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1. Name Of The Medicinal Product

Gynoxin 600 mg Vaginal Capsules

2. Qualitative And Quantitative Composition

Each vaginal capsule contains 600 mg of the active ingredient fenticonazole nitrate.

For excipients, see 6.1

3. Pharmaceutical Form

Vaginal capsule, soft

Ivory white, opaque, soft gelatin capsules

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of vulvovaginal candidiasis.

4.2 Posology And Method Of Administration

Route of Administration:

Intravaginal

Adults:

One 600 mg vaginal capsule once only, at bedtime.

The capsule must be introduced deeply into the vagina.

Gynoxin is not greasy, does not soil and can easily be removed with water.

Children:

The use of Gynoxin in children is not recommended.

4.3 Contraindications

Ascertained hypersensitive to the product and to other imidazole derivatives.

4.4 Special Warnings And Precautions For Use

The product should not be used in conjunction with barrier contraceptives.

In the event of a hypersensitivity reaction or development of resistant organisms, treatment should be discontinued and the physician consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Not investigated. Since systemic absorption of fenticonazole after application is low, interactions with other drugs are unlikely.

4.6 Pregnancy And Lactation

Oral administration of fenticonazole in rats has been reported to produce prolonged gestation and embryotoxic effects after doses above

1. Name Of The Medicinal Product

GEREF® 50

2. Qualitative And Quantitative Composition

Each ampoule of lyophilised powder contains sermorelin acetate equivalent to 50 micrograms of sermorelin.

Each ampoule of Geref is accompanied by a solvent ampoule containing 0.9% Sodium Chloride Injection BP.

3. Pharmaceutical Form

Lyophilised powder for injection after reconstitution with accompanying solvent.

4. Clinical Particulars

4.1 Therapeutic Indications

For the evaluation of the functional capacity and response of the somatotrophs of the anterior pituitary.

4.2 Posology And Method Of Administration

The test should be carried out and interpreted under specialist supervision.

Recommended procedure: A single intravenous injection of 1.0 microgram/kg body weight in the morning following an overnight fast.

Geref should be reconstituted immediately before use with a minimum of 0.5ml of the accompanying sterile solvent.

Venous blood samples should be drawn 15 minutes before and immediately prior to Geref administration. Venous blood samples are then drawn at 15, 30, 45 and 60 minutes following Geref injection. Samples at 90 and 120 minutes are optional, since in the majority of patients they do not give additional information.

4.3 Contraindications

Use in patients known to be hypersensitive to sermorelin acetate or any of the excipients of Geref.

4.4 Special Warnings And Precautions For Use

Patients already on growth hormone therapy should have therapy discontinued one to two weeks pre-test.

The test should be carried out with particular caution in patients with epilepsy.

Untre

1. Name Of The Medicinal Product

Glycerin and Blackcurrant Soothing Cough Syrup or Glycerin and Blackcurrant Linctus or Benylin Dry Coughs Blackcurrant or CalCough Children's Soothing Syrup or Benylin Children's Blackcurrant Flavour Cough Syrup

2. Qualitative And Quantitative Composition

Active Ingredient

Quantity per 5ml

Glycerin Ph. Eur.

0.75ml

Liquid sugar demineralised

1.93ml

(Equivalent to sucrose B.P.

1.7g)

3. Pharmaceutical Form

Liquid

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of irritating, tickling dry coughs and sore throats.

4.2 Posology And Method Of Administration

Adults, elderly and children over 5 years: 10ml

Children 1 - 5 years: 5ml

The dose may be repeated three or four times a day.

Children under one year: Not to be given to children under 1 year.

For oral administration.

1. Name Of The Medicinal Product

Glimepiride 1mg Tablet

2. Qualitative And Quantitative Composition

Each tablet contains 1mg glimepiride.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablet.

The tablets are pink, oblong and scored on both sides.

4. Clinical Particulars

4.1 Therapeutic Indications

Glimepiride is indicated for the treatment of type II diabetes mellitus, when diet, physical exercise and weight reduction alone are not adequate.

4.2 Posology And Method Of Administration

For oral administration.

The basis for successful treatment of diabetes is a good diet, regular physical activity, as well as routine checks of blood and urine. Tablets or insulin cannot compensate if the patient does not keep to the recommended diet.

Dosage is determined by the results of blood and urinary glucose determinations.

The starting dose is 1 mg glimepiride per day. If good control is achieved this dosage should be used for maintenance therapy.

For the different dosage regimens appropriate strengths are available.

If control is unsatisfactory the dosage should be increased, based on the glycaemic control, in a stepwise manner with an interval of about 1 to 2 weeks between each step, to 2, 3 or 4 mg glimepiride per day.

A dosage of more than 4 mg glimepiride per day gives better results only in exceptional cases. The maximum recommended dose is 6 mg glimepiride per day.

In patients not adequately controlled with the maximum daily dose of metformin, concomitant glimepiride therapy can be initiated.

While maintaining the metformin dose, the glimepiride therapy is starte

Glycerin Honey and Lemon linctus (Boots Company plc)

(Glycerol, Honey, Sucrose)

relieves coughs and sore throats

200 ml e

Read all of this label for full instructions.

Uses: A linctus which soothes and relieves the symptoms of sore throats and coughs.

Before you take this medicine

Do not take:

  • If you are allergic or intolerant to any of the ingredients

You can take this medicine if you are pregnant or breastfeeding.

How to take this medicine

Check the cap seal is not broken before first use.

If it is, do not take the medicine.

Adults and children of 12 years and over:

Two 5 ml spoonfuls. Swallow this amount 3 or 4 times a day, if you need to.

Children of 5 to 11 years: One 5 ml spoonful. Give this amount to your child to swallow 3 or 4 times a day, if you need to.

Children of 1 to 4 years: Half a 5 ml spoonful. Give this amount to your child to swallow 3 or 4 times a day, if you need to.

Do not give to children under 1 year.

If symptoms do not go away talk to your pharmacist or doctor.

If you take or give too much: Talk to a pharmacist or doctor.

Possible side effects

This medicine is not expected to cause side effects.

If you notice any side effect, please tell your pharmacist or doctor.

Keep all medicines out of the sig

1. Name Of The Medicinal Product

GONAL-f 450 IU/0.75 ml (33 micrograms/0.75 ml) solution for injection in pre-filled pen.

2. Qualitative And Quantitative Composition

Each ml of the solution contains 600 IU of follitropin alfa*, (equivalent to 44 micrograms).

Each pre-filled multidose pen delivers 450 IU (equivalent to 33 micrograms) in 0.75 ml.

* recombinant human follicle stimulating hormone (r-hFSH) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection in a pre-filled pen.

Clear colourless solution.

The pH of the solution is 6.7-7.3.

4. Clinical Particulars

4.1 Therapeutic Indications

In adult women

• Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomiphene citrate.

• Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer.

• GONAL-f in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/l.

In adult men

• GONAL-f is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chor

Glibenese Tablets

Glipizide

In this leaflet:

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

Important things that you SHOULD know about your medicine:

  • Glibenese is used to treat diabetes and helps lower your blood glucose (sugar) levels, when a change in your diet and exercise is not enough to control your diabetes.
  • Glibenese can cause hypoglycaemia (low blood sugar levels), which is characterised by confusion, faintness, sweating, dizziness, drowsiness, headache, shakiness (tremor) and visual disturbances. (These symptoms may also be unrelated to hypoglycaemia). Low blood sugar levels can be prevented by taking a regular intake of carbohydrates (e.g. bread, or other products containing starch/sugar). You should eat regular meals, and not exercise heavily or for a long period without eating something first.
  • Do not stop taking the tablets or adjust your dosage without seeing your doctor. Stopping the medicine may make the diabetes worse.

Please read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important to you.

What Glibenese is and what it is used for

Glibenese is one of a group of medicines called sulphonylureas.

Glibenese is used is used to treat diabetes (Type II, non-insulin-dependent diabetes) and helps to lower your blood glucose (sugar) levels, when a change in diet and exercise is not enough to control the condition.

Diabeti

1. Name Of The Medicinal Product

Gyno-Pevaryl™ Cream.

2. Qualitative And Quantitative Composition

Each 100 g of cream contains 1 g econazole nitrate Ph.Eur. (1% w/w).

3. Pharmaceutical Form

Vaginal Cream.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of mycotic vulvovaginitis and mycotic balanitis.

4.2 Posology And Method Of Administration

Route of Administration

For vaginal/penile administration.

Females: One applicator full (approximately 5 g) intravaginally once daily at night for not less than 14 days. The cream should also be applied to the vulva. The full 14 days treatment should be carried out even if the symptoms of vaginal itching or discharge have disappeared.

Males: Apply the cream to the penis, including under the foreskin, once daily for not less than 14 days.

The sexual partner should also be treated.

4.3 Contraindications

Hypersensitivity to any imidazole preparation, other vaginal antifungal products or to any of the ingredients of Gyno-Pevaryl cream.

4.4 Special Warnings And Precautions For Use

Not for ophthalmic or oral use.

Hypersensitivity has rarely been recorded; if it should occur administration should be discontinued.

Contact between contraceptive diaphragms or condoms and this product must be avoided since the rubber may be damaged by the preparation.

Patients using spermicidal contraceptives should consult their physician since any local vaginal treatment may inactivate the spermicidal contraceptive.

Gyno-Pevaryl Cream should not be used in conjunction with ot

1. Name Of The Medicinal Product

Gaviscon Liquid Sachets.

2. Qualitative And Quantitative Composition

Gaviscon contains 500 mg sodium alginate, 267 mg sodium bicarbonate and 160 mg calcium carbonate per 10 ml dose.

Excipients: methyl parahydroxybenzoate (E218) 40 mg/10 ml and propyl parahydroxybenzoate (E216) 6 mg/10 ml.

For a full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Oral suspension in sachets.

An off-white suspension with the odour and flavour of peppermint.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion related to reflux, for example, following meals, or during pregnancy, or in patients with symptoms related to reflux oesophagitis.

4.2 Posology And Method Of Administration

For oral administration.

Adults and children 12 years and over: One to two sachets after meals and at bedtime (up to four times a day).

Children under 12 years: Should be given only on medical advice.

Elderly: No dose modifications necessary for this age group.

4.3 Contraindications

This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Sodium content of a 10 ml, one sachet dose is 141 mg (6.2 mmol). This should be taken into account when a highly restricted salt diet is required, e.g. in some cases of congestive cardiac failure and renal impairment.

Each 10 ml, one sachet dose contains 160 mg (1.6 mmol) of calcium carbon

1. Name Of The Medicinal Product

Germoloids Ointment.

2. Qualitative And Quantitative Composition

Zinc oxide Ph. Eur. 6.6% w/w

Lidocaine hydrochloride Ph. Eur. 0.7% w/w

3. Pharmaceutical Form

Ointment for topical and rectal administration.

4. Clinical Particulars

4.1 Therapeutic Indications

The symptomatic relief of pain, swelling, irritation and itching associated with haemorrhoids, and pruritus ani.

4.2 Posology And Method Of Administration

Adults and children aged 12 years and over:

Apply at least twice a day with a minimum of three to four hours between applications. Further applications can be made at any time of day and are particularly recommended after a bowel movement.

Do not use more than four times in any 24-hour period.

External piles and pruritus ani:

Apply to the affected area.

Internal piles:

Gently insert applicator into the anal opening and expel a small amount of the ointment by squeezing the tube gently.

Children under 12 years:

Only as directed by a doctor.

The elderly:

Use as per adult directions.

4.3 Contraindications

Hypersensitivity to any of the constituents.

4.4 Special Warnings And Precautions For Use

Persons who continually suffer from haemorrhoids or who have severe haemorrhoids or who experience excessive bleeding, are advised to consult a doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of In

GlucaGen HypoKit 1mg

[Glucagon biosynthetic (rys)]

What you should know about GlucaGen Hypokit 1mg

Please read this leaflet carefully before using this medicine. This leaflet does not contain all of the information about the product that you may need to know, so please ask your doctor or pharmacist if you have any questions.

What is in your medicine

The active ingredient is glucagon biosynthetic (rys) 1mg. Other ingredients are lactose monohydrate, hydrochloric acid, sodium hydroxide and water for injections. GlucaGen HypoKit 1mg consists of a powder for injection (GlucaGen 1mg) with accompanying diluent (Diluent for GlucaGen 1mg) for preparation of glucagon injection. The pack contains:

  • 1 vial with white powder containing 1 mg glucagon (rys)
  • 1 pre-filled syringe containing 1ml diluent (water for injections, Ph.Eur.) for reconstitution

The reconstituted product contains 1mg/ml (1iu/ml) glucagon (rys).

Glucagon is a hyperglycaemic agent (i.e. increases blood glucose). It works by releasing glucose into the bloodstream from glycogen stored in the liver. Independently of this effect, glucagon also inhibits the motility (natural movement) of the smooth muscles in the gastrointestinal tract.

The marketing authorisation holder and manufacturer is:

Novo Nordisk A/S
Novo All?
DK-2880 Bagsvaerd
Denmark

What

1. Name Of The Medicinal Product

Gabapentin 400 mg Capsules

2. Qualitative And Quantitative Composition

Each capsule, hard contains 400 mg of gabapentin.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Capsule, hard

Hard gelatin capsule (size 0), with brown opaque body and cap.

4. Clinical Particulars

4.1 Therapeutic Indications

Epilepsy

Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above (see section 5.1).

Gabapentin is indicated as monotherapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above.

Treatment of peripheral neuropathic pain

Gabapentin is indicated for the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia in adults.

4.2 Posology And Method Of Administration

For oral use.

Gabapentin can be given with or without food and should be swallowed whole with sufficient fluid-intake (e.g. a glass of water).

For all indications a titration scheme for the initiation of therapy is described in Table 1, which is recommended for adults and adolescents aged 12 years and above. Dosing instructions for children under 12 years of age are provided under a separate sub-heading later in this section.

Table 1

   

1. Name Of The Medicinal Product

GONAL-f 900 IU/1.5 ml (66 micrograms/1.5 ml) solution for injection in pre-filled pen.

2. Qualitative And Quantitative Composition

Each ml of the solution contains 600 IU of follitropin alfa*, (equivalent to 44 micrograms).

Each pre-filled multidose pen delivers 900 IU (equivalent to 66 micrograms) in 1.5 ml.

* recombinant human follicle stimulating hormone (r-hFSH) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection in a pre-filled pen.

Clear colourless solution.

The pH of the solution is 6.7-7.3.

4. Clinical Particulars

4.1 Therapeutic Indications

In adult women

• Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomiphene citrate.

• Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer.

• GONAL-f in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/l.

In adult men

• GONAL-f is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorion

1. Name Of The Medicinal Product

GLYCERYL TRINITRATE TABLETS BP 600 micrograms

2. Qualitative And Quantitative Composition

Each tablet contains 600 micrograms Glyceryl Trinitrate BP.

3. Pharmaceutical Form

White uncoated tablets.

White, circular, biconvex uncoated tablets, impressed “C” on one face and the identifying letters “GS” on reverse.

4. Clinical Particulars

4.1 Therapeutic Indications

As a short-acting vasodilator in the:

1. Relief of angina pectoris

2. Prophylaxis of angina pectoris

3. Relief of acute spontaneous coronary artery spasm

4.2 Posology And Method Of Administration

Posology

1-2 tablets (0.6-1.2mg) should be placed under the tongue and allowed to dissolve slowly; this dose should be repeated as required. If pain persists after a total of 3 doses in 15minutes the patient should be advised to seek medical attention.

Dosage should be adjusted according to the response obtained by the individual patient and the severity of the anginal pain.

NB Tolerance may develop with daily use, but withdrawal for a week re-establishes the original sensitivity.

Method of Administration

For sublingual administration

4.3 Contraindications

Known hypersensitivity to nitrates and other ingredients in the tablets. Patients with rare hereditary problems of galactose intolerence, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Marked anaemia, raised intercranial pressure including that caused by head trauma, cerebral haemorrhage, closed angle glau

1. Name Of The Medicinal Product

Gynoxin 2% vaginal cream

2. Qualitative And Quantitative Composition

Gynoxin contains 20 mg of the active ingredient fenticonazole nitrate in 1 g of cream.

For excipients, see 6.1

3. Pharmaceutical Form

Vaginal cream

White homogenous cream

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of vulvovaginal candidiasis.

4.2 Posology And Method Of Administration

Route of Administration:

Intravaginal

Adults:

One applicator full (about 5 g) is administered into the vagina by a re-usable applicator (morning and evening for three days).

Gynoxin is not greasy, does not soil and can easily be removed with water.

Children:

The use of Gynoxin in children is not recommended.

4.3 Contraindications

Ascertained hypersensitive to the product and to other imidazole derivatives.

4.4 Special Warnings And Precautions For Use

The product should not be used in conjunction with barrier contraceptives.

In the event of a hypersensitivity reaction or development of resistant organisms, treatment should be discontinued and the physician consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Not investigated. Since systemic absorption of fenticonazole after application is low, interactions with other drugs are unlikely.

4.6 Pregnancy And Lactation

Oral administration of fenticonazole in rats has been reported to produce prolonged gestation and embryotoxic effects after doses above 40mg/kg/day. Fenticonazole

Gee’s Linctus B.P. (Boots Company plc)

(Opium Tincture, Squill Oxymel)

traditional relief from chesty coughs

200 ml e

Read all of this label for full instructions.

What this medicine is for

A linctus for the relief of chesty coughs.

Before you take this medicine

Do not take:

  • If you are allergic to any of the ingredients
  • If you have heart, liver or kidney problems
  • If you have severe breathing problems
  • If you have a head injury or a condition where there is raised pressure in the head
  • If you suffer from alcoholism or fits
  • If you are pregnant or breastfeeding
  • If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains sucrose)

Talk to your pharmacist or doctor:

  • If you suffer from colitis
  • If you are elderly
  • If you are taking monoamine oxidase inhibitors (for depression) or have taken them in the last 14 days
  • If you take other medicines – anaesthetics, sedatives, hypnotics, medicines known as phenothiazines (e.g. chlorpromazine)
  • If you are on a controlled sodium diet (this medicine contains 157 mg of sodium per 5 ml spoonful)

If you take this medicine continuously for a long time (e.g. 2 weeks or more), you may become dependent on it.

Driving:

This medicine may cause drowsiness. If affected do not drive or operate machinery.

Do not drink alcohol (beer, wine, spirits) when taking this medicine.

1. Name Of The Medicinal Product

Gentamicin Eye/Ear Drops 0.3% W/V

2. Qualitative And Quantitative Composition

Active Ingredient

Gentamicin sulphate equivalent to 30mg gentamicin base in 10ml of solution

3. Pharmaceutical Form

Eye/Ear Drops

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of infections of the external structures of the eye and its adnexa caused by susceptible bacteria. Such infections include conjunctivitis, keratitis, kerato-conjunctivitis, corneal ulcers, blepharitis and blepharo-conjunctivitis, acute meibomianitis, episcleritis and dacryocystitis. It may be used for the prevention of ocular infection after: removal of a foreign body, burns or lacerations of the conjunctiva; damage from chemical or physical agents and after ocular surgery.

Also indicated for the treatment of otitis externa.

4.2 Posology And Method Of Administration

Eye: Instill 1-2 drops into the affected eye every four hours as required.

Ears: The area should be cleansed and 2-4 drops instilled 3-4 times daily.

4.3 Contraindications

Should not be administered to patients with a known allergy to gentamicin and other aminoglycosides. Evidence exists that gentamicin may cause neuromuscular blockade and is therefore contra-indicated in myasthenia gravis and related conditions.

Perforated tympanic membrane.

4.4 Special Warnings And Precautions For Use

Avoid prolonged use. Not for use with contact lenses

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Potent diuretics such as ethacrynic acid and frusemide are believed

1. Name Of The Medicinal Product

Gaviscon Double Action Aniseed.

2. Qualitative And Quantitative Composition

Each 10 ml dose contains sodium alginate 500 mg, sodium bicarbonate 213 mg and calcium carbonate 325 mg.

Excipients : Methyl parahydroxybenzoate (E218) and Propyl parahydroxybenzoate (E216). For a full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Oral suspension.

Opaque, off-white to cream viscous suspension.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, for example following meals or during pregnancy, and for symptoms of excess stomach acid (hyperacidity).

4.2 Posology And Method Of Administration

For oral administration.

Adults and children 12 years and over: 10-20 ml after meals and at bedtime, up to four times per day.

Children under 12 years: Should be given only on medical advice.

Elderly: No dose modifications necessary for this age group.

4.3 Contraindications

Hypersensitivity to any of the ingredients, including the esters of hydroxybenzoates (parabens).

4.4 Special Warnings And Precautions For Use

Each 20 ml dose has a sodium content of 254.5 mg (11.06 mmol). This should be taken into account when a highly restricted salt diet is recommended, e.g. in some cases of congestive cardiac failure and renal impairment.

Each 20 ml contains 260 mg (6.5 mmol) of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.

Treatment of children younger

1. Name Of The Medicinal Product

Gabapentin 800mg film-coated tablets

2. Qualitative And Quantitative Composition

Each film-coated tablet contains 800 mg gabapentin.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet.

A white, capsule shaped, film-coated tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

Epilepsy

Adults and children over 12 years

Gabapentin is an anti-epileptic agent indicated as add-on therapy for partial seizures (with or without secondary generalisation) in patients who have not achieved satisfactory control with, or who exhibit intolerance to, standard anticonvulsants whether used alone or in combination.

Children 6-12 years of age

Gabapentin may be used as add-on therapy for partial seizures (with or without secondary generalisation) in children aged between 6-12 years, who have not achieved satisfactory control with, or who exhibit intolerance to, standard anticonvulsants whether used alone or in combination, if the risk-benefit ratio is considered favourable. Treatment should be initiated and supervised by a neurological specialist.

Children under 6 years of age

The use of gabapentin is not recommended in this age group owing to the lack of sufficient supporting data.

Neuropathic Pain

Gabapentin is indicated for the treatment of neuropathic pain in adults.

4.2 Posology And Method Of Administration

GENTAMICIN INTRATHECAL 5MG/ML SOLUTION FOR INJECTION

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 further questions, please 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.
  • Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect.

In this leaflet:

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

What gentamicin is and what it is used for

The name of this medicine is Gentamicin Intrathecal 5mg/ml solution for injection (called gentamicin in this leaflet). It contains a medicine called gentamicin sulphate. This belongs to a group of antibiotics called ‘aminoglycosides’.

Gentamicin is used to treat infections caused by bacteria. This includes infections of the:

  • Brain - including meningitis
  • Spinal cord

Before you have gentamicin