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Amaryl

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Amaril® 1
Amaril® 2
Amaril® 3
Amaril® 4
Glimepiride

COMPOSITION
Each tablet Amaryl 1,0 contains, as active ingredient, 1 mg Glimepiride.
Each tablet Amaryl 2,0 contains, as active ingredient, 2 mg Glimepiride.
Each tablet Amaryl 3,0 contains, as active ingredient, 3 mg Glimepiride.
Each tablet Amaryl 4,0 contains, as active ingredient, 4 mg Glimepiride.
Excipients: Lactose, Sodium starch glycollate, Polyvidone 25000, Microcrystalline Cellulose, Magnesium stearate, red ferric oxide (Amaryl 1.0), yellow ferric oxide (Amaryl 2.0 and Amaryl 3.0) indigo carmine alumunium lake (Amaryl 2.0 and Amaryl 4.0).

PROPERTIES
PHARMACODYNAMICS
Mode of Action/Pharmacodynamic characteristics
Glimepiride is a sulfonylurea anti-diabetic agent which decreases blood glucose concentrations. The primary mechanism of action of glimepiride appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. Glimepiride acts in concert with glucose by improving the sensitivity of beta cells to physiological glucose stimulus, resulting in insulin secretion in the rhythim of meals. In addition, extrapancreatic effects (e.g. reduction of basal hepatic glucose production and increased peripheral tissue sensitivity to insulin and glucose uptake) may also play a limited role in the activity of glimepiride.
In non-fasting diabetic patients, the hypoglycaemic action of a single dose of glimepiride persist for 24 hours. Evidence from in vitro and animal studies suggests that there is lower glucagon secretion with glimepiride than glibenclamide and this may give rise to a prolonged reduction of blood glucose levels without increased plasma insulin levels. The clinical significance of these findings is yet to be clarified. A long-term, randomized, placebo-controlled clinical trial demonstrated that Amaryl therapy improves postprandial insulin/C-peptide responses and overall glycaemic control without producing clinically meaningful increases in fasting insulin/C-peptide levels.
The efficacy of Amaryl is not affected by age, gender or weight. Amaryl therapy is effective in controlling blood glucose without deleterious changes in the plasma lipoprotein profile in patients. The physiological response to acute exercise (i.e. reduction of insulin secretion) is still present during glimepiride therapy.

PHARMACOKINETICS
The pharmacokinetics of glimepiride are similar in males and females and also in young and elderly (›65 years) patients. Intra-individual variability is low.

Absorption
Glimepiride is completely absorbed after oral administration. The peak serum concentration (Cmax) is reached in about 2.5 hours. There is a linear relationship between dose and both Cmax and AUC (area under the plasma concentration-time curve). Food does not significantly affect the rate or extent of absorption of glimepiride.

Distribution
After intravenous dosing in normal subjects, the volume of distribution was 8.8 litres (113 mL/kg) and the total body clearance was 48 mL/min. Protein binding was greater than 99 %. Glimepiride is likely to be only minimally removed by haemodialysis due to its high protein binding. Multiple-dose studies with glimepiride in diabetic patients demonstrated plasma concentration-time curves similar to single dose studies, indicating that there is no accumulation of drug in tissue depots.

Metabolism and Excretion
The elimination half-life of glimepiride at steady state is about 5 to 8 hours after oral administration. However, result of a pharmacokinetics study on patients with type 2 diabetes mellitus indicated that higher doses may be associated with a longer half-life. Glimepiride is completely metabolised by oxidative biotransformation. The major metabolites are the cyclohexyl hydroxy methyl derivative (Ml) and the carboxyl derivative (M2). In vitro studies indicate that cytochrome P450 2C9 is the principal enzyme involved in a biotransformation of glimepiride to Ml. Ml has been found to have about 40% of pharmacological activity of glimepiride. It is eliminated via the urine and also by further metabolism to M2 via one or several cytosolic enzymes. Ml has a terminal elimination half-life of 3-6 hours after an oral dose. The formation of Ml is linear up to a dose of 16 mg glimepiride. The kinetics of M2 have not been fully elucidated due to low plasma levels. Its terminal elimination half life after an oral dose is about 5-6 hours.
Following an oral dose of glimepiride, 35 % of the dose is excreted in faeces and 58 % in urine.

Renal insufficiency
In a single-dose, open label study conducted in 15 patients with renal impairment, glimepiride (3 mg) was administered to three groups of patients with different levels of mean creatinine clearance (CrCl); (Group I, CrCl = 77.7 mL/min, n=5), (Group II, CrCl = 27.4 mL/min, n=3), (Group III, CrCl = 9.4 mL/min, n=7). Glimepiride was found to be well tolerated in all three groups. The results showed that glimepiride serum levels decreased as renal function decreased. However, Ml and M2 serum levels (mean AUC values) increased 2.3 and 8.6 times from Group I to Group II. The apparent terminal half life (T½) for glimepiride did not change, while the half-lives for Ml and M2 increased as renal function decreased. Mean urinary excretion of Ml plus M2 as percent of dose, however, decreased (44.4%, 21.9 %, and 9.3 % for Group I to III)
Result from multiple-dose titration study conducted in 16 patients with renal impairment using doses ranging from 1-8 mg daily for 3 months were consistent with the result after a single dose. All patients with a CrCl ‹ 22 mL/min had adequate control of their glucose levels with a dosage regimen of only 1 mg daily. The result from this study suggested that a starting dose of 1 mg AMARYL may be given to a patient with type 2 diabetes mellitus with renal disease, and the dose may be titrated based on fasting blood glucose levels (see Contraindications, Dosage and Administration).
It is not known if glimepiride is dialysable.

Hepatic failure
The effects of hepatic failure on the clearance of glimepiride have not been systematically examined.

NON CLINICAL SAFETY DATA
Chronic toxicity
Reduced serum glucose values and degranulation of the pancreatic beta cells were observed in beagle dogs exposed to 320 mg glimepiride/kg/day for 12 months (approximately 1,000 times the recommended human dose based on surface area). No evidence of tumor formation was observed in any organ. One female and one male dog developed bilateral sub capsular cataracts. Non-GLP studies indicated that glimepiride was unlikely to exacerbate cataract formation. Evaluation of the co-cataractogenic potential of glimepiride in several diabetic and cataract rat models was negatives and there was no adverse effect of glimepiride on bovine ocular lens metabolism in organ culture.

Carcinogenicity
A standard battery of laboratory tests did not reveal any genotoxic or mutagenic potential for glimepiride. In a 2 year carcinogenicity study in mice receiving glimepiride in the diet up to 813 mg/kg/day, there was an increase in the incidence of pancreatic islet cell hyperplasia and islet cell adenomas; these are regarded to be the result of chronic stimulation of the pancreatic beta cells. In a 30 months carcinogenicity study in rats receiving glimepiride in the diet up to 345 mg/kg/day, there was an increased incidence of pancreatic islet cell adenomas, however there were considered incidental as there was no dose relationship in either sex. There were no malignant tumours in rats or mice.

Reproduction Toxicity
The sulfonylureas may enter the foetal circulation and cause neonatal hypoglycaemia. In rats, dietary glimepiride at high doses (approx. 82 mg/kg) during gestation caused limb deformations. In rabbits, effects on pregnancy were characterized by increased incidences of abortions/total resorptions and malformations. Similar foetal wastage was not seen in rats although the finding of anophthalmia in a proportion of fetuses may be indicative of a treatment-related effect as eye malformations were found in the rabbit study. Adverse pregnancy outcomes in the rat and rabbit are probably due to the pharmacodynamic effects of glimepiride at excessive doses and are not substance-specific. Glimepiride had no recognizable effects on the rearing, physical development, functional and learning behaviour , memory or fertility of the progeny. Study in rats showed that glimepiride is excreted in milk. High doses caused hypoglycaemia in suckling young rats. Dietary administration of glimepiride (120-206 mg/kg) during lactation caused limb deformations in adolescent pups from day 4 of lactation onwards.

INDICATlON
Amaryl is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with type II diabetes mellitus (NIDDM) whose hyperglycemia can not be controlled by diet and exercise alone.
Amaryl may be used concomitantly with metformin when diet, exercise, and Amaryl or Metformin alone do not result in adequate glycemic control. Amaryl is also indicated for used in combination with insulin to lower the blood glucose in patients whose hyperglycemia can not be controlled by diet and exercise in conjunction with an oral hypoglycemic agent. Combined used of glimepiride and insulin may increase the potential for hypoglycemia.

DOSAGE
In principle, the dosage of Amaryl is governed by the desired blood sugar level. The dosage of glimepiride must be the lowest which is sufficient to achieve the desired metabolic control. Treatment with Amaryl must be initiated and monitored by a doctor. Amaryl must be taken at the times and in the doses prescribed. Mistakes, e.g. forgetting to take a dose, must never be corrected by subsequently taking a larger dose.
Measure for dealing with such mistakes (in particular forgetting a dose or skipping a meal) or situations where a dose cannot be taken at the prescribed time must be discussed and agreed between doctor and patient before-hand. A doctor must be notified immediately if the dose taken is too high, or an extra dose has been taken. The initial and the maintenance doses are set based on the result of regular checks of glucose in blood and urine. Monitoring of glucose levels in blood and urine also serves to detect either primary or secondary failure of therapy. Initial dose and dose titration. The usual initial dose is 1 mg Amaryl once daily. If necessary, the daily dose can be increased. Any increase should be based on regular blood sugar monitoring, and should be gradual, i.e. at intervals of one to two weeks, and carried out stepwise, as follows: 1 mg - 2 mg - 3 mg - 4 mg, and-in exceptional cases - 8 mg.
Dose range in patients with well controlled diabetes The usual dose range in patients with well controlled diabetes is 1 to 4 mg Amaryl daily. Only some patients benefit from daily doses of more than 6 mg.
Distribution of doses Timing and distribution of doses are decided by the doctor, taking into consideration of the patient's current life-style. Normally, a single daily dose of Amaryl is sufficient. This dose should be taken immediately before a substantial breakfast of if none is taken immediately before the first main meal. It is very important not to skip meals after taking Amaryl. Secondary dosage adjustment: As the control of diabetes improves, sensitivity to insulin increases; therefore, glimepiride requirements may fall as treatment proceeds. To avoid an excessive reduction in blood sugar (hypoglycaemia) a timely dose reduction or of Amaryl therapy must be considered.
A dose adjustment must also be considered whenever the patient's weight of life-style changes, or other factors causing an increased susceptibility to hypoglycaemia or to an excessive increase in blood sugar levels (hyperglycaemia) arise (see under "Special warnings and precautions"). Duration of treatment: Treatment with Amaryl is normally a long-term therapy.
Changeover from other oral antidiabetics to Amaryl: There is no exact dosage relationship between Amaryl and other oral blood-sugar-lowering agent. When substituting Amaryl for other such agents, the initial daily dose is 1 mg; th is applies even in changeovers from the maximum dose of another oral blood sugar lowering agent. Any Amaryl dose increase should be in accordance with guidelines given above in "Initial dose and dose titration".
Consideration must be given to the potency and duration of action of the previous blood-sugar-lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia. Use in combination with metformin:
Whenever blood sugar levels cannot be controlled adequately with the maximum daily dose of either Amaryl or a metformin-containing antidiabetic alone, both medicines may be used concomitantly. In such cases, the dose of the established medicine remains unchanged. Treatment with the additional medicine is started at a low dose, which-depending on the desired blood sugar level-may then be increased gradually up to the maximum daily dose. Combined treatment should be initiated under close medical supervision.
Use in combination with insulin Whenever blood sugar levels cannot be controlled adequately with the maximum daily dose of Amaryl, insulin may be given concomitantly. In this case, the current dose of Amaryl remains unchanged. Insulin treatment is started at a low dose, which is subsequently increased stepwise according to the desired blood sugar level. Combined treatment should be initiated under close medical supervision.
Long term efficacy should be monitored by measurement of Hb Alc levels, for example every 3 to 6 months.
Short term administration of Amaryl may be sufficient during periods of transient loss of control in patients usually controlled well on diet and exercise.
There is limited information available on the use of Amaryl in renal insufficiency. Patients with impaired renal function may be more sensitive to the glucose-lowering effect of Amaryl.

ADMINISTRATION
Amaryl tablets must be swallowed without chewing and with sufficient amounts of liquid (approx. ½ glass).

CONTRAINDICATIONS
Amaryl is not suitable for the treatment of insulin-dependent (typel) diabetes mellitus (e.g. for the treatment of diabetics with a history of ketoacidosis), of diabetic ketoacidosis, or of diabetic precoma or coma.
Amaryl must not be used in patients hypersensitive to glimepiride, other sulfonylureas, other sulfonamides, or any of the excipients (see "Composition").
No experience has been gained concerning the use of Amaryl in patients with severe impairment of liver function and in dialysis patients. In patients with severe impairment of renal or hepatic function, a changeover to insulin is indicated, not least to achieve optimal metabolic control.
Use in pregnancy and lactation To avoid risk of harm to the child, Amaryl must not be taken during pregnancy; a changeover to insulin is necessary. Patients planning a pregnancy must inform their doctor, and should change over to insulin. Ingestion of glimepiride with the breast milk may harm the child. Therefore, Amaryl must not be taken by breast-feeding women and a changeover to insulin or discontinuation of breast-feeding is necessary.

SPECIAL WARNINGS AND PRECAUTIONS
To achieve optimal control of blood sugar, a correct diet, regular and sufficient physical exercise and, if necessary, reduction of body weight are just as important as regular intake of Amaryl. Clinical signs of hyperglycaemia are e.g. increased urinary frequency, intense thirst, dryness of the mouth, and dry skin. When starting treatment, the patient must be informed about the effects and risks of Amaryl and about its role in conjunction with dietary measures and physical exercise; the importance of adequate cooperation must also be stressed.
In the initial weeks of treatment, the risk of hypoglycaemia may be increased and necessitates especially careful monitoring. Factors favouring hypoglycaemia include:
  • unwillingness or (more commonly in older patients) incapacity of the patients to cooperate,
  • under nutrition, irregular meal-times, or skipped meals,
  • imbalance between physical exertion and carbohydrate intake,
  • alterations of diet,
  • consumption of alcohol, especially in combination with skipped meals,
  • impaired renal function,
  • severe impairment of liver function,
  • over dosage with Amaryl,
  • certain umcompesanted disorders of the endocrine system affecting carbohydrate metabolism or counter-regulation of hypoglycaemia (as for example in certain disorders of thyroid function and in anterior pituitary or adrenocortical insufficiency),
  • concurrent administration of certain other medicines (See "Interactions").
The doctor must be informed about such factors and about hypoglycaemic episodes, since these require particularly careful monitoring.
If such risk factors for hypoglycaemia are present, it may be necessary to adjust the dosage of Amaryl or the entire therapy. This also applies whenever illness occurs during therapy or the patient's life-style changes.
Those symptoms of hypoglycaemia which reflect the body's adrenergic counter-regulation (see under "Adverse effects") may be milder or absent in those situations where hypoglycaemia develops gradually, in the elderly, and in patients with a certain type of nervous disease (autonomic neurophaty) or those receiving concurrent treatment with beta-blockers, clonidine, reserpine, guanethidine, or other sympatholytic drugs.
Hypoglycaemia can almost always be promptly controlled by immediate intake of sugar, e.g., in the form of glucose, sugar cubes or sugar sweetened beverages. Patients should always carry at least 20 grams of glucose with them for this purpose (food or beverages containing artificial sweeteners-such as diet foods or drinks are ineffective in controlling hypoglycaemia). They may require the assistance of other persons to avoid complications. It is known from other sulfonylureas that, despite initially successful counter-measures, hypoglycaemia may recur.
Therefore, continued close observation is necessary. Severe hypoglycaemia requires, in addition, immediate treatment and follow-up by a doctor and in some circumstances, hospitalization.
If treated by different doctor (upon e.g. admission to hospital after an accident, illness while on holiday), the patients must inform them of their diabetic condition and previous treatment.
In exceptional stress situations (e.g. trauma, surgery, infections with fever) blood sugar control may deteriorate, and a temporary change to insulin may be necessary.
During treatment with Amaryl, lasting glucose levels in blood and urine must be checked regularly, as should, additionally, the proportion of glycosylated haemoglobin. Usually every 3 to 6 months to more precisely assess long term glycemic control. Pediatric use: safety and effectiveness in pediatric patients have not been established.
Alertness and reactions may be impaired due to hypo-or-hyperglycaemia, especially when beginning or after altering treatment, or when Amaryl is not taken regularly. Such impairment may, for example, affect the ability to operate a vehicle or machinery.
Treatment of patients with glucose-6-phophate dehydrogenase (G6PD) deficiency with sulfonylurea agents can lead to haemolytic anaemia. Since glimepiride belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD-deficiency and a non-sulfonylurea alternative should be considered.

INTERACTIONS
Patients who take or discontinue taking certain other medicines while undergoing treatment with Amaryl may experience changes in blood sugar control.
Based on experience with Amaryl and on what is known of other sulfonylureas, the following interactions must be considered:
Glimepiride is metabolized by cytochrome P450 2C9 (CYP2C9). This should be taken into account when glimepiride is coadministered with inducers (e.g. rifampicin) or inhibitors (e.g. fluconazole) of CYP 2C9.
Potentiation of the blood-sugar-lowering effect and, thus, in some instances hypoglycaemia may occur when one of the following medicines is taken, for example: insulin and other oral anti-diabetics, ACE inhibitors, allopurinol, anabolic steroids and male sex hormones, chloramphenicol, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluoxetine, guanethidine, ifosfamide, MAO inhibitors, miconazole, fluconazole, para-aminosalicylic acid, pentoxifylline (high dose parenteral), phenylbutazone, azapropazone, oxyphenbutazone, probenecid, quinolones, salicylates, sulfinpyrazone, clarithromycin, sulfonamides, tetracyclines, tritoqualine, trofosfamide.
Weakening of the blood-sugar-lowering effect and, thus, raised blood sugar levels may occur when one of the following medicines is taken, for example : acetazolamide, barbiturates, corticosteroids, diazoxide, diuretics, epinephrine (adrenaline) and other sympathomimetic agents, glucagons, laxatives (alter protacted use), nicotinic acid (in high doses), oestrogens and progestogens, phenothiazines, phenytoin, rifampicin, thyroid hormones.
H2 receptor antagonists, clonidine and reserpine may lead to either potentiation or weakening of the blood-sugar-lowering effect. Beta-blockers decrease glucose tolerance. In patients with diabetes mellitus, this may lead to deterioration of metabolic control. In addition, beta-blockeres may increase the tendency to hypoglycaemia (due to impaired counterregulation).
Under the influence of sympatholytic medicine su ch as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation to hypoglycaemia may be reduced or absent.
Both acute and chronic alcohol intake may potentiate or weaken the blood-sugar-lowering action of Amaryl unpredictably.
The effect of coumarin derivatives may be potentiated or weakened.

ADVERSE EFFECTS
Based on experience with Amaryl and on what is known of other sulfonylureas, the following adverse effects must be considered :
Hypoglycaemia As a result of the blood-sugar-lowering action of Amaryl, hypoglycaemia may occur, and may also be prolonged.
Possible symptoms of hypoglycaemia include headache, ravenous hunger, nausea, vomiting, lassitude, sleepiness, disordered sleep, restlessness, aggressiveness, impaired concentrations, alertness and reactions, depression, confusion, difficulty in speaking and even speech loss, aphasia, visual disorders, tremor, pareses, sensory disturbances, dizziness, helplessness, loss of sell-control, delirium, cerebral convulsions, somnolence and loss of consciousness up to and including coma, shallow respiration and slow heart rate (bradycardia). In addition, signs of adrenergic counter-regulation may be present such as sweating, clammy skin, anxiety, rapid heart rate (tachycardia), hypertension, palpitations, angina pectoris, and cardiac arrhythmias. The clinical picture of a severe hypoglycaemic attack may resemble that of a stroke. The symptoms of hypoglycaemia nearly always subside when hypoglycaemis is corrected.
Eyes: especially at the start of treatment, temporary visual impairment may occur due to the change in blood sugar levels. The cause is temporary alteration in the turgidity and hence the refractive index of the lens, this being independent on blood glucose level.
Digestive tract Occasionally, gastrointestinal symptoms such as the following may occur: nausea, vomiting, sensations of pressure of fulness in the epigastrium, abdominal pain, and diarrhoea.
In rare cases, liver enzyme levels may increase. In isolated cases, impairment of liver function (e.g. with cholestasis and jaundice) and hepatitis may develop, leading to liver failure.
Blood: severe changes in the blood picture may occur: Rarely,  thrombopenia and, in isolated cases, leucopenia, haemolytic anaemia or, e:g. erythrocytopenia, granulocytopenia, agranulocytosis, and pancytopenia (e.g. due to myelosuppression) may develop. Other adverse reactions occasionally, allergic or pseudo allergic reactions may occur, e.g.; in the form of itching, urticaria or rashes (e.g., erythema, morbiliform or maculopapular eruptions), if skin reactions persist, the drug should be discontinued. Such reactions may be mild, but also may become more serious and may be accompanied by dyspnoea and a fall in blood pressure, sometimes progressing to shock. If urticaria occurs, a doctor must be notified immediately. In isolated cases, a decrease in serum, inflammation of blood vessels (allergic vasculitis) and hypersensitivity of the skin to light may occur.
Please consult your doctor if you notice any of the adverse effects listed in this package insert or any other undesired effects or unexpected changes.
Since some adverse effects (e.g. severe hypoglycaemia, certain changes in blood picture, severe allergic or pseudoallergic reactions, or liver failure) may under certain circumstances become life-threatening, it is essential that, if sudden or severe reactions do occur, you inform a doctor at once, and on no account continue taking the drug without a doctor's express guidance.
Further to the above-mentioned adverse effect of Amaryl, the following events have been reported with sulfonylureas:
  • Porphyria cutanea tarda
  • Hepatic porphyria reaction
  • Disulfiram-like reaction 
  • Syndrome of inappropriate antidiuretic hormon (SIADH) secretion.
It has been suggested that these sulfonyl ureas may augment the peripheral action of ADH and/or increase release of ADH.

OVERDOSAGE
Signs and Symptoms:
Accidental or intentional overdose may cause severe and prolonged hypoglycaemia which may be life-threatening.

Management:
In case of overdosage with glimepiride, a doctor must be notified immediately. At the first signs of hypoglycaemia, the patient must immediately take sugar, preferably glucose, unless a doctor has already started care.
Since hypoglycaemia and its clinical symptoms may recur after apparent clinical recovery (even alter several days), close and continued medical supervision and possibly referral to a hospital are indicated. In particular, significant overdosage and severe reactions, e.g. with unconsciousness or other neurological dysfunctions, are emergency cases and require immediate care and hospitalization.
If hypoglycaemic coma is diagnosed or suspected, intravenous infusion of a 20 % glucose solution (adults: 40 to 100 ml) is indicated. Alternatively. IV, SC, or IM administration of glucagons (adults: 0.5 to 1 mg) may be considered. In infants, glucose must be dosed very carefully and close monitoring of blood glucose is required to minimize the risk of potentially severe hyperglycaemia. Other symptomatic therapy (e.g. anticonvulsants) should be administered as necessary. Alter acute glucose replacement has been completed, it is usually necessary to give an intravenous glucose infusion in lower concentration so as to ensure that hypoglycaemia does not recur. The patient's blood glucose level should be carefully monitored for at least 24 hours. In severe cases with a protracted course, hypoglycaemia, or the danger of slipping back into hypoglycaemia, may persist for several days.
In cases of acute intake of large amounts of glimepiride, detoxification (e.g.by gastric lavage and administration of medicinal charcoal) is indicated.

STORAGE
Store below 25°C

EXPIRY DATE
Do not use later than the date of expiry

Keep medicines out of the reach of children.

Presentation
Amaryl 1 mg:
Boxes of 5 blisters x 10 tablets
Reg. No. DKL0521204110Al

Amaryl 2 mg:
Boxes of 5 blisters x 10 tablets
Reg. No. DKL0521204110Bl

Amaryl 3 mg.
Boxes of 5 blisters x 10 tablets
Reg. No. DKL0521204110Cl

Amaryl 4 mg:
Boxes 2 blisters x 10 tablets
Reg. No. DKL0521204110Dl

HARUS DENGAN RESEP DOKTER ON
MEDICAL PRESCRIPTION ONLY

Manufactured by:
PT Aventis Pharma, Jakarta, Indonesia

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