EGIRAMLON. 5 mg. 5 mg. 30 capsules
EGIRAMLON. 5 mg. / 5 mg. 30 capsules
EGIRAMLON WHAT IS AND WHAT IT IS USED
Egiramlon contains two active substances called ramipril and amlodipine. Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin converting enzyme) while Amlodipine belongs to a group of medicines called calcium channel blockers.
Ramipril works by:
Reduce your body's production substances which can increase blood pressure;
Helps to relax and widen your blood vessels;
Helps the heart easier to pump blood around your body.
Amlodipine acts as:
Relax and widen your blood vessels.
Egiramlon can be used for the treatment of high blood pressure (hypertension) in patients who are adequately controlled with different products simultaneously administered at the same dose levels as in combination, but as separate tablets.
2. BEFORE YOU TAKE EGIRAMLON
Do not take Egiramlon
if you are allergic (hypersensitive) to ramipril, amlodipine (active substances), another calcium channel blocker of the dihydropyridine type drugs or ACE inhibitors, or any of the other ingredients of Egiramlon listed in section 6;
Signs of an allergic reaction may include rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue;
if you have severe narrowing of the outflow tract of the left ventricle (eg high grade aortic stenosis);
if you have ever had a serious allergic reaction called "angioedema." The signs include itching, hives (urticaria), red spots on 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. Depending on the equipment, treatment Egiramlon may not be suitable for you;
if you have kidney problems where the blood supply to the kidneys is reduced (renal artery stenosis);
If your blood pressure is abnormally low or unstable. Your doctor needs to assess this.
Do not take Egiramlon if any of the above applies to you. If you are not sure, ask your doctor before taking Egiramlon.
Take special care with Egiramlon
Ask your doctor or pharmacist before taking your medicine:
if you are elderly;
if you have heart, liver or kidney problems;
If you have lost a lot of body salts or fluids (through vomiting, diarrhea, sweating more than usual, if you are on a diet low in salt if you are taking diuretics (water pills) for a long time or you were dialziza);
if treatment is to go to reduce allergy to bee stings or wasp (desensitization);
if you will be given anesthesia. This can be given for surgery or dental procedures. You may need to stop treatment with Egiramlon the day before; Check with your doctor;
if you have high amounts of potassium in your blood (detected by blood tests);
if you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus.
If any of these apply to you (or not sure), ask your doctor before taking Egiramlon.
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 (including herbal products). Egiramlon may affect the operation of some other medicines. As some medicines can affect the operation of Egiramlon.
Please tell your doctor if you are taking any of these medicines. They may weaken the effect of Egiramlon:
Medicines used for the relief of pain and inflammation (e.g., nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and acetylsalicylic acid);
Medicines used for the treatment of low blood pressure, shock, heart failure, asthma or allergies such as ephedrine, epinephrine, or norepinephrine. Your doctor will need to check your blood pressure;
Rifampicin (antibiotic used to treat tuberculosis);
St. John's wort (a herbal treatment for depression).
Please tell your doctor if you are taking any of these medicines. They can increase the possibility of the occurrence of side effects if you take them with Egiramlon:
Medicines used for the relief of pain and inflammation (e.g., nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin);
Medicines to treat cancer (chemotherapy);
Medicines used to prevent organ rejection after organ transplants, such as cyclosporine;
Diuretics (water pills) such as furosemide;
Drugs that can increase the amount of potassium in the blood, such as spironolactone, triamterene, amiloride, potassium salts, and heparin (blood thinning);
Steroid medicines for inflammation such as prednisolone;
Allopurinol (used to reduce uric acid in your blood);
Procainamide (for heart rhythm disturbances);
Ketoconazole, itraconazole (used to treat fungal infections);
Erythromycin (antibiotic used to treat bacterial infections);
Ritonavir (used for the treatment of patients infected with HIV);
Diltiazem (for the treatment of certain heart ailments, high blood pressure).
Please tell your doctor if you are taking any of these medicines. They can be influenced by Egiramlon:
Medicines for diabetes, such as oral medications to lower blood sugar and insulin. Egiramlon can lower your blood sugar. Regularly check your blood sugar while taking Egiramlon;
Lithium (for mental health problems). Egiramlon can increase the amount of lithium in your blood. Amount of lithium should be closely monitored by your doctor.
If any of the above applies to you (or not sure), talk to your doctor before taking Egiramlon.
Taking Egiramlon with certain foods and drinks
Drinking alcohol during treatment with Egiramlon may make you feel dizzy or light-headed. If you are concerned about the amount that you can drink while taking Egiramlon, talk to your doctor as medicines used to reduce blood pressure, and alcohol may enhance each other sedative effect.
Egiramlon may also be taken before or after meals.
Pregnancy and lactation
You must tell your doctor if you think you are (or might become) pregnant.
You should not take Egiramlon during pregnancy.
If you become pregnant while taking Egiramlon, tell your doctor immediately.
Before planning pregnancy should be switched to another appropriate treatment.
You should not take Egiramlon if you are breastfeeding.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
You may feel dizzy while taking Egiramlon. This is more likely to occur when taking Egiramlon or a higher dose thereof. If this cluchi, do not drive or operate any tools or machines.
Important information about some of the ingredients of Egiramlon
The capsule shell of a 5 mg / 5 mg capsule 10 mg / 5 mg contains Allura Red AC-FD & C Red 40 (E129) and the shell of the capsule of 5 mg/10 mg capsule of 10 mg/10 mg contains azorubine, Carmoisine (E122). These dyes can cause allergic reactions.
3. HOW TO TAKE EGIRAMLON
Always take Egiramlon exactly as your doctor tells you. If you are not sure, ask your doctor or pharmacist.
Taking this medicine
Take this medicine by mouth at the same time each day, before or after a meal;
Swallow the capsules whole with fluid;
Do not crush or chew the capsules.
How much to take
The usual dose is 1 capsule concentration prescribed by the physician;
Depending on the effect, your doctor may change the dose;
The maximum dose is 1 capsule of 10 mg/10 mg once daily.
Liver and kidney disease
In hepatic and renal disease, doses can be changed.
Your doctor will reduce the initial dose and adjust your dose slowly.
In patients with very advanced age and frail health, the application of Egiramlon capsules is not recommended.
Children and adolescents
Egiramlon not recommended for use in children and adolescents below 18 years due to lack of data on safety and efficacy.
If you believe that the therapeutic effect of the drug is too strong or too weak, talk to your doctor.
If you take more dose Egiramlon
Seek a doctor or go to the nearest hospital casualty department. Do not drive to the hospital and find someone else to take you, or call for an ambulance. Take the medicine pack with you. This is necessary to enable a doctor to find out what you have taken.
If you forget to take Egiramlon
If you forget to take a dose, take your normal dose when the next intake. Do not take a double dose to make up for a forgotten capsule.
If you stop taking Egiramlon
Do not stop taking the drug abruptly or change the prescribed dose before consulting your doctor, as in such cases, your condition may temporarily worsen.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Egiramlon can cause side effects, although not everybody gets them.
Stop taking Egiramlon and call your doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:
swelling of the face, lips or throat, making it difficult to swallow or breathe, as well as itching and rashes. This may be a sign of a severe allergic reaction to Egiramlon;
severe skin reactions including rash, mouth ulcers, worsening of skin disease, redness, blistering or detachment of skin (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme).
Immediately tell your doctor if you have:
Rapid heartbeat, irregular or increased heart beat (palpitations), chest pain, chest tightness or more serious problems, including heart attack or stroke;
Shortness of breath or cough. These may be signs of lung problems;
Easier bruising, bleeding that lasts longer than usual, any signs of bleeding (eg, bleeding gums), formation of purple skin patches or easier to develop infections than usual, sore throat and fever, fatigue , nausea, dizziness, paleness of the skin. These may be signs of problems with blood or bone marrow;
Acute pain in the stomach, which can reach up to the back. This may be a sign of inflammation of the pancreas (pancreatitis);
Fever, chills, fatigue, lack of appetite, stomach pain, discomfort, yellowing of the skin or eyes (jaundice). These may be signs of liver problems such as inflammation of the liver (hepatitis) or liver damage.
Other side effects include:
Please tell your doctor if any of these effects gets serious or lasts more than a few days.
Common (affects 1 to 10 users in 100):
drowsiness (especially at the beginning of treatment);
palpitations (awareness of heartbeat), flushing;
swelling of the ankles (edema);
headache or fatigue;
dizziness. More likely to appear at the beginning of taking Egiramlon or a higher dose of it;
fainting, hypotension (very low blood pressure), especially when standing up quickly from a sitting or lying position;
dry, irritating cough, inflammation of the sinuses (sinusitis) or bronchitis, shortness of breath;
pain in stomach or abdomen, diarrhea, indigestion, nausea or vomiting;
skin rash, with or without raised areas;
cramps or muscle pain;
results of blood tests showing more potassium than usual in your blood.
Uncommon (affects 1 to 10 of 1000 users):
mood swings, insomnia;
visual disturbance (including diplopia), ringing in the ears;
sneezing / runny nose;
changes in bowel movements (including diarrhea and constipation);
increased need to urinate, especially at night; inability to obtain an erection;
gain or weight loss;
breast enlargement in men;
balance problems (vertigo);
itching and abnormal sensation of the skin, such as perception, numbness, tingling, burning or bumps on the skin (paresthesia);
loss or change in taste sensation;
depression, anxiety, more nervous than usual or anxiety;
stuffy nose, difficulty breathing or worsening of asthma;
swelling in the intestines, which is called "intestinal angioedema" and manifestation of symptoms such as abdominal pain, vomiting and diarrhea;
heartburn, constipation, or dry mouth;
more frequent urination during the day than usual;
sweating more than usual;
lack or loss of appetite (anorexia);
fast or irregular heartbeat;
swelling of the hands and feet. This may be a sign that your body retains more water than usual;
castration in men, decreased libido in men or women;
increased number of certain white blood cells (eosinophilia) found in blood tests;
results of blood tests showing changes in the liver, pancreas or kidneys;
Rare (affects 1 to 10 of 10 000 users):
a feeling of uncertainty or confusion;
redness and swelling of the tongue;
severe flaking or peeling of the skin, itchy raised spots;
nail problems (eg fall or peel off nail);
rash or bruising of the skin;
spots on the skin and cold extremities;
redness, itching, swelling or watering of the eyes;
blood tests, which show low numbers of red blood cells, white blood cells or platelets, or a reduced amount of hemoglobin.
Very rare (affects less than 1 in 10,000 users):
too high level of sugar in the blood;
inflammation of the pancreas;
inflammation of the liver, yellowing of the skin (jaundice);
more sensitive to sunlight than usual;
swelling of the gums.
Other reported adverse reactions (frequency not known):
Please tell your doctor if any of these effects gets serious or lasts more than a few days.
inflammation of the lining of the mouth with sores;
results of blood tests showing too low number of blood cells in your blood;
results of blood tests showing a low level of sodium in your blood than usual;
discoloration of the fingers and feet in cold, then tingling sensation or pain when warming (Raynaud's phenomenon);
delayed or impaired reactions;
change in sense of smell;
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE EGIRAMLON
Keep out of reach of children.
Do not store above 30 ° C.
Store in the original package to protect from moisture.
Egiramlon not use after the expiry date stated on the carton (year / month) the date refers to the last day of that month.
Do not use Egiramlon if you notice any signs of damage (eg, discoloration).
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.
6. FURTHER INFORMATION
What does Egiramlon
The active substances are:
Egiramlon 2,5 mg / 2,5 mg capsules: 2,5 mg 2,5 mg of ramipril and amlodipine in each capsule;
Egiramlon 5 mg / 5 mg capsules: 5 mg of ramipril and 5 mg of amlodipine in each capsule;
Egiramlon 5 mg/10 mg capsules: 5 mg of ramipril and 10 mg of amlodipine in each capsule;
Egiramlon 10 mg / 5 mg capsules: 10 mg of ramipril and 5 mg of amlodipine in each capsule;
Egiramlon 10 mg/10 mg capsules: 10 mg of ramipril and 10 mg of amlodipine in each capsule.
Other ingredients are:
titanium dioxide (E171) (2,5 mg / 2,5 mg, 5 mg / 5 mg, 5 mg/10 mg, 10 mg / 5 mg, 10 mg/10 mg);
gelatin (2,5 mg / 2,5 mg, 5 mg / 5 mg, 5 mg/10 mg, 10 mg / 5 mg, 10 mg/10 mg);
iron oxide red (E172) (2,5 mg / 2,5 mg, 5 mg/10 mg, 10 mg / 5 mg);
brilliant blue FCF-FD & C Blue 1 (E133) (5 mg / 5 mg, 10 mg / 5 mg);
Allura Red AC-FD & C Red 40 (E129) (5 mg / 5 mg, 10 mg / 5 mg);
Azorubine, Carmoisine (E122) (5 mg/10 mg, 10 mg/10 mg);
indigotine - FD & C Blue 2 (E132) (5 mg/10 mg, 10 mg/10 mg).
Egiramlon looks like and contents of pack
Egiramlon 2,5 mg / 2,5 mg hard capsules: no markings, self-closing type "Coni Snap", size 3 hard gelatin capsules with opaque body and pale pink opaque cap in pale pink, full white or almost white granular powder;
Egiramlon 5 mg / 5 mg hard capsules: no marking