Rowatinex capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Anethol; Borneol; Camphene; Cineole; Fenchone; Pinene

Available from:

Meadow Laboratories Ltd

INN (International Name):

Anethol; Borneol; Camphene; Cineole; Fenchone; Pinene

Dosage:

4mg ; 10mg ; 15mg ; 3mg ; 4mg ; 31mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 07040300; GTIN: 05390387001017

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
IN THIS LEAFLET:
1. What Rowatinex
®
is and what it is used for
2. Before you take Rowatinex
®
3. How to take Rowatinex
®
4. Possible side effects
5. How to store Rowatinex
®
6. Further information
1.WHAT ROWATINEX
®
IS AND WHAT IT IS USED FOR
Rowatinex
®
contains essential
oils that help to dissolve or break down and
remove (disintegrating and eliminating) kidney and urinary tract
stones.
Rowatinex
®
relieves muscle spasm thus reducing the pain of
kidney and
urinary colics. Rowatinex
®
is also used to relieve the effects associated with
mild urinary tract infections.
2.BEFORE YOU TAKE ROWATINEX
®
DO NOT TAKE ROWATINEX
®
if you are allergic (hypersensitive) to any of the
active substances or any of the other ingredients of Rowatinex
®
(see sec-
tion 6 “Further information” for details).
TAKE SPECIAL CARE WITH ROWATINEX
®
Rowatinex
®
is not suitable in patients with severe pain (colic), decrease in
urine production or severe infection of the urinary tract.
CHILDREN AND ADOLESCENTS UNDER 18
Children and adolescents under
18 years of
age should not
take
Rowatinex
®
.
TAKING OTHER MEDICINES
Please tell
your doctor or pharmacist
if
you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription. These medicines include:
- medicines to thin your blood (oral anti-coagulants e.g. Warfarin)
- medicines that are broken down in the liver (ask your doctor for
advise on
this)
TAKING ROWATINEX
®
WITH FOOD OR DRINK
Rowatinex
®
should be taken on an empty

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ROWATINEX Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains the following:
Pinene [a +
β
]
31.0mg
Camphene
15.0 mg
Cineol BPC
3.0 mg
Fenchone
4.0 mg
Borneol
10.0 mg
Anethol USP
4.0 mg
3.
PHARMACEUTICAL FORM
Yellow spherical, soft-enteric-coated gelatin capsules containing a
pale yellow
or greenish yellow oil.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Urolithiasis, nephrolithiasis and mild urinary tract infections.
ROWATINEX
promotes the disintegration of stones, and by its spasmolytic action
promotes
the
spontaneous
passage
of
stones
in
the
renal
and
urinary
tracts.
ROWATINEX gives symptomatic relief of mild to moderate renal and
urinary
colic associated with the presence of stones in the renal and urinary
tracts.
ROWATINEX is also indicated for the relief of frequency and urgency
associated with mild urinary tract infections.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of Administration: Oral.
Adults: One capsule 3 or 4 times daily before meals.
No dose recommendation for children.
4.3
CONTRAINDICATIONS
None known.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
ROWATINEX is not suitable for use in patients with severe colic,
anuria or
severe infection of the urinary tract.
Keep out of the reach of children.
4.5
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Should not be used in patients receiving oral anti-coagulants or other
drugs
metabolised by the liver where dose is critical.
4.6
PREGNANCY AND LACTATION
Although no teratogenic effects have been reported, ROWATINEX should
not
be given in the first trimester of pregnancy. Although no evidence is
available,
ROWATINEX should not be given to lactating females.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None.
4.8
UNDESIRABLE EFFECTS
An
Insignificant
number
of
patients
reported
slight
and
transient
gastric
disturbance. Vomiting has been rarely reported. In two cases there was
drug
intolerance [cause unknown] - side effects were