CELIPROLOL HYDROCHLORIDE 200 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - CELIPROLOL HYDROCHLORIDE 200 MG TABLETS

5. how to store celiprolol

Keep out ot the sight and reach ot children
Do not take this medicine after the expiry date, which you will find on the pack
Do not store above 25°C
Ask you pharmacist how to dispose of medicines no longer required. Do not dispose of medicines by flushing down a toilet or a sink or by throwing out with your normal household rubbish. This will help to protect the environment.

If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do. ______________________________________________________

6. FURTHER INFORMATION

What celiprolol contains

Each tablet contains 200mg or 400mg of celiprolol hydrochloride as the active substance. Each tablet also contains mannitol, microcrystalline cellulose, croscarmellose sodium and magnesium stearate.

Film-coating;

Opadry Y-1–7000 (white) which contains hypromellose (E464), titanium dioxide (El 71) and polyethylene glycol

Opadry YS-1–7006 (clear) which contains hypromellose (E464) and polyethylene glycol

What celiprolol looks like and the contents of the pack

Celiprolol Hydrochloride 200 mg Tablets are white, heart shaped and engraved with ‚S‘ shape on one side, and ‚200‘ and a breakline on the other.

Celiprolol Hydrochloride 400 mg Tablets are white, heart shaped and engraved with ‚S‘ shape on one side, and ‚400‘ on the other.

Celiprolol tablets are supplied in blister packs of 28 tablets.

Product Licence Holder and Manufacturer

Product Licence Holder: Paragen Pharma Ltd, 43A Summerisland Road, Loughgall, Co. Armagh,

BT61 8LG, UK

Manufacturer: Sanofi Winthrop Industrie, 56 route de Choisy au Bac, 60205 Compiegne, France.

PL 49129/0003 PL 49129/0005

POM

Leaflet date 06 September 2018.

Blind or partially sighted? To request a copy of this leaflet in an alternative format please call 028 8778 4747 xxxxxx – 4 –

PATIENT INFORMATION LEAFLET

CELIPROLOL HYDROCHLORIDE 200MG AND 400MG 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 further questions, ask your doctor or your pharmacist.
This medicine has been prescribed for you. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this

leaflet, please tell your doctor or pharmacist.

Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect

In this leaflet:

1. What celiprolol is and what it is used for 4. Possible side effects
2. Before you take celiprolol 5. How to store celiprolol
3. How to take celiprolol _________________________6._______ Further Information ___________

1. what celiprolol is and what it is used for

What celiprolol is

The name of your medicine is Celiprolol Hydrochloride 200mg &400mg Tablets (called celiprolol throughout this leaflet). It contains a medicine called celiprolol hydrochloride.This belongs to a group of medicines called beta-blockers.

How celiprolol works

It works by slowing your heart rate or lowering your blood pressure.

Celiprolol can be used to

It is used to treat high blood pressure (hypertension). __________________________________________

2. BEFORE YOU TAKE CELIPROLOL

Do not take this medicine and tell your doctor if:

You are allergic (hypersensitive) to celiprolol or any of the other ingredients in this medicine (see Section 6: Further Information).

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

* You have or have had asthma or wheezing
You have a very slow heart beat (bradycardia)
You have heart problems — where you have difficulty breathing and swollen ankles
You have kidney problems
* You have a tumour of the adrenal gland (phaeochromocytoma) and your high blood pressure has not yet been treated with a type of medicine known as an alpha blocker, such as doxazosin or terazosin
You have low blood pressure (hypotension)
You have abnormal levels of acid in your blood (metabolic acidosis)

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking celiprolol.

Take special care and check with your doctor or pharmacist before taking celiprolol if:

You have any heart problems
* You have breathing problems due to long term lung problems (called bronchitis or emphysema)
You have diabetes
You have liver problems
* You have a tumour of the adrenal gland (phaeochromocytoma) and your high blood pressure is not yet controlled by a type of medicine known as an alpha blocker, such as doxazosin or terazosin
You have an overactive thyroid gland, as celiprolol can hide some symptoms associated with this condition
You have a history of severe allergies, including anaphylactic reactions
You have ever suffered from psoriasis
You suffer from a type of chest pain called Prinzmetal's angina.
You suffer from very poor circulation (such as Raynaud's disease). Symptoms include fingers and toes changing colour when cold and tingling or painful on warming up

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking celiprolol.

Operations or anaesthetics

Tell your doctor or dentist you are taking celiprolol if you are going to have an anaesthetic or an operation (including dental surgery).

Taking celiprolol with 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, including herbal medicines.This is because celiprolol can affect the way some other medicines work. Also, some other medicines can affect the way celiprolol works.

Tell your doctor if you are taking any of the following:

Insulin or tablets to treat diabetes
Medicines, including some cough or cold medicines, containing, ephedrine, pseudoephedrine or adrenaline.
Medicines used for mental problems (antipsychotic medicines) — such as chlorpromazine or other phenothiazines
Medicines used for asthma (such as theophylline)
Medicines for chest pain (angina) — such as verapamil, nifedipine and diltiazem
Medicines used for heart problems — such as lidocaine (also used as a local

anaesthetic) amiodarone, digitalis, diltiazem, disopyramide, nifedipine, quinidine and verapamil (also used for severe allergies)

Non-Steroidal Anti-inflammatory Drugs (NSAIDs) — used to relieve pain such as ibuprofen and indometacin
Medicines used to lower blood pressure — such as chlorthalidone, hydrochlorothiazide and clonidine
Medicines used for the prevention of malaria such as mefloquine
Medicines to treat depression called MAOIs (monoamine oxidase inhibitors) or have taken them in the last 2 weeks. MAOIs are medicines such as meclobemide, phenelzine or tranylcypromine.

If you are not sure, talk to your doctor or pharmacist before taking celiprolol.

Taking celiprolol with food and drink

* Celiprolol should be taken preferably first thing in the morning, 30 minutes before food or two hours after a meal.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.

If your doctor cannot find a safer alternative you may be given celiprolol. If you take celiprolol during pregnancy, particularly in the last 3 months, you should tell your midwife.This is because your baby may be affected when it is born. Any effects usually begin on the first day after birth and can include lower than normal levels of glucose in the blood (hypoglycaemia), slow heart beat, heart failure or having trouble breathing. If your baby has any of these side effects when it is born and you are worried, tell your doctor or midwife.

You should not breast-feed if you are taking celiprolol. This is because small amounts may pass into the mothers milk. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking this medicine.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.

Driving and using machines

You may feel tired or dizzy whilst taking celiprolol. If this happens, do not drive or use any tools or machines.

Drug Tests in sport

Celiprolol may give a positive result if you have a blood or urine test to check for the presence of drugs. . 2 –

3. how to take celiprolol

Always take celiprolol exactly as your doctor has told you. The dose of celiprolol will depend on your needs and the illness being treated. Check with your doctor or pharmacist before taking celiprolol.

Taking this medicine

Swallow the tablets whole with a drink of water
* Take the tablets preferably first thing in the morning, 30 minutes before food, or 2 hours

after a meal

* Take your medicine at the same time each day preferably first thing in the morning.

How much to take

Adults

The usual starting dose is 200mg once daily
The maximum dose is 400mg once daily.

Children

Celiprolol should not be given to children.

Elderly patients and patients with kidney problems

Your doctor may decide to lower your dose of celiprolol if necessary.

If you take more celiprolol than you should

Tell your doctor or go to the nearest hospital casualty department straight away. Remember to take with you any tablets that are left and the pack. This is so the doctor knows what you have taken. The following effects may happen: feeling dizzy or weak, difficulty breathing or wheezing.

If you forget to take celiprolol

If you forget to take a dose, take it as soon as you remember, unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose.

Stopping treatment

Keep taking your medicine until your doctor tells you to stop. Do not stop taking celiprolol just because you feel better. If you stop taking celiprolol, you illness may get worse. When your doctor says that you can stop taking celiprolol, you need to do this gradually. Your doctor will help you do this.

If you have any further questions about this medicine, ask your doctor or pharmacist. ______________

4. possible side effects

Like all medicines celiprolol can cause side effects, although not everybody gets them.

Stop taking celiprolol and see a doctor or go to a hospital straight away if:

* You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria).

This may mean you are having an allergic reaction to celiprolol

* 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 usually go away after celiprolol has been stopped.

Tell your doctor as soon as possible if you have any of the following side effects:

Pain in your chest and feeling weak or dizzy. These could be signs of a heart problem
Slow heart rate or very fast, uneven or forceful heartbeart (palpitations)
Feeling dizzy or weak. These could be signs of low blood pressure.
* Stomach pain and diarrhoea
* Difficulty sleeping (insomnia), drowsiness or nightmares
Feeling that you are losing touch with reality, or are unable to think or judge things clearly.

You may also feel more aggressive than usual. These could be signs of a serious mental health problem (psychoses)