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1. Name Of The Medicinal Product

JANUVIA®

2. Qualitative And Quantitative Composition

Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet (tablet)

Round, beige film-coated tablet with “277” on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

For patients with type 2 diabetes mellitus, Januvia is indicated to improve glycaemic control :

as monotherapy

• in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.

as dual oral therapy in combination with

• metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.

• a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.

• a peroxisome proliferator-activated receptor gamma (PPAR?) agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? agonist alone do not provide adequate glycaemic control.

as triple oral therapy in combination with

• a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control.

• a PPAR? agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic c

1. Name Of The Medicinal Product

Junior Meltus Dry Coughs with Congestion

2. Qualitative And Quantitative Composition

Dextromethorphan Hydrobromide BP 3.5mg/5ml; Pseudoephedrine Hydrochloride BP 10.0mg/5ml.

3. Pharmaceutical Form

Oral solution.

4. Clinical Particulars

4.1 Therapeutic Indications

An oral solution for the symptomatic relief of unproductive coughs accompanied by congestion of the upper respiratory tract.

4.2 Posology And Method Of Administration

To be given four times a day. Do not repeat dosage more frequently than every four hours. Children 6-12 years: Two 5ml spoonfuls. Children 2-5 years: One 5ml spoonful. Adults, the elderly and children over 12 years are recommended to take Adult Meltus Dry Coughs with Congestion. Not to be given to children under two years of age.

4.3 Contraindications

Junior Meltus Dry Coughs with Congestion is contraindicated in patients with a known hypersensitivity to pseudoephedrine or dextromethorphan. Contraindicated in persons under treatment with monoamine oxidase inhibitors or within 2 weeks of stopping such treatment. Contraindicated in patients with severe hypertension or severe coronary artery disease. Junior Meltus Dry Coughs with Congestion should not be administered to patients where the cough is associated with asthma or where the cough is accompanied by excessive secretions. Dextromethorphan, in common with other centrally acting antitussive agents, should not be given to patients in or at risk of developing respiratory failure. Although pseudoephedrine has virtually no pressor effect in patients with normal blood pressure, Junior Meltus Dry Coughs with Congestion should be used with caution in patients taking antihypertensive agents, tricyclic antidepressa

Janumet 50 mg/1,000 mg film-coated tablets

sitagliptin/metformin hydrochloride

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

What Janumet Is And What It Is Used For

The name of your tablet is Janumet. It contains two different medicines called sitagliptin and metformin.

  • sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
  • metformin belongs to a class of medicines called biguanides.

They work together to control blood sugar levels in patients with a form of diabetes called ‘type 2 diabetes mellitus’. Janumet helps to improve the levels of insulin after a meal and lowers the amount of sugar made by your body.

Along with diet and exercise, this medicine helps lower your blood sugar. Janumet can be used alone or with cert

1. Name Of The Medicinal Product

J Collis Browne's Mixture.

2. Qualitative And Quantitative Composition

Each 5ml contains:

Morphine hydrochloride equivalent to 1.0mg anhydrous Morphine Peppermint Oil 1.5 microlitre

3. Pharmaceutical Form

Aqueous based mixture.

4. Clinical Particulars

4.1 Therapeutic Indications

For the alleviation of coughs and the symptoms of diarrhoea.

4.2 Posology And Method Of Administration

Oral

Adults, the Elderly and Children over 12 years of age

For coughs: One to two 5 ml medicinal teaspoonsful. May be repeated every four hours.

For diarrhoea: Two to three 5 ml medicinal teaspoonsful. May be repeated once or twice at four hourly intervals if required.

Children aged 6 to 12 years of age

For coughs: One 5 ml medicinal teaspoonful. May be repeated every four hours.

For diarrhoea: One 5 ml medicinal teaspoonful. May be repeated once or twice at four hourly intervals if required

Not suitable for children under 6 years of age

4.3 Contraindications

Contraindicated in acute respiratory depression (asthma), acute alcoholism, paralytic ileus, acute ulcerative colitis, raised intra-cranial pressure and head injury.

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Do not exceed the stated dose.

If symptoms persist, consult the doctor.

Keep out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

1. Name Of The Medicinal Product

Janumet®

2. Qualitative And Quantitative Composition

'Janumet' 50 mg/1,000 mg film-coated tablets

Each tablet contains 50 mg of sitagliptin (as phosphate monohydrate) and 1,000 mg of metformin hydrochloride.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet (tablet).

'Janumet' 50 mg/1,000 mg: Capsule-shaped, red film-coated tablet with “577” debossed on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

For patients with type 2 diabetes mellitus:

'Janumet' is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.

'Janumet' is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.

'Janumet' is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR?) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR? agonist.

'Janumet' is also indicated as add

4.2 Posology And Method Of Administration

Posology

The dose of antihyperglycaemic therapy with 'Janumet' should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose o

1. Name Of The Medicinal Product

Joy-rides Tablets

2. Qualitative And Quantitative Composition

Active constituent

Hyoscine hydrobromide 0.15 mg

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

A raspberry flavoured chewed tablet for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

Anti-muscarinic. For the prevention of motion sickness.

4.2 Posology And Method Of Administration

Route of administration: Oral.

Adults over 13 years:

2 tablets 20 minutes before start of the journey. Maximum 4 tablets in 24 hours.

Children:

20 minutes before journey. 7 - 12 years: 1 -2 tablets. 4 - 7 years: 1 tablet. Maximum 2 tablets in 24 hours. 3 – 4 years: half a tablet. Maximum 1 tablet in 24 hours.

Not recommended under 3 years except on medical advice.

Ideally taken 20 minutes before the start of the journey. However, still effective if taken at onset of nausea or after the journey has begun.

4.3 Contraindications

Glaucoma.

4.4 Special Warnings And Precautions For Use

Do not exceed the stated dose. Avoid alcoholic drink.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Javlor 25 mg/ml concentrate for solution for infusion

vinflunine

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

What Javlor Is And What It Is Used For

Javlor contains the active substance vinflunine, which belongs to a group of anticancer medicines called vinca alkaloids. These medicines affect cancer cell growth by stopping cell division, leading to cell death (cytotoxicity).

Javlor is used to treat advanced or metastatic cancer of the bladder and urinary tract when a previous therapy with platinum-containing medicines has failed.

Before You Use Javlor

Do not use Javlor

  • if you are allergic (hypersensitive) to the active substance (vinflunine) or to other vinca alkaloids (vinblastine, vincristine, vindesine, vinorelbine),
  • if you have had (within 2 weeks) or currently have a severe infection,
  • if you are breast-feeding,
  • if your levels of white blood cells and/or platelets are too low

Take special care with Javlor

Tell your doctor:

1. Name Of The Medicinal Product

Jext 150 micrograms solution for injection in pre-filled pen

2. Qualitative And Quantitative Composition

Jext 150 micrograms: One pre-filled pen delivers one dose of 0.15ml solution for injection containing 150 micrograms of adrenaline (as tartrate).

1 ml solution contains 1mg adrenaline (as tartrate).

Excipients: Sodium metabisulphite (E223) and sodium chloride.

Jext contains less than 1 mmol sodium (23 mg) per dose.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection in pre-filled pen.

Clear and colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Jext is indicated in the emergency treatment of severe acute allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs and other allergens as well as idiopathic or exercise induced anaphylaxis.

4.2 Posology And Method Of Administration

Posology:

Paediatric population

Patients between 15 kg and 30 kg in weight:

The usual dose is 150 micrograms.

A dosage below 150 micrograms cannot be administered in sufficient accuracy in children weighing less than 15 kg and use is therefore not recommended unless life-threatening situation and under medical advice. Children and adolescents over 30 kg in weight should be prescribed a Jext 300 micrograms.

An initial dose should be administered as soon as symptoms of anaphylaxis are recognised.

The effective dose is

1. Name Of The Medicinal Product

J Collis Browne's Mixture.

2. Qualitative And Quantitative Composition

Each 5ml contains:

Morphine hydrochloride equivalent to 1.0mg anhydrous Morphine Peppermint Oil 1.5 microlitre

3. Pharmaceutical Form

Aqueous based mixture.

4. Clinical Particulars

4.1 Therapeutic Indications

For the alleviation of coughs and the symptoms of diarrhoea.

4.2 Posology And Method Of Administration

Oral

Adults, the Elderly and Children over 12 years of age

For coughs: One to two 5 ml medicinal teaspoonsful. May be repeated every four hours.

For diarrhoea: Two to three 5 ml medicinal teaspoonsful. May be repeated once or twice at four hourly intervals if required.

Children aged 6 to 12 years of age

For coughs: One 5 ml medicinal teaspoonful. May be repeated every four hours.

For diarrhoea: One 5 ml medicinal teaspoonful. May be repeated once or twice at four hourly intervals if required

Not suitable for children under 6 years of age

4.3 Contraindications

Contraindicated in acute respiratory depression (asthma), acute alcoholism, paralytic ileus, acute ulcerative colitis, raised intra-cranial pressure and head injury.

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Do not exceed the stated dose.

If symptoms persist, consult the doctor.

Keep out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

1. Name Of The Medicinal Product

Jext 300 micrograms solution for injection in pre-filled pen

2. Qualitative And Quantitative Composition

Jext 300 micrograms: One pre-filled pen delivers one dose of 0.30ml solution for injection containing 300 micrograms of adrenaline (as tartrate).

1 ml solution contains 1mg adrenaline (as tartrate).

Excipients: Sodium metabisulphite (E223) and sodium chloride.

Jext contains less than 1 mmol sodium (23 mg) per dose.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection in pre-filled pen.

Clear and colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Jext is indicated in the emergency treatment of severe acute allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs and other allergens as well as idiopathic or exercise induced anaphylaxis.

4.2 Posology And Method Of Administration

Posology:

Use in adults over 30 kg in weight:

The usual dose is 300 micrograms.

Larger adults may require more than one injection to reverse the effect of an allergic reaction.

Patients between 15 kg and 30 kg in weight should be prescribed a Jext 150 micrograms.

An initial dose should be administered as soon as symptoms of anaphylaxis are recognised.

The effective dose is typically in the range of 0.005-0.01 mg/kg but higher doses may be necessary in some cases.

In the absence of clinical improvement or if deterioration occurs, a sec

1. Name Of The Medicinal Product

Junior Parapaed Paracetamol Suspension 120mg/5ml

Infant Paracetamol Suspension 120mg/5ml

Paracetamol Suspension 120mg/5ml

Asda Infant Paracetamol Oral Suspension 120mg/5ml

Enterprise Infant Paracetamol Suspension 120mg/5ml

Lexon Infant Paracetamol Oral Suspension 120mg/5ml

Tesco Children's Paracetamol Suspension 120 mg/5 ml

Paracetamol 120 mg/5 ml Oral Suspension

2. Qualitative And Quantitative Composition

Each 5ml spoonful contains Paracetamol BP 120mg

3. Pharmaceutical Form

Oral Suspension.

Pink suspension with cherry odour and taste.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of mild to moderate pain and as an anti-pyretic. Used for the relief of pain and feverishness associated with teething, toothache, headache, colds, flu and post-immunisation pyrexia.

4.2 Posology And Method Of Administration

Age

Dose

For post-vaccination fever for babies aged between 2 – 3 months

One 2.5 ml spoonful (small end)

If necessary, after 4-6 hours, give a second 2.5 ml dose

• Do not give to babies less than 2 months of age

1. Name Of The Medicinal Product

J Collis Browne's Tablets

2. Qualitative And Quantitative Composition

Morphine hydrochloride Ph. Eur.

0.35mg/tablet

Light kaolin BP1980

750mg/tablet

Calcium carbonate, heavy Ph. Eur

200mg/tablet

3. Pharmaceutical Form

Uncoated tablet

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of occasional diarrhoea.

4.2 Posology And Method Of Administration

Oral.

Adults and the Elderly:

Two or three tablets at once, then two or three tablets every four hours.

Children aged 6 to 10 years

One tablet at once, then one tablet every four hours.

Children under 6 years

Not recommended

4.3 Contraindications

Contraindicated in acute respiratory depression (asthma), acute alcoholism, paralytic ileus, acute ulcerative colitis, raised intra-cranial pressure and head injury. Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

If symptoms persist for mor

1. Name Of The Medicinal Product

Junior Meltus Chesty Coughs with Catarrh

2. Qualitative And Quantitative Composition

Guaifenesin 50mg

Cetylpyridinium Chloride 2.5mg

3. Pharmaceutical Form

Oral liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of coughs and catarrh associated with influenza, colds and mild throat infections.

4.2 Posology And Method Of Administration

To be taken three to four times daily.

Children over 6 years: Two 5ml spoonfuls.

Children 2-6 years: One 5ml spoonful

Not to be given to children under two years of age.

Not more than 4 doses should be given in any 24 hours

4.3 Contraindications

This product is contraindicated in patients hypersensitive to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Do not exceed the stated dose.

Do not take with any other cough and cold medicine.

Consult a pharmacist or other healthcare professional before use in children under 6 years.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Can cause transient abnormality in platelet aggregation patterns determined one hour after ingestion.

4.6 Pregnancy And Lactation

Although there are no known contraindications, as with all medicines, caution should be exercised when administering to pregnant or lactating women.

4.7 Effects On Ability To Drive And Use Machines

Mild drowsiness has been reported.

4.8 Undesirable Effects

Some gastrointestina

1. Name Of The Medicinal Product

Javlor 25 mg/ml concentrate for solution for infusion

2. Qualitative And Quantitative Composition

1 ml of concentrate contains 25 mg of vinflunine (as ditartrate).

One 2 ml vial contains 50 mg of vinflunine (as ditartrate).

One 4 ml vial contains 100 mg of vinflunine (as ditartrate).

One 10 ml vial contains 250 mg of vinflunine (as ditartrate).

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Concentrate for solution for infusion (sterile concentrate).

Clear, colourless to pale yellow solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen

Efficacy and safety of vinflunine have not been studied in patients with Performance Status

4.2 Posology And Method Of Administration

Vinflunine treatment should be initiated under the responsibility of a physician qualified in the use of anticancer chemotherapy.

Before each cycle, adequate monitoring of complete blood counts should be conducted to verify the absolute neutrophil count (ANC), platelets and haemoglobin as neutropenia, thrombocytopenia and anaemia are frequent adverse reactions of vinflunine.

Posology

The recommended posology is 320 mg/m? vinflunine as a 20 minute intravenous infusion every 3 weeks.

In case of WHO/ECOG performance status (PS) of 1 or PS of 0 and prior pelvic irradiation, the treatment should be started at the dose o

Januvia 100 mg film-coated tablets

Sitagliptin

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

What Januvia Is And What It Is Used For

Januvia is a member of a class of medicines you take by mouth called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in patients with type 2 diabetes mellitus. Type 2 diabetes is also called non-insulin-dependent diabetes mellitus, or NIDDM.

Januvia helps to improve the levels of insulin after a meal and decreases the amount of sugar made by the body. It is unlikely to cause low blood sugar because it does not work when your blood sugar is low. However, when Januvia is used in combination with a sulphonylurea medicine or with insulin, low blood sugar (hypoglycaemia) can occur.

Your doctor has prescribed Januvia to help lower your blood sugar, which is too high