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1. Name Of The Medicinal Product

Pregnyl 5000 I.U.

2. Qualitative And Quantitative Composition

Injection containing human chorionic gonadotrophin 5000 IU.

3. Pharmaceutical Form

Freeze dried powder for injection

4. Clinical Particulars

4.1 Therapeutic Indications

In the male

Hypogonadotrophic hypogonadism.

Delayed puberty associated with insufficient gonadotrophic pituitary function.

Sterility in selected cases of deficient spermatogenesis.

In the female

Sterility due to the absence of follicle-ripening or ovulation.

In conjunction with HMG, in the promotion of controlled superovulation in medically assisted reproduction programmes.

4.2 Posology And Method Of Administration

Dosage

In the male

Hypogonadotrophic hypogonadism:

500 - 1,000 Units 2-3 times weekly.

Delayed puberty associated with insufficient gonadotrophic pituitary function:

1,500 Units twice weekly for at least 6 months.

Sterility in selected cases of deficient spermatogenesis:

Usually, 3,000 Units per week in combination with an HMG preparation.

In the female

Sterility due to the absence of follicle-ripening or ovulation:

5000 - 10 000 Units hCG to induce ovulation, following treatment with an HMG (human menopausal gonadotrophins) preparation. Up to 3 repeat injection

1. Name Of The Medicinal Product

Pulmicort® Turbohaler® 200.

2. Qualitative And Quantitative Composition

Budesonide 200 micrograms/actuation.

There are no inactive ingredients.

3. Pharmaceutical Form

Breath-actuated metered dose powder inhaler.

4. Clinical Particulars

4.1 Therapeutic Indications

Pulmicort is recommended in patients with bronchial asthma.

4.2 Posology And Method Of Administration

Pulmicort Turbohaler is for oral inhalation.

When transferring patients to Turbohaler from other devices, treatment should be individualised, whether once or twice daily dosing is being used. The drug and method of delivery should be considered.

Divided doses (twice daily):

The dosage should be individualised.

The dose should always be reduced to the minimum needed to maintain good asthma control.

Adults (including elderly) and children over 12 years of age: When starting treatment, during periods of severe asthma and while reducing or discontinuing oral glucocorticosteroids, the dosage in adults should be 200 - 1600 micrograms daily, in divided doses.

In less severe cases and children over 12 years of age, 200 - 800 micrograms daily, in divided doses, may be used. During periods of severe asthma, the daily dosage can be increased to up to 1600 micrograms, in divided doses.

Children 5 - 12 years of age: 200 - 800 micrograms daily, in divided doses. During periods of severe asthma, the daily dose can be increased up to 800 micrograms.

Once daily dosage:

1. Name Of The Medicinal Product

Pulmicort CFC-free Inhaler 100 micrograms.

2. Qualitative And Quantitative Composition

Each metered dose (ex-valve)/actuation contains budesonide 100 micrograms.

For full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Pressurised inhalation, suspension.

The NebuChamberTM spacer device is the only spacer device to be used with Pulmicort CFC-free Inhaler.

4. Clinical Particulars

4.1 Therapeutic Indications

Asthma.

4.2 Posology And Method Of Administration

For inhalation use.

Adults, including the elderly: 200 micrograms twice daily, in the morning and in the evening. During periods of severe asthma the daily dosage can be increased up to 1600 micrograms.

In patients whose asthma is well controlled, the daily dose may be reduced below 400 micrograms but should not go below 200 micrograms.

The dose should be reduced to the minimum needed to maintain good asthma control.

Children 2-12 years:200 to 800 micrograms daily in divided doses.

A higher strength inhaler (200 microgram) is available for use in children with moderately severe/severe asthma and requiring a dose regimen of Pulmicort CFC-free Inhaler of 800 micrograms as a total daily dose.

The dose should be reduced to the minimum needed to maintain good asthma control.

Pulmicort CFC-free Inhaler is not recommended for use in children less than 2 years of age.

Patients maintained on oral glucocorticosteroids

1. Name Of The Medicinal Product

Protopic 0.03% ointment

2. Qualitative And Quantitative Composition

1 g of Protopic 0.03% ointment contains 0.3 mg of tacrolimus as tacrolimus monohydrate (0.03%).

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Ointment

A white to slightly yellowish ointment.

4. Clinical Particulars

4.1 Therapeutic Indications

Protopic 0.03% ointment is indicated in adults, adolescents and children from the age of 2 years.

Flare treatment

Adults and adolescents (16 years of age and above)

Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.

Children (2 years of age and above)

Treatment of moderate to severe atopic dermatitis in children who failed to respond adequately to conventional therapies such as topical corticosteroids.

Maintenance treatment

Treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).

4.2 Posology And Method Of Administration

Protopic treatment should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.

Protopic i

1. Name Of The Medicinal Product

Panadol Night or Panadol NightPain

2. Qualitative And Quantitative Composition

Each tablet contains Paracetamol Ph Eur 500.0 mg and Diphenhydramine hydrochloride Ph Eur 25.0 mg.

Also contains lactose monohydrate.

3. Pharmaceutical Form

Film-coated tablets

Blue film coated capsule shaped tablets embossed 'PM' on one face.

4. Clinical Particulars

4.1 Therapeutic Indications

For the short term treatment of bedtime pain, for example rheumatic and muscle pain, backache, neuralgia, toothache, migraine, headache and period pain which is causing difficulty in getting to sleep.

4.2 Posology And Method Of Administration

Oral administration only.

Do not exceed the stated dose or frequency of dosing.

Children:

Not recommended for children under 12 years of age except on medical advice.

Adults and Elderly:

2 tablets to be taken 20 minutes before bedtime. Maximum daily dose: Two tablets (1000 mg paracetamol, 50 mg diphenhydramine hydrochloride) in 24 hours. Other products containing paracetamol may be taken for daytime pain relief but at a reduced maximum dose of 6 tablets in 24 hours. The dose should not be repeated more frequently than every four hours.

Patients should not take the tablets for more than 7 consecutive nights without consulting their doctor.

1. Name Of The Medicinal Product

Pramipexole 0.088 mg tablets

2. Qualitative And Quantitative Composition

Pramipexole 0.088 mg tablets contain 0.088 mg of pramipexole base.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablet.

Strength

(mg base)

Appearance

0.088

white, round, flat tablets (diameter: 6.5mm approximately)

4. Clinical Particulars

4.1 Therapeutic Indications

Pramipexole is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on off” fluctuations).

4.2 Posology And Method Of Administration

Parkinson's disease

The tablets should be taken orally, swallowed with water, and can be taken either with or without food. The daily dosage is administered in equally divided doses 3 times a day.

Initial treatment:

Dosages should be increased gradually from a starting-dose of 0.264 mg of base (0.375 mg of salt) per day and then increased every 5 - 7 days. Providing patients do not experience intolerable

1. Name Of The Medicinal Product

Pred Forte 1% w/v, Eye Drops Suspension

2. Qualitative And Quantitative Composition

1% w/v prednisolone acetate

Excipients: Contains 0.006% w/v Benzalkonium chloride.

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Eye drops, suspension

A dense white sterile microfine eye drops suspension.

4. Clinical Particulars

4.1 Therapeutic Indications

For short-term treatment of steroid-responsive inflammatory conditions of the eye, after excluding the presence of viral, fungal and bacterial pathogens in adults.

4.2 Posology And Method Of Administration

Route of administration is by ocular instillation.

Adults: One to two drops instilled into the conjunctival sac two to four times daily. During the initial 24 to 48 hours the dosing frequency may be safely increased to 2 drops every hour. Care should be taken not to discontinue therapy prematurely.

Shake well before use

Safety and effectiveness in paediatric patients have not been established.

No posology can be recommended.

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

To reduce possible systemic absorption, it may be recommended that the lacrimal sac be compressed at the medial canthus (punctal occlusion) for 1 minute. This should be performed immediately following the instillation of each drop.

4.3 Contraindications

Acute untreated purulent ocular infections. Acute superficial herpes simplex (dendritic keratitis); vaccinia, varicella and most other viral diseases of the cornea and conjunctiva. Fungal diseas

1. Name Of The Medicinal Product

Proctosedyl Ointment

2. Qualitative And Quantitative Composition

Cinchocaine Hydrochloride (Micro) BP 0.5 %ww, Hydrocortisone (Micro) EP 0.5 %ww

3. Pharmaceutical Form

Yellowish-white translucent greasy ointment.

4. Clinical Particulars

4.1 Therapeutic Indications

The local anaesthetic cinchocaine relieves pain and relaxes sphincteric spasm. Pruritis and inflammation are relieved by hydrocortisone, which also decreases serious discharge.

Proctosedyl is, therefore, useful for the short term relief (not more than 7 days) of pain, irritation and pruritis associated with haemorrhoids and pruritis ani.

4.2 Posology And Method Of Administration

Apply the ointment in small quantities with the finger, on the painful or pruritic area, morning and evening and after each stool. For deep application attach cannula to tube, insert to full extent and squeeze tube gently from lower end whilst withdrawing.

The ointment may be used separately or concurrently with the suppositories.

4.3 Contraindications

Known hypersensitivity to any of the ingredients.

Not for use in the presence of infections.

4.4 Special Warnings And Precautions For Use

Apply only to the region of the rectum and anus and surrounding skin. Hydrocortisone can cause thinning and damage to the skin especially of the face.

As with all preparations containing topical steroids, the possibility of systemic absorption should be considered. In particular, long-term continuous therapy should be avoided in infants. Adrenal suppression can occur even without occlusion.

4.5 Interaction With Other Medicinal Products And Ot

1. Name Of The Medicinal Product

PALLADONE® capsules 1.3 mg and 2.6 mg.

2. Qualitative And Quantitative Composition

PALLADONE capsules contain Hydromorphone Hydrochloride USP 1.3 mg or 2.6 mg.

For excipients, see 6.1

3. Pharmaceutical Form

PALLADONE capsules 1.3 mg are orange/clear capsules marked HNR 1.3.

PALLADONE capsules 2.6 mg are red/clear capsules marked HNR 2.6.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of severe pain in cancer.

4.2 Posology And Method Of Administration

Route of administration

The capsules can be swallowed whole or opened and their contents sprinkled on to cold soft food.

Dosage and administration

Adults and children over 12 years

PALLADONE capsules should be used at 4-hourly intervals. The dosage is dependent upon the severity of the pain and the patient's previous history of analgesic requirements. 1.3 mg of hydromorphone has an efficacy approximately equivalent to 10 mg of morphine given orally. A patient presenting with severe pain should normally be started on a dosage of one PALLADONE capsule 4-hourly. Increasing severity of pain will require increased dosage of hydromorphone to achieve the desired relief.

Elderly and patients with renal impairment

The elderly and patients with renal impairment should be dose titrated with PALLADONE capsules in order to achieve adequate analgesia. It should be noted, however, that these patients may require a lower dosage to achieve adequate analgesia.

1. Name Of The Medicinal Product

Promixin, 1 million International Units (IU) Powder for Nebuliser Solution

2. Qualitative And Quantitative Composition

Each vial contains 1 million International Units (IU) which is approximately equivalent to 80 mg of colistimethate sodium.

3. Pharmaceutical Form

Powder for nebuliser solution. The powder is white to off-white

4. Clinical Particulars

4.1 Therapeutic Indications

Promixin is indicated for the treatment by nebulisation of colonisation and infections of the lung due to susceptible Pseudomonas aeruginosa in patients with cystic fibrosis.

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

4.2 Posology And Method Of Administration

Sputum cultures should be obtained to confirm colonisation with Pseudomonas aeruginosa sensitive to colistimethate sodium prior to initiating treatment with Promixin.

The following information provides guidance on recommended doses and the dose should be adjusted according to clinical response.

Recommended doses are:

Children >2 years and adults: 1-2 million IU two or three times daily

Children < 2 years: The safety and efficacy of Promixin has not been demonstrated in patients less than 2 years of age.

The dosage is determined by the severity and type of infection.

The dose may be varied across this range depending on the condition being treated.

Initial colonisation with Pseudomonas aeruginosa sensitive to colistimethate sodium may be treated with a 3-week course of 2 million IU twice daily in conjunction with other parenteral or oral antibiotics.

1. Name Of The Medicinal Product

Paroxetine 20mg Tablets

2. Qualitative And Quantitative Composition

Each film-coated tablet contains 22.22mg paroxetine hydrochloride anhydrous equivalent to 20mg paroxetine free base.

For excipients, see 6.1

3. Pharmaceutical Form

Film-coated tablet.

White to off-white, round, biconvex tablets, diameter 10mm, scored on both sides and walls. Marked "2" and "0" on either side of the score on one side. Marked "P"on one side of the score on the reverse.

The tablet can be divided into equal halves.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of

- Major Depressive Episodes

- Obsessive Compulsive Disorder

- Panic Disorder with and without agoraphobia

- Social Anxiety Disorder/Social phobia

- Generalised Anxiety Disorder

- Post-traumatic Stress Disorder

4.2 Posology And Method Of Administration

It is recommended that paroxetine be administered once daily in the morning with food. The tablets should be swallowed rather than chewed.

For oral administration.

MAJOR DEPRESSIVE EPISODE

The recommended dose is 20mg daily. In general, improvement in patients starts after one week but may only become evident from the second week of therapy.

As with all antidepressant medicinal products, dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate. In some patients, with sufficient response to 20mg, the dose may be increased gradually up to a maximum of 50mg a day in 10mg steps according t

1. Name Of The Medicinal Product

POTASSIUM TABLETS EFFERVESCENT BPC 1968

2. Qualitative And Quantitative Composition

Each tablet contains 500mg Potassium Hydrogen Carbonate and 300mg Potassium Hydrogen Tartrate equivalent to 6.5mmol of potassium (K+)

3. Pharmaceutical Form

White uncoated tablets.

4. Clinical Particulars

4.1 Therapeutic Indications

Indicated in all cases of potassium depletion resulting from intensive or prolonged diuretic therapy, an inadequate dietary potassium intake, and those receiving digitalis - here the elderly population are a special risk. A lack of cellular potassium in the diet can increase the toxic effect of digitalis.

Other indications include corticosteroid therapy, use of carbenoxolone sodium, advanced hepatic cirrhosis, chronic renal disease, Cushing's syndrome, diabetic ketosis, renal tubular or metabolic acidosis, patients on a low-salt diet and in conditions requiring potassium supplementation due to prolonged or chronic diarrhoea and vomiting.

4.2 Posology And Method Of Administration

Posology

Tablets should be dissolved in half a tumbler of cold water before drinking.

Adults: Usually 4-7 tablets daily (26-45.5mmol K+) but dosage should be adjusted to the individual requirements of the patient, based on clinical and laboratory evaluations.

Children: At the discretion of the physician.

Elderly: There are no special dosage requirements, but impairment of renal function should be taken into account. The elderly require monitoring of serum electrolytes.

Method of Administration

To be dissolved in water

Pantoprazole 20 mg

Gastro-resistant Tablets

Pantoprazole (as sodium sesquihydrate)

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 Pantoprazole 20 mg tablets are and what they are used for
  • 2. Before you take Pantoprazole 20 mg tablets (some of the information for your safety).
  • 3. How to take Pantoprazole 20 mg tablets
  • 4. Possible side effects
  • 5. How to store this medicine
  • 6. Further information

What Pantoprazole 20 Mg Tablets Are And What They Are Used For

Pantoprazole 20 mg tablets are a preparation for treating acid-related diseases of the stomach and intestine. They are a “selective proton pump inhibitor”, something which reduces the amount of acid produced in your stomach.

Pantoprazole 20 mg tablets are used for:

  • treating mild forms of oesophageal disease caused by reflux of acid from the stomach (with or without mild inflammation of the oesophagus) and the associated symptoms (e.g. heartburn, acid regurgitati

1. Name Of The Medicinal Product

Phenytoin 250mg/5ml Solution for Injection

2. Qualitative And Quantitative Composition

Each 5 ml ampoule contains 250 mg phenytoin sodium.

For excipients, see 6.1

3. Pharmaceutical Form

Solution for injection.

Clear, colourless, sterile, solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Phenytoin Solution for Injection is indicated for

The control of status epilepticus of the tonic-clonic (grand mal type) and the prevention and treatment of seizures occurring during or following neurosurgery and/or severe head injury.

Phenytoin is also used in the treatment of cardiac arrhythmias where first line therapy is not effective. It is of particular value when these are digitalis induced.

4.2 Posology And Method Of Administration

For intravenous administration.

Whenever solution and container permit, parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration. Phenytoin Solution for Injection is suitable for use as long as it remains clear and free of precipitate. Upon refrigeration or freezing a precipitate might form; this will dissolve again after the solution is allowed to stand at room temperature. The product is still suitable for use. Only a clear solution should be used. A faint yellow colouration may develop; however, this has no effect on the potency of this solution.

There is a relatively small margin between full therapeutic effect and minimally toxic doses of this drug. Optimum control without clinical signs of toxicity occurs most often with serum levels between 10 and 20mg/l (40-80 micromoles/l).

Phenytoin Solution for I

1. Name Of The Medicinal Product

Potaba® (Potassium para-aminobenzoate)

2. Qualitative And Quantitative Composition

Envules: foil laminate sachets containing 3g of potassium para-aminobenzoate.

3. Pharmaceutical Form

Envule; contains 3g potassium para-aminobenzoate; white/off-white powder.

4. Clinical Particulars

4.1 Therapeutic Indications

Peyronie's Disease

Scleroderma

4.2 Posology And Method Of Administration

Potaba envules should be taken orally; four times daily with food; dissolve the powder in fruit juice.

Children: not recommended.

4.3 Contraindications

Potaba should not be given to patient taking sulphonamides as it will inactivate this medication.

Severe liver damage.

4.4 Special Warnings And Precautions For Use

Treatment with Potaba should be interrupted during periods of low food intake (eg, during fasting, anorexia, nausea). This is to avoid the possible development of hypoglycaemia.

Potaba treatment should be given cautiously to patients with renal impairment and treatment discontinued if a hypersensitivity reaction occurs.

Potaba should not be taken by patients on sulphonamides; Potaba may cause inactivation of this medication.

In patients with known liver function disorders, eg hepatitis or toxic poisoning,(eg alcohol abuse), liver function tests should be performed regularly (transaminases, GGT, ALP, LDH).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

With the exception of sulphonamides, no interactions with other medicaments have been established.

4.6 Pregnancy And Lactation

1. Name Of The Medicinal Product

PENTAZOCINE TABLETS BP 25mg

2. Qualitative And Quantitative Composition

Each tablet contains 25mg Pentazocine Hydrochloride BP.

3. Pharmaceutical Form

White uncoated tablets.

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

4. Clinical Particulars

4.1 Therapeutic Indications

1) For the relief of moderate to severe pain.

4.2 Posology And Method Of Administration

Adults: The usual initial dosage is 50mg every four hours after meals followed by 25-100mg every three to four hours.

Children 6-12 years: 25mg every three to four hours as required.

Children under 6 years: Not recommended.

Elderly: Dosage should be reduced in the elderly where there is impairment of hepatic or renal function.

For oral use.

4.3 Contraindications

Patients with established respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, raised intracranial pressure, head injuries or pathological brain conditions where clouding of the sensorium is undesirable. Acute bronchial asthma, in heart failure, secondary to chronic lung disease, porphyria, and in patients known to be hypersensitive to pentazocine and any other ingredients.

4.4 Special Warnings And Precautions For Use

Administer with caution in patients with severely impaired hepatic or renal function, and to those previously on large doses of narcotics.

Caution should be exercised when administering high doses of pentazocine to patients who have suffered a recent myocardial infarction due to increases in

1. Name Of The Medicinal Product

Promixin, 1 million International Units (IU), Powder for Solution for Infusion.

2. Qualitative And Quantitative Composition

Each vial contains 1 million International Units (IU) which is approximately equivalent to 80 mg of colistimethate sodium.

3. Pharmaceutical Form

Powder for solution for infusion

The powder is white to off white

4. Clinical Particulars

4.1 Therapeutic Indications

Promixin is indicated for treatment of the following infections caused by susceptible aerobic Gram-negative bacteria (see section 5.1):

- Hospital acquired pneumonia (HAP)

- Complicated urinary tract infections

It is recommended that Promixin should be selected when antibacterial agents that are commonly used to treat these infections are not considered to be appropriate for the individual patient and/or the causative pathogen(s) (see sections 4.4 and 5.1).

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

4.2 Posology And Method Of Administration

It is recommended that Promixin should be administered under the supervision of physicians with appropriate experience in its use.

Method of Administration

Administration is by intravenous infusion. Each dose of Promixin can be diluted in 50 mL and administered by intravenous infusion over 30 minutes. Patients fitted with a totally implantable venous access device (TIVAD) may tolerate an injection of up to 2 million IU in 10 mL given over a minimum of 5 minutes.

Solutions should be used immediately after reconstitution. For instructions on dilution of the product before admin

Prostin E2 3 mg Vaginal Tablets

Dinoprostone

Pharmacia Logo

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, midwife 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, midwife or pharmacist.

In this leaflet:

  • 1. What Prostin E2 Vaginal Tablets are and what they are used for
  • 2. Before you are given Prostin E2 Vaginal Tablets
  • 3. How Prostin E2 Vaginal Tablets are given to you
  • 4. Possible side effects
  • 5. How to store Prostin E2 Vaginal Tablets
  • 6. Further information

What Prostin E2 Vaginal Tablets are and what they are used for

Prostin E2 Vaginal Tablets contain the prostaglandin dinoprostone and are used to "induce" labour. This means that the medicine will help your uterus (womb) to start contracting and you will go into labour. Dinoprostone is similar to the natural ‘E2’, type of prostaglandins which are made in your body when labour starts. It will only be given to you in a hospital or clinic which has an obstetric and maternity unit.

Before you are given Prostin E2 Vaginal Tablets

Most women can be treated with Prostin E2 Vaginal Tablets. Some women may need extra checks during treatment and for some women a different treatment may be better. Your doctor or midwife will ask you questions before gi

1. Name Of The Medicinal Product

Perindopril 2 mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains, 2 mg perindopril tert-butylamine,equivalent to 1.669 mg perindopril.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablet

White, round, biconvex tablet debossed with 2 on one side

4. Clinical Particulars

4.1 Therapeutic Indications

Hypertension:

Treatment of hypertension

Heart failure:

Treatment of symptomatic heart failure

Stable coronary artery disease:

Reduction of risk of cardiac events in patients with a history of myocardial infarction and/o revascularisation

4.2 Posology And Method Of Administration

It is recommended that Perindopril tert-butylamine is taken once daily in the morning

before a meal with sufficient amount of fluid (e.g. water).

The dose should be individualised according to the patient profile (see 4.4) and blood pressure response.

Hypertension:

Perindopril tert-butylamine may be used in monotherapy or in combination with other classes of antihypertensive therapy.

The recommended starting dose is 4 mg given once daily in the morning.

Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and/or volume depletion, cardiac decompensation or severe hypertension) may experience an excessive drop in blood pressure following the initial dose. A starting dose of 2 mg is recommended in such patients and the initiation of treatment should take place under medical supervision

1. Name Of The Medicinal Product

Pramipexole 0.18 mg tablets

2. Qualitative And Quantitative Composition

Pramipexole 0.18 mg tablets contain 0.18 mg of pramipexole base.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablet.

Strength

(mg base)

Appearance

0.18

white, biconvex, oblong, scored on both sides tablets (dimensions: 8mm ? 4mm approximately)

Pramipexole 0.18 mg tablets:

The tablet can be divided into equal halves.

4. Clinical Particulars

4.1 Therapeutic Indications

Pramipexole is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on off” fluctuations).

4.2 Posology And Method Of Administration

Parkinson's disease

The tablets should be taken orally, swallowed with water, and can be taken either with or without food. The daily dosage is administered in equally divided doses 3 times a day.

Initial treatment:

Dosages should be increased gradually from a starting-d