Понстан форте 500 инструкция по применению

Ponstan® Forte 500mg Tablets/
Mefenamic acid 500mg Tablets
(mefenamic acid)
Your medicine is known by any of the above names but will be referred to
as Ponstan Forte in this leaflet.
Patient Information Leaflet
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 onto
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 this medicine is and what it is used for
2) Before you take
3) How to take
4) Possible side effects
5) How to store
6) Further information

1) What this medicine is and what it is used 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, muscle ache or toothache
• pain after operations, trauma
• childbirth pain
• painful or heavy periods.

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 to any of the other
ingredients (see Section 6)
• have, or have ever had, stomach or intestinal conditions such as peptic
ulcer, bleeding in the stomach or severe gastritis
• have an inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s
disease)
• have severe heart, liver or kidney problems
• have just had heart bypass surgery
• are more than 6 months pregnant.
If any of the above apply to you, speak to your doctor or pharmacist.
Take special care with Ponstan Forte
Before taking the tablets, tell your doctor if you:
• are taking any other NSAIDs (e.g. ibuprofen, diclofenac)
• are taking any other anti-inflammatory medicines including steroids
(e.g. prednisolone)
• are taking aspirin or medicines that thin the blood (e.g. warfarin,
clopidogrel)
• are taking antidepressants called selective serotonin re-uptake
inhibitors (SSRIs) (e.g. paroxetine)
• have kidney or liver problems. Your doctor may check your kidney or
liver function before and during treatment
• are elderly (see Section 3)
• are trying to become pregnant (see Section on Fertility)
• have stomach or digestive tract problems or if you ever had an upset
stomach after taking pain killers such as aspirin. Bleeding in the
stomach or gut can occur in patients taking Ponstan Forte
• have a bleeding disorder or if you are going to have a major operation.
Ponstan Forte can affect the clotting of your blood. It can make you
bleed more and for longer than usual
• have asthma, or a history of asthma, as this medicine may cause
breathing difficulties
• have a connective tissue disorder, e.g. Systemic Lupus Erythematosus
(SLE)
• have epilepsy
• are dehydrated (thirsty with dry skin, dark urine, dry mouth, headache)
• have heart problems, previous stroke or think that you might be at risk
of these conditions (e.g. if you have high blood pressure, diabetes or
high cholesterol or are a smoker). Additional monitoring may be carried
out by your doctor.
Medicines such as Ponstan Forte may be associated with a small
increased risk of heart attack or stroke. Any risk is more likely with high
doses and prolonged treatment. Do not exceed the recommended dose
or duration of treatment.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription, and herbal preparations.

Some medicines may be affected by Ponstan Forte or they may affect
how well Ponstan Forte will work. Tell your doctor or pharmacist if you are
taking:
• medicines that can increase the chance of getting ulcers or a bleed in
the stomach or gut, such as:
— corticosteroids used to treat arthritis and inflammation
— medicines such as anti-platelet agents, used to thin the blood (e.g.
warfarin, aspirin, clopidogrel)
— antidepressants called selective serotonin re-uptake inhibitors
(SSRIs) (e.g. paroxetine)
— any other anti-inflammatory medicines (e.g. diclofenac, celecoxib)
• aspirin including low doses of aspirin used to prevent your blood from
clotting in certain heart conditions
• medicines used for high blood pressure (e.g. atenolol, ramipril,
valsartan)
• diuretics (water tablets) or heart medicines (e.g. digoxin, sotalol,
diltiazem)
• some diabetic medicines (e.g. glipizide, glibenclamide)
• medicines which suppress the immune system (e.g. ciclosporin,
tacrolimus, methotrexate)
• lithium, a medicine used to treat mood swings and some types of
depression
• a medicine usually prescribed through hospitals, called mifepristone
(taken within the last 12 days)
• quinolone antibiotics (antibiotics used to treat infections)
• aminoglycoside antibiotics, used under medical supervision in hospitals
• zidovudine, a medicine used for HIV
• probenecid, a medicine used in special cases, to protect the kidneys
• medicines which bind to protein in the blood — (check with your
pharmacist).
Blood tests
Your doctor may test your blood during treatment.
Pregnancy and breast-feeding
Pregnancy
Mefenamic acid will be passed to your unborn baby. It is not known
how much it will affect your unborn baby in the first 6 months of
pregnancy.
DO NOT take the tablets in the last 3 months of pregnancy as they may
delay the onset of labour and prolong its duration.
They may also increase the likelihood of bleeding in the mother and in
the baby.
If you need to take these tablets, your doctor can help you decide
whether or not to take them during the first 6 months of pregnancy.
Breast-feeding
Mefenamic acid passes into breast milk and can affect the baby. You
should not take the tablets while breast-feeding unless advised by your
doctor.
Fertility
DO NOT take the tablets if you are trying to become pregnant, as they
may make it more difficult to get pregnant. You should inform your
doctor if you are planning to become pregnant or if you have problems
becoming pregnant.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Ponstan Forte may cause drowsiness, dizziness, fatigue or affect your
vision. If any of these occur do not drive, use machinery, or perform any
tasks that may require you to be alert.
Important information about some of the ingredients of Ponstan
Forte tablets
• lactose
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicine.
• sunset yellow (E110)
This may cause allergic reactions.

3) How to take
Always take Ponstan Forte tablets exactly as your doctor has told you and
always read the label. Your doctor will decide on the appropriate dose to
suit your condition. Ask your doctor or pharmacist if you are not sure.
• Take the tablets with or immediately after a meal.
• Do NOT drink alcohol while taking Ponstan Forte. Alcohol and smoking
can irritate the stomach and make some of the side effects worse.
Doses
Adults and the elderly: the usual dose is 1 tablet three times a day.
Elderly patients are at a higher risk of side effects and should take the
lowest effective dose for the shortest possible time, with additional
monitoring carried out by their doctor.
Children: this medicine is NOT suitable for children under 12 years.

If you take more than you should
If you take more tablets than you should you may harm your stomach,
kidneys and you may get seizures (fits).
1. Tell your doctor, pharmacist or nearest hospital casualty department
immediately.
2. Take the container and any remaining tablets with you so that people
can see what you have taken.
3. Do this even if you feel well.
If you forget to take
If you forget to take a dose take it as soon as you remember, but if it is
almost time for your next dose, skip the missed dose and continue as
usual.
Do not use a double dose to make up for a missed dose.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4) Possible side effects
Like all medicines, Ponstan Forte tablets can cause side effects, although
not everybody gets them. Do not be alarmed by this list of possible side
effects. You may not experience any of them.
STOP taking the tablets and seek medical help immediately if you have
any of the following allergic reactions:
• difficulty breathing or swallowing, swelling of the face, lips, tongue or
throat
• severe itching of the skin, with a red rash or raised lumps
• blistering of the mouth, eyes, and genital region, and patchy areas of
rash, peeling skin
or any of the following reactions
• diarrhoea
• passing blood in your stools (faeces/motions)
• passing black tarry stools
• vomiting any blood or dark particles that look like coffee grounds.
Seek immediate medical attention if you have any of the following
symptoms:
• indigestion or heartburn, abdominal pain (pain in your stomach) or
other abnormal stomach symptoms, nausea (feeling sick), vomiting
• any unusual bruising or bleeding, for example nose-bleeds, pinpoint
red spots on the skin, unusual purple bruise-like rash on the skin or
in the mouth
• signs of anaemia such as feeling tired, breathless, and looking pale
• fever, sore throat, mouth ulcers, repeated infections or infections that
will not go away. This may be due to a low level of white blood cells
• seizures (fits)
• signs of low sodium levels such as headache, nausea, vomiting,
tiredness, muscle cramps
• sudden headache, stiff neck, fever, sensitivity to bright light,
drowsiness and muscle pain, with or without a rash
• fever, rash, nausea, aches and pains, passing more or less urine
than usual, passing red urine or passing urine at night. This may be
due to changes in your kidneys
• sudden loss or blurring of vision, loss of colour vision, eye pain which
worsens with eye movement
• headache, in particular on waking in the morning. This may be due to
high blood pressure
• pain behind the ribs radiating towards the back, often worse when
lying down, nausea, vomiting, fever. This may be due to inflammation
of your pancreas
• yellowing of your skin or eyes, pale faeces and dark urine,
unexplained persistent nausea, stomach problems, loss of appetite
or unusual tiredness. This may be due to changes in your liver.
Tell
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your doctor if you get any of the following side effects:
head-spins (vertigo)
fatty stools
sweating
rapid heartbeat (palpitations)
mental confusion
loss of appetite
constipation or bloating
blurred vision, eye irritation
feeling ill (malaise)
ringing or buzzing in the ears (tinnitus)
numbness or tingling in hands or feet
sudden poor blood sugar control if you have diabetes. Your doctor or
pharmacist can measure your sugar levels
asthma or asthma that is worse than usual
swelling of your hands and feet (around the ankles)
sore mouth (pain or ulcers on the tongue, cheeks, lips, throat or
gums)
dizziness, drowsiness, feeling lethargic and tired
signs of low blood pressure such as light-headedness
reactions to the sun. Your skin may become red, painful and swollen
— do not sunbathe, use a sun bed, or expose your skin to artificial UV
light.
depression
inability to sleep
hallucinations
nervousness
ear pain

Medicines such as Ponstan Forte may be associated with a small
increased risk of heart attack or stroke. (See Section 2 — end of
‘Take special care’).

Urine tests: Tell the doctor if you are having urine tests, as your medicine
may affect the results.
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. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.

5) How to store
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Keep out of the sight and reach of children.
Do not store above 30°C.
Store in in the original package.
Do not use this medicine after the expiry date which is stated on the
carton and blister. The expiry date refers to the last day of the month.
• 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.
• If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will
tell you what to do.

6) Further information
What Ponstan Forte contains:
The active ingredient is mefenamic acid. Each film-coated tablet contains
500mg mefenamic acid.
The other ingredients are: lactose monohydrate, maize starch,
pregelatinised maize starch, povidone, silicon dioxide, talc, magnesium
stearate, croscarmellose sodium type A, sodium laurilsulfate.
The film coating contains: hypromellose, titanium dioxide (E171), lactose
monohydrate, macrogol 4000, vanillin, quinoline yellow (E104), sunset
yellow (E110).
The polish contains: purified water, beeswax white, carnauba wax yellow,
polysorbate 20, sorbic acid (E200).
See end of Section 2 for further information on lactose and sunset yellow
(E110).
What Ponstan Forte looks like and contents of the pack
Ponstan Forte Tablets are yellow, film-coated tablets, marked ‘Ponstan
Forte’ on one side, plain on the other.
They are available in blister packs containing 100 tablets.
PL 10383/2213

Ponstan Forte 500mg Tablets/
Mefenamic acid 500mg Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Dales Pharmaceuticals Ltd, Snaygill
Industrial Estate, Keighley Road, Skipton, BD23 2RW, UK.
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex UB5 5QS.
Leaflet date: 10.01.2017
Ponstan® is a registered trademark of Chemidex Pharma Limited, UK.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8839 3000 to obtain the
leaflet in a format suitable for you.

Таблетки Ponstan Forte — нестероидный противовоспалительный препарат (НПВП) с обезболивающими и жаропонижающими свойствами.

Таблетки Ponstan Forte (Понстан Форте). Инструкция по применению

1. Наименование лекарственного средства

2. Cостав

3. Фармацевтическая форма

4. Клинические характеристики

4.1 Терапевтические показания

Мефенамовая кислота является нестероидным противовоспалительным средством, обладающим обезболивающими свойствами и выраженным жаропонижающим действием. Было показано, что она ингибирует активность простагландина.
Показания к применению Ponstan Forte (Понстан Форте)

• В качестве противовоспалительного анальгетика для облегчения симптомов ревматоидного артрита (включая болезнь Стилла), остеоартрита и боли, включая мышечные, травматические и зубные боли, головные боли, послеоперационные и послеродовые боли.
• Первичная дисменорея.
• Меноррагия из-за дисфункциональных причин и наличия ВМС, когда исключена другая патология таза.

4.2 Дозировка и способ применения

Нежелательные эффекты можно минимизировать, используя самую низкую эффективную дозу в течение короткого периода времени, необходимого для контроля симптомов.

Препарат предназначен для перорального применения.

Пожилые люди (старше 65 лет)

4.3 Противопоказания

• Повышенная чувствительность к мефенамовой кислоте или любым другим компонентам в составе препарата.
• Воспалительное заболевание кишечника.
• Желудочно-кишечное кровотечение или перфорации, связанные с предыдущей терапией НПВП.
• Активная или в анамнезе рецидивирующая язвенная болезнь / кровоизлияние (два или более различных эпизода доказанного изъязвления или кровотечения).
• Тяжелая сердечная недостаточность, печеночная недостаточность и почечная недостаточность.
• Поскольку существует вероятность перекрестной чувствительности к аспирину, ибупрофену или другим нестероидным противовоспалительным препаратам, нельзя назначать мефенамовую кислоту пациентам, у которых ранее наблюдалась реакция гиперчувствительности (например, астма, бронхоспазм, ринит, ангионевротический отек или крапивница) на эти препараты.
• В течение последнего триместра беременности.
• Лечение боли после операции аортокоронарного шунтирования (АКШ).

4.4 Особые предупреждения и меры предосторожности при приеме Ponstan Forte (Понстан Форте)

Пациенты с неконтролируемой гипертонией, застойной сердечной недостаточностью, установленной ишемической болезнью сердца, заболеванием периферических артерий и / или цереброваскулярными заболеваниями должны лечиться только мефенаминовой кислотой после тщательного осмотра.

Пациенты с редкими наследственными проблемами непереносимости галактозы, дефицита лаппазы или мальабсорбции глюкозы-галактозы не должны принимать это лекарство.

4.5 Взаимодействие с другими лекарственными средствами и другие формы взаимодействия

4.6 Беременность и кормление грудью

4.7 Влияние на способность управлять транспортным средством и оборудованием

4.8 Побочные эффекты от приема Ponstan Forte (Понстан Форте)

Сердечно-сосудистые заболевания
Отек, гипертония и сердечная недостаточность были зарегистрированы в связи с лечением НПВП.
Клинические исследования и эпидемиологические данные позволяют предположить, что использование некоторых НПВП (особенно в высоких дозах и при длительном лечении) может быть связано с повышенным риском развития артериальных тромботических событий (например, инфаркта миокарда или инсульта) (см. Раздел 4.4).

Сильное сердцебиение.

4.9 Передозировка

5. Фармакологические свойства

5.1 Фармакодинамические свойства

5.2 Фармакокинетические свойства

6. Фармацевтические особенности

6.1 Список вспомогательных веществ

6.2 Несовместимость

6.3 Условия хранения

6.4 Содержимое упаковки

7. Владелец торговой лицензии

Chemidex Pharma Limited
Великобритания, Англия.

   

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
                                
                                Read the complete document
                                
                            

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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