Kaldera 75 mg. 14 tablets


Kaldera contains clopidogrel, which belongs to a group of medicines called antiplatelet medicines. Platelets are very small blood cells that cling to each other in the formation of blood clots.


Kaldera 75 mg. 14 tablets

What Kaldera is and what it is used for

Kaldera contains clopidogrel, which belongs to a group of medicines called antiplatelet medicines. Platelets are very small blood cells that cling to each other in the formation of blood clots. By preventing this clogging, platelet anti-aggregates reduce the risk of blood clots (a process called thrombosis).

KALDERA is used by adults to prevent blood clots (thrombi) forming in the sealed blood vessels (arteries), a process known as atherothrombosis, which causes atherothrombotic events (such as stroke, heart or death).

You have been prescribed Called to prevent blood clots and reduce the risk of these serious incidents because:

You have a condition of arterial thickening (also known as atherothrombosis)
You have a previous heart disease, stroke, or have a condition known as peripheral arterial disease
You have experienced severe chest pain, a condition known as "unstable angina" or "myocardial infarction" (a heart attack). To treat this condition, your doctor may place a stent in the blocked or narrowed arteries to restore blood flow. You should also be given acetylsalicylic acid (a substance found in many medicines used to relieve pain and lower the temperature as well as prevent blood clotting) from your doctor.
You have an irregular heartbeat, a condition called "atrial fibrillation," and you can not take medicines known as "oral anticoagulants" (vitamin K antagonists) that prevent the formation and growth of blood clots. You should know that oral anticoagulants are more effective than acetylsalicylic acid or the combined use of Caldera plus acetylsalicylic acid in this condition. Your doctor should prescribe Caldera plus acetylsalicylic acid if you can not take "oral anticoagulants" and you are not at risk of massive bleeding.
2. What you need to know before you take Caldera

Do not take Kaldera

if you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6);
If you suffer from a condition that is currently causing bleeding, such as a stomach ulcer or hemorrhage in the brain;
If you suffer from severe liver disease.
If you think you may have any of these problems or have any doubts, talk to your doctor before Caldera treatment.
Warnings and precautions
Talk to your doctor or pharmacist before taking Caldera.

If you are at risk of bleeding such as:
a disease that puts you at risk of internal bleeding (such as a stomach ulcer);
have blood disorders that make you prone to internal bleeding (bleeding in the tissues, organs or joints of your body);
recent severe trauma;
recent surgical intervention (including dental);
imminent surgical intervention (including dental) over the next seven days.
If you have had a clot in the brain (an ischemic stroke) that occurred during the last seven days.
If you have kidney or liver disease.
If you have had an allergy or reaction to any of the medicines used to treat your illness.
While you are Caldera:

You should tell your doctor if you have planned surgery (including dental);
You should tell your doctor immediately if you develop a condition (also known as thrombotic thrombocytopenic purpura or TTP), which includes fever and bruising under the skin, which may appear as small red dots, with or without excessive tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects");
If you cut or injure yourself, it may take a little longer than usual to stop bleeding. This is related to how the medicine works to prevent the formation of blood clots. In case of minor cuts and injuries, cutting during shaving, this is usually irrelevant. However, if your bleeding troubles you, you should contact your doctor immediately (see section 4, "Possible side effects").
Your doctor may appoint blood tests.
Children and adolescents
Do not give this medicine to children because it has no effect.

Other Medicines and Caldera
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medications may affect Caldera and vice versa.

You must inform your doctor if you are taking

oral anticoagulants, medicines used to reduce blood clotting;
non-steroidal anti-inflammatory drugs commonly used to treat painful and / or inflammatory conditions of the muscles or joints;
heparin or other injectable drug used to reduce
selective serotonin reuptake inhibitors (including but not limited to fluoxetine or foupexamin), drugs commonly used to treat depression;
moclobemide, a medicine to treat depression.
If you have experienced severe chest pain (unstable angina or myocardial infarction), you may be given Caldera in combination with acetylsalicylic acid, a substance found in many medicines used to relieve pain and lower fever. Incidental use of acetylsalicylic acid (not more than 1,000 mg every 24 hours) would not be a problem, but prolonged use in other circumstances should be discussed with your doctor.

Kaldera with food and beverages
Kaldera can be taken with or without food.

Pregnancy and breastfeeding
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.

Kaldera is not recommended during pregnancy and lactation.

If you become pregnant while taking Caldera, talk to your doctor as clopidogrel is not recommended during pregnancy.

You should not breast-feed while taking this medicine.

Driving and using machines
Caldera is unlikely to affect the ability to drive and use machines.

Kaldera contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars (eg lactose), contact your doctor before taking this medicinal product.

Kaldera contains castor oil, hydrogenated.
It can cause stomach upset or diarrhea.

3. How to take Kaldera
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

If you have had severe chest pain (unstable angina or heart attack), your doctor may prescribe 300 mg Caldera (4 tablets of 75 mg) once at the start of treatment. The recommended dose is then a 75 mg Caldera tablet daily taken orally with or without food at the same time each day.

You should take Caldera until your doctor prescribes it to you.

If you take more Caldera than you should
Contact your doctor or go to the emergency room of the nearest hospital due to a risk of bleeding.

If you forget to take Caldera
If you forget to take the Caldera dose but remember within 12 hours after your usual time, take your tablet immediately and then take the next one at the usual time. If you have forgotten for more than 12 hours, just take the next single dose at the usual time. Do not take a double dose to make up for the missed tablet.

If you stop taking Kaldera
Do not stop treatment unless your doctor tells you. Contact your doctor or pharmacist before stopping taking.

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.

Contact your doctor immediately if you feel:

fever, signs of infection, excessive fatigue. This may be due to a reduced number of some blood cells;
signs of liver problems such as yellowing of the skin and / or eyes (jaundice), whether or not bleeding occurs under the skin like small red spots and / or confusion (see section 2 "Warnings and Precautions")
swelling of the mouth or skin disorders such as rashes and itching, blistering of the skin. These may be signs of an allergic reaction.
The most common side effect reported with clopidogrel is bleeding.
Bleeding may occur such as bleeding from the stomach or intestine, bruising, hematoma (abnormal bleeding or bruising under the skin), bleeding from the nose, blood in the urine. Bleeding from the eyes, including head, lungs or joints, has been reported in rare cases.

If you experience prolonged bleeding when you take Caldera
If you cut or injure yourself, it may take a little longer than usual for stopping bleeding. This effect is related to the mode of action of the drug as it reduces the ability of the blood to clot. In case of minor cuts and injuries, cutting during shaving, this is irrelevant. However, if you have any doubts, you should contact your doctor immediately (see "Warnings and Precautions").

Other side effects include:
Common side effects (may affect up to 1 in 10 people)

Diarrhea, abdominal pain, indigestion or heartburn
Uncommon side effects (may affect up to 1 in 100 people):

Headache, stomach ulcer, vomiting, nausea, constipation, stomach or intestinal gas, rash, itching, dizziness, tingling sensation and numbness.
Rare side effects
How to Store Kaldera

Keep this medicine out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light and moisture.

Do not use this medicine if you notice a product quality violation.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of your unnecessary medicines. These measures will help to protect the environment.

6. Package Contents and Additional Information

What Kaldera contains

The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel.
The other ingredients are mannitol, anhydrous lactose, microcrystalline cellulose, colloidal anhydrous silica, butylhydroxyanisole, partially pregelatinised starch 1500 (corn starch), hypromellose, ascorbic acid and hydrogenated castor oil, core tablet, and hydroxypropylcellulose, hypromellose, macrogol 8000, red iron dioxide (E172) and titanium dioxide (E171) in the tablet coating.
What Caldera looks like and what the package contains
Caldera tablets are reddish, round, film-coated tablets.

Cartons containing 10, 14, 28, 30, 56, 84, 90, 98, 100, 126, 154 or 184 tablets placed in Al / Al blisters or AL / PVC / PVDC blisters or in Al / PVC- PVDC blisters.

Not all packs may be marketed.



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