PACKAGE LEAFLET: INFORMATION FOR THE USER

MIGRADON® - Tablets

Propyphenazone, Paracetamol, Caffeine

Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Migradon® according to the instructions to get the best treatment results from it.
-    Keep this leaflet. You may need to read it again.
-    Ask your pharmacist if you need more information or advice.
-    You must contact a doctor if your symptoms worsen or do not improve .
-    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 Migradon® is and what it is used for
2.    Before you use Migradon®
3.    How to use Migradon®
4.    Possible side effects
5.    How to store Migradon®
6.    Further information

1. What Migradon® is and what it is used for
Migradon® tablets are a fast-working analgesic and antipyretic drug.
Indications:
-    To relieve acute, short-term, minor, non-inflammatory painful conditions such as headache, earache, toothache, pain in the back or period pains,
-    To lower fever

2. Before you use Migradon®
Do not use Migradon®,
-    if you are hypersensitive  (allergic) to one of the active ingredients propyphenazone, paracetamol and/or caffeine, pyrazole-derivatives or any of the other ingredients of Migradon®.
-    if you have bone marrow damage
-    if you have severe liver or kidney damage
-    if you have a genetically caused glucose-6-phosphate-dehydrogenase deficiency (a very rare, hereditary metabolic disease)
-    if you have hepatic porphyria (hereditary enzyme defects or acquired dysfunction of the metabolism)
-    in case of excessive or chronic consumption of alcohol
-    if you have a headache caused by medication
-    by children and adolescents under the age of 18
-    if you are pregnant or breastfeeding  

Take special care with Migradon®
-    if you suffer from liver dysfunctions
-    if you suffer from severe kidney dysfunctions
-    if you suffer from Gilbert’s syndrome (Meulengracht’s disease)

Consult your doctor if your fever is very high, in case of signs of an infection or if symptoms continue for more than three days.

High doses of painkillers taken over longer periods and not according to the intended use can cause headaches.  These should not be treated by taking an even higher dose of the medicine.  Exceeding the recommended dosage can lead to very severe liver damages.  In order to avoid taking an overdose, make sure that any other medicine you are taking at the same time does not contain paracetamol.

Generally, the habitual use of painkillers, especially in case of combination of several analgetic ingredients, can lead to permanent kidney damage with the risk of kidney failure (so called analgesic-nephropathy).

Abrupt discontinuation of high doses of painkillers which have been taken for longer periods of time and not according to the intended use can cause headaches as well as fatigue, muscular pain, nervousness and symptoms such as digestive disorders, cardio-rhythmic disorders, or sleeping disorders.  These troubles subside within a few days.  Until then, no more pain killers of any kind should be taken and they should not be taken again without the advice of your doctor.

Patients suffering from asthma or chronic respiratory infections (in particular if accompanied by symptoms of hay fever) and patients who are hypersensitive to painkillers and medication for rheumatism (analgesic-asthma) run the risk of shock when using Migradon®.  They should consult their doctor before taking Migradon®.

Special precautions should be taken by patients suffering from gastric or intestinal ulcers or bleeding.
Use only low doses of caffeine containing medication if you suffer from:
-    cardio-rhythmic disorders with increased heart rate
-    cirrhosis of the liver
-    hyperthyroidism
-    anxiety
-    gastric or duodenal u1cers

Using other medicines
Please tell your doctor or pharmacist if you are taking /applying or have recently taken / applied any other medicines, including medicines obtained without a prescription.

Migradon® tablets may intensify or reduce the effect of other medicines. They should therefore not be taken together with the following other medicines without medical advice.

Increase
-    the effect of anticoagulants (blood thinning drugs), especially in case of prolonged, regular administration; in case of occasional administration, there is only a negligible influence
-    the formation of harmful residues by medicines stimulating hepatic activity (such as barbiturates, anti-epileptic drugs or rifampicin)
-    certain medicines taken to reduce uric acid (probenecid) will increase the availability of paracetamol; therefore the dosage of paracetamol should be reduced.
-    salicylamides (analgesics) may lead to a prolongation of the decomposition of paracetamol and to the formation of its harmful degradation product.
Special precaution is required if you are at the same time taking medication which may damage the liver or stimulate metabolism.
     
Decrease
-    the degradation rate of certain antibiotics is reduced (chloramphenicol to one-fifth);
-    colestyramine, which reduces blood lipids, also reduces the absorption of paracetamol

If paracetamol is taken simultaneously with certain medicines against viral infections (zidovudine) the tendency to reduce certain white blood cells is intensified and can result in increased danger of infection. Therefore Migradon® should only be taken together with zidovudine with the specific advice of your doctor.
The absorption and effect of paracetamol may be delayed by the simultaneous use of medicines which slow down gastric emptying, e.g. propantheline.   The simultaneous use of medicines which speed up gastric emptying, e.g. metoclopramide, accelerates the absorption of paracetamol thus making it come into effect more quickly.

Effects on laboratory test results 
Paracetamol may influence the determination of uric acid as well as the determination of the blood sugar level.
Caffeine speeds up the absorption of certain medication for migraine (ergotamine).
Simultaneous consumption of alcohol increases the liver-damaging effect of paracetamol.

Caffeine weakens the calmative effect of numerous substances, e.g. barbiturates and anti-histamines.
Caffeine intensifies the cardiac acceleration effect of some cardiac medicines (e.g. sympathomimetics and pyridoxine).
Interactions with certain broad-spectrum sedatives vary widely and are not predictable (such as in case of benzodiazepines).
Certain contraceptives (“the pill”), medication for reducing gastric acid (cimetidine) and disulfiram (a habit-breaking drug for alcoholics) reduce the decomposition of caffeine in the liver; certain sleeping pills (barbiturates) and smoking speed up this process.
Caffeine reduces the excretion of theophylline. Caffeine increases the addiction potential of ephedrine-type substances.
The simultaneous administration of certain antibiotics (gyrase inhibitors) may delay the excretion of caffeine and its degradation product paraxanthine.

Using Migradon® with food and drink
Avoid drinking alcohol if you are taking Migradon®.
Pregnancy and breast-feeding
Please consult your doctor or pharmacist before taking medication of any kind.
Migradon® tablets should not be taken during pregnancy or if breast-feeding.
    Driving and using machines
Migradon has no effect on your ability to drive a car or operate machines.

3. How to take Migradon®
Only take Migradon® exactly in accordance with the dosage guidelines or the instructions of your doctor. Always consult your doctor or pharmacist, if you feel unsure. Unless otherwise prescribed by the doctor, the usual dose is:
Adults: 1~2 tablets as needed; up to a maximum of 5 tablets daily.
You should not take this medicine without medical advice for more than 10 days per month, or for more than 3 days at a time and you should never exceed the indicated dose.
Patients suffering from kidney/liver disorders
For patients with liver or kidney disorders and those suffering from Gilbert’s syndrome, the dosage must be reduced or the interval between each dose extended. In the case of severe kidney dysfunction (creatinine clearance 10 ml/min) an interval of at least 8 hours between each dose must be observed. 

How to take this medicine
Take with plenty of liquid or dissolve the tablets in liquid and drink plenty of liquid afterwards.
If you use more Migradon than you should
Consult your doctor immediately, as exceeding the recommended dosage may result in severe liver damage. Do not take any further medicine containing paracetamol. Your doctor will apply an antidote as soon as possible or take other adequate measures.
If you forget to take Migradon®
Do not take a double dose to make up for a forgotten dose of Migradon®.

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

4. Possible side effects

Like all medicines, Migradon can cause side effects, although not everybody gets them.
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.
The following side-effects are rare (occur in less than 1 out of 1,000 patients):
Caffeine may cause sleeping disorders and head pressure, nausea, allergic skin reactions possibly accompanied by a rise in temperature (“drug fever”) and mucous membrane wounds.
The following side-effects are very rare (occur in less than 1 out of 10,000 patients")
Allergic reactions of the bone marrow (such as pancytopenia, leucocytopenia, thrombocytopenia, agranulocytosis), certain blood diseases (methemoglobinemia), asthma, hay fever, swelling of the nasal mucous membrane.
A severe hypersensitive reaction (anaphylactic shock) may occur up to 1 hour after using propyphenazone.
In individual cases the active substance paracetamol has been known to cause hypersensitive reactions (skin swelling, shortage of breath, sweating, nausea, blood pressure decrease resulting in shock).
Taking a high dosage of paracetamol (or a prolonged chronic use of several grams per day) may result in severe damage to the liver and kidneys.

5. How to store Migradon®

Keep out of the reach and sight of children.
Do not use Migradon after the expiry date whisch is stated on the outer package and the blisterpacks. The expiry date refers to the last day of that month
Do not store above 25°C. Protect from sunlight.
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.

6. Further information

What Migradon® contains
- The active substances are: propyphenazone, paracetamol and caffeine
- The other ingredients are: potato starch, talcum, magnesium sulphate, PVP (poly vinyl pyrrolidone) K25 and aerosol 300.

1 tablet contains:      propyphenazone     250 mg
                                  paracetamol            150 mg   
                                  caffeine                     46 mg      

          
What Migradon® looks like and contents of the pack?
Round white tablets
Package size: 20 tablets – each package contains 2 blister stripes of 10 tablets

Marketring Authorosation Number
1-18363

Marketing Authorisation Holder and Manufacturer
F. Trenka Chem.-pharm. Fabrik Ges.m.b.H
 Goldeggasse 5
A 1040 Vienna
Tel.: 0043 1 505 03 41
Fax: 0043 I 505 03 41 31
e-mail: \n Esta dirección de correo electrónico está protegida contra los robots de spam, necesita tener Javascript activado para poder verla This email address is being protected from spam bots, you need Javascript enabled to view it

This leaflet was last approved in 09/2007.
 
The following information is intended for medical or healthcare professionals only: Overdose
Symptoms:
Propyphenazone and caffeine:
In the case of a severe overdose, drowsiness or unconsciousness, visual disorders, convulsions, status epilepticus, allergies, agranulocytosis, overexcitement and cardio-rhythmic disorders may occur.
Symptoms of intoxication may occur if 1g or more of caffeine has been taken within a short space of time.

Paracetamol:
There is a risk of intoxication, especially in older people, young children, and patients with liver disorders, or in cases of chronic alcohol misuse, chronic malnutrition and simultaneous intake of drugs taken for enzyme induction. In these cases an overdose may be lethal. The symptoms occur within 24 hours: nausea, vomiting, anorexia, pale skin and intestinal pain. Although an improvement of the patient’s subjective feeling may occur, slight intestinal pain will hint to liver damage.
An overdose of about 6g or more paracetamol as a single adult dose will cause liver cell necrosis, which may lead to a totally irreversible necrosis and later to hepatic cellular insufficiency, metabolic acidosis and encephalopathy. These, in turn, may lead to coma or even lethal coma. At the same time, increased concentrations of liver transaminases (AST, ALT), lactate dehydrogenise and bilirubine in combination with increased prothrombin time have been observed, which may occur 12 - 48 hours after administration.  Clinical symptoms of liver damage will usually show after 2 days and reach their peak after 4 -6 days.  Even if there is no severe liver damage, acute renal failure with acute renal tubule necrosis may occur.  Other non-hepatic-related symptoms, which have been observed following paracetamol overdoses, were myocardium anomalies and pancreatitis.
Therapy measures for an overdose

Treatment:
If paracetamol intoxication is suspected, intravenous administration of SE group donators such as acetyl-cysteine within the first 10 hours is expedient.  N-acetyl-cysteine within the first 10 hours – e.g.  rnucomyst solution (oral: initial dose 140mg per kg body weight, followed 8 hours later by doses of 70mg per kg body weight every 4 hours to maintain the level of concentration).   N-acetyl cysteine can also provide some protection after 10 and up to 48 hours. In this case long-term administration of the drug should be carried out.  Patients with an asthma anamnesis may experience a fit initiated by N-acetyl cysteine therapy. The concentration of paracetamol in plasma can be reduced by dialysis. Determination of the paracetamol concentration in the plasma is recommended. Further therapeutic measures for the treatment of Migradon intoxication are the ones usually taken in intensive care and will depend on the clinical symptoms and the extent and stage of intoxication.