In this leaflet:

1.    What Betim is and what it is used for

2.    What you need to know before you take Betim

3.    How to take Betim

4.    Possible side effects

5.    How to store Betim

6.    Contents of the pack and other information

1.    WHAT BETIM IS AND WHAT IT IS USED FOR Betim 10 mg Tablets are used to treat high blood pressure (hypertension) and chest pain (angina).

The tablets are also used to prevent a heart attack in those people who have already had one and in reducing the number of migraine attacks for those who suffer from migraine.

Betim Tablets belong to a group of medicines called beta-blockers which slow the heart rate and lower blood pressure, reducing the workload on the heart.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE BETIM

Do not take Betim if you:

■    Are allergic (hypersensitive) to timolol maleate or any of the other ingredients of Betim (these are listed in section 6, “Contents of the pack and other information”).

■    Have a history of wheezing or asthma.

■    Have chronic (long-term) breathing difficulties.

■    Have a certain type of chest pain called Prinzmetal’s angina.

■    Have uncontrolled heart failure.

■    Have been told that you have a slower than normal heart beat or a severe heart condition called cardiogenic shock.

■    Have any problems with your blood circulation.

■    Are taking medicines known as monoamine oxidase inhibitors that are used for depression.

■    Have a condition affecting your adrenal glands called phaeochromocytoma.

■    Have a condition that causes acidity of the blood called metabolic acidosis.

■    Have low blood pressure.

Warnings and Precautions

Tell your doctor before you start treatment if you have or have had in the past one of the following problems or if you develop any of these during treatment:

■    Any heart problems at all, including an abnormally slow heart rate.

■    Liver or kidney problems.

■    Diabetes. Betim may mask some of the usual signs that your blood sugar level is too low.

If you are on medication for diabetes, Betim could also increase the effectiveness of insulin or oral antidiabetic drugs so your dose of these may need to be changed.

■    The skin condition psoriasis.

■    Poor circulation in your legs or arms.

■    Any allergies (e.g. to pollen), as Betim may intensify your allergic reaction.

It is important to discuss these with your doctor because you may need to stop your treatment or have your dose changed.

Children

Betim 10 mg Tablets are not suitable for children.

Other medicines and Betim

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is very important because you should not use some other medicines while you are taking Betim. Also, certain other medicines can be used only if special precautions are taken.

In particular, tell your doctor or pharmacist if you are taking:

■    Any medicines for high blood pressure (e.g. clonidine or hydralazine).

■    Other medicines for heart problems (e.g. verapamil, disopyramide, lignocaine, tocainide, diltiazem, quinidine, amiodarone, nifedipine, digitalis glycosides (e.g. digoxin), or any of the medicines known as class I antiarrhythmic agents).

■    Other beta-blockers.

■    Medicines known as tricyclic antidepressants used for treating depression, or medicines known as phenothiazines used for treating other mental problems.

■    Medicines known as barbiturates used to treat sleeping disorders.

■    Medicines for treating diabetes (e.g. insulin and oral anti-diabetic drugs).

■    An anti-ulcer drug called cimetidine.

■    An antibiotic called rifampicin.

■    Medicines to improve circulation.

■    Medicines for breathing difficulties (e.g. salbutamol or isoprenaline).

■    Medicines for migraine known as ergot preparations.

■    Medicines known as prostaglandin synthetase inhibitors (e.g. ibuprofen, aspirin, indomethacin).

If you are going to have surgery

If you are going to have an operation in hospital or going to the dentist, tell the doctor at the hospital or the dentist that you are taking Betim Tablets. Your doctor may decide to stop Betim gradually before you have an anaesthetic such as ether, cyclopropane, trichloroethylene. You should not be given a local anaesthetic combined with adrenaline while you are taking Betim.

Taking Betim with food and drink

You should avoid excessive alcohol consumption while taking Betim.

Pregnancy and breast-feeding

You should not take Betim if you are pregnant. Therefore, tell your doctor before you start treatment if you are pregnant, think that you may be pregnant or intend to become pregnant.

Consult with your doctor immediately if you think that you have become pregnant during treatment with Betim.

Tell your doctor before you start treatment with Betim if you are breast-feeding or planning to breastfeed.

Driving and using machines

This medicine may cause tiredness or dizziness as a side effect.

Therefore you should be careful if you are going to drive or operate machinery.

3.    HOW TO TAKE BETIM

Your doctor will work out the right number of tablets for you. Always take Betim exactly as your doctor has told you.You should check with your doctor or pharmacist if you are not sure.

Swallow the tablet(s) with a glass of water.

The usual dose for adults is:

■    Half a tablet to three tablets twice a day for chest pains.

■    One to six tablets a day for high blood pressure.

■    Half a tablet to one tablet twice a day after a heart attack.

■    One to two tablets a day to prevent migraine attacks.

The tablet can be divided into equal doses.

If you are elderly the doctor will probably start with the lowest adult dose and then adjust your dose carefully, depending on how you respond to treatment.

Betim Tablets are not suitable for children.

Your doctor may change the number of tablets you take. This will depend on how well you respond to the treatment. Do not alter the number of tablets you are taking without checking with your doctor.

If you take more Betim than you should

If you or anybody else accidentally take more than the recommended dose of these tablets, call your doctor immediately or go to your nearest hospital casualty department.

If you forget to take Betim

If you forget to take your tablet(s), take the next dose as normal.

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

If you stop taking Betim

Do not stop taking the tablets without first consulting your doctor.

If it is right for you to stop taking the medicine then your doctor will probably reduce the dose gradually since it is important not to stop suddenly.

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

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Betim can cause side effects, although not everybody gets them.

Tell your doctor if you have any of the following problems:

■    Breathing difficulties or a worsening of asthma.

■    Slow heart beat or the heart slows so much that you faint, heart failure or other heart problems.

■    Cold or bluish hands and feet, low blood pressure, “pins and needles”, tingling in the hands or feet, a worsening of any problems with blood circulation in your legs or impotence (male erection problems).

■    Nausea (feeling sick), vomiting (being sick), diarrhoea or abdominal pain.

■    Dizziness or light headedness, vertigo or feeling faint, headaches, trouble with sleeping or nightmares.

■    Depression, hallucinations, drowsiness, disorientation, confusion or other mental problems.

■    Skin rashes, painful joints, visual disturbances or dry eyes.

■    Unusual tiredness or weakness.

■    Decreased urination or total inability to urinate.

Blood tests may show increased levels of antibodies.

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 BETIM

Keep Betim Tablets out of the reach and sight of children.

Do not use Betim after the expiry date which is stated on the bottle label and outer carton after the text “EXP”. The expiry date refers to the last day of that month.

This medicine requires no special storage conditions.

Medicines must 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.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Betim contains

Active substance: Timolol (as maleate). Each tablet contains 10 mg of timolol maleate.

Other ingredients: Microcrystalline cellulose, pregelatinised starch and magnesium stearate.

What Betim looks like and contents of the pack

Betim Tablets are white, flat circular tablets. Each tablet is engraved with “ _BV_T ” on one side and a breakmark on the other.

The tablets are supplied in amber glass bottles, or packs containing aluminium blister strips, of 30 or 100 tablets. Not all packs sizes may be marketed.

Marketing Authorisation Holder

Meda Pharmaceuticals Ltd.,

Skyway House, Parsonage Road, Takeley,

Bishop’s Stortford, CM22 6PU, UK

Manufacturer

Labiana Pharmaceuticals S.L.U., Casanova 27-31, 08757- Corbera de Llobregat (Barcelona), Spain.

For any information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 11/2013.

If this leaflet is difficult to see or read, or you would like it in a different format, please contact Meda Pharmaceuticals Ltd.,

Skyway House, Parsonage Road, Takeley, Bishop’s Stortford,

CM22 6PU, UK

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Studio Oberlander GmbH • Rubensstr. 33 • 60596 Frankfurt a. M. • Germany Phone: +49 69 631520-85 • Fax: -87 • E-Mail: info@studio-oberlaender.de

SPECIFICATION BOX: Leaflet		mock-up	ncDO
MANUFACTURER:	Meda Pharma GmbH & Co. KG	COLOURS USED:
PRODUCT:	Betim 10 mg		Black
	Tablets
MEDA-NO.:	56UK2037131-00
ITEM-CODE:	34830E0EU-E00
PHARMA-CODE:	30E0EUE
		COUNTRY:	United Kingdom
		LANGUAGE:	English
PACK SIZE:	135 x 260 mm	CORRECTION:	4.
FONT SIZE:	8 pt/ 9,5 pt	DATE:	18. 11. 2013

1013_GI_Betim_UK_Sonder_56UK2037131-00.indd 3 18.11.13 16:41