Package leaflet: Information for the patient

Timolol/Amiloride/Hydrochlorothiazide 10 mg/2.5 mg/25 mg Tablets

Timolol maleate/Amiloride hydrochloride/Hydrochlorothiazide

Read all of this leaflet carefully before you start using 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 any of the 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 Timolol/Amiloride/Hydrochlorothiazide Tablets is and what it is used for

2.    What you need to know before you take Timolol/Amiloride/Hydrochlorothiazide Tablets

3.    How to take Timolol/Amiloride/Hydrochlorothiazide Tablets

4.    Possible side effects

5.    How to store Timolol/Amiloride/Hydrochlorothiazide Tablets

6.    Contents of the pack and other information

1. What Timolol/Amiloride/Hydrochlorothiazide Tablets is and what it is used for

These tablets contain three active ingredients: timolol, amiloride and hydrochlorothiazide.

•    Timolol is a beta-blocker to help lower your blood pressure.

•    Amiloride is a potassium-sparing diuretic that acts by increasing the amount of urine you produce.

•    Hydrochlorothiazide is a thiazide diuretic that acts by increasing the amount of urine you produce.

2. What you need to know before you take Timolol/Amiloride/Hydrochlorothiazide Tablets

Do NOT take these tablets if you:

•    are allergic to timolol, amiloride, hydrochlorothiazide, or any of the other ingredients (see section 6)

•    are allergic to sulphonamides with include co-trimoxazole (an antibiotic) and acetazolamide (for glaucoma, heart problems, epilepsy)

•    are pregnant or planning to become pregnant

•    are breast-feeding

•    have high levels of potassium in your blood

•    are taking potassium supplements or have a potassium rich diet without blood monitoring

•    are taking a potassium-sparing diuretic, e.g. spironolactone, triamterene

•    have or have ever had asthma, wheezing, or another lung disease, such as bronchitis or emphysema

•    have a heart problem such as heart failure, heart block or a slow heart rate

•    have worsening kidney problems which means that your kidneys do not work properly, and you are unable to pass urine

•    are diabetic and are not carefully monitored.

If any of the above applies to you, speak to your doctor or pharmacist.

Warnings and precautions

Before talking the tablets, check if any of the following apply to you as additional monitoring may be needed. Tell your doctor if you have or have ever had:

•    severe allergic reaction (anaphylactic shock)

•    severe allergic reactions to some allergens, for example to insect stings or animal fur, as the usual dose adrenaline may not work

•    eczema, urticaria (nettle rash) or hay fever

•    any heart problems, such as heart failure, slow heart rate or a stroke

•    reduced blood flow to the brain (which may occur following an accident)

•    a liver or kidney problem

•    a condition known as systemic lupus erythematosus (SLE)

•    gout

•    diabetes. The symptoms of low blood sugar, such as an increase in heartbeat, may be masked by these tablets. You may also need to adjust the dose of your insulin or diabetic medicine

•    spontaneous hypoglycaemia, where your blood sugar levels can sometimes drop without any apparent reason

•    an overactive thyroid. The symptoms may be masked by this medicine

•    high levels of cholesterol/triglycerides in your blood

•    an imbalance of fluid or electrolytes as a result of serious illness

•    fluids given to you by a tube inserted into one of your veins

•    muscle weakness caused by conditions such as myasthenia gravis

•    surgery on a nerve to improve the blood supply to a limb or relieve chronic pain. This operation is called a sympathectomy

•    or are having heart surgery. These tablets will need to be stopped gradually by your doctor. Other medicines and Timolol/Amiloride/Hydrochlorothiazide Tablets

Tell your doctor or pharmacist if you are taking, recently taken or might take any other medicines.

Some medicines may be affected by these tablets or they may affect how well these tablets will work. Additional monitoring may be required, especially in elderly patients. Tell your doctor or pharmacist if you are taking:

•    non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. aspirin, ibuprofen)

•    other medicines used to treat high blood pressure (e.g. captopril, losartan, verapamil, diltiazem, nifedipine, clonidine)

•    medicine to treat abnormal heart beats (e.g. quinidine)

•    heart medicines (e.g. digitalis)

•    medicines which suppress the immune system (e.g. tacrolimus, ciclosporin)

•    barbiturates to help you sleep or to reduce anxiety

•    medicines for diabetes, including insulin, which may need adjusting

•    medicines to treat high cholesterol (e.g. cholestyramine, colestipol resins)

•    steroids to treat various conditions such as rheumatism, arthritis, asthma

•    adrenaline to treat serious allergic reactions

•    a muscle relaxant, such as tubocurarine

•    lithium, used to treat mood swings and some types of depression

•    medicines containing alcohol (see Section 3 for symptoms of use with alcohol).

If you go into hospital or to the dentist to have an operation, tell the anaesthetist or medical staff that you are taking this medicine.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you are pregnant or if you think that you are. Usually, your doctor will advise you to take another medicine instead of Timolol/Amiloride/Hydrochlorothiazide Tablets, as this medicine is not recommended during pregnancy. This is because,

Timolol/Amiloride/Hydrochlorothiazide Tablets crosses the placenta and its use after the third month of pregnancy may cause potentially harmful foetal and neonatal effects.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding.

Timolol/Amiloride/Hydrochlorothiazide Tablets is not recommended for mothers who are breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

This medicine is unlikely to affect your ability to operate machinery or to drive.

3. How to take Timolol/Amiloride/Hydrochlorothiazide Tablets

Always take these tablets exactly as your doctor has told you and always read the label. Your doctor will decide on the appropriate dose to suit your condition. Ask your doctor or pharmacist if you are not sure.

•    Swallow the tablets with a drink of water

•    Avoid alcohol while taking this medicine, if it makes you feel dizzy or light-headed when you stand up quickly.

Doses

Adults and the elderly: the usual dose is 1 or 2 tablets once a day. The usual starting dose for the elderly is 1 tablet daily.

Children: this medicine is NOT suitable for children.

Foods to avoid

Your doctor may tell you to change your diet slightly, to avoid eating foods which contain a lot of potassium. These foods include milk, bananas, raisins, prunes. Your doctor will tell you which food to avoid.

Tests/Operations

While you are taking this medicine your doctor may need to carry out simple blood tests:

•    To monitor the level of salts and a chemical called urea in your body

•    To check the levels of certain naturally-occurring chemicals in your blood.

If you are going to have a blood test tell the doctor/nurse you are taking these tablets as it can affect the results of some diagnostic tests e.g. thyroid hormone levels.

Tell your doctor or nurse if you are to be given ACTH to test if your adrenal glands are working properly.

If you are having an operation, make sure your doctor or the dentist treating you knows that you are or have been taking these tablets.

If you take more Timolol/Amiloride/Hydrochlorothiazide Tablets than you should

1.    Tell your doctor, pharmacist or nearest hospital casualty department immediately.

2.    Take the pack and any remaining tablets with you so that people can see what you have taken.

3.    Do this even if you feel well.

If you forget to take Timolol/Amiloride/Hydrochlorothiazide Tablets

If you forget to take a dose, take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as usual

Do not take a double dose to make up for a missed dose.

If you stop taking Timolol/Amiloride/Hydrochlorothiazide Tablets

Do NOT stop taking these tablets suddenly, as this could make your blood pressure worse. If you need to stop your treatment your doctor will tell you how to stop the medicine gradually.

Do not let yourself run out of medicine, especially over the weekend or on holidays.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

. Possible side effects

Like all medicines, Timolol/Amiloride/Hydrochlorothiazide can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them.

STOP taking the tablets and seek medical help immediately if you have any of the following allergic reactions:

•    difficulty breathing or swallowing, swelling of the face, lips, tongue or throat

•    severe itching of the skin, with a red rash or raised lumps

•    blistering of the mouth, eyes, and genital region, and patchy areas of rash, peeling skin.

The following side effects have been reported with these tablets.

Tell your doctor if you get any of the following:

Common side effects:

•    dizziness

•    tiredness or weakness, lack of body strength

•    slow heartbeat.

Other side effects:

•    headache

•    cold feeling in the fingers or toes

•    light-headedness due to low blow pressure

•    chest pains (angina) or disturbance in the rate or rhythm of the heartbeat

•    difficulty in breathing, wheezing

•    feeling or being sick

•    indigestion, loss of appetite

•    constipation, diarrhoea, stomach pains

•    thirst, dry or sore mouth

•    difficulty in getting an erection

•    loss of balance, often accompanied by nausea, vomiting, light headedness, dizziness

•    skin sensations, such as burning, prickling, itching, or tingling

•    shaking

•    sweating

•    muscle cramps

•    disturbed sleep patterns including abnormal dreams and inability to sleep

•    nervousness, depression, drowsiness

•    visual disturbances.

The following side effects have been reported with the individual active ingredients timolol, amiloride and hydrochlorothiazide, so they may also occur with the use of these tablets.

Timolol-related side effects:

•    chest pain, pain in fingers and toes, decreasing exercise tolerance, weight loss

•    heart attack or stroke (fallen face, droopy mouth or eye, inability to smile, slurred speech, inability to raise and hold up arms)

•    palpitations, signs of heart failure (unusual tiredness, breathing difficulties, swollen ankles and legs)

•    Raynaud’s phenomenon, a condition where fingers and/or feet lose their colour and turn blue, and can produce pins and needles, numbness and pain

•    diarrhoea, abnormal enlargement of the liver

•    changes in blood sugar levels

•    rash, intense itching, skin irritation, increased pigmentation (skin becomes darker)

•    flushing of the skin

•    severe joint pain or weakness

•    inability to concentrate, hallucinations

•    decreased sex drive

•    unusual purple bruising due to low levels of some blood cells

•    bronchitis, abnormal breathing sounds, cough

•    ringing in the ears, visual disturbances and double vision, drooping upper eyelid, eye irritation or dry eyes

•    difficulty in passing urine

•    this ingredient may also affect some laboratory tests. It is important you tell the doctor or nurse you are taking these tablets if you are having any tests.

Amiloride-related side effects:

•    weakness, back and chest pain, neck/shoulder ache, pain in fingers or toes, joint pain

•    abnormal liver function, yellowing of the skin or eyes

•    peptic ulcer, stomach cramps, intestinal bleeding, excessive wind

•    hair loss

•    rash or severe itching

•    low levels of some blood cells or abnormal levels of sodium and/or potassium in the blood detected by blood tests

•    palpitations

•    dizziness, blurred vision, especially when standing up from a sitting or lying position

•    decreased sex drive

•    mental confusion and disorders affecting the brain

•    cough, nasal congestion

•    ringing in the ears

•    increase in the pressure in the eye (picked up in eye examinations)

•    joint pain

•    difficulty in passing urine

•    change in amount of urine passed (increased or decreased)

•    contractions of the bladder which can cause urine to be passed more often.

Hydrochlorothiazide-related side effects:

•    violent allergic reactions (anaphylactic reaction)

•    fever

•    inflammation of blood vessels leading to tissue death

•    yellowing of the skin and/or whites of the eyes

•    pain behind the ribs radiating towards the back, often worse when lying down, nausea, vomiting, fever. This may be due to inflammation of your pancreas

•    stomach cramps or indigestion, inflammation of one or more of the salivary glands

•    increased sensitivity of your skin to sunlight, rash and/or itching or raised bumps of the skin, peeling, redness, loosening and blistering of the skin

•    kidney changes, with symptoms such as fever, rash, nausea, aches and pains, passing more or less urine than usual or passing urine at night

•    abnormal amounts of glucose/uric acid (gout) in urine and blood. Blood and urine may be tested

•    altered levels of blood chemicals (electrolytes)

•    restlessness

•    difficulty in breathing including fluid accumulation in the lung

•    blurred vision or objects appearing yellow (xanthopsia)

•    fever, sore throat, mouth ulcers, repeated infections or infections that will not go away

•    changes in red or white blood cell count (seen during blood tests)

•    any unusual bruising or bleeding, for example nose-bleeds, pinpoint red spots on the skin, unusual purple bruise like rash on the skin or in the mouth.

If any of the side effects get troublesome, 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 Timolol/Amiloride/Hydrochlorothiazide Tablets

•    Keep out of the reach and sight of children.

•    Do not take after the expiry date which is stated on the blister/carton/label. The expiry date refers to the last day of that month.

•    Store below 25 ^oC. Store in the original package.

•    Do not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.

6. Contents of the pack and other information

What Timolol/Amiloride/Hydrochlorothiazide 10 mg/2.5 mg/25 mg Tablets contain

•    The active ingredients in each tablet are timolol maleate (10 mg), amiloride hydrochloride (equivalent to anhydrous amiloride hydrochloride 2.5 mg) and hydrochlorothiazide (25 mg).

•    The other ingredients are:

Indigo carmine, magnesium stearate, microcrystalline cellulose, pre-gelatinised maize starch.

What Timolol/Amiloride/Hydrochlorothiazide 10 mg/2.5 mg/25 mg Tablets look like and contents of the pack

These tablets are light-blue square tablets scored on one side and marked ‘17’ on the other side. They are available in blister packs of 28 or bottles of 100. Not all packs may be marketed. Marketing Authorisation Holder

Essential Generics, 7 Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB, United Kingdom.

Manufacturer:

Dales Pharmaceuticals Ltd, Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire BD23 2RW.

This leaflet was last revised in November 2013.

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