Indapamide 2.5mg tablets

Main information

  • Trade name:
  • Indapamide 2.5mg tablets
  • Dosage:
  • 2.5mg
  • Pharmaceutical form:
  • Tablet
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Indapamide 2.5mg tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 02020100; GTIN: 5012617018151

Status

  • Source:
  • eMC
  • Last update:
  • 29-01-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Co - pharma

Front & Back Printing. To be supplied in the unfolded size.

Record Number: 165813

60 GSM Paper.

Pack Insert

150 x 310 mm

1034892

1034642

INDAPAMIDE TABLETS 2.5 mg

Black

Printing clarity to be clear & sharp.

PACKAGE LEAFLET: INFORMATION FOR THE USER

INDAPAMIDE TABLETS 2.5 mg

[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 Indapamide Tablets are and what they are

used for

2. What you need to know before you take

Indapamide Tablets

3. How to take Indapamide Tablets

4. Possible side effects

5. How to store Indapamide Tablets

6. Contents of the pack and other information

1. What Indapamide Tablets are and what they

are used for

Indapamide Tablets contain the active substance

indapamide. Indapamide is a diuretic and is intended

to reduce high blood pressure (hypertension) in adults.

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.

In addition, indapamide widens blood vessels so

that blood passes through more easily. This helps to

lower blood pressure.

2. What you need to know before you take

Indapamide Tablets

Do not take Indapamide Tablets:

If you are allergic to indapamide or any other

sulfonamide or to 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

(hypokalaemia)

If you have high calcium levels in your blood

(hypercalcaemia)

If you have low sodium levels in your blood

(hyponatraemia)

If you have a rare inherited blood disease called

porphyria

If you have an illness called Addison’s disease.

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.

Warnings and precautions

Talk to your doctor or pharmacist before taking

Indapamide Tablets:

If you have liver or kidney problems

If you have diabetes

If you suffer from gout

If you have any heart rhythm problems

If you need to have a test to check how well your

parathyroid gland is working

If you are taking thiazides or thiazide related

diuretics as photosensitivity may occur.

Keep out of direct sunlight while taking this medicine

and for a few months after you have finished taking

it. This is because your skin will become much more

sensitive to the sun and may burn, tingle or severely

blister if you do not take the following precautions:

Make sure you use high factor sun cream

Always wear a hat and clothes which cover your

arms and legs.

Indapamide may lower potassium levels and your

doctor may monitor this by means of blood tests.

This may happen in patients receiving multiple

treatments or in the elderly, or in those suffering

from cirrhosis of the liver, with fluid retention,

or from prolonged or severe diarrhoea, or

hyperaldosteronism (over production of a hormone

that controls sodium and potassium levels in the

blood).

Blood calcium levels may need to be monitored

in those patients suffering from overactivity of the

parathyroid gland. Please inform your doctor or

pharmacist if you suffer from gout. Indapamide may

cause the blood uric acid levels to increase when

treatment is commenced.

Athletes should be aware that this medicine contains

an active ingredient, which may give a positive

reaction in doping tests.

Children and adolescents

Indapamide Tablets are not recommended for use in

children and adolescents.

Other medicines and Indapamide Tablets

Tell your doctor or pharmacist if you are taking,

have recently taken or might take any other

medicines, in particular any of the following:

Medicines used for heart rhythm problems

(e.g. quinidine, hydroquinidine, disopyramide,

flecainide, amiodarone, sotalol, ibutilide, dofetilide,

digitalis)

Medicines used to treat mental disorders such as

depression, anxiety, schizophrenia (e.g. tricyclic

antidepressants, antipsychotic drugs such as

pimozide, lithium, 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 gastro-intestinal

problems such as ulcers, too much acid,

overactive digestive system)

Sparfloxacin, moxifloxacin, erythromycin by

injection, clarithromycin (antibiotics used to treat

infections)

Vincamine by injection (used to treat symptomatic

cognitive disorders in the 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)

Oral corticosteroids used to treat various

conditions including severe asthma and

rheumatoid arthritis

Amphotericin B by injection (anti-fungal medicines)

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).

Indapamide Tablets with food and drink

Indapamide Tablets should be swallowed with a

glass of water. It is advised that the tablet be taken

in the morning before breakfast.

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.

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.

Breast-feeding is not advisable if you are taking this

medicine.

No effects on human fertility are anticipated.

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

7199

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150 x 310 mm

FRONT SIDE PRINTING

Co - pharma

Front & Back Printing. To be supplied in the unfolded size.

Record Number: 165813

60 GSM Paper.

Pack Insert

150 x 310 mm

1034892

1034642

INDAPAMIDE TABLETS 2.5 mg

Black

Printing clarity to be clear & sharp.

alertness. However, under good control, these side

effects are unlikely to occur.

Indapamide Tablets contain lactose and sucrose

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 Indapamide Tablets

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

which should be swallowed with a glass of water.

It is advised that the tablet be taken in the morning

before breakfast. Treatment for high blood pressure

is usually life-long.

Use in children and adolescents

Indapamide Tablets are not recommended for use

in children and adolescents.

Use in the elderly

Only treat elderly patients who have normal kidney

function or slightly impaired function.

If you take more Indapamide Tablets than you

should

If you have taken too many tablets, contact your

doctor or nearest hospital casualty department

immediately.

A very large dose of indapamide 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 Indapamide Tablets

If you forget to take one or more doses, take

another as soon as you remember and then go on

as prescribed.

Do not take a double dose to make up for a

forgotten dose.

If you stop taking Indapamide Tablets

As the treatment for high blood pressure is usually

life-long, you should discuss with your doctor before

stopping 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 then

STOP taking the medicine and contact a doctor

immediately:

Angioedema and/or urticaria. Angioedema is

characterised by swelling of the skin of

extremities or face, swelling of the lips or

tongue, swelling of the mucous membranes of

the throat or airways resulting in shortness

of breath or difficulty of swallowing. If this

occurs, contact your doctor immediately.

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.

Life-threatening irregular heart beat

Inflamed pancreas which may cause severe

abdominal and back pain accompanied with

feeling very unwell

Disease of the brain caused by liver illness

(hepatic encephalopathy)

Inflammation of the liver (hepatitis).

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, such

as skin rashes in subjects with a predisposition

to allergic and asthmatic reactions.

Uncommon (may affect up to 1 in 100 people)

Vomiting

Red pinpoints on skin (purpura).

Rare (may affect up to 1 in 1,000 people)

Feeling of tiredness, headache, pins and needles

(paraesthesia), vertigo

Gastrointestinal disorders such as nausea

(feeling sick) or constipation, dry mouth.

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

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)

High level 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)

Abnormal hepatic function.

Not known (frequency cannot be estimated from

the available data)

Fainting

If you suffer from systemic lupus erythematosus

(a type of collagen disease), 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

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

Muscle cramps

Weakness (asthenia)

Impotence

Weight loss.

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 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 Indapamide Tablets

Keep this medicine out of the sight and reach of

children.

Do not store above 25°C. Store in the original

package.

If your doctor decides to stop the treatment, return

any tablets left over to the pharmacist. Only keep

them if your doctor tells you to.

Do not use this medicine after the expiry date which

is stated on the label. The expiry date refers to the

last day of that month.

Do not use this medicine if you notice visible signs

of deterioration.

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 Indapamide Tablets contain

The active substance is indapamide.

Each tablet contains 2.5mg indapamide.

The other ingredients are: lactose (see section 2),

maize starch, polyvidone, magnesium stearate,

Opaseal (containing polyvinylacetate phthalate,

ethyl acetate and stearic acid), purified talc, calcium

carbonate, acacia, titanium dioxide (E171), sucrose

(see section 2), Opaglos 6000P (containing shellac,

carnauba wax yellow and beeswax white).

What Indapamide Tablets look like and contents

of the pack

Description:

White, biconvex, sugar coated tablet.

Contents of pack:

Indapamide Tablets are supplied in pack sizes of

28, 30, 50, 56, 60, 100 and 120 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and

Manufacturer

Co-Pharma

Unit 4, Metro Centre, Tolpits Lane,

Watford, Herts. UK, WD18 9SS

Tel: 01923 255580

Fax: 01923 255581

This leaflet was last revised in March 2018.

150 x 310 mm

BACK SIDE PRINTING

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