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MAPEMID XL 1.5MG TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MAPEMID XL 1.5 mg 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 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 Mapemid XL 1.5 mg tablets are and
what they are used for
2. Before you take Mapemid XL 1.5 mg tablets
3. How to take Mapemid XL 1.5 mg tablets
4. Possible side effects
5. How to store Mapemid XL 1.5 mg tablets
6. Further information

1. What Mapemid XL 1.5 mg tablets
are and what they are used for
The active substance in these tablets is
called Indapamide. It belongs to a group of
medicines called diuretics. Diuretics increase
the amount of urine produced by the kidneys
and are sometimes called water tablets.
This medicine is used to treat high blood
pressure without well-known cause (essential
hypertension).

2. Before you take Mapemid XL
1.5 mg tablets
Do not take Mapemid XL 1.5 mg tablets
• if you are allergic (hypersensitive) to
Indapamide, to sulphonamides (antibiotic
compounds) or any of the other ingredients
in the tablet
• if you have severe kidney or liver problems
• if you have been told you have a low level of
potassium in your blood
Take special care with Mapemid XL 1.5 mg
tablets
Before starting to take this medicine, inform
your doctor of the following:
• if you have any kidney or liver problems
• if you suffer from diabetes or gout
• if you suffer from heart disease
• if you have been told you have a low level of
sodium in your blood
• if you need to have a test to check how well
your parathyroid gland is working
This medicine affects the levels of potassium
and sodium in the blood. Your doctor may
conduct blood tests to monitor levels of
potassium and sodium in your blood before
and during your treatment. This is especially
important in patients, who are at high risk
to develop electrolyte disturbances (such as
elderly, patients who are taking many
medicines or malnourished patients).
This medicine may increase the sensitivity
of your skin to sunlight. If this happens you
should tell your doctor as he/she may decide
to stop your treatment. When treated with this
medicine, it is recommended to protect exposed
areas of skin from the sun or to artificial UVA.
Athletes should be aware that this medicine
contains an active ingredient which may give
a positive reaction in drug tests.
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.
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 (e.g. from the
supermarket).
Especially:
Combinations that are not recommended:
• Medicine used to treat mania and depression
(Lithium)
• Some diuretics (water tablets) that cause a
decrease in blood potassium concentration
such as bumetanide, furosemide, piretanide,
thiazides and xipamide
Combinations requiring precautions for use:
• Certain medicines for treatment of irregular
heartbeat (quinidine, hydroquinidine,
disopyramide, amiodarone, sotalol, dofetilide,
ibutilide)
• Certain medicines to treat psychiatric
conditions (chlorpromazine, cyamemazine,
levomepromazine, thioridazine, trifluoperazine,
droperidol, haloperidol, amisulpride, sulpiride,
sultopride, tiapride)
• Certain medicines to treat depression (tricyclic
antidepressants)

• Some antibiotics (intravenous erythromycin,
sparfloxacin, moxifloxacin)
• Medicnes used to treat chest pain (angina)
(Bepridil)
• Medicines used to treat heart burn and
esophagitis (cisapride)
• Medicine used to treat very slow heart rate in
infants (diphemanil)
• Antimalaria medicine (halofantrine)
• Certain antihistamines (mizolastine)
• Medicines used to treat pneumonia
(pentamidine)
• Intravenous vincamine (medicine used to
treat brain disorders such as dementia and
stroke)
• Medicines for relieving inflammation and/or
pain
• Other medicines for treating high blood
pressure and/or heart failure (ACE-inhibitors,
digitalis preparations, potassium-sparing
diuretics [“water pills”])
• Intravenous steroids
• Medicines that help relax the bowels (Laxatives)
• Medicine to treat fungal infections (Intravenous
amphotericine B)
• Hormones for diagnosis or therapy
(Tetracosactide)
• Medicine for relaxing the muscles (Baclofen)
• Medicine for treatment of diabetes
(Metformin)
• Certain medicines for diagnosis (iodinated
contrast media)
• Calcium supplements
• Medicines for lowering the body’s immune
response (ciclosporine, tacrolimus)
Taking Mapemid XL 1.5 mg tablets with food
and drink
Food and drink have no impact on the way that
your medicine works. You may take it with or
after food or on an empty stomach.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice
before taking any medicine.
It is not recommended to take this medicine
during pregnancy or while breast-feeding.
Small amounts of this medicine may pass to
the baby in breast milk.
Driving and using machines
You may feel dizzy or drowsy when you take
this medicine. This could happen especially at
the beginning of the treatment or if you take
another blood pressure-lowering medicine at
the same time. If this occurs, you should not
drive or use machines.
Important information about some of the
ingredients of Mapemid XL 1.5 mg tablets
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 medicine.

3. How to take Mapemid XL 1.5 mg
tablets
Always take this medicine exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
The usual dose is 1 tablet daily, preferably in
the morning, with or without food.
Patients with impaired Kidney function
Patients with severe Kidney failure (creatininclearance below 30 ml/min) must not be treated
with this medicine (see section 2. “Do not take
Mapemid XL 1.5 mg tablets”). This medicine is
fully effective only when Kidney function is normal
or only minimally impaired.
Patients with impaired liver function
Patients with severe liver impairment must not
be treated with this medicine (see section 2.
“Do not take Mapemid XL 1.5 mg tablets”).
Elderly
Elderly patients can be treated with this
medicine when kidney function is normal or
only minimally impaired.
Children and adolescents
This medicine is not recommended for use in
children and adolescents due to a lack of data
on safety and efficacy.

Method of administration:
For oral use
Swallow the tablets with a glass of water.
Do not crush or chew the tablets, the tablets
are designed to release the medicine slowly
into the body.
If you take more Mapemid XL 1.5 mg tablets
than you should
Tell your doctor or a hospital immediately if
you have taken more tablets than your doctor
has prescribed. Overdose symptoms may include
nausea, drowsiness, dizziness, vomiting, low
blood pressure, headache, confusion, rapid
pulse, cramps, excessive production of urine
or low production of urine.
If you forget to take Mapemid XL 1.5 mg tablets
Take the next dose at the usual time. Do not
take a double dose to make up for a forgotten
dose.
If you stop taking Mapemid XL 1.5 mg tablets
Do not stop using this medicine until your doctor
tells you.
Treatment for high blood pressure is normally
life-long. You should not stop taking your
medicine without discussing it with your doctor
first.
If you have any further questions on the use
of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, these tablets can cause side
effects, although not everybody gets them.
Very common (affects more than 1 in 10 patients)
• decrease in blood potassium level which
may cause muscle weakness (mainly at the
beginning of the treatment, in the elderly, in
undernourished people)
Common (affects 1 in 10 patients)
• allergic reaction (especially in people who
tend to have allergic or asthmatic reactions)
leading to skin rashes with macules (flat
discoloured area) and papules (small raised
lumps)
Uncommon (affects 1 in 100 patients)
• vomiting
• allergic reaction (especially in people who
tend to have allergic or asthmatic reactions)
leading to purple spots or patches on the skin
Rare (affects 1 in 1000 patients)
• dizziness, fatigue, headache, numbness or
tingling in the legs or arms (paresthesia)
• nausea (feeling sick), constipation, dry mouth
Very rare (affects 1 in 10,000 patients)
• increase in calcium blood level
• decrease in certain blood cells (blood platelets,
white and/or red blood cells) which causes
• easy bruising and nasal bleeding
(thrombocytopenia)
• unexplained fever, soreness of the throat or
other flu-like symptoms (leucopenia)
• weakness, paleness, a fast heartbeat and
breathlessness (anaemia)
• irregular heart rhythm, low blood pressure
• inflammation of the pancreas
• kidney problems
• abnormal liver function
• urticaria, facial and neck swelling and
severe skin conditions like blistering of the
skin, mouth, eyes and genital organs called
toxic epidermic necrolysis or Stevens-Johnson
syndrome may appear in the hypersensitive
setting
Not known
• Your doctor may need to give you blood
tests to monitor your condition. The following
changes in laboratory parameters may occur:
• low chloride in the blood
• low sodium in the blood that may lead to
dehydration and low blood pressure
• increase in uric acid, a substance which may
cause or worsen gout (painful swelling and
redness in the joints, most commonly in the
big toe)
• increase in blood glucose levels in diabetic
patients
• in case of reduced liver function, there is a
possibility of brain disorders caused by
the reduced liver function (hepatic
encephalopathy) (see also 2. “Take special
care with MAPEMID XL 1,5 mg prolonged
release tablets”)
• worsening of a certain pre-existing autoimmune
skin-disease (acute disseminated lupus
erythematodus)
• skin-sensitivity to UV light (photosensitivity
reactions)
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.

5. How to store Mapemid XL 1.5 mg
tablets
Keep out of the reach and sight of children.
Do not use Mapemid XL 1.5 mg tablets after
the expiry date {EXP} which is stated on the
carton or blister. The expiry date refers to the
last day of that month.
Do not store above 30 °C.
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 Mapemid XL 1.5 mg tablets contains
The active substance is Indapamide.
Each prolonged-release tablet contains 1.5 mg
Indapamide.
The other ingredients are:
• lactose monohydrate
• hypromellose
• silica, colloidal anhydrous
• magnesium stearate
• glycerol 85%
• titanium dioxide (E 171)
What Mapemid XL 1.5 mg tablets look like and
contents of the pack
White to almost white, round, biconvex
film-coated tablets.
They are available in blister packs containing
10, 14, 15, 20, 28, 30, 50, 60, 90, 100
prolonged-release tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
ratiopharm GmbH, Graf-Arco-Straße 3,
D-89079 Ulm, Germany.
Manufacturer:
Merckle GmbH, Ludwig-Merckle- Straße 3,
D-89143 Blaubeuren, Germany.
This medicinal product is authorised in the
Member States of the EEA under the following
names:
DK
Indapamid ratiopharm
AT
Indapamid-ratiopharm 1,5 mg
Retardtabletten
DE
Indapamid-ratiopharm 1,5mg
Retardtabletten
ES
Indapamida retard ratiopharm 1,5 mg
comprimidos de liberación prolongada
FR
INDAPAMIDE ISOMED LP 1,5 mg,
comprimé pelliculé à libération
prolongée
LU
Indapamid-ratiopharm 1,5mg
Retardtabletten
PL
Indapamid-ratiopharm SR
SK
Indapamid ratiopharm 1,5 mg
UK
Mapemid XL 1.5 mg tablets

For a large print, audio,
Braille or CD-rom version
of this patient information
leaflet, phone 02392 313592.
This leaflet was last approved in September
2009.

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Further information

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