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Minims*

Oxybuprocaine Hydrochloride 0.4% w/v

Oxybuprocaine hydrochloride

About Minims Oxybuprocaine Hydrochloride

The name of this medicine is Minims Oxybuprocaine Hydrochloride. Each Minims unit contains 0.4% w/v oxybuprocaine hydrochloride solution.

The active ingredient in this medicine is oxybuprocaine hydrochloride. This is the new name for benoxinate hydrochloride. The ingredient itself has not changed.

It also contains purified water and a small amount of hydrochloric acid. Each Minims unit is a sterile single use eyedrop containing approximately 0.5ml of solution. Each carton contains 20 Minims units. Oxybuprocaine hydrochloride is used as a local anaesthetic.

Who makes this medicine ?

Minims Oxybuprocaine Hydrochloride 0.4% w/v are manufactured by

Laboratoire Chauvin
Z.I. Ripotier
07200/Aubenas
France

The Marketing Authorisations for Minims Oxybuprocaine Hydrochloride 0.4% (PL 0033/5004R & PA 118/9/1) are held by

Chauvin Pharmaceuticals Ltd.
106 London Road
Kingston-Upon-Thames
KT2 6TN
England

What is it for ?

This medicine is used to numb the eye temporarily. This could be necessary for a number of reasons. Most often

1. Name Of The Medicinal Product

Mirtazapine 45 mg Orodispersible Tablets

2. Qualitative And Quantitative Composition

Each orodispersible tablet contains 45 mg mirtazapine.

Excipients: aspartame (E951) 9 mg, sulphites 0.000045 mg.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Orodispersible tablet.

White to off-white, round, flat tablets with bevelled edges and plain on both sides.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of episodes of major depression.

4.2 Posology And Method Of Administration

Adults

The effective daily dose is usually between 15 and 45 mg; the starting dose is 15 or 30 mg.

Mirtazapine begins to exert its effect in general after 1-2 weeks of treatment. Treatment with an adequate dose should result in a positive response within 2-4 weeks. With an insufficient response, the dose can be increased up to the maximum dose. If there is no response within a further 2-4 weeks, then treatment should be stopped.

Elderly

The recommended dose is the same as that for adults. In elderly patients an increase in dosing should be done under close supervision to elicit a satisfactory and safe response.

Children and adolescents under the age of 18 years

Mirtazapine should not be used in children and adolescents under the age of 18 years as efficacy was not demonstrated in two short-term clinical trials (see section 5.1) and because of safety concerns (see sections 4.4, 4.8 and 5.1).

Renal impairment

MigraMax 900 mg / 10 mg, Powder for oral solution

Acetylsalicylic acid (as DL-lysine acetylsalicylate)

Metoclopramide hydrochloride

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Phone 01483 505515 for help

Read all of this leaflet carefully before you start taking this medicine

  • Keep this leaflet. You may need to read it again
  • If you have any further questions, ask your doctor or pharmacist
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

In this leaflet:

  • 1. What MigraMax is and what it is used for
  • 2. Before you take MigraMax
  • 3. How to take MigraMax
  • 4. Possible side effects
  • 5. How to store MigraMax
  • 6. Further information

What MigraMax is and what it is used for

The name of your medicine is MigraMax 900 mg / 10 mg, Powder for oral solution (called MigraMax in this leaflet).

What MigraMax contains

MigraMax contains two different medicines. These are called:

  • Metoclopramide hydrochloride: this belongs to a group of medicines called anti-emetics
    It works on muscles in the upper part of the digestive system causing your stomach to empty. It also works on a part of your brain that prevents you

1. Name Of The Medicinal Product

Migraleve

2. Qualitative And Quantitative Composition

Each Migraleve Pink tablet contains:
Paracetamol DC 96%

(equivalent to Paracetamol 500 mg)

Codeine Phosphate

Buclizine Hydrochloride

520 mg

8 mg

6.25 mg

Each Migraleve Yellow tablet contains:
Paracetamol DC 96%

(equivalent to Paracetamol 500 mg)

Codeine Phosphate

520 mg

8 mg

3. Pharmaceutical Form

Film-coated Tablets.

Migraleve Pink Tablets

Pink, capsule-shaped, film-coated tablets marked MGE on one face.

Migraleve Yellow Tablets

Yellow, capsule-shaped, film-coated tablets marked MGE on one face.

4. Clinical Particulars

4.1 Therapeutic Indications

For the short term treatment of acute moderate pain which is not relieved by Paracetamol, ibuprofen or aspirin alone such as migraine attacks including the symptoms of migraine headache, nausea and vomiting.

4.2 Posology And Method Of Administration

MicardisPlus

80 mg/25 mg tablets

telmisartan/hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

  • 1. What MicardisPlus is and what it is used for
  • 2. Before you take MicardisPlus
  • 3. How to take MicardisPlus
  • 4. Possible side effects
  • 5. How to store MicardisPlus
  • 6. Further information

What Micardisplus Is And What It Is Used For

MicardisPlus is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet. Both substances help to control high blood pressure.

  • Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin-II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.
  • Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which cause you

Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution

Read all of this leaflet carefully before you start taking this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

  • 1. What Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution is and what it is used for
  • 2. Before you take Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution
  • 3. How to take Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution
  • 4. Possible side effects
  • 5. How to store Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution
  • 6. Further information

What Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution is and what it is used for

The name of your medicine is Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution (referred to as Methadone Solution in this leaflet). It contains methadone hydrochloride. This belongs to a group of medicines called Narcotic Analgesics.

Methadone is used:

  • to treat opioid drug addiction
  • to treat moderate to severe pain

Before you take Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution

Do not take Methadone Solution and tell your doctor if:

MYOCET 50mg

powder and pre-admixtures for concentrate for liposomal dispersion for infusion

Doxorubicin HCI

Read all of this leaflet carefully, before you start using this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or your hospital pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:

  • 1. What MYOCET is and what is it used for.
  • 2. Before you use MYOCET.
  • 3. How to use MYOCET.
  • 4. Possible side effects.
  • 5. How to store MYOCET.
  • 6. Further information

What Myocet Is And What Is It Used For

MYOCET consists of a powder and pre-admixtures for concentrate for liposomal dispersion for infusion and is supplied as a three-vial system: MYOCET doxorubicin HCI, MYOCET liposomes and MYOCET buffer. The active substance is presented as a lyophilised powder for single-use.

Once the content of the vials has been mixed together the resulting liposomal dispersion is orange-red and opaque.

MYOCET is available in cartons containing 2 sets of the three constituents.

MYOCET is a preparation of the anti-tumour agent doxorubicin, which is encased in microscopic fat particles known as liposom

1. Name Of The Medicinal Product

Rhotard Morphine SR 100 mg Tablets

Morphgesic SR 100 mg Tablets

2. Qualitative And Quantitative Composition

Rhotard Morphine SR 100 mg Tablets/ Morphgesic SR 100mg Tablets contain 100mg Morphine Sulphate.

Each 100mg tablet is a grey coloured biconvex round film coated tablet.

3. Pharmaceutical Form

Controlled release tablets

4. Clinical Particulars

4.1 Therapeutic Indications

For the prolonged relief of severe pain.

4.2 Posology And Method Of Administration

Route of administration: Oral

Rhotard Morphine SR / Morphgesic SR tablets should be swallowed whole and not chewed.

Adults:

The dosage is dependent upon the severity of the pain and the patient's previous history of analgesic requirements. The tablets should normally be administered twice daily at 12 hourly intervals. One or two 10 mg tablets (10mg) twice daily is the recommended starting dosage for a patient presenting with severe pain. With increasing severity of pain it is recommended that the dosage of morphine be increased to achieve the desired relief. The dosage may be varied by choosing combinations of available strengths (10, 30, 60, and 100 mg) or by using higher strength tablets alone.

It is recommended that a patient transferred from another oral morphine preparation, having similar bioavailability to oral morphine liquid, should receive the same total morphine dose in one 24-hour period. This total dose should be divided between the morning and evening administration. Dosage titration and clinical assessment may be appropriate.

Where a patient had pre

1. Name Of The Medicinal Product

Metatone

2. Qualitative And Quantitative Composition

METATONE contains Vitamin B1 (Thiamine hydrochloride Ph Eur) 500 micrograms, Calcium glycerophosphate Ph Eur 45.6 mg, Potassium glycerophosphate 45.6 mg, Sodium glycerophosphate 22.8 mg and Manganese glycerophosphate NFX 697 micrograms in each 5 ml.

3. Pharmaceutical Form

A clear red liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

METATONE is indicated in the management of convalescence and debility.

4.2 Posology And Method Of Administration

Adults and children 12 years and over:

Oral. One or two 5 ml spoonfuls, preferably diluted, two or three times daily before meals.

Maximum daily dose: 30 ml

Children aged 6 years and over:

Oral. One 5 ml spoonful, preferably diluted, two or three times daily before meals.

Maximum daily dose: 15 ml

Children under 6 years

Metatone is not suitable for administration to children under six years of age, except under the advice of a physician.

The Elderly:

Normal adult dosage is appropriate.

4.3 Contraindications

METATONE is contraindicated in individuals with known hypersensitivity to the product or any of its components.

4.4 Special Warnings And Precautions For Use

None known.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No known contraindications.

1. Name Of The Medicinal Product

Minims Proxymetacaine hydrochloride 0.5% w/v, Eye Drops.

2. Qualitative And Quantitative Composition

Proxymetacaine hydrochloride 0.5%w/v.

For excipients see section 6.1

3. Pharmaceutical Form

Eye drops, solution.

Clear, colourless to pale yellow solution

4. Clinical Particulars

4.1 Therapeutic Indications

To be used as a topical ocular anaesthetic.

4.2 Posology And Method Of Administration

Adults (including the elderly) and children:

Deep anaesthesia: Instil 1 drop every 5 - 10 minutes for 5 - 7 applications.

Removal of sutures: Instil 1 or 2 drops 2 to 3 minutes before removal of stitches.

Removal of foreign bodies: Instil 1 or 2 drops prior to operating.

Tonometry: Instil 1 or 2 drops immediately before measurement.

Do not use if the solution is more than pale yellow in colour.

Each Minims unit should be discarded after a single use

A period of at least one minute should be allowed after administration of Minims Proxymetacaine hydrochloride 0.5%, before subsequent administration of other topical agents.

4.3 Contraindications

Do not use in patients with a known hypersensitivity to any component of the preparation.

In view of the immaturity of the enzyme system which metabolises the ester type local anaesthetics in premature babies, this product should be avoided in these patients.

4.4 Special Warnings And Precautions For Use

This product should be used cautiously and sparingly in patients with known allergies, cardiac disease or hyperthyroidism beca

1. Name Of The Medicinal Product

MEPRADEC 20 mg GASTRO-RESISTANT CAPSULES

2. Qualitative And Quantitative Composition

Omeprazole........................20 mg

For excipients, see section 6.1.

3. Pharmaceutical Form

Capsule, hard.

Omeprazole 20 mg Gastro-Resistant Capsule is a hard gelatin capsule with an opaque beige body, marked "20" and an opaque beige cap, marked "DP".

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of duodenal and benign gastric ulcers including those complicating NSAID therapy. Treatment and prophylaxis of NSAID-associated benign gastric ulcers, duodenal ulcers and gastroduodenal erosions in patients with a previous history of gastroduodenal lesions who require continued NSAID treatment.

Relief of associated dyspeptic symptoms.

Treatment of oesophageal reflux disease. In reflux oesophagitis the majority of patients are healed after 4 weeks. Symptomatic relief is rapid. Relief of reflux-like symptoms (e.g., heartburn) and/or ulcer-like symptoms (e.g., epigastric pain) associated with acid-related dyspepsia.

Relief of associated dyspeptic symptoms.

Zollinger-Ellison syndrome.

Prophylaxis of acid aspiration.

4.2 Posology And Method Of Administration

The capsules should be swallowed whole with plenty of liquid (e.g., water or fruit juice) prior to a meal. It is important that the capsules should not be crushed or chewed.

Duodenal & Benign Gastric Ulcers: The usual dose is 20 mg once daily. The majority of patients with duodenal ulcer are healed after 4 weeks. The majority of patients with benign gastric ulcer are healed after 8 week

1. Name Of The Medicinal Product

MENOPUR

2. Qualitative And Quantitative Composition

Active ingredient

Each vial with dry substance contains highly purified menotrophin (human menopausal gonadotrophin, HMG) corresponding to 75 IU human follicle stimulating hormone (FSH) and 75 IU human luteinising hormone (LH).

3. Pharmaceutical Form

Powder for injection; and solvent for parenteral use.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of female and male infertility in the following groups of patients:

- Anovulatory women: MENOPUR can be used to stimulate follicle development in amenorrhoeic patients. Clomiphene (or a similar ovulation inducing agent which influences steroid feed-back mechanisms) is the preferred treatment for women with a variety of menstrual cycle disturbances, including luteal phase insufficiency with anovulatory cycles and with normal prolactin, and also amenorrhoeic patients with evidence of endogenous oestrogen production but normal prolactin and normal gonadotrophin levels. Non-responders may then be selected for menotrophin therapy.

- Women undergoing superovulation within a medically assisted fertilisation programme: MENOPUR can be used to induce multiple follicular development in patients undergoing an assisted conception technique such as in-vitro fertilisation (IVF).

- Hypogonadotrophic hypogonadism in men: MENOPUR may be given in combination with human chorionic gonadotrophin (e.g. Choragon) for the stimulation of spermatogenesis. Patients with primary testicular failure are usually unresponsive.

4.2 Posology And Method Of Administration

Anovulatory infertility

Minims* Cyclopentolate Hydrochloride

0.5% and 1% w/v cyclopentolate hydrochloride

About Minims Cyclopentolate

The name of this medicine is Minims Cyclopentolate. Minims Cyclopentolate eye drops are available in two strengths. Each Minims unit contains either 0.5% or 1% w/v cyclopentolate hydrochloride solution. It also contains purified water and a small amount of hydrochloric acid. Each Minims unit is a sterile, single-use container which holds approximately 0.5ml of solution. Each carton contains 20 units. Cyclopentolate is a mydriatic and cycloplegic drug. These drugs are used to enlarge the pupil of the eye and to paralyse the lens temporarily.

Who makes Minims Cyclopentolate?

Minims Cyclopentolate Hydrochloride 0.5% and 1% are manufactured by

Laboratoire Chauvin S.A. ZI Ripotier
07200/Aubenas
France

The Marketing Authorisations for Minims Cyclopentolate Hydrochloride 0.5% (PL 0033/5005R and PA 118/12/2) and Minims Cyclopentolate Hydrochloride 1% (PL 0033/5006R and PA 118/12/3) are held by

Chauvin Pharmaceuticals Ltd
106 London Road
Kingston-Upon-Thames
KT2 6TN
England

What is it for?

Minims Cyclopentolate is used to enlarge the pupil of the eye and to paralyse the lens temporarily so that a doctor or eye specialist can examine it closel

Manerix 150 mg and 300 mg film-coated tablets

Moclobemide

Please read all of this leaflet carefully before you start taking this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
  • If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

  • 1. What Manerix is and what it is used for
  • 2. Before you take Manerix
  • 3. How to take Manerix
  • 4. Possible side effects
  • 5. How to store Manerix
  • 6. Further information
  • 7. More information about your condition

What Manerix is and what it is used for

Manerix contains a medicine called moclobemide. This belongs to a group of medicines called antidepressants.

Manerix is used to treat depression and social phobia. For further information about these conditions, see Section 7.

Manerix works by increasing the levels of important chemical messengers in your brain. This increase can help your depression or social phobia.

Before you take Manerix

Do not take Manerix if:

  • You are allergic (hypersensitive) to moclobemide or any of the other ingred

1. Name Of The Medicinal Product

Magnesium Hydroxide Mixture BP.

2. Qualitative And Quantitative Composition

Magnesium Hydroxide Paste Concentrated 1.325g/5ml

3. Pharmaceutical Form

Suspension

4. Clinical Particulars

4.1 Therapeutic Indications

1. For relief of the symptoms of flatulence, heartburn, dyspepsia and indigestion.

2. As a laxative for relief of occasional constipation.

4.2 Posology And Method Of Administration

Oral.

Recommended doses and dosage schedule

1. As an antacid

Adults, the elderly and children over 12 years: one to two 5ml spoonfuls in a little water when required.

Children under 12 years: not suitable.

2. As a laxative:

Adults, the elderly and children over 12 years: 25 50ml (five to ten 5ml spoonfuls) in a glass of water at bedtime.

Children under 12 years: not suitable.

Directions for use: Shake the bottle.

4.3 Contraindications

Contraindicated in severe renal failure, acute gastrointestinal conditions and in hypersensitivity to magnesium salts or any of the other ingredients.

4.4 Special Warnings And Precautions For Use

Use with caution in the elderly and debilitated and in patients with impaired liver function. Also in patients with impaired kidney function as hypermagnesaemia may result.

Keep all medicines away from children.

If constipation persists consult your doctor.

Not suitable for children under 12.

Discard any unused mixture 3 months after opening.

4.5 Interaction With Ot

1. Name Of The Medicinal Product

Meropenem 1 g, powder for solution for injection

2. Qualitative And Quantitative Composition

Each vial contains meropenem trihydrate equivalent to 1000 mg anhydrous meropenem.

The sodium content of each vial is 4.0 mmol (90 mg).

After reconstitution with 20 ml diluent the concentration of meropenem amounts to 50 mg/ml.

For full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder for solution for injection or infusion.

White to pale yellow crystalline powder.

4. Clinical Particulars

4.1 Therapeutic Indications

Meropenem is indicated for the treatment of the following infections in adults and children over 3 months of age (see sections 4.4 and 5.1):

Pneumonia, including community acquired pneumonia and nosocomial pneumonia.

Broncho-pulmonary infections in cystic fibrosis

Complicated urinary tract infections

Complicated intra-abdominal infections

Intra- and post-partum infections

Complicated skin and soft tissue infections

Acute bacterial meningitis

Meropenem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology And Method Of Administration

The tables below provide general recommendations for dosing.

The dose of meropenem administered and the duration of treatment should take into account the type of infection to be treated, including its severity, and the clinical response.

1. Name Of The Medicinal Product

Metformin hydrochloride 1000 mg film-coated tablets

2. Qualitative And Quantitative Composition

Each film-coated tablet contains 1000 mg metformin hydrochloride corresponding to 780 mg metformin.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet.

White, oval, biconvex, film-coated tablets with 'A' debossed on one side and '62' debossed on the other side. The tablets have a non-functional groove and therefore cannot be broken.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycemic control.

In adults, Metformin hydrochloride film-coated tablets may be used as monotherapy or in combination with other oral anti-diabetic agents or with insulin.

In children from 10 years of age and adolescents, Metformin hydrochloride film-coated tablets may be used as monotherapy or in combination with insulin.

A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin hydrochloride as first-line therapy after diet failure (see section 5.1).

4.2 Posology And Method Of Administration

Adults:

Monotherapy and combination with other oral antidiabetic agents:

- The usual starting dose is 500mg or 850mg metformin hydrochloride 2 or 3 times daily given during or after meals.

After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow incre

1. Name Of The Medicinal Product

Mobic 7.5 mg suppositories

2. Qualitative And Quantitative Composition

Each suppository contains 7.5 mg of Meloxicam.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Suppository

Yellowish-green suppositories

4. Clinical Particulars

4.1 Therapeutic Indications

- Short-term symptomatic treatment of exacerbations of osteoarthrosis.

- Long-term symptomatic treatment of rheumatoid arthritis.

4.2 Posology And Method Of Administration

Rectal use

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.

- Exacerbations of osteoarthrosis: 7.5 mg/day (one 7.5 mg suppository/day). If necessary, in the absence of improvement, the dose may be increased to 15 mg/day (one 15 mg suppository/day).

- Rheumatoid arthritis: 15 mg/day (one 15 mg suppository/day).

(see also section 'Special populations' below)

According to the therapeutic response, the dose may be reduced to 7.5 mg/day (one 7.5 mg suppository/day).

DO NOT EXCEED THE DOSE OF 15 MG/DAY.

Special populations

Elderly patients and patients with increased risks for adverse reaction (see section 5.2):

The recommended dose for long term treatment of rheumatoid arthritis in elderly patients is 7.5 mg per day. Patients with increased risks for adverse reactions shou

1. Name Of The Medicinal Product

Merbentyl 10mg Tablets

Merbentyl 20mg Tablets

2. Qualitative And Quantitative Composition

Dicycloverine hydrochloride 10mg or 20mg

3. Pharmaceutical Form

Tablets

4. Clinical Particulars

4.1 Therapeutic Indications

Smooth muscle antispasmodic primarily indicated for treatment of functional conditions involving smooth muscle spasm of the gastrointestinal tract.

4.2 Posology And Method Of Administration

Route of administration: Oral

10mg and 20mg tablets:

Adults and children over 12 years: 10-20mg three times daily before or after

meals.

10mg tablets only:

Children (2-12 years): 10mg three times daily.

4.3 Contraindications

Known idiosyncrasy to dicycloverine hydrochloride.

4.4 Special Warnings And Precautions For Use

Products containing dicycloverine hydrochloride should be used with caution in any patient with or suspected of having glaucoma or prostatic hypertrophy. Use with care in patients with hiatus hernia associated with reflux oesophagitis because anticholinergic drugs may aggravate the condition.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

Epidemiological studies in pregnant women with products containing dicycloverine hydrochloride (at doses up to 40mg/day) have not shown that dicycloverine hydrochloride increases the risk of foetal abnormalities if administered during the first trimester of pregnancy. Reproduction studies have been performed in rats and rabbits at doses of up to

1. Name Of The Medicinal Product

Minims Artificial Tears

2. Qualitative And Quantitative Composition

Clear, colourless, sterile eye drops containing hyetellose 0.44% w/w BP and sodium chloride EP 0.35% w/w.

3. Pharmaceutical Form

Sterile single-use eye drop.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of dry eye syndromes associated with deficient tear secretion.

4.2 Posology And Method Of Administration

One or two drops instilled into the affected eye three or four times daily, or as often as is required.

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

If irritation persists or worsens or continued redness occurs, discontinue use and consult a physician or ophthalmologist.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is no evidence of safety of the drug in human pregnancy but it has been in wide use for many years without apparent ill consequence. If drug therapy is needed in pregnancy this preparation can be used if recommended by a physician and it is considered that the benefits outweigh the possible risks.

4.7 Effects On Ability To Drive And Use Machines

May cause transient blurring of vision on instillation. Do not drive or operate hazardous machinery unless vision is clear.

4.8 Undesirable Effects

May cause transient mild stinging or temporarily blurred vision.

4.9 Overdose

Overdose would not be expected to produce symptoms.

5. Pharmacological Pr