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ALKAPAMID XL 1.5 MG PROLONGED-RELEASE TABLETS

Active substance(s): INDAPAMIDE

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Package leaflet: Information for the user

Alkapamid XL 1.5 mg prolonged-release tablets
indapamide

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
- 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 only. Do not pass it
on to others. It may harm them, even if their signs of illness
are the same as yours.
- 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.
What is in this leaflet
1. What ALKAPAMID XL is and what it is used for
2. What you need to know before you take ALKAPAMID XL
3. How to take ALKAPAMID XL
4. Possible side effects
5. How to store ALKAPAMID XL
6. Contents of the pack and other information

1. What ALKAPAMID XL 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. However, indapamide is different
from other diuretics, as it only causes a slight increase in the
amount of urine produced.

2. What you need to know before you take
ALKAPAMID XL
Do not take ALKAPAMID XL:
- if you are allergic to indapamide, any other sulphonamide or any
of the other ingredients of this medicine (listed in section 6),
- 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking ALKAPAMID XL
- 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 (if your skin has been too sensitive to light).
Your doctor may need to do you blood tests to check for low
sodium or potassium levels or high calcium levels.
If you are elderly, please tell your doctor if you have had any
problems with your kidneys.
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.

- 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, intravenous erythromycin
(antibiotics used to treat infections),
- halofantrine (antiparasitic drug 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),
- intravenous vincamine (used to treat circulatory problems in
the brain),
- 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),
- intravenous amphotericin B (used to treat severe fungal
disease),
- 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 suppress the
immune system after organ transplantation, to treat
autoimmune diseases, or severe rheumatic or dermatological
diseases,
- tetracosactide (to treat Crohn’s disease).
Children and adolescents
Indapamide is not recommended for use in children and
adolescents due to a lack of data on safety and efficacy.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.
Pregnancy
This medicine is not recommended to be taken during pregnancy.
Please tell your doctor if you are pregnant or planning to have a
baby. Your doctor will switch you to an alternative treatment as
soon as possible.
Breast-feeding
The active ingredient is excreted in milk. Breast-feeding 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 at the beginning of the
treatment and after increasing the dose. If you feel dizzy or tired,
do not drive or do not do any other activities requiring alertness.
However, under good control, these side effects are unlikely to
occur.

Athletes should be aware that this medicine contains an active
ingredient, which may result in a positive doping test.

ALKAPAMID XL contains lactose
If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicine.

Other medicines and ALKAPAMID XL
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.

3. How to take ALKAPAMID XL

You should not take ALKAPAMID XL with lithium (used to treat
depression) due to the risk of increased levels of lithium in the blood.
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),

Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
sure.
The recommended dose is one tablet each day, preferably in the
morning. The tablets can be taken with or without food. Swallow
the tablets whole with water. Do not crush or chew them.
Treatment for high blood pressure is usually life-long.
Elderly patients
If you are elderly, please tell your doctor if you have had any
problems with your kidneys. You can be treated with indapamide
only if your kidneys work normally or if
you have only minimal kidney problems.

If you take more ALKAPAMID XL than you should If you have
taken too many tablets, contact your doctor immediately.
A very large dose of ALKAPAMID XL could cause nausea (feeling
sick), vomiting, low blood pressure, cramps, dizziness,
drowsiness, confusion and changes in the amount of urine
produced by the kidneys.
If you forget to take ALKAPAMID XL
If you forget to take a dose of your medicine, 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 ALKAPAMID XL
As the treatment for high blood pressure is usually life-long, you
should discuss with your doctor before stopping to take this
medicine.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
If you experience any of the following side effects, contact your
doctor immediately:
Very rare (may affect up to 1 in 10,000 people):
- Angioedema (serious allergic reaction), which 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.
Other possible side effects with ALKAPAMID XL:
Common (may affect up to 1 in 10 patients):
- Allergic reaction (especially in people who tend to have allergic
or asthmatic reactions) leading to skin rashes with macules
and papules;
- Low potassium in blood, which may cause muscle weaknesses.
Uncommon (may affect up to 1 in 100 people):
- Vomiting;
- Allergic reactions (especially in people who tend to have allergic
or asthmatic reactions) leading to red pinpoints on skin (purpura).
Rare (may affect up to 1 in 1,000 people):
- Feeling of tiredness, dizziness, headache, pins and needles
(paresthesia);
- Nausea (feeling sick), constipation, dry mouth;
- Increased risk of dehydration in the elderly and patients
suffering from heart failure.
Very rare (may affect up to 1 in 10,000 people):
- Increase of calcium in blood;
- 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);
- Liver problems (detected by blood tests);
- 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 of 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);
- Allergic skin reactions, especially in people who tend to have
allergic or asthmatic reactions (angioedema and/or hives,
severe skin manifestations).
Not known (frequency cannot be estimated from the available data)
- Changes may occur in your blood and your doctor may need to
do you blood tests to check your condition. The following
changes in your blood test results may occur:
- 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 joint(s) especially in the feet),
- increase in blood glucose levels in diabetic patients,
- low levels of chloride in the blood, which may lead to
metabolic alkaloisis (low acidity of the blood),
- increased levels of liver enzymes;
- If you suffer from systemic lupus erythematosus (a disorder of

-

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the immune system leading to inflammation and damage to
the joints, tendons and organs with symptoms including skin
rashes, tiredness, loss of appetite, weight gain and joint pain),
taking this medicine may worsen the disease;
Cases of photosensitivity reactions (change in skin
appearance) after exposure to the sun or artificial UVA have
also been reported;
If you have existing liver problems, taking indapamide may
cause a condition called hepatic encephalopathy (damage to
the brain and nerves which can occur as a complication of liver
disease);
Abnormal ECG heart tracing;
Life-threatening irregular beat (Torsade de Pointes);
Hepatitis;
Fainting.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/ yellowcard. By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store ALKAPAMID XL
Keep this medicine out of the sight and reach of children. Do not
use this medicine after the expiry date which is stated on the
carton and blister after “EXP”. The expiry date refers to the last
day of that month.
This medicinal product does not require any special temperature
storage conditions.
Store in the original package in order to protect from light. Do not
throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer
use. These measures will help protect the environment.

6. Contents of the pack and other information
What ALKAPAMID XL contains
- The active substance is indapamide. Each prolonged-release
tablet contains 1.5 mg of indapamide.
- The other ingredients are:
Tablet core: lactose monohydrate; hydroxyethylcellulose (low
viscosity grade); hydroxyethylcellulose (high viscosity grade);
silica, colloidal anhydrous; magnesium stearate.
Film coating: hydroxypropylcellulose; titanium dioxide (E171).
What ALKAPAMID XL looks like and contents of the pack
This medicine is a round, biconvex, white to almost white
film-coated tablet.
The tablets are blister-packed in hard transparent PVC/
PVDC/Aluminium foil or in alternative hard nontransparent
Aluminium/Aluminium foil. Each blister contains 10 tablets. The
lithographed cardboard box contains 3 blisters (30 tablets) or 9
blisters (90 tablets) or 10 blisters (100 tablets) and a leaflet inside.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
ALKALOID-INT d.o.o.,
Šlandrova ulica 4, 1231 Ljubljana – Črnuče, Slovenia
tel.: +386 1 300 42 90; fax: +386 1 300 42 91
e-mail: info@alkaloid.si
This medicinal product is authorised in the Member States
of the EEA under the following names:
UK:

ALKAPAMID XL 1.5 mg prolonged-release tablets

Bulgaria:

INDAPAMIDE SR Alkaloid-INT 1.5 mg
prolonged-release tablets

Croatia:

TOND SR 1,5 mg tablete s produljenim
oslobađanjem

Germany:

INDAPAMID SR Alkaloid-INT 1,5 mg Retardtabletten

Poland:

Indapamide SR Mercapharm

Romania:

Indapamidă Alkaloid-INT 1,5 mg comprimate cu
eliberare prelungită

Slovak Republic: INDAPAMID SR Alkaloid-INT 1,5 mg
Slovenia:

TOND SR 1,5 mg tablete s podaljšanim
sproščanjem

PL 34088/0041
Distributed by
HBS Healthcare, Moor Park Avenue, Preston PR1 6AS UK 
This leaflet was last revised in 01/2016.

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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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