Celiprolol Hydrochloride 200mg Tablets
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
PACKAGE LEAFLET: INFORMATION FOR THE USER
CELIPROLOL HYDROCHLORIDE 200 mg TABLETS CELIPROLOL HYDROCHLORIDE 400 mg TABLETS
IN THIS LEAFLET:
1. What Celiprolol Hydrochloride is and what it is used for
2. Before you take Celiprolol Hydrochloride
3. How to take Celiprolol Hydrochloride
4. Possible side effects
5. How to store Celiprolol Hydrochloride
6. Further information.
1. WHAT CELIPROLOL HYDROCHLORIDE IS AND WHAT IT IS USED FOR
Celiprolol Hydrochloride belongs to a family of medicines known as beta-blockers. It is used to treat high blood pressure.
2. BEFORE YOU TAKE CELIPROLOL HYDROCHLORIDE
Do not take Celiprolol Hydrochloride if you:
• are allergic (hypersensitive) to Celiprolol Hydrochloride or any of the ingredients of the tablet (see section 6 Further information)
• have suffered an allergic reaction to a beta-blocker (propranolol, sotalol, timolol etc.) in the past
• suffer from an irregular/very slow heart beat (known as bradycardia) or low blood pressure (hypotension)
• suffer from heart failure which is not under control (heart failure is a condition in which your heart is not pumping blood as well as it should)
• suffer from missed heart beats (heart block) or other heart problems or you suffer from hardened arteries
• have severe kidney problems
• have acute and/or severe asthma or other severe breathing problems
• have a rare tumour called a phaeochromocytoma that is not being treated
• have abnormal levels of acid in your blood (metabolic acidosis), usually as a result of severe illness
• are already taking theophylline (an anti-asthma medicine).
Take special care and consult your doctor before taking Celiprolol Hydrochloride if you:
have liver or kidney problems (please see Section 3, How to take Celiprolol Hydrochloride) have Prinzmetal's angina (chest pain while resting)
have poor blood circulation e.g. Raynaud's , Burger's Disease. Your doctor will closely monitor you while taking this medicine
have inadequate circulation of blood through the coronary arteries. Your doctor will stop this medicine if you have ever had a skin condition known as psoriasis have a history of asthma or breathing problems
have a thyroid problem as the effects of an overactive thyroid gland (thyrotoxicosis) may be hidden by beta blocker medicine
need to have surgery and will be given an anaesethetic; tell your doctor, dentist or hospital staff have a history of severe allergies, including anaphylactic reactions
need anti-allergic treatment eg. following a wasp or bee sting; your doctor may wish to interupt your celiprolol treatment to prevent a possible allergic reaction
are diabetic. Patients with diabetes should be aware that the symptoms of low blood pressure (hypoglycaemia) may be hidden by beta blocker medicines
have heart failure that is under control with medication. Your doctor will give this medicine under strict medical surveillance have a slow or irregular heartbeat.
While taking Celiprolol Hydrochloride if you:
have any heart problems and your doctor wants to stop this medicine. The dose should be gradually reduced over 1-2 weeks, at the same time, if necessary, any replacement therapy for prevention of anginal attacks may be considered by your doctor.
Drug test in sport: Celiprolol may give a positive result if you have a blood or urine test to check for the presence of drugs.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Care is needed if you are taking:
• medicine to treat an abnormal heart rythym eg. Disopyramide, Quinidine, Amiodarone, Sotalol, Hydroquinidine, Ibulitide, Dafetilide, Propefenone
• other medicines to treat a heart condition or high blood pressure eg. Verapamil, Diltiazem, Nifedipine, Digitoxin, Digoxin, Alpha-methyldopa, Guanfacine, Reserpine or Clonidine. If you are taking clonidine and celiprolol together, you must not stop taking clonidine unless the doctor tells you to do so. Your doctor would stop celiprolol many days before clonidine is discontinued
• vasodilators such as glyceryl trinitrate (commonly known as nitroglycerin), isosorbide mononitrate and isosorbide dinitrate, sodium nitroprusside etc (used to treat hypertension, heart failure and angina)
• diuretics (“Water Tablets”) e.g. Chlorthalidone or Hydrochlorothiazide
• medicines used for treatment of mental depression known as monoamine oxidase inhibitors (MAOI) e.g. phenelzine, tranylcypromine, moclobemide and isocarboniazid.
• diabetic medicine e.g. insulin or oral anti-diabetic medicines (e.g. glibenclamide, metformin) blood sugar needs to be monitored closely
• noradrenaline or adrenaline (used for treatment of low blood pressure, heart failure, asthma or allergies). Noradrenaline and adrenaline are always given under medical supervision
• medicines such as phenylephrine, pseudoephedrine, phenylpropanolamine (contained in cough medicine or nose and eye drops). These medicines may counteract the effect of celiprolol
• medicines used for treating mental illnesses such as barbiturates, phenothiazines (e.g. chlorpromazine, trifluperazine), or most tricyclic antidepressants (e.g. imipramine, amitriptyline, clomipramine, desipramine).
• medicines such as ibuprofen, indomethacin (used to relieve from pain or inflammation)
• mefloquine (medicine used for the prevention and treatment of malaria)
• if you develop shock or low blood pressure due to floctafenine (medicine used to treat pain), celiprolol may reduce the effectiveness of medicines used to treat these conditions
Taking Celiprolol Hydrochloride with food and drink
If you take this medicine with food it may not work as well. Celiprolol Hydrochloride should be taken one hour before food or 2 hours after it. Do not drink alcoholic beverages until you have discussed their use with your doctor.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant, intend to become pregnant or currently breast-feeding.
If your doctor cannot find any safer alternative you may be given celiprolol. In the new born of treated mother, activity of these kind of medicines remains for several days. Therefore close monitoring of the neonate is recommended for the first 3 to 5 days of life.
If you are already taking Celiprolol Hydrochloride and have just found out you are pregnant, you should talk to your doctor immediately.
Driving and using machines
While using this medicine you may feel dizziness, fatigue as well as potentiation of side effects such as shaking, headaches or vision disturbances. If this happens, do not drive or use any tools or machines.
3. HOW TO TAKE CELIPROLOL HYDROCHLORIDE
Always take Celiprolol Hydrochloride exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
• Swallow the tablets whole with a glass of water.
• The tablets may be taken first thing in the morning, or one hour before food, or two hours after food.
• To help you remember to take your medicine, try to get into the habit of taking it at the same time each day.
Adults including the elderly - the usual starting dose is 200 mg of Celiprolol Hydrochloride once a day. If needed after 2 to 4 weeks, your doctor will increase your dose to 400 mg once a day.
If you have the impression that the effect of celiprolol tablets is too strong or too weak, talk to your doctor or pharmacist.
Adults with liver or kidney problems - if you have kidney problems, your doctor may give you a lower dose than stated above and increase it as needed. A reduction in dosage by half may be appropriate in patients with moderate impairment of kidney function (creatinine clearance in the range of 15-40 ml per minute). Celiprolol is not recommended for patients with severely impaired kidney function (creatinine clearance less than 15 ml per minute). Use of low doses of celiprolol is recommended in liver problems.
Children - Safety and effectiveness of celiprolol in children have not been established.
Elderly - Dosage as for adults.
If you take more Celiprolol Hydrochloride than you should, you may have symptoms such as slow heart beats, low blood pressure, difficulty in breathing or heart problems. Contact your doctor or go to the nearest
hospital causalty department immediately. Take this leaflet or some tablets with you so your doctor will know what you have taken.
If you forget to take Celiprolol Hydrochloride, do not worry and take them as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.
If you suddenly stop taking Celiprolol Hydrochloride
If you suddenly stop taking Celiprolol Hydrochloride your condition may worsen rapidly. Your doctor will reduce your dose slowly over a period of 7 to l0 days.
Take your tablets as directed and for as long as directed; do not stop them, even if you feel better, as otherwise the symptoms may return.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Celiprolol Hydrochloride can cause side effects, although not everybody gets them. Adverse reactions have been ranked under headings of frequency using the following convention:
Very common: Common: Uncommon: Rare:
Very rare:
Not known:
affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
frequency cannot be estimated from the available data
If any of the following happen, stop taking Celiprolol Hydrochloride and tell your doctor immediately, or go
to the casualty department or your nearest hospital:
• Allergic reaction may manifest as skin rash, hives, itching, tightness of the chest, shortness of breath or swelling of face, lips, hands / feet, fainting, high temperature.
• You get flu like symptoms, swollen or painful joints, increased sensitivity to sunlight, hair loss, abdominal pain, anaemia. This may mean you have a condition called Systemic Lupus Erythematosus (SLE). These symptoms will usually go away after celiprolol has been stopped.
These are very serious side effects. If you have them you may have had a serious allergic reaction to celiprolol.
You may need urgent medical attention or hospitalization.
Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
Commonly reported
• Dizziness or light headedness, weakness, or fainting especially when standing up from a lying position
• Fast, slow or irregular heart beat; pounding heartbeat.
Rarely reported
• Worsening of previously existing heart failure with swelling of hands, ankles or feet and difficulty in breathing after exercise, heart failure, cold and blue or purple coloration of hands and feet
• Lung disease with symptoms such as fever, chills, fatigue, breathlessness, chest tightness and cough, difficulty in breathing, shortness of breath especially in patients with asthma or history of asthma
• Allergic skin reactions such as itching, flush, rash, hives, unusual bleeding or bruising under the skin.
Not known side effects
• Worsening of previously diagnosed sugar diabetes (diabetes mellitus)
• Increased thirst, excessive urination, increased appetite, weight loss. This may be an undiagnosed case of sugar diabetes (diabetes mellitus) and may become apparent.
Medicines in this group may hide the symptoms like fast heart beat and shaking (these symptoms may appear in the presence of sugar diabetes and overactive thyroid gland).
Tell your doctor if you notice any of the following:
Commonly reported
• Headache, dizziness, excessive sleepiness, difficulty in sleeping, bad dreams, tremors (uncontrolled shaking)
• Coldness of hands or feet
• Nausea (feeling sick) or vomiting (being sick), pain and discomfort in the belly
• Muscle cramps, tiredness.
Rarely reported
• Depressed mood
• Pins and needles sensation
• Ringing in the ears
• diarrhoea (loose stools), constipation
• Muscle weakness
• Sexual inability in men, decrease sexual drive.
Very rarely reported
• Hallucinations (false or distorted sensory experiences that appear to be real perceptions. These sensory impressions are generated by the mind rather than by any external stimuli, and may be seen, heard, felt, and even smelled or tasted)
• Mood and behaviour changes
• Confusion
• Impaired vision, visual disturbances, dry eyes to be considered if patient uses contact lenses
• skin disease with thickened patches of red skin, often with silvery scales (psoriasis) or worsening of previously existing psoriasis
Not known side effects
• Temporary changes in skin colour (white to blue to red) and temperature (feels cooler) of hands and/or feet (known as Raynaud's phenomenon) or worsening of previously existing circulatory problems such as Raynaud's syndrome
• A cramp-like pain in one or both legs that develops on walking and may eventually cause a limp.
There may be changes in the results of certain laboratory tests
• Increase in Antinuclear antibodies (ANA)
• Increase in liver enzymes such as transaminases
• Blood test may also show abnormal levels of glucose in the blood.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CELIPROLOL HYDROCHLORIDE
Keep out of the reach and sight of children. Keep container in the outer carton.
Do not store above 25°C. Do not use Celiprolol Hydrochloride after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.
Medicines should not be disposed 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. FURTHER INFORMATION
What Celiprolol Hydrochloride contains:
• The active ingredient is 200mg or 400mg of Celiprolol Hydrochloride
• The other ingredient(s) are microcrystalline cellulose, mannitol, croscarmellose sodium, colloidal anhydrous silica and magnesium stearate.
The film-coating itself contains hypromellose and titanium dioxide (E171), with macrogol 400 and quinoline yellow (E104) in the 200mg tablets or with macrogol 4000 and lactose monohydrate in the 400mg tablets.
What Celiprolol Hydrochloride looks like and contents of the pack:
• Celiprolol hydrochloride 200 mg tablets are yellow coloured, capsule shaped, biconvex film-coated tablets, debossed with '200' on one side of the breakline and a deep breakline on the other side.
• Celiprolol hydrochloride 400 mg tablets are white coloured, capsule shaped, biconvex film-coated tablets, debossed with '400' on one side of the breakline and a deep breakline on the other side.
• Celiprolol hydrochloride tablets are available in packs of 10, 20, 28, 30, 50, 56 and 100 film-coated tablets in blister strips.
•
* Not all pack sizes may be marketed
Marketing Authorisation Holder
Ranbaxy (UK) Limited 5th floor, Hyde Park, Hayes 3 11 Millington Road Hayes, UB3 4AZ United Kingdom
Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87 2132JH, Hoofddorp The Netherlands
Alkaloida Chemical Company Zrt KabayJanosu.29 H-4440 Tiszavasvari Hungary
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This leaflet was last approved in June 2016.
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