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Tamayra 10 mg. / 5 mg. 28 tablets

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What Tamayra is and what it is used for
Tamara contains two active substances: ramipril and amlodipine. Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors). Amlodipine belongs to a group of medicines called calcium antagonists.

Ramipril acts as:

reduces the formation of substances in the body that can increase blood pressure;
causes relaxation and expansion of blood vessels;
facilitates the pumping of blood from the heart to the whole body.
Amlodipine acts as:

relaxes and expands blood vessels, so blood circulation facilitates.
Tamara is used to treat hypertension (high blood pressure) in adult patients whose blood pressure is well controlled with amlodipine and ramipril, given at the same doses as Tamaira but as separate medicines.

2. What you need to know before taking Tamara
Do not take Tamayra:

if you are allergic to ramipril, amlodipine (s), other ACE inhibitors or some other calcium antagonists or any of the other ingredients of this medicine (listed in section 6). The allergic reaction may appear as itching, reddening of the skin or difficulty in breathing;
if you have ever had a serious allergic reaction called angioedema. 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 in breathing and swallowing;
if you are on dialysis or any other type of blood filtration. Depending on the equipment used, Tamayra may not be suitable for you;
if you have kidney problems due to reduced blood supply to the kidneys (renal artery stenosis);
during the last 6 months of pregnancy (see section "Pregnancy, breast-feeding and fertility" below);
if you have diabetes or have impaired kidney function and are being treated with a blood pressure lowering medication containing aliskiren;
if your blood pressure is abnormally low or unstable. Your doctor needs judgment;
if you have narrowing of the heart aortic valve (aortic stenosis) or cardiogenic shock (a condition where your heart can not deliver enough blood to the body);
if you suffer from heart failure after a heart attack.
Do not take Tamara if any of the above conditions apply to you. If you are not sure, ask your doctor before taking Tamaira.

Warnings and precautions
Talk to your doctor before taking Tamira. Tell your doctor if any of the following conditions apply to you:

if you have problems with your heart, liver or kidneys;
if you have lost plenty of body fluids or salts (due to vomiting, diarrhea, more abundant sweating than usual, a low-salt diet, diuretics (long-term) or dialysis);
if you are going to treat an allergy to bee or axle sting (desensitization);
if you experience anesthesia in an operative or dental procedure. You may need to stop your treatment with Tamari one day earlier, ask your doctor for advice;
if you have elevated potassium in the blood (which is detected by a blood test);
if you have collagen vascular disease (scleroderma or systemic lupus erythematosus);
if you are taking any of the following medicines used to treat high blood pressure:
angiotensin II receptor blocker (also known as sartan - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems associated with diabetes;
if you have had a hypertonic crisis (rapid increase in blood pressure);
if you are elderly and your dose should be increased;
if you get a dry cough that lasts for a long time;
if your blood pressure is not low enough. These drugs are less effective in black patients;
if you are pregnant, it is not recommended during the first trimester and is contraindicated during the second and third trimesters of pregnancy.
Your doctor may periodically check your kidney function, your blood pressure, and the electrolyte (eg potassium) values in your blood. See also the information under the heading "Do not take Tamara".
At any time of treatment, a severe allergic reaction may occur, which occurs with a sudden swelling of the lips and face, tongue and throat, neck, possibly also on the hands and feet, difficulties in swallowing or breathing, urticaria or hoarseness (angioedema). Black patients may have a higher risk of developing such a condition. If you experience such symptoms, you should tell your doctor immediately.

Children and adolescents
Tamara is not recommended for use in children and adolescents under 18 because of the lack of information in this population.

Other drugs and Tamara
Tell your doctor or pharmacist if you are using, have recently used or are likely to use other medicines.

Tell your doctor if you are taking any of these
vildagliptin (for the treatment of type 2 diabetes);
temsirolimus (chemotherapy);
medicines used to prevent organ rejection after transplantation, such as ciclosporin;
everolimus (for prophylaxis of graft rejection);
tacrolimus (used to control the immune response that allows your body to accept the transplanted organ);
diuretics (drainage tablets), for example furosemide;
medicines that can increase the level of potassium in the blood, for example spironolactone, triamterene, amiloride, potassium salts and heparin (for blood thinning);
steroidal anti-inflammatory drugs, for example prednisolone;
allopurinol (used to reduce uric acid in the blood);
procaine (in heart rhythm disorders);
ketoconazole, itraconazole (antifungal medicines);
ritonavir, indinavir, nelfinavir (so-called protease inhibitors for HIV treatment);
trimethoprim and co-trimoxazole (for infections caused by bacteria);
clarithromycin (for infections caused by bacteria);
verapamil, diltiazem (medicines to treat heart disease or high blood pressure);
dactrolene (infusion at serious abnormalities in body temperature).
Your doctor may change the dose or take other precautions.
If you are taking angiotensin II receptor blocker (ALB) or aliskiren, see the information under the heading "Do not take Tamara" and "Warnings and precautions".
Please tell your doctor if you are taking any of the following medicines whose effects can be changed by Tamayra:

diabetes medicines, such as oral glucose lowering drugs. Tamara can lower your blood sugar. Check your blood sugar levels carefully while taking Tamara;
lithium (for mental problems). Tamara can increase the amount of lithium in the blood. The amount of lithium should be closely monitored by your doctor;
simvastatin (a cholesterol lowering drug). Tamara can 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 Tamaira.

Tamara with food, drinks and alcohol
Tamara can be taken with or without food.
Drinking alcohol with Tamayra can make you feel dizzy or dizzy. Talk to your doctor about how much you can drink while taking Tamaira, as medicines used to lower blood pressure and alcohol can have complementary effects.
Grapefruit or grapefruit juice should not be consumed by people taking Tamara as they lead to an increase in blood levels of the active ingredient amlodipine, which may cause an unpredictable fall in blood pressure.

Pregnancy, breastfeeding and fertility
If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

You should not take Tamara during pregnancy.
If you become pregnant while taking Tamaira, tell your doctor immediately. In a planned pregnancy, treatment should be replaced in advance by another appropriate treatment.

You should not take Tamira if you are breast-feeding.
You should talk to your doctor before taking any medicine.

There is insufficient data on the potential effect on fertility.

Driving and using machines
Tamara can affect your ability to drive and use machines. If Tamaira makes you feel nausea, dizziness or fatigue, or causes you headaches, do not drive or operate machinery, and contact your doctor immediately. This can happen especially at the beginning of treatment or during the passage of this medicine from treatment with other drugs.

3. How to take Tamira
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
If you have the feeling that the Tamaira effect is too strong or too weak, talk to your doctor or pharmacist.
Take this medicine orally at the same time each day, before or after a meal. Swallow the capsules whole with liquid.
Do not take Tamara with grapefruit juice.
Tamara should be given once a day.
The doctor may change the dose depending on the effect of the drug.
The maximum daily dose is one 10 mg / 10 mg capsule.

This product is not available with 10 mg / 10 mg active substances but may be available from other Marketing Authorization Holders.
Your doctor will reduce the initial dose and will adjust the treatment more slowly.

Use in children and adolescents
Tamara is not recommended for children and adolescents under 18 because there is no information available in this population.

If you take more Tamara than you should
Taking too many capsules can cause a decrease in blood pressure even at an unsafe level. You may experience dizziness, dizziness, tiredness or weakness. If the fall in blood pressure is very severe, shock may occur. You may feel your skin cold and damp and lose consciousness. Talk to a doctor or go straight to the nearest emergency medical center. Do not drive to the hospital, ask someone else to take you or call an ambulance. Take the medicine pack with you so the doctor can understand what you have taken.

If you forget to take Tamira
If you forget to take a capsule, skip this dose completely. Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Tamara
Your doctor will advise you how long to take your medicine. Your condition may get worse if you stop taking the medicine before you are advised about it.

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 everyone gets them.

Stop taking Tamara and seek a doctor immediately if you notice any of the following serious side effects - you may need urgent medical treatment:

swelling of the face, lips or throat that hinder swallowing or breathing, as well as itching and rash. This may be a sign of a severe allergic reaction to Tamara;
severe skin reaction including rash, mouth sores, worsening of existing skin condition, redness, blistering or skin peeling (eg Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme) or other allergic reactions.
Frequently, the side effects listed above are classified as' unknown '(can not be estimated from the available data).'

Contact a doctor immediately if you get:

increased heart rate, irregular or excessive palpitation, chest pain, tightness in the chest or more serious problems including heart attack and stroke. Frequently these side effects are common (chest pain, chest tightness, palpitations) or uncommon (accelerated heart rhythm, heart attack or stroke);
shortness of breath or cough. These are common side effects. These may be signs of such problems;
(eg bleeding from the gums), purple spots covering the skin, or more susceptibility to infections, sore throat and fever, feeling tired, dizzy or pale skin. These may be signs of blood or bone marrow problems. These are rare side effects;
severe stomach pain that can spread to the back. This may be a sign of pancreatitis (inflammation of the pancreas). This is an uncommon side effect;
fever, chills, fatigue, loss of appetite, stomach pain, nausea, yellowing of the skin or eyes (jaundice). These may be signs of liver problems such as hepatitis (inflammation of the liver) or hepatic impairment. These side effects are not known (can not be estimated from the available data).
Other side effects include:
Please tell your doctor if any of these side effects become serious or continue for more than a few days.
Common (may affect 1 to 10 people):

drowsiness (especially at the beginning of treatment);
palpitations (feeling of heart beat), redness;
swelling of the ankles (edema);
headache or feeling tired;
feeling dizzy. It is more likely to happen at the onset of Tamira or when the dose is increased;
seizures, hypotension (abnormally low blood pressure), especially when suddenly standing up from a lying or sitting position;
dry irritable cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath;
abdominal pain, stomach or intestinal pain, diarrhea, indigestion, nausea or vomiting;
skin rash with or without edema;
chest pain;
muscle stiffness or pain in them;
blood tests showing elevated blood potassium levels.
Uncommon (may affect up to 1 in 100 people):

mood swings, insomnia;
trembling, weakness, pain, fainting;
visual disturbances, double vision, blurred vision, tinnitus;
sneezing / rash caused by inflammation of the lining of the nose (rhinitis);
changes in rhythm of the stomach (including diarrhea or constipation), heartburn, dry mouth;
hair loss, increased sweating, skin pruritus, red spots on the skin, change in skin color;
How to Store Tamayra
This product does not require special storage conditions.
Store in the original package in order to protect from light.
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP" and "EXP". The expiry date refers to the last day of that month.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information
What is Tamayra?
The active substances are:

5 mg / 5 mg hard capsules: Each capsule contains 5 mg ramipril and amlodipine besylate equivalent to 5 mg amlodipine.
10 mg / 5 mg hard capsules: Each capsule contains 10 mg ramipril and amlodipine besylate equivalent to 5 mg amlodipine.
The other ingredients are: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinized maize starch, sodium starch glycollate (type A), sodium stearyl fumarate, red iron oxide (E172), titanium dioxide (E171), gelatin.

What the Tamayra looks like and what the package contains
Tamara 5 mg / 5 mg hard capsules have an opaque pink latch and an opaque white body.
Capsule contents: white to off-white powder.
Tamara 10 mg / 5 mg hard capsules have an opaque dark pink latch and an opaque white body.
Capsule contents: white to off-white powder.

Tamayra is available in blisters containing 28 or 30 capsules.
Not all pack sizes may be marketed.

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