BISOPROLOL 10MG TABLETS

Active substance: BISOPROLOL HEMIFUMARATE

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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.

Marketing Authorisation Holder & Manufacturer:
The Co-operative Pharmacy National Distribution Centre Limited
Enterprise Way
Meir Park
Stoke on Trent
ST3 7UN
UK
This leaflet was revised in March 2012.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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