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Bisoprolol 10mg Tablets

Document: leaflet MAH BRAND_PL 20416-0300 change

PATIENT INFORMATION LEAFLET SOLOC 5mg and 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.


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.

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.

2. Before you take Soloc Tablets

You should only take this medicine if your doctor tells you to. Let your doctor know if you have a history of wheezing or asthma.

Do not take Soloc Tablets if:

•    You have heart problems such as irregular or slow heart beats, so called heart failure (swelling of your ankles), or 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

•    You suffer from 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 suffer from:

•    Heart failure (your doctor might want to change the pattern of treatment)

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

•    High blood pressure

•    A birth defect of the    heart or a disease    of the valves of the heart

•    Heart attack

•    Asthma or other breathing problems

•    Diabetes mellitus (sugar diabetes)

•    A history of allergies, including any for which you are undergoing desensitising treatment

•    Chest pain

•    A condition characterised by red, scaly patches on the skin (psoriasis)

•    An overactive thyroid gland

•    Severe kidney or liver disease

•    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

•    Moxisylyte, used for the treatment of erection problems

•    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.

Dosages stated below are guidelines only.

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

Soloc Tablets are usually well tolerated but, as with any medicine, people can experience different side effects, particularly when treatment is first started.

If you notice any of the side effects listed below or any not listed, please tell your doctor or pharmacist immediately. A small number of patients taking Soloc Tablets have reported skin rashes and/or dry eyes, which normally clears when patients stop taking Soloc Tablets. If you have these symptoms do not stop taking your Soloc Tablets unless told to do so by your doctor. Withdrawal must always be gradual.

The following side effects have been reported:

•    Sweating

•    Tired feeling in the legs that occurs during walking and is relieved by rest

•    Altered sensation such as tingling, pricking, or numbness of the skin

•    Discoloration of the fingers, toes, and occasionally other areas that usually occurs in response to cold temperatures or stress.

Very common: (affects more than 1 in 10 patients)

•    Very slow heartbeats seen in patients with severe heart failure.

Common side-effects (between 1 in 10 and 1 in 100 patients):

•    Feeling of coldness or numbness in the fingers or toes

•    Feeling unwell

•    Loose stools

•    Tiredness

•    Dizziness

•    Headache

•    Vomiting

•    Difficulty in passing stools

•    Fall in blood pressure

•    Weakness.

Uncommon-side effects (between 1 in 100 and 1 in 1000 patients):

•    Muscle weakness and cramps

•    Interference with the normal heart rate, slow heart rate

•    Worsening of pre-existing heart failure

•    Low blood pressure upon standing up

•    Sleep disturbances

•    Depression

•    Worsening of breathing problems.

Rare side-effects (less than 1 in 1,000 patients):

•    Nightmares

•    Hallucinations

•    Skin reactions (including itching, flushing, rash)

•    Inflammation of the liver and increase in liver enzymes on examination (you would notice a yellowing of the skin or the white of your eyes)

•    Increased blood levels of some fats

•    Problems with erection

•    Hearing loss

•    Runny nose

•    Dryness of the eyes

•    Loss of consciousness.

Very rare side-effects (less than 1 in 10,000 patients):

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

•    Disturbance with your vision

•    Red, scaly patches on the skin

•    Hair loss.

Do not be alarmed as most people take Soloc Tablets without any problems.

If you notice these or any other side-effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. How to store Soloc Tablets Keep out of reach and sight 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: 5mg of bisoprolol fumarate (Bisoprolol 5mg Tablets)

10mg of bisoprolol fumarate (Bisoprolol 10mg Tablets)

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).

Both strengths of Soloc Tablets are available in pack sizes of 28, 30, 56, 100 or 112 tablets.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. The information in this leaflet applies only to Soloc Tablets.


Crescent Pharma Limited

Units 3 & 4 Quidhampton Business Units

Polhampton Lane, Overton,

Hampshire RG25 3ED UK

This leaflet was revised in November 2014.