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1. Name Of The Medicinal Product

ZYDOL XL 150 mg tablets.

2. Qualitative And Quantitative Composition

Tablets containing tramadol hydrochloride 150 mg.

For excipients, see 6.1

3. Pharmaceutical Form

Prolonged release, white, film coated tablets, marked T 150.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of moderate to severe pain.

4.2 Posology And Method Of Administration

ZYDOL XL tablets should be taken at 24-hourly intervals and must be swallowed whole and not chewed.

As with all analgesic drugs, the dose of tramadol should be adjusted according to the severity of the pain and the clinical response of the individual patient. The correct dosage for any individual patient is that which controls the pain with no or tolerable side effects for a full 24 hours. Patients transferring from immediate release tramadol preparations should have their total daily dose calculated, and start on the nearest dose in the ZYDOL XL range. It is recommended that patients are slowly titrated to higher doses to minimise transient side effects. The need for continued treatment should be assessed at regular intervals as withdrawal symptoms and dependence have been reported. (See Section 4.4 Special Warnings and Precautions for Use). A total daily dose of 400 mg should not be exceeded except in special clinical circumstances.

Adults and children over 12 years: The usual initial dose is one 150 mg tablet daily. If pain relief is not achieved, the dosage should be titrated upwards until pain relief is achieved.

Elderly and patients with renal or hepatic impairment: Dosing as for adults. The elimination half-life of tramadol may be prolonged in patients over 75 years. A starti

Zirtek

ALLERGY SOLUTION 1 mg/ml

cetirizine hydrochloride

once-a-day

What You Should Know About Your Medicine

Please read this leaflet carefully before you start taking this medicine. It provides a summary of the information currently available on Zirtek Allergy Solution. For further information or advice ask your doctor or pharmacist.

What Is In Zirtek Allergy Solution

Each pack contains 150 or 200 ml of a banana flavoured, sugar free oral solution; each ml containing 1 mg of cetirizine hydrochloride as the active ingredient. This medicine also contains sorbitol (E420), glycerol (E422), propylene glycol, saccharin sodium, methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), banana flavouring, sodium acetate (E262), acetic acid (E260) and purified water.

Product licence number: PL 00039 / 0540

This medicine is manufactured and licenced by:

UCB Pharma Ltd
208 Bath Road
Slough
Berkshire
SL1 3WE

When Is Zirtek Allergy Solution Used

Your medicine belongs to the antihistamine group of drugs.

This medicine treats adults & children aged 2 years and over: suffering from hay fever (seasonal allergic rhinitis), y

1. Name Of The Medicinal Product

ZYPREXA*

2. Qualitative And Quantitative Composition

Each vial contains 10 mg olanzapine. After reconstitution each ml of the solution contains 5 mg olanzapine.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder for solution for injection.

Yellow lyophilised powder.

4. Clinical Particulars

4.1 Therapeutic Indications

Adults

ZYPREXA powder for solution for injection is indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or manic episode, when oral therapy is not appropriate. Treatment with ZYPREXA powder for solution for injection should be discontinued and the use of oral olanzapine should be initiated, as soon as clinically appropriate.

4.2 Posology And Method Of Administration

Adults

For intramuscular use. Do not administer intravenously or subcutaneously. ZYPREXA powder for solution for injection is intended for short-term use only, for up to a maximum of three consecutive days.

The maximum daily dose of olanzapine (including all formulations of olanzapine) is 20 mg.

The recommended initial dose for olanzapine injection is 10 mg, administered as a single intramuscular injection. A lower dose (5 mg or 7.5 mg) may be given, on the basis of individual clinical status, which should also include consideration of medicinal products already administered either for maintenance or acute treatment (see section 4.4). A second injection, 5-10 mg, may be administered 2 hours after the first injection, on the basis of individual clinical status.

1. Name Of The Medicinal Product

Zydol SR 50 mg prolonged-release tablets

2. Qualitative And Quantitative Composition

Active substance: tramadol hydrochloride

Zydol SR 50 mg prolonged-release tablets

1 prolonged-release tablet contains 50 mg tramadol hydrochloride.

Excipient: Each prolonged-release tablet contains 2.5 mg lactose monohydrate (see section 4.4).

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Prolonged-release tablets

round, biconvex, film-coated tablets, marked with the manufacturer's logo on one side,

- 50 mg tablet: pale yellow coloured, marked T0 on the other side

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of moderate to severe pain.

4.2 Posology And Method Of Administration

The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient.

Unless otherwise prescribed, Zydol SR should be administered as follows:

Adults and adolescents above the age of 12 years:

The usual initial dose is 50-100 mg tramadol hydrochloride twice daily, morning and evening. If pain relief is insufficient, the dose may be titrated upwards to 150 mg or 200 mg tramadol hydrochloride twice daily.

The tablets are to be taken whole, not divided or chewed, with sufficient liquid, independent of meals.

The lowest analgesically effective dose should generally be selected. Daily doses of 400 mg active substance should not be exceeded, except in special clinical circumstances.

Zydol SR should under no circumstances be administered for longer than absolutely

1. Name Of The Medicinal Product

Zydol Solution for Injection.

2. Qualitative And Quantitative Composition

One Zydol Solution for Injection ampoule contains 100mg tramadol hydrochloride in 2ml colourless aqueous solution.

For a full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Clear glass ampoules containing injectable solution.

Solution for injection or infusion.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of moderate to severe pain.

4.2 Posology And Method Of Administration

The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient.

Unless otherwise prescribed, Zydol should be administered as follows:

Adults and adolescents above the age of 12 years:

Zydol injection may be administered intramuscularly, by slow intravenous injection, or diluted in solution (see Section 6.6) for administration by infusion or patient controlled analgesia.

The usual dose is 50 or 100mg 4-6 hourly by the intravenous or intramuscular route. Dosage should be adjusted according to pain severity and response.

Intravenous injections must be given slowly over 2-3 minutes.

For post-operative pain administer an initial bolus of 100mg. During the 60 minutes following the initial bolus, further doses of 50mg may be given every 10-20 minutes, up to a total dose of 250mg including the initial bolus. Subsequent doses should be 50mg or 100mg 4-6 hourly up to a total daily dose of 600mg.

Zydol should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with Zydol is necessary in view of the nature and sev

1. Name Of The Medicinal Product

Zalasta 2.5 mg tablets

2. Qualitative And Quantitative Composition

Each tablet contains 2.5 mg olanzapine.

Excipient:

Each tablet contains 40.4 mg lactose.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablet.

Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots.

4. Clinical Particulars

4.1 Therapeutic Indications

Adults

Olanzapine is indicated for the treatment of schizophrenia.

Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.

Olanzapine is indicated for the treatment of moderate to severe manic episode.

In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder (see section 5.1).

4.2 Posology And Method Of Administration

Adults

Schizophrenia: The recommended starting dose for olanzapine is 10 mg/day.

Manic episode: The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1).

Preventing recurrence in bipolar disorder: The recommended starting dose is 10 mg/day. For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose. If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued

1. Name Of The Medicinal Product

ZINC AND CASTOR OIL OINTMENT BP

2. Qualitative And Quantitative Composition

Zinc Oxide BP 7.5% w/w

3. Pharmaceutical Form

Ointment.

4. Clinical Particulars

4.1 Therapeutic Indications

An emollient and astringent.

4.2 Posology And Method Of Administration

This product is used as an emollient and astringent for topical application to the skin.

4.3 Contraindications

Do not use in patients who are hypersensitive to any of the ingredients.

4.4 Special Warnings And Precautions For Use

For external use only. Keep out of the reach and sight of children.

Zinc and Castor Oil Ointment contains Arachis oil (peanut oil) and should not be taken/applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid Zinc and Castor Oil Ointment.

Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Not applicable.

4.6 Pregnancy And Lactation

No contraindications known.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Skin sensitivity reactions may rarely occur.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Zinc Oxide has a mild astringent action and provides a soothing and protecting effect.

1. Name Of The Medicinal Product

Zumenon 2mg Film-coated Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 2 mg estradiol (as hemihydrate)

For excipients, see 6.1

3. Pharmaceutical Form

Brick-red, round, biconvex, film-coated tablets imprinted '

4. Clinical Particulars

4.1 Therapeutic Indications

Hormone replacement therapy (HRT) for estrogen deficiency symptoms in peri- and postmenopausal women.

Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.

(See also section 4.4)

The experience of treating women older than 65 years is limited.

4.2 Posology And Method Of Administration

Zumenon is an estrogen only continuous HRT for women with or without a uterus.

In women with a uterus, a progestagen such as Dydrogesterone 10mg, should be added to Zumenon for 12-14 days each month to reduce the risk to the endometrium. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestagen in hysterectomised women.

For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used.

In general, treatment should start with Zumenon 1mg. Depending on the clinical response, the dosage can afterwards be adjusted to individual need. If the complaints linked to estrogen deficiency are not ameliorated the dosage can be increased by using Zumenon 2mg.

For the prevention of osteoporosis Zumenon 2 mg should be used.

Zeridame SR 100mg, 150mg, 200mg

Prolonged Release Tablets

Tramadol Hydrochloride

What you should know about Zeridame SR.

Please read this leaflet carefully before you start taking your 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 are serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

What Is Zeridame Sr And What Is It Used For.

Zeridame SR is a pain killer. Zeridame SR eases the pain by inhibition of certain chemicals of the central nervous system (in the brain and the spinal cord).

Zeridame SR can be used in adults and adolescents over 12 years of age. It is used for the treatment of moderate to severe pain.

Zeridame SR is not suitable for children under the age of 12 years.

Before You Take Zeridame Sr.

1. Name Of The Medicinal Product

ZOMACTON 10 mg/ml, powder and solvent for solution for injection in pre-filled syringe.

2. Qualitative And Quantitative Composition

Somatropin*.10mg

(10mg/ml after reconstitution for one vial)

* Produced in Escherichia coli cells using recombinant DNA technology

For full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder and solvent for solution for injection in pre-filled syringe.

Zomacton is a white to off-white lyophilised powder. The solvent in prefilled syringe is clear and colourless.

4. Clinical Particulars

4.1 Therapeutic Indications

Zomacton is indicated for:

- the long

- the long-term treatment of growth retardation due to Turner's Syndrome confirmed by chromosome analysis.

4.2 Posology And Method Of Administration

Zomacton therapy should be used only under the supervision of a qualified physician experienced in the management of patients with growth hormone deficiency.

The dosage of administration of Zomacton should be individualised for each patient.

The duration of treatment, usually a period of several years will depend on maximum achievable therapeutic benefit.

The subcutaneous administration of growth hormone may lead to loss or increase of adipose tissue at the injection site. Therefore, injection sites should be alternated.

GROWTH HORMONE DEFICIENCY

Generally a dose of 0.17 0.23 mg/kg bodyweight (approximating to 4.9 mg/m2 6.9 mg/m2 body surface area) per week divided into 6 - 7 s.c. injections is recommended (corresponding to a daily injection

1. Name Of The Medicinal Product

Zomig 2.5 mg Tablets

2. Qualitative And Quantitative Composition

Tablets for oral administration containing 2.5 mg of zolmitriptan.

For excipients see 6.1.

3. Pharmaceutical Form

Tablets.

4. Clinical Particulars

4.1 Therapeutic Indications

'Zomig' is indicated for the acute treatment of migraine with or without aura.

4.2 Posology And Method Of Administration

The recommended dose of 'Zomig' to treat a migraine attack is 2.5 mg.

If symptoms persist or return within 24 hours, a second dose has been shown to be effective. If a second dose is required, it should not be taken within 2 hours of the initial dose.

If a patient does not achieve satisfactory relief with 2.5 mg doses, subsequent attacks can be treated with 5 mg doses of 'Zomig'.

In those patients who respond, significant efficacy is apparent within 1 hour of dosing.

'Zomig' is equally effective whenever the tablets are taken during a migraine attack; although it is advisable that 'Zomig' tablets are taken as early as possible after the onset of migraine headache.

In the event of recurrent attacks, it is recommended that the total intake of 'Zomig' in a 24 hour period should not exceed 10 mg.

'Zomig' is not indicated for prophylaxis of migraine.

Use in Children (under 12 years of age)

Safety and efficacy of zolmitriptan tablets in paediatric patients have not been evaluated. Use of Zomig in children is therefore not recommended.

Adolescents (12 - 17 years of age)

The efficacy of Zomig tablets was not demonstrated in a placebo

Zometa 4 mg/5 ml concentrate for solution for infusion

Zoledronic acid

Read all of this leaflet carefully before you are given Zometa.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, nurse or pharmacist.
  • If any of the side effects gets serious, or if you notice side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

In this leaflet

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

What Zometa Is And What It Is Used For

The active substance in Zometa is zoledronic acid, which belongs to a group of substances called bisphosphonates. Zoledronic acid works by attaching itself to the bone and slowing down the rate of bone change. It is used:

  • To treat bone metastases (spread of cancer from the primary cancer site to the bone) and to prevent associated/related bone complications, e.g. fractures.
  • To reduce the amount of calcium in the blood in cases where it is too high due to the presence of a tumour. Tumours can accelerate normal bone change in such a way that the release of calcium from bone is increased. This condition is known as tumour-induced hypercalcaemia (TIH).

Before You Are Given Zometa

Follow carefully al

1. Name Of The Medicinal Product

ZANIDIP 20 mg film-coated tablets

2. Qualitative And Quantitative Composition

One tablet contains 20 mg of lercanidipine hydrochloride, which is equivalent to 18.8 mg of lercanidipine.

For excipients, see 6.1.

3. Pharmaceutical Form

Film-coated tablet.

Pink, circular, biconvex tablets, scored on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

ZANIDIP is indicated for the treatment of mild to moderate essential hypertension.

4.2 Posology And Method Of Administration

The recommended dosage is 10 mg orally once a day at least 15 minutes before meals; the dose may be increased to 20 mg depending on the individual patient's response.

Dose titration should be gradual, because it may take about 2 weeks before the maximal antihypertensive effect is apparent.

Some individuals, not adequately controlled on a single antihypertensive agent, may benefit from the addition of ZANIDIP to therapy with a beta-adrenoceptor blocking drug (atenolol), a diuretic (hydrochlorothiazide) or an angiotensin converting enzyme inhibitor (captopril or enalapril).

Since the dose-response curve is steep with a plateau at doses between 20-30 mg, it is unlikely that efficacy will be improved by higher doses; whereas side effects may increase.

Use in the elderly: although the pharmacokinetic data and clinical experience suggest that no adjustment of the daily dosage is required, special care should be exercised when initiating treatment in the elderly.

Use in children: since there is no clinical experience in patients under the age of 18 years, use

1. Name Of The Medicinal Product

Zidovudine 100 mg capsules, hard

2. Qualitative And Quantitative Composition

Each capsule contains 100 mg of zidovudine.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Capsule, hard

White/white size '3' hard gelatin capsules filled with white to off-white granular powder and imprinted with 'D' on white cap and '01' on white body with black ink.

4. Clinical Particulars

4.1 Therapeutic Indications

Zidovudine is indicated in anti-retroviral combination therapy for Human Immunodeficiency Virus (HIV) infected adults and children.

Zidovudine chemoprophylaxis is indicated for use in HIV-positive pregnant women (over 14 weeks of gestation) for prevention of maternal-foetal HIV transmission and for primary prophylaxis of HIV infection in newborn infants.

4.2 Posology And Method Of Administration

Oral use.

Zidovudine should be prescribed by physicians who are experienced in the treatment of HIV infection.

Dosage in adults:

The usual recommended dose of Zidovudine in combination with other anti-retroviral agents is 500 or 600 mg/day in two or three divided doses.

Dosage in children:

3 months - 12 years:

The recommended dose of Zidovudine is 360 to 480 mg/m2 per day, in 3 or 4 divided doses in combination with other antiretroviral agents. The maximum dosage should not exceed 200 mg every 6 hours.

Less than 3 months:

The limited data available are insufficient to propo

1. Name Of The Medicinal Product

Zometa 4 mg/100 ml solution for infusion

2. Qualitative And Quantitative Composition

One bottle contains 4 mg zoledronic acid, corresponding to 4.264 mg zoledronic acid monohydrate.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for infusion

Clear and colourless solution

4. Clinical Particulars

4.1 Therapeutic Indications

- Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.

- Treatment of adult patients with tumour-induced hypercalcaemia (TIH).

4.2 Posology And Method Of Administration

Zometa must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.

Posology

Prevention of skeletal related events in patients with advanced malignancies involving bone

Adults and elderly

The recommended dose in the prevention of skeletal related events in patients with advanced malignancies involving bone is 4 mg zoledronic acid every 3 to 4 weeks.

Patients should also be administered an oral calcium supplement of 500 mg and 400 IU vitamin D daily.

The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2-3 months.

Treat

Zestril 2.5 mg Tablets

Zestril 5 mg Tablets

Zestril 10 mg Tablets

Zestril 20 mg Tablets

lisinopril

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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

What Zestril is and what it is used for

Zestril contains a medicine called lisinopril. This belongs to a group of medicines called ACE inhibitors.

Zestril can be used for the following conditions:

  • To treat high blood pressure (hypertension).
  • To treat heart failure.
  • If you have recently had a heart attack (myocardial infarction).
  • To treat kidney problems caused by Type II diabetes in people with high blood pressure.

Zestril works by making your blood vessels widen. This helps to lower your blood pressure. It also makes

Zomig Rapimelt
2.5 mg
orodispersible tablets

zolmitriptan

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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

What Zomig Rapimelt is and what it is used for

Zomig Rapimelt contains zolmitriptan and belongs to a group of medicines called triptans.

Zomig Rapimelt is used to treat migraine headache.

  • Migraine symptoms may be caused by swollen blood vessels in the head. Zomig Rapimelt is thought to reduce the widening of these blood vessels. This helps to take away the headache and other symptoms of a migraine attack, such as feeling or being sick (nausea or vomiting) and being sensitive to light and sound.
  • Zomig Rapimelt works only when a migraine attack has started. It will not stop you from getting an attack.

1. Name Of The Medicinal Product

Zantac Tablets 300 mg

2. Qualitative And Quantitative Composition

Each tablet contains ranitidine 300 mg (as the hydrochloride).

3. Pharmaceutical Form

Tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

Adults

Zantac Tablets are indicated for:

treatment of duodenal ulcer and benign gastric ulcer, including that associated with non-steroidal anti-inflammatory agents.

treatment of duodenal ulcers associated with Helicobacter pylori infection.

treatment of post-operative ulcer

Zollinger-Ellison syndrome

oesophageal reflux disease

chronic episodic dyspepsia, characterised by pain (epigastric or retrosternal) which is related to meals or disturbs sleep but is not associated with the preceding conditions may benefit from ranitidine treatment.

Zantac Tablets are indicated for the following conditions where reduction of gastric secretion and acid output is desirable:

prophylaxis of gastrointestinal haemorrhage from stress ulceration in seriously ill patients

prophylaxis of recurrent haemorrhage in patients with bleeding peptic ulcers

before general anaesthesia in patients considered to be at risk of acid aspiration (Mendelson's syndrome), particularly obstetric patients during labour.

For appropriate cases Zantac Injection is also available (see separate SPC).

Children (3 to 18 years)

Short term treatment of peptic ulcer

Treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic

1. Name Of The Medicinal Product

Zoladex 3.6 mg Implant

2. Qualitative And Quantitative Composition

Goserelin acetate (equivalent to 3.6 mg goserelin).

For excipients, see 6.1.

3. Pharmaceutical Form

Implant, in pre-filled syringe.

4. Clinical Particulars

4.1 Therapeutic Indications

(i) Treatment of prostate cancer in the following settings (see also section 5.1):

In the treatment of metastatic prostate cancer where Zoladex has demonstrated comparable survival benefits to surgical castrations (see section 5.1)

In the treatment of locally advanced prostate cancer, as an alternative to surgical castration where Zoladex has demonstrated comparable survival benefits to an anti-androgen (see section 5.1)

As adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer where Zoladex has demonstrated improved disease-free survival and overall survival (see section 5.1)

As neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced prostate cancer where Zoladex has demonstrated improved disease-free survival (see section 5.1)

As adjuvant treatment to radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression where Zoladex has demonstrated improved disease-free survival (see section 5.1)

(ii) Advanced breast cancer in pre and perimenopausal women suitable for hormonal manipulation.

(iii) Zoladex 3.6 mg is indicated as an alternative to chemotherapy in the standard of care for pre/perimenopausal women with oestrogen receptor (ER) positive early breast cancer.

(iv) Endometriosis: In the

1. Name Of The Medicinal Product

Zyomet Gel

2. Qualitative And Quantitative Composition

Metronidazole 0.75% w/w

3. Pharmaceutical Form

Gel for cutaneous use

4. Clinical Particulars

4.1 Therapeutic Indications

Zyomet Gel is indicated for the treatment of acute inflammatory exacebations of acne rosacea

4.2 Posology And Method Of Administration

Adults: Apply to the affected skin of the face in a thin film twice a day for eight to nine weeks. Thereafter, further applications may be necessary depending on the severity of the condition.

Use in the elderly: As detailed for adults.

Use in Children: Not recommended

4.3 Contraindications

Patients with known hypersensitivity to any of the ingredients should not use the product.

4.4 Special Warnings And Precautions For Use

If a reaction suggesting local irritation occurs patients should be directed to use the medication less frequently, discontinue use temporarily or discontinue use until further instructions. Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of, blood dyscrasia. Exposure of treated sites to ultraviolet or strong sunlight should be avoided during use of metronidazole. Unnecessary and prolonged use of this medication should be avoided.

Zyomet Gel has been reported to cause lacrimation of the eyes, thereforeavoid contact with eyes; if eye contact does occur the gel should be washed out carefully with water. Avoid drinking alcohol while using Zyomet Gel.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There is evidence to suggest that systemic absorption of