INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ACI-MED OTC

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ACI-MED OTC

COMPOSITION:
Each ACI-MED OTC tablet contains
cimetidine 200 mg.

PHARMACOLOGICAL CLASSIFICATION:
A: 11.4.3 Antacids, other

PHARMACOLOGICAL ACTION:
ACI-MED OTC
inhibits both the stimulated and basal secretion of gastric acid and reduces pepsin output. It competitively inhibits the action of histamine at the histamine H2 receptor and is thus a histamine H2-receptor antagonist.
Studies have shown the degree of inhibition of basal acid secretion to vary between 80 and 100% and of stimulated acid secretion between 56 and 98% with a duration of up to 5 hours, depending on the dosage and the type of stimulation.

INDICATIONS:
ACI-MED OTC
is indicated for the short-term symptomatic relief of heartburn, dyspepsia and hyperacidity.

CONTRA-INDICATIONS:
Contra-indicated in any patients who are known to have hypersensitivity to cimetidine. Pregnancy and lactation.
ACI-MED OTC is not recommended for minor digestive complaints. It is also not recommended for patients with impaired renal function. ACI-MED OTC should not be taken by patients suffering from any other illness or taking any other medication unless prescribed by a doctor.
Middle-aged or older patients with new or recently changed dyspeptic symptoms should consult a doctor. Patients suffering from dyspepsia, with unintended weight loss should consult a doctor.

DOSAGE AND DIRECTIONS FOR USE:
ADULTS AND CHILDREN OVER 16 YEARS:
One ACI-MED OTC tablet should be taken when symptoms appear, day or night. Most patients find one or two tablets per day sufficient, however, up to 4 tablets may be taken in a 24 hour period. Patients are advised to consult their doctor or pharmacist if symptoms persist, worsen or continue for fourteen days.
Do not exceed the maximum daily dosage of 800 mg. Do not take for longer than 2 weeks without consulting your doctor or pharmacist, since persistent symptoms may indicate other medical problems.

CHILDREN:
ACI-MED OTC is not recommended for children under sixteen years of age.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Diarrhoea, tiredness, dizziness, headache, rash and sometimes severe and reversible alopecia have been reported in patients during treatment with cimetidine. Gynaecomastia and impotence have been reported with cimetidine treatment.
Decreased white cell counts in H2 antagonist treated patients including agranulocytosis have been reported including reports of occurrence on rechallenge. Cases of thrombocytopenia, pancytopenia and aplastic anaemia have also been reported.
Cases of reversible confusional states, slurred speech, hallucinations, delirium and coma, have been reported, usually in children, elderly and/or severely ill patients, such as those with renal insufficiency or organic brain syndrome.
Increases in plasma creatinine have been reported. These did not progress with continued therapy and disappeared at the end of therapy. Some increases in serum transaminase and cases of hepatitis, fever and interstitial nephritis and pancreatitis, which cleared on withdrawal of the medicine, have been reported.
Contra-indicated for patients with impaired renal function.
Hypersensitivity reactions and fever, arthralgia and myalgia, hepatotoxicity and cardiovascular disorders have been reported.
The possibility of malignancy in gastric ulcer should be excluded before treatment with cimetidine since the symptoms may respond to cimetidine treatment
Interactions:
It is recommended that no anticholinergic agents should be administered concurrently with cimetidine for maintenance treatment because of the possibility of interaction. In view of a report that glucose handling was impaired after long-term cimetidine administration, caution should be observed in the treatment of diabetics or elderly patients with cimetidine.
Cimetidine, through an effect on certain microsomal enzyme systems, has been reported to reduce the hepatic metabolism of warfarin-type anticoagulants, phenytoin, propranolol, chlordiazepoxide, diazepam, nifedipine and theophylline, thereby delaying elimination and increasing blood levels of these agents. Since clinically significant effects have been reported with the warfarin anticoagulants close monitoring of prothrombin time is recommended, and adjustment of the anticoagulant dose may be necessary when cimetidine is administered concomitantly. Interaction with phenytoin, theophylline and calcium channel blockers has also been reported to produce adverse clinical effects. Increased plasma levels of nifedipine have been reported during concomitant cimetidine administration. For concomitant administration of these two agents cautious titration of nifedipine is advised.
Doses of the medicines mentioned above and other similarly metabolized medicines may require adjustments when starting or stopping concomitantly administered cimetidine to maintain safe, optimum therapeutic blood levels.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects and special precautions.
Induction of vomiting and/or gastric lavage may be employed together with symptomatic and supportive therapy.

IDENTIFICATION'
ACI-MED OTC
Tablets: Pale green, biconvex, round, film coated tablets with the Clonmel logo on the one face and the code 274 on the reverse.

PRESENTATION:
ACI-MED OTC
is available as blister pack of 20's.

STORAGE INSTRUCTIONS:
Store in a cool, dry place below 25°C.
Keep the container well-closed.
Do not remove the tablets from the container and blister pack until required for use.
KEEP OUT OF THE REACH OF CHILDREN.

REGISTRATION NUMBER:
32/11.4.3/0512

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Triomed (Pty) Ltd
6b Phumelela Park
Montague Drive
Montague Gardens

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
        PS134
        04/2000
        Britepak

Information for the patient on

ACI-MED OTC

Please read this leaflet carefully before you start to take the medicine. It is a summary of the most important aspects of your medicine. Never give your medicine to anybody else or share it.

What you should know about your Aci-med OTC tablets
What is the name of your medicine?
The name of the medicine is ACI-MED OTC (cimetidine).

What is ACI-MED OTC?
It is a pale green, biconvex, round, film coated tablet containing 200 mg cimetidine as the active substance. The tablets also contain other inactive components namely povidone K30, microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulphate, colloidal silicon dioxide and magnesium stearate.

How ACI-MED OTC tablets work
The stomach contains hydrochloric acid which helps to digest your food. Sometimes the stomach secretes too much hydrochloric acid which can lead to conditions such as heartburn, excessive acid or dyspepsia.
ACI-MED OTC tablets treat the conditions associated with excessive acid secretion. ACI-MED OTC prevents the stomach secreting too much acid and thus acts on the cause of the problem rather than just neutralising the acid. ACI-MED OTC can relieve the symptoms for up to 5 hours.

What should I tell my doctor or pharmacist before I take ACI-MED OTC tablets?
Inform your doctor or pharmacist if you answer 'YES' to any of the following statements:
I am allergic to cimetidine or to any of the components in ACI-MED OTC.
I have a stomach/duodenal peptic ulcer.
I am pregnant, trying to become pregnant or I am breast feeding.
I have liver or kidney problems.
I suffer from porphyria.
I unexpectedly lost a lot of weight due to dyspepsia.
I am middle-aged or older and have symptoms of dyspepsia for the first time.
Always inform your doctor if you have any other illness, or are taking any medication either prescribed or bought from your pharmacist or elsewhere.

How should I take ACI-MED OTC tablets?
Adults (including the elderly) and children of 16 years and older
One ACI-MED OTC tablet should be taken with a glass of water as soon as the symptoms appear, whether day or night. Most people find one or two tablets sufficient, although up to a maximum of 4 tablets can be taken within 24 hours.
Children younger than 16 years
ACI-MED OTC
is not recommended for children under 16 years.

What will happen after I have taken my medicine?
You should find that these tablets relieve your symptoms. If your symptoms do not improve or they deteriorate or they are sustained after you have taken the medication regularly for two weeks, consult your doctor or pharmacist.

What undesirable effects can ACI-MED OTC have?
Most people taking this medicine find that it causes no problems. As with all medicines allergic reactions may occur rarely. If any of the symptoms below occur shortly after the ACI-MED OTC tablet is taken, DISCONTINUE it immediately and contact your doctor.
Low blood pressure associated with a cold, damp, pale skin.
Sudden wheezing and chest pain or tightness in the chest.
Swelling of the eyelids, face, lips mouth or tongue.
Skin rash or hives any place on the body.
Inexplicable fever.
Feeling of weakness, especially when rising.
Other side-effects are rare but if you experience any, contact your doctor or pharmacist.
Diarrhoea
Fatigue
Dizziness
Headache
Skin rash
Confusion
Slurred speech
Hallucinations
Always inform the people involved if you need blood-; urine-; or any other tests since this medicine can influence the test results.

What do I have to do if I accidentally take too many tablets?
If you have perhaps taken more than the prescribed number of tablets, consult your doctor or pharmacist.

Where should I keep my tablets?
Store in a cool, dry place.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.

General information
Always consider the above information when taking your medicine. Your doctor or pharmacist can also suggest changes in your lifestyle to limit the following factors that play a role in excessive acid secretion leading to heartburn, excessive acid or indigestion.
overeating
poor diet
overweight
too little exercise
smoking
excessive alcohol intake

How can I learn more about ACI-MED OTC?
Should you wish to obtain further information about your medicine, ask your doctor or pharmacist.

For how long can I keep my medicine?
Do not use the medicine beyond the expiry date indicated on the container. The first figures indicate the month, the last figures the year.

Name and business address of applicant
Triomed (Pty) Ltd
6b Phumelela Park
Montague Drive
Montague Gardens

        PS134
        04/2000

Updated on this site: October 2001

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