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Laboratorios ERN, S.A. informs that some of the contents of this website are addressed exclusively to healthcare professionals, authorized for prescribing or dispensing of drugs. Specialized knowledge is required for proper interpretation.

DOLMEN-ERN

Dolmen

Ácido acetilsalicílico, fosfato de codeína y ácido ascórbico.

Comprimidos efervescentes.

Alivio sintomático de los dolores ocasionales leves o moderados.

Tratamiento de la inflamación no reumática.

Tratamiento de la artritis reumatoide, artritis juvenil, osteoartritis y fiebre reumática.

Estados febriles.


    Packet with 10 effervescent tablets

    Financed by the S.N.S.

    N.C. 747097.7


    Packet with 20 effervescent tablets

    Financed by the S.N.S.

    N.C. 747105.9

ORALLY ADMINISTERED

Adults and those over 16: take i1effervescent tablet every 4-6 hours, up to a maximum of 8 effervescent tablets a day if necessary.
Patients with reduced renal or liver functions: consult your doctor as the dose will have to be reduced.

Administration of this medicine is dependent on the apparition of symptoms of pain or fever. As these disappear this medication must be suspended.

DOLMEN

Read the whole of this medication guide in detail, because it contains information that will be important to you.
This medication can be obtained without a prescription for the treatment of minor afflictions without the intervention of a doctor. However, you must use Dolmen with care to obtain the best results.
-Keep this leaflet; you may need to read it again.
-If you have any doubts, consult your doctor or pharmacists.
This medicine has been prescribed to you and must not be given to others. It may harm them, even when their symptoms are the same as yours.

In this leaflet:
1. What is Dolmen and what is it used for?
2. Before taking Dolmen
3. How to take Dolmen
4. Possible side effects
5. Conservation of Dolmen

Each effervescent tablet contains 500 mg of acetyl salicylic acid, 10 mg of codeine phosphate and 250 mg of ascorbic acid as its principal ingredients. The remaining components are citric acid, sodium benzoate (E-211), sodium bicarbonate, anhydrous monosodium citrate, nuclearoma orange 32N-1, povidone K-30, sodium saccharin.

1. WHAT IS DOLMEN AND WHAT IS IT USED FOR?

DOLMEN is presented in containers of 10 and 20 effervescent tablets, in an aluminium tube. The tablets are round, white and do not have any marks.

Acetyl salicylic acid belongs to the analgesic, antipyretic and anti inflammatory non steroid group of medicines, codeine phosphate is a light opiate and ascorbic acid is vitamin C. Dolmen is indicated for the symptomatic relief of occasional light or moderate pain, such as headaches, dental pain, menstrual pain and back ache. It is also indicated for the treatment of non rheumatic inflammation and the treatment of rheumatoid arthritis, juvenile arthritis, osteoarthritis and rheumatic fever.
It is also indicated for fevers.

2. BEFORE TAKING DOLMEN

Do not take Dolmen:
-If you suffer from or have suffered from gastric ulcers, repeated duodenal or gastric discomfort.
-If you have had allergic reactions like asthmatic ones (breathing difficulty, drowning feeling, bronco spasms, and in some cases coughing or whistling when breathing) upon taking anti inflammatories, acetyl salicylic acid, analgesics, or the colouring agent, tartrazine.
-If you are allergic to codeine phosphate, ascorbic acid or any other component of this medicine.
-If you suffer from or have suffered asthma, rhinitis, or uticaria.
-If you suffer from haemophilia or other blood coagulation problems which predispose you to internal haemorrhages.
-If you are having treatment with drugs for blood clotting (oral anticoagulants).
-If you have kidney and/or liver problems (renal and/or hepatic insufficiency).
-If you suffer from renal stone fragmentation accompanied by oxaluria or aciduria or normal urinary pH.
-If you have haematic alterations like a deficit of glucose-6-phosphate dehydrogenase, haemocromatosis, sideroblastic anaemia and talasaemia.
-If you have respiratory insufficiency.
-If you are under 16, as acetyl salicylic acid has been associated with Reye’s Syndrome, an infrequent but serious illness.
-If you suffer bile disorders.
-If you are in the third trimester of pregnancy.

Be especially careful with Dolmen:
If the kidney, heart or liver functions are reduced, have cranial injuries, hyperthyroidism, prostatic hypertrophia, suprarenal insufficiency, present alterations of blood clotting or are being treated with anticoagulants you must consult your doctor before taking this medicine.
If you are taking anti inflammatories or other types of medicine as certain medicines can interact with Dolmen and produce unwanted effects (see ‘Use of other medicines’).
If you suffer from or have suffered from rhinitis or hives.
Patients with a history of gallstones or gout must consult their doctor before taking this medicine.
If you are diabetic, due to this medicine’s ascorbic acid content, it is possible that it produces erroneous results in tests for glucose in urine, including tests with reactive strips.
In the case of suffering high intracranial pressure and cranial trauma, as codeine can increase the pressure of cerebrospinal fluid.
If you consider it necessary to continue the treatment beyond 10 days, consult your doctor.
If you habitually consume alcohol (3 or more drinks a day) as it can provoke liver damage and increase the risk of digestive haemorrhage.
If your doctor asks for a blood, urine, or other diagnostic test, indicate that you are taking this medication, as the values of the determinations can be altered.

In the case of continued administration you must inform your doctor or dentist before possible surgical interventions.

As it contains codeine it must be administered with care to those patients with a tendency towards addiction and abuse, as prolonged use can produce dependence.

Do not administer systematically as a form of prevention against possible discomfort caused by vaccines.

Taking Dolmen with food and drink:
Take this medication after meals or with some food.

If you habitually consume alcohol (3 or more drinks, beer, wine, spits… a day) taking Dolmen may produce a stomach hemorrhage.

Pregnancy
Consult your doctor or pharmacist before taking any medicine.

IMPORTANT FOR WOMEN
If you are pregnant or think you could be, consult your doctor before taking this medication. The consumption of Bioplak during the first and second trimester of pregnancy could be dangerous for the foetus or embryo and must be monitored by your doctor. You must not take Bioplak during the third trimester of pregnancy.

Breast feeding
Consult your doctor or pharmacist before taking any medicine.
Do not administer while breast feeding as this medicine is excreted with the maternal milk

Driving and using machines
Dolmen can make you feel drowsy, and so it is recommended to be careful when driving, using dangerous machines or in general doing activities where a lack of concentration is risky.

Important information about some of the components in Dolmen:
As this medicine contains 384mg of sodium in each tablet it can be prejudicial in patients with low sodium diets.

Use of other medicines:
Certain medicines can interact with Dolmen, in these cases it may be necessary to change the dose or interrupt the treatment of some of these medicines, as such they must not be used without consulting your doctor.
This is especially important in the case of:
-Other analgesics
-Blood clotting medicine (oral anticoagulants and anti platelets).
-Medication to reduce the amount of sugar in the blood (oral anti diabetics).
-Barbiturates (medicines used as sedatives, anti convulsions and for sleep problems).
-Corticoids, as they can increase the risk of digestive haemorrhage.
-Cymetidine and ranitidine (used for stomach acid).
-Dygoxine (heart medication).
-Phenytoin and valproic acid (anti epileptics).
-Lithium (used with depressions).
-Methotrexate (used in the treatment of cancer and rheumatoid arthritis).
-Probenicide and sulphenprazone (used in the treatment of gout).
-The antibiotic Vancomicine and Sulphamides (used with infections).
-Zidovudin (used in the treatment of HIV infections).
-Anticholinergics and codeine as they can cause intestinal obstruction.
-Ansyolitics and anti psychotics, as it can increase their sedative effect.
-Tricycle anti depressives or monominoxidose inhibitors.
-Hormonal contraceptives.

Inform your doctor or pharmacist if you are using or have recently used any other medicine, including those acquired without prescription.

Interference with diagnostic tests:
If you are going to have a diagnostic test (including blood, urine tests etc..) inform your doctor that you are taking this medication, as may alter the results, including those with reactive strips.

3. HOW TO TAKE DOLMEN

Follow these instructions unless your doctor has given you different ones.
Remember to take your medicine. Your doctor will indicate the duration of the treatment with Dolmen, do not suspend the treatment before this.

If you consider the effect of Dolmen to be too strong or weak, communicate this to your doctor or pharmacist.

In order to take Dolmen disolve the effervescent tablet in half a glass of wáter and wait till it disappears and the bubbling and effervescence disappears before drinking it. This medicine must be taken after meals or with some food.

ORALLY ADMINISTERED

Adults and those over 16: take i1effervescent tablet every 4-6 hours, up to a maximum of 8 effervescent tablets a day if necessary.
Patients with reduced renal or liver functions: consult your doctor as the dose will have to be reduced.

Administration of this medicine is dependent on the apparition of symptoms of pain or fever. As these disappear this medication must be suspended.

If the pain is maintained for longer than 10 days, or the fever for more than 3 days, or they worsen or new symptoms appear, you must interrupt the treatment and consult your doctor.

If you take more Dolmen than you should:
The principal symptoms of overdose are: headaches, dizziness, buzzing in the ears, blurred vision, drowsiness, sweating, nausea, vomiting and occasionally diarrhoea.
In the case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or phone the Toxicology Information Service, telephone 915620420, indicating the medicine and amount ingested.

If you forgot to take Dolmen:
Do not take a double dose to compensate the forgotten ones.

4. POSSIBLE SIDE EFFECTS

As with all medicines, Dolmen can have side effects.

The most common are gastrointestinal disorders , skin rashes, breathing difficulty drowsiness and dizziness.

Frequent side effects:
•    Gastrointestinal disorders, like gastric ulcers, duodenal ulcers, gastrointestinal bleeding, abdominal pain, gastric discomfort, nausea, vomiting.
•    Breathing disorders, such as breathing difficulty, bronchial spasms, rhinitis.
•    Hives, skin rashes, angioedema.
•    Hypothrombism (with high doses)
Infrequent side effects:

•    Reye’s Syndrome in those under 16 with fevers, flu or chicken pox.
•    Hepatic disorders, especially in patients with juvenile arthritis.
•    Occasionally, and at doses superior to 600 mg/day of vitamin C (3 tablets/day): diarrhea, reddening of the skin, headaches, nausea, vomiting and stomach cramps.
•    The risk of gallstones forming in the urinary paths or attacks of gout in individuals predisposed to these conditions exists.

If you observe the apparition of:
•    Gastric discomfort or pain, gastric or intestinal hemorrhage or black faeces.
•    Skin disorders, like rashes or reddening.
•    Breathing difficulty.
•    Unexpected change in the quantity or appearance of urine.
•    Swelling of the face, feet or legs.
Stop taking the medicine and consult your doctor immediately as they may indicate the apparition of side effects that need urgent medical attention.
Si se observa estos o cualquier otro efecto adverso no descrito en este prospecto, consulte a su médico o farmacéutico.

If you observe these or any other side effect not described in this leaflet consult your doctor or pharmacist.

5. CONSERVATION OF DOLMEN

Keep Dolmen out of reach and sight of children.

Keep the tube well closed and at temperatures below 25°C.

Do not use Dolmen after the expiry ate indicated on the container.

Medicines must not be disposed of in the drains or thrown away. Leave unwanted medicines and containers at the SIGRE point in a chemist. Ask your pharmacist how to dispose of any containers or unneeded medicines. This way you will help look after the environment.

Holder of the authorisation for the commercialisation and fabrication of the product.

LABORATORIOS ERN, S.A.
Pedro IV, 499
08020 Barcelona, España

Responsable for fabrication.
J. Uriach y Compañía, S.A.
Av. Camí Reial 51-57
08184 Palau-solità i Plegamans, Barcelona. España

This medication guide was approved: January 2006

Detailed and updated information about this product is available on the webpage of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/