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Bisoprolol 10mg Tablets

Document: leaflet MAH BRAND_PL 17496-0026 change

PATIENT INFORMATION LEAFLET SOLOC 10mg TABLETS Bisoprolol Fumarate

Please read this leaflet carefully before you start to take this medicine.

Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.


In this leaflet:

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

2.    Before you take Soloc Tablets.

3.    How to    take Soloc Tablets.

4.    Possible side effects.

5.    How to    store Soloc Tablets.

6.    Further    information.

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

Bisoprolol belongs to a class of medicines called beta-blockers, which help slow the heart beat and relax blood vessels. This reduces blood pressure and the heart’s demand for oxygen, and makes the heart more efficient at pumping blood around the body.

Bisoprolol is used to treat the following conditions:

•    High blood pressure (hypertension)

•    Chest pain (angina): Bisoprolol helps prevent or reduce chest pains which may occur when your heart cannot get enough oxygen, such as when doing exercise

•    Stable heart failure. Bisoprolol is given as an additional treatment to other medications for heart failure.

2. Before you take Soloc Tablets

You should only take this medicine if your doctor tells you to.

Do not take Soloc Tablets if:

•    You have heart problems such as irregular or slow heart beats, have heart failure (swelling of your ankles) that suddenly becomes worse and/or may require hospital treatment, or have poor circulation (cramp in the legs or cold feet)

•    You have a condition in which your heart is unable to pump enough blood to the body

•    Y ou suffer from second or third degree heart block and do not have a pacemaker

•    You suffer from low heart rate or your heart rate is abnormal because of a condition known as sick sinus syndrome

•    You have a history of breathing difficulties or wheezing, asthma or other lung disorders

•    You have or have had an allergic reaction to Bisoprolol or any of its ingredients

•    You have poor circulation, resulting in discoloration of the fingers due to lack of blood supply (Raynaud's phenomenon)

•    You have unusually low blood pressure

•    You suffer from a tumour of a gland situated on top of the kidney (pheochromocytoma)

•    You suffer from a condition in which your blood becomes acidic (metabolic acidosis).

Take special care with Soloc Tablets and tell your doctor if:

•    You have heart failure (your doctor might want to change the pattern of treatment)

•    You have a condition of the heart (ischaemic heart disease) characterized by reduced blood supply to the heart muscle

•    You have a birth defect of the heart or a disease of the valves of the heart

•    You have had a heart attack within the last 3 months

•    You have a rare form of heart muscle disease (restrictive cardiomyopathy)

•    You have first degree heart block

•    You have    asthma or other breathing problems

•    You have    diabetes mellitus    (sugar diabetes)

•    You are fasting

•    You have a history of allergies, including any for which you are undergoing desensitising treatment

•    You have    chest pain

•    You have a condition characterised by red, scaly patches on the skin (psoriasis)

•    You have an overactive thyroid gland

•    You have severe kidney or liver disease

•    You have myasthenia gravis (characterized by muscle weakness, weakness of facial muscles including the eye muscles and difficulty in swallowing).

When taking other medicines

Please inform your doctor or pharmacist if you are taking, or have recently taken any other medicines,

even those bought without a prescription or herbal preparations. You can take Soloc Tablets with other medicines but there are some medicines, which can interfere with its actions, in particular, any of the

following medicines:

•    Verapamil, Clonidine, Moxonidine, Rilmenidine, Felodipine, Amlodipine, Diltiazem, Methyldopa used for the treatment of high blood pressure

•    Disopyramide, Quinidine, Lidocaine, Flecainide, Propafenone and Amiodarone used for the treatment of irregular heart beat

•    Eye-drops used for the treatment of glaucoma (increased pressure in the eyes)

•    Medicines used for the treatment of diabetes e.g. insulin and other oral antidiabetic medicines

•    General anaesthetics

•    Digitalis, Isoprenaline and dobutamine for heart problems.

•    Medicines for depression e.g. tricyclic antidepressants, monoamine oxidase inhibitors (e.g hydralazine) or phenothiazines

•    Non-steroidal anti-inflammatory drugs (NSAIDs) used for the treatment of swelling and inflammation

•    Barbiturates used for sedation and to induce sleep

•    Mefloquine, used for the treatment and prevention of malaria

•    Rifampicin used for the treatment of infections

•    Adrenaline, noradrenaline used to treat hypersensitivity reactions and to restore cardiac rhythm in cardiac arrest

•    Phenytoin used to treat seizures

•    Ergotamine derivatives used to treat migraine attacks.

Surgery

Soloc Tablets may react with certain anaesthetics, so in the event you need any form of surgery, you should tell the medical staff at the hospital that you are taking Soloc Tablets.

Pregnancy and breast-feeding

If you are pregnant or think you could be pregnant or you are breast-feeding, you should not take Soloc

Tablets unless necessary. You should consult your doctor.

Driving or using machines

Your ability to drive or operate machinery may be impaired, especially if you have drunk alcohol, particularly during the first few weeks of treatment. If this happens, do not drive or operate machinery.

Ask your doctor for advice before you drive or operate machinery.

3. How to take Soloc Tablets

Always take Soloc Tablets as instructed by your doctor. You should ask your doctor or pharmacist if you are unsure about anything.

Soloc Tablets are for oral use only. They should be taken in the morning, before, with or after breakfast. Swallow the tablets with some water and do not chew or crush them.

Dosages stated below are guidelines only.

Treatment of hypertension or angina

The usual dosage for adults is: 10mg once daily. Your doctor may decide to increase or decrease the dose.

Maximum dose: 20mg once daily.

Treatment of stable heart failure

Before you start using this medicine you should already be taking other medicines for heart failure including an ACE-inhibitor, a diuretic and (as an added option) a cardiac glycoside.

Your doctor will gradually increase your dose of this medicine until the dose that is suitable for you has been found.

The usual dose for adults and the elderly is:

1.25mg once daily for 1 week. If this is well tolerated, the dose may be increased to:

2.5mg once daily during the next week. If this is well tolerated, the dose may be increased to: 3.75mg once daily during the next week. If this is well tolerated, the dose may be increased to:

5mg once daily during the next 4 weeks. If this is well tolerated, the dose may be increased to: 7.5mg once daily during the next 4 weeks. If this is well tolerated, the dose may be increased to: 10mg once daily as a maintenance dose.

Maximum dose: 10mg once daily.

The doctor will determine the most suitable dose for you based on your tolerance to bisoprolol and side effects.

Your heart rate and blood pressure will be monitored closely as the dose is increased.

Patients with liver or kidney problems

Your doctor will take extra care when adjusting the dose of this medicine.

Maximum dose: 10mg once daily.

Do not stop taking Soloc Tablets unless told to do so by your doctor.

Your doctor will reduce your dose gradually whilst monitoring your blood pressure before they recommend stopping your medication.

Bisoprolol is not recommended for use in children.

If you forget to take Soloc Tablets take it when you remember, but if it is near to the time your next dose is due then take your normal dose as per normal. Do not take twice the normal dose.

If you take more Soloc Tablets than the recommended dose seek medical help immediately.

4. Possible side effects

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

If you have any side effects do not stop taking your medicine unless told to do so by your doctor. Withdrawal must always be gradual.

If you notice any of the side effects listed below tell your doctor immediately:

• Worsening of pre-existing heart failure causing increased breathlessness and/or fluid retention.

The following side effects have also been reported:

Very common: (may affect more than 1 in 10 people)

•    Slow heartbeat (seen in patients with severe heart failure).

Common (may affect up to 1 in 10 people):

•    Feeling of coldness or numbness in the fingers or toes

•    Feeling or being sick, diarrhoea, constipation

•    Tiredness

•    Dizziness, headache

•    Low blood pressure (especially in patients with heart failure)

•    Weakness (in patients with heart failure).

Uncommon (may affect up to 1 in 100 people):

•    Muscle weakness and cramps

•    Interference with the normal heart rate, slow heart beat (in patients with high blood pressure or angina)

•    Sleep disturbances

•    Depression

•    Breathing problems (in patients with asthma or a history of obstructive airways disease)

•    Weakness (in patients with high blood pressure or angina).

Rare (may affect up to 1 in 1,000    people):

•    Nightmares, hallucinations

•    Allergic reactions (including    itching, flushing, rash)

•    Inflammation of the liver (symptoms are yellowing of the skin or the white of your eyes, loss of appetite, stomach discomfort, pale stools and dark urine), increase in liver enzymes on examination

•    Increased    blood levels of some fats

•    Problems    with erection

•    Hearing problems

•    Runny nose caused by swelling and irritation inside the nose

•    Dryness of the eyes (may be troublesome if you use contact lenses)

•    Fainting.

Very rare (may affect up to 1 in 10,000 people):

•    Inflammation, redness and watering of the eyes (conjunctivitis)

•    Red, scaly patches on the skin or worsening of psoriasis

•    Hair loss.

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 Soloc Tablets Keep out of sight and reach of children.

Do not store above 25°C.

On the carton you will find the letters ‘Expiry Date:’ followed by some numbers. These numbers are the date when the medicine is to be used before. Do not take this medicine after this date, it should be returned to your pharmacist.

6.    Further information

What Soloc Tablets contain:

Active substance:

10mg of bisoprolol fumarate

Other ingredients:

Maize starch, microcrystalline cellulose, crospovidone, calcium hydrogen phosphate, magnesium stearate and colloidal silica.

The tablet coating contains:

Hypromellose, macrogol 6000, dimeticone, iron oxide (E172), and titanium dioxide (E171).

Soloc Tablets are available in pack sizes of 28, 30, 56, 100 or 112 tablets. Not all pack sizes may be marketed.

Marketing authorisation holder

Dalkeith Laboratories Ltd, 2 Park Street, Woburn, Bedfordshire, MK17 9PG, UK

Manufacturer:

Crescent Pharma Limited

Units 3 & 4 Quidhampton Business Units

Polhampton Lane, Overton,

Hampshire RG25 3ED UK

This leaflet was revised in August 2016.