Patient Information Leaflet    GB727-1588LF-AM01

Pindolol/Clopamide 10mg/5mg Tablets

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AMDIPHARM

Read all of this leaflet carefully before you start taking this medicine.

Please 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. Do not pass it on to others.

It may harm them, even if their symptoms are the same as yours. - If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of medicine is Pindolol/Clopamide 10mg/5mg Tablets. It will be referred to as Pindolol/Clopamide Tablets for ease of use hereafter.

In this leaflet:

1.    What Pindolol/Clopamide Tablets are and what they are used for

2.    Before you take Pindolol/Clopamide Tablets

3.    How to take Pindolol/Clopamide Tablets

4.    Possible side effects

5.    How to store Pindolol/Clopamide Tablets

6.    Further information

1.    WHAT PINDOLOL/CLOPAMIDE TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Pindolol/Clopamide Tablets. Pindolol/Clopamide Tablets contains the active ingredient pindolol and clopamide.

Pindolol belongs to a group of medicines called beta-blockers and clopamide belongs to a group of medicines called diuretics (water tablets). Pindolol/Clopamide Tablets is used to treat moderately high blood pressure (hypertension).

2.    BEFORE YOU TAKE PINDOLOL/CLOPAMIDE TABLETS Do not take Pindolol/Clopamide Tablets if you:

•    are allergic to pindolol or clopamide or any of the other ingredients of Pindolol/Clopamide Tablets (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing);

•    have a history of asthma or wheezing attacks;

•    have any heart problems (e.g. heart failure, heart disease);

•    have an untreated tumour of the adrenal gland (phaeochromocytoma);

•    have any heart rhythm disorders (sick-sinus syndrome);

•    have a very low pulse rate (less than 50 beats per minute);

•    have Prinzmetal's angina (a specific type of chest pain);

•    have high levels of acid in your blood (metabolic acidosis);

•    have low levels of sodium or potassium in your blood;

•    have high levels of calcium in your blood;

•    have Addison's disease (a hormone deficiency which affects the adrenal glands);

•    have severe kidney or liver problems;

•    have symptomatic hyperuricaemia (a condition where there is an elevated level of uric acid in the blood stream);

•    are taking a medicine which belongs to a group of medicines called calcium channel blockers (e.g. verapamil).

Pindolol/Clopamide Tablets are not recommended for use in children.

Take special care with Pindolol/Clopamide Tablets if you:

•    have heart disease;

•    have recently had a heart attack;

•    have a history of lung problems (e.g. chronic obstructive pulmonary disease);

•    are diabetic and taking insulin or any other anti-diabetic drugs;

•    have ever had a serious allergic reaction (e.g. abnormal sensitivity to insect bites or stings, severe eczema, hayfever);

•    have gout (a condition which causes pain, swelling and inflammation of one or more joints).

If you are going to have a general anaesthetic, you should tell the doctor or dentist in charge that you are taking Pindolol/Clopamide Tablets, as your treatment might need to be stopped a few days before the surgery.

If any of the above applies to you, or if you are not sure, please tell your doctor before taking Pindolol/Clopamide Tablets.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

This is especially important if you are taking:

•    any calcium channel blockers (used to treat high blood pressure and angina) (e.g. verapamil, nifedipine);

•    any barbiturates (e.g. phenobarbitone);

•    any other medicines for high blood pressure (hypertension);

•    a medicine which belong to a group of medicines called sympathomimetics (e.g. phenylephrine);

or if you are taking any medicines for:

•    problems such as depression or mental illness (lithium, monoamine oxidase inhibitors (MAOIs), tri-cyclic antidepressants, phenothiazides);

•    heart failure (e.g. digoxin);

•    an irregular heart beat (e.g. Iidocaine, amiodarone, disopyramide);

•    diabetes (e.g. insulin or other sugar lowering anti-diabetic medicines);

•    stomach ulcers (e.g. cimetidine);

•    relief of pain (e.g. aspirin, ibuprofen, naproxen or other medicines known as non steroidal antiinflammatory drugs).

Taking Pindolol/Clopamide Tablets with food and drink

It is advisable not to drink alcohol whilst taking Pindolol/Clopamide Tablets as it may increase the effect of your medicine.

Pregnancy and breast feeding

Do not take Pindolol/Clopamide Tablets if you are pregnant, think you may be pregnant or are planning to become pregnant or if you are breast-feeding.

Driving and using machines

You can drive while being treated with Pindolol/Clopamide Tablets but do not drive until you know how it affects you. It may make you feel dizzy, if it affects you in this way, do not drive or operate any machinery.

Important information about some of the ingredients of Pindolol/Clopamide Tablets

Tell your doctor before taking this medicine if you have been told that you have an intolerance to some sugars. This is because Pindolol/Clopamide Tablets contain lactose, a type of sugar.

3.    HOW TO TAKE PINDOLOL/CLOPAMIDE TABLETS

Always take Pindolol/Clopamide Tablets exactly as your doctor has instructed you. You should check with your pharmacist or doctor if you are unsure.

The usual dose is:

One tablet daily taken in the morning.

No more than three tablets should be taken in one day.

Swallow the tablet whole with a glass of water. Do not chew the tablet. If you take more Pindolol/Clopamide Tablets than you should

If you take more Pindolol/Clopamide Tablets than you should, contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you.

If you forget to take Pindolol/Clopamide Tablets

If you forget to take a dose, just take the next dose at the usual time. DO NOT take a double dose.

If you stop taking Pindolol/Clopamide Tablets

Ask your doctor before stopping treatment with Pindolol/Clopamide Tablets, as treatment should be reduced gradually over several days and you must be monitored carefully by your doctor.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Pindolol/Clopamide Tablets can cause side effects, although not everybody gets them.

If you notice:

•    Itching or skin rashes;

•    Difficulty in breathing or wheeziness.

Stop taking the medicine and seek medical advice immediately. These may be signs of an allergic reaction.

Other side effects may include:

•    tiredness

•    dizziness

•    headache

•    confusion

•    mood changes

•    depression

•    heart failure

•    low blood pressure

•    cold, blue hands and feet (Raynaud's phenomenon)

•    pins and needles, numbness or tingling of hands and feet

•    worsening of existing pain in legs (intermittent claudication)

•    feeling sick or being sick

•    worsening of any existing lung problems such as asthma

•    impotence

•    nightmares

•    difficulty sleeping

•    a very slow pulse (less than 50 beats per minute)

•    diarrhoea

•    problems with vision

•    seeing things that aren't there

•    skin rash

•    dry eyes

•    increased levels of proteins found in the blood vessels called antinuclear antibodies

•    low blood pressure when you stand up (which causes dizziness and fainting)

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AMDIPHARM

•    low levels of potassium in the blood (which can cause muscle weakness, muscle twitching or abnormal heartbeat)

•    low levels of magnesium in the blood

•    low levels of sodium in the blood

•    low levels of chloride in the blood

•    increased levels of calcium in the blood

•    increased levels of uric acid in the blood

•    gout (a condition which causes pain, swelling and inflammation of one or more joints)

•    increased blood sugar levels

•    high cholesterol

Less common side effects include:

•    skin rashes

•    sensitivity to light

•    low levels of neutrophils in the blood (neutropenia)

•    reduction in blood platelets which increases the risk of bruising or bleeding

•    inflammation of the pancreas which causes severe stomach and back pain

•    a build up of bile in the liver

Pindolol/Clopamide Tablets may hide the symptoms of low blood sugar levels or an over active thyroid gland.

If any of the side effects becomes severe, or if you notice any side effect not listed in this leaflet, please tell you doctor or pharmacist immediately.

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 PINDOLOL/CLOPAMIDE TABLETS

Do not take Pindolol/Clopamide Tablets after the expiry date which is stated on the carton.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

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.    FURTHER INFORMATION

What Pindolol/Clopamide Tablets contain

Each Pindolol/Clopamide Tablets contains the active ingredients 10 mg pindolol and 5 mg clopamide.

The other ingredients are: magnesium stearate, maize starch and lactose.

What Pindolol/Clopamide Tablets look like and the contents of the pack

White, uncoated, round, flat, bevelled tablets, marked VISKALDIX on one side and with a score line on the other.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

They are packed in foil blister packs and are available in cartons of 28 tablets.

Marketing Authorisation Holder and Manufacturer

Amdipharm UK Limited Regency House,

Miles Gray Road,

Basildon, Essex. SS14 3AF.

This leaflet was last revised in October 2013.

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