Normoretic Amiloride Hydrochloride and Hydrochlorothiazide Tablets

NORMORETIC™ TABLETS
(Amiloride Hydrochloride + Hydrochlorothiazide)

For Oral use

 

DESCRIPTION

Normoretic (Amiloride HCI USP and Hydrochlorothiazide USP) is a dual action antihypertensive agent combining the potent diuretic action of hydrochlorothiazide with the potassium sparing action of Amiloride HCI.

Amiloride Hydrochloride: N-Amidino-3, 5-diamino-6-Chloropyrazinecarboxamide Monohydrochloride dehydrate.

Hydrochlorothiazide: 6-Chloro-3, 4-dihydro-2H-1,2,4-benzothiadiazine-7-Sulfonamide-1, 1-dioxide.

 

ACTIONS

Normoretic diuretic and antihypertensive action is due primarily to the hydrochlorothiazide component while its Amiloride component prevents the excessive potassium loss that may occur in patients on thiazide diuretics. Thus, Normoretic achieves the overall effrct of the mild diuretic and hypertensive actions of Amiloride HCI with the natriuretic, diuretic and antihypertensive activity of the hydrochlorothiazide while minimizing the loss of Potassium and Bicarbonate and lessening the event of Acid-base imbalance.

Normoretic achieves onset of diuretic action within 2 hours and this is sustained for approximately 24 hours.

 

Amiloride HCl

Amiloride HCI is a Potassium – sparing drug which possesses mild natriuretic, diuretic and antihypertensive activity. The principal function is to conserve Potassium in patients receiving diuretic agents in whom excessive Potassium losses occur or are expected.

Amiloride HCI usually begins to act within 2 hours after an oral dose, its effect on electrolyte excretion reaches a peak between 6 and 10 hours and lasts about 24 hours and the plasma half life varies from 6 to 9 hours.

 

Hydrochlorothiazide

This is an orally effective diuretic and antihypertensive. Onset of action following oral administration occurs in 2 hours and reaches a peak effect in about 4 hours. The diuretic action persists for approximately 6 to 12 hours. Hydrochlorothiazide does not affect normal blood pressure.

 

INDICATIONS

Normoretic is indicated in the treatment of hypertension, oedema of cardiac origin, and hepatic cirrhosis with ascites and oedema.

It can be used alone or as an adjunct to other antihypertensive agents.

Normoretic is also indicated in patients in whom Potassium depletion might be suspected or anticipated.

The combination of Amiloride HCI and Hydrochlorothiazide minimizes the possibility of the development of excessive Potassium loss in patients during vigorous diuresis for prolonged periods.

 

CONTRAINDICATIONS

* Hyperkalemia, other concomittant antikaiuretic therapy or potassium Supplementation.

* Renal insufficiency.

* Hypersensitivity to any of the components or other sulphonamide derived drugs.

* Pregnancy.

* Nursing mothers and children.

* Concurrent administration of lithium.

 

WARNINGS AND PRECAUTIONS

– Hyperkalemia: The risk of Hyperkalemia is high in patients with renal impairment or diabetes mellitus (even without recognised diabetic nephropathy). Hyperkalemia, if uncorrected is potentially fatal hence it is essential to monitor serum Potassium levels in patients receiving Normoretic therapy particularly during first administration and during any illness that could affect renal function.

– Amiloride HCL: Concommitant administration with an angiotensin converting enzyme inhibitor increases the risk of hyperkalemia hence they should be used with caution.

– Hydrochlorothiazide: Alcohol, barbiturates or narcotics when used with thiazide diuretics, orthostatic hypotension may occur.

 

ADVERSE REACTIONS

Headache, Fatigue, Chest pain, Rash, Arrhythmia, Tachycardia, Nausea, Vomiting, Abdominal pain, Insomnia, Nervousness, Mental confusion may occur.

 

OVERDOSAGE

There are no available data as regards overdosage in humans and no specific antidote is available. The treatment of overdosage is symptomatic, and supportive; and therapy with Normoretic should be discontinued. Suggested measures include induction of emesis and/or gastric lavage.

 

DOSAGE AND ADMINISTRATION

The dosage is based on the disease condition being treated thus:

Hypertension

One tablet of Normoretic is administered once a day or in divided doses.

Edema of Cardiac Origin

Treatment commences at a dosage of one tablet daily, with a maximum of two tablets daily.

Hepatic Cirrhosis with Ascites

Treatment commences with one tablet daily, maximum recommended daily dosage is two tablets.

 

PRESENTATION

Normoretic is supplied in blister packs of 100s (10 x 10 strips), jar of 200s and 1000s. Each tablet contain 5mg Amiloride Hydrochloride and 50mg Hydrochlorothiazide.

 

KEEP OUT OF THE REACH OF CHILDREN

 

Manufactured by

NEIMETH INT’L PHARM. PLC. IKEJA, NIGERIA.

Plot 16, Akanni Doherty Layout, Oregun, Lagos, Nigeria.

Megalex Silymarin Liver Support Tablets

Megalex Tablets
Silymarin 70 mg Liver support

 

Composition

Each tablet contains:

Silymarin 70 mg

 

Properties

The liver has several vital functions to perform in the human body: e.g. it plays a dominate role in metabolism (sugar, protein and fats), in digestion (bile secretion) and in the detoxication of waste products.

Every form of liver damage causes changes in the membranes of the liver cell and in this way impairs the functional capacity of the liver.

 

Pharmacodynamics

Silyimarin is of plant origin. It acts as a cell membrane stabilizer and is capable of protecting the liver against deleterious agents, which can cause toxic liver disease and accelerates the regenerative capacity of the damaged liver. These effects are reflected in improvement in general condition, relief of digestive symptoms, improvement of signs of liver disease and normalization of liver function test.

The mode of action of Silymarin is summarized as follows:

1- Silymarin modifies the structure of the exterior  cell membrane of the hepatocytes preventing hepatic toxins from penetrating into the interior of the cell.

2- Silymarin stimulates the activity of nuclear polymerase A, hence increasing ribosomal synthesis at proteins and resulting in a stimulation of the regenerating capacity of the liver and of the formation of new hepatocytes.

3- Silymarin also has an antioxidant effect preventing the formation of free radicals, which are often formed in the liver, such as reactive metabolites, as a result of the intake of toxins and they are responsible for cell membrane damage. Treatment of hepatic diseases resulting from biharziasis, viral hepatitis and amoebiasis has not yet been substantiated.

 

Pharmacokinetics

After the oral administration of Silymarin, the plasma concentration is insignificant; the main constituent measured is silibinin. Maximum concentration is attained after 2 hours on average.

Only about 1% of the administered dose is excreted in the urine 24 hours following the administration of the drug. On the contrary, a relatively high percentage of silibinin is detectable in bile in free and conjugated forms, permitting the estimation of the total quantity of silibinin found in bile, which is approximately 20 to 40% of the administered dose. The biliary half-life (the time of biliary half-elimination) is about 4 hours, while the total stay of the drug in the body is about 8 hours on average. The time of biliary elimination is relatively long bringing to belief that the silibinin remains long enough in the liver and/or takes part in the entero-hepatic circulation; this was proven with animal studies.

The excretion of silibinin takes place essentially through the bile as sulphate and glucuronide, as well as a small portion unchanged. On the other hand, urinary elimination is very little. Other metabolites cannot be lactated in appreciable concentrations.

 

Indications and Usage

Megalex Tablets are used for liver support only, in toxic and inflammatory hepatic disease.

 

Side Effects

A moderate laxative effect has been observed in isolated cases.

 

Contra – Indications

None are known.

 

Warnings and Precautions

None are known.

 

Drug Interactions

The concomitant use of Silymarin and butyrophenones or phenothiazines results in a reduction of lipid peroxidation.

Silymarin has an antagonistic effect with yohimbine and phentolamine when given simultaneously.

 

Pregnancy and Lactation

– No known clinical studies concerning the drug’s use in pregnant women exist.

– Animal studies have revealed no toxicity, neither direct nor indirect, having an effect on pregnancy, on embryonic development and post-natal development.

–  The potential risk on the foetus is unknown.

– The drug should he used with caution during pregnancy.

– The drug should not be administered during pregnancy except when absolutely necessary.

 

Effect on driving ability and on the use of machinery

Megalex does not have any influence on the driving ability or on the use of machinery.

 

Overdosage

There are no known specific antidotes. In cases of enetual urgency, treatment is symptomatic.

 

Dosage and Administration

As directed by the physician or as follows:

The daily dosage has been effective and well tolerated at 140 to 420 mg divided in 2 to 3 doses.

Initial dose (or in severe cases): 420 mg/day equivalent to 2 tablets 3 times daily.

Maintenance dose (or in moderate cases): reduce the dose to 3 tablets per day.

Swallow the tablets without crunching them, independently of meals, with some liquid.

 

Packing

Carton box contains 4 or 100 (pvc/al) strips each of 10 tablets.

 

Storage Conditions

Store below 25oC. Protect from light.

 

NAFDAC Reg. No.: B4 -4405

 

– Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.

– Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sells the medicament.

– The doctor and the pharmacist are experts in medicine, its benefits and risks.

– Do not by yourself interrupt the period of treatment prescribed for you.

– Do not repeat the same prescription without consulting your doctor.

– Keep medicament out of reach of children.

 

Produced by

Alexandria Co. for Pharmaceuticals and Chemical Industries

Gamila Bohreid Road-Awayed-Alex,

Misr Station Alexandria-Egypt.

Essentiale Forte Soybean Phospholipids Hard Capsules

Essentiale® Forte 300 mg
Soybean Phospholipids Hard Capsules.

 

Read all of this leaflet carefully because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• Ask your pharmacist if you need more information or advice.

• You must contact a doctor if your symptoms worsen or do not improve after a few days.

• If any of the side effects become serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

 

In this leaflet

1. What ESSENTIALE FORTE 300 mg hard capsules are and what they are used for

2. Before you take ESSENTIALE FORTE 300 mg hard capsules

3. How to take ESSENTIAL.E FORTE 300 mg hard capsules

4. Possible side effects

5. How to store ESSENTIALE FORTE 300 mg hard capsules

6. Further information

 

1. WHAT ESSENTIALE FORTE 300 mg HARD CAPSULES ARE AND WHAT THEY ARE USED FOR

Essentiale Forte 300 mg is an herbal medicine for liver diseases.

Essentiale Forte 300 mg is used to improve subjective symptoms, such as loss of appetite or a feeling of pressure in the upper right abdomen, in patients with liver damage caused by substances harmful to the liver as well as poor diet (toxic effects of certain foods) and in those with chronic liver inflammation (hepatitis).

 

2. BEFORE YOU TAKE ESSENTIALE FORTE 300 mg HARD CAPSULES

Do not take ESSENTIALE FORTE 300 mg

• If you have a known allergy to preparations containing soybeans or to any of the other ingredients in this medicine.

This medicine contains soy oil. In rare cases, it may therefore cause severe allergic reactions.

Take special care with Essentiale Forte 300 mg

• If symptoms worsen or if other unclear symptoms appear. In this case, you should consult a doctor.

This medicinal treatment is not a substitute for avoiding substances that damage the liver (e.g. alcohol).

If you have chronic hepatitis, supportive treatment with soybean phospholipids is only justified if an improvement in the subjective signs of your condition is observed under treatment.

Children

Sufficient studies are not available concerning use of Essentiale Forte 300 mg in children. It should therefore not be used in children under 12 years of age.

Taking or using other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken other medicines, including those obtained without a prescription.

An interaction between Essentiale Forte 300 mg and medicines that inhibit coagulation of the blood cannot be ruled out. It may therefore be necessary to adjust the dosage of this medicine if you are taking Essentiale Forte 300 mg at the same time as this type of medicine, you should consult your doctor.

Pregnant and breast-feeding women

To date, widespread use of soybeans as a foodstuff has yielded no evidence of risks in pregnancy and breast-feeding. Sufficient studies are not available. Therefore, use of this medicine during pregnancy and breast-feeding is not recommended.

Driving and using machines

No specific precautions are required.

3. HOW TO TAKE ESSENTIALE FORTE 300 mg HARD CAPSULES

Always take Essentiale Forte 300 mg exactly as indicated in this package leaflet, if you are unsure of anything, please ask your doctor or pharmacist for advice.

Unless your doctor prescribes otherwise, the usual dosage is as follows:

Age (Body weight) Single dose Total daily dose
Children from 12 years of age (about 43 kg) Adolescents and adults 2 hard capsules (600 mg soybean phospholipids) 2 hard capsules
3 times daily (1,800 mg soybean
phospholipids)

Swallow the capsules whole at meal times with sufficient liquid (preferably a glass of water [200 ml]).

In principle, there is no time limit for how long you can take this medicine. Please consult the information in Section 2.

Please consult your doctor or pharmacist if you think that the effect of Essentiale Forte 300 mg is too strong or too weak.

If you take more Essentiale Forte 300 mg than you should

No symptoms of overdose or poisoning are known for Essentiale Forte 300 mg.
It is possible that the side effects listed below could occur with greater intensity. If this happens, please inform a doctor. He or she can decide whether any measures need to be taken.

If you forget to take Essentiale Forte 300 mg

If you take too little Essentiale Forte 300 mg or forget to take a dose, do not take a double dose next time, but continue taking the medicine as prescribed by your doctor or as indicated in the package leaflet.

If you have other questions about taking this medicine, please consult your doctor or pharmacist.

 

4. POSSIBLE SIDE EFFECTS

Like all medicines, Essentiale Forte 300 mg can cause side effects, although not everybody gets them.

The following categories are used for the frequency of side effects:

Very common

More than 1 in 10 treated patients.

Common

1 to 10 in 100 treated patients.

Uncommon

1 to 10 in 1,000 treated patients.

Rare

1 to 10 in 10,000 treated patients.

Very rare

Fewer than 1 in 10,000 treated patients.

Unknown

Frequency cannot be determined based on available data.

Significant signs or side effects that you should be aware of and measures to be taken if you have a side effect

Uncommonly, digestive disorders may occur, such as stomach disorders, soft stools or diarrhea.

Very rarely, allergic reactions can occur, such as skin rash or hives.

Pruritus (itching) may occur; the frequency is not known.

If you notice that you have any of the side effects listed above, particularly allergic reactions, stop taking Essentiale Forte 300 mg and inform your doctor. He or she can determine the severity of the side effect and decide whether any measures need to be taken.

If any of the listed side effects become serious, or if you notice any side effects not listed in this package leaflet, please inform your doctor or pharmacist.

 

5. HOW TO STORE ESSENTIALE FORTE 300 mg HARD CAPSULES

Keep this medicine out of the reach and sight of children.

This medicine should no longer be used after the expiry date printed on the container and box after the note “EXP”. The expiry date is the last day of the month indicated.

 

Storage conditions

Store at a temperature no higher than 25°C.

Store in the original packaging to protect the contents from moisture.

 

6. FURTHER INFORMATION

What Essentlale Forte 300 mg contains

The active substance is:

300 mg enriched deoiled soy phospholipids.

The other ingredients are: 96% ethanol, hard fat, soy oil (Ph.Eur.), hydrogenated castor oil, ethyl vanillin, acetanisole, alpha-tocopherol, gelatin, coloring agent E171, 172, sodium dodecyl sulfate, purified water.

What Essentiale Forte 300 mg looks like and contents of the pack

Standard pack containing 50 hard capsules.

 

MAH/Manufacturer

A. Nattermann & Cie. GmbH

Nattermannallee 1

50829 Cologne

Germany

For sanofi groupe.

 

This package leaflet was last revised in August 2009.