APRODIP 1.5 MG PROLONGED-RELEASE TABLETS - patient leaflet, side effects, dosage

Patient leaflet - APRODIP 1.5 MG PROLONGED-RELEASE TABLETS

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

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 (degenerative disease of the brain).
have low potassium levels in your blood.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking 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.
experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to a week of taking Aprodip tablets. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this.

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 or might take any other medicines. 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 such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotic drugs, neuroleptics)

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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 gastro-intestinal problems)
sparfloxacin, moxifloxacin, erythromycin by injection (antibiotics used to treat infections)
vincamine by injection (used to treat symptomatic cognitive disorders in elderly including memory loss)
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)
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)
amphotericin B by injection (anti-fungal medicines)
oral corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis
stimulant laxatives
baclofen (to treat muscle stiffness occuring in diseases such as multiple sclerosis)
allopurinol (for the treatment of gout)
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

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

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.

3. how to take aprodip

Always take Aprodip exactly as your doctor or pharmacist 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 glass of water. Do not crush or chew them

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), vomiting, 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.

Stop taking the medicinal product and see a doctor immediately, if you experience any of the following side effects:

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. (Very rare) (may affect up to 1 in 10,000 people)
Severe skin reactions including intense skin rash, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome) or other allergic reactions, (Very rare) (may affect up to 1 in 10,000 people)
Life-threatening irregular beat. (Not known)
Inflamed pancreas which may cause severe abdominal and back pain accompained with feeling very unwell (Very rare) (may affect up to 1 in 10,000 people)
Disese of the brain caused by liver illness (Hepatic encephalopathy) (Not known)
Inflammation of the liver (Hepatitis) (Not known)

In decreasing order of frequency, other side effects can include:

Common (may affect up to 1 in 10 people):

Red raised skin rash, Allergic reactions, mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions.

Uncommon (may affect up to 1 in 100 people): Vomiting, purpura (red pinpoints on skin)

Rare (may affect up to 1 in 1000 people)

– Feeling of tiredness, headache, pins and needles (paresthesia), spinning sensation and loss of balance
– Nausea (feeling sick), constipation, dry mouth

Very rare (may affect up to 1 in 10,000 people):

– 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)
– 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)
– High level of calcium in blood
– Abnormal liver function

Not Known:

– Fainting
– 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
– increased levels of liver enzymes
– Abnormal ECG heart tracing
– 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
– Short sightedness (myopia)
– Blurred vision
– Visual impairment
– Decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

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: or search for MHRA Yellow Card in the Google Play or Apple App Store. 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.

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

Unit C, Harcourt Way

Leicester

LE19 1WP

Manufacturer:

Morningside Pharmaceuticals Ltd

5 Pavilion Way