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LORVACS XL 1.5 MG PROLONGED-RELEASE TABLETS

Active substance(s): INDAPAMIDE

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PIL Lorvacs XL 1.5 mg

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Lorvacs XL 1.5 mg
Prolonged-release Tablets
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 get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Lorvacs XL 1.5 mg is and what it is used for
2. Before you take Lorvacs XL 1.5 mg
3. How to take Lorvacs XL 1.5 mg
4. Possible side effects
5. How to store Lorvacs XL 1.5 mg
6. Further information
1. WHAT LORVACS XL 1.5 MG IS AND WHAT IT
IS USED FOR
This medicine is intended to reduce high blood
pressure (hypertension).
It is a prolonged-release tablet containing indapamide as the active ingredient.
Indapamide is a diuretic. Most diuretics increase
the amount of urine produced by the kidneys.
2. BEFORE YOU TAKE LORVACS XL 1.5 MG
Do not take Lorvacs XL 1.5 mg
- if you are allergic (hypersensitive) to indapamide
or any other sulphonamide or to any of the other
ingredients of Lorvacs XL 1.5 mg,
- if you have severe kidney disease,
- if you have severe liver disease or suffer from a
condition called hepatic encephalopathy (liver
problems which affect the brain and central
nervous system),
- if you have low potassium levels in your blood.
Take special care with Lorvacs XL 1.5 mg
- if you have liver problems,
- if you have diabetes,
- if you suffer from gout,
- if you have any heart rhythm problems or problems with your kidneys,
- if you need to have a test to check how well your
parathyroid gland is working.
You should tell your doctor if you have had photosensitivity reactions.
Your doctor may give you blood tests to check for
low sodium or potassium levels or high calcium
levels.
If you think any of these situations may apply to you
or you have any questions or doubts about taking
your medicine, you should consult your doctor or
pharmacist.
Athletes should be aware that this medicine contains
an active ingredient, which may give a positive
reaction in doping tests.
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.

Make sure to tell your doctor if you are taking any of
the following medicines, as special care may be
required:
- medicines used for heart rhythm problems (e.g.
quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis),
- medicines used to treat mental disorders such as
depression, anxiety, schizophrenia (e.g. tricyclic
antidepressants, antipsychotic drugs, neuroleptics),
- bepridil (used to treat angina pectoris, a condition
causing chest pain),
- cisapride (used to treat reduced movement of the
gullet and stomach),
- diphemanil (used to treat gastric problems such
as ulcers, too much acid, overactive digestive
system),
- sparfloxacin, moxifloxacin (antibiotics used to
treat infections),
- halofantrine (antiparasitic drugs used to treat
certain types of malaria),
- pentamidine (used to treat certain types of pneumonia),
- mizolastine (used to treat allergic reactions, such
as hay fever),
- non-steroidal anti-inflammatory drugs for pain
relief (e.g. ibuprofen) or high doses of acetylsalicylic acid,
- angiotensin converting enzyme (ACE) inhibitors
(used to treat high blood pressure and heart
failure),
- oral corticosteroids used to treat various conditions including severe asthma and rheumatoid
arthritis,
- stimulant laxatives,
- baclofen (to treat muscle stiffness occurring in
diseases such as multiple sclerosis),
- potassium-sparing diuretics (amiloride, spironolactone, triamterene),
- metformin (to treat diabetes),
- iodinated contrast media (used for tests involving
X-rays),
- calcium tablets or other calcium supplements,
- ciclosporin, tacrolimus or other medicines to
depress the immune system after organ transplantation, to treat autoimmune diseases, or
severe rheumatic or dermatological diseases,
- tetracosactide (to treat Crohn’s disease).
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.
This medicine is not recommended during pregnancy. When a pregnancy is planned or confirmed, the
switch to an alternative treatment should be initiated as soon as possible. Please tell your doctor if
you are pregnant or wish to become pregnant. The
active ingredient is excreted in milk. Breastfeeding
is not advisable if you are taking this medicine.
Driving and using machines
This medicine can cause side effects such as
dizziness or tiredness due to lowering of the blood
pressure (see section 4). These side effects are
more likely to occur after initiation of the treatment
and after dose increases. If this occurs, you should
refrain from driving and other activities requiring
alertness.
Important information about some of the ingredients of Lorvacs XL 1.5 mg
This medicine contains lactose monohydrate. If you
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicinal product.
3. HOW TO TAKE LORVACS XL 1.5 MG
Always take Lorvacs XL 1.5 mg exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.

You should not take Lorvacs XL 1.5 mg with lithium The usual dose is one tablet each day, preferably
(used to treat depression) due to the risk of increa- in the morning. The tablets can be taken with or
without food. They should be swallowed whole
sed levels of lithium in the blood.

PIL Lorvacs XL 1.5 mg

with water. Do not crush or chew them. Treatment ness, loss of appetite, weight gain and joint pain),
for high blood pressure is usually life-long.
this might get worse. Cases of photosensitivity
If you take more Lorvacs XL 1.5 mg than you reactions (change in skin appearance) after exposure to the sun or artificial UVA have also been
should
reported.
If you have taken too many tablets, contact your
Some changes may occur in your blood and your
doctor or pharmacist immediately.
doctor may need to give you blood tests to check
A very large dose of Lorvacs XL 1.5 mg could cause
your condition. The following changes in your blood
nausea (feeling sick), vomiting, low blood pressure,
test results may occur:
cramps, dizziness, drowsiness, confusion and
changes in the amount of urine produced by the - low potassium in the blood,
- low sodium in the blood that may lead to dehydrakidneys.
tion and low blood pressure,
If you forget to take Lorvacs XL 1.5 mg
If you forget to take a dose of your medicine, take - increase in uric acid, a substance which may
cause or worsen gout - painful joint(s) especially
the next dose at the usual time. Do not take a douin the feet,
ble dose to make up for the forgotten dose.
- increase in blood glucose levels in diabetic paIf you stop taking Lorvacs XL 1.5 mg
tients,
As the treatment for high blood pressure is usually - increase of calcium in blood.
life-long, you should discuss with your doctor before stopping this medicinal product.
If any of the side effects get serious, or if you
notice any side effects not listed in this
If you have any further questions on the use of
leaflet, please tell your doctor or pharmacist.
this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Lorvacs XL 1.5 mg can cause
side effects, although not everybody gets them.
These can include:
Commonly (less than 1 patient in 10 but more
than 1 in 100):
- Low potassium in the blood, which may cause
muscle weakness, allergic reactions, mainly dermatological, such as skin rashes
Uncommonly (less than 1 patient in 100 but
more than 1 in 1000):
- Vomiting, purpura (red pinpoints on skin) in
subjects with a tendency to allergic and asthmatic reactions.
Rarely (less than 1 patient in 1000 but more
than 1 in 10,000):
- Feeling of tiredness, dizziness, headache, pins
and needles (paresthesia);
- Nausea (feeling sick), constipation, dry mouth;
- Increased risk of dehydration in the elderly and in
patients suffering from heart failure.
Very rarely (less than 1 patient in 10,000):
- Heart rhythm irregularities (causing palpitations,
feeling of the heart pounding), low blood pressure;
- Kidney disease (causing symptoms of tiredness,
increased need to urinate, itchy skin, feeling sick,
swollen extremities);
- Pancreatitis (inflammation of the pancreas which
causes upper abdominal pain), abnormal liver
function (with symptoms such as tiredness, loss
of appetite, feeling or being sick, swollen extremities, yellow skin). In cases of liver failure, there is
a possibility of getting hepatic encephalopathy
(liver problems which affect the brain and central
nervous system);
- Changes in blood cells, such as thrombocytopenia (decrease in the number of platelets which
causes easy bruising and nasal bleeding), leucopenia (decrease in white blood cells which may
cause unexplained fever, soreness of the throat
or other flu-like symptoms – if this occurs, contact
your doctor) and anaemia (decrease in red blood
cells);
- Angioedema and/or urticaria, severe skin manifestations. Angioedema is characterised by
swelling of the skin around the eyes, lips, hands
or feet. It may cause swelling of the throat, tongue
or airways resulting in shortness of breath or difficulty in swallowing. If this occurs, contact your
doctor immediately.
If you suffer from systemic lupus erythematosus
(a disorder of the immune system leading to inflammation and damage to the joints, tendons and
organs with symptoms including skin rashes, tired-

5. HOW TO STORE LORVACS XL 1.5 MG
Keep out of the reach and sight of children.
Do not use this medicine after the expiry data which
is stated on the carton and blister. The expiry date
refers to the last day of that month.
This product does not require any special storage
conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.
6. FURTHER INFORMATION
What Lorvacs XL 1.5 mg contains
The active substance is indapamide. Each tablet
contains 1.5 mg of indapamide.
The other ingredients are lactose monohydrate,
pregelatinised maize starch, hypromellose, silica
colloidal anhydrous, magnesium stearate, macrogol 6000, titanium dioxide (E171).
What Lorvacs XL 1.5 mg looks like and contents
of the pack
White to off-white, round shaped, biconvex, prolonged-release film-coated tablets which come in
boxes of 10, 14, 15, 20, 30, 50, 60, 90 and 100. Not
all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court,
County Oak Way
Crawley
West Sussex. RH11 7XA
United Kingdom
Manufacturer
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court,
County Oak Way
Crawley
West Sussex. RH11 7XA
United Kingdom
This leaflet was last approved in 01/2011.
PL 36687/0001

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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