Spiriva, powder for inhalation 18 μg hard capsules 30 pcs — Made in Germany — Free Delivery

(Spiriva)
Spiriva, powder for inhalation 18 μg hard capsules 30 pcs — Made in Germany — Free Delivery
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Boehringer Ingelheim Brand: Boehringer Ingelheim

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Description Spiriva, powder for inhalation 18 μg hard capsules 30 pcs — Made in Germany — Free Delivery

Indications

Supportive bronchodilator therapy to relieve symptoms of the host.

Application

The medicinal product is intended for inhalation use only.
The recommended dose of Spiriva consists of inhalation of the contents of 1 capsule once a day using the HendiHeiler inhalation device. Inhalation should be done at the same time of day.
The recommended dose should not be exceeded. Capsules are not intended for oral use, capsules of Spiriva should not be swallowed.
The drug should be used only with the HendiHeiler inhalation device.

Special groups

Elderly patients should use Spiriva only in the dose recommended by the doctor.
Patients with renal insufficiency should take Spiriva according to the dose recommended by the doctor. Information on the use of the drug in patients with moderate to severe renal insufficiency (creatinine clearance ≤50 ml / min) is given in the SPECIAL INSTRUCTIONS and Pharmacokinetics sections.
Patients with hepatic impairment can use Spiriva according to the dose recommended by the doctor (see Pharmacokinetics).
Instructions for use. To ensure proper use of the drug, it is necessary to inform the patient how to use the inhaler.
When using Spiriva, you should follow the doctor's recommendations.
The Heyler inhalation device has been specially designed for Spiriva capsules. It should not be used with other medicines.
You can use HandiHeiler for 1 year, using it as directed.
1. Press the spray button fully down and release to open the dust cap.
2. Open the dust cap by lifting it up.
Then open the mouthpiece by lifting it up.
3. Remove the Spiriva capsule from the blister (just before use) and place it on a platform with a central chamber. It does not matter which side the capsule is placed in the chamber.
4. Close the mouthpiece tightly until it clicks, leave the dust cap open.
5. Hold the HandyHeiler with the mouthpiece up and press the spray button all the way once and release. This makes holes in the capsule shell and allows the drug to be released when inhaled.
6. Exhale completely.
Important: do not exhale into the mouthpiece in any case.
7. Raise the HandyHeiler device to your mouth and clasp the mouthpiece tightly with your lips. Keep your head straight and inhale slowly and deeply, but in such a way as to hear or feel the vibration of the capsule.
Inhale until the lungs are full; then hold your breath for as long as possible and at the same time remove the mouthpiece from your mouth.
Resume breathing.
Repeat steps 6 and 7 - this will completely empty the capsule.
8. Open the mouthpiece again. Remove used capsule and discard.
Close the mouthpiece and dust cap for storing the HandyHeiler device.
Cleaning the HandyHeiler device
It is necessary to clean the HandyHeiler device once a month.
Open the dust cap and mouthpiece. Then open the base by lifting the spray button. Rinse entire inhaler with warm water to remove powder. Thoroughly dry the HandyHeiler by blotting off the remaining water with a paper towel and air-drying, leaving the dust cap, mouthpiece and base open. Air drying takes 24 hours, therefore, cleaning must be started immediately after use so that the device is ready for the next use.
If necessary, the mouthpiece can be cleaned from the outside with a damp but not wet cloth.
Blister opening
A. Separate the blister stripes by tearing along the perforation.
B. Open (just before use) until the words "Stop". If another capsule has been accidentally opened, then it should be discarded.
C. Remove the capsule.
Spiriva capsules contain a small amount of powder, so the capsule is only partially filled.

Contraindications

Powder for inhalation spiriva is contraindicated in patients with known hypersensitivity to tiotropium bromide, atropine or its derivatives (ipratropium or oxitropium) or other components of the drug.

Side effects

Many of these side effects can be attributed to the anticholinergic properties of spiriva.
Adverse reactions to the drug were determined based on data obtained from clinical studies and from spontaneous reports during the post-marketing period. The clinical trial database includes 9647 patients who received tiotropium in 28 placebo-controlled clinical trials with treatment periods ranging from 4 weeks to 4 years.
The incidence of adverse reactions in accordance with the MedDRA Convention: very often (≥1 / 10); often (≥1 / 100, 1/10); infrequently (≥1 / 1000, 1/100); single (≥1 / 10,000, 1/1000); very rare (1/10 000); unknown (cannot be determined from the available data).
From the side of metabolism: unknown - dehydration.
From the side of the central nervous system: infrequently - dizziness, headache, impaired taste; isolated - insomnia.
From the side of the organ of vision: infrequently - blurred vision; isolated - glaucoma, increased intraocular pressure.
From the side of the cardiovascular system: infrequently - atrial fibrillation; isolated - supraventricular tachycardia, tachycardia, palpitations.
From the respiratory system, chest and mediastinal organs: infrequently - cough, dysphonia, pharyngitis; isolated - bronchospasm, nosebleeds, laryngitis, sinusitis.
From the digestive system: often - dry mouth; infrequently - constipation, gastroesophageal reflux disease, oral and pharyngeal candidiasis; isolated - intestinal obstruction, including paralytic intestinal obstruction; dysphagia, gingivitis, glossitis, stomatitis, nausea; unknown - dental caries.
From the immune system, skin and subcutaneous tissue: infrequently - rash; isolated - angioedema, hypersensitivity (including immediate allergic reactions), itching, urticaria; unknown - dry skin, skin infections and ulceration, anaphylactic reactions.
From the side of the musculoskeletal system and connective tissue: unknown - joint edema.
From the urinary system: infrequently - urinary retention, dysuria; isolated - urinary tract infection.
Description of selected adverse reactions. In controlled clinical trials, anticholinergic adverse reactions, such as dry mouth, were commonly observed, which occurred in about 4% of patients.
In 28 clinical trials, dry mouth resulted in drug discontinuation in 18 (0.2%) of 9647 patients.
Serious side effects include glaucoma, constipation, bowel obstruction, including paralytic bowel obstruction and urinary retention.
Other special populations. Anticholinergic effects may increase with age.

special instructions

Spiriva is a bronchodilator that is prescribed once a day for maintenance therapy, and is not intended for the initial treatment of acute attacks of bronchospasm.
After using the drug, immediate-type hypersensitivity reactions may occur.
Like other anticholinergics, Spiriva should be used with caution in patients with angle-closure glaucoma, prostatic hyperplasia, or bladder neck obstruction (see SIDE EFFECTS).
Inhaled drugs can cause inhalation-induced bronchospasm.
The drug should be used with caution in such patients: recent myocardial infarction (6 months); Any unstable or life-threatening arrhythmia or arrhythmia that required intervention or treatment change in the past year; have been admitted to a hospital with NYHA class III or IV heart failure within the past year. These patients were excluded from clinical trials. Under these conditions, the anticholinergic effect can harm them.
Since the plasma concentration of tiotropium bromide increases in patients with moderate to severe renal insufficiency (creatinine clearance ≤50 ml / min), Spiriv should be used only if the expected benefit outweighs the potential risk. There are no data on long-term use of the drug in patients with renal insufficiency (see Pharmacokinetics).
Patients should avoid getting the powder in the eyes. This can lead to worsening angle-closure glaucoma, eye pain or discomfort, temporary blurred vision, a feeling of halo or colored spots before the eyes, combined with reddening of the eye in the form of conjunctival or corneal hyperemia.
If the listed symptoms appear in any combination, you should not waste time seeking specialized medical help.
Dry mouth seen with anticholinergic therapy may potentially be associated with caries.
Spiriv should not be used more than 1 time per day.
The drug contains 5.5 mg of lactose monohydrate in 1 capsule.
Use during pregnancy and lactation. Pregnancy. Data on the use of tiotropium in pregnant women are very limited. In preclinical studies, no direct or indirect harmful effects have been identified regarding reproductive toxicity at clinically significant doses. As a precaution, you should avoid using Spiriva during pregnancy.
Lactation. It is not known whether tiotropium bromide passes into breast milk. The use of the drug during breastfeeding is not recommended.
Tiotropium bromide is a long acting compound. The decision to continue / stop breastfeeding or continue / stop using Spiriva should be made in light of the assessment of the benefits of breastfeeding for the baby and the benefits of the therapy for the mother.
Children. The drug is not intended for use in children.
The ability to influence the reaction rate when driving or operating other mechanisms. Studies of the effect on the ability to drive a car or other mechanisms have not been conducted. Dizziness or blurred vision may affect your ability to drive or operate mechanical devices.

Interactions

Despite the fact that formal studies of interaction with other drugs have not been conducted, tiotropium bromide was used simultaneously with other drugs (sympathomimetic bronchodilators, methylxanthines, oral and inhaled steroids, which are used in the treatment of host) without clinical evidence of their interaction.
It has not been established that the use of long-acting β-adrenergic receptor agonists or inhaled corticosteroids alters the exposure of tiotropium.
However, the use of Spiriva in combination with anticholinergic drugs has not been investigated and is therefore not recommended.

Overdose

High doses of Spiriva can cause anticholinergic symptoms.
However, systemic anticholinergic side effects were absent in healthy volunteers after a single dose of up to 340 μg of tiotropium bromide.
No serious adverse reactions other than dry mouth were noted after 7 days of taking tiotropium bromide up to a dose of 170 mcg in healthy volunteers.
In multiple dose studies in patients with COPD, a maximum daily dose of 43 mcg of tiotropium bromide for 4 weeks did not lead to serious adverse reactions.
Acute intoxication with oral administration of tiotropium capsules is unlikely due to the low oral bioavailability.

Storage conditions

At a temperature not exceeding 25 ° c. protect from direct sunlight, heat and frost.
Term of use. After the first opening, the blister strip should be used within 9 days.
Children
HIV-1. For adolescents aged 12 to <18 years, whose body weight is ≥ 35 kg, the recommended dose of Viread® is one tablet once a day, which is taken orally with food.
Chronic hepatitis B. For adolescents aged 12 to <18 years, whose body weight ≥ 35 kg, the recommended dose of Viread® is one tablet once a day, which is taken orally with food. The optimal duration of treatment is currently unknown.

Way to use

Viread® tablets should be taken orally once a day with food.
If patients have difficulty swallowing, Viread® tablets can be crushed and dissolved in about 100 ml of water, orange or grape juice and consumed immediately.

Application features

Pregnant
The use of tenofovir disoproxil fumarate is possible during pregnancy, if necessary.
Tenofovir has been found to pass into a woman's breast milk. There is insufficient information on the effects of tenofovir on neonates / infants. Therefore, "Viread®" should not be used during breastfeeding. In general, HIV and HBV-infected women are generally advised not to breastfeed to avoid transmitting HIV or HBV to their baby.
There is limited clinical evidence on the effect of tenofovir disoproxil fumarate on fertility. In animal studies, no adverse effects on fertility were found with tenofovir disoproxil fumarate.
Drivers
There have been no studies of the effect on the ability to drive and work with other mechanisms. Patients should be advised that dizziness may occur during treatment with tenofovir disoproxil fumarate.

Overdose

Symptoms: In case of overdose, the patient should be monitored for signs of toxicity, if necessary, standard supportive care should be used.
Treatment: tenofovir can be removed by hemodialysis, the median clearance of tenofovir is 134 ml / minute. The withdrawal of tenofovir by peritoneal dialysis has not been investigated.

Side effects

Adverse reactions in frequency are determined: very often (≥ 1/10), often (from ≥ 1/100 to <1/10).
Disorders of nutrition and metabolism: very often - hypophosphatemia.
From the nervous system: very often - dizziness; often a headache.
From the digestive system: very often - diarrhea, nausea, vomiting; often - abdominal pain, bloating, flatulence.
From the hepatobiliary system: often - an increased level of transaminases.
On the part of the skin and subcutaneous tissue: very often - rashes.
Systemic disorders and disorders associated with the method of administration: very often - asthenia; often tiredness.

Storage conditions

Store at a temperature not exceeding 30 ° C, out of the reach of children.
The shelf life is 5 years.

Tags: Spiriva

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