Pentoxifylline Extended Release Tablets 400mg Taj Pharma

  1. NAME OF THE MEDICINAL PRODUCT

Pentoxifylline Extended Release Tablets 400mg Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION
    a) Each film coated tablet contains:
    Pentoxifylline USP                       400mg
    Excipients                                             q.s.
  1. PHARMACEUTICAL FORM

Tablet.

  1. CLINICAL PARTICULARS

4.1 Therapeutic indications

Pentoxifylline 400 is indicated in the treatment of peripheral vascular disease, including intermittent claudication and rest pain.

4.2 Posology and method of administration

The recommended initial dose is 1 tablet (400 mg) three times daily; two tablets daily may prove sufficient in some patients, particularly for maintenance therapy. Tablets should be taken with or immediately after meals, and swallowed whole with plenty of water.

Elderly: No special dosage requirements.
Children: Pentoxifylline 400 is not suitable for use in children.

Special Cases: In patients with impairment of renal function (creatinine clearance below 30ml/min) a dose reduction by approximately 30% to 50% may be necessary guided by individual tolerance.

4.3 Contraindications

Pentoxifylline 400 is contra-indicated in cases where there is known hypersensitivity to the active constituent, pentoxifylline other methyl xanthines or any of the excipients. Also in patients with cerebral haemorrhage, extensive retinal haemorrhage, acute myocardial infarction and severe cardiac arrhythmias.

4.4 Special warnings and precautions for use

At the first signs of an anaphylactic/anaphylactoid reaction, Pentoxifylline 400 must be discontinued immediately, and a physician must be informed.

Particular careful monitoring is required:

In patients with hypotension or severe coronary artery disease, Pentoxifylline 400 should be used with caution, as a transient hypotensive effect is possible and, in isolated cases, might result in a reduction in coronary artery perfusion.

Particularly careful monitoring is required in patients with impaired renal function. In patients with a creatinine clearance of less than 30 ml/min it may be necessary to reduce the daily dose of Pentoxifylline 400 to one or two tablets to avoid accumulation. In patients with severely impaired liver function the dosage may need to be reduced.

In patients treated concomitantly with pentoxifylline and anti-vitamin K or platelet aggregation inhibitors (see also section 4.5).

In patients treated concomitantly with pentoxifylline and antidiabetic agents (see also section 4.5).

In patients treated concomitantly with pentoxifylline and ciprofloxacin (see also section 4.5).

In patients treated concomitantly with pentoxifylline and theophylline (see also section 4.5).

4.5 Interaction with other medicinal products and other forms of interaction

High doses of Pentoxifylline injection have been shown, in rare cases, to intensify the hypoglycaemic action of insulin and oral hypoglycaemic agents. However, no effect on insulin release has been observed with Pentoxifylline following oral administration. It is recommended that patients under medication for diabetes mellitus be carefully monitored.

Post-marketing cases of increased anti-coagulant activity have been reported in patients concomitantly treated with pentoxifylline and anti-vitamin K. Monitoring of anti-coagulant activity in these patients is recommended when pentoxifylline is introduced or the dose is changed.

Pentoxifylline 400 may potentiate the effect of anti-hypertensive agents and the dosage of the latter may need to be reduced.

Pentoxifylline 400 should not be given concomitantly with ketorolac as there is increased risk of bleeding and/or prolongation of prothrombin time.

Concomitant administration of pentoxifylline and theophylline may increase theophylline levels in some patients. Therefore there may be an increase in and intensification of adverse effects of theophylline.

Concomitant administration with ciprofloxacin may increase the serum concentration of pentoxifylline in some patients. Therefore, there may be an increase in and intensification of adverse reactions associated with co-administration.

Potential additive effect with platelet aggregation inhibitors: Because of the increased risk of bleeding, the concomitant administration of a platelet aggregation inhibitor (such as clopidogrel, eptifibatide, tirofiban, epoprostenol, iloprost, abciximab, anagrelide, NSAIDs other than selective COX-2 inhibitors, acetylsalicylates (ASA/LAS), ticlopidine, dipyridamole) with pentoxifylline should be undertaken with caution.

Concomitant administration with cimetidine may increase the plasma concentration of pentoxifylline and the active metabolite, lisofylline.

4.6 Pregnancy and lactation

There is no information on the use of Pentoxifylline in pregnancy but no untoward effects have been found in animal studies. Pentoxifylline 400 should not be administered during pregnancy.

Pentoxifylline passes into breast milk in minute quantities. Because insufficient experience has been gained, the possible risks and benefits must be weighed before administration of Pentoxifylline 400 to breast feeding mothers.

4.7 Effects on ability to drive and use machines

No effect is known.

4.8 Undesirable effects

These adverse reactions have been reported in clinical trials or post-marketing. Frequencies are unknown.

System Organ Class Adverse Reaction
Investigations Transaminases increased
Cardiac disorders Arrhythmia, Tachycardia, Angina Pectoris
Blood and lymphatic system disorders Thrombocytopenia, Leukopenia/neutropenia
Nervous system disorders Dizziness, headache, meningitis aseptic*
Gastrointestinal disorders Gastrointestinal disorder, Epigastric discomfort, Abdominal distension, Nausea, Vomiting, Diarrhoea, Constipation, Hypersalivation
Skin and subcutaneous tissue disorders Pruritus, Erythema, Urticaria, Hot flush, Rash
Vascular disorders Haemorrhage**, Hypotension
Immune system disorders Anaphylactic reactions, Anaphylactoid reaction, Angioedema
Hepatobiliary disorders Cholestasis
Psychiatric disorders Agitation, Sleep disorder
Respiratory disorders Bronchospasm

 

Description of selected adverse reactions

* Reports of aseptic meningitis were predominantly in patients with underlying connective tissue disorders

** A few very rare events of bleeding (e.g. skin, mucosa) have been reported in patients treated with Pentoxifylline with and without anticoagulants or platelet aggregation inhibitors. The serious cases are predominantly concentrated in the gastrointestinal, genitourinary, multiple site and surgical wound areas and are associated with bleeding risk factors. A causal relationship between Pentoxifylline therapy and bleeding has not been established. Thrombocytopenia has occurred in isolated cases.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

The treatment of overdosage should be symptomatic with particular attention to supporting the cardiovascular system.

  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Leukocyte properties of haemorrheologic importance have been modified in animal and in vitro human studies. Pentoxifylline has been shown to increase leukocyte deformability and to inhibit neutrophil adhesion and activation.

5.2 Pharmacokinetic properties

The half-life of absorption of Pentoxifylline 400 is 4-6 hours. Pentoxifylline is extensively metabolised, mainly in the liver. Sixty percent of a single dose of Pentoxifylline 400 is eliminated via the kidney over 24 hours.

5.3 Preclinical safety data

Nothing of clinical relevance.

  1. PHARMACEUTICAL PARTICULARS
    a) Each film-coated tablet contains:
    Pentoxifylline USP                       400mg
    Excipients                                             q.s.

6.1 List of excipients

Hydroxyethyl cellulose, povidone, talc, magnesium stearate, hypromellose, macrogol 8000, erythrosine. titanium dioxide.

6.2 Incompatibilities

None known.

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 25°C. Store in the original package.

6.5 Nature and contents of container

PVC/PVDC/Al blisters.

Pack sizes: Blisters: 7, 14, 28, 30, 50, 90, 100 and 500mg modified-release tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and another handling

None.

  1. 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

Pentoxifylline Extended-Release Tablets 400mg Taj Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this medicine

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET:

  1. What Pentoxifylline is and what it is used for
  2. Before you take Pentoxifylline
  3. How to take Pentoxifylline
  4. Possible side effects
  5. How to store Pentoxifylline
  6. Further information1. WHAT PENTOXIFYLLINE IS AND WHAT IT IS USED FOR

Pentoxifylline contains a medicine called pentoxifylline.

This belongs to a group of medicines called peripheral vasodilators. It works by increasing the blood flow to the arms and legs.

Pentoxifylline can be used to treat:

  • Peripheral vascular disease (poor circulation to the arms and legs).
  • Intermittent claudication (pain on walking or at rest caused by poor circulation to the legs).
  1. BEFORE YOU TAKE PENTOXIFYLLINE

Do not take Pentoxifylline if:

  • You are allergic (hypersensitive) to pentoxifylline, other similar medicines such as theophylline or aminophylline or to any of the other ingredients of Pentoxifylline (see Section 6: Further Information)
    Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
  • You have heart problems or have recently had a heart attack
  • You have severe palpitations (very fast and uneven heartbeats)
  • You have had a stroke with bleeding in the brain (cerebral haemorrhage)
  • You have had bleeding in the eye (retinal haemorrhage)

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Pentoxifylline.

Take special care with Pentoxifylline

Check with your doctor or pharmacist before taking your medicine if:

  • You feel dizzy, light-headed or faint when you stand or sit up too quickly (hypotension)
  • You have problems with the blood supply to your heart caused by hardening or narrowing of the arteries
  • You have liver or kidney problems

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Pentoxifylline.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

This includes medicines you buy without a prescription, including herbal medicines. This is because Pentoxifylline can affect the way some other medicines work. Also some medicines can affect the way Pentoxifylline works.

In particular, tell your doctor if you are taking any of the following:

Pentoxifylline may increase the effect of the following medicines:

  • Medicines for diabetes including tablets or insulin
  • Medicines for high blood pressure
  • Anticoagulants such as warfarin

When taken with Pentoxifylline, the following medicines increase the chance of you getting side effects:

  • Ketorolac used for pain relief
  • Theophylline used to treat wheezing or difficulty in breathing
  • Ciprofloxacin used to treat bacterial infections
  • Medicines used to stop blood clots from forming
  • Cimetidine used to treat heartburn and stomach ulcers

Taking Pentoxifylline with food and drink

Take Pentoxifylline with or just after meals.

Pregnancy and breast-feeding

You should not take Pentoxifylline if you are pregnant.

Ask your doctor or pharmacist for advice before taking any medicine.

If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking Pentoxifylline. This is because very small amounts may pass into the mothers’ milk.

Driving and using machines

You may feel dizzy while taking this medicine. If this happens, do not drive or use any tools or machines.

  1. HOW TO TAKE PENTOXIFYLLINE

Always take Pentoxifylline exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

  • If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor
  • Take this medicine by mouth
  • Swallow the tablets whole with a drink of water
  • Take with or just after a meal

Adults including the elderly

The usual starting dose is 1 tablet (400mg) three times a day. Your doctor may lower your dose to 1 tablet twice a day.

Patients with kidney problems

Your doctor may give you a lower dose if necessary.

Children

Pentoxifylline is not suitable for use in children.

If you take more Pentoxifylline than you should

If you take more tablets than you should, talk to a doctor or go to a hospital straight away. The following effects may happen: low blood pressure, feeling sleepy, fits (seizures) or uneven heartbeat.

If you forget to take Pentoxifylline

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Pentoxifylline

Keep taking Pentoxifylline until your doctor tells you to stop taking it.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

  1. POSSIBLE SIDE EFFECTS

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

Stop taking Pentoxifylline and see your doctor or go to a hospital straight away if;

  • If you have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
  • Bleeding under the skin
  • Blood in your vomit or stools (motions)
  • If you develop a condition called aseptic meningitis. Signs include headache, neck stiffness, eye pain or discomfort in bright light

Tell your doctor as soon as possible if you have any of the following side effects:

  • You bruise more easily than usual. This could be because of a blood disorder (thrombocytopenia).
  • Increased or fast heart beat (tachycardia)
  • Chest pain (angina)
  • Irregular heart beat (palpitations)
  • Frequent infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called ‘leukopenia’
  • You get more infections than usual. This could be caused by a decrease in the number of white blood cells (neutropenia)

Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days. Also tell them if you notice any side effects not listed in this leaflet:

  • Feeling sick (nausea) or being sick (vomiting), diarrhoea
  • Headache, feeling dizzy, light-headed or faint
  • Flushing
  • Feeling agitated, sleep problems
  • An illness where the removal of bile from the liver is blocked (intrahepatic cholestasis). Signs include jaundice, rash or fever, and the colour of your water (urine) becomes darker
  • Discomfort or bloating in the abdomen
  • Rash
  • Constipation
  • Producing more saliva than usual

Blood tests

Pentoxifylline can change the levels of liver enzymes shown up in blood tests. This can mean that your liver is not working properly.

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.

United Kingdom

  1. HOW TO STORE PENTOXIFYLLINE

Keep out of the reach and sight of children.

Do not use Pentoxifylline after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not use Pentoxifylline if you notice your tablets are crumbling, broken or discoloured.

Do not store above 25°C. Store in the original package.

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.

  1. FURTHER INFORMATION

What Pentoxifylline contains:
Each film-coated tablet contains:
Pentoxifylline USP                           400mg
Excipients                                             q.s.
The other ingredients are hydroxyethyl cellulose, povidone, talc, magnesium stearate, hypromellose, macrogol 8000, erythrosine, and titanium dioxide

What Pentoxifylline looks like and contents of the pack

PVC/PVDC/Al blisters.

Pack sizes: Blisters: 7, 14, 28, 30, 50, 90, 100 and 500mg modified-release tablets.

Not all pack sizes may be marketed.

  1. 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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