NAME OF THE MEDICAL PRODUCT
Pepsamar (Aluminium Hydroxide)
Antacid of rapid and prolonged action.

Both Pepsamar tablets and gel are effective antacids, which produce a quick relief of the gastrointestinal symptoms, such as burning sensation, heartburn and acidity, by neutralization of the stomach chloridric acid. By reducing the gastric acidity, through an increase of the stomach pH, Pepsamar helps to prevent gastric irritation.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tea spoon of 5 ml contains 6.15% (307 mg) of Aluminium Hydroxide in a suspension with peppermint flavour.

PHARMACEUTICAL FORM
Gel in a 200 ml vial.

PHARMACOTHERAPEUTIC CLASS
Group VII-3-a) Antacids.

NAME OR DESIGNATION OF THE RESPONSIBLE FOR THE M.A
L. Lepori, Lda
R. João Chagas, nº 53-3º Piso
1495-072 Algés

THERAPEUTIC INDICATIONS
Pepsamar quickly relieves heartburn, burning sensation of the stomach, acidity and gastric discomfort.

CONTRAINDICATIONS AND SIDE EFFECTS
Hypersensitivity to the components of the product. The use of medicines containing aluminium hydroxide is contraindicated during treatments with tetracyclines, quinolones and other substances that form complexes with aluminium, since antacid interferes with the absorption of these antibiotics.

The administration to patients with renal impairment is contraindicated. The only side effects observed were constipation, which occurred in 30% of the patients and xerostomy, which was referred by just 5%.

In the last years, it has been suggested that, in rare cases of elderly individuals, specially predisposed, the administration of aluminium hydroxide during prolonged periods, can contribute to the emergence of dementia cases, due to the accumulation of very small quantities of absorbed cation.

DRUG INTERACTIONS AND OTHER FORMS OF INTERACTION
Aluminium hydroxide interferes with the intestinal absorption of tetracyclines, quinolones and other substances that form complexes with aluminium.

SPECIAL PRECAUTIONS FOR USE
It is recommended particular caution when applying high doses in patients with renal impairment, since in those patients the administration of aluminium compounds may aggravate an existent osteodistrofy or cause a proximal myopathy.
It is also recommended special caution in the use of the product in geriatric patients with osteoporosis, since this can be aggravated by phosphorus depletion, hypercalciuria and inhibition of fluor absorption, which in many cases are the result of the administration of aluminium compounds in high doses and for long periods.

Do not take more than 12 tea spoons in 24 hours or use the maximum dose for more than two weeks except if it is a direct indication of the doctor. If the symptoms persist or aggravate during treatment, consult your doctor.

EFFECTS ON PREGNANT WOMEN, BREAST-FEEDING WOMEN, CHILDREN, ELDERLY PATIENTS AND PATIENTS WITH SPECIAL PATHOLOGIES
There is no suggestive data that the use of aluminium hydroxide, during pregnancy or breast-feeding, has any harmful effects for the foetus or for the breast-fed children.
However, if you are pregnant or breast-feeding children under the age of 3 months, ask the advice of your doctor or pharmacist, before using this medicine.

EFFECTS ON THE ABILITY TO DRIVE OR TO USE MACHINES
No effects on the ability to drive and use machines were observed.

LIST OF EXCIPIENTS
Sodium benzoate, soluble saccharine, peppermint essence, sorbitol and purified water.

USUAL POSOLOGY, WITH REFERENCE TO MAXIMUM DOSE
One to three tea spoons, taken between meals and before going to bed at night, up to four times a day, or according to the doctor’s indication.

INDICATION OF THE MOST FAVOURABLE MOMENT FOR THE ADMINISTRATION OF THE MEDICINE
As soon as the acid syntomatology appears (heartburn, burning sensation in the stomach).

DURATION OF THE AVERAGE TREATMENT WHEN IT SHOULD BE LIMITED
The duration of the treatment depends on the clinical situation and its evolution.
However, if the symptoms continue or aggravate during treatment, you should see a doctor.

In the recommended doses, Pepsamar is practically devoided of toxicity and its use is not accompanied by unpleasant reactions.

Do not exceed the maximum dose for more than two weeks.

INDICATION OF HOW TO DISCONTINUE THE TREATMENT WHEN ITS DISCONTINUATION CAUSES WITHDRAWAL EFFECTS
If the administration of one or more doses is omitted, treatment should continue.

No special precaution is necessary to suspend the treatment.

MEASURES TO ADOPT IN CASE OF OVERDOSAGE AND/OR INTOXICATION, EMERGENCY SYMPTOMS AND ANTIDOTES
In case of accidental overdosage seek medical assistance immediately. It is unlikely the occurrence of severe symptoms after an overdosage, in any case treatment should be symptomatic.

The ingestion of the medicine in large quantities can be harmful in patients with renal impairment, due to the action of the aluminium ion, which can cause flaccid paralysis and risk of respiratory depression. In such cases, patients must be hydrated, with the administration of 10 to 20 ml of gluconate or calcium chloride through endovenous route. Haemodialysis will only be necessary in extreme cases.

ADVICE TO THE PATIENT
If you notice any side effect not mentioned in this leaflet, please inform your doctor or pharmacist.

Check if the product is within the expiry date mentioned in the package.

Always keep medicines out of reach and sight of children.
Medicine not subject to medical prescription.
If you have any doubts, ask your doctor or pharmacist.

If the symptoms persist or aggravate, see your doctor or pharmacist.

SPECIAL PRECAUTIONS OF STORAGE AND INDICATION OF VISIBLE SIGNS OF DETERIORATION, IF THEY EXIST
Do not store above 25ºC.

DATE OF THE LAST REVISION OF THE LEAFLET : February 2004 .

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