid heart rate, heart attack or stroke);
Shortness of breath or cough. These are common side effects. These may be signs of lung problems;
Easier bruising, prolonged bleeding than normal, any sign of bleeding (eg. Bleeding gums), purple spots blotching on the skin; easier succumbing to infections, sore throat and fever, feeling tired, dizzy or having pale skin. These may be signs of problems with the blood or bone marrow. These are rare side effects;
Severe stomach pain which may spread to the back. This may be a sign of pancreatitis (inflammation of the pancreas). This is an uncommon side effect;
Fever, chills, tiredness, loss of appetite, abdominal pain, nausea, yellowing of skin or eyes (jaundice). These may be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage. The frequency of these adverse effects is not known (can not be estimated from the available data).
Other side effects include:
Tell your doctor if any of the following gets serious or lasts longer than a few days.
Common (may affect 1 to 10 people):
Sleepiness (especially at the beginning of treatment);
Palpitations (awareness of the heartbeat), flushing;
Swelling of the ankles (edema);
Headache or fatigue;
Feeling dizzy. More likely to happen when you start taking Ramipril / Amlodipine Zentiva or when increasing the dose;
Fainting, hypotension (abnormally low blood pressure), especially when you stand up from a lying or sitting position;
Dry irritating cough, inflammation of the sinuses (sinusitis) or bronchitis, shortness of breath;
Abdominal pain, stomach or intestinal pain, diarrhea, indigestion, nausea or vomiting;
Skin rash with or without swelling;
Cramps or muscle pain;
Blood tests showing elevated levels of potassium in the blood.
Uncommon (may affect up to 1 in 100 people):
mood swings, insomnia;
tremor, weakness, pain, nausea;
visual disturbances, double vision, blurred vision, ringing in the ears;
sneezing / runny nose caused by inflammation of the lining of the nose (rhinitis);
a change in the normal peristalsis of the intestine (including diarrhea or constipation), heartburn, dry mouth;
hair loss, increased sweating, itchy skin, red spots on the skin, discoloration of the skin;
abnormal urination, frequent urination at night, increased urinary frequency;
inability to produce an erection, sexual inability in men, reduced sexual desire in men or women;
discomfort or breast enlargement in men;
joint or muscle pain, muscle cramps, back pain;
increase or decrease in body weight;
balance disorders (vertigo);
itching and abnormal skin sensations such as numbness, tingling, pricking, burning or creeping on your skin (paresthesia), loss of feeling pain;
loss or change of taste;
feeling depressed, anxious, more nervous or shaky than usual;
stuffy nose, difficulty breathing or worsening of asthma;
swelling in your gut called "intestinal angioedema" presenting with symptoms like abdominal pain, vomiting and diarrhea;
Loss or reduction of appetite (anorexia);
fast or irregular heartbeat;
swollen hands or feet. This may be a sign to retain more fluid in the body;
An increased number of certain white blood cells (eosinophilia), detected in blood tests;
Blood tests showing changes in the function of the liver, pancreas or kidneys.
Rare (may affect up to 1 in 1000 people):
feelings of uncertainty or confusion;
red and swollen tongue;
severe flaking or peeling of the skin, itchy, bumpy rash;
Nail problems (eg loss or separation of the nail from the nail bed);
skin rash or bruising;
patches on the skin and cold extremities;
red, itchy, swollen or watery eyes;
blood tests showing a reduction in red blood cells, white blood cells or platelets or the amount of hemoglobin.
Very rare (may affect up to 1 in 10,000 people):
more sensitive to sunlight than usual;
high blood sugar (hyperglycemia);
swelling of the gums;
impaired liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice);