Drugs Index
Medical Conditions:
- Medical Conditions G
- Medical Conditions I
- Medical Conditions P
- Medical Conditions C
- Medical Conditions N
- Medical Conditions T
- Medical Conditions E
- Medical Conditions D
- Medical Conditions F
- Medical Conditions H
- Medical Conditions M
- Medical Conditions B
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- Medical Conditions O
- Medical Conditions S
- Medical Conditions A
- Medical Conditions R
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- Medical Conditions W
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- Medical Conditions X
Drug Classes
- Drug Classes A
- Drug Classes M
- Drug Classes H
- Drug Classes C
- Drug Classes B
- Drug Classes U
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- Drug Classes I
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- Drug Classes D
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- Drug Classes 5
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Drugs Information:
Drugs List
1. Name Of The Medicinal Product
Xomolix®
2. Qualitative And Quantitative Composition
Each millilitre of the solution contains 2.5 mg droperidol.
Excipient: sodium < 23 mg per ml.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Solution for injection.
Clear colourless solution, free from visible particles.
The pH of droperidol solution for injection is 3.0 – 3.8 and has an osmolarity of approximately 300 milliosmol /kg water.
4. Clinical Particulars
4.1 Therapeutic Indications
• Prevention and treatment of post-operative nausea and vomiting in adults and, as second line, in children and adolescents.
• Prevention of nausea and vomiting induced by morphine derivates during post-operative patient controlled analgesia (PCA) in adults.
Certain precautions are required when administering droperidol: see sections 4.2, 4.3, and 4.4.
4.2 Posology And Method Of Administration
For intravenous use.
Prevention and treatment of post-operative nausea and vomiting (PONV).
Adults: 0.625 mg to 1.25 mg (0.25 to 0.5 ml).
Elderly: 0.625 mg (0.25 ml)
Renal/hepatic impairment: 0.625 mg (0.25 ml)
Children (over the age of 2 years) and adolescents: 20 to 50 microgram/kg (up to a maximum of 1.25 mg).
Children (below the age of 2 years): not recommended.
Administration of droperidol is recommended 30 minutes before the anticipated end of surgery. Repeat doses may be given every 6 hours as required.
The dosage should be adapted to each ind
1. Name Of The Medicinal Product
Xatral XL 10 mg prolonged release tablets
2. Qualitative And Quantitative Composition
Each tablet contains 10mg alfuzosin hydrochloride.
Excipient: Hydrogenated castor oil
For a full list of excipients, see section 6.1
3. Pharmaceutical Form
Prolonged release tablet.
Round biconvex, three layer tablet: one white layer between two yellow layers.
4. Clinical Particulars
4.1 Therapeutic Indications
Treatment of the functional symptoms of benign prostatic hypertrophy (BPH).
For information on use in acute urinary retention (AUR) related to BPH see sections 4.2 and 5.1.
4.2 Posology And Method Of Administration
Xatral XL should be swallowed whole (see section 4.4).
BPH: The recommended dose is one 10mg tablet to be taken once daily after a meal.
AUR: In patients 65 years and older, one 10 mg tablet daily after a meal to be taken from the first day of catheterisation. The treatment should be administered for 3-4 days, 2-3 days during catheterisation and 1 day after its removal. In this indication no benefit has been established in patients under 65 years of age or if treatment is extended beyond 4 days.
Paediatric Population
Efficacy of Xatral XL has not been demonstrated in children aged 2 to 16 years (see section 5.1). Therefore Xatral XL is not indicated for use in the paediatric population.
4.3 Contraindications
• Hypersensitivity to the active substance or to any of the excipients (see Section 6.1 List of excipients);
• history of orthostatic hypotension;
• combination with other
1. Name Of The Medicinal Product
Xamiol 50 micrograms/g + 0.5 mg/g gel
2. Qualitative And Quantitative Composition
One gram of gel contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).
Excipient: 160 micrograms butylated hydroxytoluene/g gel.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Gel.
An almost clear, colourless to slightly off-white gel.
4. Clinical Particulars
4.1 Therapeutic Indications
Topical treatment of scalp psoriasis in adults.
4.2 Posology And Method Of Administration
Posology
Xamiol gel should be applied to affected areas once daily. The recommended treatment period is 4 weeks. If it is necessary to continue or restart treatment after this period, treatment should be continued after medical review and under regular medical supervision.
When using calcipotriol containing medicinal products, the maximum daily dose should not exceed 15 g. The body surface area treated with calcipotriol containing medicinal products should not exceed 30% (see section 4.4).
All the affected scalp areas may be treated with Xamiol gel. Usually an amount between 1 g and 4 g per day is sufficient for treatment of the scalp (4g corresponds to one teaspoon).
Special populations
Renal and hepatic impairment
The safety and efficacy of Xamiol gel in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.
Paediatric population
The safety
1. Name Of The Medicinal Product
ISIB 60 XL Prolonged Release Tablets
and
CIBRAL 60 XL Prolonged Release Tablets
and
XISMOX 60 XL Prolonged Release Tablets
2. Qualitative And Quantitative Composition
Isosorbide mononitrate 60.0 mg
For excipients, see section 6.1.
3. Pharmaceutical Form
Prolonged Release Tablets
Light yellow, biconvex, oval-shaped, prolonged release tablets, scored on both sides and marked "DX 31" on one side.
4. Clinical Particulars
4.1 Therapeutic Indications
Prophylaxis of angina pectoris
4.2 Posology And Method Of Administration
Adults: The recommended dose is one 60 mg tablet once daily to be taken in the morning. The dose may be increased to 120 mg (two tablets) daily, both to be taken once daily in the morning. The dose can be titrated, by initiating treatment with 30 mg (half tablet) for the first 2-4 days to minimize the possibility of headache.
Children: The safety and efficacy in children has not been established.
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.
There is a risk of tolerance developing when nitrate therapy is given. For this reason it is important that the tablets are taken once a day to achieve an interval with low nitrate concentration, thereby reducing the risk of tolerance development.
When necessary the product may be used in combination with beta-adrenoreceptor blocker
P023526
Xylocaine 1% and 2% with adrenaline (epinephrine) 1:200,000 Solution for Injection
lidocaine, adrenaline (epinephrine)
Read all of this leaflet carefully before Xylocaine with adrenaline is given to you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- 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 nurse.
In this leaflet:
- 1. What Xylocaine with adrenaline is and what it is used for
- 2. Before Xylocaine with adrenaline is given to you
- 3. How Xylocaine with adrenaline is given to you
- 4. Possible side effects
- 5. How to store Xylocaine with adrenaline
- 6. Further information
What Xylocaine with adrenaline is and what it is used for
The name of your medicine is ‘Xylocaine 1% with adrenaline (epinephrine) 1:200,000’ or ‘Xylocaine 2% with adrenaline (epinephrine) 1:200,000’. It is referred to as ‘Xylocaine with adrenaline’ in the rest of this leaflet.
Xylocaine with adrenaline contains two different medicines: lidocaine and adrenaline (epinephrine). Each of these works in a different way.
- Lidocaine belongs to a group of medicines called local anaesthetics. These medicines numb (anaesthetise) parts of the body.
1. Name Of The Medicinal Product
Xatral 2.5 mg film coated tablet
2. Qualitative And Quantitative Composition
Each tablet contains 2.5mg alfuzosin hydrochloride.
Excipient: Lactose
For a full list of excipients, see section 6.1
3. Pharmaceutical Form
Film coated tablet.
White round tablet marked Xatral 2.5 on one side.
4. Clinical Particulars
4.1 Therapeutic Indications
Treatment of the functional symptoms of benign prostatic hypertrophy.
4.2 Posology And Method Of Administration
Xatral tablets should be swallowed whole. The first dose should be given just before bedtime.
Adults
The usual dose is one tablet three times daily. The dose may be increased to a maximum of 4 tablets (10mg) per day depending on the clinical response.
Elderly and treated hypertensive patients
As a routine precaution when prescribing alfuzosin to elderly patients (aged over 65 years) and the treated hypertensive patient, the initial dose should be 1 tablet in the morning and 1 tablet in the evening.
Renal insufficiency
In patients with renal insufficiency, as a precaution, it is recommended that the dosing be started at Xatral 2.5mg twice daily adjusted according to clinical response.
Hepatic insufficiency
In patients with mild to moderate hepatic insufficiency, it is recommended that therapy should commence with a single dose of Xatral 2.5mg/day to be increased to Xatral 2.5mg twice daily according to clinical response.
1. Name Of The Medicinal Product
Xarelto 10 mg film-coated tablets
2. Qualitative And Quantitative Composition
Each film-coated tablet contains 10 mg rivaroxaban.
Excipients:
Each film-coated tablet contains 27.9 mg lactose monohydrate, see section 4.4.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Film-coated tablet (tablet).
Light red, round tablets marked with the BAYER-cross on one side and "10" and a triangle on the other side.
4. Clinical Particulars
4.1 Therapeutic Indications
Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.
4.2 Posology And Method Of Administration
Posology
The recommended dose is 10 mg rivaroxaban taken orally once daily. The initial dose should be taken 6 to 10 hours after surgery, provided that haemostasis has been established.
The duration of treatment depends on the individual risk of the patient for venous thromboembolism which is determined by the type of orthopaedic surgery.
• For patients undergoing major hip surgery, a treatment duration of 5 weeks is recommended.
• For patients undergoing major knee surgery, a treatment duration of 2 weeks is recommended.
If a dose is missed the patient should take Xarelto immediately and then continue the following day with once daily intake as before.
Xarelto can be taken with or without food.
Renal impairment
No dose adjustment is necessary in patients with mild renal impairment (creatinine
1. Name Of The Medicinal Product
XEPLION
XEPLION
XEPLION
XEPLION
2. Qualitative And Quantitative Composition
Each pre-filled syringe contains 78 mg paliperidone palmitate equivalent to 50 mg paliperidone.
Each pre-filled syringe contains 117 mg paliperidone palmitate equivalent to 75 mg paliperidone.
Each pre-filled syringe contains 156 mg paliperidone palmitate equivalent to 100 mg paliperidone.
Each pre-filled syringe contains 234 mg paliperidone palmitate equivalent to 150 mg paliperidone.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Prolonged release suspension for injection.
The suspension is white to off-white. The suspension is pH neutral (approximately 7.0).
4. Clinical Particulars
4.1 Therapeutic Indications
XEPLION is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone.
In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, XEPLION may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.
4.2 Posology And Method Of Administration
Posology
Recommended initiation of XEPLION is with a dose of 150 mg on treatment day 1 and 100 mg one week later (day 8), both administered in the deltoid muscle in order to attain therapeutic concentrations rapidly (see section 5.2). The recommended monthly maintenance dose is 75 mg; some patients may benefit from lower or higher doses within the recommended range of 25 to 150 mg based
1. Name Of The Medicinal Product
Omalizumab
Omalizumab
2. Qualitative And Quantitative Composition
Xolair 75 mg solution for injection:
Each pre-filled syringe of 0.5 ml solution contains 75 mg of omalizumab*.
Xoliar 150 mg solution for injection:
Each pre-filled syringe of 1 ml solution contains 150 mg of omalizumab*.
*Omalizumab is a humanised monoclonal antibody manufactured by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell line.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Solution for injection.
Clear to opalescent, slightly yellow to brown solution.
4. Clinical Particulars
4.1 Therapeutic Indications
Xolair is indicated in adults, adolescents and children (6 to <12 years of age).
Xolair treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma (see section 4.2).
Adults and adolescents (12 years of age and older)
Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.
Children (6 to <12 years of age)
Xolair is indicated as add-on therapy to improve asthma co
Xanax Tablets 250 micrograms and 500 micrograms
alprazolam
In this leaflet:
- 1. What Xanax is and what it is used for
- 2. Before you take Xanax
- 3. How to take Xanax
- 4. Possible side effects
- 5. Storing Xanax
- 6. Further information
Read all of this leaflet carefully before you start using this medicine.
It contains important information on the safe and effective use of your medicine. Keep this leaflet, you may need to read it again. If you have further questions, please ask your doctor or your pharmacist.
What Xanax is and what it is used for
- Xanax is a tranquilliser containing the active ingredient alprazolam. Alprazolam belongs to one of a group of medicines called benzodiazepines. Benzodiazepines affect chemical activity in the brain to promote sleep and to reduce anxiety and worry.
- Xanax tablets are only used to treat severe anxiety and severe anxiety associated with depression.. Xanax is not recommended for the treatment of depression.
- Xanax tablets should only be used for short-term treatment of anxiety. The overall duration of treatment should not be more than 12 weeks including a period where the dose is gradually reduced (this is called dose ‘tapering’).
Before you take Xanax
Do not take Xanax if you:
- are allergic to alprazolam or other similar benzodiazepine medicines, or to any of the other ingredients (see Section 6 ‘Further information’ for more details)
- suffer from a disease called ‘myasthenia gravis’ where
Xylocaine 10 mg Spray
lidocaine
Read all of this leaflet carefully before Xylocaine spray is given to you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, dentist 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 dentist.
In this leaflet:
- 1. What Xylocaine Spray is and what it is used for
- 2. Before Xylocaine Spray is given to you
- 3. How Xylocaine Spray is given to you
- 4. Possible side effects
- 5. How to store Xylocaine Spray
- 6. Further information
What Xylocaine Spray is and what it is used for
The name of your medicine is ‘Xylocaine 10 mg Spray’. It is referred to as ‘Xylocaine Spray’ in the rest of this leaflet.
Xylocaine Spray contains a medicine called lidocaine. This belongs to a group of medicines called local anaesthetics.
Xylocaine Spray is used to numb (anaesthetise) parts of the body. It stops pain happening during:
- Medical examinations and operations of the nose and throat.
- Childbirth, and after the birth if stitches are needed.
- Treatment at the dentist.
Before Xylocaine Spray is given to you
1. Name Of The Medicinal Product
Xalatan 0.005% w/v eye drops solution.
2. Qualitative And Quantitative Composition
100 ml eye drops solution contains 0.005 g latanoprost.
One drop contains approximately 1.5 micrograms latanoprost.
Excipient: Benzalkonium chloride 0.02% w/v is included as a preservative.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Eye drops, solution.
The solution is a clear colourless liquid.
4. Clinical Particulars
4.1 Therapeutic Indications
Reduction of elevated intraocular pressure in patients with open angle glaucoma and ocular hypertension.
Reduction of elevated intraocular pressure in paediatric patients with elevated intraocular pressure and paediatric glaucoma.
4.2 Posology And Method Of Administration
Recommended dosage for adults (including the elderly):
Recommended therapy is one eye drop in the affected eye(s) once daily. Optimal effect is obtained if Xalatan is administered in the evening.
The dosage of Xalatan should not exceed once daily since it has been shown that more frequent administration decreases the intraocular pressure lowering effect.
If one dose is missed, treatment should continue with the next dose as normal.
As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute. This should be performed immediately following the instillation of each drop.
Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes.
1. Name Of The Medicinal Product
Xanax® Tablets 250 and 500 micrograms
2. Qualitative And Quantitative Composition
Alprazolam 250 and 500 micrograms
3. Pharmaceutical Form
White, oval, biconvex tablets containing 250 microgram (0.25 mg) alprazolam, scored on one side and marked "Upjohn 29" on the other.
Pink, oval, biconvex tablets containing 500 microgram (0.5 mg) alprazolam, scored on one side and marked "Upjohn 55" on the other.
4. Clinical Particulars
4.1 Therapeutic Indications
Xanax is indicated for the short-term treatment of moderate or severe anxiety states and anxiety associated with depression. It is only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.
Xanax should not be used to treat short-term mild anxiety, such as anxiety or tension associated with the stress of everyday life. As the efficacy of Xanax in depression and in phobic or obsessional states has yet to be established, specific treatment may have to be considered.
4.2 Posology And Method Of Administration
Treatment should be as short as possible. It is recommended that the patient be reassessed at the end of no longer than 4 weeks' treatment and the need for continued treatment established, especially in case the patient is symptom free. The overall duration of treatment should not be more than 8-12 weeks, including a tapering off process.
In certain cases extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient's status with special expertise. As with all benzodiazepines, physicians should be aware that long-term use might lead to dependence in certain patients.
The optimum dosage o
1. Name Of The Medicinal Product
Xylocaine 1% with Adrenaline (Epinephrine) 1:200,000.
Xylocaine 2% with Adrenaline (Epinephrine) 1:200,000.
2. Qualitative And Quantitative Composition
Xylocaine 1% with Adrenaline (Epinephrine) 1:200,000:
Each ml of solution for injection contains lidocaine hydrochloride monohydrate Ph. Eur., equivalent to 10 mg of lidocaine hydrochloride anhydrous (200 mg per 20 ml vial), 5 micrograms of adrenaline (epinephrine) as the acid tartrate (100 micrograms per 20 ml vial).
Xylocaine 2% with Adrenaline (Epinephrine) 1:200,000:
Each ml of solution for injection contains lidocaine hydrochloride monohydrate Ph. Eur., equivalent to 20 mg of lidocaine hydrochloride anhydrous (400 mg per 20 ml vial), 5 micrograms of adrenaline (epinephrine) as the acid tartrate (100 micrograms per 20 ml vial).
For excipients see 6.1
3. Pharmaceutical Form
Solution for injection
4. Clinical Particulars
4.1 Therapeutic Indications
Xylocaine with Adrenaline is indicated for the production of local anaesthesia by the following techniques:
- Local infiltration
- Minor and major nerve blocks
4.2 Posology And Method Of Administration
Adults and children above 12 years of age
The dosage is adjusted according to the response of the patient and the site of administration. The lowest concentration and smallest dose producing the required effect should be given (see section 4.4). The maximum single dose of Xylocaine when given with adrenaline is 500 mg.
The following table is a guide for the more commonly used techniques in the average adult. The figures reflect the expected avera
1. Name Of The Medicinal Product
Xyrem 500 mg/ml oral solution
2. Qualitative And Quantitative Composition
Each ml of solution contains 500 mg of sodium oxybate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Oral solution.
The oral solution is clear to slightly opalescent.
4. Clinical Particulars
4.1 Therapeutic Indications
Treatment of narcolepsy with cataplexy in adult patients.
4.2 Posology And Method Of Administration
Treatment should be initiated by and remain under the guidance of a physician experienced in the treatment of sleep disorders.
Due to the well known potential of abuse of sodium oxybate, physicians should evaluate patients for a history of or susceptibility to drug abuse prior to commencing treatment. During treatment, patients should be monitored for the risk of diversion, misuse and abuse of sodium oxybate (see section 4.4).
Posology The recommended starting dose is 4.5 g/day sodium oxybate divided into two equal doses of 2.25 g/dose. The dose should be titrated to effect based on efficacy and tolerability (see section 4.4) up to a maximum of 9 g/day divided into two equal doses of 4.5 g/dose by adjusting up or down in dose increments of 1.5 g/day (i.e. 0.75 g/dose). A minimum of one to two weeks is recommended between dose increments. The dose of 9 g/day should not be exceeded due to the possible occurrence of severe symptoms at doses of 18 g/day or above (see section 4.4).
Single doses of 4.5 g should not be given unless the patient has been titrated previously to that dose level.
Discontinuation of Xyrem
1. Name Of The Medicinal Product
2. Qualitative And Quantitative Composition
One vial contains 150 mg of omalizumab*.
* Omalizumab is a humanised monoclonal antibody manufactured by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell line.
After reconstitution one vial contains 125 mg/ml of omalizumab (150 mg in 1.2 ml).
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Powder and solvent for solution for injection.
Xolair is an off-white lyophilised powder.
4. Clinical Particulars
4.1 Therapeutic Indications
Xolair is indicated in adults, adolescents and children (6 to <12 years of age).
Xolair treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma (see section 4.2).
Adults and adolescents (12 years of age and older)
Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.
Children (6 to <12 years of age)
Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awa
1. Name Of The Medicinal Product
Xeomin 100 LD50 units powder for solution for injection
2. Qualitative And Quantitative Composition
1 vial contains 100 LD50 units* of Clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins.
* One unit corresponds to the median lethal dose (LD50) when the reconstituted product is injected intraperitoneally into mice under defined conditions.
Due to differences in the LD50 assay, these units are specific to Xeomin and are not interchangeable with other Botulinum toxin preparations.
Excipient(s):
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Powder for solution for injection
White powder
4. Clinical Particulars
4.1 Therapeutic Indications
Xeomin is indicated for the symptomatic treatment of blepharospasm, cervical dystonia of a predominantly rotational form (spasmodic torticollis) and of post-stroke spasticity of the upper limb presenting with flexed wrist and clenched fist in adults.
4.2 Posology And Method Of Administration
Unit doses recommended for Xeomin are not interchangeable with those for other preparations of Botulinum toxin.
Xeomin may only be used by physicians with suitable qualifications and proven experience in the application of Botulinum toxin and in the use of the necessary equipment, e.g. electromyography (EMG).
Reconstituted Xeomin is intended for intramuscular injection.
The optimum dosage and number of injection sites in the treated muscle should be determined by the physician individually for each patient. A titration of the dose should be perfo
1. Name Of The Medicinal Product
Xenical 120 mg hard capsules
2. Qualitative And Quantitative Composition
Each hard capsule contains 120 mg orlistat.
For a full list of excipients, see 6.1.
3. Pharmaceutical Form
Hard capsule.
The capsule has a turquoise cap and turquoise body bearing the imprint of “ROCHE XENICAL 120”.
4. Clinical Particulars
4.1 Therapeutic Indications
Xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m?, or overweight patients (BMI > 28 kg/m?) with associated risk factors.
Treatment with orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5 % of the body weight as measured at the start of therapy.
4.2 Posology And Method Of Administration
Adults
The recommended dose of orlistat is one 120 mg capsule taken with water immediately before, during or up to one hour after each main meal. If a meal is missed or contains no fat, the dose of orlistat should be omitted.
The patient should be on a nutritionally balanced, mildly hypocaloric diet that contains approximately 30 % of calories from fat. It is recommended that the diet should be rich in fruit and vegetables. The daily intake of fat, carbohydrate and protein should be distributed over three main meals.
Doses of orlistat above 120 mg three times daily have not been shown to provide additional benefit.
The effect of orlistat results in an increase in faecal fat as early as 24 to 48 hours after dosing. Upon discontinuation of therapy,
1. Name Of The Medicinal Product
2. Qualitative And Quantitative Composition
One film-coated tablet contains:
Rifaximin 200 mg
Excipients:
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Film-coated tablet
Pink circular biconvex film-coated tablets, with “AW” printed on both sides.
4. Clinical Particulars
4.1 Therapeutic Indications
Xifaxanta 200mg film-coated tablets are indicated for the treatment of travellers' diarrhoea that is not associated with any of:
Fever
Bloody diarrhoea
Eight or more unformed stools in the previous 24 h
Occult blood or leucocytes in the stool.
Xifaxanta 200mg film-coated tablets may shorten the duration of diarrhoea when this is associated with non-invasive strains of E.coli (see sections 4.4 and 5.1).
4.2 Posology And Method Of Administration
Posology
200 mg every 8 hours for three days (total 9 doses).
Rifaximin must not be used for more than 3 days even if symptoms continue and a second course of treatment must not be taken (see section 4.4).
Rifaximin can be administered with or without food.
Paediatric population
The safety and efficacy of Xifaxanta 200 mg film-coated tablets in children (aged less than 18 years) have not been established.
A dosage adjustment for patients with hepatic or renal insufficiency is not necessary.
Method of administration
Orally with a glass of water.
4.3 Contrai
1. Name Of The Medicinal Product
Xalacom 50 microgram/ml and 5 mg/ml eye drops, solution.
2. Qualitative And Quantitative Composition
1ml solution contains latanoprost 50 micrograms and timolol maleate 6.8 mg equivalent to 5 mg timolol.
Excipient: Benzalkonium chloride 200 microgram/ml.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Eye drops, solution
The solution is a clear colourless liquid.
4. Clinical Particulars
4.1 Therapeutic Indications
Reduction of intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.
4.2 Posology And Method Of Administration
Recommended dosage for adults (including the elderly):
Recommended therapy is one eye drop in the affected eye(s) once daily.
If one dose is missed, treatment should continue with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily.
Administration:
Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes (see section 4.4).
If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.
Use in children and adolescents:
Safety and effectiveness in children and adolescents has not been established.
4.3 Contraindications
Xalacom is contraindicated in patients with:
- Reactive airway disease includ