Uniphyllin Continus 300 mg prolonged release tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• 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.
• You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

What is in this leaflet:

1. What Uniphyllin Continus tablets are and what they are used for
2. What you need to know before you take Uniphyllin Continus tablets
3. How to take Uniphyllin Continus tablets
4. Possible side effects
5. How to store Uniphyllin Continus tablets
6. Contents of the pack and other information

Do not take Uniphyllin Continus tablets if you:

• are allergic to theophylline, aminophylline or any of the other ingredients of the tablets (listed in section 6);
• have porphyria (a rare disease of the blood pigments).

Do not give to your child if they are under 6 months of age or if they are also taking a cough medicine or if they are less than 6 years of age (or less than 22 kg) and taking a decongestant containing ephedrine.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking these tablets if you:

• have an irregular heartbeat, high blood pressure or any other heart problems;
• experience worsening of chest symptoms e.g. breathlessness or cough;
• have an over or under-active thyroid gland (hyper/hypothyroidism);
• have a stomach ulcer;
• have liver problems;
• have cystic fibrosis;
• suffer from seizures, fits or convulsions;
• are unwell with a high temperature or fever;
• have a viral infection;
• are addicted to alcohol;
• are male and have difficulty in passing urine (for example due to an enlarged prostate gland);
• smoke, as smoking may alter the way your tablets work.

Other medicines and Uniphyllin Continus tablets

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including:

• certain other medicines to treat asthma or breathing conditions that contain theophylline, aminophylline, salbutamol, terbutaline or salmeterol, as you may need additional monitoring;
• steroids;
• diuretics to increase urine production;
• oral contraceptives;
• a herbal remedy called St John’s Wort (also known as Hypericum perforatum);
• aminoglutethimide, methotrexate or lomustine to treat cancer;
• carbamazepine or phenytoin to treat seizures, fits or convulsions;
• medicines known as barbiturates to help you sleep;
• adenosine, diltiazem, isoprenaline, mexiletine, propafenone, propranolol, verapamil or beta blockers to treat high blood pressure and other heart problems;
• regadenoson or dipyridamol used in heart problems;
• pentoxifylline to treat diseased blood vessels;
• medicines known as benzodiazepines, which are used as a sedative or to treat anxiety;
• aciclovir to treat Herpes viruses;
• sulphinpyrazone or allopurinol to treat gout;
• carbimazole to treat problems with your thyroid gland;
• cimetidine or nizatidine to treat stomach ulcers, indigestion or heartburn;
• certain antibiotics such as ciprofloxacin, clarithromycin, erythromycin, enoxacin;
• fluconazole to treat fungal infections;
• rifampicin or isoniazid to treat tuberculosis;
• ritonavir to treat HIV;
• medicines known as interferons, which you may be taking to treat conditions such as herpes, cancer, leukaemia or hepatitis;
• thiabendazole to treat worms such as threadworms;
• fluvoxamine or lithium to treat depression;
• doxapram to stimulate breathing;
• disulfiram to treat alcoholism;
• a cough medicine or decongestant containing ephedrine.

Also tell your doctor or pharmacist if:

• you are going to have an operation, as these tablets may interact with certain anaesthetics such as halothane and ketamine;
• you have recently had, or are going to have a flu injection.

Uniphyllin Continus tablets and alcohol

Alcohol can alter the way these tablets work. Please consult your doctor if you intend to drink alcohol whilst taking these tablets.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Adults

The recommended starting dose for adults is one 200 mg tablet every 12 hours. Your doctor may increase your dose to one 300 mg or 400 mg tablet every 12 hours, depending upon how you respond to treatment. If you are elderly your doctor may suggest a lower dose.

Different doses will also be required if you have certain other medical conditions. Your doctor may ask you to have regular blood tests to ensure you are taking the correct dose.

Use in children

Children over six years of age can take these tablets. The required dose will depend on their weight, age and the severity of their breathing problems. This should be discussed with your doctor, pharmacist or nurse.

Do not exceed the dose recommended by your doctor. Check with your doctor, pharmacist or nurse if you are not sure.

If you take more Uniphyllin Continus tablets than you should or if someone accidentally swallows your tablets

Call your doctor or hospital straight away. People who have taken an overdose may have stomach pains and feel or be sick (possibly vomiting blood). They may also have a fast or irregular heartbeat, low blood pressure, feel very restless, experience overactive reflexes or unusual muscle stiffness, have a fit or even go into a coma. These symptoms may appear up to 12 hours after the overdose. When seeking medical attention make sure that you take this leaflet and any remaining tablets with you to show the doctor.

If you forget to take Uniphyllin Continus tablets

If you remember within 4 hours of the time your tablet was due, take your tablet straight away. Take your next tablet at your normal time. If you are more than 4 hours late, please call your doctor or pharmacist for advice. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Uniphyllin Continus tablets

You will probably take these tablets for a long time. Do not stop taking them unless your doctor tells you to, even if you feel better.

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.

What Uniphyllin Continus tablets contain

The active ingredient is theophylline. Each tablet contains 200 mg, 300 mg or 400 mg of theophylline (as theophylline monohydrate).

The other ingredients are:

• Hydroxyethylcellulose
• Povidone
• Magnesium stearate
• Cetostearyl alcohol
• Macrogol
• Talc

What Uniphyllin Continus tablets look like and the contents of the pack

The tablets are white and capsule shaped.

The 200 mg tablets are plain on one side and marked “U200” on the other.

The 300 mg tablets are plain on one side and marked “U300” on the other.

The 400 mg tablets are marked “UNIPHYLLIN” on one side and “U400 NAPP” on the other.

In each box there are [8 or] 56* tablets.

(* The printed leaflet will refer to marketed pack sizes only. Note: this text relates to blister packed tablets only.)

Marketing Authorisation Holder and Manufacturer

The tablets are made by

for the marketing authorisation holder

This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line (free of charge) on:

0800 198 5000

You will need to give details of the product name and reference number.

These are as follows:

Product name: Uniphyllin Continus tablets

Reference number: 16950/0066