Actal

Actal

Manufacturer:

A. Menarini

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Sodium polyhydroxyaluminum monocarbonate hexitol complex.
Description
The active ingredient is sodium polyhydroxyaluminium monocarbonate hexitol complex which contains aluminium hydroxide. Each ACTAL tablet contains 360.0mg of sodium polyhydroxyaluminium monocarbonate hexitol complex which is equivalent to 216.0mg of aluminium hydroxide.
Free from foreign matter, no chipping and capping.
Excipients/Inactive Ingredients: corn starch, mannitol, purified talcum, magnesium stearate, sodium saccharin, peppermint oil and purified water.
Action
ACTAL Tablet rapidly neutralizes hyperacidity of gastric contents.
Indications/Uses
ACTAL Tablet is used for the relief of stomach discomfort such as indigestion, heartburn due to gastric hyperacidity (excessive acid) and peptic ulcer (an ulcer of the stomach, duodenum or lower end of esophagus).
Dosage/Direction for Use
ACTAL Tablet should be sucked and chewed before swallowed.
How much to take: Gastric Hyperacidity: Suck and chew 1 to 2 tablets, half an hour to one hour after each meal and at bed time.
Heartburn / Indigestion: Suck and chew 1 to 2 tablets, half an hour to one hour after each meal and at bed time.
Peptic Ulcer: Suck and chew 2 to 4 tablets, half an hour to one hour after each meal and at bed time.
ACTAL Tablet should be sucked and chewed before swallowed.
Do not take more than 4 tablets in a 24 hour period or use the maximum dosage for more than 2 weeks, except under the supervision of a physician.
When to take ACTAL Tablet: The administration depends on the patient's condition. It is important to take the medicine at the right time. The patient should talk to the doctor or pharmacist for further information.
How long to take it: The administration depends on the condition. The patient should talk to the doctor or pharmacist for further information.
If the patient forget to take ACTAL Tablet:
The patient should tell the doctor or pharmacist. Do not take a double dose to make up for a forgotten dose.
Overdosage
Large doses can cause intestinal obstruction. Excessive doses, even normal doses in patient with low-phosphate diets may lead to phosphate depletion accompanied by increased resorption (the process by which something is re-absorbed) and urinary excretion of calcium with the risk of renal rickets (a disorder which leads to softening and weakening of the bones) in the young or bone softening in the older patients.
In order to reduce the constipating effects, aluminium hydroxide is often given with a magnesium-containing antacid, such as magnesium oxide or magnesium hydroxide.
Aluminium hydroxide is poorly absorbed and unlikely to cause serious symptoms following overdosage.
Hence, there is no specific treatment or antidote (a medicine or substance that counteracts or neutralizes the effects of a poison) for overdosage.
If the patient take more ACTAL Tablet than the patient should, tell the doctor or pharmacist.
Contraindications
Do not take ACTAL Tablet if the patient is a hypophosphataemia (low level of phosphorus in the blood) patient.
ACTAL Tablet is an antacid. Antacids should preferably not be taken at the same time as other medicines as they may impair their absorption. Antacids may also damage enteric (intestinal) coatings designed to prevent dissolution in the stomach. The complete list of interactions is stated under Interactions.
If the patients have known hypersensitivity to the active ingredient and any other component of the preparation.
Special Precautions
Before the patient start to take ACTAL Tablet: Before taking ACTAL Tablet, tell the doctor or pharmacist.
There are a few precautions to be noted: Antacids should preferably not be taken at the same time as other medicines as they may impair their absorption. Antacids may also damage enteric coatings designed to prevent dissolution in the stomach.
In general, aluminium salts are not well absorbed from the gastrointestinal tract. Therefore, systemic effects (adverse effect of a medical treatment that affects the body as a whole, rather than one part) are rare in patients with normal renal (kidney) function.
Care is necessary in patients with chronic renal impairment. Diseases such as: osteomalacia (bone softening); adynamic bone (causing a loss of strength or function of the bone); encephalopathy (disorder of the brain); dementia (loss the ability to think); microcytic hypochromic anaemia (red blood cells are smaller and paler than normal); have been associated with aluminium accumulation in such patients when given large doses of aluminium hydroxide as a phosphate-binding agent. Similar side effects have also been associated with the aluminium content of dialysis fluid.
While taking ACTAL Tablet: Things the patient must do: Tell all the doctors, dentists and pharmacists that the patient is taking ACTAL Tablet.
Things the patient must not do: Do not give ACTAL Tablet to anyone else, even if they have the same symptoms or condition as the patient.
Things to be careful of: This medicine or the stomach discomfort itself may affect the ability to drive or use machines. If the tablets or the discomfort make the patient feel sick, dizzy or tired, or gives the patient a headache, do not drive or use machines and contact the doctor immediately.
Use In Pregnancy & Lactation
Safety in pregnancy and lactation is not established.
Side Effects
ACTAL Tablet contains aluminium hydroxide. Aluminium hydroxide, like other aluminium compounds, is astringent and may cause constipation; large doses can cause intestinal obstruction.
The patient may report any side effects or adverse drug reactions directly to the National Centre for Adverse Drug Reaction Monitoring by calling Tel: 03-78835550, or visiting the website portal.bpfk.gov.my (Consumers - Reporting).
Drug Interactions
Antacids interact with many other medicines both by alterations in gastric acidity and emptying, and by formation of complexes that are not absorbed.
Interactions can be minimized by giving the antacid and any other medications 2 to 3 hours apart.
The complete list of interactions is stated as follows: ACE Inhibitors: antacids reduce absorption of fosinopril.
Analgesics: excretion of aspirin increased in alkaline urine; antacids reduce absorption of diflunisal.
Anti-arrhythmics: excretion of quinidine reduced in alkaline urine (may occasionally increase plasma concentrations).
Antibacterials: antacids reduce absorption of azithromycin, cefpodoxime, ciprofloxacin, isoniazid, nitrofurantoin, norfloxacin, ofloxacin, pivampicillin, rifampicin, and most tetracyclines.
Antiepileptics: antacids reduce absorption of gabapentin and phenytoin.
Antifungals: antacids reduce absorption of itraconazole and ketoconazole.
Antiplatelet Drugs: dipyridamole patient information leaflet advises avoidance of antacids.
Antimalarials: antacids reduce absorption of chloroquine and hydroxychloroquine.
Antipsychotics: antacids reduce absorption of phenothiazines.
Bisphosphonates: antacids reduce absorption.
Iron: magnesium trisilicate reduces absorption of oral iron.
Lithium: sodium bicarbonate increases excretion (reduced plasma-lithium concentration).
Mycophenolate Mofetil: antacids reduce absorption of mycophenolate mofetil.
Penicillamine: antacids reduce absorption.
Please tell the doctor or pharmacist if the patient is taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines.
Caution For Usage
Disposal: If the doctor or pharmacist tells the patients to stop taking the tablets, or the tablets have passed their expiry date, ask the pharmacist what to do with any left over.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Storage
Store ACTAL Tablet below 30°C.
ATC Classification
A02AB01 - aluminium hydroxide ; Belongs to the class of aluminium-containing antacids.
Presentation/Packing
Chewable tab 360 mg (round white mint flavoured with 'ACTAL' markings on both sides) x 2 x 10's, 12 x 10's.
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