Salagen 5mg tablets

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktīvā sastāvdaļa:

Pilocarpine hydrochloride

Pieejams no:

Norgine Pharmaceuticals Ltd

ATĶ kods:

N07AX01

SNN (starptautisko nepatentēto nosaukumu):

Pilocarpine hydrochloride

Deva:

5mg

Zāļu forma:

Oral tablet

Ievadīšanas:

Oral

Klase:

No Controlled Drug Status

Receptes veids:

Valid as a prescribable product

Produktu pārskats:

BNF: 12030500; GTIN: 5010678919134

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SALAGEN® 5MG FILM-COATED TABLETS
(pilocarpine hydrochloride)
This medicine is available as the above name, but will be
referred to as Salagen throughout the following leaflet.
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.
What is in this leaflet:
1. What Salagen is and what it is used for
2. What you need to know before you take Salagen
3. How to take Salagen
4. Possible side effects
5. How to store Salagen
6. Contents of the pack and other information
1. WHAT SALAGEN IS AND WHAT IT IS USED FOR
Salagen contains the active substance pilocarpine hydrochloride,
which belongs to a group of medicines called
parasympathomimetic agents or cholinergic agents.
Salagen stimulates certain nerves and glands in your body. After
you take Salagen, your body will produce more saliva, tears,
sweat, gastric juices and mucus.
SALAGEN IS USED
•
if you have been given radiotherapy for cancer of the head
or neck, and your mouth feels very dry
•
If you have been diagnosed with a condition called Sjögren’s
syndrome, and your mouth and/or your eyes are dry and/or
itchy
If you have any questions about how Salagen works or why this
medicine has been prescribed for you, ask your doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SALAGEN
DO NOT TAKE SALAGEN
•
if you are allergic (hypersensitive) to pilocarpine
hydrochloride or to any of the other ingredients of Salagen
(listed in section 6).
•
if you have untreated asthma
•
if you have untreated heart or kidney disease
•
if you have a chronic disease that is being treated with a
medicinal product that ac

Produkta apraksts

OBJECT 1
SALAGEN 5 MG FILM COATED TABLETS
Summary of Product Characteristics Updated 01-Jun-2016 | Merus Labs
Luxco S.a.R.L.
1. Name of the medicinal product
Salagen
®
5 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 5 mg of pilocarpine hydrochloride.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Salagen film-coated tablets are white, round biconvex tablets, marked
“SAL“ on one side and “5“ on
the other side.
4. Clinical particulars
4.1 Therapeutic indications
• Alleviation of symptoms of salivary gland hypofunction in patients
with severe xerostomia following
irradiation for head and neck cancer.
• Treatment of symptoms of dry mouth and dry eyes in patients with
Sjögren's syndrome.
4.2 Posology and method of administration
• For head and neck cancer patients:
The recommended initial dose for adults is 1 tablet of 5 mg three
times daily. Tablets should be taken
with a glass of water during or directly after meals. The last tablet
should always be taken in conjunction
with the evening meal. The maximal therapeutic effect is normally
obtained after 4 to 8 weeks of therapy.
For patients who have not responded sufficiently after 4 weeks and who
tolerate the dose of 5 mg three
times daily, doses of up to a maximum of 30 mg daily may be
considered. However, higher daily doses
are probably accompanied by an increase in drug-related adverse
effects. Therapy should be discontinued
if no improvement in xerostomia is noted after 2 to 3 months of
therapy.
• For Sjögren's syndrome patients:
The recommended dose for adults is one tablet of 5 mg four times
daily. Tablets should be taken with a
glass of water at mealtimes and bedtime. For patients who have not
responded sufficiently to a dosage of
5 mg four times daily and who tolerate this dosage, increasing the
dose up to a maximum of 30 mg daily,
divided over the day, may be considered. Therapy should be
discontinued if no improvement in the
symptoms of dry mouth an