Registered Tanzania · TMDA

INHALEX

Equivalent to Tiotropium Bromide 0.018 mg/6 mL,Lactose Monohydrate (Lactohale 300) 0.2739 mg/6 mL,Lactose monohydrate (Lactohale 200) 5.2036 mg/6 mL,Tiotropium Bromide Monohydrate equivalent to Tiotropium 0.0225 mg/6 mL

TAN 25 HM 0062 Capsules INN generic

What it does

Lactose is a sugar found in milk and dairy products. It is often used as an excipient in medications.

Commonly used for: lactose intolerance, as a filler in tablets and capsules

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Sourcing - Kenya only

Registration & product details

Registration no.
TAN 25 HM 0062
Registration date
2025-02-13
Expiry date
2030-02-12
Status
Registered/Compliant
Active ingredient
Equivalent to Tiotropium Bromide 0.018 mg/6 mL,Lactose Monohydrate (Lactohale 300) 0.2739 mg/6 mL,Lactose monohydrate (Lactohale 200) 5.2036 mg/6 mL,Tiotropium Bromide Monohydrate equivalent to Tiotropium 0.0225 mg/6 mL
Dosage form
Capsules
Strength
-
Pack size
-
Therapeutic class
-
RxNorm RxCUI
6211
Manufacturer / MAH
Eva Pharma
Country of origin
EGYPT
Manufacturer location
السادات، Zawya Abou Muslim, Al Haram, Giza Governorate 3380304, Egypt

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:51:22 · updated 2026-10-19 03:00:45

Drug Interactions

2
Check interactions

Pharmacodynamic Warnings

Tiotropium appears in TABLE 10: Drugs with antimuscarinic effects

Unknown (2)

Tiotropium - additive effect

Clozapine can cause constipation, as can tiotropium; concurrent use might increase the risk of developing intestinal obstruction. Also see TABLE 10 p. 1519

Unknown Theoretical

Tiotropium - additive effect

Antipsychotics, second generation (clozapine) can cause constipation, as can tiotropium; concurrent use might increase the risk of developing intestinal obstruction. Also see TABLE 10 p. 1519 Tipranav

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About lactose

Lactose is a sugar found in milk and dairy products. It is often used as an excipient in medications.

What it treats

  • lactose intolerance
  • as a filler in tablets and capsules

How it works

Lactose helps improve the texture and stability of medications and is sometimes used as a sweetener.

Who it's for

Individuals who require lactose as part of their medication or those who consume dairy products.

Cautions

  • • May cause digestive issues in people with lactose intolerance.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About tiotropium

Tiotropium is a medication used to help open the airways in the lungs, making it easier to breathe.

What it treats

  • chronic obstructive pulmonary disease (COPD)
  • asthma

How it works

It works by relaxing the muscles around the airways, which helps to keep them open.

Who it's for

This medicine is for adults with respiratory conditions like COPD and asthma.

Cautions

  • • Avoid using with other medications that have antimuscarinic effects.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: lactose

BNF-referenced

Lactose is a disaccharide sugar composed of galactose and glucose, primarily found in milk and dairy products. It serves as a source of energy and is metabolized by the enzyme lactase. In individuals with lactase deficiency, lactose can lead to gastrointestinal symptoms such as bloating, diarrhea, and abdominal pain.

Indications

  • Lactose intolerance
  • As a filler or excipient in pharmaceutical formulations

Dosage

Children: Refer to the BNF for Children for specific dosing information based on age and clinical context.

Adults: Refer to the BNF for specific dosing information based on clinical context.

Mechanism of action

Lactose is metabolized in the intestine by the enzyme lactase into its constituent monosaccharides, glucose and galactose. In individuals with lactase deficiency, unabsorbed lactose passes into the colon, where it is fermented by bacteria, leading to gas production and osmotic effects that contribute to diarrhea.

Pharmacodynamics

The pharmacodynamics of lactose are primarily related to its effects on gastrointestinal function. In healthy individuals, lactose is effectively broken down into glucose and galactose, which are absorbed and utilized for energy. In individuals with lactose intolerance, the unabsorbed lactose can cause osmotic diarrhea and colonic fermentation, leading to discomfort and symptoms associated with lactose intolerance.

Pharmacokinetics

Lactose is not absorbed in the gastrointestinal tract until it is hydrolyzed into glucose and galactose by lactase. The absorption of glucose and galactose occurs in the small intestine. The half-life is not applicable as lactose is not typically administered as a medication but is rather ingested as a natural component of food. Its metabolism primarily occurs in the intestine.

Adverse effects

  • Bloating
  • Diarrhea
  • Abdominal pain
  • Flatulence

Precautions

  • Use with caution in patients with lactose intolerance.
  • Consider potential for gastrointestinal upset in sensitive individuals.

Pregnancy

Lactose is generally considered safe for use during pregnancy. However, consult a healthcare professional for individual advice.

Breast-feeding

Lactose is safe to use while breastfeeding, as it is a natural sugar present in breast milk.

Storage

Store in a cool, dry place, away from direct sunlight.

Formulations

  • Powder
  • Granules
  • Tablets
  • Syrup

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: Tiotropium

BNF-referenced

Tiotropium is a long-acting antimuscarinic agent used primarily in the management of chronic obstructive pulmonary disease (COPD) and asthma. It acts as a bronchodilator by inhibiting the muscarinic receptors in the airways, thereby reducing bronchoconstriction and improving airflow. Tiotropium is administered via inhalation and offers once-daily dosing, making it a convenient option for patients requiring maintenance therapy.

Indications

  • Maintenance treatment of chronic obstructive pulmonary disease (COPD)
  • Severe asthma as an add-on therapy to inhaled corticosteroids and other controllers

Dosage

Children: For children aged 6-11 years: 5 micrograms once daily. For children aged 12-17 years, refer to BNF for Children for specific dosing guidance.

Adults: 1 capsule (18 micrograms) once daily by inhalation.

Mechanism of action

Tiotropium exerts its effects by selectively blocking the M3 muscarinic acetylcholine receptors in the bronchial smooth muscle. This blockade leads to relaxation of the bronchial muscles and dilation of the airways. The inhibition of these receptors prevents bronchoconstriction and facilitates easier breathing in patients with obstructive pulmonary diseases.

Pharmacodynamics

Tiotropium has a long duration of action due to its slow dissociation from the M3 receptors, allowing for sustained bronchodilation over a 24-hour period. The onset of action typically begins within 30 minutes of administration, with peak effects occurring around 3 hours post-dose. It significantly improves lung function, reduces exacerbation rates, and enhances exercise tolerance in patients with COPD.

Pharmacokinetics

Tiotropium is primarily absorbed through the lungs when inhaled, with approximately 20% of the delivered dose reaching systemic circulation. The drug undergoes minimal hepatic metabolism, primarily via cytochrome P450 enzymes, and is mainly excreted unchanged in the urine. The elimination half-life is approximately 5 to 6 days, which supports its once-daily dosing regimen.

Contra-indications

  • Hypersensitivity to tiotropium, atropine or its derivatives
  • Patients with narrow-angle glaucoma
  • Patients with urinary retention

Adverse effects

  • Cough
  • Dizziness
  • Dry mouth
  • Headache
  • Nausea
  • Constipation
  • Dysphonia
  • Palpitations
  • Skin reactions
  • Stomatitis
  • Urinary disorders
  • Vision blurred

Interactions

  • Clozapine: Unknown (additive effect)
  • Second-generation antipsychotics: Unknown (additive effect)

Precautions

  • Counsel patients on appropriate administration technique
  • Warn against accidental contact with the eye due to risk of ocular complications
  • Increased risk of dizziness affecting driving and skilled tasks

Pregnancy

Manufacturer advises only use if potential benefit outweighs risk.

Breast-feeding

No information available-manufacturer advises only use if potential benefit outweighs risk.

Storage

Store in a cool, dry place, away from direct sunlight.

Formulations

  • {'name': 'Spiriva® Inhalation Powder', 'dose': '18 micrograms per capsule', 'route': 'inhalation'}
  • {'name': 'Braltus® Inhalation Powder', 'dose': '13 micrograms per capsule', 'route': 'inhalation'}
  • {'name': 'Nebuliser liquid', 'dose': 'Variable, refer to specific product information', 'route': 'nebulisation'}
BNF 85 (British National Formulary) p.289 BNF for Children 2019-2020 p.177 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: lactose

PubChem CID 6134

Molecular formula: C12H22O11

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

Molecular reference: Tiotropium

PubChem CID 5487427

Molecular formula: C19H22NO4S2+

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.