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ULCAID 75 (Tablets)

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ULCAID 75 (Tablets)

COMPOSITION
Each film-coated tablet contains ranitidine hydrochloride equivalent to ranitidine 75 mg.

PHARMACOLOGICAL CLASSIFICATION:
A 11.4.3 Antacids - Other

PHARMACOLOGICAL ACTION:
Ulcaid 75 inhibits the basal and nocturnal gastric acid by competitive inhibition of the interaction of histamine at the histamine H₂ receptors of the parietal cells. Ulcaid 75 reduces both the volume of gastric juices and its H⁺-concentration.
ranitidine is rapidly and well absorbed from the gastro-intestinal tract with peak concentrations in plasma occurring within 1 or 2 hours after oral administration. The bioavailability of ranitidine is about 50 %. The absorption is not significantly impaired by the co-administration of food or antacids. About 15%, of ranitidine is bound to plasma proteins. The elimination half-life is about 2 to 3 hours.
ranitidine is excreted via the kidneys in the free and metabolised forms. Its major metabolite is the N-oxide, S-oxide and desmethyl ranitidine. ranitidine generally does not bind to microsomal cytochrome P_450.

INDICATIONS:
Ulcaid 75 tablets are indicated for the prevention and symptomatic relief of heartburn and hyperacidity.

CONTRA-INDICATIONS:
ranitidine is contra-indicated in patients hypersensitive to ranitidine or any of the histamine H₂-receptor antagonists.
The safety in pregnancy and lactation has not been established. ranitidine is not recommended for children under 16 years of age. ranitidine should be avoided in patients with a history of acute porphyria.

DOSAGE AND DIRECTIONS FOR USE:
Prevention:
The usual dose of Ulcaid 75 for adults and adolescents of 16 years of age and older is one tablet 30 minutes to one hour before eating a meal that is expected to cause symptoms. Not more than 4 tablets per day should be taken.
Relief: One tablet when the symptoms appear, day or night. Up to 4 tablets may be taken in a 24-hour period. Do not use Ulcaid 75 for longer than 2 weeks.
For patients with impaired renal functions (creatinine clearance of less than 50 mL per minute), dosage adjustment is required: Not more than 150 mg/day (2 tablets of Ulcaid 75 per day) should be given to such patients.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Cardio-vascular system - Less frequently bradycardia, atrioventricular block and cardiac arrest.
Central nervous system - Confusion, loss of colour vision, aggressiveness, hallucinations and severe headache.
Gastro-intestinal system - Recurrent parotitis, hepatotoxicity.
Eye - Increased intraocular pressure.
Dermatological - Vasculitic rash, hypersensitivity.
Blood disorders - Agranulocytosis, neutropenia, thrombocytopenia.
Others - Interstitial nephritis, fever, arthralgia, myalgia.
There have been a few reports of breast enlargement symptoms in men taking ranitidine.
Precautions:
General:
Risk benefit should be assessed before prescribing ranitidine to patients with the following diseases/ conditions. The patient must consult the treating doctor before taking ranitidine when these exist:

(i)	Patients with hepatic or renal function impairment
(ii)	Pregnant or breast-feeding women (See Contra-indications)
(iii)	Elderly patients

Interactions:
Antacids - Concurrent administration decreases the absorption of ranitidine.
Alcohol, Glipizide, Glyburide, Metoprolol, Phenytoin, Midazolam, Nifedipine, Theophylline or Warfarin - ranitidine is a weak inhibitor of hepatic medicine metabolism. However, isolated cases of medicines interactions have been reported between ranitidine and any one of these medicines.
Phenytoin - Concurrent use with ranitidine increases the level of phenytoin in blood and may increase the risk of ataxia.
Procainamide - ranitidine can inhibit tubular secretion of procainamide, thereby increasing the plasma concentration of procainamide.
Laboratory value alterations
Serum creatinine, serum gamma-glutamyl transpeptidase and transaminase

-	Levels may be increased when ranitidine is given.

Urinary protein
-False-positive reactions may be produced during ranitidine therapy.Gastric acid Secretion test
-ranitidine is not recommended during 24 hours preceding the test as it may antagonise the effect of pentagastrin and histamine in the evaluation of gastric acid secretory function.Skin tests using allergen extracts
-H₂-receptor antagonists may inhibit the cutaneous histamine response, thus producing false-negative results.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See “Side-effects and special precautions”. Treatment is symptomatic and supportive.

IDENTIFICATION:
Light pink, round, biconvex, film-coated tablets imprinted with ‘75’in black edible ink on one side.

PRESENTATION:
Carton containing one or two blister strips of 6 tablets each.

STORAGE INSTRUCTIONS:
Store below 25°C, protected from moisture and light. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
32/11.4.3/0665

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
RANBAXY (SA) (PTY) LTD
Lincoln House
Epsom Downs Office Park
13 Sloane Street
Epsom Downs
BRYANSTON

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
July 2000

Marketed by Triomed (Pty) Ltd
        5009101

Information for the patient on
Ulcaid 75

Please read this leaflet carefully before you start to take the medicine. It provides a summary of information about your medicine. Please ask your doctor or pharmacist if you have any questions. This leaflet only applies to Ulcaid 75.

COMPOSITION:
Your medicine is called Ulcaid 75. The active ingredient is ranitidine hydrochloride. Each tablet contains ranitidine hydrochloride, equivalent to 75 mg ranitidine.
The tablets also contain the following inactive ingredients: Microcrystalline cellulose, hypromellose, croscarmellose sodium, castor oil, colloidal anhydrous silica, purified talc, magnesium stearate, titanium dioxide (E171) and ferric oxide red (E172).

INDICATIONS:

•	These tablets contain ranitidine, one of a group of medicines called H2-antagonists. These reduce the amount of acid in your stomach which can prevent and relieve the symptoms of hyperacidity and heartburn.

Before taking this medicine:
If you answer YES to any of the following questions, talk to your doctor or pharmacist before taking Ulcaid 75:

•	Have you ever had an allergic reaction (this may include rash, itching, swelling or breathing difficulties) to ranitidine or any of the tablet ingredients listed above?
•	Are you intending to become pregnant?
•	Do you have kidney disease?
•	Do you suffer from porphyria?
•	Have you ever had treatment with ranitidine which did not work?
•	Do you suffer from a disorder of the gullet called Barrett's disease?
•	Have the symptoms shown sudden change or worsening?
•	Are you taking medicines for arthritis such as aspirin or ibuprofen?

CONTRA-INDICATIONS:
Ranitidine is contra-indicated in patients hypersensitive to ranitidine or any of the histamine H₂-receptor antagonists. Ulcaid 75 is not recommended for children under 16 years of age.

INTERACTIONS:
Ulcaid 75 tablets should not be taken with antacids, alcohol, glipizide, glyburide, metoprolol, midazolam, nifedipine, theophylline, warfarin, phenytoin or procainamide.
If you are taking any of these medicines, consult your doctor. If you are taking other medicines on a regular basis, concomitant use of this medicine may cause undesirable interactions. Please consult your doctor or pharmacist.
If you are pregnant or breast-feeding your baby while taking this medicine, please contact your doctor/pharmacist or other healthcare professional for advice.

HOW TO TAKE THIS MEDICINE:
Check the package insert to see how many tablets to take and how often to take them. The tablets should be swallowed whole with a glass of water. The usual doses are as follows:
Adults, elderly and children(over the age of 16 years)
Take one Ulcaid 75 tablet, 30 minutes to 1 hour before eating a meal that is expected to cause symptoms to help reduce heartburn and hyperacidity. To relieve symptoms, take one tablet when the symptoms appear. Do not take more than 4 tablets in one day. Therapy should not be continued for more than 14 days continuously.
Consult your doctor if you are suffering from impaired kidney function as dosage adjustment is required. If you are unsure about how many tablets to take or when to take them, ask your doctor or pharmacist.
Do not take more tablets than recommended. If you ever take too many, go to the nearest hospital casualty department, taking the medicine with you, or tell your doctor immediately.

SIDE-EFFECTS:
If you are taking Ulcaid 75 together with arthritis medication, your doctor will check you regularly.
The side-effects with Ulcaid 75 tablets are not very frequent but, as with any medicine, they can cause unwanted side-effects:
Allergic reactions:
If you experience any of the following side-effects soon after taking these tablets, tell your doctor at once and stop taking the tablets:

•	Sudden wheeziness, tightness in the chest
•	Lumpy skin rash anywhere on the body, or swelling of eyelids, face or lips
•	Unexplained fever, sore throat
•	Feeling faint, especially on standing up

If you experience any of these less frequently occurring effects, tell your doctor as soon as possible:

•	Severe stomach pain, rarely caused by inflamed pancreas
•	Unusual tiredness, short of breath, tendency to bruising or frequent infections
•	Slow or irregular heartbeat
•	Nausea, loss of appetite
•	Jaundice (yellow skin or whites of eyes)
•	Confusion, loss of colour vision, aggressiveness
•	Skin rash consisting of red spots

If you experience the following effects, tell your pharmacist:

•	Headache
•	Dizziness
•	Pain in muscles and joints
•	Depression
•	Hallucinations
•	Swollen and breast tenderness in men

If you are taking Ulcaid 75 with antibiotics amoxicillin and metronidazole, diarrhoea may occur.
It you suffer from any other undesirable effect, tell your doctor or pharmacist.
Not all side-effects reported for this medicine are included in this leaflet. If your general state of health worsens while taking this medicine, please consult your doctor.

STORAGE AND DISPOSAL INFORMATION
Keep your tablets in the original pack, at room temperature (below 25°C), protected from light and moisture.
Do not take Ulcaid 75 after the expiry date on the carton. Please return unwanted tablets to the pharmacist.
Do not share medicines prescribed for you with others. Store all medicines out of reach of children.

DATE OF LEAFLET PREPARATION:
September 1997

New addition to this site: February 2002
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