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APRODIP 1.5 MG PROLONGED RELEASE TABLETS

Active substance(s): INDAPAMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Aprodip

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 Aprodip is and what it is used for
2. What you need to know before you take Aprodip
3. How to take Aprodip
4. Possible side effects
5. How to store Aprodip
6. Contents of the pack and other information
1. What Aprodip is and what it is used for
This medicine is intended to reduce high blood pressure
(hypertension).
It is a prolonged-release film-coated tablet containing
indapamide as the active ingredient.
Indapamide is a diuretic. Most diuretics incease 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 Aprodip

• 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 aid,
• 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 occuring indiseases
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).
Aprodip with food and drink
The tablets can be taken with or without food.
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.

Do not take Aprodip if you:
• are allergic to indapamide or any other sulphonamide or
to any of the other ingredients of Aprodip Tablets.
• have severe kidney disease.
• have severe liver disease or suffer from a condition
called hepatic encephalopathy (liver problems which
affect the brain and central nervous system).
• have low potassium levels in your blood.

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 efects 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. However, under good control,
these side effects are unlikley to occur.

Warnings and precautions

Important information about some of the ingredients
of Aprodip 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
medicinal product.

Take special care with Aprodip Tablets if you:
• have liver problems
• have diabetes
• suffer from gout
• have any heart rhythm problems or problems with your
kidneys
• 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.
Other medicines and Aprodip
Please tell your doctor or pharmacist if you are taking or
have recently taken other medicines, including medicines
obtained without prescription.
You should not take this medicine with lithium (used to
treat depression) due to the risk of increased levels of
lithium in the blood.
Make sure you 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 wich as
depression, anxiety, schizophrenia (e.g. tricyclic
antidepressants, antipsychotic drugs, neuroleptics),
• bepridil (used to treat angina pectoris, a condition
causing chest pain),
• diphemanil (used to treat gastric problems such as
ulcers, too much acid, overactive digestive system),
• sparfloxacin, moxifloxacin (antibiotics used to treat
infections),
• halofantrine (antiparasitic drug used to treat certain
types of malaria)
• pentamidine (used to treat certain types of pneumonia),

3. How to take Aprodip
Always take Aprodip exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
not sure.
Taking this medicine
• Keep taking this medicine until your doctor tells you to
stop. It may take several months before this medicine
shows its full effect.
• Tablets can be taken with or without food
• Swallow the tablets whole with a drink of water
Adults and Elderly
The usual dose is one tablet, once a day, taken in the
morning.
If you take more Aprodip than you should
If you have taken too many tablets, contact your doctor
or pharmacist immediately. A very large dose of Aprodip
Tablets could cause nausea (feeling sick) vomitting,
low blood pressure, cramps, dizziness, drowsiness,
confusion and changes in the amount of urine produced by
the kidneys.
If you forget to take Aprodip
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 the forgotten dose.
If you stop taking Aprodip
As the treatment for high blood pressure is usually life-long,
you should discuss with your doctor before stopping this
medicinal product.
If you have any further questions on the use of this
product, ask the doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Common (less than 1 patient in 10, but more than 1 in 100):
Low potassium in the blood which may cause muscle
weakness.
Uncommon (less than 1 patient in 100 but more than 1 in
1000):
Vomitting, allergic reactions, mainly dermatological,
such as skin rashes, purpura (red pinpoints on skin)
in subjects with a predisposition to allergic asthmatic
reactions.
Rare (less than 1 patient in 1000 but more than 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 rare (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 possibility of getting
hepatic encephalopathy (liver problems which affect the
brain and central nervous system),
- Changes in blood cells, such as thrombocytopenia
(degrease 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 (degrease 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 swallowing. If this
occurs, contact your doctor immediately.

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. Contents of the pack and other information
What Aprodip contains
- The active substance is Indapamide
- The other ingredients are:
- 
Tablet core: lactose monohydrate, maize starch,
hypromellose, colloidal anhydrous silica, magnesium
stearate.
- 
Film-coating: hypromellose, macrogol 6000, titanium
dioxide (E171).
What Aprodip looks like and contents of the pack
Aprodip 1.5 mg prolonged-release tablets are white to
off-white, round-shaped, biconvex film-coated tablets.
Aprodip 1.5 mg prolonged-release tablets are available in
PVC/Aluminium blisters of 10, 14, 15, 20, 30, 50, 60, 90,
100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Morningside Healthcare Ltd
115 Narbrough Road
Leicester
LE3 0PA
UK
Manufacturer:
Morningside Pharmaceuticals Ltd
5 Pavilion Way
Loughborough
LE11 5GW
UK
This leaflet was last revised in January 2016.

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, tiredness, loss of appetite, weight gain and
joint pain), this might get worse. Cases of photosensitivity
reactions (change in skin appearance) after exposure to
the sun or artificial UVA have also been reported.
Not Known (frequency cannot be extimated from the
available data):
- Changes may occur in your blood and your doctor may
need to give you blood tests to check your condition.
The following changes in your blood test results may
occur:
- low potassium 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 joint(s) especially in the feet),
- Increase in blood glucose levels in diabetic patients,
- Increase of calcium in blood,
- increased levels of liver enzymes,
- Abnormal ECG heart tracing.
- Life-threatening irregular beat (Torsade de Pointes)
- Hepatitis
- Fainting
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. 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 Aprodip
Keep this medicine out of the sight and reach of children.
Do not use Aprodip Tablets after the expiry date which is
stated on the carton and blister. The expiry date refers to
the last day of that month.
This medicinal product does not require any special
storage conditions.

M0221LAMUKNA-001

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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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