Rowatinex Gastro-resistant Capsules, Soft

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Beta pinene; Cineole; Camphene; Alpha pinene; Fenchone; Anethole; Borneol

Available from:

Rowa Pharmaceuticals Limited

INN (International Name):

Beta pinene; Cineole; Camphene; Alpha pinene; Fenchone; Anethole; Borneol

Dosage:

12.5 percent volume/volume

Pharmaceutical form:

Gastro-resistant capsule, soft

Prescription type:

Product not subject to medical prescription

Authorization status:

Marketed

Authorization date:

1983-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ROWATINEX®
GASTRO-RESISTANT CAPSULES, SOFT
Α-PINENE, Β-PINENE, CAMPHENE, BORNEOL, ANETHOL, FENCHONE, CINEOLE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist
has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- 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.
- You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET:
1. What Rowatinex® is and what it is used for
2. What you need to know before you take Rowatinex®
3. How to take Rowatinex®
4. Possible side effects
5. How to store Rowatinex®
6. Contents of the pack and other information
1. WHAT ROWATINEX® IS AND WHAT IT IS USED FOR
Rowatinex® helps to dissolve/break down and remove (disintegrate and
eliminate) kidney
and urinary tract stones.
Rowatinex® relieves muscle spasm thus reducing the pain of renal and
urinary colic. It
increases blood flow and reduces inflammation, which could be
associated with the
presence of kidney stones.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROWATINEX®
DO NOT TAKE ROWATINEX®:
-
if you are allergic to α-pinene, β-pinene, camphene, borneol,
anethol, fenchone, cineole
or any of the other ingredients of this medicine (listed in section
6).
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR FIRST BEFORE YOU TAKE ROWATINEX®
DO NOT TAKE ROWATINEX FOR TREATMENT OF URINARY STONES UNLESS YOUR
DOCTOR HAS CONFIRMED A
DIAGNOSIS OF URINARY STONES ESPECIALLY IN THE CASE OF CHILDREN.
Talk to your doctor or pharmacist before taking Rowatinex® if you are
taking medicines to
thin your blood or medicines that are broken down by the liver.
OTHER MEDICINES AND ROWATINEX®
Tell your doctor or pharmacist if you are taking, h

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rowatinex Gastro-resistant Capsules, Soft
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
-Pinene 24.8 mg,
-Pinene 6.2 mg, Camphene 15.0 mg, Borneol 10.0 mg, Anethol 4.0 mg,
Fenchone 4.0 mg, Cineole
3.0 mg.
Excipient(s) with known effect
Each capsule also contains Sodium Ethyl Parahydroxybenzoate (E215),
Sodium Propyl Parahydroxybenzoate (E217)
and Sunset Yellow FCF 85% (E110).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant Capsules, soft
Yellow, spherical, soft gelatine gastro-resistant capsules containing
a pale yellow to greenish-yellow oral solution with
a strong aromatic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of urolithiasis WHERE A DEFINITE DIAGNOSIS HAS BEEN
MADE BY A DOCTOR ESPECIALLY IN THE CASE OF
CHILDREN.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Method of Administration: Oral.
Adults: 1 capsule 4 to 5 times daily before meals.
_Paediatric Population:_
Children aged 0 to 6 years: No data are available.
Children aged 6 to 14 years: 1 to 2 capsules twice daily before meals.
Adolescents aged 14 to 18 years: 1 capsule 4 to 5 times daily before
meals.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1.
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