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Paratram

PARATRAM
Content:

Per FCT: Tramadol HCl 37.5 mg, paracetamol 325 mg.

PPD Classification:

Opiates & Antagonists

Needs a prescription :

Yes (please see your doctor for proper supervision)

What is this product for(Indication):

Moderate-severe pain.

How to use it (Dosing):

For dosage information of prescription medicine, please consult with your


doctor.

Available forms:

Film-coated tab 30's.

Company:

Getz Pharma (Phils.), Inc.

PARATRAM
Content:

Per FCT: Tramadol HCl 37.5 mg, paracetamol 325 mg.

PPD Classification:

Opiates & Antagonists

Needs a prescription :

Yes (please see your doctor for proper supervision)

What is this product for(Indication):

Moderate-severe pain.

How to use it (Dosing):

For dosage information of prescription medicine, please consult with your


doctor.

Situations in which this should not be


used (Contraindications):

Hypersensitivity.

Health concerns to watch out for;


situations in whichPrecautions are
recommended before or while using
this product:

Allergic reaction incl bronchial asthma. Pregnancy Risk Category C.

Side effects that may occur while using


this product:

Nausea, vomiting, constipation, drowsiness, hematological reactions,


respiratory depression & hypotension.

Available forms:

Film-coated tab 30's.

Company:

Getz Pharma (Phils.), Inc.

What is Micardis?
Micardis (telmisartan) is an angiotensin II receptor antagonist. Telmisartan keeps blood vessels from
narrowing, which lowers blood pressure and improves blood flow.

Micardis is used to treat high blood pressure(hypertension). It is sometimes given together with other
blood pressure medications.
Micardis is also used to reduce the risk of stroke, heart attack, or death from heart problems in
people who are at least 55 years old with risk factors for serious heart disorders.

Important information
Stop using Micardis and tell your doctor right away if you become pregnant. Telmisartan can
cause injury or death to the unborn baby if you take the medicine during your second or third
trimester.

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

If you have diabetes, do not use Micardis together with any medication that contains aliskiren
(Amturnide, Tekturna, Tekamlo, Valturna).
In rare cases, Micardis can cause a condition that results in the breakdown of skeletal muscle tissue,
leading to kidney failure. Call your doctor right away if you have unexplained muscle pain,
tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored
urine.

Before taking this medicine


You should not use Micardis if you are allergic to telmisartan.
If you have diabetes, do not use Micardis together with any medication that contains aliskiren
(Amturnide, Tekturna, Tekamlo, Valturna).
You may also need to avoid taking Micardis with aliskiren if you have kidney disease.
To make sure this medicine is safe for you, tell your doctor if you have:

kidney disease (or if you are on dialysis);

liver disease;
heart disease;
if you are dehydrated; or
if you are on a low salt diet.

FDA pregnancy category D. Do not use Micardis if you are pregnant. Stop using and tell your
doctor right away if you become pregnant. Telmisartan can cause injury or death to the unborn
baby if you take the medicine during your second or third trimester. Use effective birth control.
See also: Pregnancy and breastfeeding warnings (in more detail)
It is not known whether telmisartan passes into breast milk or if it could harm a nursing baby. You
should not breast-feed while using this medicine.

How should I take Micardis?


Take Micardis exactly as prescribed by your doctor. Follow all directions on your prescription label.
Your doctor may occasionally change your dose to make sure you get the best results. Do not take
this medicine in larger or smaller amounts or for longer than recommended.
You may take Micardis with or without food.
Do not crush, chew, or break a Micardis tablet. Swallow the tablet whole. Keep each tablet in its
blister pack until you are ready to take it. Tear or cut the blister apart from the rest of the package
and peel back the paper liner. Push the tablet through the foil to remove it.
It may take 2 to 4 weeks before your symptoms improve. Keep using the medicine as directed and
tell your doctor if your symptoms do not improve.
Your blood pressure will need to be checked often.
You may have very low blood pressure while taking Micardis. Call your doctor if you are sick with
vomiting or diarrhea, or if you are sweating more than usual.
If you are being treated for high blood pressure, keep using this medicine even if you feel well. High
blood pressure often has no symptoms. You may need to use blood pressure medication for the rest
of your life.
Store Micardis tablets in their original package at room temperature, away from moisture and heat.

Micardis dosing information


Usual Adult Dose for Hypertension:
Initial dose: 40 mg orally once a day with or without food, assuming adequate intravascular volume
Maintenance dose: 20 mg to 80 mg orally once a day
Usual Adult Dose for Cardiovascular Risk Reduction:

Cardiovascular risk reduction in patients unable to take ACE inhibitors: 80 mg orally once a day with
or without food
It is unknown whether doses lower than 80 mg are effective in reducing the risk of cardiovascular
morbidity or mortality.
When initiating Micardis for cardiovascular risk reduction, monitoring of blood pressure is
recommended, and appropriate adjustment of medications that lower blood pressure may be
necessary.

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your
next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Micardis?


Avoid drinking alcohol. It can lower your blood pressure and may increase some of theside effects of
Micardis.
Do not use potassium supplements or salt substitutes while you are taking Micardis, unless your
doctor has told you to.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and
steady yourself to prevent a fall.

Micardis side effects


Get emergency medical help if you have any of these signs of an allergic reaction to
Micardis: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
In rare cases, Micardis can cause a condition that results in the breakdown of skeletal muscle tissue,
leading to kidney failure. Call your doctor right away if you have unexplained muscle pain,
tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored
urine.
Also call your doctor at once if you have:

a light-headed feeling, like you might pass out;


little or no urinating;

swelling, rapid weight gain; or


high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling).

Common Micardis side effects may include:

stuffy nose, sinus pain;


back pain; or
diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor formedical advice
about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)

What other drugs will affect Micardis?


Tell your doctor about all medicines you use, and those you start or stop using during your treatment
with Micardis, especially:

digoxin;
lithium;
a diuretic or "water pill";
NSAIDs (non-steroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen
(Aleve), celecoxib, diclofenac, indomethacin, or meloxicam, and others; or
ramipril or other blood pressure medicines.

This list is not complete. Other drugs may interact with telmisartan, including prescription and overthe-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this
medication guide.
SIDE EFFECTS: Dizziness or lightheadedness may occur as your body adjusts to the medication. If
either of these effects persists or worsens, tell your doctor or pharmacist promptly.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying
position.
Remember that your doctor has prescribed this medication because he or she has judged that the
benefit to you is greater than the risk of side effects. Many people using this medication do not have
serious side effects.
Tell your doctor right away if you have any serious side effects, including: fainting, unusual change in
the amount of urine, symptoms of a high potassium blood level (such as muscle weakness,
slow/irregular heartbeat).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you
notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the
face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact
your doctor or pharmacist.

In the US Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to
Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking telmisartan, tell your doctor or pharmacist if you are allergic to it; or if
you have any other allergies. This product may contain inactive ingredients, which can cause allergic
reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver
disease, bile duct blockage, high blood levels of potassium in the blood (hyperkalemia), loss of too
much body water and/or minerals (volume depletion, dehydration).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires
alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Too much sweating, diarrhea, or vomiting may cause you to feel lightheaded. Report prolonged
diarrhea or vomiting to your doctor.
This product may increase your potassium levels. Before using potassium supplements or salt
substitutes that contain potassium, consult your doctor or pharmacist.
Before having surgery, tell your doctor or dentist about all the products you use (including
prescription drugs, nonprescription drugs, and herbal products).
This medication is not recommended for use during pregnancy. It may harm an unborn baby.
Consult your doctor for more details. (See also Warning section.)
It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty
breathing; swelling of your face, lips, tongue, or throat.
In rare cases, telmisartan can cause a condition that results in the breakdown of skeletal muscle
tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or
weakness especially if you also have fever, nausea or vomiting, and dark colored urine.
Call your doctor at once if you have any other serious side effects, such as:

feeling like you might pass out;

painful or difficult urination;

chest pain;

feeling short of breath, even with mild exertion;

swelling in your hands or feet; or

high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling).
Less serious side effects may include:

stuffy nose, sinus pain, cough;

back pain;

stomach pain, diarrhea;

headache, dizziness;

tired feeling;

weakness; or

mild skin rash.


This is not a complete list of side effects and others may occur. Call your doctor for medical advice
about side effects. You may report side effects to FDA at 1-800-FDA-1088.

GENERIC NAME: telmisartan


BRAND NAME: Micardis
DRUG CLASS AND MECHANISM: Telmisartan is a member of a family of drugs called angiotensin
receptor blockers (ARBs), which includes losartan(Cozaar), valsartan (Diovan), irbesartan (Avapro),
and candesartan(Atacand). Angiotensin, formed in the blood by the action of angiotensin converting
enzyme (ACE), is a powerful chemical that attaches to angiotensin receptors found in many tissues
but primarily on muscle cells of blood vessels. Angiotensin's attachment to the receptors causes
muscle cells to shorten and narrow the blood vessels (vasoconstrict), which leads to an increase in
blood pressure (hypertension). Telmisartan blocks the angiotensin receptor. By blocking the action
of angiotensin, telmisartan widens blood vessels (vasodilate) and reduces blood pressure.
Telmisartan was approved by the FDA in November 2000.
PRESCRIPTION: Yes
GENERIC AVAILABLE: No
PREPARATIONS: Tablets: 20, 40, and 80 mg.
STORAGE: Telmisartan should be stored at room temperature, 15-30 C (59-86 F). The tablets
should be kept in their blister-pack packaging until they are used.
PRESCRIBED FOR: Telmisartan is used for the treatment of hypertension (high blood pressure). It
also is used for reducing the risk of heart attack,stroke, or death from cardiovascular causes in
patients 55 years of age or older at high risk of developing major cardiovascular events but who are
unable to take ACE inhibitors.
DOSING: The recommended dose for treating hypertension is 20-80 mg daily. The recommended
dose for cardiovascular risk reduction is 80 mg daily.
DRUG INTERACTIONS: Telmisartan can increase blood concentrations ofdigoxin (Lanoxin)
and lithium (Eskalith, Lithobid). Therefore blood levels of digoxin and lithium should be monitored
and doses adjusted if necessary. Combining telmisartan with potassium-sparing diuretics (for
example.,spironolactone (Aldactone), triamterene, amiloride), potassium supplements, or salt
substitutes containing potassium may lead to hyperkalemia (elevated potassium in the blood).
Combining telmisartan or other ARBs withnonsteroidal anti-inflammatory drugs (NSAIDs) in patients
who are elderly, fluid-depleted (including those on diuretic therapy), or with poor kidney function may
result in reduced kidney function, including kidney failure. These effects usually are reversible. There

have been reports that aspirinand other NSAIDs such as ibuprofen (Advil, Children's Advil/Motrin,
Medipren, Motrin, Nuprin, PediaCare Fever, etc.), indomethacin (Indocin, Indocin-SR),
and naproxen (Anaprox, Naprelan, Naprosyn, Aleve) may reduce the effects of ARBs.
PREGNANCY: Medications that interfere with the angiotensin converting enzyme system, such as
telmisartan, have been found to cause fetal and neonatal toxicity and death when taken by pregnant
women. Pregnant mothers should discontinue use of telmisartan as soon as they know they
are pregnant.
NURSING MOTHERS: It is not known if telmisartan is secreted into breast milk. Since most
medicines are secreted into breast milk, potential risks and benefits need to be assessed in women
who are nursing to determine if breast feeding or telmisartan should be discontinued.
SIDE EFFECTS: Like other angiotensin receptor blockers, telmisartan generally is well-tolerated.
The most common side effects are headache,dizziness, back pain, fatigue, stomach upset, upper
respiratory tract infections, hyperkalemia, and diarrhea. Patients also may experienceimpotence,
reduced renal function, and allergic reactions. Rhabdomyolysis(inflammation and destruction of
muscle) and angioedema (swelling of soft tissues including those of the throat and larynx) are rare
but serious side effects of telmisartan.
What is the most important information I should know about telmisartan (Micardis)?
Do not use telmisartan if you are pregnant. Stop using this medication and tell your doctor right
away if you become pregnant.
You should not use this medication if you are allergic to telmisartan.
Avoid drinking alcohol. It can lower your blood pressure and may increase some of the side effects of
telmisartan.
Do not use potassium supplements or salt substitutes while you are taking telmisartan, unless your doctor
has told you to.
Your blood pressure will need to be checked often. Visit your doctor regularly.
If you are being treated for high blood pressure, keep using this medication even if you feel well. High
blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of
your life.
In rare cases, telmisartan can cause a condition that results in the breakdown of skeletal muscle tissue,
leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or
weakness especially if you also have fever, unusual tiredness, and dark colored urine.

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