Tranexamic Acid 500mg film coated Tablets BP Taj Pharma

  1. Name of the medicinal product

Tranexamic Acid 250mg film coated Tablets BP Taj Pharma
Tranexamic Acid 500mg film coated Tablets BP Taj Pharma

  1. Qualitative and quantitative composition

Each film coated tablet contains:
Tranexamic acid  BP                         250mg.
Excipients                                          q.s
Colours: Titanium Dioxide USP

Each film coated tablet contains:
Tranexamic acid  BP                         500mg.
Excipients                                          q.s
Colours: Titanium Dioxide USP

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Tablets.

Tranexamic Acid 500mg film coated tablets are white to off white, capsule shaped, biconvex film-coated tablets.

  1. Clinical particulars

4.1 Therapeutic indications

Tranexamic Acid is indicated for short term use for haemorrhage or risk of haemorrhage in those with increased fibrinolysis or fibrinogenolysis. Local fibrinolysis as occurs in the following conditions:

  1. a) Prostatectomy and bladder surgery
  2. b) Menorrhagia
  3. c) Epistaxis
  4. d) Conisation of the cervix
  5. e) Traumatic hyphaema
  6. Management of dental extraction in haemophiliacs.
  7. Hereditary angioneurotic oedema.

4.2 Posology and method of administration

Posology

Adults:

Local Fibrinolysis: The recommended standard dose is 15-25mg/kg bodyweight (i.e. 2-3 tablets) two to three times daily. For the indications listed below the following doses may be used:

1a. Prostatectomy: Prophylaxis and treatment of haemorrhage in high risk patients should commence per- or post-operatively with an injectable form; thereafter 2 tablets three to four times daily until macroscopic haematuria is no longer present.

1b. Menorrhagia: Recommended dosage is 2 tablets 3 times daily as long as needed for up to 4 days. If very heavy menstrual bleeding, dosage may be increased. A total dose of 4g daily (8 tablets) should not be exceeded. Treatment with tranexamic acid should not be initiated until menstrual bleeding has started.

1c. Epistaxis: When repeated bleeding is anticipated oral therapy (2 tablets three times daily) should be administered for 7 days.

1d. Cervix Conisation: 3 tablets three times daily

1e. Traumatic Hyphaema: 2-3 tablets 3 times daily. The dose is based on 25mg/kg three times a day.

  1. Haemophilia: In the management of dental extractions 2-3 tablets every eight hours. The dose is based on 25mg/kg.
  2. Hereditary angioneurotic oedema: Some patients are aware of the onset of illness; suitable treatment for these patients is intermittently 2-3 tablets two to three times daily for some days. Other patients are treated continuously at this dosage.

Pediatric population:

This should be calculated according to bodyweight at 25mg/kg per dose at the adult dosing frequencies. However, data on efficacy, posology and safety for these indications are limited.

Elderly:

No reduction in dosage is necessary unless there is evidence of renal failure (see guidelines below).

Renal insufficiency

By extrapolation from clearance data relating to the intravenous dosage form, the following reduction in the oral dosage is recommended for patients with mild to moderate renal insufficiency:

Serum Creatinine( μmol/l) Oral Dose Dose Frequency
120-249 15 mg/kg body weight twice daily
250-500 15 mg/kg body weight daily

Method of administration

Oral

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

Severe renal failure because of risk of accumulation.

Active thromboembolic disease.

History of venous or arterial thrombosis

Fibrinolytic conditions following consumption coagulopathy

History of convulsions

4.4 Special warnings and precautions for use

In case of haematuria of renal origin (especially in haemophilia), there is a risk of mechanical anuria due to formation of a ureteral clot.

In the long-term treatment of patients with hereditary angioneurotic oedema, regular eye examinations (e.g. visual acuity, slit lamp, intraocular pressure, visual fields) and liver function tests should be performed.

Patients with irregular menstrual bleeding should not use Tranexamic Acid until the cause of irregular bleeding has been established. If menstrual bleeding is not adequately reduced by Tranexamic Acid, an alternative treatment should be considered.

Tranexamic acid should be administered with care in patients receiving oral contraceptives because of the increased risk of thrombosis.

Patients with a previous thromboembolic event and a family history of thromboembolic disease (patients with thrombophilia) should use Tranexamic Acid only if there is a strong medical indication and under strict medical supervision.

The blood levels are increased in patients with renal insufficiency. Therefore a dose reduction is recommended (see section 4.2).

The use of tranexamic acid in cases of increased fibrinolysis due to disseminated intravascular coagulation is not recommended.

Patients who experience visual disturbance should be withdrawn from treatment.

Clinical experience with Tranexamic Acid in menorrhagic children under 15 years of age is not available.

4.5 Interaction with other medicinal products and other forms of interaction

Tranexamic Acid will counteract the thrombolytic effect of fibrinolytic preparations.

4.6 Pregnancy and lactation

Pregnancy

Although there is no evidence from animal studies of a teratogenic effect, the usual caution with use of drugs in pregnancy should be observed.

Tranexamic acid crosses the placenta.

Breast-feeding

Tranexamic acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.

4.7 Effects on ability to drive and use machines

Tranexamic Acid has no or negligible influence on the ability to drive and use machines

4.8 Undesirable effects

Adverse effects have been ranked under headings of frequency using the following convention:

Very common (≥ 1/10)
Common (≥1/100, <1/10)
Uncommon (≥1/1000, <1/100)
Rare (≥ 1/10,000, <1/1,000)
Very rare (<1/10,000) including isolated reports
Not known (cannot be estimated from the available data).

The following undesirable effects have been reported

Immune system disorders

Very rare: Hypersensitivity reactions including anaphylaxis

Gastrointestinal disorders

Very rare: Digestive effects such as nausea, vomiting and diarrhoea my occur but disappear when the dosage is reduced

Skin and subcutaneous tissue disorders

Rare: Allergic skin reactions.

Vascular disorders

Rare: thromboembolic events.

Very rare: Arterial or venous thrombosis at any sites

Eye disorders

Rare: impaired colour vision and other visual disturbances, retinal/artery occlusion

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

4.9 Overdose

Symptoms may be nausea, vomiting, orthostatic symptoms and/or hypotension. Initiate vomiting, then stomach lavage, and charcoal therapy. Maintain a high fluid intake to promote renal excretion. There is a risk of thrombosis in predisposed individuals. Anticoagulant treatment should be considered.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: antifibrinolytic agent.

Tranexamic acid is an antifibrinolytic compound which is a potent competitive inhibitor of the activation of plasminogen to plasmin. At much higher concentrations it is a non-competitive inhibitor of plasmin. The inhibitory effect of tranexamic acid in plasminogen activation by urokinase has been reported to be 6-100 times and by streptokinase 6-40 times greater than that of aminocaproic acid. The antifibrinolytic activity of tranexamic acid is approximately ten times greater than that of aminocaproic acid.

5.2 Pharmacokinetic properties

Absorption

Peak plasma Tranexamic acid concentration is obtained immediately after intravenous administration (500mg). Then concentration decreases until the 6th hour. Elimination half-life is about 3 hours.

Distribution

Tranexamic acid administered parenterally is distributed in a two compartment model. Tranexamic acid is delivered in the cell compartment and the cerebrospinal fluid with delay. The distribution volume is about 33% of the body mass.

Tranexamic acid crossed the placenta, and may reach one hundredth of the serum peak concentration in the milk of lactating women.

Elimination

Tranexamic acid is excreted in urine as unchanged compound. 90% of the administered dose is excreted by the kidney in the twelve first hours after administration (glomerular excretion without tubular reabsorption).

Following oral administration, 1.13% and 39% of the administered dose were recovered after 3 and 24 hours respectively.

Plasma concentrations are increased in patients with renal insufficiency.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics

  1. Pharmaceutical particulars

6.1 List of excipients

Tablet core: Cellulose microcrystalline, povidone, croscarmellose sodium, silica colloidal anhydrous, talc, magnesium stearate;

Film coating: methacrylate polymers, titanium dioxide, talc, magnesium stearate, macrogol.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 30°C. Store in the original package.

6.5 Nature and contents of container

The blister pack (PVC/aluminium) contains 60 tablets.

6.6 Special precautions for disposal and other handling

There are no special storage precautions. Any unused product or waste material should be disposed of in accordance with local requirements.

7.Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Tranexamic Acid 250 mg film coated Tablets BP Taj Pharma
Tranexamic Acid 500 mg film coated Tablets BP Taj Pharma

Package leaflet: Information for the user

Read this entire leaflet carefully because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

  • This medicine is available without However, you still need to take it carefully to get the best results.
  • Keep this leaflet. You may need to read it
  • Ask your pharmacist if you need more information or
  • If any side-effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section
  • You must talk to a doctor if you do not feel better or if you feel worse after 4

What is in this leaflet:

  1. What Tranexzmic acid is and what it is used for
  2. What you need to know before you take Tranexzmic acid
  3. How to take Tranexzmic acid
  4. Possible side effects
  5. How to store Tranexzmic acid
  6. Contents of the pack and other information

 

  1. What Tranexzmic acid is and what it is used for

Tranexzmic acid contains the active substance Tranexamic acid which belongs to a group of medicines called anti-fibrinolytics. These are used to control bleeding. When you bleed your body forms clots to stop the bleeding. In some people these clots break  down  causing  too  much bleeding. This medicine stops these clots from dissolving and so reduces bleeding.

This medicine is used only when your periods are regular to control heavy menstrual bleeding (see section 2 if you are unsure whether or not your periods are regular). This medicine reduces the amount of blood lost during your period but may not help other symptoms such as period pain.

Heavy menstrual bleeding can cause anaemia (reduction in red blood cells). People with anaemia may be pale and feel tired, weak, dizzy or faint. If you think you may have anaemia, you should see your doctor.

  1. What you need to know before you take Tranexzmic acid

How do I know if my periods are heavy?

Your periods are heavy if:

  • you bleed through to your clothes or onto bedding at night – called “flooding”
  • you need to change your sanitary protection every 2 hours or more often
  • you need to use double sanitary protection (tampon plus towels)
  • you pass large blood clots
  • your periods prevent you from doing normal activities, such as going out, working or

Do not take Tranexzmic acid if your periods are not heavy.

How do I know if my periods are regular?

Your periods are regular if both of the following apply to you:

  • your menstrual cycle (i.e. the number of days between the 1st day of one period and the 1st day of the next) is between 21 and 35 days long
  • your menstrual cycle is about the same number of days long each time (i.e does not change by more than 3 days each time).

Do not take Tranexzmic acid if your periods are not regular.

Do not take Tranexzmic acid if:

  • you are allergic to tranexamic acid or any of the other ingredients in this medicine (listed in section 6)
  • you are under 18 years of age
  • your periods are irregular
  • you are pregnant
  • you are taking the combined oral contraceptive (“the pill”)
  • you have kidney disease
  • you have blood in your urine between your periods
  • you have or have ever had a blood clot in your blood vessels (called a “thrombosis”).
  • you have a history of convulsions

See immediately below for the warning signs of a blood clot.

  • anyone in your family has suffered from blood clots in their blood vessels
  • you are taking medicines to prevent or treat blood clots
  • (e.g. warfarin).

If any of the above applies to you, do not take this medicine.

Warning signs of a blood clot to look out for:

  • pains or feelings of heaviness in your chest
  • unusual pains or swellings of your arms or one of your legs
  • sudden shortness of breath
  • fainting
  • coughing up blood.

If you experience any of these symptoms you should see your doctor immediately.

Check with your doctor before starting this medicine if:

  • you have recently noticed a change in your normal bleeding pattern
  • you are over 45 years old
  • your mother, grandmother, aunt or sister has suffered from endometrial cancer
  • you are diabetic
  • you are very overweight (obese)
  • you have polycystic ovary syndrome (PCOS)
  • you have abnormal bleeding between your periods
  • you bleed after sexual intercourse
  • you thought you had gone through the menopause, but now you have started bleeding again
  • you have pain during sexual intercourse
  • you have pain before the start of your period (also known as premenstrual pain)
  • you have pelvic pain (pain in the lower abdomen).

Your doctor may prescribe a different medicine which is better for treating your symptoms.

Warning signs of endometrial cancer

Occasionally heavy periods may be due to an abnormality of the lining of the womb. One of the most serious conditions is endometrial cancer. There are almost always other warning signs of endometrial cancer such as:

  • irregular periods
  • prolonged periods
  • abnormal bleeding between

If any of the above applies to you, see your doctor.

Important: Regular AND heavy periods alone are unlikely to be caused by endometrial cancer.

Other medicines and Tranexzmic acid

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, in particular if you are taking any of the following medicines:

  • the “pill” (a combined oral contraceptive). You must not take this medicine if you are already taking this medicine
  • fibrinolytic drugs such as streptokinase (used to dissolve blood clots)
  • tamoxifen (a drug used to treat breast cancer)
  • an oestrogen
  • any other medicine, including medicines obtained without a

Pregnancy, breast-feeding and fertility

Do not take this medicine if you are pregnant as it may cause problems for your unborn baby. If you think you

  1. How to take Tranexzmic acid

might be pregnant, planning to have a baby or are breast-feeding, you should ask your doctor for advice before taking this medicine.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Remember: This medicine should only be taken on the days when your period is heavy Do not take this medicine before your period has started as it will not work properly Swallow the tablets whole, with water if needed

Do not take this medicine for more than 4 days during each of your periods.

Use in adults:

  • The usual dose is two tablets taken 3 times a day

(e.g. in the morning, afternoon, and evening) for up to 4 days

  • If your bleeding is not reduced, you can take an extra 2 tablets at night
  • Heavy bleeding usually only lasts for the first two days of your

When the bleeding becomes less, you should reduce the number of tablets you take, for example, to 2 tablets twice a day

  • Do not take more than 8 tablets per

Use in children under 18 years of age:

  • Do not give to children under 18 years of

Use in the elderly:

  • This medicine is not for use in the

Using Tranexzmic acid every month

This medicine may be used every month as long as it continues to reduce your bleeding AND there are no changes in your bleeding pattern.

If Tranexzmic acid is not working

See your doctor if:

  • Your bleeding has not been reduced by this medicine after using it for 3 periods in a row
  • This medicine seems to have stopped

If you take more Tranexzmic acid than you should

If you accidentally take too many tablets you should contact your doctor immediately, or go to the nearest hospital casualty department.

If you forget to take Tranexzmic acid

Do not take a double dose to make up for a missed dose. Take your next dose at the. If you have any further questions on the use of this product, ask your pharmacist.

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking this medicine and go immediately to hospital if you experience any of the following rare symptoms:

  • pain or feelings of heaviness in your chest
  • unusual pain or swelling in your arms or legs
  • sudden shortness of breath
  • fainting
  • coughing up blood.

You may have developed a blood clot in your leg or lungs.

Stop taking this medicine and go immediately to hospital if you experience any of the following rare symptoms:

  • pain or feelings of heaviness in your chest
  • unusual pain or swelling in your arms or legs
  • sudden shortness of breath
  • fainting
  • Coughing up blood.

You may have developed a blood clot in your leg or lungs.

Stop taking this medicine and tell your doctor immediately if you experience any of the following symptoms:

Rare (affects 1 to 10 users in 1,000)

  • problems with your eyesight, especially your colour vision
  • a blood clot in the This may cause bleeding in the eye, or a loss of vision
  • itchy, red or swollen

Other side effects:

Very rare (affects less than 1 user in 10,000)

  • feeling sick
  • being sick

These are usually mild and pass very quickly, but if they continue, stop taking this medicine and tell your doctor or pharmacist.

Frequency not known (cannot be estimated from the available data)

  • Convulsions, particularly in cases of misuse

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

  1. How to store Tranexzmic acid

Keep out of the sight and reach of children.

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

Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  1. Contents of the pack and other Information

What Tranexzmic acid contains:

  • The active substance is tranexamic acid. Each fim-coated tablet contains 500mg tranexamic acid.
  • The other ingredients are microcrystalline cellulose, hyprolose, talc, magnesium stearate, colloidal anhydrous silica, povidone, methacrylate copolymer, titanium dioxide, macrogol 8000 and vanillin.

What Tranexzmic acid looks like and contents of the pack

The tablets are white, oblong film-coated tablets. They are marked with CY with an arc above and below the lettering. They come in packs of 18 tablets.

7.Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

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