Понстан форте 500 инструкция по применению взрослым

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Mefenamic acid is a non-steroidal anti-inflammatory agent with analgesic properties, and a demonstrable antipyretic effect. It has been shown to inhibit prostaglandin activity.

Indications

1. As an anti-inflammatory analgesic for the symptomatic relief of rheumatoid arthritis (including Still’s Disease), osteoarthritis, and pain including muscular, traumatic and dental pain, headaches of most aetiology, post-operative and post-partum pain.

2. Primary dysmenorrhoea.

3. Menorrhagia due to dysfunctional causes and presence of an IUD when other pelvic pathology has been ruled out.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms

For oral administration

Adults

1 tablet (500mg) three times daily.

In menorrhagia to be administered on the first day of excessive bleeding and continued according to the judgement of the physician

In dysmenorrhoea to be administered at the onset of menstrual pain and continued according to the judgement of the physician.

Elderly (over 65 Years)

As for adults.

Whilst no pharmacokinetic or clinical studies specific to the elderly have been undertaken with Ponstan, it has been used at normal dosage in trials which included many elderly patients.

The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

Ponstan should be used with caution in elderly patients suffering from dehydration and renal disease. Non-oliguric renal failure and proctocolitis have been reported mainly in elderly patients who have not discontinued mefenamic Acid after the development of diarrhoea.

Children

It is recommended that children under 12 years of age should be given Mefenamic Acid Suspension (50mg/5ml).

Do not exceed the stated dose.

Ponstan Forte tablets should be taken preferably with or after food.

Hypersensitivity to mefenamic acid or any of the other ingredients.

Inflammatory bowel disease

History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

Severe heart failure, hepatic failure and renal failure.

Because the potential exists for cross-sensitivity to aspirin, ibuprofen, or other non-steroidal anti-inflammatory drugs, mefenamic acid must not be given to patients who have previously shown hypersensitivity reaction (e.g. asthma, bronchospasm, rhinitis, angioedema or urticaria) to these medicines.

During the last trimester of pregnancy.

Treatment of pain after coronary artery bypass graft (CABG) surgery.

).

Patients on prolonged therapy should be kept under regular surveillance with particular attention to liver dysfunction, rash, blood dyscrasias or development of diarrhoea.

Appearance of any of these symptoms should be regarded as an indication to stop therapy immediately.

Use with concomitant NSAIDs including cyclooxygenase 2 specific inhibitors.

Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of ‘Medication Overuse Headache’ should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.

Precaution should be taken in patients suffering from dehydration and renal disease, particularly the elderly.

Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

Respiratory disorders: Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients

Cardiovascular, Renal and Hepatic impairment: The administration of an NSAID may cause a dose dependant reduction in prostaglandin formation and precipitate renal failure.).

Cardiovascular and cerebrovascular effects: Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for mefenamic acid.

Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with mefenamic acid after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).

As NSAIDs can interfere with platelet function, they should be used in caution in patients with intracranial haemorrhage and bleeding diathesis.

Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. Smoking and alcohol use are added risk factors.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation , and in the elderly. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for patients at risk of GI bleeding such as the elderly, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see below and 4.5).

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of gastrotoxicity or bleeding such as corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-platelet agents such as aspirin.

When GI bleeding or ulceration occurs in patients receiving mefenamic acid the treatment should be withdrawn.

SLE and mixed connective tissue disease: In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis.

Skin reactions: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported in association with use of NSAIDs. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Mefenamic acid should be stopped at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.

Female fertility: The use of mefenamic acid may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of mefenamic acid should be considered.

In dysmenorrhoea and menorrhagia lack of response should alert the physician to investigate other causes.

Epilepsy: Caution should be exercised when treating patients suffering from epilepsy.

Sunset yellow may cause allergic-type reactions.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

In patients who are known or suspected to be poor CYP2C9 metabolisers based on previous history/experience with other CYP2C9 substrates, mefenamic acid should be administered with caution as they may have abnormally high plasma levels due to reduced metabolic clearance.

Effects on ability to drive and use machines

Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.

Undesirable effects

Overdose

Pharmacodynamic properties

Pharmacokinetic properties

Preclinical safety data

Preclinical safety data does not add anything of further significance to the prescriber.

List of excipients

Shelf life

Special precautions for storage

Store below 30°C.

Nature and contents of container

Special precautions for disposal and other handling

Not applicable

Marketing authorisation holder

Marketing authorisation number(s)

PL 17736/0007

Date of first authorisation/renewal of the authorisation

10/10/2005

Date of revision of the text

12/07/2015

Ponstan Forte price

We have no data on the cost of the drug.
However, we will provide data for each active ingredient

The approximate cost of Mefenamic Acid 250 mg per unit in online pharmacies is from 0.48$ to 0.95$, per package is from 48$ to 95$.

The approximate cost of Mefenamic Acid 500 mg per unit in online pharmacies is from 0.58$ to 0.58$, per package is from 58$ to 58$.

Patient Information leaflet

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
PONSTAN FORTE 500 MG FILM-COATED TABLETS
mefenamic acid
IR1-2/L/x/1
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

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 only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. WHAT PONSTAN FORTE IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PONSTAN FORTE
3. HOW TO TAKE PONSTAN FORTE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE PONSTAN FORTE
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT PONSTAN FORTE IS AND WHAT IT IS USED FORE
d for
Ponstan Forte tablets contain mefenamic acid which is a non-steroidal
anti-inflammatory
drug (NSAID).
They can help to relieve:

symptoms of inflammation, such as redness and swelling

pain and discomfort caused by arthritis, muscular or rheumatic
disorders

headache or toothache

pain after operations, trauma

childbirth pain

painful or heavy periods

symptoms of premenstrual syndrome (PMS).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PONSTAN FORTE
2. BEFORE YOU TAKE
DO NOT TAKE PONSTAN FORTE:

if you are allergic to mefenamic acid, to any other anti-inflammatory
medicines (such
as aspirin, ibuprofen, celecoxib), or any of the other ingredients of
this medicine
(listed in section 6)

if you have, or have ever had, stomach or intestinal conditions such
as peptic ulcer,
bleeding in the stomach, intestines or bowel, or severe gastritis,
especially if you
have taken NSAIDs before

if you have an inflammatory bowel disease (e.g. ulcerative colitis,
Crohn's disease)

if you have severe heart, liver or kidney problems

if you ar
                                
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Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ponstan Forte 500 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg mefenamic acid
Excipients with known effect:
Each film-coated tablet contains 22.73 mg lactose monohydrate, 0.067
mg Sunset yellow (E110) and less than 1 mmol
sodium (23 mg)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet. (Tablet)
Ovoid tablets with yellow film-coating inscribed ‘PONSTAN FORTE’
on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.
As an anti-inflammatory analgesic for symptomatic relief of mild to
moderate pain associated with rheumatic,
muscular or arthritic disorders (including rheumatoid arthritis and
osteoarthritis), trauma, headache, dental pain,
post-operative or post-partum states.
2.
In the management of dysfunctional menorrhagia.
3.
Primary dysmenorrhoea.
4.
Premenstrual syndrome.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms_ (see section 4.4, Special warnings and precautions for
use)._
_ADULTS:_
The usual total daily dosage is 1500 mg in divided doses.
_ELDERLY:_
NSAIDs should be used with particular caution in elderly patients who
are more prone to adverse events, especially
with long-term use. Therefore, the risks versus the benefits of
chronic therapy in the elderly should be carefully
considered. The lowest dose compatible with adequate safe clinical
control should be employed_ (see section 4.4,_
_Special warnings and precautions for use)._
Treatment should be reviewed at regular intervals and discontinued if
no benefit is seen or intolerance occurs.
_CHILDREN:_
Not recommended for children under 12 years of age.
Do not exceed the stated dose.
Ponstan should be taken preferably with or after food.
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