Adalgur N®
Paracetamol
Thiocolchicoside

COMPOSITION
Paracetamol (DCI) ..................................... 500 mg
Thiocolchicoside .......................................... 2 mg

Excipients...........q.s. ............................... 1 tablet

PHARMACEUTICAL FORM
Package with 20 or 50 tablets.

PHARMACOTHERAPEUTIC GROUP
2.3.2
Association of one analgesic and one antipyretic, with a muscle relaxant.

This way, we are able to eliminate the pain and contraction in several clinical processes, when these factors are present at the same time.

MARKETING AUTHORIZATION HOLDER
ANGELINI FARMACÊUTICA, LDA Rua João Chagas, nº 53 – 3º Piso
1495-072 ALGÉS

INDICATIONS
Symptomatic treatment of mild to moderate pains of muscle-skeletal origin.

Complementary treatment muscular contractures in rheumatology.

CONTRAINDICATIONS AND SIDE EFFECTS
Contraindications

Hypersensitivity to the active substance or any of its excipients.
The medicine is contraindicated in case of serious hepatic impairment.
Do not administer in case of flaccid paralysis or muscular hypotonia. Contraindicated in children under 10 years.
Paracetamol is contraindicated in individuals that suffer from renal disorders, unless recommended by the doctor.

Side effects

Side effects are generally infrequent but they can be important in some cases, particularly when related to paracetamol.
Hepatotoxicity with high doses and prolonged treatments.
Rarely, rash and changes in blood values may occur (trombocytopenia, pancytopenia, neutropenia, agranulocytosis and haemolytic anaemia). It was also described the occurrence of pancreatitis, fever, hypoglicemia and jaundice.
Exceptionally it may occur gastralgias and diarrhoea.

DRUG INTERACTIONS AND OTHER FORMS OF INTERACTION
Adalgur N may increase the toxicity of chloramphenicol.

Adalgur N may potentiate the effect of anticoagulants. However, in case of treatment with oral anticoagulants, you can take Adalgur N, occasionally, as preferred analgesic.

The simultaneous administration of Adalgur N with aspirin, salicylates or non-steroidal anti-inflammatory drugs is not recommended. The concomitant use of diflunisal with Adalgur N increases the risk of hepatotoxicity. The expected analgesic response of this medicine is changed by the administration of barbiturates. The effect of Adalgur N is inhibited by the administration of cholestipol, cholestiramine and estrogens. Isoniazide reinforces the hepatotoxic capacity of Adalgur N.

The following laboratory values may be increased: (plasmatic transaminases, alkaline phosphatase, ammoniac, creatinine, lactatedehydrogenase and urea. Adalgur N may cause interferences in the determination of glucose and uric acid in the blood and metadrenaline ad uric acid in the urine.

SPECIAL PRECAUTIONS FOR USE
Do not exceed the maximum dose recommended per day.
In treatments of more than 3 days, it is recommended that the patient consults a doctor.
The concomitant treatment with drugs that have a potentially hepatotoxic action should be avoided. Do not associate to the consumption of alcoholic drinks.

EFFECTS ON PREGNANT WOMEN, BREAST-FEEDING WOMEN, CHILDREN, ELDERLY PATIENTS AND PATIENTS WITH SPECIAL PATHOLOGIES
Pregnancy

In studies with animals there are reports of malformations caused by Thiocolchicoside. There are no adequate studies in pregnant women.
Therefore, the use of this medicine during pregnancy is not recommended, particularly, during the first three months of pregnancy, because the safety to the embryo and foetus was not established. The ingestion of this medicine during pregnancy should be monitored by the doctor, who should evaluate the risk-benefit relationship of the prescription.

Lactation
Adalgur N passes to human milk therefore it is not recommended in breast-feeding women.

Elderly
No special precaution is necessary when the product is used in geriatric patients.

Patients with other pathologies
In patients with hepatic and/or renal impairment, anaemia, cardiac or pulmonary problems avoid prolonged treatments. In case of prolonged administration, these patients should be clinically monitored.

EFFECTS ON THE ABILITY TO DRIVE OR TO USE MACHINES
No changes were reported.

EXCIPIENTS
Corn starch
Hydroxypropylcellulose
Carboxymethyilamide
Magnesium stearate
Talc

POSOLOGY
Adults:
- 1 to 2 tablets, 3 or 4 times a day.
Do not exceed the dose of 8 tablets in 24 hours.
The use of the medicine is not recommended in children.

The administration of Adalgur N is not indicated in painful symptoms, fever and contracture.
As soon as symptoms disappear, the medication should be discontinued.

ADMINISTRATION MODE AND ROUTE
Oral route.

MEASURES TO ADOPT IN CASE OF OVERDOSAGE AND/OR INTOXICATION
The symptoms of overdosage include nauseas, vomits, anorexia, abdominal pain and diarrhoea. If you have ingested an overdosage (more than 6 g of paracetamol in a single administration, equivalent to 12 tablets in adults or more than 100 mg/kg in children), you should go to the nearest hospital even if you do not experience any symptoms, since symptoms, generally very serious, only start on the 3rd day following ingestion of the overdosage.

Treatment includes:
• Gastric lavage or vomit induction
• Oral administration of activated carbon
• Haemodialysis
• Administration of acethylcisteine in adequate doses.

The patient should inform his/her doctor or pharmacist about the undesirable effects detected and which are not included in the patient leaflet.

The patient should check the expiry term stated on the package or container.

DATE OF THE REVISION OF THE LEAFLET : January 2005.

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