Celiprolol is a vasoactive beta-1 selective adrenoceptor antagonist with partial beta-2 agonist activity. The beta-2 agonist activity is thought to account for its mild vasodilating properties. It lowers blood pressure in hypertensive patients at rest and on exercise. The effects on heart rate and cardiac output are dependent on the pre-existing background level of sympathetic tone. Under conditions of stress such as exercise, celiprolol attenuates chronotropic and inotropic responses to sympathetic stimulation. However, at rest minimal impairment of cardiac function is seen.

Celiprolol Hydrochloride belongs to a group of medicines called beta-blockers. It works by slowing your heart rate or lowering your blood pressure. It is used to treat high blood pressure (hypertension).

Adults including the elderly: the recommended 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. The maximum dose is 400 mg once a day. If you have the impression that the effect of Celiprolol Hydrochloride 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 Hydrochloride is not recommended for patients with severely impaired kidney function (creatinine clearance less than 15 ml per minute). Use of low doses of Celiprolol Hydrochloride is recommended in patients with liver problems.

Administration

Always take this medicine exactly as your doctor has told you. Swallow the tablets whole with a glass of water. Take the tablets preferably first thing in the morning, 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, preferably first thing in the morning.

Do not take Celiprolol Hydrochloride if you:

• are allergic to celiprolol hydrochloride or any of the ingredients of this medicine. Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• have suffered an allergic reaction to a beta-blocker (propranolol, sotalol, timolol etc.) in the past
• suffer from an irregular/very slow heartbeat (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), have an abnormal heart rhythm, difficulty breathing and swollen ankles
• suffer from missed heart beats (heart block) or other heart problems or you suffer from hardened arteries
• have severe kidney problems
• have, or have had, episodes of asthma, wheezing 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).
• have late stage peripheral arterial occlusive disease or Raynaud’s syndrome.

Serious side effects: Allergic reaction: a rash, swallowing or breathing problems, swelling of your face, lips, throat or tongue. 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 Hydrochloride has been stopped. These are very serious side effects. If you have them you may have had a serious allergic reaction to Celiprolol Hydrochloride. You may need urgent medical attention or hospitalization.

Common side effects (may affect up to 1 in 10 people): Dizziness or light headedness, weakness, or fainting especially when standing up from a lying position. These could be signs of low blood pressure. Skin rashes, excessive itching

Overdose Effects

You may have symptoms such as slow heart beats, low blood pressure, feeling dizzy or weak, difficulty in breathing, wheezing 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.

Take special care and consult your doctor before taking Celiprolol Hydrochloride if you:

• have liver or kidney problems
• have Prinzmetal’s angina (chest pain while resting)
• have poor blood circulation e.g. Raynaud’s, Burger’s Disease. Symptoms of Raynaud’s disease include fingers and toes changing colour when cold and tingling or painful on warming up. Your doctor will closely monitor you while taking this medicine.
• have inadequate circulation of blood through the coronary arteries.
• have ever had a skin condition known as psoriasis. Your doctor will stop this medicine if you have.
• have asthma or breathing problems due to long term lung problems (called bronchitis or emphysema)
• have a thyroid problem as the effects of an overactive thyroid gland (thyrotoxicosis) may be hidden by beta blocker medicine
• have a history of severe allergies, particularly to other medicines, including anaphylactic reactions
• need anti-allergic treatment eg. following a wasp or bee sting; your doctor may wish to interupt your Celiprolol Hydrochloride 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 any heart failure that is under control with medication. Your doctor will give this medicine under strict medical surveillance
• have a slow or irregular heartbeat.

Use in Special Populations

Use in children: Celiprolol Hydrochloride is not recommended for use in children.

Use in elderly: Your doctor may decide to lower your dose of Celiprolol Hydrochloride if necessary.