Rawel XL 1.5mg tablets

Valsts: Lielbritānija

Valoda: angļu

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

Aktīvā sastāvdaļa:

Indapamide

Pieejams no:

Krka UK Ltd

ATĶ kods:

C03BA11

SNN (starptautisko nepatentēto nosaukumu):

Indapamide

Deva:

1.5mg

Zāļu forma:

Modified-release tablet

Ievadīšanas:

Oral

Klase:

No Controlled Drug Status

Receptes veids:

Valid as a prescribable product

Produktu pārskats:

BNF: 02020100; GTIN: 5391512450588

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE USER RAWEL XL PROLONGED-RELEASE TABLETS 1.5 MG INDAPAMIDE
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 Rawel XL is and what it is used for
2. Before you take Rawel XL
3. How to take Rawel XL
4. Possible side effects
5. How to store Rawel XL
6. Further information
1. WHAT RAWEL XL IS AND WHAT IT IS USED FOR
Rawel XL is a drug that reduces blood pressure by promoting the
excretion of urine and by dilating blood vessels.
Rawel XL is used to treat increased blood pressure.
2. BEFORE YOU TAKE RAWEL XL
DO NOT TAKE RAWEL XL
•
If you are allergic (hypersensitive) to indapamide or any of the other
ingredients of Rawel XL or to other drugs of the same
type (called sulphonamides).
•
If you have severe impairment of kidney function.
•
If you have severe impairment of liver function.
•
If you have a low level of potassium in your blood.
TAKE SPECIAL CARE WITH RAWEL XL
•
If you have impairment of liver function.
•
If you have disorders of blood electrolyte levels or body water
depletion.
•
If you have diabetes.
•
If you have gout.
•
If you have impairment of kidney function.
•
If you have a skin reaction when exposed to sunlight.
•
If you are an athlete. Rawel XL can interfere with results of doping
tests.
•
You should monitor your blood pressure and heart rate regularly during
treatment.
•
If you are an elderly person, your doctor will check your kidney
function before the start of therapy.
•
If you are a child or an adolescent, this medicine is not recommended
for you.
Your doctor will give you a detailed

Produkta apraksts

OBJECT 1
RAWEL XL PROLONGED-RELEASE TABLETS 1.5 MG
Summary of Product Characteristics Updated 20-May-2016 | Consilient
Health Ltd
1. Name of the medicinal product
Rawel XL prolonged-release tablets 1.5 mg
2. Qualitative and quantitative composition
Each prolonged-release tablet contains 1.5 mg indapamide.
Also contains lactose monohydrate 97.58 mg.
For a full list of excipients, see 6.1.
3. Pharmaceutical form
Prolonged-release tablet
White, round, slightly biconvex.
4. Clinical particulars
4.1 Therapeutic indications
Essential hypertension.
4.2 Posology and method of administration
Indapamide is administered orally.
One tablet should be taken once a day, preferably in the morning. It
should be swallowed whole with
water and not chewed.
At higher doses the antihypertensive effect of indapamide is not
enhanced but the excretion of salt is
increased (saluretic effect).
In the elderly, this plasma creatinine must be adjusted in relation to
age, weight and gender. Elderly
patients can be treated with Rawel XL when renal function is normal or
only minimally impaired.
Rawel XL is not recommended for use in children and adolescents due to
lack of data on safety and
efficacy.
Renal failure (see sections 4.3 and 4.4):
In severe renal failure (creatinine clearance below 30 ml/min),
treatment is contraindicated.
Thiazide and related diuretics are fully effective only when renal
function is normal or only minimally
impaired.
Patients with hepatic impairment (see sections 4.3 and 4.4):
In severe hepatic impairment, treatment is contraindicated.
4.3 Contraindications
Indapamide is contraindicated in:
• Hypersensitivity to indapamide, to other sulfonamides or to any of
the excipients
• Severe renal failure
• Hepatic encephalopathy or severe impairment of liver function
• Hypokalaemia
4.4 Special warnings and precautions for use
_WARNING_
In patients with impaired liver function, thiazide-related diuretics
may cause hepatic encephalopathy
particularly in case of electrolyte imbalance. Administration of the
diuretic must