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1. Name Of The Medicinal Product

Roaccutane 10 mg soft capsules

2. Qualitative And Quantitative Composition

Each soft capsule contains 10 mg of isotretinoin.

Excipients: Contains soya bean oil (refined, hydrogenated and partially hydrogenated) and sorbitol (E420).

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Capsules, soft

10 mg capsules: Oval, opaque, brown-red capsules imprinted with ROA 10 in black ink.

4. Clinical Particulars

4.1 Therapeutic Indications

Severe forms of acne (such as nodular or conglobate acne or acne at risk of permanent scarring) resistant to adequate courses of standard therapy with systemic anti-bacterials and topical therapy.

4.2 Posology And Method Of Administration

Isotretinoin should only be prescribed by or under the supervision of physicians with expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the risks of isotretinoin therapy and monitoring requirements.

The capsules should be taken with food once or twice daily.

Adults including adolescents and the elderly:

Isotretinoin therapy should be started at a dose of 0.5 mg/kg daily. The therapeutic response to isotretinoin and some of the adverse effects are dose-related and vary between patients. This necessitates individual dosage adjustment during therapy. For most patients, the dose ranges from 0.5-1.0 mg/kg per day.

Long-term remission and relapse rates are more closely related to the total dose administered than to either duration of treatment or daily dose. It has been shown that no substantial additional benefit is to be expected beyond a cum

1. Name Of The Medicinal Product

Restandol® TestocapsTM 40mg capsule, soft.

2. Qualitative And Quantitative Composition

Each capsule contains Testosterone Undecanoate 40.0mg which is equivalent to 25.3mg testosterone.

For excipients, see 6.1.

3. Pharmaceutical Form

Oval, glossy capsules, transparent, orange in colour, with a yellow oily fill.

4. Clinical Particulars

4.1 Therapeutic Indications

Clinical Indications

Testosterone replacement therapy in male hypogonadal disorders, for example:

after castration;

eunuchoidism;

hypopituitarism;

endocrine impotence;

male climacteric symptoms like decreased libido and decreased mental and physical activity;

certain types of infertility due to disorders of spermatogenesis

Testosterone therapy may also be indicated in osteoporosis due to androgenic deficiency.

4.2 Posology And Method Of Administration

Dosage

Adults

The initial dosage required will usually be 120-160 mg daily for 2-3 weeks. Subsequent dosage (40-120 mg daily) should be based on the clinical effect obtained during the first weeks of therapy.

Elderly Patients

It should be noted that smaller and less frequent doses may achieve the same response.

Children

Safety and efficacy has not been determined in children.

Administration

Oral.

To e

1. Name Of The Medicinal Product

Effervescent Paracetamol and Caffeine Granules

Resolve Extra

2. Qualitative And Quantitative Composition

Paracetamol 1 g

Caffeine 60 mg

Sodium Hydrogen Carbonate 1408 mg

3. Pharmaceutical Form

Effervescent granules.

4. Clinical Particulars

4.1 Therapeutic Indications

Recommended for the relief of headache with gastric upset, particularly associated with over-indulgence in food or drink or both. Contains an extra strength pain relieving formula with an antacid to settle the stomach.

4.2 Posology And Method Of Administration

Oral administration.

The granules should be dissolved in a glass of water.

Adults: One sachet up to four times daily.

Do not exceed 4 sachets in 24 hours.

The Elderly: As for adults

Children: Not recommended for children under 18 years

4.3 Contraindications

Hypersensitivity to paracetamol, caffeine, sodium bicarbonate or any of the other constituents.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Excessive intake of tea or coffee should be avoided while taking this product.

This product contains dextrose (glucose) and patients should consult their physician if they are suffering from diabetes before using this product.

Do not exceed the stated dose.

Patients should be advised not to take other paracetamol-cont

1. Name Of The Medicinal Product

Riamet 20 mg/120 mg tablets

2. Qualitative And Quantitative Composition

One tablet contains 20 mg artemether and 120 mg lumefantrine.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablet.

Light yellow, round tablet with “NC” debossed on one side and “CG” on the other.

4. Clinical Particulars

4.1 Therapeutic Indications

Riamet is indicated for the treatment of acute uncomplicated Plasmodium falciparum malaria in adult, children and infants of 5 kg and above.

Consideration should be given to official guidance regarding the appropriate use of antimalarial agents.

4.2 Posology And Method Of Administration

Tablets for oral administration.

To increase absorption, Riamet should be taken with food or a milky drink (see section 5.2). If patients are unable to tolerate food, Riamet should be administered, but the systemic exposure may be reduced. Patients who vomit within 1 hour of taking the medication should repeat the dose.

For administration to small children and infants, the tablet/s may be crushed.

Adults and children weighing 35 kg and above

For patients 12 years of age and above and 35 kg body weight and above, a course of treatment comprises six doses of four tablets i.e. total of 24 tablets, given over a period of 60 hours as follows: the first dose of four tablets, given at the time of initial diagnosis, should be followed by five further doses of four tablets given at 8, 24, 36, 48 and 60 hours thereafter.

Children and infants weighing 5 kg to less than 35 kg

A s

1. Name Of The Medicinal Product

Risedronate sodium 30 mg film-coated tablets.

2. Qualitative And Quantitative Composition

Each film-coated tablet contains 30 mg risedronate sodium (equivalent to 27.8 mg risedronic acid).

Excipient: 1.9 mg lactose in each tablet. For a full list of excipients see section 6.1.

3. Pharmaceutical Form

Film-coated tablet. White round biconvex film-coated tablet with diameter of 11.2 mm, 4.5 mm in thickness and embossed with “30” on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of Paget's disease of the bone.

4.2 Posology And Method Of Administration

The recommended daily dose in adults is one 30 mg tablet orally for 2 months. If re-treatment is considered necessary (at least two months post-treatment), a new treatment with the same dose and duration of therapy could be given. The absorption of Risedronate is affected by food, thus to ensure adequate absorption patients should take Risedronate:

• Before breakfast: At least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day.

In the particular instance that before breakfast dosing is not practical, Risedronate can be taken between meals or in the evening at the same time every day, with strict adherence to the following instructions, to ensure Risedronate is taken on an empty stomach:

• Between meals: Risedronate should be taken at least 2 hours before and at least 2 hours after any food, medicinal product or drink (other than plain water).

• In the evening: Risedronate should be taken at least 2 hours after the last food, medicinal product or drink (other than plain water) of the day. Risedronate should be tak

1. Name Of The Medicinal Product

Rogitine® ampoules 10mg

2. Qualitative And Quantitative Composition

Phentolamine mesilate PhEur 10mg.

3. Pharmaceutical Form

Colourless to pale yellow solution in 1ml Water for Injections PhEur

4. Clinical Particulars

4.1 Therapeutic Indications

Management of hypertensive episodes that may occur in patients with phaeochromocytoma, for example during pre-operative preparation and surgical manipulation.

Diagnosis of phaeochromocytoma by Rogitine blocking test if other more specific tests are not available.

4.2 Posology And Method Of Administration

Adults

Management of hypertensive episodes in patients with phaeochromocytoma

For the management of hypertensive crises that arise during the pre-operative phase or during induction of anaesthesia, intubation, or surgical removal of the tumour, 2 to 5mg of Rogitine is injected intravenously and repeated if necessary. The blood pressure response should be monitored.

Diagnosis of phaeochromocytoma - Rogitine blocking test

The test is most reliable in detecting phaeochromocytoma in patients with sustained hypertension and least reliable in those with paroxysmal hypertension. False-positive tests may occur in patients with hypertension without phaeochromocytoma.

Preparation for the test:

Sedatives, analgesics and all other medications except those that might be deemed essential (such as digitalis and insulin) are withheld for at least 24 hours, and preferably 48 to

1. Name Of The Medicinal Product

Ramipril 1.25 mg Capsules

2. Qualitative And Quantitative Composition

1.25 mg ramipril.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Yellow opaque/white opaque hard gelatin capsules.

4. Clinical Particulars

4.1 Therapeutic Indications

- Treatment of hypertension.

- Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with:

 
  o manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or

o diabetes with at least one cardiovascular risk factor (see section 5.1).

- Treatment of renal disease:  
  o Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria,

o Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1),

o Manifest glomerular non diabetic nephropathy as defined by macroproteinuria

- Treatment of symptomatic heart failure.

- Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started > 48 hours foll

1. Name Of The Medicinal Product

Rifadin Syrup 100mg/5ml

2. Qualitative And Quantitative Composition

Rifampicin Ph Eur 100 mg

3. Pharmaceutical Form

Raspberry coloured and flavoured suspension.

4. Clinical Particulars

4.1 Therapeutic Indications

Indications for use

Tuberculosis: In combination with other active anti-tuberculosis drugs in the treatment of all forms of tuberculosis, including fresh, advanced, chronic and drug-resistant cases. Rifadin is also effective against most atypical strains of Mycobacteria.

Leprosy: In combination with at least one other active anti-leprosy drug in the management of multibacillary and paucibacillary leprosy to effect conversion of the infectious state to a non-infectious state.

Other Infections: In the treatment of Brucellosis, Legionnaires Disease, and serious staphylococcal infections. To prevent emergence of resistant strains of the infecting organisms, Rifadin should be used in combination with another antibiotic appropriate for the infection.

Prophylaxis of meningococcal meningitis: For the treatment of asymptomatic carriers of N. meningitidis to eliminate meningococci from the nasopharynx.

Haemophilus influenzae: For the treatment of asymptomatic carriers of H.influenzae and as chemoprophylaxis of exposed children, 4 years of age or younger.

4.2 Posology And Method Of Administration

Recommended Dosage

For oral administration

The daily dose of Rifadin, calculated from the patient's body weight, should preferably be taken at least 30 minutes before a meal or 2 hours after

1. Name Of The Medicinal Product

Replenine®-VF, 50 IU/mL human factor IX, a powder for solution.

2. Qualitative And Quantitative Composition

Replenine-VF is a high purity factor IX. This product is prepared from plasma from screened donors. Donors are selected from the USA.

Replenine-VF is presented as a sterile powder for solution, containing nominally 250 IU, 500 IU or 1000 IU human coagulation factor IX per vial. The product contains approximately 50 IU/mL when reconstituted with either 5 mL (250 IU vial), 10 mL (500 IU vial) or 20 mL (1000 IU Vial) of Sterilised Water for Injections, Ph.Eur..

One mL of Replenine-VF contains approximately 100 IU of human coagulation factor IX after reconstitution at half volume (see 6.6).

The potency (IU) is determined using the European Pharmacopoeia one stage clotting test. The specific activity of Replenine-VF is approximately 100 IU per mg of protein.

For excipients, see section 6.1.

3. Pharmaceutical Form

Replenine-VF is a powder for solution; it is a freeze-dried concentrate of factor IX for reconstitution with Sterilised Water for Injections, Ph.Eur.. After reconstitution with the supplied sterile water diluent, the product is administered intravenously.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment and prophylaxis in patients with haemophilia B (congenital factor IX deficiency).

4.2 Posology And Method Of Administration

Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia.

Posology

The dosage and duration of the substitution therapy depend on the severity of the factor IX deficiency, on

1. Name Of The Medicinal Product

Rhumalgan XL 100mg modified-release capsules

2. Qualitative And Quantitative Composition

Each capsule contains 100 mg diclofenac sodium.

For excipients, see 6.1.

3. Pharmaceutical Form

Modified release capsule for oral use.

Pink opaque hard capsules marked 'DIC100'.

4. Clinical Particulars

4.1 Therapeutic Indications

Adults and Elderly:

Relief of all grades of pain and inflammation in a wide range of conditions, including:

(i) arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout,

(ii) acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder): tendinitis, tenosynovitis, bursitis,

(iii) other painful conditions resulting from trauma: including fracture, low back pain, sprains, strains: dislocations, orthopaedic, dental and other minor surgery.

Children: Rhumalgan XL 100mg Modified Release Capsules are not suitable for children.

4.2 Posology And Method Of Administration

For oral administration.

Rhumalgan XL 100 capsules should be swallowed whole and should be taken preferably with or after food.

Where the symptoms are most pronounced during the night or in the morning Rhumalgan XL 100 capsules should preferably be taken in the evening.

Adults:

The recommended initial daily dose is 100 mg, administered as Rhumalgan XL 100 once daily.

Elderly:

The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is consider

CSL Behring

Rhophylac 300 micrograms / 2 ml, solution for injection in pre-filled syringe

Active substance: Human anti-D immunoglobulin

Please read all of this leaflet carefully before you are given this medicine

  • Keep this leaflet. You may need to read it again.
  • If you have further questions, please ask your doctor or healthcare professional.
  • 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 healthcare professional.

In this leaflet:

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

What Rhophylac Is And What It Is Used For

What is Rhophylac?

Rhophylac is a ready-to-use solution for injection, which comes in a pre-filled syringe. The solution contains special proteins, isolated from human blood plasma. These proteins belong to the class of so called "immunoglobulins", also called antibodies. The active ingredient of Rhophylac is a specific antibody called "anti-D (Rh) immunoglobulin". This antibody works against Rhesus factor type D.

What is Rhesus factor type D?

Rhesus factors are special characteristics of human red blood cells. About 85% of the population carry the so called Rhesus factor type D (abbreviated "Rh(D)"). These people are called Rh(D)-positive. People who do not carry Rhesus factor type D are called Rh(D)-negative.

What is anti-D (Rh) immunoglobulin?

1. Name Of The Medicinal Product

Retrovir 100 mg capsules, hard

2. Qualitative And Quantitative Composition

Each capsule contains 100 mg zidovudine

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Capsules, hard

Hard gelatin capsules with opaque white cap and bodycoded GSYJU.

4. Clinical Particulars

4.1 Therapeutic Indications

Retrovir oral formulations are indicated in anti-retroviral combination therapy for Human Immunodeficiency Virus (HIV) infected adults and children.

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

4.2 Posology And Method Of Administration

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

An oral solution of Retrovir is also available.

Dosage in adults and adolecents weighing at least 30 kg: The usual recommended dose of Retrovir in combination with other anti-retroviral agents is 250 or 300 mg twice daily.

Dosage in children:

Children weighing more than 21 kg and less than 30 kg: The recommended dose of Retrovir is two 100 mg capsules twice daily in combination with other antiretroviral agents.

Children weighing at least 14 kg and less than or equal to 21 kg: The recommended dose of Retrovir is one 100 mg capsule taken in the morning and two 100 mg capsules taken in the evening.

Children weighing at least 8 kg and less than 14 kg:The recommended dose of zidovudone is one 100 mg c

1. Name Of The Medicinal Product

Rivastigmine Sandoz 6 mg hard capsules

2. Qualitative And Quantitative Composition

Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 6 mg.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Hard capsule

Off-white to slightly yellow powder in a capsule with red cap and orange body, with red imprint “RIV 6 mg” on the body.

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic treatment of mild to moderately severe Alzheimer's dementia.

Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.

4.2 Posology And Method Of Administration

Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia or dementia associated with Parkinson's disease. Diagnosis should be made according to current guidelines. Therapy with rivastigmine should only be started if a caregiver is available who will regularly monitor intake of the medicinal product by the patient.

Rivastigmine should be administered twice a day, with morning and evening meals. The capsules should be swallowed whole.

Initial dose

1.5 mg twice a day.

Dose titration

The starting dose is 1.5 mg twice a day. If this dose is well tolerated after a minimum of two weeks of treatment, the dose may be increased to 3 mg twice a day. Subsequent increases to 4.5 mg and then 6 mg twice a day should also be based on good tolerability of the current dose and may be considered after a minimum of two weeks

1. Name Of The Medicinal Product

Robinul Powder

2. Qualitative And Quantitative Composition

Robinul Powder consists of Glycopyrrolate (glycopyrronium bromide) 100% w/w.

3. Pharmaceutical Form

White, crystalline powder.

4. Clinical Particulars

4.1 Therapeutic Indications

Iontophoretic treatment of the plantar and palmar skin for idiopathic hyperhidrosis.

4.2 Posology And Method Of Administration

Route of Administration: Iontophoresis

Dosage and Administration:

A 0.05% solution in distilled water of Glycopyrrolate USP is applied to palmar or plantar skin. When treating the foot or hand, sufficient solution to cover the palm or sole is placed in a non-metallic container and the anode, of sheet metal larger in area than the part being treated, is placed in the solution. The sole or palm is separated from the anode by 5mm of plastic foam or a layer of lint or sponge sheet.

In all cases an electrical circuit is completed by placing another limb in lukewarm tap water containing the cathode, similarly shielded from direct contact with the skin.

Recommended average conditions are 90 volts DC at 10-20 mA for adults (including older patients) and 2-10 mA for children, for 12 minutes at each site, depending on the patient's skin tolerance, body weight and size. Only one site should be treated at a time and only two sites in any one day. Treatments should not be repeated within seven days, but may be repeated later varying the precise conditions according to the recurrence and severity of hyperhidrosis. See also 'Special warnings and special precautions for use' below.

4.3 Contraindications

Glaucoma. Do n

1. Name Of The Medicinal Product

Risperidone 1mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 1 mg risperidone

Excipients:

Each tablet contains 40 mg Lactose-Monohydrate.

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Film-coated tablet

Product description:

White, biconvex, oblong tablets with score line on one side

4. Clinical Particulars

4.1 Therapeutic Indications

Risperidone is indicated for the treatment of schizophrenia.

Risperidone is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders.

Risperidone is indicated for the short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer's dementia unresponsive to non pharmacological approaches and when there is a risk of harm to self or others.

Risperidone is indicated for the short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment. Pharmacological treatment should be an integral part of a more comprehensive treatment programme, including psychosocial and educational intervention. It is recommended that risperidone be prescribed by a specialist in child neurology and child and adolescent psychiatry or physicians well familiar with the treatment of conduct disorder of children and adolescents.

4.2 Posology And Method Of Administration

1. Name Of The Medicinal Product

Rivastigmine Sandoz 2 mg/ml oral solution

2. Qualitative And Quantitative Composition

Each ml contains rivastigmine hydrogen tartrate corresponding to rivastigmine base 2.0 mg.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Oral solution

Clear, yellow solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic treatment of mild to moderately severe Alzheimer's dementia.

Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.

4.2 Posology And Method Of Administration

Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia or dementia associated with Parkinson's disease. Diagnosis should be made according to current guidelines. Therapy with rivastigmine should only be started if a caregiver is available who will regularly monitor intake of the medicinal product by the patient.

Rivastigmine oral solution should be administered twice a day, with morning and evening meals. The prescribed amount of solution should be withdrawn from the container using the oral dosing syringe supplied. Rivastigmine oral solution may be swallowed directly from the syringe. Rivastigmine oral solution and rivastigmine capsules may be interchanged at equal doses.

Initial dose

1.5 mg twice a day.

Dose titration

The starting dose is 1.5 mg twice a day. If this dose is well tolerated after a minimum of two weeks of treatment, the dose may be increased to 3 mg twice a day. Subsequent i

1. Name Of The Medicinal Product

Rozex Gel

2. Qualitative And Quantitative Composition

Metronidazole Ph. Eur 0.75% w/w

3. Pharmaceutical Form

Gel

4. Clinical Particulars

4.1 Therapeutic Indications

Indicated in the treatment of inflammatory papules, pustules and erythema of rosacea

4.2 Posology And Method Of Administration

For topical administration only.

The average period of treatment is three to four months. The recommended duration of treatment should not be exceeded. However, if a clear benefit has been demonstrated, continued therapy for a further three to four months period may be considered by the prescribing physician depending on the severity of the condition. In clinical studies, topical metronidazole therapy for rosacea has been continued for up to 2 years. In the absence of a clear clinical improvement, therapy should be stopped.

Adults: Rozex Gel should be applied in a thin layer to the affected areas of the skin twice daily, morning and evening. Areas to be treated should be washed with a mild cleanser before application. Patients may use non-comedogenic and non-astringent cosmetics after application of Rozex Gel.

Elderly: The dosage recommended in the elderly is the same as that recommended in adults.

Children: Not recommended. Safety and efficacy have not been established.

4.3 Contraindications

Contraindicated in individuals with a history of hypersensitivity to Metronidazole, or other ingredients of the formulation.

4.4 Special Warnings And Precautions For Use

Contact with mucous membranes should be avoided.

Rozex Gel has been reported to cause lacrimatio

ROPINIROLE 0.25MG, 0.5MG & 2MG FILM-COATED TABLETS

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

What Ropinirole Is And What It Is Used For

Ropinirole belongs to a group of medicines called dopamine agonists.

Dopamine is natural substance occurring in the brain. Dopamine agonists (such as ropinirole) work in the same way as dopamine found in the body.

Ropinirole is used

  • for the treatment of moderate-to-severe Restless Legs Syndrome

Restless Legs Syndrome is a disorder in which patients feel an irresistible urge to move their legs and (occasionally) the arms. They suffer from unpleasant sensations such as pins and needles, burning or stabbing pains in their arms or legs. Such sensations occur when the patient is at rest or ina

1. Name Of The Medicinal Product

Risedronate sodium 35 mg film-coated tablets.

2. Qualitative And Quantitative Composition

Each film-coated tablet contains 35 mg risedronate sodium (equivalent to 32.5 mg risedronic acid).

Excipients: Each film-coated tablet contains lactose.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet.

Oval light-orange film-coated tablet with RSN on one side and 35 mg on the other.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures (see section 5.1).

Treatment of osteoporosis in men at high risk of fractures (see section 5.1).

4.2 Posology And Method Of Administration

The recommended dose in adults is one 35 mg tablet orally once a week. The tablet should be taken on the same day each week.

The absorption of risedronate sodium is affected by food, thus to ensure adequate absorption patients should take Risedronate sodium 35 mg:

Before breakfast: At least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day.

Patients should be instructed that if a dose is missed, one Risedronate sodium 35 mg tablet should be taken on the day that the tablet is remembered. Patients should then return to taking one tablet once a week on the day the tablet is normally taken. Two tablets should not be taken on the same day.

The tablet must be swallowed whole and not sucked or chewed. To aid delivery of the tablet to the stomach Risedronate sodium 35 m

1. Name Of The Medicinal Product

Rivastigmine ATS 1.5 mg hard capsules

2. Qualitative And Quantitative Composition

Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 1.5 mg.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Hard capsule (Capsule).

Off-white to slightly yellow powder in a hard capsule with yellow cap and yellow body, with red imprint "RIV 1.5mg" on body.

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic treatment of mild to moderately severe Alzheimer's dementia.

Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.

4.2 Posology And Method Of Administration

Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia or dementia associated with Parkinson's disease. Diagnosis should be made according to current guidelines. Therapy with rivastigmine should only be started if a caregiver is available who will regularly monitor intake of the medicinal product by the patient.

Rivastigmine should be administered twice a day, with morning and evening meals. The capsules should be swallowed whole.

Initial dose

1.5 mg twice a day.

Dose titration

The starting dose is 1.5 mg twice a day. If this dose is well tolerated after a minimum of two weeks of treatment, the dose may be increased to 3 mg twice a day. Subsequent increases to 4.5 mg and then 6 mg twice a day should also be based on good tolerability of the current dose and may be considered after a