Indapamide 1.5 mg Tablets

INDAPAMIDE 1.5 mg SR PD contains indapamide, one of a group of medicines called vasodilators. INDAPAMIDE 1.5 mg SR PD is prescribed by doctors to treat high blood pressure.

Do not take INDAPAMIDE 1.5 mg SR PD:

• if you are hypersensitive (allergic) to indapamide, other sulphonamide type medications (also called sulfa medications and used for the treatment of different infections), or any of the other ingredients of INDAPAMIDE 1.5 mg SR PD (see section 6)
• if you have severe liver disease or suffer from a condition called hepatic encephalopathy (degenerative disease of the brain)
• if you have severe kidney failure
• if you have low potassium levels in your blood.

Warnings and precautions

Special care should be taken with INDAPAMIDE 1.5 mg SR PD:

• if you are elderly, as you may be more sensitive to the electrolyte and blood pressure lowering effect of INDAPAMIDE 1.5 mg SR PD
• if you have kidney damage or are unable to urinate
• if you have diabetes, monitoring of blood glucose (blood sugar) is important in the presence of hypokalaemia
• if you suffer from gout, which may worsen due to increased levels of uric acid in the blood
• if you have any damage to your liver resulting in loss of liver function
• if you had a sympathectomy (operation to block a nerve in the middle of your body to treat conditions such as excessive sweating or severe facial flushing/blushing)
• if you have electrolyte imbalance due to dehydration. Your doctor may check for low sodium, magnesium or potassium levels or high calcium levels
• if you have an irregular heart rhythm condition
• if you are taking other diuretics while taking INDAPAMIDE 1.5 mg SR PD it may cause hypokalaemia, and is not recommended (see INTERACTIONS section 4.5)
• if your liver does not function properly, INDAPAMIDE 1.5 mg SR PD should not be taken
• if you have a photosensitivity reaction while taking INDAPAMIDE 1.5 mg SR PD. If you have to continue taking the medication, it is recommended to protect exposed areas to the sun or to artificial UVA
• if you have rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, you should not take this medicine
• if you are an athlete, you must be aware of the fact that this medicinal product contains an ingredient which may give a positive reaction in doping tests
• if you 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 weeks of taking INDAPAMIDE 1.5 mg SR PD.

Children and adolescents

Children: Safety and efficacy have not been established and INDAPAMIDE 1.5 mg SR PD is not recommended for use in children.

Do not share medicines prescribed for you with any other person. Always take INDAPAMIDE 1.5 mg SR PD exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults: The usual dose is one INDAPAMIDE 1.5 mg SR PD tablet every day, preferably taken on arising in the morning. The tablet should be swallowed whole with water and not chewed, preferably taken when waking in the morning. Your doctor will tell you how long your treatment with INDAPAMIDE 1.5 mg SR PD will last.

If you have the impression that the effect of INDAPAMIDE 1.5 mg SR PD is too strong or too weak, tell your doctor or pharmacist.

If you take more INDAPAMIDE 1.5 mg SR PD than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Symptoms of overdose may include: water/electrolyte disturbances, nausea, vomiting, low blood pressure, cramps, vertigo, drowsiness, confusion, increased urination, decreased urination polyuria or oliguria possibly to the point of anuria (when the kidneys aren't producing urine).

If you forget to take INDAPAMIDE 1.5 mg SR PD, take a dose as soon as you remember, then continue to take INDAPAMIDE 1.5 mg SR PD at the usual times. Do not take a double dose to make up for forgotten individual doses.

If you stop taking INDAPAMIDE 1.5 mg SR PD

The treatment for high blood pressure is usually life-long and you should discuss with your doctor before stopping this medicinal product.

INDAPAMIDE 1.5 mg SR PD can have side effects. Not all side effects reported for INDAPAMIDE 1.5 mg SR PD are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using INDAPAMIDE 1.5 mg SR PD, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop using INDAPAMIDE 1.5 mg SR PD and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to INDAPAMIDE 1.5 mg SR PD. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• difficulty breathing, shortness of breath, tight chest
• abnormal heart rhythm which can lead to sudden cardiac death
• reduced liver function with symptoms such as abdominal pain or swelling, jaundice, nausea and vomiting, diagnosed with hepatitis (viral infection of the liver) (viral infection of the liver, cholestatic jaundice (symptoms include yellow skin or eyes)
• toxic epidermic necrolysis and Stevens-Johnson syndrome (fever and flu-like symptoms a flat red rash followed by skin blisters and peeling, and blisters and sores on the mucous membranes)
• kidney failure, symptoms include loss of appetite and fatigue
• pancreatitis (inflammation of the pancreas with symptoms that include severe abdominal and back pain accompanied with feeling very unwell)
• disease of the brain caused by liver illness (Hepatic encephalopathy) with symptoms that may include confusion, fatigue, flapping hand tremor, sleepiness, bad breath from liver disease, irritability, memory loss, or slurred speech
• 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)
• rhabdomyolysis (a serious medical condition that can be fatal or result in permanent disability, symptoms include muscle cramps, aches, or pains that are more severe than expected, dark urine (tea- or cola-colored), feeling weak or tired, unable to complete job tasks or finish a workout routine).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent side effects:
• both flat and raised ‘bumps’ on the skin.
• Less frequent side effects:
• abnormal blood counts, anaemia, tendency to bleed easily, 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)
• headaches, dizziness especially when standing up from lying or sitting position), tiredness, ‘pins and needles’ feeling on the skin
• low blood pressure
• anorexia (eating disorder characterized by low body weight), stomach pain, gas and bloatedness, nausea, vomiting, constipation, diarrhoea, dry mouth
• discolouration of the skin produced by small bleeding vessels, urticaria or hives (a kind of skin rash with red, raised, itchy bumps)
• erectile dysfunction.

The following side effects have been reported but the frequency for them to occur is not known:

• electrolyte imbalance – sodium, potassium (symptoms such as tiredness and leg cramps), calcium
• short sightedness, blurred vision, vision loss
• possible worsening of pre-existing acute disseminated lupus erythematosus (collection of autoimmune diseases in which the immune system attacks healthy tissues), photosensitivity reactions (an extreme sensitivity to ultraviolet (UV) rays from the sun and other sources of light)
• abnormal electrocardiogram (showing the heartbeat pattern), blood tests showing increased glucose/sugar levels, uric acid and liver enzyme levels
• muscle weakness, spasms or pain.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children. Store at or below 30 °C in original container. Do not remove the blisters from the outer carton until required for use. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).