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1. Name Of The Medicinal Product

Diclofenac injection 75 mg / 3 ml

2. Qualitative And Quantitative Composition

One ampoule contains 75 mg diclofenac sodium in 3 ml injectable solution For excipients see section 6.1.

3. Pharmaceutical Form

Solution for Injections

4. Clinical Particulars

4.1 Therapeutic Indications

Ampoules for Intramuscular use-

Diclofenac ampoules are indicated in

-acute forms of pain, including renal colic

-exacerbations of osteo- and rheumatoid arthritis

-acute back pain

-acute gout

-acute trauma and fracture

- post operative pain

Ampoules for Intravenous use

-For the treatment or prevention of post-operative pain in the hospital setting.

4.2 Posology And Method Of Administration

Ampoules for Intramuscular use: The following directions for intramuscular injection must be adhered to in order to avoid damage to a nerve or other tissue at the injection site.

Adults:

One ampoule once (or in severe cases twice) daily intramuscularly by deep intragluteal injection into the upper outer quadrant. If two injections daily are required it is advised that the alternate buttock be used for the second injection. Diclofenac injection 75 mg / 3 ml (given i.m. or i.v.) should not be given for more than 2 days; if necessary, treatment can be continued with tablets or suppositories.

Combinations with other dosage forms of Diclofenac (tablets or suppositories) can be used up to the maximum daily dosage of 150mg.

Renal colic: One 75 mg ampoule intramuscularly. A f

1. Name Of The Medicinal Product

Disodium Pamidronate 15mg/ml Concentrate for Solution for Infusion

2. Qualitative And Quantitative Composition

1ml of concentrate contains 15mg disodium pamidronate.

One ampoule of 1ml contains 15mg of disodium pamidronate.

One ampoule of 2ml contains 30mg of disodium pamidronate.

One ampoule of 4ml contains 60mg of disodium pamidronate.

One ampoule of 6ml contains 90mg of disodium pamidronate.

3. Pharmaceutical Form

Concentrate for solution for infusion.

Colourless solution, free from particles.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of conditions associated with increased osteoclast activity:

• Tumour-induced hypercalcaemia

• Osteolytic lesions and bone pain in patients with bone metastases associated with breast cancer or multiple myeloma

• Paget's disease of bone.

4.2 Posology And Method Of Administration

Disodium pamidronate concentrate must never be given as a bolus injection (see "Warnings"). The concentrate of disodium pamidronate concentrate in ampoules should be diluted in a calcium-free infusion solution (0.9 % Sodium Chloride Intravenous Infusion B.P. is recommended) and infused slowly.

The infusion rate should never exceed 60mg/hour (1mg/min), and the concentration of disodium pamidronate concentrate in the infusion solution should not exceed 60mg/250ml. In patients with established or suspected renal impairment (e.g. those with tumour-induced hypercalcaemia or multiple myeloma) it is recommended that the infusion rate does not exceed 20mg/h (see also "Renal Impairment"). In order to minimise local reactions at the infusion site,

Difflam 0.15% Spray

Benzydamine hydrochloride

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

  • This medicine is available without prescription. However, you still need to use it carefully to get the best results.
  • Keep this leaflet. You may need to read it again.
  • Ask your doctor or pharmacist if you need more information or advice.
  • You must contact a doctor if your symptoms worsen or do not improve.

In this leaflet:

1. What Difflam Spray is for
2. Before you use Difflam Spray
3. How to use Difflam Spray
4. Possible side effects
5. How to store Difflam Spray
6. Further information.

What Difflam Spray is for

Difflam Spray belongs to a group of medicines called non-steroidal anti-inflammatory drugs or NSAIDS.

Difflam Spray works by stopping pain and swelling (inflammation). It is used to treat many painful conditions of the mouth or throat including:

  • Mouth ulcers
  • Teething
  • Sore throat
  • Sore tongue or gums
  • Discomfort associated with dentures or dental work.

Before you take Difflam Spray

Do not use Difflam Spray if:

  • You are allergic to benzydamine hydrochloride
  • You are allergic to any of the other ingredients

in Difflam Spray (listed in section 6).

If either of these applies to you, talk to your doctor or pharmacist.

Taking other medicines

Tell your doctor of pharmacist before using Difflam Spray if you are taking other med

1. Name Of The Medicinal Product

Deponit 5

2. Qualitative And Quantitative Composition

One patch contains glyceryl trinitrate 18.7 mg

The average amount of glyceryl trinitrate absorbed from each patch in 24 hours is 5 mg.

3. Pharmaceutical Form

Transdermal patch

White, translucent square patch with convex round corners with “Deponit 5” marked on the outer face.

4. Clinical Particulars

4.1 Therapeutic Indications

Prophylaxis of angina pectoris alone or in combination with other anti-anginal therapy.

4.2 Posology And Method Of Administration

Dermal

Adults: Treatment should be initiated with one patch daily. If necessary the dosage may be increased to two patches.

It is recommended that the patch is applied to healthy, undamaged, relatively crease free and hairless skin. The best places to apply Deponit patches are the easily reached, fairly static areas at the front or side of the chest. However, Deponit patches may also be applied to the upper arm, thigh, abdomen or shoulder. Skin care products should not be used before applying the patch. The replacement patch should be applied to a new area of skin. Allow several days to elapse before applying a fresh patch to the same area of skin.

Tolerance may occur during chronic nitrate therapy. Tolerance is likely to be avoided by allowing a patch-free period of 8-12 hours each day, usually at night.

Additional anti-anginal therapy with drugs not containing nitro compounds should be considered for the nitrate-free interval if required.

As with any nitrate therapy, treatment with these patches should not be stopped abruptly. If the patient is being changed to another type of treatment

1. Name Of The Medicinal Product

Difflam Sore Throat Rinse.

2. Qualitative And Quantitative Composition

Benzydamine Hydrochloride 0.15% w/v.

3. Pharmaceutical Form

Solution for use as a gargle/oral rinse.

4. Clinical Particulars

4.1 Therapeutic Indications

Difflam Sore Throat Rinse is a locally acting analgesic and anti-inflammatory treatment for the relief of painful inflammatory conditions of the throat including pharyngitis.

4.2 Posology And Method Of Administration

Adults: Rinse or gargle with 15ml (using measuring cup provided) every 1? to 3 hours as required for pain relief.

The solution should be expelled from the mouth after use.

Children: Not suitable for children aged 12 years or under.

Elderly: No special dosage recommendations are made for elderly patients.

Uninterrupted treatment should not exceed seven days, except under medical supervision.

4.3 Contraindications

Difflam Sore Throat Rinse is contra-indicated in patients with known hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Difflam Sore Throat Rinse should generally be used undiluted, but if 'stinging' occurs the rinse may be diluted with water. Avoid contact with the eyes.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Difflam should not be used in pregnancy or lactation unless considered essential by the physician. There is no evidence of a teratogenic effect in animal studies.

4.7 Effects On Ability To Drive And Use Machines

1. Name Of The Medicinal Product

Dioctyl Capsules.

DulcoEase 100mg Capsules

2. Qualitative And Quantitative Composition

Docusate sodium 100 mg.

For excipients, see Section 6.1.

3. Pharmaceutical Form

Capsules

A two colour (opaque white and opaque yellow) soft, oval, gelatin capsule with a clear, colourless liquid fill.

4. Clinical Particulars

4.1 Therapeutic Indications

a) To prevent and treat chronic constipation.

(i) to soften hard, dry stools in order to ease defaecation and reduce straining at stool; and

(ii) in the presence of haemorrhoids and anal fissure, to prevent hard, dry stools and reduce straining.

b) As an adjunct in abdominal radiological procedures.

4.2 Posology And Method Of Administration

Route of administration: Oral

Adults and elderly:

Up to 500 mg should be taken daily in divided doses. Treatment should be commenced with large doses, which should be decreased as the condition of the patient improves.

For use with barium meals:

400 mg to be taken with the meal.

Children under 12 years:

Not recommended.

4.3 Contraindications

These capsules should not be administered when abdominal pain, nausea, vomiting or intestinal obstruction is present.

This product should not be given to patients with a known hypersensitivity to Dioctyl capsules or any of the components.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

4.4 Special Warnings And Precautions For Use

Organic

What you should know about

Dovonex Ointment

calcipotriol

This leaflet gives you some helpful information about Dovonex Ointment.

Read the leaflet carefully before you use the ointment.

If you have any questions or are not sure about anything, ask your doctor or pharmacist.

What is in Dovonex Ointment?

Dovonex Ointment contains an ingredient called calcipotriol. There are 50 micrograms of calcipotriol in each gram of ointment. Calcipotriol is the active ingredient which treats your psoriasis.

The other ingredients in the ointment are disodium edetate, disodium phosphate dihydrate, DL-? tocopherol, liquid paraffin, macrogol (2) stearyl ether, propylene glycol, purified water and white soft paraffin. These are inactive ingredients which do not treat the psoriasis and are only included to make the ointment.

The ointment comes in tubes of 60 grams and 120 grams.

The product licence is held by:

LEO Laboratories Limited
Longwick Road
Princes Risborough
Buckinghamshire
HP27 9RR
UK

The ointment is made by:

LEO Laboratories Limited
Cashel Road
Dublin 12
Ireland

What is Dovonex Ointment for?

You u

1. Name Of The Medicinal Product

DOUBLEBASE™ EMOLLIENT BATH ADDITIVE

2. Qualitative And Quantitative Composition

Liquid Paraffin 65.0% w/w.

For excipients see Section 6.1.

3. Pharmaceutical Form

Bath additive. Dye- and fragrance-free white to off-white mobile liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of contact dermatitis, atopic dermatitis, senile pruritus, ichthyosis and related dry skin disorders.

4.2 Posology And Method Of Administration

Adults, including the elderly:

Shake the bottle to mix contents and add 15 to 20 ml (1? to 2 inner capfuls) to a standard bath of water (20 cm/8 inch depth). Immerse and cover the affected areas with the bath water and soak for 10 to 20 minutes. Pat dry with a towel.

Infants and children:

Shake the bottle to mix contents and add 5 to 10 ml (? to 1 inner capful) to a small bath or wash basin of water. Immerse and cover the affected areas with the bath water and soak for 10 to 20 minutes. Alternatively, repeatedly gently sponge over the affected areas. Pat dry with a towel.

There is no differentiation between the dosage quantities for the symptomatic relief of the conditions listed.

4.3 Contraindications

Sensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Take care not to slip in the bath. Surfaces that have been in contact with the product should be cleaned with a proprietary detergent. Keep out of the reach of children. For external use only.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

1. Name Of The Medicinal Product

Diclofenac Potassium 25 mg Tablets

2. Qualitative And Quantitative Composition

Each film-coated tablet contains 25 mg of diclofenac potassium

Also contains Lecithin Soya E322.

This medicine contains 0.075 mmol (2.92mg) potassium per 25mg tablet.

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Film-coated tablets

Pink, circular, coated, biconvex tablets, diameter 6mm

4. Clinical Particulars

4.1 Therapeutic Indications

Rheumatoid arthritis

Osteoarthrosis

Low back pain

Migraine attacks

Acute musculo-skeletal disorders and trauma such as periarthritis (especially frozen shoulder), tendinitis, tenosynovitis, bursitis, sprains, strains and dislocations; relief of pain in fractures

Ankylosing spondylitis

Acute gout

Control of pain and inflammation in orthopaedic, dental and other minor surgery

Pyrophosphate arthropathy and associated disorders

Children aged 9 yrs and above:

The short term treatment of fever related to infections of the ear, nose or throat (ENT), e.g. pharyngotonsillitis, otitis media.

As monotherapy or as adjunct therapy with morphine or other opiates (due to its opiate-sparing effect) for the relief of acute post-operative pain.

4.2 Posology And Method Of Administration

For oral administration.

To be taken preferably with or after food.

The tablets should be swallowed whole with liquid

Undesirable effects may be minimised by using

1. Name Of The Medicinal Product

Docetaxel ATS 80 mg/2 ml concentrate and solvent for solution for infusion

2. Qualitative And Quantitative Composition

Each single dose vial contains docetaxel 80mg/2ml.

Each single dose vial contains 40mg/ml of docetaxel.

Each single dose vial contains 10mg/ml of docetaxel after reconstitution with the accompanying solvent.

Excipients:

Each single dose 80mg/2ml vial of concentrate contains 200mg ethanol absolute.

Each single dose vial of solvent contains 9.53% (w/w) ethanol absolute.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Concentrate and solvent for solution for infusion.

The concentrate is a clear, oily, yellow solution.

The solvent is a clear colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Breast cancer

Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node- positive breast cancer.

Docetaxel in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.

Docetaxel monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.

Docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress HER2 and who previously

1. Name Of The Medicinal Product

Destolit 150 mg tablets

2. Qualitative And Quantitative Composition

Each tablet contains 150 mg ursodeoxycholic acid (UDCA)

3. Pharmaceutical Form

Tablet

4. Clinical Particulars

4.1 Therapeutic Indications

The dissolution of radiolucent (i.e. non-radio opaque) cholesterol gallstones in patients with a functioning gallbladder

4.2 Posology And Method Of Administration

Adults and the elderly

Dissolution of gallstones:

A daily dose of 8 to 12mg/kg UDCA will produce cholesterol desaturation in the majority of cases. The measurement of the lithogenic index on bile-rich duodenal drainage fluid after 4-6 weeks of therapy may be useful for determining the minimum effective dose. The lowest effective dose has been found to be 4 mg/kg. The daily dose for most patients is 3 or 4 tablets, according to body weight. The dose should be divided into two administrations after meals, with one administration always after the evening meal.

The duration of treatment needed to achieve dissolution will not usually exceed 2 years, and should be monitored with regular cholecystograms. Treatment should be continued for 3-4 months after the radiological disappearance of gallstones.

Any temporary discontinuation of treatment, if prolonged for 3-4 weeks, will allow the bile to return to a state of supersaturation, and will extend the total time taken for litholysis. In some cases stones may recur after successful treatment.

Children and adolescents

Not recommended.

For oral administration.

4.3 Contraindications

Acute inflammation of the gallbladder or biliary tract.

1. Name Of The Medicinal Product

Derbac M Liquid

2. Qualitative And Quantitative Composition

Malathion 0.5% w/w

For excipients, see 6.1.

3. Pharmaceutical Form

Liquid emulsion.

4. Clinical Particulars

4.1 Therapeutic Indications

For the eradication of head lice, pubic lice and their eggs. Treatment of scabies.

4.2 Posology And Method Of Administration

For topical external use only.

Adults, the elderly and children aged 6 months and over:

As this product does not contain alcohol, it may be more suitable for those with asthma or eczema.

1. Treatment of head lice:

Rub the liquid into the scalp until all the hair and scalp is thoroughly moistened. Leave the hair to dry naturally in a warm but well ventilated room. After 12 hours, or the next day if preferred, shampoo the hair in the normal way.

Rinse the hair and comb whilst wet to remove the dead lice and eggs (nits) using the Derbac Nit Comb.

Treatment should be repeated after 7 days.

2. Treatment of crab (pubic) lice:

Apply Derbac M Liquid to the entire skin surface. Pay particular attention to all hairy areas including beards and moustaches.

Avoid any other areas above the neck. Leave on for at least one hour before washing but preferably Derbac M Liquid should be left on overnight. Wash off in the usual manner.

Treatment should be repeated after 7 days.

3. Treatment of scabies:

Apply Derbac M Liquid to the entire skin surface. In adults it may not be

1. Name Of The Medicinal Product

Diazepam Syrup 2mg/5ml.

2. Qualitative And Quantitative Composition

Each 5ml of syrup contains diazepam BP 2mg.

3. Pharmaceutical Form

Syrup.

4. Clinical Particulars

4.1 Therapeutic Indications

Diazepam has anti-convulsant, anxiolytic, sedative, muscle relaxant and amnesic properties.

It is indicated:

Adults:

i)

For the short-term relief (2 to 4 weeks only) of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic or psychotic illness;

 

ii)

As a sedative and premedicant;

 

iii)

As an anti-convulsant in the management of status epilepticus, febrile convulsions and poisoning;

 

iv)

In the control of muscle spasms as in tetanus;

 

1. Name Of The Medicinal Product

Dulcolax® Pico Perles®, 2.5 mg soft capsules.

2. Qualitative And Quantitative Composition

Each capsule contains 2.5 mg sodium picosulfate as Sodium Picosulfate Monohydrate.

For excipients, see 6.1

3. Pharmaceutical Form

Small, pearl-shaped, soft gelatin capsules.

4. Clinical Particulars

4.1 Therapeutic Indications

Short term relief of constipation.

For the management of constipation of any aetiology.

4.2 Posology And Method Of Administration

For oral administration

Unless otherwise prescribed by the doctor, the following dosages are recommended:

Adults and children over 10 years:

Two to four capsules (5 - 10 mg) at night

Children under 10 years:

Not to be taken by children under 10 years without medical advice.

Children (4 - 10 years):

One to two capsules (2.5 - 5 mg) at night.

Children under 4 years:

Not recommended for children under 4 years of age.

Once regularity has restarted dosage should be reduced and can usually be stopped.

The capsules should be swallowed with adequate fluid.

4.3 Contraindications

DULCOLAX is contraindicated in patients with ileus, intestinal obstruction, acute abdominal conditions including appendicitis, acute inflammatory bowel diseases, and severe abdominal pain associated with nausea and vomiting which may be indicative of the aforementioned severe conditions.

DULCOLAX is also contraindic

1. Name Of The Medicinal Product

Daktarin Aktiv Powder

2. Qualitative And Quantitative Composition

Miconazole nitrate 2.0% w/w

(Each gram of powder contains 20mg of miconazole nitrate)

For excipients, see Section 6.1

3. Pharmaceutical Form

Cutaneous powder

White Powder

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of athlete's foot.

4.2 Posology And Method Of Administration

Adults

Twice daily application of the powder to the lesions, treatment being prolonged for some 10 days after all lesions have disappeared to prevent relapse.

Elderly

As for adults.

Children

As for adults.

Method of administration: Cutaneous use.

4.3 Contraindications

Known hypersensitivity to miconazole or any other component of this product.

The powder should not be recommended for treatment of infections of the hair and nails.

4.4 Special Warnings And Precautions For Use

If a reaction suggesting sensitivity or irritation should occur, the treatment should be discontinued.

Daktarin Aktiv Powder must not come into contact with the eyes.

Daktarin Aktiv Powder contains talc. Avoid inhalation of the powder to prevent irritation of the airways. In particular, when treating infants and children, careful application should be used to prevent inhalation by the child.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Miconazole administered systemic