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1. Name Of The Medicinal Product

Temazepam 10mg/5ml Oral Solution

2. Qualitative And Quantitative Composition

Temazepam BP 10mg/5ml

3. Pharmaceutical Form

An elixir containing 10mg Temazepam BP per 5ml for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

Temazepam is indicated for the short term treatment of sleep disturbances, considered severe or disabling or where insomnia is subjecting the individual to extreme distress. This product is especially useful in those patients for whom particularly rapid onset of hypnotic action is required and for whom the persistence of hypnotic effect after rising would be undesirable.

Temazepam is particularly suitable for patients with transient sleep disorders in whom re-establishment of normal sleep patterns is expected following the resolution of precipitating factors.

It is also indicated for pre-medication for minor surgical and investigative procedures, especially in the case of outpatients.

4.2 Posology And Method Of Administration

For oral administration only.

Adults:

Insomnia: Each 5ml dose of Temazepam Elixir is equivalent to 10mg Temazepam. The usual dose is 5 - 15ml orally on retiring; a dose of 10ml will be found to be satisfactory for most patients. This may be increased to 15 - 20ml (30 - 40mg Temazepam) in patients who do not respond to the lower dose. Lower doses may be adequate for some patients, as for the elderly.

Pre- medication

10 - 20ml from half an hour to one hour prior to surgery or investigative procedures.

Elderly:

Elderly patients or those suffering from cerebral vascular changes such as arteriosclerosis are li

1. Name Of The Medicinal Product

Trazodone Hydrochloride 100mg Capsules

2. Qualitative And Quantitative Composition

Trazodone hydrochloride 100mg per capsule.

For excipients see 6.1

3. Pharmaceutical Form

Capsules.

4. Clinical Particulars

4.1 Therapeutic Indications

Anxiety, depression, mixed anxiety and depression.

4.2 Posology And Method Of Administration

Route of administration: Oral.

DEPRESSION:

Adults:

Initially 150mg/day in divided doses after food or as a single dose on retiring.

This may be increased up to 300mg/day in a single or divided doses. The major portion of a divided dose to be taken on retiring. The dose may be further increased to 600mg/day in divided doses in hospitalised patients.

Elderly:

For very elderly or frail patients, the recommended initial starting dose is reduced to 100mg/day given in divided doses or as a single night-time dose. This may be incrementally increased, under supervision, according to efficacy and tolerance. In general, single doses above 100mg should be avoided in these patients. It is unlikely that 300mg/day will be exceeded.

Children:

There are insufficient data on safety to recommend the use of Trazodone in children below the age of 18 years.

DEPRESSION ACCOMPANIED BY ANXIETY:

As for depression.

ANXIETY:

75mg/day increasing to 300mg/day as necessary.

A decrease in side-effects (increase of the resorption and decrease of the peak plasma concentration) can be reached by taking Trazodone after a meal..

Hepatic Impairment:

TRILEPTAL 150 mg film-coated tablets

TRILEPTAL 300 mg film-coated tablets

TRILEPTAL 600 mg film-coated tablets

Oxcarbazepine

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 or your child. 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 Trileptal is and what it is used for
  • 2. Before you take Trileptal
  • 3. How to take Trileptal
  • 4. Possible side effects
  • 5. How to store Trileptal
  • 6. Further information

What Trileptal Is And What It Is Used For

What Trileptal is

The active ingredient of Trileptal is oxcarbazepine.

Trileptal belongs to a group of medicines called anticonvulsants or antiepileptics.

What Trileptal is used for

Medicines such as Trileptal are the standard treatment for epilepsy.

Patients diagnosed with epilepsy have had repeated seizures, or convulsions. Seizures happen because of a temporary fault in the brain’s electrical system. Normally brain cells coordinate b

1. Name Of The Medicinal Product

Temomedac 180 mg hard capsules

2. Qualitative And Quantitative Composition

Each hard capsule contains 180 mg temozolomide.

Excipient: Each hard capsule contains 150 mg of anhydrous lactose.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Hard capsule

The hard capsules have a white opaque body and cap with two stripes in red ink on the cap and with “T 180 mg” in red ink on the body.

4. Clinical Particulars

4.1 Therapeutic Indications

Temomedac hard capsules is indicated for the treatment of:

- adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.

- children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

4.2 Posology And Method Of Administration

Temomedac hard capsules should only be prescribed by physicians experienced in the oncological treatment of brain tumours.

Anti-emetic therapy may be administered (see section 4.4).

Posology

Adult patients with newly-diagnosed glioblastoma multiforme

Temomedac hard capsules is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).

Concomitant phase

TMZ is administered orally at a dose of 75 mg/m? daily for 42 days concomitant with focal radiotherapy

Geigy

TEGRETOL 125 and 250 mg Suppositories

(carbamazepine)

What you need to know about Tegretol Suppositories

Your doctor has decided that you need this medicine to help treat your condition.

Please read this leaflet carefully before you start to use the suppositories. It contains important information. Keep the leaflet in a safe place because you may want to read it again.

If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist.

This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be 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 Tegretol Suppositories are and what they are used for
  • 2. Things to consider before you are treated with Tegretol Suppositories
  • 3. How to use Tegretol Suppositories
  • 4. Possible side effects
  • 5. How to store Tegretol Suppositories
  • 6. Further information

What Tegretol Suppositories are and what they are used for

Carbamazepine, the active ingredient in Tegretol Suppositories is an anti-convulsant medicine (prevents fits).

Tegretol Suppositories are used to treat some forms of epilepsy. They are useful in the short term, (maximum 7 days), for patients who cannot take medicines by mouth, e.g. after surgery or if unconscious.

Things to consider before you are treated with Tegretol Suppositories

1. Name Of The Medicinal Product

Tegretol® Retard 200mg and 400mg Tablets

2. Qualitative And Quantitative Composition

The active ingredient is 5H-dibenzo[b,f]azepine-5-carboxamide.

Each coated tablet contains 200mg or 400mg carbamazepine Ph.Eur.

3. Pharmaceutical Form

The 200mg tablets are beige-orange, oval, slightly biconvex, coated tablets with a score on each side. One side bears the imprint “H/C”, the other “C/G”.

The 400mg tablets are brownish-orange, oval, slightly biconvex coated tablets with a score on each site. One side bears the imprint “ENE/ENE”, the other “C/G”.

4. Clinical Particulars

4.1 Therapeutic Indications

Epilepsy - generalised tonic-clonic and partial seizures. Tegretol Retard is indicated in newly diagnosed patients with epilepsy and in those patients who are uncontrolled or unable to tolerate their current anti-convulsant therapy.

Note: Carbamazepine is not usually effective in absences (petit mal) and myoclonic seizures. Moreover, anecdotal evidence suggests that seizure exacerbation may occur in patients with atypical absences.

The paroxysmal pain of trigeminal neuralgia.

For the prophylaxis of manic-depressive psychoses in patients unresponsive to lithium therapy.

4.2 Posology And Method Of Administration

Tegretol Retard is given orally, generally in the same total daily dose as conventional Tegretol dosage forms but usually in two divided doses. In a few patients when changing from other oral dosage forms of Tegretol to Tegretol Retard the total daily dose may need to be increased, particularly when it is used in polytherapy. When starting treatment with Tegretol Retard in monotherapy, 100-200mg once or twice daily is recomm

1. Name Of The Medicinal Product

TIMOPTOL® 0.25% w/v Eye Drops Solution

TIMOPTOL® 0.5% w/v Eye Drops Solution

2. Qualitative And Quantitative Composition

'Timoptol' 0.25% w/v Eye Drops Solution contains timolol maleate equivalent to 0.25% w/v solution of timolol with preservative.

'Timoptol' 0.5% w/v Eye Drops Solution contains timolol maleate equivalent to 0.5% w/v solution of timolol with preservative.

3. Pharmaceutical Form

Eye drops solution.

Clear, colourless to light yellow, sterile eye drops solution.

4. Clinical Particulars

4.1 Therapeutic Indications

'Timoptol' Eye Drops Solution is a beta-adrenoreceptor blocking agent used topically in the reduction of elevated intra-ocular pressure in various conditions including the following: patients with ocular hypertension; patients with chronic open-angle glaucoma including aphakic patients; some patients with secondary glaucoma.

4.2 Posology And Method Of Administration

Recommended therapy is one drop 0.25% solution in the affected eye twice a day.

If clinical response is not adequate, dosage may be changed to one drop 0.5% solution in each affected eye twice a day. If needed, 'Timoptol' may be used with other agent(s) for lowering intra-ocular pressure. The use of two topical beta-adrenergic blocking agents is not recommended (see 4.4 'Special warnings and precautions for use').

Intra-ocular pressure should be reassessed approximately four weeks after starting treatment because response to 'Timoptol' may take a few weeks to stabilise.

Provided that the intra-ocular pressure is maintained at satisfactory levels, many patients can than be placed on once-a-day therapy.

1. Name Of The Medicinal Product

Trisequens®

2. Qualitative And Quantitative Composition

28 sequential tablets: 12 blue, 10 white, 6 red.

Active ingredients:

Blue tablets - Estradiol hemihydrate EP corresponding to estradiol 2mg

White tablets - Estradiol hemihydrate EP corresponding to estradiol 2mg

Norethisterone acetate EP 1mg

Red tablets - Estradiol hemihydrate EP corresponding to estradiol 1mg

Excipients: Lactose monohydrate. For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablets for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

a) Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms.

b) 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

Trisequens is a continuous sequential preparation for hormone replacement therapy. The oestrogen is dosed continuously. The progestogen is added for 10 days in each 28 day cycle, in a sequential manner.

Trisequens is administered orally, without chewing, one tablet daily without interruption, starting with the blue tablets. After taking the last red tablet, treatment is continued with the first blue tablet of a new pack on the next day. A regular shedding of the endometrium is usually induced during the red tablet phase or at the end of the white tablet phase.

In menstruating w

1. Name Of The Medicinal Product

TRANGINA XL 60mg TABLETS.

2. Qualitative And Quantitative Composition

Each tablet contains 60mg isosorbide-5-mononitrate.

3. Pharmaceutical Form

Prolonged-release tablets.

White, oval-shaped tablets impressed “C” on one face and the identifying letters “CY” on either side of a central division line on the reverse.

4. Clinical Particulars

4.1 Therapeutic Indications

Prophylatic treatment of angina pectoris.

4.2 Posology And Method Of Administration

Posology

Adults: Isosorbide mononitrate (one tablet) once daily to be taken in the morning. The dose of 60mg may be increased to 120mg (two tablets) daily, both to be taken once daily in the morning. The dose can be titrated to minimise the possibility of headache, by initiating treatment with 30mg (half a tablet) for the first 2-4 days.

Isosorbide mononitrate tablets must not be chewed or crushed. They should be swallowed whole with half a glass of water.

Children: The safety and efficacy of isosorbide mononitrate in children has not been establised.

Elderly: No evidence of a need for routine dosage adjustment in the elderly has been found, but special care may be needed in those with increased susceptibility to hypotension or marked hepatic or renal insufficiency.

The core of the tablet is insoluble in the digestive juices but disintegrates into small particles when all active substance has been released. Very occasionally the matrix may pass through the gastrointestinal tract without disintegrating and be found visible in the stool, but all active substance has been released.

Me

1. Name Of The Medicinal Product

Targretin 75 mg soft capsules

2. Qualitative And Quantitative Composition

Each capsule contains 75 mg of bexarotene.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Soft capsule.

Off-white capsule, containing a liquid suspension and imprinted with “Targretin”.

4. Clinical Particulars

4.1 Therapeutic Indications

Targretin capsules are indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) patients refractory to at least one systemic treatment.

4.2 Posology And Method Of Administration

Bexarotene therapy should only be initiated and maintained by physicians experienced in the treatment of patients with CTCL.

The recommended initial dose is 300 mg/m2/day. Targretin capsules should be taken as a single oral daily dose with a meal (see section 4.5). Initial dose calculations according to body surface area are as follows:

Initial dose level (300 mg/m2/day)

Number of 75 mg Targretin capsules

 

Body Surface Area (m2)

Total daily dose (mg/day)

 

0.88 – 1.12

300

1. Name Of The Medicinal Product

Tranexamic Acid 500 mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 500mg Tranexamic Acid.

For excipients, see 6.1.

3. Pharmaceutical Form

Tablet.

White, capsule shaped tablet embossed with 'T500' on one side and a break line on the other side.

4. Clinical Particulars

4.1 Therapeutic Indications

Tranexamic Acid 500mg Tablets are indicated for short term use for haemorrhage or risk of haemorrhage in those with increased fibrinolysis or fibrinogenolysis. Local fibrinolysis as occurs in the following conditions:

1. a) Prostatectomy and bladder surgery

b) Menorrhagia

c) Epistaxis

d) Conisation of the cervix

e) Traumatic hyphaema

2. Management of dental extraction in haemophiliacs.

3. Hereditary angioneurotic oedema.

4.2 Posology And Method Of Administration

Route of administration: Oral.

Adults:

Local Fibrinolysis: The recommended standard dose is 15-25mg/kg bodyweight (i.e. 2-3 tablets) two to three times daily. For the indications listed below the following doses may be used:

1a Prostatectomy: Prophylaxis and treatment of haemorrhage in high risk patients should commence per- or post-operatively with tranexamic acid injection; thereafter 2 tablets three to four times daily until macroscopic haematuria is no longer present.

1b Menorrhagia: Recommended dosage is 2 tablets 3 times daily as long as needed for up to 4 days. If very heavy menstrual bleeding, dosage may be increa

1. Name Of The Medicinal Product

Tixylix® Chesty Cough

2. Qualitative And Quantitative Composition

Each 5ml contains Guaifenesin 50mg

For excipients see section 6.1

3. Pharmaceutical Form

Linctus

A clear, colourless or straw coloured solution

4. Clinical Particulars

4.1 Therapeutic Indications

Expectorant for the symptomatic relief of acute productive (chesty) cough.

The linctus is for the lubrication and relief of the sore throat and hoarseness, which may be associated with the cough.

4.2 Posology And Method Of Administration

The following dose is taken 4 hourly. Do not exceed 6 doses in 24 hours.

Tixylix Chesty Cough is contra-indicated in children under 6 years of age.

6 – 10 years 5 to 10ml

Not to be used for more than 5 days without the advice of a doctor. Parents or carers should seek medical advice if the child's condition deteriorates during treatment.

Do not exceed the stated dose.

Keep out of the sight and reach of children.

4.3 Contraindications

Hypersensitivity to the active ingredients or to any of the excipients.

Not to be used in children under 6 years of age.

4.4 Special Warnings And Precautions For Use

Consult a doctor before use if suffering from an acute asthma attack, a chronic cough or are asthmatic.

Stop use and consult a healthcare professional if the cough persists for longer than 5 days.

Stop use and consult a healthcare professional if the cough is accompanied by a fever, rash or persistent headache or is recurrent.

If symptoms persist, consult a doct

Tostran 2% Gel

Testosterone

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 further questions, please ask your doctor or your 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 Tostran is and what it is used for
  • 2. Before you use Tostran
  • 3. How to use Tostran
  • 4. Possible side effects
  • 5. How to store Tostran
  • 6. Further information

What Tostran Is And What It Is Used For

The active substance, testosterone, is a male hormone, which is a type of androgen.

Tostran is used in males who have a deficiency or lack of testosterone, named hypogonadism.

Before You Use Tostran

Tostran must only be used if hypogonadism has been confirmed by your doctor, based on your symptoms and laboratory tests. Other reasons for your symptoms must have been excluded by your doctor prior to the start of treatment.

Only men can use Tostran. Tostran has not been tested in males less than 18 years of age, and there is limited experience of treating men older than 65 years of age.

Do not use Tostran:

1. Name Of The Medicinal Product

Tarceva

2. Qualitative And Quantitative Composition

Tarceva 25mg

One film-coated tablet contains 25 mg erlotinib (as erlotinib hydrochloride).

Excipients: Each film-coated tablet contains 27.43 mg Lactose monohydrate.

Tarceva 100mg

One film-coated tablet contains 100 mg erlotinib (as erlotinib hydrochloride).

Excipients: Each film-coated tablet contains 69.21 mg Lactose monohydrate.

Tarceva 150mg

One film-coated tablet contains 150 mg erlotinib (as erlotinib hydrochloride).

Excipients: Each film-coated tablet contains 103.82 mg Lactose monohydrate.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet.

White to yellowish, round, biconvex tablets with 'Tarceva 25' and logo printed in brownish yellow on one side.

White to yellowish, round, biconvex tablets with 'Tarceva 100' and logo printed in grey on one side.

White to yellowish, round, biconvex tablets with 'Tarceva 150' and logo printed in brown on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

Non-small cell lung cancer (NSCLC):

Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations.

Tarceva is also indicated as monotherapy for maintenance treatment in patients with locally advanced or metastatic NSCLC with stable disease after 4 cycles of standard platinum-based first-line chemotherapy.

Tarceva is also indicated for the treatment of patients wi

TEVETEN
300 mg, 400 mg and 600 mg Film-coated Tablets

Eprosartan

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

What Teveten is and what it is used for

What Teveten is used for

Teveten contains a medicine called eprosartan mesylate. This belongs to a group of medicines called ‘angiotensin II receptor antagonists’.

This medicine is used to treat high blood pressure, also called hypertension.

The main cause of high blood pressure is narrowing of the blood vessels. This increases the amount of work your heart must do to pump blood around your body.You may not feel unwell, but, if high b

1. Name Of The Medicinal Product

Tracleer

2. Qualitative And Quantitative Composition

Each film-coated tablet contains 62.5 mg bosentan (as monohydrate).

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet (tablets):

Orange-white, round, biconvex, film-coated tablets, embossed with “62,5” on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III. Efficacy has been shown in:

• Primary (idiopathic and heritable) PAH

• PAH secondary to scleroderma without significant interstitial pulmonary disease

• PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger's physiology

Some improvements have also been shown in patients with PAH WHO functional class II (see section 5.1).

Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease (see section 5.1).

4.2 Posology And Method Of Administration

Tablets are to be taken orally morning and evening, with or without food. The film-coated tablets are to be swallowed with water.

Pulmonary arterial hypertension

Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension.

In adult patients, Tracleer treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily.

For paediat

1. Name Of The Medicinal Product

Tambocor™ 50mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains flecainide acetate 50mg

3. Pharmaceutical Form

Tablet

4. Clinical Particulars

Tambocor is a potent sodium channel blocking agent for the treatment of the conditions listed below:

The effect on the JT interval is insignificant at therapeutic levels.

4.1 Therapeutic Indications

Tambocor tablets are indicated for:

a) AV nodal reciprocating tachycardia; arrhythmias associated with Wolff-Parkinson-White Syndrome and similar conditions with accessory pathways.

b) Paroxysmal atrial fibrillation in patients with disabling symptoms when treatment need has been established and in the absence of left ventricular dysfunction (see 4.4, Special warnings and special precautions for use). Arrhythmias of recent onset will respond more readily.

c) Symptomatic sustained ventricular tachycardia.

d) Premature ventricular contractions and/or non-sustained ventricular tachycardia which are causing disabling symptoms, where these are resistant to other therapy or when other treatment has not been tolerated.

Tambocor tablets can be used for the maintenance of normal rhythm following conversion by other means.

Tambocor tablets are for oral administration.

4.2 Posology And Method Of Administration

Adults: Supraventricular arrhythmias: The recommended starting dosage is 50mg twice daily and most patients will be controlled at this dose. If required the dose may be increased to a maximum of 300mg daily.

Ventricular arrhythmias: The recommended starting dosage is 100mg twice daily. The maximum daily dose is

1. Name Of The Medicinal Product

TRENTAL 400.

2. Qualitative And Quantitative Composition

Pentoxifylline 400MG.

3. Pharmaceutical Form

Modified release tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

Trental 400 is indicated in the treatment of peripheral vascular disease, including intermittent claudication and rest pain.

4.2 Posology And Method Of Administration

The recommended initial dose is 1 tablet (400 mg) three times daily; two tablets daily may prove sufficient in some patients, particularly for maintenance therapy. Tablets should be taken with or immediately after meals, and swallowed whole with plenty of water.

Elderly:

No special dosage requirements.

Children:

Trental 400 is not suitable for use in children.

Special Cases: In patients with impairment of renal function (creatinine clearance below 30ml/min) a dose reduction by approximately 30% to 50% may be necessary guided by individual tolerance.

4.3 Contraindications

Trental 400 is contra-indicated in cases where there is known hypersensitivity to the active constituent, pentoxifylline other methyl xanthines or any of the excipients. Also in patients with cerebral haemorrhage, extensive retinal haemorrhage, acute myocardial infarction and severe cardiac arrhythmi

TIMODINE

PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE. IF YOU ARE NOT SURE ABOUT ANYTHING ASK YOUR PHARMACIST OR DOCTOR.

What Is Timodine?

Timodine is a pale yellow cream which is applied thinly to the inflamed skin. It contains an antifungal agent, a corticosteroid, an antiseptic and a water-repellent.

Each tube of Timodine contains 30 g.

The active ingredients are nystatin BP 100,000 IU/g, hydrocortisone Ph Eur 0.5% w/w, dimeticone 350 BP 10% w/w and benzalkonium chloride solution BP 0.2% w/w.

The other ingredients are butylated hydroxyanisole, cetostearyl alcohol, cellulose nitrate, dibutyl phthalate, glyceryl monostearate, methyl hydroxybenzoate, propyl hydroxybenzoate, sorbic acid, stearic acid, sodium metabisulphite and water.

Marketing Authorisation Holder:

Alliance Pharmaceuticals Ltd
Avonbridge House
Bath Road
Chippenham
Wiltshire
SN15 2BB
UK

Manufacturer:

Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU8 7DS

What Is Timodine Used For?

Timodine is a medicine to treat inflamed skin conditions, particularly where infection by a germ called Candida albicans can occur.

Where two folds of skin rub together, chafing can occur, leading to a sore inflamed area of skin. This particularly happens in

1. Name Of The Medicinal Product

Tilade CFC-Free Inhaler

2mg per actuation pressurised inhalation suspension

2. Qualitative And Quantitative Composition

One metered dose (ex-valve) contains 2 mg nedocromil sodium.

For the full list of excipients, see section 6.1.

3. Pharmaceutical Form

Pressurised inhalation suspension.

Tilade CFC-Free Inhaler contains a new propellant, HFA-227, and does not contain any chlorofluorocarbons (CFCs).

4. Clinical Particulars

4.1 Therapeutic Indications

Tilade CFC-Free is recommended for the treatment of bronchial asthma where regular preventative anti-inflammatory therapy is indicated and, in particular, in patients whose asthma is not adequately controlled by bronchodilators alone. Tilade CFC-Free may be given in addition to all existing therapies and in many cases will provide added therapeutic benefit.

4.2 Posology And Method Of Administration

Posology

For inhalation use.

Adults, including the elderly and children over 6 years of age.

The initial dose is 4 mg (2 actuations) four times daily. Once control of symptoms has been achieved it may be possible to reduce the dose to a maintenance dose of 4mg (2 actuations) twice daily.

Tilade CFC-Free is intended for regular daily use and should not be used for the relief of symptoms in an acute attack.

Tilade CFC-Free is not recommended for use in children 6 years of age and younger.

Concomitant Bronchodilator Therapy

Where a concomitant inhaled bronchodilator is prescribed it is recommended that this