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1. Name Of The Medicinal Product

Omeprazole 20 mg gastro-resistant capsules, hard

2. Qualitative And Quantitative Composition

Omeprazole 20 mg: one capsule contains 20 mg of omeprazole.

Excipient: Lactose monohydrate.

Each 20 mg capsule contains 2 mg of lactose monohydrate

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Gastro-resistant capsule, hard

Reddish brown / Pink, size '1' hard gelatin capsules imprinted with 'E' on Reddish brown cap and '67' on pink body with black ink filled with white to off-white granules covered with a gastro-resistant coating.

4. Clinical Particulars

4.1 Therapeutic Indications

Omeprazole capsules are indicated for:

Adults

• Treatment of duodenal ulcers

• Prevention of relapse of duodenal ulcers

• Treatment of gastric ulcers

• Prevention of relapse of gastric ulcers

• In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease

• Treatment of NSAID-associated gastric and duodenal ulcers

• Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk

• Treatment of reflux esophagitis

• Long-term management of patients with healed reflux esophagitis

• Treatment of symptomatic gastro-esophageal reflux disease

• Treatment of Zollinger-Ellison syndrome

Paediatric use

Children over 1 year of age and

• Treatment of reflux esophagitis

1. Name Of The Medicinal Product

OVYSMEN® Oral Contraceptive Tablets

2. Qualitative And Quantitative Composition

OVYSMEN are tablets for oral administration.

Each tablet contains norethisterone PhEur 0.5 mg and ethinylestradiol PhEur 0.035 mg.

3. Pharmaceutical Form

Tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

Contraception and the recognised indications for such oestrogen/progestogen combinations.

4.2 Posology And Method Of Administration

For oral administration

4.2.1 Adults

How to take Ovysmen:

One tablet is taken daily at the same time (preferably in the evening) without interruption for 21 days, followed by a break of 7 tablet-free days. Each subsequent pack is started after the 7 tablet-free days have elapsed. Additional contraceptive precautions are not then required. During the tablet-free period, bleeding can be expected, usually beginning 2 to 4 days after the last tablet

Starting treatment:

It is preferable that tablet intake from the first pack is started up to and including day 5 of menstruation in which case no extra contraceptive precautions are necessary.

Ovysmen can be started at any other time, if pregnancy can reasonably be excluded. In this case additional contraceptive precautions must be taken for the first 7 days of tablet taking.

Switching from another contraceptive

Hormonal methods: Ovysmen can be started immediately if the patient has been using the current

1. Name Of The Medicinal Product

Oxaliplatin 5mg/ml powder for solution for infusion

2. Qualitative And Quantitative Composition

1 ml of the reconstituted solution for infusion contains 5mg oxaliplatin.

50 mg vial: Each vial contains 50 mg oxaliplatin for reconstitution in 10 ml of solvent.

100 mg vial: Each vial contains 100 mg oxaliplatin for reconstitution in 20 ml of solvent.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder for solution for infusion.

A white or almost white powder.

4. Clinical Particulars

4.1 Therapeutic Indications

Oxaliplatin in combination with 5-fluorouracil (5-FU) and folinic acid (FA) is indicated for:

- Adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of primary tumour.

- Treatment of metastatic colorectal cancer.

4.2 Posology And Method Of Administration

The preparation of injectable solutions of cytotoxic agents must be carried out by trained specialist personnel with knowledge of the medical product used, in conditions that guarantee the integrity of the medical product, the protection of the environment and in particular the protection of the personnel handling the medicinal products, in accordance with the hospital policy. It requires a preparation area reserved for this purpose. It is forbidden to smoke, eat or drink in this area.

Posology

For adults only.

The recommended dose for oxaliplatin in adjuvant setting is 85 mg/m2 intravenously repeated every two weeks for 12 cycles (6 months).

The recommended dose for oxaliplatin in trea

1. Name Of The Medicinal Product

Oxycodone Hydrochloride 5mg/5ml Oral Solution

2. Qualitative And Quantitative Composition

Each 5ml contains oxycodone hydrochloride 5 mg (equivalent to 4.5 mg of oxycodone base).

This medicinal product contains approximately 3.5mg sodium per 5ml.

For full list of excipients, see Section 6.1.

3. Pharmaceutical Form

A clear, colourless oral solution.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of moderate to severe pain in patients with cancer and post-operative pain. For the treatment of severe pain requiring the use of a strong opioid.

4.2 Posology And Method Of Administration

Route of administration:

Oral use.

Post-operative pain:

In common with other strong opioids, the need for continued treatment should be assessed at regular intervals.

Elderly and adults over 18 years:

Oxycodone solution should be taken at 4-6 hourly intervals. The dosage is dependent on the severity of the pain, and the patient's previous history of analgesic requirements.

Increasing severity of pain will require an increased dosage of Oxycodone solution. The correct dosage for any individual patient is that which controls the pain and is well tolerated throughout the dosing period. Patients should be titrated to pain relief unless unmanageable adverse drug reactions prevent this.

The usual starting dose for opioid na?ve patients or patients presenting with severe pain uncontrolled by weaker opioids is 5 mg, 4-6 hourly. The dose should then be carefully titrated, as frequently as once a

1. Name Of The Medicinal Product

Osmanil 25 micrograms/h transdermal patch

2. Qualitative And Quantitative Composition

Each patch releases 25 micrograms fentanyl per hour. Each patch of 7.5 cm2 contains 4.125 mg fentanyl.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Transdermal patch

Transparent and colourless patch with blue imprint on the backing foil: “fentanyl 25 µg/h“.

4. Clinical Particulars

4.1 Therapeutic Indications

The product is indicated in severe chronic pain which can be adequately managed only with opioid analgesics.

4.2 Posology And Method Of Administration

The dosing is individual and based on the patient's opioid history and takes into account:

- the possible development of tolerance,

- the current general condition,

- the medical status of the patient and

- the degree of severity of the disorder.

The required fentanyl dosage is adjusted individually and should be assessed regularly after each administration.

Patients receiving opioid treatment for the first time

For initial dosing patches with a release rate of 12.5 micrograms/hour should be used. In very elderly or weak patients, it is not recommended to initiate an opioid treatment with Osmanil, due to their known susceptibility to opioid treatments. In these cases, it would be preferable to initiate a treatment with low doses of immediate release morphine and to prescribe Osmanil after determination of the optimal dosage.

Switching from other opioids

When changing over from oral or parenteral opioids to

1. Name Of The Medicinal Product

Olanzapine Sandoz 7.5 mg Film-coated Tablets

2. Qualitative And Quantitative Composition

Each film-coated tablet contains 7.5 mg olanzapine.

Excipient: 222.33 mg lactose/film-coated tablet

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Film-coated tablet

White, round (9 mm diameter).

4. Clinical Particulars

4.1 Therapeutic Indications

Adults

Olanzapine is indicated for the treatment of schizophrenia.

Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.

Olanzapine is indicated for the treatment of moderate to severe manic episode.

In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder (see section 5.1).

4.2 Posology And Method Of Administration

Adults

Schizophrenia: The recommended starting dose for olanzapine is 10 mg/day.

Manic episode: The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1).

Preventing recurrence in bipolar disorder: The recommended starting dose is 10 mg/day. For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose. If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued (with dose optimisation

One-Alpha Capsules 0.25 microgram

One-Alpha Capsules 0.5 microgram

One-Alpha Capsules 1 microgram

alfacalcidol

Please 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 become serious, or you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.
  • In this leaflet One-Alpha capsules will be called One-Alpha.

In this leaflet:

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

What One-Alpha Is And What It Is Used For

One-Alpha belongs to a group of medicines called vitamin D analogues. It is a type of vitamin D.

Vitamin D controls the levels of two substances in your body. These substances are called calcium and phosphate. Your body needs both of these substances for healthy bones and teeth.

One-Alpha works by increasing the amount of vitamin D in your body. This means the levels of calcium

1. Name Of The Medicinal Product

Octanate 100 IU/ml

Powder and solvent for solution for injection

2. Qualitative And Quantitative Composition

Octanate 100 IU/ml is presented as powder and solvent for solution for injection containing nominally 1000 IU human coagulation factor VIII per vial.

The product contains approximately 100 IU* per ml human coagulation factor VIII when reconstituted with 10 ml of solvent.

The product contains approximately

This medicinal product contains up to 1.75 mmol sodium (40 mg) per dose. To be taken into consideration by patients on a controlled sodium diet.

For a full list of excipients, see section 6.1.

* The potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The mean specific activity of Octanate is

3. Pharmaceutical Form

Powder and solvent for solution for injection.

A white or pale yellow powder or friable solid.

The solvent is a clear, colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)

This preparation does not contain von Willebrand factor in pharmacologically effective quantities and is therefore not indicated in von Willebrand's disease.

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 VIII deficiency,

1. Name Of The Medicinal Product

Omeprazole 10 mg gastro-resistant capsules, hard

2. Qualitative And Quantitative Composition

Omeprazole 10 mg: one capsule contains 10 mg of omeprazole.

Excipient: Lactose monohydrate.

Each 10 mg capsule contains 1 mg of lactose monohydrate

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Gastro-resistant capsule, hard

Pink / Pink, size '3' hard gelatin capsules imprinted with 'E' on pink cap and '65' on pink body with black ink filled with white to off-white granules covered with a gastro-resistant coating.

4. Clinical Particulars

4.1 Therapeutic Indications

Omeprazole capsules are indicated for:

Adults

• Treatment of duodenal ulcers

• Prevention of relapse of duodenal ulcers

• Treatment of gastric ulcers

• Prevention of relapse of gastric ulcers

• In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease

• Treatment of NSAID-associated gastric and duodenal ulcers

• Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk

• Treatment of reflux esophagitis

• Long-term management of patients with healed reflux esophagitis

• Treatment of symptomatic gastro-esophageal reflux disease

• Treatment of Zollinger-Ellison syndrome

Paediatric use

Children over 1 year of age and

• Treatment of reflux esophagitis

• Symptomatic treat

1. Name Of The Medicinal Product

Orfadin 2 mg hard capsules

2. Qualitative And Quantitative Composition

Each capsule contains 2 mg nitisinone.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Hard capsule.

White, opaque capsules imprinted “NTBC 2mg” in black on the body of the capsule.

The capsules contain a white to off white powder.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.

4.2 Posology And Method Of Administration

Posology

Nitisinone treatment should be initiated and supervised by a physician experienced in the treatment of HT-1 patients. Treatment of all genotypes of the disease should be initiated as early as possible to increase overall survival and avoid complications such as liver failure, liver cancer and renal disease. Adjunct to the nitisinone treatment, a diet deficient in phenylalanine and tyrosine is required and should be followed by monitoring of plasma amino acids (see sections 4.4 and 4.8).

The dose of nitisinone should be adjusted individually.

The recommended initial dose in the paediatric and adult population is 1 mg/kg body weight/day divided in 2 doses administered orally.

Dose adjustment

During regular monitoring, it is appropriate to follow urine succinylacetone, liver function test values and alpha-fetoprotein levels (see section 4.4). If urine succinylacetone is still detectable one month after the start of nitisinone treatment, the nitisin

1. Name Of The Medicinal Product

Otrivine® Adult Nasal Spray

2. Qualitative And Quantitative Composition

Xylometazoline Hydrochloride 0.1% w/v

For excipients see section 6.1

3. Pharmaceutical Form

Nasal spray, solution

The spray is a clear, colourless solution

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of nasal congestion, perennial and allergic rhinitis (including hay fever), sinusitis.

4.2 Posology And Method Of Administration

Adults, children over 12 years and the elderly: One application in each nostril 2 or 3 times daily

Route of administration: Nasal use

4.3 Contraindications

Known hypersensitivity to Otrivine.

Patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater.

4.4 Special Warnings And Precautions For Use

Patients are advised not to take decongestants for more than seven consecutive days. Otrivine, like other preparations belonging to the same class of active substances, should be used only with caution in patients showing a strong reaction to sympathomimetic agents as evidenced by signs of insomnia, dizziness etc.

• Do not exceed the recommended dosage

• Decongestants should not be used for more than seven consecutive days. If symptoms persist consult your doctor

• If you are pregnant or taking other medicines or are under a doctor's care consult him before using Otrivine

• The adult spray should not be used for infants or children under 12 years

• Each Otrivine pack should be used by one person only to prevent any cross infection

• So

1. Name Of The Medicinal Product

Omeprazole 40 mg Powder for Solution for Infusion

2. Qualitative And Quantitative Composition

Each vial of powder for solution for infusion contains omeprazole sodium, equivalent to 40 mg omeprazole.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder for solution for infusion.

The powder for solution for infusion is a white to almost white powder.

The reconstituted solution has a pH of about 9-10.5.

The osmolarity of the solution reconstituted with100 ml of 5 % glucose solution is about 0.297Osmol/kg.

The osmolarity of the solution reconstituted with 100 ml of 0.9 % saline is about 0.282 Osmol/kg

4. Clinical Particulars

4.1 Therapeutic Indications

As alternative treatment of the oral formulation where pronounced acidity inhibition is required for:

Duodenal ulcer

Benign gastric ulcer

Reflux oesophagitis

Zollinger-Ellison syndrome

4.2 Posology And Method Of Administration

Dosage

Omeprazole 40 mg as once daily intravenous application is only recommended in those incidental cases where oral therapy is inappropriate and pronounced acidity inhibition is essential. The mean reduction of acid production in the stomach during 24 hours is circa 90%. With Zollinger-Ellison patients the recommended initial dosage is 60 mg omeprazole per day. For a 60 mg dose an additional half (50 ml) of the reconstituted solution should be given as an intravenous infusion. Any unused solution should be discarded. Higher dosages can be necessary and the dosage should be individually adjusted. With a total dosage of

1. Name Of The Medicinal Product

Omeprazole 20mg Capsules

2. Qualitative And Quantitative Composition

Omeprazole 20 mg:

Each capsule contains 20mg of omeprazole.

Excipient(s):

Each 20 mg gastro-resistant capsule, hard contains 117 mg lactose, anhydrous

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Capsule

White cap, white body, each imprinted with “OME 20” containing dull yellowish, brown granules

4. Clinical Particulars

4.1 Therapeutic Indications

Omeprazole capsules are indicated for:

Adults

• Treatment of duodenal ulcers

• Prevention of relapse of duodenal ulcers

• Treatment of gastric ulcers

• Prevention of relapse of gastric ulcers

• In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease

• Treatment of NSAID-associated gastric and duodenal ulcers

• Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk

• Treatment of reflux esophagitis

• Long-term management of patients with healed reflux esophagitis

• Treatment of symptomatic gastro-esophageal reflux disease

• Treatment of Zollinger-Ellison syndrome

Paediatric use

Children over 1 year of age and

• Treatment of reflux esophagitis

• Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease

Child

1. Name Of The Medicinal Product

Optrex Infected Eye Ointment

When sold by Boots The Chemist, the name will be Boots Pharmacy Antibiotic Eye Ointment

2. Qualitative And Quantitative Composition

Chloramphenicol 1.0% w/w.

Each 1 gram of ointment contains 10mg chloramphenicol

For excipients, see 6.1.

3. Pharmaceutical Form

Eye ointment.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of acute bacterial conjunctivitis.

4.2 Posology And Method Of Administration

Topical administration to the eye only.

Adults, children aged 2 years and over and elderly

The recommended dose is a small amount of ointment (~ 1cm) to be applied to the affected eye(s). The ointment should be applied either at night if eye drops are used during the day, or 3 to 4 times a day if eye ointment is used alone

The pharmacist will advise on the most suitable treatment. Treatment should continue for 5 days even if symptoms improve.

4.3 Contraindications

Chloramphenicol eye ointment must not be administered to:

• Patients who have a history of hypersensitivity to chloramphenicol or to any other ingredient of the ointment.

• Patients who have experienced myelosuppression during previous exposure to chloramphenicol.

• Patients with a family history of blood dyscrasias.

4.4 Special Warnings And Precautions For Use

Chloramphenicol is absorbed systemically from the eye and systemic toxicity has been reported (see section 4.8).

In severe bacterial conjunctivitis and in cases where infection is not confined to the conjunctivae, the topical u

1. Name Of The Medicinal Product

Oruvail 100

2. Qualitative And Quantitative Composition

Ketoprofen 100mg

3. Pharmaceutical Form

Controlled release capsules

4. Clinical Particulars

4.1 Therapeutic Indications

Oruvail is recommended in the management of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute articular and peri-articular disorders, (bursitis, capsulitis, synovitis, tendinitis), cervical spondylitis, low back pain (strain, lumbago, sciatica, fibrositis), painful musculo-skeletal conditions, acute gout, dysmenorrhoea and control of pain and inflammation following orthopaedic surgery.

Oruvail reduces joint pain and inflammation and facilitates increase in mobility and functional independence. As with other non-steroidal anti-inflammatory agents, it does not cure the underlying disease.

4.2 Posology And Method Of Administration

Adults: 100 - 200mg once daily, depending on patient weight and on severity of symptoms.

The maximum daily dose is 200mg. The balance of risks and benefits should be carefully considered before commencing treatment with 200mg daily, and higher doses are not recommended (see also section 4.4).

Elderly: The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

Paediatric dosage not established.

Oruvail capsules are for oral administration. To be taken preferably with or after food.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration neces

1. Name Of The Medicinal Product

OCTAGAM

50 mg/ml solution for infusion

2. Qualitative And Quantitative Composition

2.1 Active ingredients

Human normal immunoglobulin (IVIg)

2.2 Quantitative composition

1 ml solution contains:

Protein, of which > 95% is

 

 

 

 

human normal immunoglobulin G

50

mg

IgA

< 0.2

mg

Distribution of IgG subclasses:

IgG1

ca. 60%

1. Name Of The Medicinal Product

Omnitrope 3.3 mg/ml solution for injection

2. Qualitative And Quantitative Composition

Somatropin* 3.3 mg (corresponding to 10 IU)/ ml.

One cartridge contains 1.5 ml corresponding to 5 mg Somatropin* (15 IU).

* produced in Escherichia coli by recombinant DNA technology.

Excipients:

One ml contains 9 mg benzyl alcohol.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection

The solution is clear and colourless.

4. Clinical Particulars

4.1 Therapeutic Indications

Infants, children and adolescents

- Growth disturbance due to insufficient secretion of growth hormone (GH).

- Growth disturbance associated with Turner syndrome.

- Growth disturbance associated with chronic renal insufficiency.

- Growth disturbance (current height standard deviation score (SDS) < -2.5 and parental adjusted SDS < -1) in short children/adolescents born small for gestational age (SGA), with a birth weight and/or length below -2 standard deviation (SD), who failed to show catch-up growth (height velocity (HV) SDS < 0 during the last year) by 4 years of age or later.

- Prader-Willi syndrome (PWS), for improvement of growth and body composition. The diagnosis of PWS should be confirmed by appropriate genetic testing.

Adults

- Replacement therapy in adults with pronounced growth hormone deficiency. Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic

1. Name Of The Medicinal Product

OreloxTM Tablets 100mg.

2. Qualitative And Quantitative Composition

Each Orelox tablet contains 130mg of cefpodoxime proxetil (equivalent to 100mg cefpodoxime).

3. Pharmaceutical Form

Tablet for oral use.

4. Clinical Particulars

4.1 Therapeutic Indications

Orelox is a bactericidal cephalosporin antibiotic active against a wide range of Gram-negative and Gram-positive organisms. It is indicated for the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity.

Upper respiratory tract infections caused by organisms sensitive to cefpodoxime, including sinusitis.

In tonsillitis and pharyngitis, Orelox should be reserved for recurrent or chronic infections, or for infections where the causative organism is known or suspected to be resistant to commonly used antibiotics.

Lower respiratory tract infections caused by organisms sensitive to cefpodoxime, including acute bronchitis, relapses or exacerbations of chronic bronchitis and bacterial pneumonia.

Upper and lower urinary tract infections caused by organisms sensitive to cefpodoxime including cystitis and acute pyelonephritis.

Skin and soft tissue infections caused by organisms sensitive to cefpodoxime such as abscesses, cellulitis, infected wounds, furuncles, folliculitis, paronychia, carbuncles and ulcers.

Gonorrhoea - uncomplicated gonococcal urethritis.

4.2 Posology And Method Of Administration

Route of administration: oral.

Adults:

Opticrom

Allergy eye drops

Sodium Cromoglicate 2.0% w/v

Please read this leaflet before you start to use your medicine.

It contains a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your pharmacist.

Contents:

5 ml eye drops (approximately 125 drops) containing Sodium Cromoglicate 2.0 % w/v (active ingredient).

Other ingredients include benzalkonium chloride, disodium edetate, purified water. The active ingredient, sodium cromoglicate, belongs to a class of medicines known as anti-inflammatory/anti-allergy agents.

Manufacturer:

Aventis Pharma Le Trait
76580 Le Trait
Seine Maritime
France

Marketing Authorisation Holder:

Sanofi-aventis
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Tel:01483 505515
Fax:01483 535432
email:ukmedicalinformation@sanofi-aventis.com

Oxis Turbohaler 12 micrograms per dose Inhalation Powder

Formoterol fumarate dihydrate

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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

What Oxis Turbohaler is and what it is used for

Oxis Turbohaler is an inhaler. It contains a medicine called formoterol. This belongs to a group of medicines called ‘long-acting beta-agonists’ or ‘bronchodilators’.

It works by relaxing the muscles in your airways. This helps you to breathe more easily. It starts to work within 1 to 3 minutes and the effects last up to 12 hours.

Your doctor has prescribed this medicine to treat asthma or chronic obstructive pulmonary disease (COPD).

Asthma

For asthma, your doctor will prescribe two asthma inhalers: Oxis Turbohaler and a separate ‘corticosteroid’ inhaler. These should be used together.

  • Oxis Turbohaler is used to help prevent asthma symptoms from happening.
  • Some people also us