Lansoprazole 15mg gastro-resistant capsules

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Lansoprazole

Dostupné z:

Zentiva Pharma UK Ltd

ATC kód:

A02BC03

INN (Medzinárodný Name):

Lansoprazole

Dávkovanie:

15mg

Forma lieku:

Gastro-resistant capsule

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 01030500; GTIN: 5000283631521

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
LANSOPRAZOLE 15MG & 30MG GASTRO-RESISTANT
CAPSULES
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
•
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 only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What lansoprazole is and what it is used for
2. What you need to know before you take lansoprazole
3. How to take lansoprazole
4. Possible side effects
5. How to store lansoprazole
6. Contents of the pack and other information
1. WHAT LANSOPRAZOLE IS AND WHAT IT IS USED FOR
The name of your medicine is Lansoprazole 15 mg & 30 mg
gastro-resistant capsules (called lansoprazole throughout this
leaflet). It belongs to a group of medicines called proton pump
inhibitors.
Lansoprazole works by lowering the amount of acid in your
stomach.
It can be used for:
•
Healing ulcers in your stomach or duodenum (gut)
•
Healing and preventing ulcers caused by medicines called
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). This includes
medicines like aspirin, ibuprofen, ketoprofen and piroxicam
•
Gastro-Oesophageal Reflux Disease (GORD). This happens when
acid from your stomach escapes into your food pipe (oesophagus)
causing damage and inflammation
Lansoprazole can relieve symptoms that can happen with the above
conditions and stop them from coming back.
It can also be used to treat:
•
The pain of indigestion or heartburn caused by too much acid
(acid-related dyspepsia) in your stomach
•
Illnesses, such as Zollinger-Ellison Syndrome, where the stomach
makes large amounts of acid. This can lead to diarrhoea and pain
in the stomach
•
Infections caused by the

Súhrn charakteristických

OBJECT 1
LANSOPRAZOLE 15MG GASTRO-RESISTANT
CAPSULES
Summary of Product Characteristics Updated 24-Jun-2020 | Zentiva
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
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3. Pharmaceutical form
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4. Clinical particulars
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4.1 Therapeutic indications
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4.2 Posology and method of administration
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4.3 Contraindications
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4.4 Special warnings and precautions for use
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4.5 Interaction with other medicinal products and other forms of
interaction
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4.6 Fertility, pregnancy and lactation
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4.7 Effects on ability to drive and use machines
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4.8 Undesirable effects
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4.9 Overdose
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5. Pharmacological properties
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5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
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6.2 Incompatibilities
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6.3 Shelf life
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6.4 Special precautions for storage
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6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
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7. Marketing authorisation holder
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8. Marketing authorisation number(s)
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9. Date of first authorisation/renewal of the authorisation
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10. Date of revision of the text
1. Name of the medicinal product
Lansoprazole 15 mg gastro-resistant capsules
2. Qualitative and quantitative composition
Each gastro-resistant capsule contains 15 mg of lansoprazole.
Excipient(s) with known effect
Also contains sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant capsules, hard
Size 3, opaque white hard gelatine capsule printed LAN 15, containing
white to slightly pink/beige
spherical pellets.
4. Clinical particulars
4.1 Therapeutic indications
• Treatment of duodenal and gastric ulcer
• Treatment of reflux oesophagitis
• Prophylaxis of reflux oesophagitis
• Eradication of _Helicobacter pylori_ (_H. pylori_) concurrently
given with appropriate antibiotic therapy for
treatment of _H.pylori_-associated ulcers
• Treatment of NSAID-associated benign gastric and duodenal u