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Viskaldix Tablets

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Patient Information Leaflet    GB726-8287LF-AM01

Viskaldix® Tablets

Pindolol & Clopamide

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.



In this leaflet:

1.    What Viskaldix Tablets are and what they are used for

2.    Before you take Viskaldix Tablets

3.    How to take Viskaldix Tablets

4.    Possible side effects

5.    How to store Viskaldix Tablets

6.    Further information

1.    WHAT VISKALDIX TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Viskaldix Tablets.

Viskaldix contains the active ingredients 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).

Viskaldix is used to treat moderately high blood pressure (hypertension).

2.    BEFORE YOU TAKE VISKALDIX TABLETS Do not take Viskaldix Tablets if you:

   are allergic to pindolol or clopamide or any of the

other ingredients of Viskaldix (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)

Viskaldix is not recommended for use in children.

Take special care with Viskaldix if you:

•    have heart disease;

•    have recently had a heart attack;

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


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•    are diabeticand 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 Viskaldix, 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 Viskaldix.

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 belongs 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 anti-inflammatory drugs).

Taking Viskaldix with food and drink

It is advisable not to drink alcohol whilst taking Viskaldix as it may increase the effect of your medicine.

Pregnancy and breast-feeding Do not take Viskaldix 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 Viskaldix 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 Viskaldix Tablets

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


3.    HOW TO TAKE VISKALDIX TABLETS

Always take Viskaldix exactly as your doctor 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 Viskaldix than you should

If you take more Viskaldix 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 Viskaldix

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 Viskaldix

Ask your doctor before stopping treatment with Viskaldix, 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, Viskaldix 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 phenomena)

•    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


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•    increased levels of proteins found in the blood vessels called anti-nuclear antibodies

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

•    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

Viskaldix 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 your doctor or pharmacist immediately.

5.    HOW TO STORE VISKALDIX TABLETS

Do not take Viskaldix 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 Viskaldix Tablets contain

Each Viskaldix Tablet contains the active ingredients 10 mg pindolol and 5 mg clopamide.

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

What Viskaldix 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 August 2013


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PRODUCT NAME:

Viskaldix Tablets

PIP CODE:

GB726-8287LF-AM01

COMPONENT:

Leaflet

SIZE:

148 x 210mm

MARKET:

Great Britain

COMMODITY NO.:

TBC

PRODUCT SITE:

TBC

SCALE:

100%

COLOURS:

Black

DATE:

07/08/2013

FONT SIZE:

8 pt

VERSION NO:

1

AMENDED BY:

AM Co

PROJECT:

CNC

REGULATORY AUTHORITY APPROVAL CONFIRMATION

Confirmation that this artwork has been approved by the appropriate market authority (if applicable, e.g. MHRA, IMB, etc and that Amdipharm have license approval to distribute this component for sale in the relevent market.


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