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BISOPROLOL 10MG TABLETS

Active substance(s): BISOPROLOL FUMARATE / BISOPROLOL HEMIFUMARATE / BISOPROLOL FUMARATE / BISOPROLOL HEMIFUMARATE

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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

You 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.

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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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